세계의 바이오의약품 수탁 제조 시장 : 시장 규모 분석 - 서비스별, 공급원별, 제품별, 지역별 예측(2025-2035년)

The Global Biopharmaceutical Contract Manufacturing Market is valued at approximately USD 16.65 billion in 2024 and is projected to expand at a robust CAGR of 15.30% over the forecast period 2025-2035. Biopharmaceutical contract manufacturing encompasses the outsourcing of production, analytical testing, packaging, and quality control services for biologics and biosimilars to specialized third-party facilities. These services are increasingly critical for pharmaceutical companies aiming to streamline operations, reduce capital expenditures, and accelerate time-to-market for complex therapeutics. The growth of the market is predominantly fueled by the rising prevalence of chronic diseases, the expansion of the biologics pipeline, and an intensified focus on cost-effective, scalable manufacturing solutions.

Escalating demand for biologics and biosimilars, coupled with increasing regulatory pressures for high-quality manufacturing standards, has significantly amplified the need for specialized contract manufacturing services. Outsourcing production operations allows pharmaceutical companies to focus on research, development, and commercialization while leveraging the technical expertise of contract manufacturing organizations (CMOs). According to recent industry reports, the global biologics market is expected to continue its upward trajectory, driven by innovative therapies and an expanding patient population, creating substantial opportunities for CMOs. Furthermore, advances in cell line development, process optimization, and automation technologies are reshaping manufacturing efficiencies and capacity utilization across the sector.

Regional insights reveal that North America remains the dominant market for biopharmaceutical contract manufacturing due to its mature pharmaceutical ecosystem, presence of leading CMOs, and supportive regulatory infrastructure. The United States, in particular, benefits from extensive R&D investment, advanced production facilities, and robust demand for biologics and biosimilars. Europe, with established pharmaceutical hubs in Germany, France, and the UK, is also a significant contributor, emphasizing high-quality manufacturing and stringent compliance standards. Meanwhile, Asia Pacific is anticipated to witness the fastest growth over the forecast period, fueled by increasing healthcare expenditures, rising biologics adoption, expansion of manufacturing capacities in countries like China and India, and favorable government policies promoting pharmaceutical exports. Latin America and the Middle East & Africa are emerging as lucrative markets due to growing healthcare infrastructure, increasing biopharmaceutical production investments, and rising demand for affordable biologics.

Major market players included in this report are:

• Samsung Biologics
• Catalent, Inc.
• Lonza Group AG
• WuXi AppTec
• Patheon (Thermo Fisher Scientific)
• Sartorius AG
• Recipharm AB
• Boehringer Ingelheim BioXcellence
• CordenPharma International
• FUJIFILM Diosynth Biotechnologies
• Ajinomoto Bio-Pharma Services
• Polymun Scientific Immunbiologische Forschung GmbH
• Vetter Pharma International
• AMRI (Albany Molecular Research Inc.)
• BioVectra Inc.

Global Biopharmaceutical Contract Manufacturing Market Report Scope:

• Historical Data - 2023, 2024
• Base Year for Estimation - 2024
• Forecast period - 2025-2035
• Report Coverage - Revenue forecast, Company Ranking, Competitive Landscape, Growth factors, and Trends
• Regional Scope - North America; Europe; Asia Pacific; Latin America; Middle East & Africa
• Customization Scope - Free report customization (equivalent up to 8 analysts' working hours) with purchase. Addition or alteration to country, regional & segment scope*

The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values for the coming years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within the countries involved in the study. The report also provides detailed information about crucial aspects, such as driving factors and challenges, which will define the future growth of the market. Additionally, it incorporates potential opportunities in micro-markets for stakeholders to invest, along with a detailed analysis of the competitive landscape and product offerings of key players. The detailed segments and sub-segments of the market are explained below:

By Service:

• Manufacturing
• Upstream Processing
• Downstream Processing
• Fill & Finish Operations
• Analytical & QC Studies
• Packaging

By Source:

• Mammalian
• Non-Mammalian

By Product:

• Biologics
• Biosimilars

By Region:

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

Key Takeaways:

• Market Estimates & Forecast for 10 years from 2025 to 2035.
• 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 Biopharmaceutical Contract Manufacturing Market Report Scope & Methodology

• 1.1. Research Objective
• 1.2. Research Methodology
  • 1.2.1. Forecast Model
  • 1.2.2. Desk Research
  • 1.2.3. Top-Down and Bottom-Up Approach
• 1.3. Research Attributes
• 1.4. Scope of the Study
  • 1.4.1. Market Definition
  • 1.4.2. Market Segmentation
    • By Service
      • Manufacturing
      • Upstream Processing
      • Downstream Processing
      • Fill & Finish Operations
      • Analytical & QC Studies
      • Packaging
    • By Source
      • Mammalian
      • Non-Mammalian
    • By Product
      • Biologics
      • Biosimilars
    • By Region
      • North America
      • Europe
      • Asia Pacific
      • Latin America
      • Middle East & Africa
• 1.5. Research Assumptions
  • 1.5.1. Inclusion & Exclusion
  • 1.5.2. Limitations
  • 1.5.3. Years Considered for the Study

