세계의 바이오시밀러 수탁제조 시장 : 시장 규모, 점유율 및 동향 분석(공급원별, 치료 영역별, 서비스별, 지역별), 부문별 예측(2025-2033년)

Biosimilar Contract Manufacturing Market Summary

The global biosimilar contract manufacturing market size was estimated at USD 7.84 billion in 2024 and is projected to reach USD 25.19 billion by 2033, growing at a CAGR of 13.87% from 2025 to 2033. The increasing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is driving demand for affordable biologics.

Biosimilars offer cost-effective alternatives to expensive branded biologics, making them highly suitable for healthcare systems and patients. Pharmaceutical companies are increasingly outsourcing biosimilar production to contract manufacturing organizations (CMOs) to reduce operational costs, ensure regulatory compliance, and accelerate time-to-market. This growing demand and patent expirations of blockbuster biologics fuel strong market expansion for contract manufacturing services, enabling drug developers to focus on innovation while leveraging CMOs' expertise in large-scale, efficient biosimilar production.

In addition, expiration of patents for blockbuster biologics such as monoclonal antibodies, insulin analogs, and growth factors has opened significant opportunities for biosimilar manufacturers. With billions of dollars in biologics revenue at stake, pharmaceutical companies are increasingly racing to develop biosimilars to capture market share. However, due to high production complexity, many companies rely on contract manufacturing organizations (CMOs) with specialized expertise in biologics development, scale-up, and regulatory compliance. This trend accelerates outsourcing partnerships, enabling faster biosimilar launches while reducing risks and operational costs, thereby driving market growth.

Furthermore, contract manufacturing organizations are heavily investing in advanced biomanufacturing technologies, including single-use systems, high-capacity bioreactors, and continuous processing, to meet the rising demand for biosimilars. These technological advancements enhance efficiency, flexibility, and scalability, attracting pharmaceutical companies to partner with CMOs. In addition, CMOs are expanding global facilities to comply with regional regulatory standards, supporting multinational drug launches. Such expansions enable biosimilar developers to overcome infrastructure limitations, reduce upfront investment costs, and accelerate commercialization timelines. The increasing sophistication and global footprint of CMOs make them indispensable partners, propelling market growth.

Besides these, supportive regulatory environments in key markets such as the U.S., Europe, and emerging economies are fostering the adoption of biosimilars. Regulatory agencies such as the U.S. FDA and EMA have established streamlined approval pathways, ensuring safety and efficacy while expediting market entry. These frameworks encourage investment in biosimilar development, driving demand for high-quality manufacturing partners. Contract manufacturing organizations benefit from their expertise in adhering to stringent regulatory standards, providing companies with compliance assurance and global market access. As regulatory clarity improves worldwide, the reliance on CMOs for biosimilar production is expected to intensify, boosting market growth further.

Global Biosimilar Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at regional and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global biosimilar contract manufacturing market report based on source, service, therapeutic area, and region

• Source Outlook (Revenue, USD Million, 2021 - 2033)
• Mammalian
• Non-mammalian
• Service Outlook (Revenue, USD Million, 2021 - 2033)
• Recombinant Non-glycosylated Proteins
• Recombinant Glycosylated Proteins
• Therapeutic Area Outlook (Revenue, USD Million, 2021 - 2033)
• Oncology
• Blood Disorders
• Growth Hormonal Deficiency
• Chronic & Autoimmune Disorders
• Rheumatoid Arthritis
• Others
• Regional Outlook (Revenue, USD Million, 2021 - 2033)
• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • India
  • China
  • Japan
  • South Korea
  • Australia
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait
  • Oman
  • Qatar

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation and Scope
• 1.2. Market Definitions
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased database
  • 1.4.2. GVR's internal database
  • 1.4.3. Secondary sources
  • 1.4.4. Primary research
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity flow analysis (Model 1)
  • 1.7.2. Value chain based analysis (Model 2)
  • 1.7.3. Multivariate Analysis (Model 3)
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
• 2.3. Competitive Insights

