Biopharmaceutical CMO and CRO Market Size, Share, Trends & Competitive Analysis By Type: Clinical Manufacturing, Commercial Manufacturing By Service: CMOs, CROs By Product Type: Biologics, Biosimilars, Cell and Gene Therapies, Vaccines By Source: Mammalian, Non-Mammalian By Scale of Operation: By End-User: By Regions, and Industry Forecast, Global Report 2024-2032

The global Biopharmaceutical CMO and CRO Market size was valued at USD 37.86 Billion in 2024 and is projected to expand at a compound annual growth rate (CAGR) of 6.3% during the forecast period, reaching a value of USD 60.05 Billion by 2032.

Biopharmaceutical CMO and CRO Market research report by Future Data Stats, offers a comprehensive view of the Market's historical data from 2019 to 2022, capturing trends, growth patterns, and key drivers. It establishes 2023 as the base year, analysing the Market landscape, consumer behaviour, competition, and regulations. Additionally, the report presents a well-researched forecast period from 2024 to 2032, leveraging data analysis techniques to project the Market's growth trajectory, emerging opportunities, and anticipated challenges.


Biopharmaceutical Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) play crucial roles in the development and production of biopharmaceuticals. CMOs provide manufacturing services to biotechnology and pharmaceutical companies, allowing them to outsource the production of their products. This outsourcing helps companies focus on research and development while ensuring that the manufacturing process meets regulatory standards and quality requirements.

CROs, on the other hand, offer research and development services, including clinical trials, to biopharmaceutical companies. They help manage various stages of drug development, from preclinical studies to regulatory approval. By partnering with CROs, biopharmaceutical companies can accelerate their development timelines and access specialized expertise, ultimately bringing new therapies to market more efficiently.


The increasing demand for biologics and biosimilars, driven by advancements in biotechnology, has propelled the need for specialized manufacturing and research services. Companies are outsourcing to CMOs and CROs to leverage their expertise, reduce time to market, and manage costs effectively. Additionally, the rise in chronic diseases and an aging population have spurred the development of new therapies, further fueling market expansion.

However, High costs associated with biopharmaceutical development and manufacturing, stringent regulatory requirements, and the complexity of biologic products can hinder growth. The growing trend of personalized medicine and the increasing investment in research and development. Emerging markets and technological advancements, including automation and digitalization, offer further potential for growth and innovation in the biopharmaceutical CMO and CRO sectors.



Companies seek to reduce costs and streamline operations, leading to a surge in outsourcing both clinical and commercial manufacturing. This trend allows biopharmaceutical firms to leverage the expertise and infrastructure of CMOs and CROs, ensuring efficient and high-quality production. Clinical manufacturing services provided by CMOs are crucial during the drug development phase. They help biopharmaceutical companies manage the complex process of producing drugs for clinical trials, ensuring compliance with regulatory standards. This partnership is essential for accelerating the development of new therapies and bringing them to market quickly and safely.

In the commercial manufacturing sector, CMOs play a key role in scaling up production once a drug receives regulatory approval. They offer the necessary resources and expertise to meet market demand efficiently. The collaboration with CMOs and CROs enables biopharmaceutical companies to focus on innovation while ensuring their products are manufactured and delivered to patients effectively.


CMOs provide specialized manufacturing services that help companies bring biologics and biosimilars to market more efficiently. They offer expertise in production, scalability, and regulatory compliance, making them essential partners in the biopharmaceutical industry. This partnership allows biopharma companies to focus on innovation while CMOs handle the complexities of manufacturing.

CROs play a critical role in the market by offering comprehensive research services. They manage clinical trials, regulatory submissions, and data analysis, which accelerates the drug development process. Their involvement reduces the time and cost associated with bringing new therapies to patients. The expertise and resources CROs provide are indispensable, especially for smaller biotech firms that lack extensive infrastructure.


Companies increasingly outsource the production and research of complex biologics to CMOs and CROs, benefiting from their specialized capabilities. This outsourcing ensures that biologics are manufactured to high standards, meeting regulatory requirements efficiently. Biosimilars also play a significant role in the market's growth. As patents for original biologic drugs expire, the demand for cost-effective biosimilars rises. CMOs and CROs provide the expertise needed to develop and manufacture these products, helping companies bring them to market more quickly and competitively.

