Biosimilars Market Outlook, Growth Trends, Regulatory Landscape and Opportunities 2025–2034

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Luton, Bedfordshire, United Kingdom, June 23, 2025 (GLOBE NEWSWIRE) -- Biosimilars Market Report: 2024–2025 Overview
Foreword
Biosimilars have emerged as a powerful tool in the global healthcare arsenal, delivering cost-effective alternatives to high-priced biologics and expanding patient access. As policymakers, payers, providers, and manufacturers align incentives around value, biosimilars are reshaping therapeutic landscapes and fueling generics-style competition in biologics.
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The biosimilars market is anticipated to reach a valuation of approximately $25 billion in 2024, driven by increasing demand for cost-effective biologic therapies and a growing prevalence of chronic diseases. The market is projected to expand significantly, with an estimated value of $60 billion by 2034, reflecting a robust Compound Annual Growth Rate (CAGR) of around 9% during the forecast period from 2025 to 2034.
Segmentation
By Product, Indication, and Region.
BY PRODUCT
Monoclonal Antibodies
Infliximab
Trastuzumab
Rituximab
Adalimumab
Other
Insulin
Granulocyte Colony-Stimulating Factor
Erythropoietin
Recombinant Human Growth Hormone
Etanercept
Follitropin
Teriparatide
Interferons
Enoxaparin Sodium
Glucagon
Calcitonin
BY INDICATION
Oncology
Inflammatory & Autoimmune Disorders
Chronic Diseases
Blood Disorders
Growth Hormone Deficiency
Infectious Diseases
Others
BY REGION
North America
Europe
Asia Pacific
South America
Middle East and Africa
As one health policy expert remarked during a POLITICO Focus roundtable: > 'Experts explored the pivotal role that biosimilars play in strengthening the nation's health care system…'
Scientific and regulatory leaders also emphasize mitigating biases and reinforcing confidence. Professor Schellekens notes: > 'Biosimilars often have even a higher quality than the reference products.'
Additional insights from industry leaders underline the ongoing transformation: - Sarah Yim (FDA): 'Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.' - Adam Fein (Drug Channels): 'For 2025, the three largest pharmacy benefit managers… have again each excluded hundreds of drugs from their standard formularies… creating an increasingly confusing and crowded biosimilar marketplace.' - Alex Brill (Matrix Global Advisors): 'Is the biosimilar market a failure with respect to these pharmacy benefit drugs like Humira? Maybe in March it was, but in April it's starting to look functional again.' - Jon Martin (Organon): 'That's what gives us some optimism,' referring to expectations that biosimilars can gain ~50% share over time, as seen with Remicade. - AMCP 2025 Reports: 'High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US.' - Sandoz Spokesperson: 'Misaligned incentives across the US healthcare system have led to meaningful delays and barriers to biosimilar adoption, resulting in significant missed opportunities for healthcare savings.'
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Market Size & Segmentation
Global Valuation & Growth:
USD 18.65 billion (2024), rising to 21.95 billion in 2025. Estimated CAGR: 17.7% to USD 42.16 billion by 2029.
Other projections suggest growth from USD 40.4 billion (2025) to USD 176 billion by 2034 at 17.8% CAGR.
Segmentation:
By Therapeutic Area: Oncology, autoimmune diseases, metabolic disorders.
By Molecule Type: Monoclonal antibodies, G-CSF, insulin, epoetins.
By Application: Chronic and acute care.
By Region: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.
Key Players
Established Leaders: Amgen, Novartis/Sandoz, Samsung Bioepis, Pfizer, Celltrion, Biogen, Coherus, Merck & Co., Dr. Reddy's, Biocon, Intas.
Emerging Names: CVS/Cordavis, Alvotech, Kashiv BioSciences, Fresenius Kabi.
Key Market Events (2024–2025)
FDA Approvals: Over 60 biosimilars approved in the U.S. as of late 2024.
Ustekinumab Biosimilars Launch: Products like Wezlana, Pyzchiva, and Imuldosa began sales in Q1 2025.
