Top 10 Pharmaceutical Companies by Revenue and Market Cap in 2025 (September Edition)
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| Credit: fiercepharma.com |
Lilly—boosted by sales of its diabetes and obesity drugs Moujaro and Zepbound—projects its sales to fall between $58 billion and $61 billion. At the midpoint of the projection, it would be a 32% increase, matching the sales boom it saw last year. Meanwhile, Novo—which also has been powered by sales of its diabetes and obesity treatments—is projecting sales to increase by a range of between 16% and 24%.
Top 10 Pharmaceutical Companies by Revenue
1. Johnson & Johnson
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| For 2025, Johnson & Johnson projects overall sales growth of roughly 4% to $92 billion. Johnson & Johnson |
- 2024 revenue: US$88.8 billion (pharmaceutical segment, $57.07 billion and MedTech division, $32 billion)
- 2025 First-Quarter reported sales growth of 2.4% to $21.9 Billion
- 2025 Second-Quarter reported sales growth of 5.8% to $23.7 Billion (jnj.com)
- Headquarters: New Brunswick, New Jersey
Through these developments—and even more now in the wake of them—the company has remained focused on its innovative drug business. Thanks to new approvals and future label expansions, the company has projected that its innovative medicines business can deliver annual growth of 5% to 7% from 2025 to 2030.
Of J&J’s $88.8 billion in global sales last year, its innovative medicines group delivered annual sales of nearly $57 billion. Its medtech division, meanwhile, pulled down nearly $32 billion. Both groups delivered sales growth of 4% to 5% compared with 2023.
Related: The top 10 drugs losing US exclusivity in 2025
For 2025, J&J projects overall sales growth of roughly 4% to $92 billion. To get there, the company expects to fight “headwinds associated with U.S. biosimilar entries for Stelara,” CEO Joaquin Duato told analysts on an earnings call in January. California's Amgen launched the Stelara biosimilar onslaught at the start of the year, and, since then, several other copycats have entered the market. More are on the way, so J&J is bracing for sales of its megablockbuster immunology medicine to continue to decline. Last year, Stelara’s sales declined by 4.6% to about $10.4 billion.
In addition to the Stelara biosim pressure, the company is anticipating some challenges from a Medicare Part D redesign in the U.S. and macroeconomic factors in China, Duato informed analysts during the January earnings call.
On the flip side, J&J says it has 10 or more medicines that could generate more than $5 billion in peak-year sales. This list includes multiple myeloma drugs Talvey, Tecvayli and investigational oral medicine icotrokinra. Another 15 assets—or more—could generate between $1 billion and $5 billion at peak, including depression spray Spravato.
In all, J&J expects to deliver 70 new products or label expansions (or the associated regulatory filings for these expansions) by 2030, according to its Enterprise Business Review presentation (PDF) in 202
“I cannot think of any other company that would be able to deliver growth through the first year of losing exclusivity of a multibillion-dollar product,” Duato said on January’s call. “We are able to achieve these results because of the diversification of our business, the strength of our commercial assets, as well as the breadth of our pipeline, with additional launches in 2025, including Tremfya in [inflammatory bowel disease], Rybrevant and Lazcluze in lung cancer, and Varipulse and the Dual Energy Thermocool Smarttouch SF catheter in electrophysiology.”
Related: J&J launches AI surgery funding competition with Nvidia, AWS
2. Roche
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| Last year, Roche's sales grew 3% to about 60.5 billion Swiss francs, including 46.2 billion Swiss francs from the pharma division. trabantos/Getty Images |
- 2024 revenue: US$75.2 billion (60.5 billion Swiss francs, CHF)*
- 2025 First-Quarter reported sales growth of 6% to US$18.7 Billion (CHF 15.4 billion)
- 2025 H1 group sales: US$33 billion.
- Roche’s reported group sales for the first half (H1) of 2025 reached CHF 30.9 billion, representing a 7% increase at constant exchange rates. Converting this to USD, considering currency exchange impacts and market discussions around the Swiss franc’s strength against the US dollar, the approximate equivalent of the H1 2025 group sales would be close to $33 billion USD.
- Price-to-Sales (P/S) ratio: 262.9/73.6 = 3.57
- Headquarters: Basel, Switzerland
If one were to name 2024’s star pharmaceutical products beyond the GLP-1s, Roche’s eye injection Vabysmo would likely be on the list. First approved by the FDA in January 2022 as a competitor to Bayer and Regeneron’s Eylea, Vabysmo already reached 3.86 billion Swiss francs (about $4.5 billion) of sales in 2024.
The VEGFxAng-2 bispecific antibody became even more competitive last year by offering a more convenient single-dose prefilled syringe option.
The rise of Vabysmo pushed the checkpoint inhibitor Tecentriq off Roche’s top three medicines list by sales.
Then, a few months later, Roche said the closely watched Skyscraper-01 trial of its TIGIT antibody tiragolumab failed to show an overall survival benefit when combined with Tecentriq in first-line PD-L1-high non-small cell lung cancer, despite an earlier positive signal.
Given the importance of the indication, the trial failure pushed the entire TIGIT idea—once billed as the potential next big immune checkpoint target after PD-1/L1—ever closer to its graveyard. Bristol Myers Squibb, Merck & Co. and, most recently, BeiGene, have all ditched TIGIT, although Roche still has a few ongoing phase 3 trials that are fully enrolled.
Also in cancer immunotherapy, Roche last year struck a $1.5 billion deal to purchase its then-partner Poseida Therapeutics, giving the cell therapy field a much-needed injection of confidence. The deal brought to Roche an allogeneic cell therapy platform, which includes a gene editing tool that allows for the delivery of multiple CARs in a single step.The Poseida buy also strengthened Roche’s flourishing hematology portfolio. Its hemophilia drug Hemlibra grew sales by 12% at constant exchange rates, reaching 4.5 billion Swiss francs last year. Diffuse large B-cell lymphoma (DLBCL) antibody-drug conjugate Polivy crossed the blockbuster threshold with 1.1 billion Swiss francs in 2024. Its two CD19xCD3 bispecifics, Columvi and Lunsumio, are anticipated to receive an FDA decision and a phase 3 readout, respectively, in second-line DLBCL this year.
Roche also bought a portfolio of CDK inhibitors from China’s Regor Pharmaceuticals last year for $850 million upfront. What’s more, two important phase 3 trials of the company’s oral SERD, giredestrant, could read out this year.
3 . Merck
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| In 2024, Merck generated global sales of $64.2 billion, a 7% increase from the prior year. Merck & Co. |
- 2024 revenue: $64.2 billion
- 2025 First-Quarter reported sales growth of -2% (compared to the same period in 2024) to USD $15.5 Billion
- 2025 Second-Quarter reported sales: USD $15.8 Billion
- Price-to-Sales (P/S) ratio: 206.3/64.2 = 3.21
- R&D Spending 2024: $17.9 billion
- Headquarters: Rahway, New Jersey
During its fourth-quarter earnings report in February 2025, Merck said it was halting Gardasil shipments to China as the company and its local distribution partner, Zhifei, had been experiencing lower-than-expected demand in the key market. The company further pulled its $11 billion long-term sales target for the HPV shot, its second-biggest product by revenue behind Keytruda.
All told, Gardasil sales fell 3% last year to $8.6 billion.
On the flip side, sales of Merck's megablockbuster checkpoint inhibitor Keytruda climbed 18% last year to $29.48 billion.
While Merck has long enjoyed the booming success of Keytruda, including securing a 40th U.S. indication last year, the drug's trajectory will eventually change. And it’s not just generics waiting around the corner: In a recent securities filing, Merck said it expects the U.S. government to select Keytruda for Inflation Reduction Act (IRA) "government price setting" in 2026. After a two-year process, the new negotiated prices for Medicare would take effect at the start of 2028.
“As a result, U.S. sales of Keytruda will decline after that time," the company explained in its annual report."
Merck halts Gardasil shipments to China, withdraws $11B sales target as demand nosedives. Besides the IRA process, Merck lists 2028 as the expiration of Keytruda’s “key patent protection.” Together, Keytruda and Gardasil were responsible for roughly 59% of Merck’s annual sales in 2024. With both products facing future uncertainties, Merck execs have been busy figuring out the company’s growth path for the years to come. On Merck’s fourth-quarter earnings conference call, CEO Robert Davis said the company has been “very focused from a business development perspective, with nearly $40 billion invested in the last 3.5 years across really a diverse set of assets that have built out the pipeline.”
After Merck’s Acceleron buyout, one drug getting a significant amount of attention at the New Jersey drug giant is Winrevair. The pulmonary arterial hypertension therapy scored its initial FDA nod in 2024 and is carrying blockbuster expectations.
Going forward, business development deals worth up to $15 billion are in the company’s “sweet spot,” Davis added on the February conference call. The company is eyeing a range of investigational and commercial opportunities, he said.
In 2024, Merck generated global sales of $64.2 billion, a 7% increase from the prior year. The company has set a somewhat cautious tone for 2025, expecting its sales this year to land between $64.1 billion and $65.5 billion. Even at the high end of the range, the growth rate would be just 2%.
4. AstraZeneca
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| AstraZeneca’s stock price reached an all-time high last year. AstraZeneca |
- 2024 revenue: $54.1 billion
- 2025 First-Quarter Revenue: US$13.6B (up 10% from 1Q 2024)
- 2025 Second-Quarter Revenue: US$14.5B
- Price-to-Sales (P/S) ratio: 220.4/54.1 = 4.07
- Headquarters: Cambridge, U.K.
By full-year numbers, AstraZeneca had one of the best 2024 among Big Pharma companies. Its 2024 revenue of $54.1 billion marked an impressive 18% increase year over year, fueled by the likes of SGLT2 inhibitor Farxiga, Sanofi-partnered respiratory syncytial virus prevention drug Beyfortus, blood cancer drug Calquence and Daiichi Sankyo-partnered antibody-drug conjugate Enhertu. The British drugmaker’s stock price even reached an all-time high last year.
AstraZeneca stole the show at the largest cancer conference (ASCO 2025). AstraZeneca had an impressive slate of top-level plenary talks geared toward using drugs earlier on for breast, gastric, and lung cancer survival.The biggest splash was from AstraZeneca's drug Imfinzi (durvalumab), which trains a patient's body to attack a protein in their cancer. Imfinzi's already routinely used in some late-stage, recurrent and metastatic cancers (in the treatment of solid lung and liver tumors, for example), but it hasn't been a go-to treatment for earlier-stage cancers.
The results from the company's late-stage phase-3 "Matterhorn" trial (NEJM 2025) presented at the conference, Imfinzi, taken with chemo after surgery, boosted gastric cancer patients' two-year survival rates from 70% (without the immunotherapy) to nearly 76% — a significant jump.
However, investigations into the company’s Chinese operations cast a shadow over AZ’s overall performance toward the end of the year. Chinese authorities have detained AZ’s then-China president, Leon Wang, and the probes are reportedly centered on the alleged illegal importation of Enhertu and the cancer immunotherapy Imjudo from Hong Kong to the mainland as well as improper collection of patient data.
After logging double-digit quarterly sales growth in China in the first nine months of 2024, AZ instead posted a 3% decrease at constant exchange rates in the country in the fourth quarter. Rather than the ongoing investigation, AZ attributed the decline to “year-end hospital ordering dynamics” of Tagrisso and Farxiga, plus lower demand for its respiratory medicines because of a mild infection season.
Despite China’s weak contribution, AZ’s overall four-quarter revenue still jumped 25% at constant exchange rates.
AZ’s biggest product, Farxiga, saw sales up an impressive 29% last year to reach $7.7 billion. The drug is, however, slated to take a mandatory price cut under the Inflation Reduction Act (IRA) in 2026.
The EGFR inhibitor king, Tagrisso also managed a 13% sales growth to $6.6 billion with two new FDA approvals last year, one in combination with chemotherapy in first-line EGFR-mutated non-small cell lung cancer and the other for stage 3 EGFR lung cancer. But the drug is facing competition from Johnson & Johnson’s cocktail of Rybrevant and Lazcluze.