Cell and gene therapies, along with vaccines, are driving innovation within the CMO and CRO market. These advanced therapies require specialized manufacturing processes and rigorous testing. By partnering with CMOs and CROs, biopharmaceutical companies can ensure the safe and efficient production of cutting-edge treatments and vaccines, ultimately improving patient outcomes and public health.


Mammalian sources are crucial for producing complex biologics like monoclonal antibodies and recombinant proteins. Their ability to perform post-translational modifications ensures the production of high-quality therapeutics, which is vital for treating various diseases.

Non-mammalian sources, such as microbial and plant-based systems, offer unique benefits in the market. These sources often lead to faster production times and lower costs, making them attractive for producing vaccines, enzymes, and certain biosimilars. Their simpler growth requirements and scalability make non-mammalian systems a valuable asset for rapid and cost-effective biopharmaceutical production. Their complementary strengths allow for the development and manufacturing of a wide range of therapeutic products, addressing diverse medical needs and enhancing the overall capacity of the industry to deliver innovative treatments.


At this stage, CMOs and CROs assist companies with laboratory studies and initial testing. Their expertise and resources enable biopharmaceutical firms to advance their drug candidates efficiently through early development phases. During the clinical phase, CMOs and CROs provide critical support for clinical trials. They manage the production of clinical trial materials, ensuring compliance with regulatory standards. This partnership allows biopharmaceutical companies to conduct robust and efficient clinical studies, essential for gaining regulatory approval and demonstrating the safety and efficacy of new therapies.

In the commercial stage, CMOs play a key role in large-scale manufacturing once a drug is approved. They offer the necessary infrastructure to produce drugs at high volumes, meeting market demand. By collaborating with CMOs and CROs, biopharmaceutical companies can focus on innovation while ensuring their products are manufactured and distributed effectively to patients worldwide.


These companies rely heavily on CMOs and CROs for their expertise in manufacturing and research, which helps accelerate the development and commercialization of new therapies. By outsourcing these critical functions, they can focus on innovation and core competencies while leveraging specialized capabilities to bring products to market more efficiently.

Academic and research institutes also play a significant role in this market. These institutions often collaborate with CMOs and CROs for advanced research and clinical trials, contributing to the discovery and development of new treatments. Their involvement ensures a continuous pipeline of innovative solutions and scientific advancements, further fueling market growth. Other end-users, such as government agencies and non-profit organizations, add to the market's diversity. They engage CMOs and CROs for various projects, including public health initiatives and large-scale research programs. These collaborations enhance the market's capacity to address a wide range of medical needs and support the development of novel therapies across different sectors.


In North America, the strong presence of major pharmaceutical companies and advanced healthcare infrastructure drive demand for outsourcing services. Europe follows closely, benefiting from robust regulatory frameworks and a high concentration of biotech firms, which fuels the growth of CMOs and CROs.

In the Asia Pacific region, the market is expanding rapidly due to lower operational costs and an increasing number of skilled professionals. Countries like China and India are becoming prominent players, attracting significant investments. Latin America, the Middle East, and Africa are also witnessing growth, albeit at a slower pace, driven by improving healthcare infrastructure and increasing interest from global biopharmaceutical companies seeking new opportunities for expansion.


  • Lonza Group
  • WuXi AppTec
  • Catalent Inc.
  • Samsung Biologics
  • Boehringer Ingelheim
  • Charles River Laboratories
  • Thermo Fisher Scientific
  • Parexel International Corporation
  • ICON plc
  • PRA Health Sciences
  • LabCorp (Laboratory Corporation of America)
  • Syneos Health
  • Jubilant Biosys
  • PPD (Pharmaceutical Product Development)
  • Covance Inc.
  • AMRI (Albany Molecular Research Inc.)
  • Medpace Holdings, Inc.
  • Pharmaron
  • BioReliance
  • SGS Life Sciences
  • CMIC Group
  • KBI Biopharma
  • Evotec AG
  • Recipharm AB
  • BioDuro

