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Biosimilars Market - Global Forecast 2025-2032

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    Report

  • 192 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 6083156
UP TO OFF until Jan 01st 2026
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The biosimilars market is evolving rapidly, marked by increasing adoption, technological advances, and strategic collaborations that are transforming competitive dynamics for industry leaders and new entrants alike.

Market Snapshot: Biosimilars Market Size and Growth

The biosimilars market grew from USD 31.83 billion in 2024 to USD 35.27 billion in 2025. It is expected to continue growing at a CAGR of 11.61%, reaching USD 76.68 billion by 2032. This strong expansion reflects escalating demand for more affordable biologic alternatives across major therapeutic areas and an expanded global reach driven by supportive regulatory frameworks.

Scope & Segmentation

  • 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: Americas (United States, Canada, Mexico, Brazil, Argentina, Chile, Colombia, Peru), Europe (United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland), Middle East (United Arab Emirates, Saudi Arabia, Qatar, Turkey, Israel), Africa (South Africa, Nigeria, Egypt, Kenya), and Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan).
  • Companies Analyzed: 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.

Key Takeaways for Decision-Makers

  • Scientific innovation and collaboration are fueling biosimilars adoption, providing fresh momentum across major therapeutic classes.
  • Streamlined regulatory approval processes and evolving global harmonization are lowering barriers to entry while building confidence among providers and payers.
  • Biosimilars are driving transformation in both hospital and outpatient care with expanded administration options, from intravenous infusions to home-based subcutaneous delivery.
  • Strategic alliances, vertical integration, and digital supply chain monitoring are becoming critical levers in response to evolving policy and pricing pressures.
  • Market leaders are investing in flexible manufacturing technologies and next-generation cell lines to optimize production and ensure product consistency.

2025 United States Tariffs: Impact on the Biosimilars Market

New tariffs imposed by the United States in 2025 present significant challenges for supply chain stability, cost structures, and international procurement. Manufacturers reliant on imported raw materials are reassessing sourcing strategies, pursuing domestic partnerships and longer-term agreements to reduce exposure. Downstream, these changes may require renegotiation with payers and group purchasing organizations to sustain attractive value propositions and prevent cost burdens from undermining competitiveness. Real-time scenario planning and stakeholder engagement are advised to mitigate policy risks and maintain reliability across the supply chain.

SEO Focus: Biosimilars Market and Secondary Keywords

The biosimilars market demonstrates strong growth potential amid increasing biologic drug utilization and maturing regulatory oversight. Therapeutic alternatives; global healthcare ecosystems; product comparability; and advanced bioprocessing are central themes underpinning expansion and innovation.

Methodology & Data Sources

This report integrates primary research with senior executives and experts alongside comprehensive secondary research from journals, filings, and proprietary transaction records. Triangulation of qualitative and quantitative data, peer review, and cross-functional validation underpin methodological rigor and ensure actionable reliability for decision-makers.

Why This Report Matters

  • Provides a strategic roadmap for pipeline optimization, market access acceleration, and regulatory navigation.
  • Enables scenario planning to proactively respond to shifting policy, tariff, and market access challenges.
  • Delivers practical, actionable intelligence for R&D, commercial, and regulatory functions determining biosimilars investments.

Conclusion

Biosimilars are set to transform mainstream healthcare through expanded patient access, advanced manufacturing, and innovative partnerships. Leveraging this analysis can empower leadership teams to navigate uncertainty and accelerate sustainable growth across the biosimilars value chain.

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
List of Tables
List of Figures

Samples

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Companies Mentioned

The key 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

Table Information