Biopharmaceutical CMO and CRO Market Analysis & Forecast: 2025-2032

Biopharmaceutical CMO and CRO Market Analysis & Forecast: 2025-2032

Biopharmaceutical CMO and CRO Market is estimated to be valued at USD 40.6 Bn in 2025 and is expected to reach USD 60.65 Bn in 2032, exhibiting a compound annual growth rate (CAGR) of 5.9% from 2025 to 2032.

Key Takeaways

• By Source, the Mammalian segment is expected to dominate the biopharmaceutical CMO and CRO market, capturing a significant market share of 56.9% in 2025.
• By Regional Insight, North America is projected to command the largest revenue share of 39.2% in the biopharmaceutical CMO and CRO market by 2025.

Market Overview

The biopharmaceutical CMO and CRO market is experiencing robust global growth, propelled by the increasing demand for biologics, biosimilars, and advanced therapies such as monoclonal antibodies and gene therapies. Key drivers include the need to reduce operational costs, accelerate drug development timelines, and gain access to specialized expertise in manufacturing and research. Pharmaceutical companies are increasingly outsourcing to CMOs and CROs to focus on core competencies and navigate complex regulatory requirements efficiently.

Current Events and its Impact on the Biopharmaceutical CMO and CRO Market

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Biopharmaceutical CMO and CRO Market Trends

• Increasing demand for API manufacturing is a recent trend

Active Pharmaceutical Ingredients (API) manufacturing is witnessing a steady growth in demand over the last few years. This is attributed to rise in burden of cancer and age-related diseases, rise in the global generic production capacities, and innovation in biologics market.

In February 2023, Lonza completed the expansion of its bioconjugation facility in Visp, Switzerland. This expansion added two manufacturing suites and supporting infrastructure to enhance capabilities for the clinical and commercial supply of bioconjugates and antibody-drug conjugates (ADCs). The investment aimed to meet the growing market demand for bioconjugates and strengthen Lonza's position in the biologics API sector.

• Increase in research and development is another trend

Players in the market are engaged in research and development activities for the development of safe and effective drugs to treat chronic, genetic, respiratory, and other age-related diseases and to reduce global disease burden.

Opportunities in the Biopharmaceutical CMO and CRO Market

The rising incidence of chronic diseases globally is fueling the demand for safe and effective therapeutics, accelerating drug discovery and development processes. This, in turn, is creating significant growth opportunities for Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) in the biopharmaceutical sector.

For example, in May 2023, Alkem Oncology launched Cetuxa, the world’s first biosimilar of Cetuximab, developed by Enzene Biosciences. Additionally, the rapid expansion of the biopharmaceutical industry is driving increased outsourcing. According to IBEF, India’s biotechnology industry is projected to reach US$ 150 billion by 2025 and up to US$ 300 billion by 2030.

Segmental Insights

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Global Biopharmaceutical CMO and CRO Market Insights, by Source

By source insight, the mammalian segment is expected to dominate the global biopharmaceutical CMO and CRO market in 2025. This dominance is primarily driven by the growing reliance on mammalian cell culture systems for the production of complex biologics, such as monoclonal antibodies, therapeutic proteins, and vaccines.

Regional Insight

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North America Biopharmaceutical CMO and CRO Market Trends and Analysis

The North American market is projected to lead the global biopharmaceutical Contract Manufacturing Organization (CMO) and Contract Research Organization (CRO) market in 2025. This dominant position is attributed to a robust biopharmaceutical sector infrastructure and a high concentration of CMO and CRO service providers in the region.

Dominating Countries of Biopharmaceutical CMO and CRO Market

United States Biopharmaceutical CMO and CRO Market

The U.S. leads the worldwide biopharmaceutical CMO and CRO market due to its advanced healthcare infrastructure, extensive pharmaceutical industry base, and high R&D spending. Most major U.S. players outsource manufacturing and research to increase operational efficiency and reduce drug development time.

The United States, as the core of North America's biopharma buffer industry, is home to a concentration of leading CMO and CRO firms, biotech start-ups, and major pharmaceutical companies. The region benefits from an established base of clinical trial networks and advanced manufacturing technologies, which fosters greater outsourcing across various stages of drug development.

Germany Biopharmaceutical CMO and CRO Market

Germany is becoming a European powerhouse in the biopharmaceutical CMO and CRO market with strong research infrastructure, highly trained talent, and solid government backing. The nation's resolve to drug discovery was manifested in April 2023 through the opening of European Screening Port GmbH in Hamburg a state-of-the-art drug discovery service centre designed to enhance Europe's academic and commercial pharmaceutical strengths. This initiative is evidence of the strategic emphasis of Germany on service outsourcing and innovation, making the country a hub pillar of Europe's biopharmaceutical development and production chain.

