세계의 바이오시밀러 단클론항체 시장 : 시장 규모 분석(종류별, 적응증별, 최종사용자별, 지역별) 및 예측(2022-2032년)

Global Biosimilar Monoclonal Antibodies Market is valued approximately at USD 10.63 billion in 2023 and is anticipated to grow with a remarkable CAGR of 22.20% over the forecast period 2024-2032. The biosimilar monoclonal antibodies industry is ushering in a new era of therapeutic affordability and accessibility, significantly reshaping the biologics landscape. Monoclonal antibodies, once confined to branded, high-cost biological drugs, are now entering a phase of democratization through biosimilar counterparts that promise comparable efficacy, safety, and quality. These agents, designed to target specific cell receptors and pathways, have become vital tools in the treatment of chronic illnesses ranging from oncology to autoimmune conditions. With blockbuster patents expiring and regulatory frameworks streamlining approvals, the biosimilar monoclonal antibody market is poised for exponential uptake, particularly in healthcare systems struggling with escalating biologics spending.

Multiple factors converge to drive this dynamic market. Chief among them is the surging incidence of cancers and immune-related diseases worldwide, necessitating cost-effective yet high-impact therapeutic options. Additionally, healthcare providers are increasingly favoring biosimilars to contain drug costs without compromising clinical outcomes. Governments and payers are also stepping in, enacting substitution-friendly policies and incentivizing biosimilar prescriptions. Biopharmaceutical innovators are capitalizing on this momentum by accelerating biosimilar development pipelines and investing in cutting-edge manufacturing technologies to scale production efficiently. However, despite the momentum, challenges such as physician skepticism, limited awareness among patients, and complex regulatory demands in emerging economies pose tangible hurdles.

In an increasingly competitive environment, market players are executing a multifaceted approach-combining aggressive pricing strategies, strategic collaborations, and localized supply chains to strengthen their foothold. Several companies are expanding into unpenetrated geographies through licensing agreements and public-private partnerships, especially in Asia and Latin America, where demand for affordable biologics is surging. Moreover, biosimilar developers are leveraging advanced analytics and artificial intelligence to enhance comparability studies and streamline clinical trial design. These tactics not only speed up time-to-market but also reduce operational burdens, ultimately making biosimilars a more viable investment for innovators and stakeholders alike.

Patient-centricity is gradually becoming the heart of this evolving landscape. Companies are creating biosimilar formulations with user-friendly delivery mechanisms such as prefilled syringes and autoinjectors to enhance adherence and treatment convenience. In oncology, biosimilar monoclonal antibodies are transforming the way treatment is approached by lowering costs across both first-line and advanced care regimens. Meanwhile, the autoimmune segment is also witnessing a rise in off-label biosimilar use, especially in inflammatory conditions like rheumatoid arthritis and Crohn's disease. The ongoing alignment between biosimilar developers, healthcare professionals, and advocacy groups is fostering greater trust and uptake, particularly as real-world evidence continues to validate the efficacy of these products.

Geographically, North America leads the market with robust regulatory backing from the FDA and increasing biosimilar adoption within clinical practice. Europe, long considered a pioneer in biosimilars, maintains a stronghold thanks to mature reimbursement policies and widespread physician acceptance. The Asia Pacific region is forecasted to exhibit the highest growth rate during the forecast period, driven by expanding patient populations, rising biologic demand, and government initiatives to reduce drug spending. Countries like China, India, and South Korea are becoming biosimilar manufacturing powerhouses, with streamlined regulatory pathways enabling rapid development. Latin America and the Middle East & Africa are also gaining momentum, spurred by cross-border alliances and WHO-led immunotherapy initiatives.