Related: AstraZeneca, facing lung cancer challenge from J&J, touts life-extension benefit for Tagrisso combo
While locked in a fierce competition with BeiGene’s rival BTK inhibitor Brukinsa, Calquence was included in the second round of IRA price negotiations.
Following mixed phase 3 data and an FDA resubmission, AZ and Daiichi have in January 2025 won the FDA’s go-ahead for their second ADC, TROP2-directed Datroway, in HR-positive, HER2-negative breast cancer.
In a new approval in 2024, AZ’s Alexion picked up an FDA nod for the factor D inhibitor Voydeya as an add-on therapy to treat paroxysmal nocturnal hemoglobinuria patients with extravascular hemolysis.
On the dealmaking front, AZ last year inked a $2 billion buyout of radiopharmaceuticals specialist Fusion Pharmaceuticals. AZ also paid CSPC Pharma $100 million upfront for a preclinical candidate targeting lipoprotein (a), which has also attracted the interest of Eli Lilly and Merck & Co.
For 2025, AZ doesn’t expect the same level of growth it saw in 2024, instead projecting revenue to increase by a high single-digit percentage at unchanged exchange rates. Part of that is the result of pressure from the Medicare Part D redesign that just went into effect this year, along with the U.S. loss of exclusivity of blood thinner Brilinta. With several key readouts anticipated throughout 2025, AZ believes it will have a good sense as to whether it can reach the $80 billion-by-2030 revenue target CEO Pascal Soriot outlined in 2024.
Related:- Ticagrelor doubts: inaccuracies uncovered in key studies for AstraZeneca’s billion dollar drug (BMJ 2025)
- Zegfrovy (Sunvozertinib) from Dizal: US FDA OKs First-of-Its-Kind Lung Cancer Pill (July 2025)
5. Pfizer
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| Pfizer bounced back after COVID-related fluctuations sent sales spiraling in 2023. Pfizer |
- 2024 revenue: $63.6 billion
- 2025 First-Quarter reported sales growth of -8% (compared to the same period in 2024) to USD $13.7 Billion
- 2025 2nd-Quarter reported sales growth of 10% (compared to the same period in 2024) to USD $14.7 Billion
- Headquarters: New York City
- Pfizer Inc., the U.S.-based multinational pharmaceutical company, is listed on the New York Stock Exchange (NYSE) under the ticker symbol PFE. Its Indian subsidiary, Pfizer Limited, is listed on the Bombay Stock Exchange (BSE) under the security code 500680 and on the National Stock Exchange of India (NSE) under the symbol PFIZER.
The past few years for Pfizer have reflected both high highs and low lows as the company’s COVID-19 products reacted to inconsistent demand. The company seems to have emerged from the choppy waters on solid ground as it ended 2024 with a clutch of new products sweetening its revenue pot.
A significant change to Pfizer’s 2024 revenue was new earnings from its $43 billion Seagen buyout, which wrapped up at the end of 2023 and added four established oncology drugs and a major pipeline upgrade. In reporting its 2024 revenue, the company opted to retroactively add sales from the Seagen medicines to its 2023 bottom line, reflecting a more accurate growth rate in comparing the two years.
With Seagen’s products and the $3.4 billion they earned included, the New York-based drugmaker's revenues had a 7% growth spurt. Taking out sales from COVID-19 antiviral Paxlovid and BioNTech-partnered vaccine Comirnaty, that figure jumps to a 12% sales increase.
It’s a welcome return to growth for Pfizer after COVID products in 2023 prompted an overall revenue decline of more than 40%. The company now finds itself firmly back on track, with revenue volatility “largely in the past” as COVID-related uncertainties have “diminished,” Pfizer declared in its earnings presentation (PDF).
In 2024, however, those uncertainties played out largely in Pfizer’s favor with surprise revenue boosts for Comirnaty and Paxlovid. Both pulled around $5 billion in sales, which was down for Comirnaty compared to 2023 but a boost on Paxlovid’s end. Usage of the antiviral is in line with COVID-19 burden and the ebb and flow of infection rates, the company pointed out, demonstrating the “sustainability” of the two-product COVID portfolio.
As for the company’s other vaccines, respiratory syncytial virus vaccine Abrysvo was negatively impacted by narrowed vaccine recommendations from the Centers for Disease Control and Prevention. The agency flipped on its previous recommendation for all adults aged 60 and older to instead recommend the vaccine for people 75 years and older and those aged 60 to 74 with a higher risk of severe disease. A decline in vaccination rates due to the shrunken U.S. market played a part in Abrysvo sales falling 62% during 2024’s fourth quarter, Pfizer said, although the shot picked up $890 million in yearly sales.
Meanwhile, Pfizer’s long-dominant pneumococcal vaccine franchise, Prevnar, saw relatively flat sales over the year but could face trouble on the horizon with Merck and its 21-serotype Capvaxive eager to edge in on Prevnar’s turf.
6. AbbVie
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| AbbVie's fast-growing immunology duo Skyrizi and Rinvoq is more than making up for the company's sinking Humira sales. AbbVie |
- 2024 revenue: $56.3 billion
- 2025 First-Quarter Revenue: US$13.3B (up 8.4% from 1Q 2024).
- 2025 Second-Quarter Revenue: US$15.4B (up 8.4% from 1Q 2024).
- Price-to-Sales (P/S) ratio: 337.7/56.3 = 5.99
- Headquarters: North Chicago
Together, Skyrizi and Rinvoq pulled in upward of $17 billion in 2024 sales, more than making up for Humira’s 37.6% sales dip to $8.9 billion with both Skyrizi and Rinvoq each achieving individual sales growth of more than 50%.The drugs, which both first hit the market in 2019, were central to AbbVie’s plan for success in its post-Humira operations. Still, it took the pair a few quarters to pick up enough steam to live up to Humira’s sales dominance. After creeping up behind Humira in sales for several quarters, Skyrizi finally eclipsed its predecessor in October, officially snatching the top sales crown with its $3.2 billion quarterly haul. Skyrizi holds biologic share leadership in approximately 30 countries and boasts a “best-in-class profile” that presents a “very high bar” for rivals, AbbVie's chief commercial officer Jeffrey Stewart said on a company earnings call. Skyrizi added a key ulcerative colitis indication to its belt in June, which, together with its prior Crohn’s disease nod, allows the drug to treat both forms of inflammatory bowel disease (IBD). Rinvoq, too holds indications for both forms of IBD.
The duo’s showing in IBD prompted AbbVie to crank up its 2027 sales projection for the meds to a combined $31 billion, making for a $4 billion increase to its previous guidance. Out of that $4 billion, $2 billion goes to Skyrizi’s estimated sales in IBD and $500 million was added to Rinvoq’s in the same indication.
The company expects Skyrizi will bring in $20 billion in 2027 and Rinvoq’s sales will hit $11 billion. That $31 billion total is more than Humira, Skyrizi and Rinvoq together achieved in 2022 sales.
Outside of immunology, the company is working on priming another blockbuster after nabbing a long-awaited FDA approval for its Parkinson’s disease therapy Vyalev, a follow-up to its 2015 infusion pump Duopa. The drug could eventually achieve more than $2 billion in peak sales, analysts at Evercore ISI previously forecast.
2025, meanwhile, should see AbbVie grow its sales by mid-single-digit percentages, the company forecast. With no major losses of exclusivity in the near future, AbbVie is working with a “clear runway to growth for at least the next eight years,” CEO Rob Michael noted during the company’s fourth-quarter earnings call.
2024 was former Chief Operating Officer Michael’s first year at the helm after longtime chief Richard Gonzalez hung up the gloves after seeing Humira out. The company awarded Michael about $18.5 million in pay after he “achieved or exceeded” multiple goals over the year.
7. Novartis
- 2024 revenue: $50.3 billion
- 2025 First-Quarter Revenue: US$13.2B (up 12% from 1Q 2024)
- 2025 Second-Quarter Revenue: US$14.1 B (up 11% from 2Q 2024) (Novartis.com)
- 2025 First-Half Revenue: US$27.3 B
- Price-to-Sales (P/S) ratio: 245.5/50.3 = 4.88
- Headquarters: Basel, Switzerland
As a new corporate structure and business priorities set in, Novartis is focused on growth at a compound annual rate of 6% from 2023 to 2028, or 5% from 2024 to 2029, according to a plan unveiled in November.
The Swiss pharma was off to a good start. In 2024, the first full year that Novartis operated as a pure-play innovative medicines company without Sandoz, sales were up 12% in constant currencies (11% in U.S. dollars) from continuing operations, reaching $50.3 billion.
The company’s top four brands—heart medication Entresto, immunology treatment Cosentyx, multiple sclerosis drug Kesimpta and breast-cancer-targeted Kisqali—all contributed to the growth big time, with sales rising 30%, 23%, 49% and 46%, respectively.
In a key approval last year, Kisqali expanded into the adjuvant treatment of certain early-stage HR-positive, HER2-negative breast cancers. The new label gives Kisqali an edge over Eli Lilly’s Verzenio by covering patients who don’t have cancer cells in their lymph nodes.
By Novartis’ projection, the broad adjuvant nod could lift Kisqali to more than $8 billion in peak sales, versus the $3.2 billion the CDK4/6 inhibitor generated in 2024 mainly from metastatic disease use.
While potential significant growth still lies ahead for Kisqali, the good days of Entresto may be numbered, as Novartis expects the heart failure combo medication will lose U.S. market exclusivity in the coming months. Besides, even if no generics entered this year, Entresto is subject to a price cut under the Inflation Reduction Act beginning in 2026.
Despite the looming Entresto patent cliff, Novartis still expects 2025 sales to grow by mid- to high-single-digit percentages.
From the Medicare Part D reforms, Novartis expects a “modest headwind,” with the biggest impact to come from coverage for the catastrophic phase for Cosentyx and Kisqali in 2025, CEO Vas Narasimhan said during the company’s fourth-quarter earnings call. As to the policies’ potential impact on Novartis’ midterm performance as outlined above, Narasimhan said he’s “very comfortable” with Novartis’ modeling, which takes “appropriately conservative assumptions.”
In two other major expansions for Novartis last year, the FDA granted accelerated approvals to Scemblix in newly diagnosed chronic myeloid leukemia and Fabhalta in the kidney disease immunoglobulin A nephropathy. For both drugs, Novartis has outlined peak sales potential at above $3 billion.
Another potential multibillion-dollar asset, radioligand therapy Pluvicto, also delivered good news for Novartis. With a favorable final overall survival analysis last year from a phase 3 trial, the FDA has in March 2025 approved the PSMA-targeted therapy for metastatic castration-resistant prostate cancer before chemotherapy.
Novartis last year beefed up its radiopharmaceuticals capabilities with the $1 billion upfront acquisition of Mariana Oncology. While Pluvicto uses lutetium as the active substance, Mariana was focused on actinium.
The Swiss drugmaker also acquired gene therapy specialist Kate Therapeutics in a deal potentially worth $1.1 billion. The buyout was followed by a positive readout for an intrathecal formulation of Novartis’ spinal muscular atrophy gene therapy Zolgensma in older patients.
However, one Novartis acquisition last year immediately went into trouble. Just a few months after the $2.9 billion takeover of MorphoSys, Novartis pushed back its regulatory plan for the deal’s centerpiece, BET inhibitor pelabresib, in myelofibrosis after running into a safety signal that the company now hopes to shed more light on after longer follow-ups.8. Eli Lilly
- 2024 revenue: $45 billion
- H1 2025 Revenue: Q1: $12.73B; Q2: $15.6B
- Headquarters: Indianapolis
September 2025 Updates:
- Lilly’s Q2 earnings, released on Aug. 7, came in strong. The company posted sales growth of $15.6 billion, an increase of 38%.
- Shares fell 13% as investors took in the news. The market wasn't happy with Eli Lilly's (LLY, Financials) highly anticipated weight-loss medication trial findings that recently came out. The drug, which was taken once a day, helped people lose roughly 12% of their body weight over the course of 72 weeks. That's good, but not as good as the 15% some experts had expected.
