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Biosimilars Market - Global Forecast 2025-2032

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    Report

  • 192 Pages
  • November 2025
  • Region: Global
  • 360iResearch™
  • ID: 6083156
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The global biosimilars market is at a pivotal phase, marked by innovation, regulatory evolution, and growing interest from healthcare stakeholders. This comprehensive report provides in-depth insights tailored to senior decision-makers seeking to evaluate opportunities and risks within the expanding biosimilars landscape.

Market Snapshot: Growth and Competitive Landscape in the Biosimilars Market

The biosimilars market grew from USD 31.83 billion in 2024 to USD 35.27 billion in 2025, maintaining an impressive compound annual growth rate (CAGR) of 11.61%. Forecasts indicate the sector will reach USD 76.68 billion by 2032. This sustained advancement is driven by a steady pipeline of biosimilar applicants, the expiration of exclusivity periods for key biologic patents, and accelerating adoption across diverse therapeutic areas. Market players are responding by investing in advanced manufacturing, forging strategic alliances, and developing new commercialization models to enhance accessibility and cost containment across global healthcare systems.

Scope & Segmentation: Mapping the Biosimilars Market

This report offers an extensive segmentation analysis, enabling a granular view of the biosimilars ecosystem across product categories, indications, administration methods, user channels, and regions.

  • Product Types: Erythropoietin, Follitropin, Granulocyte-Colony Stimulating Factor (G-CSF), Human Growth Hormone, Insulin, Interferons, Monoclonal Antibodies (mAbs)
  • Indications: Autoimmune Diseases, Blood Disorders, Diabetes, Growth Hormone Deficiency, Infectious Diseases, Oncology
  • Administration Routes: Intramuscular, Intravenous, Subcutaneous
  • End Users: Clinics, Homecare, Hospitals
  • Regions & Sub-Regions: Americas (United States, Canada, Mexico, Brazil, Argentina, Chile, Colombia, Peru), Europe, Middle East & Africa (United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland, United Arab Emirates, Saudi Arabia, Qatar, Turkey, Israel, South Africa, Nigeria, Egypt, Kenya), Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan)
  • Key Industry Players: Alvotech S.A, Amgen Inc., Apotex Inc., Biocon Limited, BioFactura, Inc., Biogen Inc., Boehringer Ingelheim International GmbH, Catalent, Inc, Celltrion Healthcare Co.,Ltd., Coherus BioSciences, Dr. Reddy's Laboratories Limited, Eden Biologics, Inc., F. Hoffmann-La Roche AG, Fresenius Kabi, Innovent Biologics, Inc., Intas Pharmaceuticals Ltd., Kashiv BioSciences, LLC., Merck KGaA, NeuClone, Nippon Kayaku Co., Ltd., Novartis AG, Panacea Biotec Limited, Pfizer Inc., Samsung Bioepis Co., Ltd., Sanofi S.A., Shanghai Henlius Biotech, Inc., Teva Pharmaceutical Industries Ltd., Thermo Fisher Scientific, Inc., Apobiologix

Biosimilars Market: Key Takeaways for Strategy and Decision-Making

  • Market expansion is closely tied to advances in manufacturing efficiency and the scalability of expression systems, supporting comparative quality to reference biologics.
  • Regulatory harmonization in major regions simplifies international launches and supports consistent pharmacovigilance, easing barriers for global market entry.
  • Strategic alliances across development and commercialization enable reduced time-to-market and risk mitigation amid increasing competition and complex supply chains.
  • Shifts in payer and provider perceptions are facilitating greater acceptance of biosimilars, especially as robust real-world evidence and educational initiatives gain traction.
  • Companies are diversifying their portfolios, targeting high-value therapeutic areas such as oncology and diabetes, supported by the adoption of state-of-the-art manufacturing technologies.
  • Segment-specific product design—including prefilled delivery devices and adaptable administration options—improves patient adherence and supports homecare adoption.

Impact of 2025 US Tariffs on Supply Chains and Pricing

The introduction of US tariffs in 2025 is reshaping procurement and sourcing strategies for biosimilar manufacturers. Companies dependent on imported raw materials or intermediates face increased input costs, prompting a shift toward domestic sourcing and revised contractual agreements to mitigate volatility. Manufacturers are emphasizing operational agility through procurement adaptations, and proactive stakeholder engagement is critical to preserving supply chain resilience, cost control, and market competitiveness within the biosimilars sector.

Methodology & Data Sources

This report combines primary interviews with senior industry executives and regulatory experts alongside secondary research from peer-reviewed journals, patent filings, and proprietary transaction databases. Findings are validated through methodological audits, interview triangulation, and in-depth case study analyses to ensure accuracy and actionable insights for strategic planning.

Why This Report Matters for Senior Decision-Makers

  • Provides a comprehensive outlook across segmentation, regional trends, and competitive positioning to inform strategic investments or market entry decisions.
  • Equips leaders with scenario analyses for navigating policy changes, supply chain challenges, and evolving regulatory frameworks essential to the biosimilars market.
  • Supports data-driven portfolio diversification and risk management by highlighting opportunities in emerging therapeutic areas and geographic markets.

