Top 10 most anticipated drug launches of 2025
来源：Fierce Pharma | 发布时间：2025-06-30
摘要：2025年生物制药行业将迎来一场繁荣，预计有10种新药上市，至2030年这些药物的年销售额将高达290亿美元，这一数字几乎是去年预测的两倍。Vertex制药的Alyftrek（用于治疗囊性纤维化）以83亿美元的预期销售额位居榜首，紧随其后的是Daiichi Sankyo和阿斯利康的Datroway（用于治疗肺癌和乳腺癌），预期销售额接近60亿美元。Vertex的另一款药物Suzetrigine（用于治疗急性疼痛和神经病理性疼痛）则以近30亿美元的预期销售额位列第三。此外，赛诺菲、GSK、强生等公司开发的药物也榜上有名，涵盖多发性硬化症、重度哮喘、肥胖症和2型糖尿病等多种适应症。若这些药物顺利上市，生物制药行业将真正迎来一场轰动的繁荣。
Biopharma may soon be in for a blockbuster boom.
In the latest edition of its annual ranking of the biggest potential drug launches of the coming year, Evaluate listed 10 drugs that are slated to earn approvals in 2025. According to the analysts’ forecasts, all together, the meds stand to generate a whopping $29 billion in annual sales by the end of the decade.
1
Vanza triple
Company: Vertex Pharmaceuticals
Used 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.
2
Datopotamab deruxtecan
Company: Daiichi Sankyo/AstraZeneca
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 lungand 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.
3
Suzetrigine
Company: Vertex Pharmaceuticals
Used 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.”
4
Aficamten
Company: Cytokinetics
Used 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.”
5
Brensocatib
Company: Insmed
Used 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.
6
Tolebrutinib
Company: Sanofi
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.”
7
Mazdutide
Company: Innovent/Eli Lilly
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.
8
Depemokimab
Company: GSK
Used 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.”
9
MenABCWY vaccine
Company: GSK
Used 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.
10
Nipocalimab
Company: Johnson & Johnson
Used 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.
预计年销售额290亿美元！2025年最受期待的全球十大药物
全球知名行业媒体Fierce Pharma对2025年最受期待的十大药物进行分析，
分析师预测，到2030年前后，这些药物的年销售额将达到290亿美元。
药品：Vanza triple（Alyftrek）
公司：福泰制药用于：囊性纤维化预计2030年销售额：83亿美元
2024年12月底，福泰制药的最新囊性纤维化治疗药物Alyftrek在美获批上市，用于6岁及以上携带对该疗法有反应的基因突变的囊性纤维化患者。该药物是福泰制药获得监管机构批准的第五款囊性纤维化跨膜传导调节因子（CFTR）调节剂。
药品：Datopotamab deruxtecan（Datroway）
公司：第一三共/阿斯利康
用于：肺癌和乳腺癌
预计2030年销售额：59亿美元
该药物为第一三共和阿斯利康联合研发的大型抗体药物偶联物（ADC）。目前，美国食品药品监督管理局（FDA）已经受理了该药物用于肺癌治疗的申请并给予优先审评，此外，1月17日，FDA对Dato-DXd批准，允许在不可切除或转移性HR阳性、HER2阴性乳腺癌患者中销售这款ADC药物。
药品：Suzetrigine
公司：福泰制药
用于：急性和神经性疼痛
预计2030年销售额：29亿美元
这一非阿片类疼痛候选药物是一种NaV1.8抑制剂，旨在阻断钠通道中的疼痛信号。当地时间1月30日，FDA宣布其获批上市。福泰制药去年公布的三期临床数据显示，suzetrigine在患者接受腹部整形和拇囊炎切除术后48小时内，显著改善了疼痛水平，达到了主要终点，安全性良好。
药品：Aficamten
公司：Cytokinetics
用于：肥厚型心肌病
预计2030年销售额：28亿美元
Cytokinetics已在美国和欧洲提交了aficamten用于治疗梗阻性肥厚型心肌病的上市申请，预计在9月底，FDA将做出审批决定。今年上半年，公司公布一项将aficamten与β受体阻滞剂进行对比试验的3期数据。
药品：Brensocatib
公司：Insmed
用于：中性粒细胞介导的疾病
预计2030年销售额：28亿美元
2024年，Insmed向FDA提交了brensocatib用于治疗非囊性纤维化支气管扩张的申请，公司表示目前正在接受监管审查，预计将在2025年第三季度开始推出这一药物。与此同时，Insmed还计划今年在欧盟、英国和日本提交更多申请。如果获得FDA批准上市，该药物将成为首个获批用于治疗支气管扩张的药物。
药品：Tolebrutinib
公司：赛诺菲
用于：多发性硬化症
预计2030年销售额：14亿美元
2020 年，赛诺菲收购了药企Principia Biopharma，获得了这一药品管线。2024年12月，它成为首个获得FDA突破性疗法认定的用于多发性硬化症的BTK抑制剂，赛诺菲表示，计划向FDA提交Tolebrutinib用于治疗非复发型继发进展型多发性硬化症（nrSPMS）的批准申请。
药品：玛仕度肽
公司：信达生物/礼来
用途：2型糖尿病和肥胖症
预计2030年销售额：13亿美元
礼来在胰高血糖素样肽-1（GLP-1）药物研发方面取得许多成果。2019 年，信达生物获得了玛仕度肽在中国的权益。去年，信达生物报告了两项3期试验的结果，在中国提交了用于成人肥胖或超重患者体重管理以及2型糖尿病患者血糖控制的批准申请。这些申请有望为玛仕度肽赢得全球首批批准，使其成为中国GLP-1市场的有力竞争者。
药品：Depemokimab
公司：葛兰素史克
用于：严重过敏性哮喘
预计2030年销售额：12亿美元
Depemokimab是一种单克隆抗体，可阻止人白细胞介素- 5（IL-5）与其受体结合。这种长效药物只需每六个月给药一次。目前，葛兰素史克尚未确认是否已向美国监管机构提交Depemokimab的申请。
药品：五价脑膜炎球菌疫苗
公司：葛兰素史克
用途：预防A、B、C、W-135和Y群脑膜炎球菌感染
预计2030年销售额：12亿美元
FDA将在2月14日前决定是否批准这一疫苗。五合一疫苗的优势在于，它有可能减少患者的注射次数，并让更多人获得针对所有菌株的防护。与已有相关产品获批上市的辉瑞一起，葛兰素史克也将在脑膜炎球菌疾病疫苗市场的竞争中开辟新战线。
药品：Nipocalimab
公司：强生
用于：重症肌无力及其他自身免疫性疾病
预计2030年销售额：12亿美元
2020 年，强生以65亿美元收购了药企Momenta Pharmaceuticals，获得这一管线后，开展了广泛的研发项目。2025年初，FDA受理了Nipocalimab用于治疗全身性重症肌无力（gMG）的上市申请，并给予优先审评。