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Biologics Contract Development Market - Global Forecast 2025-2032

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    Report

  • 180 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 6011399
UP TO OFF until Jan 01st 2026
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Biologics contract development plays a foundational role in modern biopharmaceutical innovation, providing the expertise and capacity required for organizations to bring increasingly complex therapies to market efficiently and at scale. Senior decision-makers need timely, actionable insights into the critical market drivers, evolving technology, and strategic priorities that shape success in this dynamic sector.

Market Snapshot: Biologics Contract Development Market Outlook

The Biologics Contract Development Market expanded from USD 7.30 billion in 2024 to USD 8.17 billion in 2025. Sustained by an anticipated CAGR of 12.15%, the industry is projected to reach USD 18.29 billion by 2032. This robust growth reflects rising demand for specialized outsourcing solutions, advancements in biological therapy modalities, and increased investments in global biomanufacturing capacity. The primary keyword, “biologics contract development,” captures both current demand and key transitions across the value chain.

Scope & Segmentation of the Biologics Contract Development Market

This report comprehensively covers market trends, service offerings, and technology platforms. It provides a granular breakdown across industry segments, end users, regions, and leading companies.

  • Service Types: Clinical manufacturing (Phase I, II, III), commercial manufacturing, fill-finish, and both downstream and upstream process development.
  • Molecule Types: Cell and gene therapy, monoclonal antibodies (bispecific, conjugated, naked), recombinant proteins, vaccines (bacterial, mRNA, viral).
  • Therapeutic Areas: Autoimmune disorders, cardiovascular indications, infectious diseases (bacterial, viral), oncology (hematology, solid tumors).
  • Host Systems: Mammalian platforms (CHO cells, NS0 cells), microbial systems (E. coli), and yeast-based expression.
  • End Users: Biopharmaceutical companies, contract manufacturing organizations, pharmaceutical companies.
  • Technologies: Continuous manufacturing (perfusion, single pass), single-use systems, stainless steel systems.
  • Regions: Americas (North America, Latin America), Europe, Middle East & Africa, Asia-Pacific.
  • Notable Companies: Lonza Group Ltd, Catalent Inc, Thermo Fisher Scientific Inc, Samsung Biologics Co. Ltd, Boehringer Ingelheim International GmbH, WuXi Biologics Ltd, Fujifilm Diosynth Biotechnologies U.S.A. Inc, AGC Biologics A/S, Recipharm AB, Rentschler Biopharma SE.

Key Takeaways for Senior Decision-Makers

  • Advancement in process analytical technologies and digital monitoring platforms are driving enhanced quality, reduced cycle times, and improved regulatory compliance.
  • Growing demand for next-generation biologics and personalized therapies is shaping preferences for flexible, modular manufacturing systems and innovative process design.
  • Strategic outsourcing and partnerships have become essential to reduce capital intensity, accelerate time to market, and access specialized technical expertise.
  • Regulatory requirements are increasingly nuanced, requiring robust quality management and proactive engagement to ensure compliance across jurisdictions.
  • Sustainability is influencing technology adoption, with continuous perfusion and single-use platforms being evaluated for their environmental and operational benefits.
  • The emergence of open innovation models, including collaboration with academic and clinical partners, is propelling technology transfer and accelerating commercial readiness.

Tariff Impact: Navigating New U.S. Tariff Measures

Recent U.S. tariff changes on imported materials have led organizations to reassess procurement and supply chain strategies. The shift is prompting increased onshore sourcing, renegotiation of supplier agreements, and strategic alliances with domestic manufacturers. Flexibility in commercial terms, enhanced cost transparency, and adaptive risk management are emerging as competitive differentiators in response to these impacts.

Methodology & Data Sources

This report uses a rigorous research methodology integrating primary interviews with senior industry and process experts, combined with secondary analysis of peer-reviewed journals, regulatory guidance, association reports, and market data. Detailed quantitative benchmarks and qualitative trends were cross-validated by independent scientific and regulatory specialists to ensure reliability.

Why This Report Matters: Strategic Benefits

  • Enables targeted investment decisions by clarifying market segmentation, regional growth patterns, and evolving customer requirements.
  • Reveals operational and technology trends that inform strategic planning, risk management, and supplier selection in biologics contract development.
  • Highlights actionable strategies for optimizing outsourcing, enhancing compliance, and fostering resilience in global supply chains.

Conclusion

The Biologics Contract Development Market is marked by technological progress, evolving regulatory dynamics, and new partnership paradigms. Organizations that proactively adopt integrated manufacturing solutions and resilient sourcing strategies will remain at the forefront of sector innovation and growth.

 

Additional Product Information:

  • Purchase of this report includes 1 year online access with quarterly updates.
  • This report can be updated on request. Please contact our Customer Experience team using the Ask a Question widget on our website.