- Eli Lilly (LLY) currently has an estimated Price-to-Sales (P/S) ratio* of 14 - 16 (September 2025 range), making it relatively overvalued compared to its industry peers.* (TradingView)
- Recommendation (Buy/Hold/Sell) for LLY: Buy (Grok 4)
- Confidence Level: High
- Expected time frame: Buy and Hold for 12 months
- 1 month price target: $780
The second quarter of 2025 also marked the first time that Lilly’s combined worldwide sales of Mounjaro (diabetes) and Zepbound (obesity) topped those of Novo’s first-to-market products Ozempic (diabetes) and Wegovy (obesity).
The margin was $8.6 billion for Lilly and $8 billion for Novo, with Mounjaro and Zepbound also individually edging their Novo counterparts for the first time. It was a massive shift from the first quarter, when the combined sales of Novo’s two products came in at $7.5 billion, compared to $6.1 billion for Lilly. With its second-quarter report, Lilly bumped up the midpoint of its annual guidance by $1.5 billion to a new range of $60 billion to $62 billion.
Revenue in Q1 2025 increased 45% to $12.73 billion driven by volume growth from Mounjaro (Tirzepatide) and Zepbound.
In the eternal struggle for obesity market dominance, Indianapolis’ Eli Lilly may be gaining an upper hand over its chief metabolic medicine rival Novo Nordisk.
Last year, Lilly recorded $45 billion in total sales, good for 32% growth over the roughly $34 billion it pocketed in 2023. In the fourth quarter alone, Lilly’s sales swelled 45% to $13.53 billion, which the company credited in no uncertain terms to the 60% revenue jump its Type 2 diabetes blockbuster Mounjaro enjoyed over the last three months of the year.
Meanwhile, Mounjaro’s GLP-1 sibling Zepbound—which is approved for obesity—grew sales roughly elevenfold in 2024’s fourth quarter, taking home $1.9 billion versus just $175 million during the quarter in 2023.
Those drugs’ performance likely “dispelled suspense” among both industry watchers and investors, analysts at Citi wrote in a note to clients earlier this year. The comments followed a third-quarter sales scare for Lilly last year, during which the company’s GLP-1 duo failed to meet Wall Street expectations. Some keeping tabs on the field speculated that the lackluster sales performance could be evidence that the larger GLP-1 market had started to plateau.
Lilly executives, for their part, have pointed to the uncertainties underpinning the burgeoning GLP-1 industry.
"The scale of this business and the way it's been growing, the consumer part of it, along with the stocking dynamics, it's just been a learning [experience] for us," Lilly CEO David Ricks said at the J.P. Morgan Healthcare Conference in January, reflecting on an unpopular sales guidance cut that the helmsman attributed to an overestimation of the pace of growth for Mounjaro and Zepbound.
In January, Lilly cut its sales guidance for 2024 to about $45 billion, representing a decline from the $45.4 billion to $46 billion the company had previously projected.
But, while Lilly may have fallen short of its own expectations toward the end of 2024, the fact remains that “it’s early days on a very, very large opportunity,” Ricks said of the GLP-1 situation on a recent conference call. Further, the company thinks its still far from reaching the edge of the demand curve for obesity, Ricks added.
Looking ahead, Lilly expects to reel in 2025 sales between $58 billion and $61 billion. Mounjaro and Zepbound will contribute greatly to that haul, naturally, but a suite of new drugs like cancer med Jaypirca, atopic dermatitis treatment Ebglyss, ulcerative colitis drug Omvoh and Alzheimer’s disease therapy Kisunla are also expected to pull their weight this year, Ricks said in early February.
Meanwhile, much like Novo, the continued success of Lilly’s GLP-1 franchise hinges on manufacturing capacity and the company’s ability to meet rampant demand.
Related:
- GLP-1 Receptor Agonists May Modestly Reduce Risk of Fourteen Obesity-Related Cancers for People with Diabetes (2025 American Society of Clinical Oncology)
- Tirzepatide: a novel therapeutic approach for Alzheimer’s disease (2025 Metabolic Brain Disease)
- Clinical Evidence for GLP-1 Receptor Agonists in Alzheimer’s Disease: A Systematic Review (J Alzheimers Dis Rep. 2024)
- Neurodegeneration and Stroke After Semaglutide and Tirzepatide in Patients With Diabetes and Obesity (2025 JAMA)
To that end, Lilly recently revealed plans to build out four new production facilities in the U.S. beginning this year. The project, which is backed by a $27 billion investment, more than doubles what Lilly has earmarked for U.S. manufacturing since 2020 and will help expand domestic capacity for both active pharmaceutical ingredients and injectable drugs.
Mazdutide
Eli Lilly’s wildly successful GLP-1 drug discovery engine is poised to deliver another blockbuster. But, this time around, Innovent is set to be the near-term beneficiary, with the Chinese biotech awaiting approvals for the dual GLP-1/glucagon receptor agonist mazdutide in two indications in its home territory.
Innovent secured Chinese rights to mazdutide in 2019. Last year, the biotech reported two phase 3 wins, leading to filings for approval in China to aid in weight management for adults with obesity or who are overweight and in glycemic control for adults with Type 2 diabetes. The filings could secure the first global approvals for mazdutide and establish the molecule as a challenger for the Chinese GLP-1 market.
If approved, mazdutide will become the first dual GLP-1/glucagon receptor agonist for use in diabetes and obesity. Activating the glucagon receptor may increase energy expenditure, driving changes in the liver, brain and white and brown adipose tissue that complement the reduced energy intake triggered by GLP-1 activation. Innovent reported 18.6% weight loss at Week 48 in a trial of Chinese adults.
Work to expand the anticipated label of mazdutide is already underway. Innovent is running a late-phase trial of a 9-mg dose in obesity, having initially filed for approval of a 6-mg dose. Another late-phase trial is pitting the drug candidate against Novo Nordisk’s semaglutide—the active ingredient in Ozempic and Wegovy—in people with Type 2 diabetes and obesity.
Late-phase trials in obesity with metabolic dysfunction-associated steatotic liver disease, adolescent obesity and obstructive sleep apnea are at the planning stages. Innovent’s earlier-stage pipeline includes studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction.
The expansion into MASH is underpinned by a study that linked mazdutide to an 80% reduction in liver fat at Week 48. Speaking at the J.P. Morgan Healthcare Conference in January 2025, Innovent CEO Michael Yu, Ph.D., said the data were “way better than the FDA approval for MASH,” referring to Madrigal’s Rezdiffra, which earned the FDA’s first approval in the indication last year. Yu said he views mazdutide as a way to improve metabolism and make people healthier rather than just as a weight loss drug.
Innovent spent 2024 working to expand its cardiovascular and metabolism team in preparation for the launches of mazdutide and teprotumumab, the thyroid eye disease therapy that Amgen sells outside of China as Tepezza.
Lilly owns the rights to mazdutide outside of China, but how far the Big Pharma takes the candidate will depend on its ability to clear the bar set by tirzepatide, the active ingredient in Mounjaro and Zepbound. The prospects for mazdutide at Lilly could become clearer this year, with a phase 2 trial of the asset set to wrap up in the coming months. Lilly has recruited 179 patients for the trial, mainly using U.S. sites.
9. Bristol Myers Squibb
- 2024 revenue: $48.3 billion
- 2025 First-Quarter reported a total revenue of USD 11.2 B. 6% decrease year over year.
- 2025 Second-Quarter reported a total revenue of USD 12.3 B.
- Headquarters: Princeton, New Jersey
Heading into 2025, however, BMS is anticipating another contraction. The company forecast total revenues of approximately $45.5 billion for this year, which would represent a decrease of about 5.8%.
On a February conference call, while discussing the expected revenue drop—which came in about $1 billion short of consensus expectations—CEO Chris Boerner, Ph.D., noted: “We’re seeing the increased step-down on Revlimid.”
Elsewhere in 2025, the company will be continuing a multiyear cost-cutting plan that aims to save $2 billion by the end of 2027. Boerner said on the call that about half of the savings will be accomplished by the end of this year, and, while the restructuring is expected to include layoffs, the company did not specify how many jobs would be affected.
The latest cost-cutting effort begins as BMS works on wrapping up another initiative that it introduced in early 2024, aimed at slashing $1.5 billion in costs by the end of this year and including more than 2,000 total layoffs.
Both savings drives come as the pharma prepares for both Opdivo and Eliquis to lose exclusivity before the end of the decade, when they’re set to join Revlimid in seeing their sales plummet. Eliquis sales may take a further hit in 2026, when it becomes part of the first group of drugs to see their prices negotiated down under the Inflation Reduction Act.10. Sanofi
- 2024 revenue: USD 44.46 B ($41.1 billion euros)
- 2025 Q1 revenue: USD 11.3 B ($9.9 billion euros)
- 2025 Q2 revenue: USD 11.34 B ($9.99 billion euros)
- Headquarters: Paris
Although Sanofi slipped in Fierce Pharma’s 2024 rankings of the top pharma companies by sales, the change doesn't mark any tangible setback for the drugmaker.
In fact, the move down the ladder can easily be explained by the drugmaker’s planned sale of a controlling stake in its consumer health unit Opella, which, for all intents and purposes, was treated as though it’s a done deal in Sanofi’s 2024 financials.
For all of 2024, Sanofi logged sales of 41.08 billion euros ($44.46 billion), a step down from the roughly 43 billion euros it reported in 2023 but an 8.6% increase when accounting for the subtraction of consumer health sales last year.
Word of a planned consumer health sale by Sanofi began to materialize around September, when Bloomberg reported that the French pharma had received separated offers from equity firms PAI Partners and Clayton, Dubilier & Rice for the roughly 15 billion euro over-the-counter business.
Reports of mounting interest in the unit, dubbed Opella, followed an announcement by Sanofi in October 2023 that the company was reviewing multiple separation scenarios for the business, including a potential listing or sale.
Soon after the Bloomberg report, Sanofi confirmed last October that it had entered negotiations with Clayton, Dubilier & Rice to potentially sell a 50% controlling stake in Opella, which produces well-known brands like Allegra, Icy Hot, Gold Bond and Selsun Blue. Those talks became “exclusive” several weeks later and, as of February, Sanofi said it continues to expect to close the 50% stake sale with Clayton, Dubilier & Rice in 2025’s second quarter “at the earliest.”
Looking at Sanofi’s core 2024 performance, new launches paid off well for the company, making up 11% of the drugmaker’s total sales last year. That launch momentum was led by the company’s respiratory syncytial virus antibody for infants and young children Beyfortus, which delivered nearly 1.7 billion euros ($1.84 billion) for the entire year, followed up by hemophilia med Altuviiio, Pompe disease drug Nexviazyme and Rezurock for graft-versus-host disease.
Looking ahead, Sanofi is optimistic it can continue its growth trajectory in 2025, with the expectation that it’ll grow sales by a mid- to high-single-digit percentage over the year to come.
Meanwhile, with so many launches in the hopper, Sanofi has been continuously investing in its manufacturing network, too, with many of those investments piling up toward the end of 2024.
Following the opening of a half-billion-dollar modular plant for biologics and vaccines in September, Sanofi unveiled a production expansion in France and then touted the debut of a separate modular vaccine site in Singapore. Then, in December, Sanofi rolled out its largest investment in China to date when it revealed plans to build a 1 billion euro insulin “manufacturing base” in the country.11 - 20 (Others):
11. Novo Nordisk
- 2024 revenue: USD $42.1 billion (290 billion Danish kroner)
- H1 2025 revenue: USD $24.25 billion
- Price-to-Sales (P/S) ratio: 308/42.1 = 7.3
Over the last 12 months, Novo’s share price has fallen by more than 60%, and the company—formerly with the highest market cap in Europe—has tumbled to No. 7 in the region. With the slide, Novo has replaced eight-year CEO Lars Fruergaard Jørgensen, promoting international operations chief Maziar Mike Doustdar effective earlier this month.
12. GSK
13. Amgen
14. Takeda
15. Boehringer Ingelheim
16. Gilead Sciences
17. Bayer
18. Merck KGaA
19. Teva Pharmaceuticals
20. CSL
Key Highlight: Sinopharm Group
- 2024 revenue: $73.9 B (USD)
- Market Cap: $7.37 B (USD)
- Price-to-Sales (P/S) ratio: 7.37/73.9 = 0.1*
For context, Eli Lilly’s P/S ratio is approximately 15.5 (market cap of $700 billion divided by $45 billion revenue), highlighting the stark valuation difference between the two companies despite Sinopharm’s substantial revenue.
This discrepancy suggests that Sinopharm’s stock price does not fully reflect its revenue-generating capacity, potentially due to market perceptions, regional factors, or other risks affecting investor confidence.
Top 10 Pharma Companies by Market Cap in 2025
1. Eli Lilly
- 2024 revenue: $45 billion
- H1 2025 Revenue: Q1: $12.73B; Q2 est.: $15.6B
- Market Cap: $690 - 710 billion (September 2025 range) (TradingView)
- Headquarters: Indianapolis
- Recommendation (Buy/Hold/Sell) for LLY: Buy (Grok 4)
- Confidence Level: High
- Expected time frame: Buy and Hold for 12 months
- 1 month price target: $780
2. Johnson & Johnson
- 2024 revenue: $88.8 billion
- H1 2025 Revenue: Approx. $43.8 billion (Q1: $21.9B; Q2 est.: ~$21.9B)
- Market Cap: $425 - 435 B (September 2025 range) (TradingView)
- Price-to-Sales (P/S) ratio: 374/88.8 = 4.21*
- Headquarters: New Brunswick, New Jersey
3. AbbVie
- 2024 revenue: $56.3 billion
- H1 2025 Revenue: Approximately $26.6 billion (Q1: $13.3B; Q2 est.: $13.3B)
- Market Cap: $376 B (as of September 5, 2025)
- Price-to-Sales (P/S) ratio: 337.7/56.3 = 5.99
- Headquarters: North Chicago
4. AstraZeneca
- 2024 revenue: $54.1 billion
- H1 2025 Revenue: $28 billion (11% growth at constant exchange rates)
- Market Cap: $254 B
- Price-to-Sales (P/S) ratio: 220.4/54.1 = 4.07
- Headquarters: Cambridge, U.K.
5. Novo Nordisk (NVO)
- 2024 revenue: USD $42.1 billion (290 billion Danish kroner)
- H1 2025 Revenue: Q1: $12.1B; Q2: $11.68B
- Market Cap: $249 B.
- 2024 revenue: USD $42.1 billion (290 billion Danish kroner)
- H1 2025 Revenue: Q1: $12.1B; Q2: $11.68B
- Market Cap: $249 B.
6. Roche
- 2024 revenue: USD $73.6 billion (60.5 billion Swiss francs)
- H1 2025 Revenue: $32.1 billion (Q1: $18.7B; Q2: $13.4B est.)
- Market Cap: $258 B (Swiss Exchange)
- Price-to-Sales (P/S) ratio: 262.9/73.6 = 3.57
- Headquarters: Basel, Switzerland
7. Novartis
- 2024 revenue: $50.3 billion
- H1 2025 Revenue: Approx. $26.4 billion (Q1: $13.2B; Q2 est.: $13.2B)
- Market Cap: $244 B
- Price-to-Sales (P/S) ratio: 245.5/50.3 = 4.88
- Headquarters: Basel, Switzerland
8 . Merck
- 2024 revenue: $64.2 billion
- H1 2025 Revenue: Approximately $31 billion (Q1: $15.5B; Q2 est.: $15.5B)
- Market Cap: $210 B
- Price-to-Sales (P/S) ratio: 206.3/64.2 = 3.21
- R&D Spending 2024: $17.9 billion
- Headquarters: Rahway, New Jersey
9. Amgen
- 2024 revenue: $33.4 billion
- H1 2025 Revenue: Estimated $16.5 billion
- Market Cap: $151 B
- Price-to-Sales (P/S) ratio: 159/33.4 = 4.76
10. Pfizer
- 2024 revenue: $63.6 billion
- H1 2025 Revenue: Approx. $27.4 billion (Q1: $13.7B; Q2 est.: $13.7B)
- Market Cap (NYSE): $139 B*
- Price-to-Sales (P/S) ratio: 143/63.6 = 2.25
- Headquarters: New York City
Top 10 Most Anticipated Drug Launches of 2025
So, what exactly is responsible for the predicted 2030 deluge? Topping Evaluate’s 2025 list is a new cystic fibrosis offering from Vertex Pharmaceuticals, already a giant in the space. Vanza triple snagged its FDA approval a bit early, at the end of 2024, after which it was christened with the commercial name Alyftrek. The triple combination drug improves on its predecessor Trikafta in multiple areas, and Evaluate is predicting a massive $8.3 billion annual haul for Alyftrek by 2030.Second on this year’s slate is a repeat from last year. Daiichi Sankyo and AstraZeneca’s datopotamab deruxtecan, which came in at No. 5 in 2024, didn’t end up earning an FDA nod last year. It's already off to a strong start in 2025, though, as the antibody-drug conjugate gained its first approval in January. Evaluate is predicting 2030 sales of nearly $6 billion for the drug, which is now marketed as Datroway.
Elsewhere on this year’s list are offerings from Sanofi, GSK, Johnson & Johnson and more, spanning indications such as multiple sclerosis, severe asthma and, of course, the hyperpopular obesity and Type 2 diabetes space.
1. Vanza triple
Company: Vertex PharmaceuticalsUsed for: Cystic fibrosis
Est. 2030 sales: $8.3 billion
The first entry on Evaluate’s list of the most anticipated drug launches of this year is also the first to get the go-ahead to begin that launch. Vertex won FDA approval for its newest cystic fibrosis treatment, Alyftrek, in late December 2024, about two weeks ahead of a planned PDUFA date.
The drug, a triple combination of vanzacaftor, tezacaftor and deutivacaftor that was previously known as vanza triple, is Vertex’s fifth cystic fibrosis transmembrane conductance regulator (CFTR) modulator to gain the regulator’s approval. It's the first in the group designed to be administered just once daily.
The FDA cleared the drug for use by CF patients ages 6 and older who have genetic mutations responsive to the therapy.
As CEO Reshma Kewalramani, M.D., noted in the company's approval announcement, Alyftrek expands the reach of Vertex’s CF franchise into 31 additional mutations. Vertex estimates this will allow about 150 CF patients in the U.S. to become eligible for a CFTR modulator treatment for the first time.
Alyftrek also improves on the sweat chloride levels associated with the use of Vertex’s Trikafta, which in 2019 became the first triple combination therapy for CF to earn the FDA’s green light with a label spanning approximately 90% of the CF patient population.
The Alyftrek approval was based on the results of what Vertex has termed “the most comprehensive Phase 3 pivotal program ever conducted in CF,” as it included more than 1,000 patients in around two dozen countries.
The studies showed that, in patients aged 12 and up, Alyftrek was noninferior to Trikafta in terms of ppFEV1, a measure of how much air an individual can forcefully exhale in one second, and it also outdid its predecessor in the reduction of sweat chloride. Meanwhile, a study in children ages 6 to 11 proved Alyftrek’s safety in the younger population.
Like Trikafta before it, Alyftrek comes with a black box warning about the risk of liver toxicities, mandating annual liver function monitoring and frequent tests during the first year of treatment.
In a presentation at the annual J.P. Morgan Healthcare Conference earlier this month, Stuart Arbuckle, Vertex’s chief operating officer, outlined three main patient groups for whom Alyftrek will be “particularly interesting." Those are patients with the 31 mutations not treated by Trikafta, those currently taking Trikafta who “would like the benefits of greater CFTR function and also the convenience of once-daily dosing,” and the approximately 6,000 patients around the world who have discontinued the use of a CFTR modulator, according to Arbuckle.
Analysts have suggested that while the conversion of patients to Alyftrek will be “fairly straightforward,” the drug will likely make a smaller initial splash than Trikafta did in 2019 when it arrived on the scene as the first-ever triple combination therapy for CF, with efficacy results far outperforming those of Vertex’s previous offerings.
Even so, Evaluate has pegged Alyftrek’s 2030 sales at more than $8 billion, well above the other entries on this list, based at least in part on “the success of the company’s existing CF franchise”—already a $10 billion juggernaut—which the firm said bodes well for “another commercial hit.”
A company securities filing at the time of the approval noted a planned annual list price of $370,269 for Alyftrek, 7% higher than Trikafta’s $346,048.
With Alyftrek’s approval secured in the U.S., Vertex now awaits additional international nods; the company has already submitted applications in the EU, the U.K., Canada, Switzerland, Australia and New Zealand.
2. Datopotamab deruxtecan
Used for: Lung and breast cancers
Est. 2030 sales: $5.9 billion
Daiichi Sankyo and AstraZeneca’s TROP2-directed datopotamab deruxtecan (Dato-DXd) could be the next big antibody-drug conjugate (ADC) from the teams behind Enhertu. However, doubts raised by patient deaths in 2023 intensified in 2024 as the partners suffered a series of setbacks.
Last year, Dato-DXd failed to improve overall survival (OS) in phase 3 lung and breast cancer trials. When its makers shared a closer look at the lung cancer data, Daiichi’s stock dropped as investors unpacked the implications of an OS fail that was worse than expected. The partners withdrew filings for approval for use in second-line lung cancer patients in the U.S. and Europe as 2024 drew to a close.
Speaking at an event in December, Dale Shuster, head of global precision medicine at Daiichi, said the lung cancer trial “was not reviewed favorably with the FDA.” The partners are now seeking FDA approval in a subset of second-line non-small cell lung cancer (NSCLC) patients with EGFR-mutated tumors.
Shuster was speaking shortly after AstraZeneca and Daiichi shared the analyses behind the pivot to the NSCLC subgroup. A pooled analysis of EGFR-mutated patients from two trials found median OS in people on Dato-DXd was 15.6 months. Median OS in the overall population of the phase 3 trial was 12.9 months on Dato-DXd and 11.8 months on docetaxel, the chemotherapy drug used in the control cohort.
The FDA recently accepted the lung cancer filing for priority review, positioning it to make a decision on the submission by July 12. Meanwhile, AstraZeneca and Daiichi won the first FDA approval for Dato-DXd on Jan. 17, securing a green light to sell the ADC in unresectable or metastatic HR-positive, HER2-negative breast cancer.
Gilead Sciences’ rival TROP2 ADC Trodelvy is already approved in breast cancer, but Dato-DXd, which will be sold as Datroway, is authorized for earlier use. While patients need to have tried endocrine-based therapy and at least two additional systemic therapies to start on Trodelvy, the Datroway label allows use after endocrine-based therapy and at least one additional systemic therapy.
Lung cancer is the bigger opportunity, though, and Gilead exited the second-line race after failing a phase 3 trial last year. While working to win approval in the subset of second-line NSCLC patients, AstraZeneca and Daiichi are also advancing toward data from a phase 3 trial that is testing their ADC as a first-line treatment for lung cancer. Data from the first-line AVANZAR trial are due in the second half of the year.
Positive AVANZAR data would open up a major market. Working with Merck & Co., Gilead is still trying to bring Trodelvy to the first-line NSCLC market, so AstraZeneca and Daiichi have a chance to leap ahead and launch the first TROP2-directed ADC in the indication.
Evaluate’s forecast suggests the analysts continue to believe in Dato-DXd despite the setbacks it faced in recent years, with their estimate for 2030 coming in $4.1 billion above the 2028 prediction they made one year ago. The coming 12 months will go a long way toward showing whether Dato-DXd can become the big blockbuster expected by analysts.
3. Suzetrigine
Company: Vertex PharmaceuticalsUsed for: Acute and neuropathic pain
Est. 2030 sales: $2.9 billion
Though the 2030 sales estimate for Vertex’s suzetrigine falls well short of the prediction for the company’s other trendy new drug, list-topper Alyftrek, suzetrigine may still steal some of its cousin’s thunder.
The non-opioid pain candidate is a NaV1.8 inhibitor designed to block pain signals in the sodium channel, and its approval would make for “the first novel pain mechanism to reach the market for decades,” per Evaluate.
