바이오의약품 수탁 제조 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, biopharmaceuticals contract manufacturing market size in 2026 is estimated at USD 53.68 billion, growing from 2025 value of USD 47.42 billion with 2031 projections showing USD 99.84 billion, growing at 13.21% CAGR over 2026-2031.

This report is Segmented by Product Type (Peptides/Proteins, Antibodies, Vaccines, and More), Service Type (Process Development, CGMP Drug Substance Manufacturing, and More), by Development Phase (Pre-Clinical, Phase I, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Sizes and Forecasts are Provided in Terms of Value (USD).

Global Biopharmaceuticals Contract Manufacturing Market Trends and Insights

Outsourcing Surge Among Large Bio-Pharma Sponsors

The proportion of developers outsourcing at least one major activity rose to 86.9% in 2024 as firms sought flexibility and capital efficiency. Sponsors increasingly turn to CDMOs for complex modalities such as antibody-drug conjugates and autologous cell therapies that require niche expertise and rigorous regulatory stewardship. Outsourcing also shortens clinical timelines, with integrated providers offering process development, analytics, and commercial scale-up under a single quality system. Capacity reservations tied to multi-year master service agreements have become the norm, ensuring priority access as pipeline demand surges. Together, these forces embed the CDMO partnership model firmly within corporate manufacturing strategies, reinforcing the growth trajectory of the biopharmaceuticals contract manufacturing market.

Rapid Expansion of Biologics / Biosimilar Pipelines

More than 700 gene-based therapies and 450 biosimilar molecules are advancing through global development programs in 2025. Small and mid-sized innovators rarely possess industrial-scale capability, so they depend on external manufacturers that bring cell-culture know-how, global regulatory track records, and agility to pivot among regional filings. Harmonized guidelines across the United States, Europe, and key Asia Pacific jurisdictions further reward CDMOs with multinational site networks. As biologics complexity rises, differentiated purification, formulation, and delivery technologies become critical value drivers, prompting deep collaboration and technology-transfer frameworks that embed CDMOs across the product life cycle.

Stringent cGMP & Data-Integrity Compliance Burden

Implementation of EU GMP Annex 1 heightens sterile-manufacturing requirements, compelling extensive contamination-control and quality monitoring upgrades. FDA warning letters in 2024 spotlighted governance lapses and software validation gaps, reinforcing regulators' focus on ALCOA+ data principles. Smaller CDMOs face disproportionate financial pressure when deploying electronic batch-record systems, track-and-trace platforms, and advanced environmental monitoring. The compliance load can delay facility utilization, tempering short-term revenue growth even as it lifts long-term quality standards across the biopharmaceuticals contract manufacturing industry.

Other drivers and restraints analyzed in the detailed report include:

1. Adoption of Single-Use & Modular Bioprocess Skids
2. Capacity Gap for Cell- & Gene-Therapy Vectors
3. Global Shortage of Skilled Bioprocess Engineers

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

The antibodies segment generated 37.74% market share in 2025, cementing its role as the anchor modality for oncology and autoimmune indications. Continued clinical activity sustains high batch volumes, while process intensification lifts titers and economics. In parallel, biosimilar monoclonal antibodies stimulate incremental demand from cost-sensitive health systems in Latin America, Eastern Europe, and parts of Asia.

Cell and gene therapy vectors are expanding at an 17.76% CAGR due to the scarcity of GMP vector capacity, bespoke analytics, and stringent regulatory oversight, which combine to create high-margin opportunities for specialized CDMOs. Viral vector innovation, including next-generation AAV serotypes and non-viral delivery alternatives, deepens the service scope and accelerates convergence between development and manufacturing skill sets in the biopharmaceuticals contract manufacturing market.

Mammalian expression platforms, chiefly CHO cells, held 63.02% of market share in 2025 as advances in cell-line engineering, vector design, and media optimization boost specific productivity, reinforcing this platform's dominance for glycosylated proteins and complex mAbs.

Bacterial and yeast systems remain cost-efficient for simple recombinant proteins and enzymes, especially in emerging economies where pricing pressure is acute. Plant and insect cell technologies show promise for niche applications, yet regulatory familiarity limits broader adoption. Providers balance portfolios across systems to meet client needs while maximizing facility utilization, an increasingly important lever as single-use suites enable flexible switching between platforms.

Complete Report Scope:

• By Product Type
  • Peptides/Proteins
  • Antibodies (mAbs & ADCs)
  • Vaccines
  • Biosimilars
  • Other Biologics
• By Service Type
  • Process Development
  • cGMP Drug Substance Manufacturing
  • Fill-Finish & Lyophilization
  • Analytical & QC Services
  • Packaging & Logistics
• By Expression System
  • Mammalian
  • Microbial
  • Insect & Plant
• By Development Phase
  • Pre-clinical
  • Phase I
  • Phase II
  • Phase III & Commercial
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • Rest of Asia Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America remained the largest regional contributor with a 36.25% biopharmaceuticals contract manufacturing market share in 2025, sustained by deep venture funding, advanced regulatory ecosystems, and dense talent pools in Boston-Cambridge and the San Francisco Bay Area. Capacity expansions such as Fujifilm Diosynth's USD 3.2 billion North Carolina campus and WuXi Biologics' Massachusetts site broaden service breadth and keep the region at the forefront of late-stage and commercial projects. Potential enactment of the BIOSECURE Act could reshape vendor selection by favoring domestic and allied suppliers, yet strong demand and diversified pipelines maintain robust outlooks across modalities.