Table of Contents

  1. Introduction

    • Market Definition
    • Market Scope
    • Research Methodology
  2. Executive Summary

    • Key Findings
    • Market Trends
    • Market Opportunities
  3. Market Dynamics

    • Market Drivers
    • Market Restraints
    • Market Opportunities
    • Market Challenges
  4. Market Segmentation

    • By Type
      • Clinical Manufacturing
      • Commercial Manufacturing
    • By Service
      • Contract Manufacturing Organizations (CMOs)
      • Contract Research Organizations (CROs)
    • By Product Type
      • Biologics
      • Biosimilars
      • Cell and Gene Therapies
      • Vaccines
    • By Source
      • Mammalian
      • Non-Mammalian
    • By Scale of Operation
      • Preclinical
      • Clinical
      • Commercial
    • By End-User
      • Pharmaceutical and Biotechnology Companies
      • Academic and Research Institutes
      • Others
    • By Region
      • North America
      • Europe
      • Asia Pacific
      • Latin America
      • Middle East & Africa
  5. Competitive Landscape

    • Market Share Analysis
    • Key Players
    • Competitive Strategies
  6. Company Profiles

    • Overview
    • Financial Performance
    • Product Portfolio
    • Recent Developments
    • SWOT Analysis
  7. Market Outlook and Future Forecast

    • Market Size and Growth Projections
    • Emerging Trends
    • Future Opportunities
  8. Appendix

    • Glossary of Terms
    • List of Abbreviations
    • Research Methodology
    • Sources and References

Biopharmaceutical CMO and CRO Market segmentation:

By Type:

  • Clinical Manufacturing
  • Commercial Manufacturing

By Service:

  • Contract Manufacturing Organizations (CMOs)
  • Contract Research Organizations (CROs)

By Product Type:

  • Biologics
  • Biosimilars
  • Cell and Gene Therapies
  • Vaccines

By Source:

  • Mammalian
  • Non-Mammalian

By Scale of Operation:

  • Preclinical
  • Clinical
  • Commercial

By End-User:

  • Pharmaceutical and Biotechnology Companies
  • Academic and Research Institutes
  • Others

By Geography:

  • North America (USA, Canada, Mexico)
  • Europe (Germany, UK, France, Russia, Italy, Rest of Europe)
  • Asia-Pacific (China, Japan, South Korea, India, Southeast Asia, Rest of Asia-Pacific)
  • South America (Brazil, Argentina, Columbia, Rest of South America)
  • Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Rest of MEA)

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·         Market Trends and Opportunities: By purchasing this report, you gain access to up-to-date information on the latest market trends and emerging opportunities. This knowledge can help you identify potential growth areas and adapt your business strategies accordingly.

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·         Investment Decision Support: The reliable and data-driven information in this report can aid investors, venture capitalists, and financial institutions in their investment decision-making processes, helping evaluate market potential and expected returns.

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With a collective industry experience of about 70 years of analysts and experts, Future Data Stats encompasses the most infallible research methodology for its market intelligence and industry analysis. Not only does the company dig deep into the innermost levels of the market, but also examines the minutest details for its market estimates and forecasts.

This approach helps build a greater market-specific view of size, shape, and industry trends within each industry segment. Various industry trends and real-time developments are factored into identifying key growth factors and the future course of the market. The research proceeds are the results of high-quality data, expert views & analysis, and valuable independent opinions. The research process is designed to deliver a balanced view of the global markets and allows stakeholders to make informed decisions, to attain their highest growth objectives.

Future Data Stats offers its clients exhaustive research and analysis, based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. These analytical tools and models distill the data & statistics and enhance the accuracy of our recommendations and advice.


With Future Data Stats calibrated research process and 360° data-evaluation methodology, the clients receive:

·         Consistent, valuable, robust, and actionable data & analysis that can easily be referenced for strategic business planning

·         Technologically sophisticated and reliable insights through a well-audited and veracious research methodology

·         Sovereign research proceeds that present a tangible depiction of the marketplace

·         With this strong methodology, Future Data Stats ensures that its research and analysis is most reliable and guarantees sound business planning.