Conclusion

This analysis empowers stakeholders to navigate the evolving biosimilars environment with data-backed clarity. By leveraging segmentation insights and scenario planning, organizations can secure sustainable growth and competitive differentiation in the global biosimilars market.

Table of Contents

1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Regulatory alignment across regions accelerates approval pathways for complex biosimilars
5.2. Advanced cell line engineering drives cost-effective manufacturing of high-demand biosimilars
5.3. Surge in real-world evidence studies boosts clinician and payer confidence in biosimilar use
5.4. Emerging market expansions reshape global competition and pricing strategies for biosimilars
5.5. Interchangeability designations and pharmacist substitution laws transform biosimilar adoption
5.6. Digital health integrations support biosimilar pharmacovigilance and real world evidence generation at scale
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Biosimilars Market, by Product Type
8.1. Erythropoietin
8.2. Follitropin
8.3. Granulocyte-Colony Stimulating Factor (G-CSF)
8.4. Human Growth Hormone
8.5. Insulin
8.6. Interferons
8.7. Monoclonal Antibodies (mAbs)
9. Biosimilars Market, by Indication
9.1. Autoimmune Diseases
9.2. Blood Disorders
9.3. Diabetes
9.4. Growth Hormone Deficiency
9.5. Infectious Diseases
9.6. Oncology
10. Biosimilars Market, by Administration Route
10.1. Intramuscular
10.2. Intravenous
10.3. Subcutaneous
11. Biosimilars Market, by End User
11.1. Clinics
11.2. Homecare
11.3. Hospitals
12. Biosimilars Market, by Region
12.1. Americas
12.1.1. North America
12.1.2. Latin America
12.2. Europe, Middle East & Africa
12.2.1. Europe
12.2.2. Middle East
12.2.3. Africa
12.3. Asia-Pacific
13. Biosimilars Market, by Group
13.1. ASEAN
13.2. GCC
13.3. European Union
13.4. BRICS
13.5. G7
13.6. NATO
14. Biosimilars Market, by Country
14.1. United States
14.2. Canada
14.3. Mexico
14.4. Brazil
14.5. United Kingdom
14.6. Germany
14.7. France
14.8. Russia
14.9. Italy
14.10. Spain
14.11. China
14.12. India
14.13. Japan
14.14. Australia
14.15. South Korea
15. Competitive Landscape
15.1. Market Share Analysis, 2024
15.2. FPNV Positioning Matrix, 2024
15.3. Competitive Analysis
15.3.1. Alvotech S.A
15.3.2. Amgen Inc.
15.3.3. Apotex Inc.
15.3.4. Biocon Limited
15.3.5. BioFactura, Inc.
15.3.6. Biogen Inc.
15.3.7. Boehringer Ingelheim International GmbH
15.3.8. Catalent, Inc
15.3.9. Celltrion Healthcare Co.,Ltd.
15.3.10. Coherus BioSciences
15.3.11. Dr. Reddy's Laboratories Limited
15.3.12. Eden Biologics, Inc.
15.3.13. F. Hoffmann-La Roche AG
15.3.14. Fresenius Kabi
15.3.15. Innovent Biologics, Inc.
15.3.16. Intas Pharmaceuticals Ltd.
15.3.17. Kashiv BioSciences, LLC.
15.3.18. Merck KGaA
15.3.19. NeuClone
15.3.20. Nippon Kayaku Co., Ltd.
15.3.21. Novartis AG
15.3.22. Panacea Biotec Limited
15.3.23. Pfizer Inc.
15.3.24. Samsung Bioepis Co., Ltd.
15.3.25. Sanofi S.A.
15.3.26. Shanghai Henlius Biotech, Inc.
15.3.27. Teva Pharmaceutical Industries Ltd.
15.3.28. Thermo Fisher Scientific, Inc.
15.3.29. Apobiologix

Companies Mentioned

The companies profiled in this Biosimilars market report include:
  • Alvotech S.A
  • Amgen Inc.
  • Apotex Inc.
  • Biocon Limited
  • BioFactura, Inc.
  • Biogen Inc.
  • Boehringer Ingelheim International GmbH
  • Catalent, Inc
  • Celltrion Healthcare Co.,Ltd.
  • Coherus BioSciences
  • Dr. Reddy's Laboratories Limited
  • Eden Biologics, Inc.
  • F. Hoffmann-La Roche AG
  • Fresenius Kabi
  • Innovent Biologics, Inc.
  • Intas Pharmaceuticals Ltd.
  • Kashiv BioSciences, LLC.
  • Merck KGaA
  • NeuClone
  • Nippon Kayaku Co., Ltd.
  • Novartis AG
  • Panacea Biotec Limited
  • Pfizer Inc.
  • Samsung Bioepis Co., Ltd.
  • Sanofi S.A.
  • Shanghai Henlius Biotech, Inc.
  • Teva Pharmaceutical Industries Ltd.
  • Thermo Fisher Scientific, Inc.
  • Apobiologix

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