CVS Cordavis x Sandoz: Hyrimoz launched as a private-label biosimilar for Humira in the U.S. (Apr 2024).
Humira Dynamics: Despite biosimilar competition, Humira retained over 80% U.S. market share in 2024 due to PBM rebates.
India Rule Overhaul: Indian regulators revised biosimilar manufacturing and quality frameworks (May 2025).
Recent Company Developments: Adalimumab Biosimilars (2024–2025)
1. Amgen – Amjevita
Key 2025 Development: Listed as a preferred biosimilar on the Optum Rx formulary, which is one of the largest pharmacy benefit managers (PBMs) in the U.S. This significantly improves market access.
Real-World Evidence (RWE): Amgen has emphasized clinical performance data and safety outcomes to support payer decisions. The strong RWE backing is helping Amjevita remain competitive despite the influx of newer biosimilars.
Market Insight: Despite being the first biosimilar launched in the U.S. (January 2023), initial uptake was slow due to high WAC pricing. However, Amgen's subsequent pricing strategies and improved payer contracts have revitalized adoption.
2. Boehringer Ingelheim – Cyltezo
Milestone Achievement: Cyltezo remains the only FDA-approved interchangeable biosimilar to Humira that is available in both high- and low-concentration formulations.
Market Differentiation: Interchangeability status is a key competitive edge as it allows automatic substitution at the pharmacy level (subject to state laws), improving prescription volume.
Strategic Positioning: Being early to achieve interchangeability has helped Boehringer establish trust among prescribers and pharmacists, especially in rheumatology and gastroenterology.
3. Sandoz – Hyrimoz
Recent Development: Though initially launched with multiple dosage strengths (including citrate-free and high-concentration options), Hyrimoz faced formulary exclusion in 2025 from several key PBMs.
Market Impact: This exclusion impacted Sandoz's market share, pushing the company to focus on institutional sales and non-PBM-aligned providers.
Commercial Focus: Sandoz is working on reinforcing relationships with IDNs (Integrated Delivery Networks) and specialty clinics to maintain uptake.
4. Coherus BioSciences – Yusimry
Remarkable Market Share: By early 2025, Yusimry had captured ~33% of the rheumatology market, becoming a major player.
Cost Leadership Strategy: Coherus pursued an aggressive low-cost model, offering Yusimry at a 70–85% discount to branded Humira.
Retail Success: Coherus partnered with Mark Cuban's Cost Plus Drug Company, making Yusimry directly accessible to consumers at discounted prices, thereby bypassing traditional PBMs.
5. Biocon Biologics / Viatris (Mylan) – Hulio
Key Update: In June 2025, Hulio received FDA interchangeability designation, allowing it to be substituted for Humira at the pharmacy level.
Competitive Edge: This places Hulio in a more favorable reimbursement tier, potentially improving market access in the latter half of 2025.
Partnership Model: Now solely marketed by Biocon (after acquiring Viatris' biosimilar business), Hulio's commercialization is focused on cost competitiveness and institutional penetration.
6. Pfizer – Abrilada
Launch Recap: Though approved earlier, Pfizer launched Abrilada in late 2023. By 2024–2025, it secured strong placement in major PBM formularies, including CVS Caremark.
Advantages: Abrilada benefits from Pfizer's established distribution network and payer negotiation strength.
Clinical Support: Pfizer's robust clinical trial data and real-world validation helped in promoting Abrilada among conservative prescribers.
7. Organon / Samsung Bioepis – Hadlima
Dosing Options: Hadlima is unique in offering multiple administration options, including autoinjectors and prefilled syringes with both high- and low-concentration versions.
Evolving Formulary Position: While not the first-mover, Hadlima is gradually gaining access across PBMs and health systems by undercutting competitors on pricing and offering flexibility in administration.
Target Market: Focused on dermatology and GI segments due to its versatility and delivery mechanisms.
8. Celltrion – Yuflyma
High-Concentration Formulation: One of the few biosimilars that mimic the high-concentration, citrate-free version of Humira, preferred by many patients due to reduced injection volume and discomfort.
Interchangeability Status: Expected by late 2024, this could significantly enhance Yuflyma's market access through automatic substitution pathways.
Commercial Strength: Celltrion's U.S. entry has been backed by a direct sales force and aggressive discounting.
9. Fresenius Kabi – Idacio
Institutional Play: Idacio is marketed primarily in low-concentration injectable form, making it attractive for hospital and outpatient clinic use.
Strategic Niche: Rather than competing head-on in retail, Fresenius is targeting group purchasing organizations (GPOs) and long-term care facilities.
Moderate Uptake: While slower in market penetration, its institutional strategy is ensuring a steady adoption curve.
10. Alvotech – Simlandi
Key Approval: In February 2024, Alvotech's Simlandi became the first high-concentration Humira biosimilar to gain FDA approval with interchangeability.
Significance: This combination (high concentration + interchangeability) makes Simlandi a major competitive threat to both Amjevita and Yuflyma.
Commercial Expansion: Alvotech is partnering with Teva for U.S. commercialization and focusing on payer contracts and formulary inclusion throughout 2025.
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Key Funding Deals (2024–2025)
Biocon Biologics: Continued global expansion and investment.
Bio-RIDE Scheme (India): $1.2B biotech initiative supporting biosimilar development.
Cloudsek (APAC threat analytics): $19M funding round relevant to regulatory compliance and digital oversight.
Government Initiatives & Regulations
U.S. FDA Biosimilars Action Plan: Ongoing efforts to improve biosimilar approvals, labeling, and interchangeability.
BPCI Act: Continues to guide abbreviated regulatory pathway for biosimilar market entry.
Bio-RIDE Scheme (India): Supporting local biotech infrastructure and biosimilar manufacturing.
EU and UK Regulatory Expansion: EU's centralized procedure and NHS guidance help drive biosimilar uptake.
Most Sold Biosimilars by Region
USA: - High-volume products: Filgrastim (Zarxio), Pegfilgrastim, Rituximab, Bevacizumab, Infliximab, Ranibizumab. - 2024 Adoption Trend: Humira biosimilars like Amjevita, Hyrimoz, Cyltezo, Simlandi began capturing 20%+ share.
Europe: - Dominant biosimilars: Adalimumab (Amgevita, Hulio), Infliximab (Remsima, Inflectra), Etanercept (Benepali), Aflibercept, Ustekinumab.
APAC: - Top products: Truxima, Remsima, Herzuma (Infliximab biosimilars); Yuflyma, Cadalimab (Adalimumab). - Usage Drivers: Broad use in India, China, South Korea; strong domestic production.
LATAM: - Common imports: Remsima, Amgevita, Benepali. - Adoption via: Public tenders in Brazil, Mexico, and Argentina.
Volume-Based Rankings & Sales Figures
USA: - Filgrastim: ~88% volume share. - Pegfilgrastim: ~82% share. - Rituximab: ~76% share. - Bevacizumab: ~64% share. - Infliximab: ~49% share. - Ranibizumab: ~42–51% share. - Humira Biosimilars: USD 1.54B in 2025, forecast to USD 7.7B by 2032 (26% CAGR).
EU: - IQVIA estimate: ~30–37% of total biologic volume from biosimilars.
APAC: - Regional Revenue: USD 8.43B (2023), forecast to USD 46B by 2033.
LATAM: - Limited data: Highest volume for infliximab, adalimumab via EU imports.
The biosimilars market is rapidly advancing toward USD 90–176 billion by 2034, propelled by patent cliffs (e.g., Humira, Stelara), policy reforms, payer cost pressures, and improved trust in biosimilar interchangeability. As stakeholders navigate volume penetration, pricing battles, and rebate challenges, success will rely on clear clinical guidance, supply chain localization, and educational outreach.
This report compiles key data for manufacturers, investors, regulators, and health systems to strategize entry, pricing, policy, and growth in biosimilars across therapeutic classes and global markets.
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