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Biopharmaceutical CMO & CRO Market - Global Forecast 2025-2032

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    Report

  • 194 Pages
  • October 2025
  • Region: Global
  • 360iResearch™
  • ID: 6010880
UP TO OFF until Jan 01st 2026
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The biopharmaceutical CMO and CRO sector is rapidly evolving as organizations adjust outsourcing models, integrate novel technologies, and address dynamic regulatory shifts. Senior decision-makers require precise market intelligence to safeguard business resilience and uncover new opportunities in an increasingly complex environment.

Market Snapshot: Biopharmaceutical CMO & CRO Market

The global biopharmaceutical contract manufacturing and contract research market is set for robust growth, projected to reach USD 95.65 billion in 2024. This expansion is fueled by rising demand for biologics, consistent therapeutic innovation, and growing reliance on outsourced solutions across clinical and commercial operations. Industry leaders are adapting by revisiting operational frameworks to manage compressed timelines, regulatory stringency, and increasing global demand. The capacity to realign partnerships and resources allows organizations to better navigate the shifting landscape of product pipelines and compliance regulations.

Scope & Segmentation of the Biopharmaceutical CMO and CRO Market

This executive-focused report offers a detailed sector analysis, guided segmentation, and region-centered perspectives that highlight differentiation opportunities and emerging trends. Understanding these divisions enables more effective strategic planning, competitive benchmarking, and targeted investment across the biopharmaceutical outsourcing industry.

  • Service Types: Analytical workflows, clinical development, cell culture, fill-finish, formulation technology, preclinical services, and process development each play a major role in streamlining new drug development, boosting efficiency, and managing biologics complexity.
  • Product Types: Monoclonal antibodies, recombinant proteins, vaccines, biosimilars, generic pharmaceuticals, and new small molecule therapeutics represent a diverse pipeline, which supports rapid innovation and fulfills evolving healthcare needs worldwide.
  • Applications: Cell and gene therapies, monoclonal antibody treatments, protein-based drugs, and novel vaccine platforms such as mRNA and subunit vaccines enable rapid responses to new therapeutic targets and changing disease profiles.
  • End Users: Biotechnology firms, pharmaceutical manufacturers, research organizations, and contract partners help facilitate efficient commercialization, ensure global delivery, and streamline the navigation of regulatory pathways.
  • Regions: The Americas, Europe, Middle East and Africa, and Asia-Pacific offer varied regulatory landscapes, infrastructure strengths, and unique market-entry challenges, each shaping distinct growth pathways and partnership strategies.
  • Featured Companies: Profiles of IQVIA Services Inc., Laboratory Corporation of America Holdings, Lonza Group AG, Syneos Health, Charles River Laboratories International, ICON plc, Catalent, Parexel International, WuXi Biologics, and Samsung Biologics underscore their pivotal roles as innovation engines and sector benchmarks.

Key Takeaways for Executive Decision Makers

  • Integrating research and manufacturing functions increases operational flexibility, allowing for more agile product portfolio management.
  • Technology-enabled digital supply chains strengthen supplier agility, improve process transparency, and enhance outsourcing partnerships.
  • Early, consistent engagement with regulatory agencies streamlines compliance processes and builds stakeholder trust within intricate networks.
  • Investment in modular manufacturing infrastructure enables organizations to scale capacity responsively, supporting proactive risk management.
  • Localizing operations improves regulatory alignment, maintains quality standards, and facilitates access to specialized talent for advanced projects.
  • Synergetic collaborations between technology vendors and outsourcing specialists drive innovation and reliable project execution within complex initiatives.

Tariff Impact and Global Supply Chain Adjustments

Forthcoming US tariffs on essential biopharmaceutical raw materials, effective in 2025, are compelling companies to reconsider sourcing strategies. Organizations are expanding supplier diversification, building domestic capacity, and forming cross-border alliances to maintain uninterrupted supply chains. Enhanced digital tools are being adopted for real-time monitoring, regulatory compliance, and streamlined logistics, fostering improved risk mitigation and operational resilience in increasingly intricate procurement and distribution networks.

Methodology & Data Sources

Research insights are drawn from executive interviews with leaders in biotechnology and outsourcing, proprietary capital analysis, and independent validation by regulatory experts. This multifaceted approach assures recommendations are robust and aligned with current industry dynamics.

Why This Report Matters for Biopharmaceutical Strategic Planning

  • Provides evidence-based segmentation and regional intelligence to inform market entry and support effective partnership development strategies.
  • Enables anticipation of emerging risks, better management of regulatory complexities, and adoption of innovations in outsourced development and manufacturing.
  • Supports systematic planning for ongoing competitiveness and organizational agility amid industry evolution.

Conclusion

This report delivers senior leaders the strategic intelligence, actionable insights, and technology-driven guidance required to navigate biopharmaceutical outsourcing’s rapidly changing environment with greater confidence.