Asia Pacific is the fastest-growing territory, advancing at an 11.18% CAGR to 2031. China's regulatory reforms and infrastructure build-out elevate its status as a manufacturing option for early-stage runs, although geopolitical tensions influence dual-sourcing habits. South Korea's Samsung Biologics commands global attention with a cumulative capacity of 784,000 L by 2025, underscoring the region's ascent. India leverages cost advantages and English-language talent, while Singapore markets its stringent quality oversight and government incentives to capture advanced-therapy projects.

Europe sustains its position through incumbents such as Lonza, Boehringer Ingelheim, and Catalent, each reinforcing local ecosystems with billion-dollar investments in Switzerland, Germany, and Austria. The Vacaville acquisition adds 330,000 L of capacity to Lonza's network, highlighting continued commitment despite Brexit-related supply chain complexity. EMA's harmonized review pathways and robust IP protections entice U.S. and Asian clients seeking regulatory diversification. Collectively, mature infrastructure, automation initiatives, and green-manufacturing incentives place Europe firmly in the strategic plans of multinational sponsors evaluating the biopharmaceuticals contract manufacturing market.

1. Samsung Group
2. Lonza Group
3. Wuxi Biologics
4. Thermo Fisher Scientific (Patheon)
5. Catalent Pharma Solutions
6. Boehringer Ingelheim BioXcellence
7. FUJIFILM
8. AGC Biologics
9. Siegfried Holding
10. Recipharm
11. ProBioGen
12. AbbVie Contract Manufacturing
13. Novartis (Lek)
14. INCOG BioPharma Services
15. Lotte Biologics
16. Thermex (Merck Life Science)
17. Emergent Bio Solutions

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Outsourcing Surge Among Large Bio-Pharma Sponsors
  • 4.2.2 Rapid Expansion Of Biologics / Biosimilar Pipelines
  • 4.2.3 Adoption Of Single-Use & Modular Bioprocess Skids
  • 4.2.4 Capacity Gap For Cell- & Gene-Therapy Vectors
  • 4.2.5 China-Plus-One Procurement Shift Benefiting Korean/EU CDMOs
  • 4.2.6 AI-Driven Predictive Bioprocess Control Boosting Yield & Margins
• 4.3 Market Restraints
  • 4.3.1 Stringent cGMP & data-integrity compliance burden
  • 4.3.2 Global shortage of skilled bioprocess engineers
  • 4.3.3 Sustainability pressure on single-use plastics
  • 4.3.4 Over-building risk creating idle stainless & SU capacity
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Rivalry

5 Market Size & Growth Forecasts (Value & Capacity)

• 5.1 By Product Type
  • 5.1.1 Peptides/Proteins
  • 5.1.2 Antibodies (mAbs & ADCs)
  • 5.1.3 Vaccines
  • 5.1.4 Biosimilars
  • 5.1.5 Other Biologics
• 5.2 By Service Type
  • 5.2.1 Process Development
  • 5.2.2 cGMP Drug Substance Manufacturing
  • 5.2.3 Fill-Finish & Lyophilization
  • 5.2.4 Analytical & QC Services
  • 5.2.5 Packaging & Logistics
• 5.3 By Expression System
  • 5.3.1 Mammalian
  • 5.3.2 Microbial
  • 5.3.3 Insect & Plant
• 5.4 By Development Phase
  • 5.4.1 Pre-clinical
  • 5.4.2 Phase I
  • 5.4.3 Phase II
  • 5.4.4 Phase III & Commercial
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Samsung Biologics
  • 6.3.2 Lonza Group
  • 6.3.3 WuXi Biologics
  • 6.3.4 Thermo Fisher Scientific (Patheon)
  • 6.3.5 Catalent Pharma Solutions
  • 6.3.6 Boehringer Ingelheim BioXcellence
  • 6.3.7 Fujifilm Diosynth Biotechnologies
  • 6.3.8 AGC Biologics
  • 6.3.9 Siegfried Holding
  • 6.3.10 Recipharm
  • 6.3.11 ProBioGen
  • 6.3.12 AbbVie Contract Manufacturing
  • 6.3.13 Novartis (Lek)
  • 6.3.14 INCOG BioPharma Services
  • 6.3.15 Lotte Biologics
  • 6.3.16 Thermex (Merck Life Science)
  • 6.3.17 Emergent BioSolutions

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment