Biosimilars Market Trends 2025: Understanding Erosion and Growth

This article explores how biosimilars market trends are transforming the biologics market, making treatments more affordable and reshaping competition. Drawing from a 2022 comparative analysis of US, Germany, and Switzerland markets (2011–2020) [1] and updated 2024–2025 data [2-4] it analyzes trends in market growth, uptake, and pricing to uncover what’s driving this shift. With over 60 FDA approvals and 40+ US launches by early 2025 (up from just 15 marketed in 2020) [AAM, 2025], the pace of change is accelerating, and understanding these dynamics is key to navigating or capitalizing on this growing market. In the world of biologics, where US net spending reached an estimated ~$390 billion in 2024 (up from $350B in 2023), biosimilars are driving $20.2 billion in savings in 2024 and $56.2 billion cumulatively since 2015.

The Entry Game: Scaling Up, But US Barriers Persist

Biosimilar erosion starts with market access. Europe’s EMA pathway has enabled ~90+ approvals and 80+ marketed products by 2025, compared to the US’s over 60 approvals and 40+ launches—still behind but gaining ground post-2020 [EMA, 2022 with updates; FDA, 2025]. The 2022 analysis highlighted 15 US vs. 52 in Germany/28 in Switzerland by 2020 [1]; today’s figures show Europe maintaining its lead, but US progress from resolved patents (e.g., multiple Humira biosimilars launched in 2023) is narrowing the difference [AAM, 2025].

• Patent Thickets and Litigation Delays: Originators like Humira used extensive patents to delay US entry [1]. Settlements held back adalimumab biosimilars for years, but 2023 launches reduced Humira’s $15B+ annual revenue by notable amounts within months [1; IQVIA, 2025]. Europe’s faster timelines (e.g., earlier adalimumab availability) heighten competitive pressure.

• Regulatory Fragmentation: The US’s 2010 pathway has challenges, excluding some molecules [1], but updates like the Biosimilars Action Plan and IRA have pushed approvals beyond 60 [FDA, 2025]. Still, without a unified system like Europe’s, erosion remains uneven. The US landscape is evolving: By 2024, biosimilars held ~20% average market share (e.g., 40%+ for filgrastim), up from <5% in 2020 [AAM, 2025; 1].

Uptake Acceleration: From Modest Gains to Rapid Share Capture

Uptake—biosimilar units as a share of total sales—has grown quickly, eroding references more than the 2022 data indicated. Historical trends showed steady increases (e.g., 36% for US bevacizumab in year one) [1], but 2024–2025 marks a key shift.

• Initial Highs in Europe, Surge in the US: Germany leads with high launch shares (48% for adalimumab) through tenders [1], with Europe at 20–30% average uptake [EMA, 2022]. The US, starting lower (3% for infliximab), now sees 15%+ annual growth for recent entrants, reaching ~20% overall—driven by Humira erosion and greater awareness [1; IQVIA, 2025]. Filgrastim uptake exceeded 40% by 2024 [AAM, 2025].

• Ingredient-Specific Vulnerabilities: Oncology (bevacizumab) and immunology (adalimumab) experience the fastest erosion, while insulins trail (1–2% in Switzerland) [1]. High-volume categories now face 20–50% share loss within 1–2 years post-launch [IQVIA, 2025]. This creates momentum: As shares reach 20%, payers encourage switches, boosting volume shifts. US biologics’ ~40% spending share on 3% prescriptions makes this area ripe for change [IQVIA, 2025].

Pricing Pressures: Deeper Discounts, Narrowing Gaps

Biosimilars launch at 20–35% discounts today [AAM, 2025], influencing reference pricing. Net prices post-rebates can drop 50–70% [IQVIA, 2025].

• Relative Discounts at Play: US biosimilars enter at 65–80% of references (improved from 55–90% in 2020) [1; FDA, 2025]. Germany varies (65–103%) [1], Switzerland caps at 70–80% [1]. Competition amplifies this, with Humira biosimilars at 85% list price but 50% net or more [AAM, 2025].

• US Cost Premium: Annual savings for Humira biosimilars averaged $4,505 per patient in 2024 (from higher prior medians) [Evernorth, 2025; 1], vs. $700–$1,000 monthly in Germany [1]. References average $8,000–$10,000 US (down from $11,503) [1; IQVIA, 2025]. The US stays 1.5–2x higher than Europe, but IRA negotiations are helping close the gap. This impacts overall margins: Europe’s tenders favor biosimilars; US systems allow rebates, but increasing trust (>70% physician acceptance) speeds adoption [IQVIA, 2025].

The Core Drivers: Accelerators Outpacing Barriers

• Erosion Accelerators:

  • Awareness and Trust: US uptake for recent launches is 20% higher than early ones [1; IQVIA, 2025]. Efforts have reduced skepticism.

  • Payer and Policy Push: IRA and scrutiny have added launches since 2022 [FDA, 2025]; Europe’s approaches support 3–4x more products [EMA, 2022].

  • Economic Imperative: Estimated $390B US biologics spending drives $56.2B+ savings [AAM, 2025].

• Erosion Barriers:

  • Anticompetitive Tactics: Settlements delayed Humira, but recent launches indicate weakening [1; AAM, 2025].

  • Switching Inertia: Some physician hesitation remains, but acceptance has grown [IQVIA, 2025].

  • Supply Constraints: Scaling issues are mostly resolved; underreporting is minimal [1; IQVIA, 2025]. Barriers are less effective now—accelerators are leading the way post-2022.

Strategic Takeaways for Market Participants

• Manage Product Lifecycles: Extend value through innovation and competitive pricing; prepare for 30–50% share shifts by late 2020s [IQVIA, 2025].

• Explore Biosimilar Opportunities: Margins remain viable (20–35% discounts); focus on development in immunology/oncology for growth [FDA, 2025].

• Forecast and Adapt: Use benchmarks like Humira (significant erosion post-launch) to model scenarios [AAM, 2025].

• Global Lessons: Combine Europe’s scale with US momentum for effective strategies.

The Bottom Line: Erosion Accelerates, Access Expands

Biosimilars are expanding affordable access, with ~$34.4 billion global sales in 2024 and $56.2 billion in US cumulative savings signaling a major shift [Precedence Research, 2025; AAM, 2025]. The US premium continues but erodes faster than 2020 trends [1]. Understanding these dynamics can help navigate or capitalize on the $40B+ global opportunity in 2025 and beyond.

References:

1. Carl DL, Laube Y, Serra-Burriel M, Naci H, Ludwig W, Vokinger KN. Comparison of Uptake and Prices of Biosimilars in the US, Germany, and Switzerland. JAMA Netw Open. 2022;5(12):e2244670. doi:10.1001/jamanetworkopen.2022.44670

2. FDA Biosimilars Action Plan Progress Report (July 2024) and Association for Accessible Medicines (AAM), “Biosimilar & Interchangeable Biologics: Driving Savings for America” (2024). Available at: https://www.fda.gov/media/180300/download (FDA) and https://accessiblemeds.org/resources/reports/2024-biosimilars-report/ (AAM)

3. FDA Purple Book (updated monthly, accessed September 2024) and EMA Biosimilars Overview (August 2024). Available at: https://www.fda.gov/drugs/development-approval-process-drugs/purple-book-lists-licensed-biological-products-reference-product-exclusivity-and-biosimilarity-or (FDA) and https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview (EMA)

4. IQVIA Institute for Human Data Science, “Biosimilars in the United States 2023–2027” (October 2023). Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports/biosimilars-in-the-united-states-2023-2027