Market Report Scope

Analyst Viewpoint – Biopharmaceutical CMO and CRO Market

• The biopharmaceutical CMO and CRO industry is expected to grow significantly, driven by the rising demand for biologics, biosimilars, and personalized medicines. Experts point out that drug and biotechnology firms are increasingly seeking to outsource manufacturing and research activities to lower their operational costs, enhance efficiency, and gain a quicker time-to-market. This phenomenon of outsourcing is one of the drivers for growth of the industry, especially in well-established geographies like North America and Europe.
• New bio manufacturing technologies like continuous processing, single-use technologies, and AI-based drug discovery platforms are changing the business model. Experts see these advancements as allowing for faster and more responsive production options, thus attracting increasing numbers of sponsors to CMO and CRO partnerships. These advances are expected to increase efficiency and reduce timelines in clinical and commercial manufacture.
• The growing prevalence of chronic illnesses and need for advanced biologics has compelled CMOs and CROs to expand capabilities and infrastructure. North America stands as the leader with its well-established pharmaceutical culture, followed by rapidly arising Asia Pacific with cheap services and growing technical expertise.
• Regulatory monitoring and compliance requirements are increasing, compelling service providers to conform to high standards of quality. Though this would drive up the cost of services, analysts expect it will boost long-term industry name and customer confidence, backing continued market growth.

Biopharmaceutical CMO and CRO Market: Key Development

• In February 2023, Lonza inaugurated the expansion of its Visp, Switzerland biologics manufacturing site with a focus on capacity expansion for mammalian cell culture technologies. Investment will cover rising demand for biologics manufacture and makes Lonza a top CMO partner for biopharma companies worldwide.
• In June 2023, Samsung Biologics entered into a long-term agreement with Pfizer for the supply of drug substance manufacturing and aseptic fill-finish solutions for various oncology biologics. It is a signal of the expanding contribution of CMOs to the manufacture of complex cancer therapies.

Market Segmentation

• Global Biopharmaceutical CMO and CRO Market, By Source
• Mammalian
• Non-mammalian
• Global Biopharmaceutical CMO and CRO Market, By Service
• Contract Manufacturing
• Contract Research
• Global Biopharmaceutical CMO and CRO Market, By Product
• Biologics
• Biosimilars
• Global Biopharmaceutical CMO and CRO Market, By Region
• North America
  • U.S.
  • Canada
• Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
• Europe
  • Germany
  • U.K.
  • Spain
  • France
  • Italy
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
• Middle East
  • GCC Countries
  • Israel
  • Rest of Middle East
• Africa
  • South Africa
  • North Africa
  • Central Africa
• Company Profiles
• Allphase Clinical Research
• AlcheraBio
• Alcami
• Akos Urgent Care
• Agilent
• AGC Biologics
• Affinity Life Sciences, Inc
• Actimus Bio
• ACI Clinical
• Accumedix, Inc
• Absorption Systems
• A10 Clinical Solutions
• Albuquerque Clinical Trials (ACT)
• Ajinomoto Bio-Pharma Services
• Advanced Clinical Services LLC
• ACM Global Laboratories
• Accelerated Enrollment Solutions
• AbbVie Contract Manufacturing
• Advanced BioScience Laboratories
• Advanced Clinical Research Institute
• Alliance for Clinical Trials in Oncology

Sources

The Stakeholders Consulted

• Biopharmaceutical manufacturers and production heads
• Contract manufacturing organizations (CMOs) and contract research organizations (CROs)
• Regulatory affairs specialists and compliance officers in pharmaceutical firms
• R&D directors and clinical trial managers in biotech and pharma companies
• Investment analysts and corporate strategy consultants focused on life sciences
• Academic researchers in pharmaceutical sciences and biotechnology
• Government health and drug regulatory agencies
• Procurement and outsourcing managers in global pharmaceutical companies

Databases Opened

• U.S. Food and Drug Administration (FDA) – Drug Approval and Biologics License Application (BLA) Data
• European Medicines Agency (EMA) – Clinical Trials and Manufacturing Authorizations
• ClinicalTrials.gov – Drug Development and CRO Activity Records
• World Health Organization (WHO) – Global Health Observatory and Pharmaceuticals Database
• BioProcess International Reports – Biopharma Manufacturing Trends

Magazines & Trade Publications

• BioPharm International
• Pharmaceutical Technology
• Contract Pharma Magazine
• Outsourced Pharma
• Fierce Biotech – Manufacturing & R&D Section
• Genetic Engineering & Biotechnology News (GEN)

Scientific and Industry Journals

• Journal of Pharmaceutical Sciences
• Biotechnology Progress
• Bioprocess and Biosystems Engineering
• International Journal of Pharmaceutics
• Journal of Clinical Research & Regulatory Affairs

Newspapers & Media Outlets

• Bloomberg – Healthcare & Pharmaceuticals
• Reuters – Biotech and Drug Manufacturing News
• The Wall Street Journal – Pharma & Biotech Section
• Financial Times – Healthcare Markets
• The Economic Times – Pharma & Lifesciences News

Associations and Regulatory Bodies

• U.S. Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
• Biotechnology Innovation Organization (BIO)
• Indian Drug Manufacturers’ Association (IDMA)
• Pharmaceuticals Export Promotion Council of India (Pharmexcil)

Public Domain Sources

• U.S. National Library of Medicine
• World Bank – Global Health and Pharmaceutical Industry Reports
• OECD – Health Innovation and Bioeconomy Data
• European Commission – Biotech and Pharma Industry Updates
• Ministry of Health and Family Welfare (India) – Pharmaceutical Policy Reports

Proprietary Research Elements

• CMI Data Analytics Tool
• Proprietary CMI Repository of Biopharma Industry Data (covering past 8 years)
• CMI Expert Interviews and Transcripts (focused on CMO/CRO trends, biologics outsourcing, and regulatory developments)