Suzetrigine’s application in moderate to severe acute pain was granted priority review by the FDA, with a target action date set for Jan. 30.
Phase 3 data that Vertex shared last year showed suzetrigine meeting its primary endpoints by significantly improving pain levels over placebo in the 48 hours after patients underwent tummy tucks and bunionectomies, with a clean safety profile.
However, the drug failed to meet a secondary endpoint that pitted it against Vicodin, the widely used (and frequently abused) opioid medication. Though suzetrigine offered a numerical advantage over Vicodin among the tummy tuck patients, it fell short of statistical significance in that group. In the bunion surgery trial, patients treated with Vicodin experienced greater pain relief than those who received suzetrigine.
Still, armed with the primary endpoint wins, Vertex has plowed ahead with suzetrigine in acute pain. Analysts have predicted a favorable launch for the drug, with Leerink Partners setting its 2026 sales estimate at a whopping $866 million.
During Vertex’s presentation at the 2025 J.P. Morgan Healthcare Conference, the company confirmed that it is “launch ready,” with plans to begin rolling out suzetrigine across the U.S. as soon as FDA approval is secured.
Preparing for that rollout has included discussions with government and commercial payers and with retail pharmacy chains, according to Chief Operating Officer Stuart Arbuckle.
“Once a patient gets a prescription for it and they turn up at their retail pharmacy, we certainly want to make sure the product is there,” he said. “These patients are in acute pain—if the product isn’t on the shelves, they’re going to abandon that prescription and get a prescription for something else.”
Though Vertex has yet to announce a list price for suzetrigine, Arbuckle discussed the considerations that go into the setting that price during the JPM presentation.
“We want to make sure that we are pricing it in that sweet spot that allows us to get access for patients, whilst at the same time reflects the clinical value of suzetrigine, the cost offsets that it will have in terms of reducing the opioid epidemic here in America, but also reflects the significant investment we’ve made over literally decades to get to this point,” he said.
In terms of access, Vertex is expected to be helped along in the U.S. by the recently passed Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which is aimed at encouraging the use of non-opioid pain management approaches for Medicare patients in clinical settings.
While it awaits a decision on suzetrigine in acute pain, Vertex is also in the process of advancing the candidate in chronic pain, with studies ongoing on diabetic peripheral neuropathy and lumbosacral radiculopathy.
A recent update in the latter use case spooked some investors and caused a lasting dip in the company’s stock, as phase 2 results incidentally showed that suzetrigine performed similarly to placebo, though that wasn’t the intended comparator of the study.
4. Aficamten
Company: CytokineticsUsed for: Hypertrophic cardiomyopathy
Est. 2030 sales: $2.8 billion
There was a time about a year ago when aficamten’s entry on this list would’ve opened with “Company: Novartis.” But talks of a takeover of Cytokinetics collapsed at the last minute, leading the South San Francisco biotech to mount a solo challenge to Bristol Myers Squibb’s rival cardiac myosin inhibitor Camzyos in the U.S. and Europe.
Novartis was only named as the interested buyer in media reports, but Cytokinetics CEO Robert Blum has admitted that talks with a potential buyer reached an advanced stage, using this month’s J.P. Morgan Healthcare Conference to report that “we thought we had agreed on a deal,” but it “did not happen for reasons we don’t know.” After seeing the deal collapse, Cytokinetics raised more than $1 billion to fund commercialization.
The biotech has filed for approval of aficamten for obstructive hypertrophic cardiomyopathy in the U.S., where the FDA is set to make a decision by late September, and in Europe. Cytokinetics plans to commercialize aficamten itself in those two markets. Sanofi has the rights to aficamten in China, where the asset could win approval this year, and Bayer is handling Japan.
Blum has acknowledged that biotechs new to selling drugs often disappoint, quoting McKinsey data showing only 20% to 30% of first-time commercial companies exceed launch expectations. Established companies, for their part, exceed expectations 40% to 50% of the time. The CEO made the case that Cytokinetics can be one of the winners by comparing the characteristics of his biotech and successful first-time launchers.
“These are companies that have concentrated customer segments. These are companies that have high profit margins, payer leverage. These are companies that produce bespoke patient experience, rely on omnichannel micromarketing to ensure lean sales and marketing infrastructure,” Blum said. “Cytokinetics has ... been investing for two to three years already in just those very same tenets.”
Cytokinetics plans to hire 125 to 150 sales reps in the U.S. this year. Though the reps will target a market already served by Camzyos, the drug BMS acquired in its $13 billion takeover of MyoKardia, Blum said it’s “not important that we compete with the current entrant.” Rather, the CEO wants to reach “the over 80% of patients who are diagnosed, symptomatic, eligible for treatment and not yet receiving treatment.”
That said, Cytokinetics is bullish about its ability to compete. According to Blum, “We can reasonably anticipate a majority of market share based on the differentiating features.”
Cytokinetics believes its drug candidate has an edge over Camzyos in terms of efficacy, speed of onset and safety. Work to communicate those differences will ramp up post-approval, but the company’s near-term focus is on disease awareness efforts aimed at physicians and patients.
None of this comes cheap. Cytokinetics told investors to expect $440 million to $470 million of operating spend in 2024, and Blum said the figure will “go up as we go to market with aficamten later this year.” The money is funding commercial preparations and further development of aficamten.
Cytokinetics is set to post phase 3 data from a trial that is comparing aficamten to a beta blocker in the first half of 2025.
5. Brensocatib
Company: InsmedUsed for: Neutrophil-mediated diseases
Est. 2030 sales: $2.8 billion
A Fierce Pharma analysis found that smaller companies overshadowed Big Pharma’s presence on the list of FDA drug approvals in 2024. Among those angling to join the ranks of smaller, lesser-known biotechs making an outsized splash on the industry is Insmed, which closed out 2024 by submitting an application to the FDA for its brensocatib in non-cystic fibrosis bronchiectasis, a lung disease.
With the submission now under regulatory review, Insmed said in a presentation at January’s J.P. Morgan Healthcare Conference that it’s expecting to begin brensocatib’s launch in the third quarter of this year, pending the granting of priority review and, of course, the agency’s ultimate sign-off.
In the meantime, Insmed is also planning to submit additional applications this year in the EU, the U.K. and Japan, where it’s aiming to begin commercial rollouts next year should brensocatib earn green lights in each region.
Bronchiectasis is a chronic condition in which the walls of the airway widen and thicken due to inflammation and infection. It’s estimated to affect between 350,000 and 500,000 adults each year in the U.S. alone. According to Insmed, an FDA nod would make brensocatib the first approved treatment for bronchiectasis as well as the first approved dipeptidyl peptidase 1 (DPP1) inhibitor.
The drug hugely impressed investors and analysts alike last year, when Insmed shared phase 3 results showing a major win in the primary endpoint of reducing pulmonary exacerbations. Among more than 1,700 patients split into two dosage groups, those in the 10-mg group experienced a 21% reduction in exacerbations compared with placebo, while patients in the 25-mg group saw a 19% reduction.
Alongside additional wins in several of the trial’s secondary endpoints, patients taking brensocatib also experienced fewer treatment-emergent adverse events than those assigned to the placebo group.
While Insmed awaits a decision on the use of brensocatib in bronchiectasis, the biotech is also forging ahead in applying the drug to a variety of other neutrophil-mediated diseases, a group of inflammatory conditions that are affected by the activity of the most common type of white blood cell and which includes diabetes, lupus, multiple sclerosis, rheumatoid arthritis and more.
As a DPP1 inhibitor, brensocatib is designed to inhibit an enzyme that activates neutrophil serine proteases (NSPs) in white blood cells. Though NSPs normally help mediate inflammation and destroy pathogens, in certain diseases, they’re activated to excess, leading to inflammation and the destruction of organs.
A phase 2b trial of brensocatib in chronic rhinosinusitis without nasal polyps has completed almost 70% of its target enrollment, and top-line data are expected before the end of this year, Insmed said at the JPM conference. In December, the company randomized the first participant in a separate phase 2 trial of the drug in hidradenitis suppurativa.
Evaluate has predicted brensocatib sales could reach $2.8 billion by 2030. That would be a major boon for Insmed, which currently markets only one approved drug, Arikayce, and is expecting to report full-year 2024 revenues of just over $363 million.
6. Mazdutide
Used for: Type 2 diabetes and obesity
Est. 2030 sales: $1.3 billion
Eli Lilly’s wildly successful GLP-1 drug discovery engine is poised to deliver another blockbuster. But, this time around, Innovent is set to be the near-term beneficiary, with the Chinese biotech awaiting approvals for the dual GLP-1/glucagon receptor agonist mazdutide in two indications in its home territory.
Innovent secured Chinese rights to mazdutide in 2019. Last year, the biotech reported two phase 3 wins, leading to filings for approval in China to aid in weight management for adults with obesity or who are overweight and in glycemic control for adults with Type 2 diabetes. The filings could secure the first global approvals for mazdutide and establish the molecule as a challenger for the Chinese GLP-1 market.
If approved, mazdutide will become the first dual GLP-1/glucagon receptor agonist for use in diabetes and obesity. Activating the glucagon receptor may increase energy expenditure, driving changes in the liver, brain and white and brown adipose tissue that complement the reduced energy intake triggered by GLP-1 activation. Innovent reported 18.6% weight loss at Week 48 in a trial of Chinese adults.
Work to expand the anticipated label of mazdutide is already underway. Innovent is running a late-phase trial of a 9-mg dose in obesity, having initially filed for approval of a 6-mg dose. Another late-phase trial is pitting the drug candidate against Novo Nordisk’s semaglutide—the active ingredient in Ozempic and Wegovy—in people with Type 2 diabetes and obesity.
Late-phase trials in obesity with metabolic dysfunction-associated steatotic liver disease, adolescent obesity and obstructive sleep apnea are at the planning stages. Innovent’s earlier-stage pipeline includes studies in metabolic dysfunction-associated steatohepatitis (MASH) and heart failure with preserved ejection fraction.
The expansion into MASH is underpinned by a study that linked mazdutide to an 80% reduction in liver fat at Week 48. Speaking at the J.P. Morgan Healthcare Conference in January, Innovent CEO Michael Yu, Ph.D., said the data were “way better than the FDA approval for MASH,” referring to Madrigal’s Rezdiffra, which earned the FDA’s first approval in the indication last year. Yu said he views mazdutide as a way to improve metabolism and make people healthier rather than just as a weight loss drug.
Innovent spent 2024 working to expand its cardiovascular and metabolism team in preparation for the launches of mazdutide and teprotumumab, the thyroid eye disease therapy that Amgen sells outside of China as Tepezza.
Lilly owns the rights to mazdutide outside of China, but how far the Big Pharma takes the candidate will depend on its ability to clear the bar set by tirzepatide, the active ingredient in Mounjaro and Zepbound. The prospects for mazdutide at Lilly could become clearer this year, with a phase 2 trial of the asset set to wrap up in the coming months. Lilly has recruited 179 patients for the trial, mainly using U.S. sites.
7. Tolebrutinib
Used for: Multiple sclerosis
Est. 2030 sales: $1.4 billion
It’s been a long, winding road for tolebrutinib, but Sanofi is finally nearing a potential FDA approval.
The French pharma initially picked up the BTK inhibitor in its $3.7 billion acquisition of Principia Biopharma in 2020. The buyout gave Sanofi full ownership over tolebrutinib, which it had developed in partnership with Principia and which it planned to quickly move into several phase 3 trials.
In 2022, however, the FDA placed a partial clinical hold on phase 3 trials of tolebrutinib in MS and myasthenia gravis after reported cases of drug-induced liver injury. By early 2023, Sanofi had made the decision to scrap the myasthenia gravis program while continuing on in MS.
The drug’s competitors have faced similar setbacks, with Roche’s fenebrutinib and Merck KGaA’s evobrutinib, for example, both facing partial clinical holds in recent years, both also due to liver toxicities. Merck ultimately decided to drop evobrutinib last year after it failed to beat Sanofi’s Aubagio in a pair of MS trials.