Chapter 3. Biosimilar Contract Manufacturing Market Variables, Trends, & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Ancillary Market Outlook
• 3.2. Market Dynamics
  • 3.2.1. Market Driver Analysis
  • 3.2.2. Market Restraint Analysis
• 3.3. Business Model Analysis
• 3.4. Product Pipeline Analysis
• 3.5. Service Pricing Model Analysis
• 3.6. Technological Advancements
• 3.7. Supply Chain Analysis
• 3.8. Biosimilar Contract Manufacturing Market Analysis Tools
  • 3.8.1. Porter's Five Forces Analysis
  • 3.8.2. PESTEL by SWOT Analysis

Chapter 4. Biosimilar Contract Manufacturing Market: Source Estimates & Trend Analysis

• 4.1. Segment Dashboard
• 4.2. Biosimilar Contract Manufacturing Market: Source Movement Analysis
• 4.3. Biosimilar Contract Manufacturing Market Estimates and Forecasts, by Source, 2021 - 2033 (USD Million)
• 4.4. Mammalian
  • 4.4.1. Mammalian Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Non-mammalian
  • 4.5.1. Non-mammalian Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. Biosimilar Contract Manufacturing Market: Service Estimates & Trend Analysis

• 5.1. Segment Dashboard
• 5.2. Biosimilar Contract Manufacturing Market: Service Movement Analysis
• 5.3. Biosimilar Contract Manufacturing Market Estimates and Forecasts, by Service, 2021 - 2033 (USD Million)
• 5.4. Recombinant Non-glycosylated Proteins
  • 5.4.1. Recombinant Non-glycosylated Proteins Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Recombinant Glycosylated Proteins
  • 5.5.1. Recombinant Glycosylated Proteins Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. Biosimilar Contract Manufacturing Market: Therapeutic Area Estimates & Trend Analysis

• 6.1. Segment Dashboard
• 6.2. Biosimilar Contract Manufacturing Market: Therapeutic Area Movement Analysis
• 6.3. Biosimilar Contract Manufacturing Market Estimates and Forecasts, by Therapeutic Area, 2021 - 2033 (USD Million)
• 6.4. Oncology
  • 6.4.1. Oncology Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.5. Blood Disorders
  • 6.5.1. Blood Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.6. Growth Hormonal Deficiency
  • 6.6.1. Growth Hormonal Deficiency Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.7. Chronic & Autoimmune Disorders
  • 6.7.1. Chronic & Autoimmune Disorders Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.8. Rheumatoid Arthritis
  • 6.8.1. Rheumatoid Arthritis Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.9. Others
  • 6.9.1. Others Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 7. Biosimilar Contract Manufacturing Market: Regional Estimates & Trend Analysis