The research methodology of the global market involves extensive primary and secondary research. Primary research includes about 24 hours of interviews and discussions with a wide range of stakeholders that include upstream and downstream participants. Primary research typically is a bulk of our research efforts, coherently supported by extensive secondary research. Over 3000 product literature, industry releases, annual reports, and other such documents of key industry participants have been reviewed to obtain a better market understanding and gain enhanced competitive intelligence. In addition, authentic industry journals, trade associations' releases, and government websites have also been reviewed to generate high-value industry insights.


Primary Research:

·         Identify key opinion leaders

·         Questionnaire design

·         In-depth Interviews

·         Coverage across the value chain

Desk Research:

·         Company Website

·         Company Annual Reports

·         Paid Databases

·         Financial Reports

Company Analysis:

·         Market Participants

·         Key Strengths

·         Product Portfolio

·         Mapping as per Value Chain

·         Key focus segment


Primary research efforts include reaching out to participants through emails, telephonic conversations, referrals, and professional corporate relations with various companies that make way for greater flexibility in reaching out to industry participants and commentators for interviews and discussions.


The aforementioned helps to:

·         Validate and improve data quality and strengthen the research proceeds

·         Develop a market understanding and expertise

·         Supply authentic information about the market size, share, growth, and forecasts


The primary research interview and discussion panels comprise experienced industry personnel, including Chief executives and VPs of leading corporations specific to an industry, Product and sales managers or country heads, Channel partners & top-level distributors, and Banking, investments, and valuation experts.


Secondary Research:

A broad array of industry sources for the secondary research typically includes, but is not limited to:

·         Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for a competitive scenario and shape of the industry

·         Patent and regulatory databases to understand technical & legal developments

·         Scientific and technical writings for product information and related preemptions

·         Regional government and statistical databases for macro analysis

·         Authentic news articles, web-casts, and other related releases to evaluate the market

·         Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecasts


Analyst Tools and Models:

Bottom-up Approach:

·         Arriving at Global Market Size

·         Arriving at Regional/Country Market Size

·         Market Share of Key Players

Top-down Approach:

·         Key Market Players

·         Market Share of Key Players

·         Arriving at Regional/Country Market Size

·         Arriving at Global Market Size



  • Increasing demand for biologics and biosimilars
  • Growing need for specialized manufacturing and testing capabilities
  • Rise in outsourcing of biopharmaceutical development and production
  • Advancements in technology and automation in biomanufacturing


  • Regulatory complexities and stringent quality requirements
  • Limited availability of skilled talent and experienced personnel
  • High capital investment required for setting up biomanufacturing facilities
  • Intellectual property and data privacy concerns


  • Expanding global pharmaceutical and biotechnology industry
  • Emergence of novel therapy modalities like cell and gene therapies
  • Increasing adoption of continuous manufacturing and single-use technologies
  • Growing demand in emerging markets and developing economies


  • Ensuring consistent product quality and supply chain reliability
  • Managing complex manufacturing processes and analytical techniques
  • Adapting to changing regulatory guidelines and evolving industry standards
  • Maintaining competitive pricing and margins in a crowded market landscape

Frequently Asked Questions

The global Biopharmaceutical CMO and CRO Market size was valued at USD 37.86 Billion in 2024 and is projected to expand at a compound annual growth rate (CAGR) of 6.3% during the forecast period, reaching a value of USD 60.05 Billion by 2032.

The rising demand for biologics and biosimilars, advancements in biotechnology, and the need for cost-effective manufacturing and research solutions. Additionally, the growing prevalence of chronic diseases and an aging population contribute significantly to market expansion.

The adoption of personalized medicine, advancements in cell and gene therapies, and increased use of digital and automated technologies. These advancements enhance efficiency, reduce costs, and improve the speed and accuracy of biopharmaceutical development and production.

North America and Europe are expected to dominate the market due to their well-established biopharmaceutical industries and strong investment in research and development. However, Asia-Pacific is rapidly emerging as a significant player, driven by increasing investments and a growing biopharma sector.

High costs associated with biopharmaceutical development, stringent regulatory requirements, and the complexity of biologic products. However, opportunities abound in the form of technological advancements, expanding markets in developing countries, and the growing trend towards personalized medicine and specialty biologics.
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