And though Sanofi recently reported fails in two of three MS trials of tolebrutinib, the med still appears to have pulled ahead in the race, as it became in December 2024 the first BTK inhibitor for MS to earn breakthrough therapy designation from the FDA, potentially speeding up its regulatory review.
Sanofi is set to submit tolebrutinib for FDA approval in non-relapsing secondary progressive multiple sclerosis (nrSPMS). In the breakthrough therapy designation announcement, the company confirmed that regulatory submissions were “currently being finalized for the US and prepared for the EU.”
During a presentation at the J.P. Morgan Healthcare Conference at the start of this year, Sanofi executives played coy about the exact timeline of the FDA submission, but R&D head Houman Ashrafian, M.D., Ph.D., noted, “Tolebrutinib will launch likely in SPMS this year—subject to regulatory review and approval, but that’s our confidence and our aspiration—and later in the year, [primary progressive MS] will follow.”
Evaluate is forecasting 2030 sales of $1.4 billion for the drug, which, if approved, would become the first disease-modifying therapy specifically indicated to treat nrSPMS.
Ashrafian suggested during the JPM presentation that the sizable unmet need in both primary and secondary progressive MS will allow Sanofi to “have a nice smooth growth dynamic” with tolebrutinib and take “a meaningful chunk of this $23 billion market.”
According to Sanofi, the breakthrough therapy designation was based on the results of its HERCULES phase 3 trial in nrSPMS, in which tolebrutinib was shown to delay the time to onset of six-month confirmed disability progression by 31% compared to placebo.
The company noted that just over 4% of patients in the tolebrutinib group experienced liver enzyme elevations compared to 1.6% in the placebo group, though all but one of the cases resolved without further medical intervention.
8. Depemokimab
Company: GSKUsed for: Severe allergic asthma
Est. 2030 sales: $1.2 billion
GSK is expecting depemokimab to do quite a number for its IL-5 franchise—and Evaluate’s sales estimates seem to back up that prediction.
At the J.P. Morgan Healthcare Conference in San Francisco this month, depemokimab made the “major value unlock” tier of GSK’s list (PDF) of five anticipated approvals for 2025. As CEO Emma Walmsley explained in a presentation, between the expected FDA nod for depemokimab and a potential label expansion into chronic obstructive pulmonary disease (COPD) for Nucala, the company has placed the IL-5 franchise’s peak sales potential at more than 4 billion pounds sterling ($4.9 billion).
Depemokimab is a monoclonal antibody that blocks human interleukin-5 (IL-5) from binding to its receptor. It’s aimed at eosinophilic-associated diseases, which occur when the body releases too many eosinophils, a type of white blood cell, leading to inflammation and tissue damage.
The long-acting med requires dosing only every six months—quite the improvement over competitors like Sanofi and Regeneron’s Dupixent, Novartis’ Xolair and GSK’s own Nucala, the typical dosing schedules for which all fall within the two- to four-week range. Per GSK, nearly 90% of patients have indicated that they would prefer a six-month dosing regimen.
Walmsley suggested that, to start, the expected launch of depemokimab could create a “step change” in treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Only one-third of potential asthma patients are currently being treated with biologics, according to GSK research.
“This medicine will not only provide patients with a twice-yearly dosing option, but we believe it will also expand the entire market for asthma biologics," she explained.
Though GSK hasn’t confirmed the submission of an application for depemokimab to U.S. regulators, while sharing data from several phase 3 trials of the drug last fall, the company said results of all four studies "will be used in regulatory filings around the world.”
Those studies included two each in severe asthma and CRSwNP. In severe asthma, the SWIFT-1 and SWIFT-2 trials enrolled a combined 760 adults and adolescents with severe asthma and type 2 inflammation. Over the course of a year, depemokimab was shown to reduce asthma exacerbations by 54% compared to placebo.
Results on the secondary endpoints, however, were more mixed. The experimental group experienced a 72% reduction in clinically significant exacerbations that required hospitalization or a visit to an emergency department, but the drug was less successful when pitted against the placebo group in terms of quality of life, asthma control and how much air a patient could exhale.
Kaivan Khavandi, M.D., Ph.D., GSK’s global head of respiratory/immunology R&D, confirmed to Fierce Biotech at the time that the secondary misses wouldn’t “alter the strategy at all,” as “it’s well recognized that the most important clinical outcome to prevent is exacerbations.”
Meanwhile, in the ANCHOR-1 and ANCHOR-2 trials of 528 patients with CRSwNP, depemokimab achieved both primary endpoints: improving the total endoscopic nasal polyp score at 52 weeks and the mean nasal obstruction score from weeks 49 to 52 compared to placebo.
Following closely behind depemokimab’s efforts in severe asthma and CRSwNP, phase 3 trials are also ongoing in eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. Plus, according to Walmsley’s presentation at JPM, GSK is planning to begin a phase 3 trial of depemokimab in COPD sometime this year.
9. Meningococcal ABCWY vaccine
Company: GSKUsed for: Meningococcal A, B, C, W-135 and Y vaccine
Est. 2030 sales: $1.2 billion
GSK is poised to open a new front in its tussle with Pfizer for the meningococcal disease vaccine market. The British company already sells vaccines against meningococcal A, C, W-135 and Y and meningococcal B. With GSK-3536819, GSK has combined Menveo and Bexsero’s antigenic components into one vaccine.
The FDA is set to decide whether to approve GSK’s five-in-one vaccine candidate by Feb. 14. If the agency shows its love for GSK-3536819 on Valentine’s Day, the pentavalent vaccine will enter a market already served by Pfizer’s Penbraya. The FDA approved Penbraya in 2023. Like GSK, Pfizer also sells two separate vaccines, Nimenrix and Trumenba, that together cover the same five components as its pentavalent shot.
GSK is aiming to generate peak sales of around 2 billion pounds sterling ($2.4 billion) across its portfolio of meningitis vaccines. The company’s existing portfolio pulled in 1.1 billion pounds over the first nine months of 2024, driven by Menveo and, in particular, Bexsero.
Launching the pentavalent vaccine could boost growth of the portfolio, building on the 16% increase in sales reported over the first nine months of 2024. However, questions about exactly how the five-in-one shots will fit into vaccination schedules in the long term remain unanswered.
In 2023, the U.S. Advisory Committee on Immunization Practices (ACIP) said Pfizer’s Penbraya may be given to people aged 10 years and up when a quadrivalent and meningococcal B vaccine are indicated at the same visit. The recommendations also detailed a standard three-dose regimen for those in need of protection against all five bacteria types, with patients receiving a quadrivalent shot starting at age 11 and then, starting at age 16, either a second quadrivalent dose plus a meningococcal B vaccine or a dose of a pentavalent shot followed six months later by another meningococcal B shot.
Following the recommendations, an analyst asked (PDF) Pfizer, “If the [pentavalent] vaccine is effectively only used for dose two of three, does that significantly reduce the commercial opportunity you had anticipated?”
In response, Angela Hwang, then Pfizer’s chief commercial officer, said the company could share more data with the ACIP in 2024, giving it “a second bite of the apple, which will allow us to achieve our peak sales”—though, to date, the 2023 recommendations are still in place.
Pfizer has yet to start breaking out sales of Penbraya. In the third quarter of 2024, the company included (PDF) meningococcal vaccine revenues among the $652 million made by multiple unnamed primary care products. Nimenrix and Trumenba, Pfizer’s quadrivalent and meningococcal B vaccines, generated $179 million and $126 million, respectively, in 2023.
GSK has a bigger meningococcal vaccine business, but, as with Pfizer’s Penbraya, uptake of its pentavalent shot will be shaped by ACIP recommendations. The case for the five-in-one shots rests on their potential to reduce the number of injections patients receive and to increase the number of people with protection against all the bacterial strains.
10. Nipocalimab
Company: Johnson & JohnsonUsed for: Myasthenia gravis and other autoimmune disorders
Est. 2030 sales: $1.2 billion
Nipocalimab represents a major bet by Johnson & Johnson. The Big Pharma acquired the asset in its $6.5 billion takeover of Momenta Pharmaceuticals in 2020 and proceeded to run a broad R&D program to validate its belief that FcRn blockade represents a “pipeline in a pathway.” In 2025, J&J could start recouping some of its outlay.
The FDA accepted an application for approval of nipocalimab in generalized myasthenia gravis (gMG) for priority review in early 2025. J&J secured the truncated path to market for the antibody despite the availability of other FcRn blockers: argenx won FDA approval for its FcRn drug Vyvgart in 2021 and later bagged OKs for a subcutaneous version in two indications, and UCB’s Rystiggo entered the fray in 2023.
J&J is positioned to secure a broader label than argenx or UCB. Argenx won FDA approval in people who are positive for anti-AChR antibodies, while UCB’s label covers patients with antibodies against AChR or MuSK. J&J went one better by enrolling people with antibodies against AChR, MuSK and LRP4.
The inclusion criteria have enabled J&J to pitch nipocalimab as a treatment for the broadest population of gMG patients and to secure priority review. However, most gMG patients are already eligible for treatment with Vyvgart and Rystiggo, as anti-AChR antibodies are found in up to 90% of gMG patients. The LRP4-positive patients that differentiate the J&J trial account for up to 5% of cases.
Approval in gMG could be the start of a series of authorizations for nipocalimab. J&J is running phase 3 trials in hemolytic disease of the fetus and newborn, warm autoimmune hemolytic anemia and chronic inflammatory demyelinating polyneuropathy. The roster of phase 2 trials includes studies in rheumatoid arthritis, systemic lupus erythematosus and Sjogren’s disease.
The broad R&D program is built on evidence that blocking FcRn cuts levels of circulating immunoglobulin G (IgG) antibodies without impacting other immune functions. IgG antibodies mediate a wide range of autoimmune diseases, leading J&J and its rivals to conclude that FcRn blockade is a “pipeline in a pathway.”
However, argenx’s stuttering efforts to expand beyond gMG have raised doubts about just how broadly FcRn drugs can be used, with the biotech chalking up failures for its subcutaneous formulation in a bleeding disorder and a group of chronic blistering diseases in 2023. The company is studying its intravenous product in the bleeding disorder—immune thrombocytopenia—and is on course to report data next year.
UCB is also testing Rystiggo in other indications, and Immunovant is studying its investigational FcRn prospect in gMG, Graves’ disease, thyroid eye disease and chronic inflammatory demyelinating polyneuropathy. J&J’s target indications could keep nipocalimab clear of rival FcRn blockers in some settings, but it will face competition from drugs with different mechanisms in conditions such as rheumatoid arthritis.
Read More: https://www.fiercepharma.com/marketing/top-10-most-anticipated-drug-launches-2025
Top 10 Drugs Losing US Exclusivity in 2025
Johnson & Johnson’s Stelara is already contending with several biosimilars, with more expected throughout the year. With $6.72 billion in U.S. sales projected for 2024, Stelara represents the largest U.S. loss of exclusivity since AbbVie’s Humira patent cliff in early 2023. Although Johnson & Johnson had anticipated a “late 2023” patent expiration, the company extended Stelara’s market life through legal settlements (1, 2, 3).
Johnson & Johnson is not alone in losing exclusivity on key revenue drivers this year. Regeneron faces biosimilar competition for its eye drug Eylea, Amgen for its bone medicines Prolia and Xgeva, and Novartis for its heart failure therapy Entresto.
Eylea encountered its first U.S. biosimilar when Amgen launched Pavblu in November 2024. Despite the biosimilar launch occurring last year, Eylea remains relevant for this report due to ongoing market developments for Regeneron (2).
Amgen generated $4.39 billion in revenue from Prolia and Xgeva in 2024. The company, known for its biosimilar portfolio, will now face competition as biosimilars begin to erode the market share of these originators starting in late May and early June (2).
Novartis has warned of a “mid-2025” loss of U.S. exclusivity for Entresto, as a key patent expires this summer. Novartis also has two other major products on this list: Promacta and Tasigna.Further down the list, AstraZeneca has two high-profile drugs nearing patent expiration. Soliris, acquired through AZ’s purchase of Alexion, is expected to face its first biosimilar from Amgen in the second quarter of 2025. Brilinta, a cardiometabolic drug once projected as a blockbuster but which underperformed expectations, is also losing U.S. patent protection soon (2).
