With the $30B Keytruda franchise leading, Oncology maintained its top position among the top 50 drugs in FY2024, but significant shifts occurred across therapeutic areas. Metabolic Diseases saw major growth, as GLP-1 agonists like Ozempic (+26%), Mounjaro (+124%), and Wegovy (+86%) reshaped the diabetes and obesity markets. Landmark trials from late 2023 to present also confirmed their cardiovascular benefits as next-generation incretins advance. Immunology experienced upheaval; the U.S. biosimilar impact reduced Humira sales (-38%), creating space for Dupixent (+22%) and Skyrizi (+51%) while novel targets advance. Elsewhere, Cardiovascular blockbusters held firm as newer heart failure and transthyretin amyloid cardiomyopathy (ATTR-CM) therapies gained share, and Rare Diseases featured gene therapy approvals alongside established performers like Trikafta (+14.5%). This report details the data and pipeline trends driving these dynamic markets into 2025.
Data reflects performance among leading therapies based on company financial reports.
FY2024 Performance Highlights
FY2024 Sales Snapshot & Trends (Top 50 Drugs)
Sum of 2024 sales for drugs in the Pharma 50 list, grouped by Disease Area.
Drugs with the highest percentage sales growth from 2023 to 2024 (>$2B sales). Note: While Paxlovid tops the list in 2024, its sales have fluctuated significantly from year to year. Paxlovid’s high growth in 2024 reflects a rebound from a low 2023 baseline incurred after a transition from government contracts to the commercial market and related write-offs.
Drugs with the largest absolute increase and decrease in sales (USD Billions) from FY2023 to FY2024.
Therapeutic area highlights (FY2024 Performance), explored in our Pharma 50: Deep Dives report:
Oncology
Remained the top revenue area. Keytruda ($29.5B) continued its dominance in the waning years before its 2028 patent cliff. Darzalex (+19.8% to $11.7B) and Verzenio (+37.4% to $5.3B) posted strong gains alongside ADC expansion. Pipeline focuses on novel combos and cell therapies.
Detailed ADC pipeline analysis & cell therapy forecasts in full report
Metabolic disease
As has been the case in recent years, GLP-1s remain a disruptive force: Ozempic (+25.8%), Mounjaro (+123.5%), and Wegovy (+85.7%) expanded market share in T2D/obesity. Pipeline features next-gen incretins and oral options.
Next-gen incretin analysis & oral GLP-1 timeline in full report
Immunology
Humira biosimilar impact eroded sales (–37.6%), while Dupixent (+22.1%), Skyrizi (+50.9%), and Rinvoq (+50.4%) gained. Meanshile, Stelara (-4.6%) faced pre-biosimilar pressure as novel targets like TL1A advance.
Biosimilar impact modeling and TL1A target analysis in full report
Cardiovascular
Market leaders like Eliquis (> $20B combined) anchored the segment, while Entresto (+29.6%) and Vyndaqel (+64.1%) showed high growth in FY2024. Pipeline targets residual risk via oral PCSK9i, Lp(a), and Factor XI agents.
Oral PCSK9i, Lp(a), & Factor XI pipeline deep dive in full report
Rare diseases
Blockbuster Trikafta ($10.2B, +14.5%) and rapid Vyndaqel growth highlighted the area. Gene therapy approvals (e.g., sickle cell disease) mark a new era, though market access remains key.
Gene therapy market access analysis & rare disease forecasts in full report
Other areas
Includes strong performance in Respiratory (Trikafta), steady growth in Neurology (Ocrevus), fluctuations in Vaccines (COVID-19 products), and key Psychiatry drugs (Vraylar). Several areas show innovation.
Multi-therapeutic area innovation tracking & market dynamics in full report
Aggregated FY2024 sales from the list for leading manufacturers (based on first listed manufacturer for collaborations).
This chart plots FY2024 Sales (Log Scale X-axis) against 2023-2024 % Growth (Y-axis). Note the extreme growth percentage for Paxlovid (350%), an artifact of its post-pandemic sales normalization. High-volume oncology drugs (blue) cluster with moderate growth, while several metabolic (e.g., peach) and Immunology (e.g., green) drugs show strong growth from smaller or mid-sized bases.