Major market player included in this report are:

• Pfizer Inc.
• Amgen Inc.
• Celltrion Healthcare
• Novartis AG
• Mylan N.V.
• Biocon Biologics Ltd.
• Teva Pharmaceutical Industries Ltd.
• Samsung Bioepis Co., Ltd.
• Merck & Co., Inc.
• Fresenius Kabi AG
• Dr. Reddy's Laboratories Ltd.
• STADA Arzneimittel AG
• Coherus BioSciences, Inc.
• Boehringer Ingelheim International GmbH
• Eli Lilly and Company

The detailed segments and sub-segment of the market are explained below:

By Type

• Adalimumab
• Bevacizumab
• Infliximab
• Rituximab
• Trastuzumab
• Others

By Indication

• Oncology
• Autoimmune Diseases
• Others

By End User

• Hospitals
• Cancer Treatment Centers
• Others

By Region:

• North America
• U.S.
• Canada
• Europe
• UK
• Germany
• France
• Spain
• Italy
• Rest of Europe
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• Rest of Asia Pacific
• Latin America
• Brazil
• Mexico
• Rest of Latin America
• Middle East & Africa
• Saudi Arabia
• South Africa
• Rest of Middle East & Africa

Years considered for the study are as follows:

• Historical year - 2022
• Base year - 2023
• Forecast period - 2024 to 2032

Key Takeaways:

• Market Estimates & Forecast for 10 years from 2022 to 2032.
• Annualized revenues and regional level analysis for each market segment.
• Detailed analysis of geographical landscape with Country level analysis of major regions.
• Competitive landscape with information on major players in the market.
• Analysis of key business strategies and recommendations on future market approach.
• Analysis of competitive structure of the market.
• Demand side and supply side analysis of the market.

Table of Contents

Chapter 1. Global Biosimilar Monoclonal Antibodies Market Executive Summary

• 1.1. Global Biosimilar Monoclonal Antibodies Market Size & Forecast (2022-2032)
• 1.2. Regional Summary
• 1.3. Segmental Summary
  • 1.3.1. By Type
  • 1.3.2. By Indication
  • 1.3.3. By End User
• 1.4. Key Trends
• 1.5. Recession Impact
• 1.6. Analyst Recommendation & Conclusion

Chapter 2. Global Biosimilar Monoclonal Antibodies Market Definition and Research Assumptions

• 2.1. Research Objective
• 2.2. Market Definition
• 2.3. Research Assumptions
  • 2.3.1. Inclusion & Exclusion
  • 2.3.2. Limitations
  • 2.3.3. Supply Side Analysis
    • 2.3.3.1. Availability
    • 2.3.3.2. Infrastructure
    • 2.3.3.3. Regulatory Environment
    • 2.3.3.4. Market Competition
    • 2.3.3.5. Economic Viability (Payer & Provider Perspective)
  • 2.3.4. Demand Side Analysis
    • 2.3.4.1. Regulatory Frameworks
    • 2.3.4.2. Technological Advancements
    • 2.3.4.3. Environmental Considerations
    • 2.3.4.4. Stakeholder Awareness & Acceptance
• 2.4. Estimation Methodology
• 2.5. Years Considered for the Study
• 2.6. Currency Conversion Rates

Chapter 3. Global Biosimilar Monoclonal Antibodies Market Dynamics

• 3.1. Market Drivers
  • 3.1.1. Patent expiries of blockbuster biologics boosting biosimilar uptake
  • 3.1.2. Escalating oncology and autoimmune disease incidence
  • 3.1.3. Cost-containment pressures on healthcare systems
• 3.2. Market Challenges
  • 3.2.1. Complex regulatory pathways and interchangeability concerns
  • 3.2.2. Physician and patient skepticism regarding biosimilar efficacy
• 3.3. Market Opportunities
  • 3.3.1. Emerging-market expansion and government incentives
  • 3.3.2. Strategic collaborations and licensing agreements
  • 3.3.3. Adoption of AI and advanced analytics for comparability studies

Chapter 4. Global Biosimilar Monoclonal Antibodies Market Industry Analysis

• 4.1. Porter's Five Forces Model
  • 4.1.1. Bargaining Power of Suppliers
  • 4.1.2. Bargaining Power of Buyers
  • 4.1.3. Threat of New Entrants
  • 4.1.4. Threat of Substitutes
  • 4.1.5. Competitive Rivalry
  • 4.1.6. Futuristic Approach to Porter's Model
  • 4.1.7. Impact Analysis
• 4.2. PESTEL Analysis
  • 4.2.1. Political
  • 4.2.2. Economic
  • 4.2.3. Social
  • 4.2.4. Technological
  • 4.2.5. Environmental
  • 4.2.6. Legal
• 4.3. Top Investment Opportunities
• 4.4. Top Winning Strategies
• 4.5. Disruptive Trends
• 4.6. Industry Expert Perspectives
• 4.7. Analyst Recommendation & Conclusion