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. Adoption of single-use bioreactor technology to enhance flexibility and reduce contamination risks in biologics manufacturing
5.2. Expansion of cell and gene therapy manufacturing services through modular CDMO facilities for rapid clinical scale-up
5.3. Implementation of continuous chromatography and perfusion bioprocessing for increased productivity and cost efficiencies in biologics production
5.4. Integration of AI and machine learning in process development for predictive modeling and accelerated biologic candidate selection
5.5. Growth of specialized fill-finish services tailored for mRNA vaccines and gene therapies with stringent cold chain requirements
5.6. Rising collaborations between regional CMOs and biotech firms to navigate complex global biologics regulatory pathways
5.7. Investment in green biomanufacturing initiatives and sustainable practices to reduce environmental impact of biologics production
5.8. Deployment of digital twin technology and real-time analytics for end-to-end biologics supply chain visibility and risk management
5.9. Emergence of biosimilar-focused CDMOs offering advanced glycoengineering services for next-generation therapeutic antibodies
5.10. Integration of blockchain-enabled traceability solutions to ensure transparency and compliance in biologics serum sourcing
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Biologics Contract Development Market, by Service Type
8.1. Clinical Manufacturing
8.1.1. Phase I
8.1.2. Phase II
8.1.3. Phase III
8.2. Commercial Manufacturing
8.3. Fill Finish
8.4. Process Development
8.4.1. Downstream Development
8.4.2. Upstream Development
9. Biologics Contract Development Market, by Molecule Type
9.1. Cell Gene Therapy
9.2. Monoclonal Antibodies
9.2.1. Bispecific
9.2.2. Conjugated
9.2.3. Naked
9.3. Recombinant Proteins
9.4. Vaccines
9.4.1. Bacterial
9.4.2. Mrna
9.4.3. Viral
10. Biologics Contract Development Market, by Therapeutic Area
10.1. Autoimmune Disorders
10.2. Cardiovascular
10.3. Infectious Diseases
10.3.1. Bacterial
10.3.2. Viral
10.4. Oncology
10.4.1. Hematology
10.4.2. Solid Tumors
11. Biologics Contract Development Market, by Host System
11.1. Mammalian
11.1.1. Cho Cells
11.1.2. Ns0 Cells
11.2. Microbial
11.2.1. E Coli
11.3. Yeast
12. Biologics Contract Development Market, by End User
12.1. Biopharmaceutical Companies
12.2. Contract Manufacturing Organizations
12.3. Pharmaceutical Companies
13. Biologics Contract Development Market, by Technology
13.1. Continuous Manufacturing
13.1.1. Perfusion
13.1.2. Single Pass
13.2. Single Use Systems
13.3. Stainless Steel Systems
14. Biologics Contract Development Market, by Region
14.1. Americas
14.1.1. North America
14.1.2. Latin America
14.2. Europe, Middle East & Africa
14.2.1. Europe
14.2.2. Middle East
14.2.3. Africa
14.3. Asia-Pacific
15. Biologics Contract Development Market, by Group
15.1. ASEAN
15.2. GCC
15.3. European Union
15.4. BRICS
15.5. G7
15.6. NATO
16. Biologics Contract Development Market, by Country
16.1. United States
16.2. Canada
16.3. Mexico
16.4. Brazil
16.5. United Kingdom
16.6. Germany
16.7. France
16.8. Russia
16.9. Italy
16.10. Spain
16.11. China
16.12. India
16.13. Japan
16.14. Australia
16.15. South Korea
17. Competitive Landscape
17.1. Market Share Analysis, 2024
17.2. FPNV Positioning Matrix, 2024
17.3. Competitive Analysis
17.3.1. Lonza Group Ltd
17.3.2. Catalent, Inc
17.3.3. Thermo Fisher Scientific Inc
17.3.4. Samsung Biologics Co., Ltd
17.3.5. Boehringer Ingelheim International GmbH
17.3.6. WuXi Biologics Ltd
17.3.7. Fujifilm Diosynth Biotechnologies U.S.A., Inc
17.3.8. AGC Biologics A/S
17.3.9. Recipharm AB
17.3.10. Rentschler Biopharma SE
List of Tables
List of Figures

Samples

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Companies Mentioned

The key companies profiled in this Biologics Contract Development market report include:
  • Lonza Group Ltd
  • Catalent, Inc
  • Thermo Fisher Scientific Inc
  • Samsung Biologics Co., Ltd
  • Boehringer Ingelheim International GmbH
  • WuXi Biologics Ltd
  • Fujifilm Diosynth Biotechnologies U.S.A., Inc
  • AGC Biologics A/S
  • Recipharm AB
  • Rentschler Biopharma SE

Table Information