Top 10 Most Anticipated Drug Launches of 2025

The year 2025 promises significant breakthroughs in the pharmaceutical market with 10 newly anticipated drug launches, expected to generate nearly $29 billion in revenue by 2030. These innovative therapies focus on treating life-threatening diseases such as cancer, genetic disorders, and complex conditions, offering hope to millions of patients worldwide.

1. Alyftrek

• • Company: Vertex Pharmaceuticals
  • Indication: Cystic Fibrosis
  • Key Highlights:
    • Vertex received FDA approval for Alyftrek in late December 2024.
    • Alyftrek is the fifth CFTR modulator from Vertex, formerly known as Vanza triple, offering a once-daily treatment for cystic fibrosis.
    • Approved for patients aged 6 and older with responsive gene mutations, expanding Vertex’s CF treatment coverage to 31 new mutations.
    • Vertex forecasts Alyftrek’s revenue could exceed $8 billion by 2030, with an expected list price of $370,269 (7% higher than Trikafta).
  • Estimated revenue: $8.3 billion by 2030.

2. Datroway (Dato–DXd)

• • Company: Daiichi Sankyo and AstraZeneca
  • Indication: Breast Cancer, Lung Cancer
  • Key Highlights:
    • Dato–DXd is an antibody drug conjugate (ADC) targeting the TROP2 protein, expected to become the next blockbuster drug after Enhertu.
    • FDA approved for unresectable or metastatic breast cancer in January 2025, sold under the name Datroway in January 2025, opening up the opportunity for earlier treatment for breast cancer patients.
    • The drug has great potential in treating lung cancer, especially non-small cell lung cancer (NSCLC) with EGFR mutations. The FDA has accepted Dato–DXd’s lung cancer application for priority review, with a decision expected by July 12.
  • Estimated revenue: $5.9 billion by 2030.

3. Suzetrigine

• • Company: Vertex Pharmaceuticals
  • Indication: Acute and Neuropathic Pain
  • Key Highlights:
    • Suzetrigine is a non-opioid analgesic that acts as a NaV1.8 inhibitor to block pain signals via sodium channels, marking a new mechanism of pain relief in decades.
    • Vertex continues to push suzetrigine for acute pain, with 2026 sales estimated at $866 million according to Leerink Partners.
    • While awaiting a decision for acute pain, Vertex is also investigating suzetrigine for chronic pain
  • Estimated revenue: $2.9 billion by 2030.

4. Aficamten

• • Company: Cytokinetics
  • Indication: Hypertrophic Cardiomyopathy
  • Key Highlights:
    • A cardiac myosin inhibitor that competes with Bristol Myers Squibb’s Camzyos. Aficamten was originally expected to be owned by Novartis, but the Cytokinetics acquisition collapsed at the last minute, leaving the company to compete alone in the marketg.
    • Cytokinetics believes its drug has superior efficacy, rapid onset of action, and safety.
    • Potential to capture a large market share. The company has filed for approval of aficamten for hypertrophic cardiomyopathy in the US and in Europe, with plans to commercialize the product in both markets. In China, aficamten is marketed by Sanofi, while Bayer has the Japanese market.
  • Estimated revenue: $2.8 billion by 2030.

5. Brensocatib

• • Company: Insmed
  • Indication: Non-CF Bronchiectasis, Neutrophil-Mediated Diseases
  • Key Highlights:
    • The FDA approval makes brensocatib the first approved therapy for non-cystic fibrosis bronchiectasis and the first approved dipeptidyl peptidase 1 (DPP1) inhibitor.
    • Brensocatib also has potential for use in other inflammatory diseases through its ability to inhibit the neutrophil serine protease activating enzyme (NSP).
  • Estimated revenue: $2.8 billion by 2030.

6. Tolebrutinib

• • Company: Sanofi
  • Indication: Multiple sclerosis –MS
  • Key Highlights:
    • A BTK (Bruton’s Tyrosine Kinase) inhibitor, poised as a breakthrough MS treatment .
    • Despite recent reports of failures in two of three MS trials, tolebrutinib is poised to be granted “breakthrough therapy” status by the FDA in December 2024 – becoming the first BTK inhibitor for MS to receive this designation, potentially shortening the approval process.
  • Estimated revenue: $1.4 billion by 2030.

7. Mazdutide

• • Company: Innovent và Eli Lilly
  • Indication: Type 2 Diabetes, Obesity
  • Key Highlights:
    • If approved, mazdutide would become the first dual GLP-1/glucagon receptor agonist for diabetes and obesity, with a mechanism of glucagon receptor activation that increases energy expenditure and improves metabolism in the liver, brain and adipose tissue.
    • The study showed that mazdutide reduced liver fat by 80% after 48 weeks, surpassing the FDA standard for MASH (Metabolic dysfunction–associated steatohepatitis) – a reference to Madriga’s Rezdiffra.
    • owns the rights to develop mazdutide outside of China, but Lilly’s investment will depend on how well mazdutide competes with tirzepatide (the main ingredient in Mounjaro and Zepbound).
  • Estimated revenue: $1.3 billion by 2030.

8. Depemokimab

• • Company: GSK
  • Indication: Severe Asthma
  • Key Highlights:
    • GSK predicts depemokimab will be a “gold mine” for the IL–5 product line, with a potential revenue of more than £4 billion ($4.9 billion) thanks to FDA approval and the possibility of expanding the indication.
    • As a monoclonal antibody that inhibits IL–5, with a duration of use lasting 6 months/time, it is preferred by patients over competing products with 2–4-week doses (Dupixent, Xolair, Nucala, …), improving patient compliance.
    • Depemokimab is currently undergoing phase 3 trials for eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES) with a phase 3 trial planned for COPD this year, expanding the drug’s treatment potential.
  • Estimated revenue: $1.2 billion by 2030.

9. MenABCWY vaccine

• • Company: GSK
  • Indication: Meningococcal Disease Prevention
  • Key Highlights:
    • GSK is preparing to expand its market share in the meningitis vaccine market, competing directly with Pfizer.
    • This is a combination of antigenic components from two vaccines Menveo and Bexsero to create a five-in-one vaccine (GSK–3536819), which reduces the number of injections for patients.
    • Protects against five common strains of meningitis bacteria: A, B, C, W-135 and Y.
    • The FDA is expected to make a decision on approval of the MenABCWY vaccine in February 2025. If approved, the vaccine will compete with Pfizer’s Penbraya in the meningitis vaccine market.
  • Estimated revenue: $1.2 billion by 2030.

10. Nipocalimab

• • Company: Johnson & Johnson
  • Indication: Myasthenia Gravis, Autoimmune Disorders
  • Key Highlights:
    • Nipocalimab is a major investment by Johnson & Johnson (J&J), acquired from Momenta Pharmaceuticals for $6.5 billion in 2020.
    • A different FcRn receptor inhibitor than Vyvgart (indicated for patients with anti-AChR antibodies) and Rystiggo (indicated for patients with anti-AChR or MuSK antibodies), nipocalimab also includes patients with anti-LRP4 antibodies, expanding the potential patient pool.
  • Estimated revenue: $1.2 billion by 2030.

References

1. 1. Top 10 most anticipated drug launches of 2025
   2. Journavx