• 7.1. Regional Outlook
• 7.2. Biosimilar Contract Manufacturing Market: Regional Movement Analysis
• 7.3. Biosimilar Contract Manufacturing Market Estimates and Forecasts, by Region, 2021 - 2033 (USD Million)
• 7.4. North America
  • 7.4.1. North America Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.2. U.S.
    • 7.4.2.1. Key Country Dynamics
    • 7.4.2.2. Competitive Scenario
    • 7.4.2.3. Regulatory Framework
    • 7.4.2.4. U.S. Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.3. Canada
    • 7.4.3.1. Key Country Dynamics
    • 7.4.3.2. Competitive Scenario
    • 7.4.3.3. Regulatory Framework
    • 7.4.3.4. Canada Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.4.4. Mexico
    • 7.4.4.1. Key Country Dynamics
    • 7.4.4.2. Competitive Scenario
    • 7.4.4.3. Regulatory Framework
    • 7.4.4.4. Mexico Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.5. Europe
  • 7.5.1. Europe Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.2. UK
    • 7.5.2.1. Key Country Dynamics
    • 7.5.2.2. Competitive Scenario
    • 7.5.2.3. Regulatory Framework
    • 7.5.2.4. UK Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.3. Germany
    • 7.5.3.1. Key Country Dynamics
    • 7.5.3.2. Competitive Scenario
    • 7.5.3.3. Regulatory Framework
    • 7.5.3.4. Germany Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.4. France
    • 7.5.4.1. Key Country Dynamics
    • 7.5.4.2. Competitive Scenario
    • 7.5.4.3. Regulatory Framework
    • 7.5.4.4. France Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.5. Italy
    • 7.5.5.1. Key Country Dynamics
    • 7.5.5.2. Competitive Scenario
    • 7.5.5.3. Regulatory Framework
    • 7.5.5.4. Italy Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.6. Spain
    • 7.5.6.1. Key Country Dynamics
    • 7.5.6.2. Competitive Scenario
    • 7.5.6.3. Regulatory Framework
    • 7.5.6.4. Spain Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.7. Denmark
    • 7.5.7.1. Key Country Dynamics
    • 7.5.7.2. Competitive Scenario
    • 7.5.7.3. Regulatory Framework
    • 7.5.7.4. Denmark Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.8. Sweden
    • 7.5.8.1. Key Country Dynamics
    • 7.5.8.2. Competitive Scenario
    • 7.5.8.3. Regulatory Framework
    • 7.5.8.4. Sweden Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.5.9. Norway
    • 7.5.9.1. Key Country Dynamics
    • 7.5.9.2. Competitive Scenario
    • 7.5.9.3. Regulatory Framework
    • 7.5.9.4. Norway Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.6. Asia Pacific
  • 7.6.1. Asia Pacific Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.2. Japan
    • 7.6.2.1. Key Country Dynamics
    • 7.6.2.2. Competitive Scenario
    • 7.6.2.3. Regulatory Framework
    • 7.6.2.4. Japan Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.3. China
    • 7.6.3.1. Key Country Dynamics
    • 7.6.3.2. Competitive Scenario
    • 7.6.3.3. Regulatory Framework
    • 7.6.3.4. China Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.4. India
    • 7.6.4.1. Key Country Dynamics
    • 7.6.4.2. Competitive Scenario
    • 7.6.4.3. Regulatory Framework
    • 7.6.4.4. India Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.5. South Korea
    • 7.6.5.1. Key Country Dynamics
    • 7.6.5.2. Competitive Scenario
    • 7.6.5.3. Regulatory Framework
    • 7.6.5.4. South Korea Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.6. Australia
    • 7.6.6.1. Key Country Dynamics
    • 7.6.6.2. Competitive Scenario
    • 7.6.6.3. Regulatory Framework
    • 7.6.6.4. Australia Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.6.7. Thailand
    • 7.6.7.1. Key Country Dynamics
    • 7.6.7.2. Competitive Scenario
    • 7.6.7.3. Regulatory Framework
    • 7.6.7.4. Thailand Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.7. Latin America
  • 7.7.1. Latin America Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.2. Brazil
    • 7.7.2.1. Key Country Dynamics
    • 7.7.2.2. Competitive Scenario
    • 7.7.2.3. Regulatory Framework
    • 7.7.2.4. Brazil Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.7.3. Argentina
    • 7.7.3.1. Key Country Dynamics
    • 7.7.3.2. Competitive Scenario
    • 7.7.3.3. Regulatory Framework
    • 7.7.3.4. Argentina Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 7.8. Middle East & Africa
  • 7.8.1. Middle East & Africa Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.2. South Africa
    • 7.8.2.1. Key Country Dynamics
    • 7.8.2.2. Competitive Scenario
    • 7.8.2.3. Regulatory Framework
    • 7.8.2.4. South Africa Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.3. Saudi Arabia
    • 7.8.3.1. Key Country Dynamics
    • 7.8.3.2. Competitive Scenario
    • 7.8.3.3. Regulatory Framework
    • 7.8.3.4. Saudi Arabia Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.4. UAE
    • 7.8.4.1. Key Country Dynamics
    • 7.8.4.2. Competitive Scenario
    • 7.8.4.3. Regulatory Framework
    • 7.8.4.4. UAE Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.5. Kuwait
    • 7.8.5.1. Key Country Dynamics
    • 7.8.5.2. Competitive Scenario
    • 7.8.5.3. Regulatory Framework
    • 7.8.5.4. Kuwait Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.6. Oman
    • 7.8.6.1. Key Country Dynamics
    • 7.8.6.2. Competitive Scenario
    • 7.8.6.3. Regulatory Framework
    • 7.8.6.4. Oman Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)
  • 7.8.7. Qatar
    • 7.8.7.1. Key Country Dynamics
    • 7.8.7.2. Competitive Scenario
    • 7.8.7.3. Regulatory Framework
    • 7.8.7.4. Qatar Biosimilar Contract Manufacturing Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 8. Competitive Landscape