Chapter 5. Global Biosimilar Monoclonal Antibodies Market Size & Forecasts by Type (2022-2032)

• 5.1. Segment Dashboard
• 5.2. Adalimumab Revenue Trend, 2022 & 2032 (USD Million)
• 5.3. Bevacizumab Revenue Trend, 2022 & 2032 (USD Million)
• 5.4. Infliximab Revenue Trend, 2022 & 2032 (USD Million)
• 5.5. Rituximab Revenue Trend, 2022 & 2032 (USD Million)
• 5.6. Trastuzumab Revenue Trend, 2022 & 2032 (USD Million)
• 5.7. Others Revenue Trend, 2022 & 2032 (USD Million)

Chapter 6. Global Biosimilar Monoclonal Antibodies Market Size & Forecasts by Indication (2022-2032)

• 6.1. Segment Dashboard
• 6.2. Oncology Revenue Trend, 2022 & 2032 (USD Million)
• 6.3. Autoimmune Diseases Revenue Trend, 2022 & 2032 (USD Million)
• 6.4. Others Revenue Trend, 2022 & 2032 (USD Million)

Chapter 7. Global Biosimilar Monoclonal Antibodies Market Size & Forecasts by Region (2022-2032)

• 7.1. North America Market
  • 7.1.1. U.S. Market
    • 7.1.1.1. By Type (2022-2032)
    • 7.1.1.2. By Indication (2022-2032)
    • 7.1.1.3. By End User (2022-2032)
  • 7.1.2. Canada Market
• 7.2. Europe Market
  • 7.2.1. UK Market
  • 7.2.2. Germany Market
  • 7.2.3. France Market
  • 7.2.4. Spain Market
  • 7.2.5. Italy Market
  • 7.2.6. Rest of Europe Market
• 7.3. Asia Pacific Market
  • 7.3.1. China Market
  • 7.3.2. India Market
  • 7.3.3. Japan Market
  • 7.3.4. Australia Market
  • 7.3.5. South Korea Market
  • 7.3.6. Rest of Asia Pacific Market
• 7.4. Latin America Market
  • 7.4.1. Brazil Market
  • 7.4.2. Mexico Market
  • 7.4.3. Rest of Latin America Market
• 7.5. Middle East & Africa Market
  • 7.5.1. Saudi Arabia Market
  • 7.5.2. South Africa Market
  • 7.5.3. Rest of Middle East & Africa Market

Chapter 8. Competitive Intelligence

• 8.1. Key Company SWOT Analysis
  • 8.1.1. Pfizer Inc.
  • 8.1.2. Amgen Inc.
  • 8.1.3. Celltrion Healthcare
• 8.2. Top Market Strategies
• 8.3. Company Profiles
  • 8.3.1. Pfizer Inc.
    • 8.3.1.1. Key Information
    • 8.3.1.2. Overview
    • 8.3.1.3. Financial (Subject to Data Availability)
    • 8.3.1.4. Product Summary
    • 8.3.1.5. Market Strategies
  • 8.3.2. Amgen Inc.
  • 8.3.3. Celltrion Healthcare
  • 8.3.4. Novartis AG
  • 8.3.5. Mylan N.V.
  • 8.3.6. Biocon Biologics Ltd.
  • 8.3.7. Teva Pharmaceutical Industries Ltd.
  • 8.3.8. Samsung Bioepis Co., Ltd.
  • 8.3.9. Merck & Co., Inc.
  • 8.3.10. Fresenius Kabi AG
  • 8.3.11. Dr. Reddy's Laboratories Ltd.
  • 8.3.12. STADA Arzneimittel AG
  • 8.3.13. Coherus BioSciences, Inc.
  • 8.3.14. Boehringer Ingelheim International GmbH
  • 8.3.15. Eli Lilly and Company

Chapter 9. Research Process

• 9.1. Research Process
  • 9.1.1. Data Mining
  • 9.1.2. Analysis
  • 9.1.3. Market Estimation
  • 9.1.4. Validation
  • 9.1.5. Publishing
• 9.2. Research Attributes