Chapter 2. Executive Summary

• 2.1. CEO/CXO Standpoint
• 2.2. Strategic Insights
• 2.3. ESG Analysis
• 2.4. Key Findings

Chapter 3. Global Biopharmaceutical Contract Manufacturing Market Forces Analysis

• 3.1. Market Forces Shaping The Global Biopharmaceutical Contract Manufacturing Market (2025-2035)
• 3.2. Drivers
  • 3.2.1. Rising Demand for Biologics & Biosimilars
  • 3.2.2. Expansion of Biologics Pipeline
• 3.3. Restraints
  • 3.3.1. Regulatory Compliance Challenges
  • 3.3.2. High Capital Investment for CMOs
• 3.4. Opportunities
  • 3.4.1. Advances in Cell Line Development & Automation
  • 3.4.2. Emerging Markets Growth

Chapter 4. Global Biopharmaceutical Contract Manufacturing Industry Analysis

• 4.1. Porter's Five Forces Model
  • 4.1.1. Bargaining Power of Buyers
  • 4.1.2. Bargaining Power of Suppliers
  • 4.1.3. Threat of New Entrants
  • 4.1.4. Threat of Substitutes
  • 4.1.5. Competitive Rivalry
• 4.2. Porter's Five Forces Forecast Model (2025-2035)
• 4.3. PESTEL Analysis
  • 4.3.1. Political
  • 4.3.2. Economical
  • 4.3.3. Social
  • 4.3.4. Technological
  • 4.3.5. Environmental
  • 4.3.6. Legal
• 4.4. Top Investment Opportunities
• 4.5. Top Winning Strategies (2025)
• 4.6. Market Share Analysis (2024-2025)
• 4.7. Global Pricing Analysis and Trends 2025
• 4.8. Analyst Recommendation & Conclusion

Chapter 5. Global Biopharmaceutical Contract Manufacturing Market Size & Forecasts by Service 2025-2035

• 5.1. Market Overview
• 5.2. Manufacturing
  • 5.2.1. Upstream Processing
  • 5.2.2. Downstream Processing
• 5.3. Fill & Finish Operations
• 5.4. Analytical & QC Studies
• 5.5. Packaging

Chapter 6. Global Biopharmaceutical Contract Manufacturing Market Size & Forecasts by Source 2025-2035

• 6.1. Market Overview
• 6.2. Mammalian
• 6.3. Non-Mammalian

Chapter 7. Global Biopharmaceutical Contract Manufacturing Market Size & Forecasts by Product 2025-2035

• 7.1. Market Overview
• 7.2. Biologics
• 7.3. Biosimilars

Chapter 8. Global Biopharmaceutical Contract Manufacturing Market Size & Forecasts by Region 2025-2035

• 8.1. Market, Regional Snapshot & Leading Countries
• 8.2. North America
  • 8.2.1. U.S.
    • 8.2.1.1. By Service
    • 8.2.1.2. By Source
    • 8.2.1.3. By Product
  • 8.2.2. Canada
    • 8.2.2.1. By Service
    • 8.2.2.2. By Source
    • 8.2.2.3. By Product
• 8.3. Europe
  • 8.3.1. UK
  • 8.3.2. Germany
  • 8.3.3. France
  • 8.3.4. Italy
  • 8.3.5. Spain
  • 8.3.6. Rest of Europe
• 8.4. Asia Pacific
  • 8.4.1. China
  • 8.4.2. India
  • 8.4.3. Japan
  • 8.4.4. Australia
  • 8.4.5. South Korea
  • 8.4.6. Rest of Asia Pacific
• 8.5. Latin America
  • 8.5.1. Brazil
  • 8.5.2. Mexico
• 8.6. Middle East & Africa
  • 8.6.1. UAE
  • 8.6.2. Saudi Arabia
  • 8.6.3. South Africa
  • 8.6.4. Rest of Middle East & Africa

Chapter 9. Competitive Intelligence

• 9.1. Top Market Strategies
• 9.2. Samsung Biologics
  • 9.2.1. Company Overview
  • 9.2.2. Key Executives
  • 9.2.3. Company Snapshot
  • 9.2.4. Financial Performance
  • 9.2.5. Product/Services Portfolio
  • 9.2.6. Recent Developments
  • 9.2.7. Market Strategies
  • 9.2.8. SWOT Analysis
• 9.3. Catalent, Inc.
• 9.4. Lonza Group AG
• 9.5. WuXi AppTec
• 9.6. Patheon (Thermo Fisher Scientific)
• 9.7. Sartorius AG
• 9.8. Recipharm AB
• 9.9. Boehringer Ingelheim BioXcellence
• 9.10. CordenPharma International
• 9.11. FUJIFILM Diosynth Biotechnologies
• 9.12. Ajinomoto Bio-Pharma Services
• 9.13. Polymun Scientific Immunbiologische Forschung GmbH
• 9.14. Vetter Pharma International
• 9.15. AMRI (Albany Molecular Research Inc.)
• 9.16. BioVectra Inc.