• 8.1. Company Categorization
  • 8.1.1. Market Leaders
  • 8.1.2. Emerging Players
• 8.2. Company Market Assessment Analysis, 2024 (Company Heat Map Analysis)
• 8.3. Key Company Profiles
  • 8.3.1. Boehringer Ingelheim GmbH
    • 8.3.1.1. Company Overview
    • 8.3.1.2. Financial Performance
    • 8.3.1.3. Product Benchmarking
    • 8.3.1.4. Strategic Initiatives
  • 8.3.2. Lonza
    • 8.3.2.1. Company Overview
    • 8.3.2.2. Financial Performance
    • 8.3.2.3. Product Benchmarking
    • 8.3.2.4. Strategic Initiatives
  • 8.3.3. Rentschler Biopharma SE
    • 8.3.3.1. Company Overview
    • 8.3.3.2. Financial Performance
    • 8.3.3.3. Product Benchmarking
    • 8.3.3.4. Strategic Initiatives
  • 8.3.4. AGC Biologics
    • 8.3.4.1. Company Overview
    • 8.3.4.2. Financial Performance
    • 8.3.4.3. Product Benchmarking
    • 8.3.4.4. Strategic Initiatives
  • 8.3.5. ProBioGen
    • 8.3.5.1. Company Overview
    • 8.3.5.2. Financial Performance
    • 8.3.5.3. Product Benchmarking
    • 8.3.5.4. Strategic Initiatives
  • 8.3.6. FUJIFILM Diosynth Biotechnologies
    • 8.3.6.1. Company Overview
    • 8.3.6.2. Financial Performance
    • 8.3.6.3. Product Benchmarking
    • 8.3.6.4. Strategic Initiatives
  • 8.3.7. Toyobo Co. Ltd.
    • 8.3.7.1. Company Overview
    • 8.3.7.2. Financial Performance
    • 8.3.7.3. Product Benchmarking
    • 8.3.7.4. Strategic Initiatives
  • 8.3.8. Samsung Biologics
    • 8.3.8.1. Company Overview
    • 8.3.8.2. Financial Performance
    • 8.3.8.3. Product Benchmarking
    • 8.3.8.4. Strategic Initiatives
  • 8.3.9. Thermo Fisher Scientific, Inc.
    • 8.3.9.1. Company Overview
    • 8.3.9.2. Financial Performance
    • 8.3.9.3. Product Benchmarking
    • 8.3.9.4. Strategic Initiatives
  • 8.3.10. Binex Co., Ltd.
    • 8.3.10.1. Company Overview
    • 8.3.10.2. Financial Performance
    • 8.3.10.3. Product Benchmarking
    • 8.3.10.4. Strategic Initiatives
  • 8.3.11. WuXi Biologics
    • 8.3.11.1. Company Overview
    • 8.3.11.2. Financial Performance
    • 8.3.11.3. Product Benchmarking
    • 8.3.11.4. Strategic Initiatives
  • 8.3.12. AbbVie, Inc.
    • 8.3.12.1. Company Overview
    • 8.3.12.2. Financial Performance
    • 8.3.12.3. Product Benchmarking
    • 8.3.12.4. Strategic Initiatives
  • 8.3.13. ADMA Biologics, Inc.
    • 8.3.13.1. Company Overview
    • 8.3.13.2. Financial Performance
    • 8.3.13.3. Product Benchmarking
    • 8.3.13.4. Strategic Initiatives
  • 8.3.14. Catalent, Inc
    • 8.3.14.1. Company Overview
    • 8.3.14.2. Financial Performance
    • 8.3.14.3. Product Benchmarking
    • 8.3.14.4. Strategic Initiatives
  • 8.3.15. Cambrex Corporation
    • 8.3.15.1. Company Overview
    • 8.3.15.2. Financial Performance
    • 8.3.15.3. Product Benchmarking
    • 8.3.15.4. Strategic Initiatives
  • 8.3.16. Pfizer Inc.
    • 8.3.16.1. Company Overview
    • 8.3.16.2. Financial Performance
    • 8.3.16.3. Product Benchmarking
    • 8.3.16.4. Strategic Initiatives
  • 8.3.17. Siegfried Holding AG
    • 8.3.17.1. Company Overview
    • 8.3.17.2. Financial Performance
    • 8.3.17.3. Product Benchmarking
    • 8.3.17.4. Strategic Initiatives