To illustrate the prominence of drugs on this list, last year’s leader was Bristol Myers Squibb’s Sprycel, with $1.45 billion in prior-year U.S. sales. However, compared to the 2025 patent expirations, Sprycel would rank only sixth.This year’s wave of biosimilar launches and patent expirations marks a significant shift in the pharmaceutical landscape, with major implications for market dynamics, pricing, and patient access. Johnson & Johnson and other top pharma players will need to navigate these challenges while leveraging newer therapies to sustain growth.
1. Stelara
Diseases: Psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitisCompany: Johnson & Johnson
2024 U.S. sales: $6.72 billion
Johnson & Johnson’s immunology blockbuster first appeared on the loss-of-exclusivity radar in 2023, as key patents were set to expire that fall. However, J&J managed to delay biosimilar competition in the U.S. by reaching settlements with several biosimilar developers, postponing their product launches until this year (1).
Now, the U.S. market is seeing a surge of Stelara biosimilars. Amgen’s Wezlana, approved in late 2023, was the first to launch on January 1, 2025, following a legal agreement that delayed its entry in exchange for resolving patent litigation. Since then, at least six more Stelara biosimilars have received FDA approval and are planning 2025 launches, including Alvotech and Teva’s Selarsdi, Sandoz and Samsung Bioepis’ Pyzchiva, Biocon’s Yesintek, and Celltrion’s Steqeyma. Fresenius Kabi and Formycon’s Otulfi, along with Accord’s Imuldosa, are also expected to enter the market in the first half of the year.
Many of these biosimilars have already launched in Europe, where Stelara’s exclusivity ended in July 2024. The influx of competition has had a significant impact on sales: J&J reported a nearly 33% year-over-year decline in international Stelara sales in its first full quarter facing biosimilar rivals, while U.S. sales dropped 5% in the fourth quarter of 2024. Globally, Stelara’s annual sales fell 4.6% to $10.4 billion.
Despite these headwinds, J&J remains optimistic. CEO Joaquin Duato stated in January that the company expects to achieve 3% annual growth in 2025, only a slight decrease from the previous year’s 4.3% growth, by offsetting Stelara losses with new product launches and portfolio management.
J&J is also looking to recoup lost Stelara revenue by transitioning patients to its newer immunology therapy, Tremfya. This strategy mirrors AbbVie’s approach after Humira’s patent loss, where the company successfully shifted patients to Skyrizi and Rinvoq. Tremfya, already approved for psoriatic arthritis, plaque psoriasis, and ulcerative colitis, received FDA approval for Crohn’s disease in March 2025, aligning its indications with Stelara’s and strengthening J&J’s succession plan for its immunology franchise.
In summary, Stelara’s loss of exclusivity in 2025 marks a major shift in the U.S. immunology market, with multiple biosimilars entering the field and J&J executing a strategic transition to maintain its leadership in autoimmune therapies.
2. Eylea
Company: Regeneron
2024 U.S. sales: $4.77 billion
Eylea’s trajectory has diverged from the typical megablockbuster story. Even before the loss of patent protection, Eylea’s sales plateaued due to competition from Roche’s Vabysmo, which entered the market in early 2022 and quickly gained ground. From 2021 to 2024, Eylea’s global sales remained steady, ranging between $9.2 billion and $9.6 billion annually, while Vabysmo’s 2024 sales surpassed $4 billion, echoing Eylea’s own rapid ascent a decade earlier.
The competitive landscape intensified in November 2024, when Amgen launched Pavblu, the first Eylea biosimilar in the U.S., generating $31 million in its initial nine weeks. This launch followed a West Virginia judge’s decision favoring Amgen, after previously blocking launches from Biocon’s Yesafili and Biogen/Samsung Bioepis’ Opuviz—both of which remain barred from the U.S. market until 2027 despite FDA approvals.
Regeneron continues to defend its franchise on multiple fronts. The company is engaged in legal and regulatory battles with Formycon over the FDA-approved biosimilar Ahzantive and with Celltrion over Eydenzelt, approved in Europe but not yet in the U.S. Additionally, Regeneron has filed a patent infringement suit against Sandoz, whose biosimilar Enzeevu has also received FDA approval.
Compounding these challenges, Regeneron’s longer-acting follow-up, Eylea HD, has struggled to gain traction. Sales dropped from $392 million in the third quarter of 2024 to $305 million in the fourth quarter. With Vabysmo expected to maintain market exclusivity until 2039, Regeneron’s best hope for the Eylea franchise is to strengthen Eylea HD’s competitive profile.
Despite these headwinds, the aging global population and advances in diagnostic imaging continue to expand the overall market for retinal disease treatments.
3. Prolia/Xgeva
Company: Amgen
2024 U.S. sales: $4.39 billion
Amgen’s Prolia and Xgeva, which share the active ingredient denosumab, have enjoyed a strong market presence since their launch in 2010. Together, they reached blockbuster status early, with combined global sales of $1.22 billion in 2012.
By 2024, both drugs continued to grow globally: Prolia’s sales rose 8% year-over-year to $4.37 billion, while Xgeva increased 5% to $2.23 billion. In the U.S., Prolia and Xgeva generated $4.39 billion combined, with Prolia’s sales up 6% and Xgeva’s down 1%. Prolia was Amgen’s top-selling drug in 2024, with Xgeva ranking third.
The two drugs serve different indications and dosing schedules. Prolia primarily treats osteoporosis in men and postmenopausal women at high fracture risk, while Xgeva is used to prevent skeletal-related events in cancer patients with bone metastases. Denosumab works by binding to RANKL, blocking its interaction with the receptor RANK, thereby inhibiting osteoclast-mediated bone resorption.
The key RANKL antibody patent protecting Prolia and Xgeva expired on February 19, 2025.
Sandoz was the first to receive FDA approval for interchangeable biosimilars referencing Prolia and Xgeva, launching Jubbonti and Wyost in March 2024. However, as is typical with major blockbusters, Amgen initiated patent litigation against Sandoz in March 2023, asserting infringement of 21 patents expiring as late as 2037. The companies settled in March 2024, with Sandoz agreeing to launch its biosimilars in the U.S. no earlier than May 31, 2025, or sooner under certain conditions tied to market competition.
In January 2025, Amgen also settled with Celltrion, permitting the Korean company to launch its denosumab biosimilars in the U.S. as early as June 1, 2025. Celltrion announced FDA approval for these biosimilars earlier that month.
Amgen continues to pursue legal action against Samsung Bioepis, Fresenius Kabi, and Accord BioPharma, with their cases consolidated for coordinated pretrial proceedings in New Jersey federal court.
Meanwhile, Shanghai Henlius Biotech and partner Organon had their biosimilar HLX14 accepted for FDA review in October 2024. Amneal, partnered with Fresenius Kabi’s mAbxience, also submitted two denosumab biosimilars for FDA review recently.
Despite the impending biosimilar competition, Prolia and Xgeva remain significant contributors to Amgen’s portfolio. In the first quarter of 2025, Xgeva sales increased 1% year-over-year to $566 million, though Amgen expects sales erosion later in the year due to biosimilars. Prolia’s first-quarter sales rose 10% to $1.1 billion, driven by volume growth offsetting pricing pressures.
Overall, Amgen’s strategic settlements and ongoing legal efforts aim to manage biosimilar competition while maintaining strong sales momentum for Prolia and Xgeva in a changing market landscape.
4. Entresto
Disease: Heart failureCompany: Novartis
2024 U.S. sales: $4.05 billion
Novartis is preparing for the potential entry of generic versions of Entresto in the U.S. this year, while vigorously defending its blockbuster heart failure drug. Entresto, approved by the FDA in 2015 for heart failure treatment, faces a key patent expiration in July 2025. This patent, covering the sacubitril-valsartan combination, is central to Novartis’ market exclusivity, which the company forecasts will end in mid-2025, subject to ongoing patent and regulatory litigation.
Multiple generic manufacturers—including Torrent, Dr. Reddy’s, Zydus, MSN, Alkem, and Lupin—have secured FDA approvals for their Entresto biosimilars or generics. Since 2020, Novartis has actively pursued legal action against several of these companies, resulting in confidential settlements and mixed legal outcomes.
A focal point of recent patent disputes involves MSN Pharmaceuticals, which received FDA approval for its Entresto generic in July 2024. Novartis responded by suing the FDA, alleging that the approval led to labeling that “inappropriately rewrites Entresto’s approved indication.” The FDA rejected Novartis’ Citizen Petition to block other generics, and a federal judge upheld MSN’s approval in October 2024.
Novartis also sought to block MSN’s generic launch through injunctions, but a Delaware judge denied the request in August 2024. Although Novartis appealed, it again lost in federal court in December. However, in January 2025, the U.S. Court of Appeals for the Federal Circuit ordered MSN to delay its launch “until further notice” while the court reviews Novartis’ efforts to extend patent protection.
In a significant January 2025 ruling, the Federal Circuit upheld the validity of Novartis’ key Entresto patent, reversing an earlier district court decision that had invalidated it. Novartis plans to enforce this patent through its pediatric exclusivity period, which expires in July 2025.
Entresto remains Novartis’ top-selling drug, generating approximately $7.8 billion in net sales in 2024. Beyond patent challenges, the drug is among the first subject to Medicare price negotiations under the Inflation Reduction Act, effective in early 2026. Novartis CEO Vas Narasimhan has expressed confidence that the company can manage the impact of these price reductions, noting that the affected drugs are nearing patent expiration and companies have been preparing alternative revenue streams.
Overall, while Novartis faces mounting generic competition and pricing pressures, the company continues to leverage legal strategies and patent protections to defend Entresto’s market position through mid-2025 and beyond.
5. Soliris
Diseases: Paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), neuromyelitis optica spectrum disorder (NMOSD)Company: AstraZeneca
2024 U.S. sales: $1.52 billion
AstraZeneca’s Soliris has enjoyed nearly two decades of market exclusivity since its 2007 FDA approval for paroxysmal nocturnal hemoglobinuria (PNH). Now, as biosimilar competition looms, AstraZeneca is leveraging its follow-up drug, Ultomiris, to sustain its leadership in rare complement-mediated diseases.
AstraZeneca acquired Soliris through its $39 billion purchase of Alexion Pharmaceuticals in 2021. Since then, Soliris has remained a significant revenue driver, though sales have declined recently as the company has shifted focus to Ultomiris. Approved in 2018 for the same indications, Ultomiris benefits from a longer patent life, with exclusivity extending to 2035. In 2024, Ultomiris surpassed Soliris in global sales, generating $3.9 billion compared to Soliris’ $2.59 billion. AstraZeneca attributes Soliris’ 18% worldwide sales decline to the “successful conversion” of patients to Ultomiris.
Alongside Soliris and Ultomiris, AstraZeneca markets Voydeya, a recently approved add-on therapy, aiming to maintain dominance in the PNH market despite challenges from Novartis’ oral PNH drug Fabhalta and Apellis’ C3 inhibitor Empaveli. Biosimilars have already impacted Soliris sales in Europe, but the U.S. market will face its first biosimilar launches this year.
Amgen’s Soliris biosimilar, Bkemv (eculizumab-aeeb), received FDA approval in May 2024 as the first interchangeable biosimilar for PNH and aHUS. The interchangeable designation allows pharmacy-level substitution without prescriber approval. Under a 2020 settlement with Alexion, Amgen is set to launch Bkemv in the U.S. in the second quarter of 2025. The FDA has confirmed that Bkemv is “highly similar with no clinically meaningful differences” from Soliris and carries the same boxed warning and Risk Evaluation and Mitigation Strategy (REMS) due to the risk of serious meningococcal infections.