 

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. Strategic partnerships between small molecule CMOs and lipid nanoparticle technology providers to enhance mRNA vaccine manufacturing capacity
5.2. Adoption of continuous bioprocessing platforms by contract manufacturers to accelerate monoclonal antibody production timelines
5.3. Integration of artificial intelligence-driven process analytical technology in CRO services for real-time biopharmaceutical quality monitoring
5.4. Expansion of single-use bioreactor systems by CMOs to support flexible and scalable pandemic response manufacturing capabilities
5.5. Emergence of decentralized clinical trial supply models facilitated by CROs to optimize cold chain logistics and patient engagement
5.6. Implementation of modular plug and play production units by contract manufacturers for rapid-response biologics scale-up
5.7. Growing demand for gene therapy manufacturing services driving capacity investments in viral vector production at CMOs
5.8. Utilization of digital twin simulations by biopharmaceutical CMOs to optimize upstream process development and reduce time to clinic
5.9. Rise of specialized CROs offering integrated pharmacovigilance and real-world evidence analytics for post-marketing biotherapeutics
5.10. Development of end-to-end RNA drug development platforms by integrated CMO-CRO partnerships to streamline regulatory submissions
6. Cumulative Impact of United States Tariffs 2025
7. Cumulative Impact of Artificial Intelligence 2025
8. Biopharmaceutical CMO & CRO Market, by Service Type
8.1. Analytical
8.2. Cell Culture
8.3. Clinical Development
8.3.1. Phase I
8.3.2. Phase II
8.3.3. Phase III
8.4. Fill-Finish
8.5. Formulation
8.6. Preclinical Development
8.7. Process Development
9. Biopharmaceutical CMO & CRO Market, by Product Type
9.1. Large Molecule
9.1.1. Biologics
9.1.1.1. Monoclonal Antibodies
9.1.1.2. Recombinant Proteins
9.1.1.3. Vaccines
9.1.2. Biosimilars
9.2. Small Molecule
9.2.1. Generics
9.2.2. New Chemical Entities
10. Biopharmaceutical CMO & CRO Market, by Application
10.1. Cell Therapies
10.1.1. CAR T
10.1.2. Stem Cell
10.2. Gene Therapies
10.2.1. Non Viral
10.2.2. Viral Vector
10.3. Monoclonal Antibodies
10.3.1. Bispecific
10.3.2. Conjugated
10.3.3. Naked
10.4. Recombinant Proteins
10.4.1. Enzymes
10.4.2. Growth Factors
10.4.3. Hormones
10.5. Vaccines
10.5.1. Inactivated
10.5.2. Live Attenuated
10.5.3. mRNA
10.5.4. Subunit
11. Biopharmaceutical CMO & CRO Market, by End User
11.1. Biotechnology Companies
11.1.1. Large Biotech
11.1.2. Small Biotech
11.2. CROs
11.2.1. Full Service
11.2.2. Niche Service
11.3. Pharmaceutical Companies
11.3.1. Tier I
11.3.2. Tier II
11.3.3. Tier III
11.4. Research Institutions
11.4.1. Academia
11.4.2. Government
12. Biopharmaceutical CMO & CRO Market, by Region
12.1. Americas
12.1.1. North America
12.1.2. Latin America
12.2. Europe, Middle East & Africa
12.2.1. Europe
12.2.2. Middle East
12.2.3. Africa
12.3. Asia-Pacific
13. Biopharmaceutical CMO & CRO Market, by Group
13.1. ASEAN
13.2. GCC
13.3. European Union
13.4. BRICS
13.5. G7
13.6. NATO
14. Biopharmaceutical CMO & CRO Market, by Country
14.1. United States
14.2. Canada
14.3. Mexico
14.4. Brazil
14.5. United Kingdom
14.6. Germany
14.7. France
14.8. Russia
14.9. Italy
14.10. Spain
14.11. China
14.12. India
14.13. Japan
14.14. Australia
14.15. South Korea
15. Competitive Landscape
15.1. Market Share Analysis, 2024
15.2. FPNV Positioning Matrix, 2024
15.3. Competitive Analysis
15.3.1. IQVIA Services Inc.
15.3.2. Laboratory Corporation of America Holdings
15.3.3. Lonza Group AG
15.3.4. Syneos Health, Inc.
15.3.5. Charles River Laboratories International, Inc.
15.3.6. ICON plc
15.3.7. Catalent, Inc.
15.3.8. Parexel International Corporation
15.3.9. WuXi Biologics Co., Ltd.
15.3.10. Samsung Biologics Co., Ltd.

Companies Mentioned

The companies profiled in this Biopharmaceutical CMO & CRO market report include:
  • IQVIA Services Inc.
  • Laboratory Corporation of America Holdings
  • Lonza Group AG
  • Syneos Health, Inc.
  • Charles River Laboratories International, Inc.
  • ICON plc
  • Catalent, Inc.
  • Parexel International Corporation
  • WuXi Biologics Co., Ltd.
  • Samsung Biologics Co., Ltd.

Table Information