Trends to watch in 2025: FDA workforce changes, China’s momentum, and IRA legal battles
The pharmaceutical industry faces unprecedented transformation in 2025 as multiple forces converge: a 20% FDA workforce reduction threatens to create regulatory bottlenecks, China’s R&D expenditure reaches 96% of U.S. levels with Chinese assets now representing 31% of molecules in-licensed by multinationals, and the IRA’s price negotiations demonstrate 38-79% reductions from list prices. Meanwhile, ongoing supply chain vulnerabilities persist despite GLP-1 shortage resolutions:
- Value-driven growth and biologics shift: IQVIA projects global biotech spending to grow 9.5-12.5% annually (CAGR) through 2028, hitting $890 billion. By then, it will constitute 39% of the total pharma market. Oncology is likely to continue its lead with 14-17% CAGR and immunology growing at a steadier pace (2-5% CAGR). High-value modalities like mAbs (pipeline grew 18% last year), ADCs (22% pipeline growth, expanding beyond oncology), and bispecifics are growing at a swift pace. But high costs are attracting intense payer scrutiny (e.g., IRA, EU HTA).
- Intensifying biosimilar competition: As of April 2025, at least six biosimilars to ustekinumab (Stelara) have entered the U.S. market. Amgen’s Wezlana (ustekinumab-auub) received FDA approval in October 2023 as an interchangeable biosimilar and launched in January 2025 following a settlement with J&J. Teva and Alvotech’s Selarsdi (ustekinumab-aekn) was approved in April 2024 and became available in February 2025 under a similar agreement. Selarsdi has been granted provisional interchangeability status, with full interchangeability permitted after April 30, 2025, upon the expiration of Wezlana’s exclusivity period. As noted above, biosimilar uptake is also cutting into sales of Humira, a modified version of which is pictured at right.
[Protein Data Bank]
- Supply chain vulnerabilities: As of February 21, 2025, FDA declared the shortages of semaglutide-based medications, Ozempic and Wegovy, officially resolved, concluding nearly three years of limited availability due to surging demand. Despite this resolution, systemic vulnerabilities continue to affect essential medicines. The United States Pharmacopeia’s (USP) 2024–2025 Vulnerable Medicines List identifies that roughly seven out of ten of the 100 most at-risk medications are injectables. Of those, the top five are sodium chloride injection, dextrose injection, heparin sodium injection, propofol injectable emulsion, and lidocaine hydrochloride injection. Adding to the supply chain uncertainty are tariffs. On February 4, 2025, the U.S. implemented additional tariffs on imports from China and Hong Kong. The U.S. imposed a 10% ad valorem duty on a broad range of products, including pharmaceutical materials. As of April 2025, the tariff situation remains volatile. on April 9, 2025, the U.S. increased tariffs on Chinese goods to 125% while signaling intent to impose tariffs on pharmaceutical imports.
[Adobe Stock]
- U.S. Inflation Reduction Act (IRA) questions: The first negotiated Maximum Fair Prices showed 38–79% reductions from 2023 list prices (effective 2026). Meanwhile, CMS named 15 more Part D drugs (all small molecules) for 2027 prices. Ten lawsuits challenge constitutionality, with the first appellate decision (Third Circuit) expected Q1 2025; Supreme Court appeals are likely. Small molecule R&D funding reportedly dipped 70% owing to the 9-year vs. 13-year negotiation eligibility (“pill penalty”). Meanwhile bipartisan bills (EPIC, Orphan Cures Act) propose amendments. The $2,000 Part D out-of-pocket cap became effective in 2025. There are, however, active discussion about repealing or modifying portions of the Inflation Reduction Act (IRA), especially its clean energy provisions. Yet a full repeal faces a potential uphill battle.
[Pexels]
China and AI are gaining R&D clout: AI-developed candidates show demonstrably higher Phase 1 success rates (reported 80-90%) versus traditional methods (roughly 40%), fueling adoption. The 2024 Nobel Prize in Chemistry was awarded to Demis Hassabis and John Jumper of DeepMind, and David Baker of the University of Washington, for their work on AlphaFold and computational protein design. Meanwhile, China’s role as an innovation source surged. Roche partnered with China’s Innovent in January 2025 for an ADC (IBI3009) targeting small cell lung cancer, with $80 million upfront and up to $1 billion in milestones. GSK entered two major ADC deals: in December 2023 with Hansoh Pharma for HS-20093 (B7-H3-targeting; $1.7 billion total), and in December 2024 with DualityBio for DB-1324 (gastrointestinal cancers; up to $1 billion).
FDA resource constraints: HHS initiated a roughly 3,500 FDA position cuts (nearly 20% of full-time staff) in early 2025 under Secretary Kennedy Jr. While aiming to spare frontline reviewers, cuts significantly hit crucial support staff (Project Managers, application handlers, policy, regulatory science) and coincided with leadership exits. Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), resigned effective April 5, 2025. Similarly, Dr. Peter Stein, Director of the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs, was reportedly forced out amid the restructuring. These developments come as the HHS drug shortage coordinator role is set to expire in May 2025.
Filed Under: Pharma 50