Samsung Bioepis’ Epysqli (eculizumab-aagh), the second FDA-approved Soliris biosimilar, gained approval in July 2024 for PNH, aHUS, and later expanded indications to include generalized myasthenia gravis. In January 2025, Teva Pharmaceuticals entered a licensing and commercialization agreement with Samsung Bioepis to market Epysqli in the U.S., while Samsung handles development, manufacturing, and supply. Epysqli is offered at a 30% discount to Soliris’ wholesale acquisition cost and is already marketed in Europe. The FDA has provisionally designated Epysqli as interchangeable once Amgen’s exclusivity expires.
The U.S. launch of Epysqli was announced in April 2025, marking a significant expansion of biosimilar options for patients with rare complement-mediated disorders. Both Bkemv and Epysqli carry the same safety profiles and are subject to REMS programs to mitigate serious infection risks.
AstraZeneca’s strategic transition from Soliris to Ultomiris, combined with the introduction of biosimilars, reflects the evolving competitive landscape in rare disease treatment. While Soliris faces biosimilar erosion, Ultomiris and Voydeya position AstraZeneca to maintain a strong presence in this specialized market.
6. Promacta
Diseases: Thrombocytopenia, aplastic anemiaCompany: Novartis
2024 U.S. sales: $1.18 billion
While much attention surrounds Novartis’ impending loss of exclusivity for its heart failure drug Entresto, two other blockbusters—Promacta and Tasigna—are also set to face generic competition in the U.S. in 2025. For forecasting, Novartis projects all three drugs will lose U.S. market exclusivity by mid-2025, subject to ongoing patent and regulatory developments.
Promacta, originally developed by Ligand and GSK and acquired by Novartis in 2014 as part of a $16 billion oncology portfolio purchase, has steadily grown since its 2008 FDA approval. The drug, known as Revolade in Europe, expanded its label to include first-line aplastic anemia in 2018, the year it first achieved blockbuster status. In 2024, Promacta generated $2.2 billion globally, with $1.2 billion from the U.S., marking a 2% decline attributed by Novartis to reduced proactive promotion.
Promacta is a daily oral therapy for thrombocytopenia and competes primarily with Amgen’s Nplate, a once-weekly injection approved in 2008 for chronic immune thrombocytopenia. Nplate’s 2024 sales reached $1.46 billion, down 1% from the prior year. Other competitors include Sobi’s Doptelet and Rigel Pharmaceuticals’ Tavalisse, which posted sales of $108 million and $105 million respectively in 2024.
The composition-of-matter patent for Promacta expired in the U.S. in July 2025. The FDA granted its first generic approval to Annora in April 2024, awarding a 180-day exclusivity period. In January 2025, a generic from Hetero also received FDA approval. Additional companies with tentative approvals include Actavis, Amneal, and Teva.
Novartis holds multiple patents and exclusivities protecting Promacta, with the last outstanding orphan drug exclusivity set to expire in November 2025. Legal challenges and patent term adjustments continue to shape the timeline for generic entry, with the estimated generic launch date currently around early 2026.
Overall, Promacta remains a key revenue driver for Novartis, but the approaching patent cliff and increasing generic competition are expected to pressure sales in the coming years.
7. Simponi/Simponi Aria
Diseases: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, polyarticular juvenile idiopathic arthritisCompany: Johnson & Johnson
2024 U.S. sales: $1.08 billion
For the past decade, golimumab—marketed as Simponi (subcutaneous injection) and Simponi Aria (intravenous infusion)—has been a consistent blockbuster for Johnson & Johnson. The drug first surpassed $1 billion in annual global sales in 2014, a few years after its initial FDA approvals in 2009 for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Over the following years, as Simponi gained additional indications, sales steadily increased, peaking at just under $2.28 billion in 2021.
Although revenues have since stabilized, they remain strong, with Simponi generating $2.19 billion globally in 2024, split nearly evenly between U.S. and international markets.
However, Simponi’s market position faces uncertainty as biosimilar competition approaches in the U.S. The U.S. composition-of-matter patent for golimumab expired in 2024, paving the way for biosimilar entrants. While Simponi has not yet faced the extensive biosimilar competition seen by J&J’s Stelara, at least two biosimilars are in development, with the first potentially launching in late 2025 pending FDA approval.
Teva Pharmaceuticals and Alvotech, who previously developed biosimilars for Humira and Stelara, announced in January 2025 that the FDA accepted their biologics license application for their golimumab biosimilar, AVT05, with a decision expected in the fourth quarter of 2025.
Separately, Bio-Thera Solutions is developing a Simponi biosimilar, BAT2506. In February 2025, the company submitted an application for BAT2506 in Europe and granted exclusive U.S. rights to Accord BioPharma, though the drug has not yet been submitted to the FDA.
In response to looming biosimilar competition, J&J continues to support Simponi’s market presence. In December 2024, the company submitted an FDA application to expand Simponi’s label to include children aged 2 and older with moderately to severely active ulcerative colitis, an indication currently approved only for adults.
J&J has not publicly commented on Simponi’s loss of exclusivity in recent earnings calls, which have focused primarily on Stelara’s biosimilar challenges. However, the company completed the takeover of European distribution rights for Simponi and Remicade from Merck in the fourth quarter of 2024. This transition contributed to a 32% year-over-year increase in international Simponi sales during that period, while U.S. sales grew modestly by 1.3%.
Overall, Simponi remains a significant product for J&J, but the expiration of its core patent and the arrival of biosimilars in the U.S. market mark a pivotal moment for the drug’s future growth.
8. Tysabri
Diseases: Multiple sclerosis, Crohn’s diseaseCompany: Biogen
2024 U.S. sales: $920 million
Biogen’s multiple sclerosis (MS) drug Tysabri has faced the prospect of biosimilar competition since the FDA approved Sandoz’s biosimilar, Tyruko, in 2023. After a delay, Sandoz is now preparing for a planned U.S. launch of Tyruko in 2025.
Tysabri, first approved in 2004 for MS and in 2008 for Crohn’s disease, became a blockbuster by 2009. Although its sales have declined from a peak of $2.06 billion in 2021, Tysabri remains a key contributor to Biogen’s MS portfolio, with U.S. sales totaling $920 million in 2024.
Biogen has vigorously defended its market position, filing a 2022 patent lawsuit against Sandoz and its partner Polpharma, accusing them of attempting to “reap the benefits of Biogen’s hard work and success.” Despite these efforts, Tyruko received FDA approval in August 2023 as the first biosimilar to Tysabri for relapsing forms of MS and Crohn’s disease.
While Tyruko is already marketed in England and Germany, its U.S. launch has been delayed due to the need for FDA approval of a companion John Cunningham virus (JCV) antibody test. JCV antibodies are a known risk factor for progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection linked to Tysabri use. Biogen pioneered JCV antibody testing with its STRATIFY assay, approved in 2012 and used alongside Tysabri.
Sandoz developed its own JCV assay, ImmunoWELL, designed to closely match Biogen’s test. The company initially targeted a 2024 U.S. launch but postponed it to 2025, citing longer-than-expected FDA review of the JCV assay. Despite the delay, Tyruko remains a key launch priority for Sandoz in 2025.
In Europe, Tyruko’s introduction has coincided with reports of complications following patient switches from Tysabri, prompting Sandoz to investigate the issue at a London hospital.
Overall, Biogen’s MS sales declined 7% in 2024 amid biosimilar competition to Tysabri in Europe and generic challenges to other MS therapies, leading the company to focus more on new product launches.
9. Tasigna
Disease: Chronic myeloid leukemiaCompany: Novartis
2024 U.S. sales: $848 million
While Novartis’ loss of exclusivity for Entresto dominates headlines in 2025, its chronic myeloid leukemia (CML) therapy Tasigna is also poised to face generic competition this year. Originally approved in 2007, Tasigna’s composition-of-matter patent has expired in the U.S. and Europe, opening the door for generics, Novartis noted in its latest annual report.
Novartis expects generic versions of Tasigna to enter the U.S. market around mid-2025. In 2024, Tasigna generated $848 million in U.S. sales, while global revenue declined 8% to $1.7 billion, a drop attributed to “lower demand and increasing competition” across all regions.
Several companies—including Apotex, MSN Laboratories, and Hetero Labs—have secured tentative FDA approvals for their Tasigna generics. Apotex was the first to receive preliminary approval in January 2024.
Despite limited generic competition so far, Tasigna faces pressure from alternative CML treatments. In November 2024, Azurity Pharmaceuticals received FDA approval for Danziten, a reformulated version of nilotinib that does not require fasting. Azurity’s CEO highlighted that unlike Tasigna, Danziten’s label lacks a boxed warning mandating administration on an empty stomach, offering greater convenience for patients.
Novartis has also engaged proactively with generic manufacturers. In June 2023, the company signed a sublicense agreement via the United Nations’ Medicines Patent Pool, permitting four generic drugmakers to supply Tasigna copies to 44 low- and middle-income countries. This agreement is part of the Access to Oncology Medicines Coalition formed in 2022.
While Tasigna’s core patents have expired or are nearing expiration, several secondary patents and exclusivities remain active, with some extending into the late 2020s. The drug holds multiple orphan drug exclusivities, the last of which expires in 2029, potentially delaying broader generic entry.
Overall, Tasigna’s upcoming patent cliff and expanding generic approvals signal significant market shifts in 2025, challenging Novartis to adapt amid evolving competitive dynamics in CML treatment.
10. Brilinta
Diseases: Acute coronary syndrome, coronary artery disease, acute ischemic stroke, high-risk transient ischemic attackCompany: AstraZeneca
2024 U.S. sales: $751 million
Alongside SGLT2 inhibitor Farxiga, AstraZeneca’s blood thinner Brilinta was launched to drive cardiometabolic growth following the costly loss of exclusivity for Crestor. Initially approved in 2011 to reduce secondary cardiovascular events in patients with acute coronary syndromes, Brilinta’s label expanded in 2015 to extend use beyond the first year. In 2020, it gained further approvals to reduce the risk of first heart attack or stroke in certain high-risk patients and in select stroke populations.
However, Brilinta faced clinical setbacks. In 2016, it failed two phase 3 trials—Socrates and Euclid—in peripheral artery disease (PAD). In Socrates, Brilinta did not outperform aspirin in preventing strokes, heart attacks, or death. In Euclid, it failed to surpass Bristol Myers Squibb and Sanofi’s Plavix in preventing major adverse cardiac events.
When AstraZeneca CEO Pascal Soriot repelled Pfizer’s hostile takeover bid in 2014, he projected Brilinta sales of $3.5 billion by 2023. After the PAD trial failures, the company acknowledged this target was unattainable. Brilinta peaked at $1.59 billion globally in 2020. Its growth was further hampered by COVID-19’s impact on cardiovascular hospitalizations and China’s volume-based procurement (VBP) program, which pressured prices.
Generics are expected to enter the U.S. market in 2025. Brilinta’s main regulatory exclusivity expires on May 9, 2025, with an additional six months of pediatric exclusivity extending to November 9, according to the FDA’s Orange Book. Multiple companies—including Sandoz, Dr. Reddy’s Laboratories, and Torrent Pharmaceuticals—have tentative FDA approvals for their generic versions. AstraZeneca lists 2025 as the expiration year for a key patent on Brilinta.
A pharmacy benefit manager’s report predicted the first U.S. generics would launch in May 2025. AstraZeneca has fought generic challengers in court since 2015, reaching multiple settlements in 2020, 2022, and 2024 to manage market entry timing.
Despite these challenges, AstraZeneca remains optimistic. On its fourth-quarter 2024 earnings call, CEO Soriot expressed confidence in strong 2025 performance despite Brilinta’s impending loss of exclusivity and potential VBP inclusion for Farxiga and roxadustat.
With generics poised to capture significant market share, payers are expected to mandate substitutions, driving rapid uptake of lower-cost alternatives. This transition will require careful management to reassure patients about therapeutic equivalence amid changes in tablet appearance and packaging.
In summary, Brilinta’s patent cliff in mid-2025 marks a turning point, ushering in generic competition that will reshape the U.S. antiplatelet market and challenge AstraZeneca’s cardiometabolic portfolio.
Source & Reference: https://www.fiercepharma.com/special-reports/top-10-drugs-losing-us-exclusivity-2025
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