세계의 CRDMO 서비스 시장 평가 : 서비스 유형별, 제품 유형별, 치료 영역별, 최종사용자별, 지역별, 기회, 예측(2018-2032년)

CRDMO services market is projected to witness a CAGR of 10.08% during the forecast period 2025-2032, growing from USD 154.11 billion in 2024 to USD 332.28 billion in 2032. The market expansion is driven by the rising trend of outsourcing within the pharmaceutical and biotech industries. Companies increasingly partner with CRDMOs to streamline drug development, cut costs, and tap into specialized expertise. Meanwhile, technological strides in biologics manufacturing enable more precise and scalable production of complex therapies. Building on this momentum is the increasing demand for innovative treatments targeting oncology, rare diseases, and personalized medicine. This dynamic landscape positions CRDMOs as essential allies in accelerating drug discovery, development, and commercialization, redefining the future of therapeutic innovation.

CRDMOs play a pivotal role in supporting the development of complex therapeutics, including biologics, cell and gene therapies, and high-potency APIs. Their capabilities span early-stage research, formulation, clinical trial support, and commercial-scale manufacturing. The market's evolution is shaped by technological advancements, including AI-driven process optimization, digital twins, and modular manufacturing platforms. Additionally, the rise of personalized medicine and precision therapies is fueling demand for flexible, specialized development models.

As the industry shifts toward integrated outsourcing and digital innovation, CRDMOs are positioned to become innovation hubs, bridging discovery and commercialization while meeting global regulatory and quality standards.

Rising Outsourcing of R&D and Manufacturing by Pharma and Biotech Firms Driving Growth

The rising complexity of drug discovery and development, coupled with the pressure to reduce time-to-market, is driving pharmaceutical and biotechnology companies to increasingly rely on Contract Research, Development, and Manufacturing Organizations (CRDMOs). These service providers offer integrated solutions across the drug development lifecycle, enabling sponsors to focus on core competencies while improving operational efficiency. The trend is particularly notable in biologics and advanced therapies, where specialized expertise and infrastructure are crucial.

For instance, in February 2024, WuXi AppTec announced the opening of a new R&D and manufacturing facility in Suzhou, China, designed to accelerate the discovery and preclinical development for global customers. This facility integrates advanced platforms for small molecules and biologics, addressing demand for faster and more cost-effective development programs. This investment reflects the broader industry move toward outsourcing high-value research and development to specialized partners with global reach and cutting-edge capabilities.

Expansion of Biologics and Cell & Gene Therapies Driving CRDMO Growth

The proliferation of biologics, including monoclonal antibodies, vaccines, and emerging cell & gene therapies, has significantly boosted the need for CRDMO services. Biology requires specialized manufacturing expertise, stringent regulatory compliance, and advanced facilities, making outsourcing an attractive option for biopharma companies.

According to the National Institutes of Health (NIH), over 60% of drugs in late-stage pipelines in 2024 are biologics or advanced therapies, underscoring the shift in demand. In May 2024, the Lonza Group announced an investment of CHF 1 billion to expand its biologics manufacturing capacity in Visp, Switzerland, in response to the increasing demand for large-scale biologics production and gene therapy programs. This capacity addition will directly support clients developing innovative therapies, demonstrating how CRDMOs are critical enablers of the next generation of treatments.

Stringent Regulatory Standards Fueling Demand for Specialized CRDMO Expertise

The evolving global regulatory landscape, with heightened quality and compliance expectations, particularly in advanced therapies and combination products, has increased the need for CRDMOs with proven regulatory expertise. Regulatory agencies, such as the U.S. FDA and EMA, have updated GMP, data integrity, and traceability guidelines in response to emerging therapeutic modalities and lessons learned from pandemics.

For instance, in March 2024, the European Medicines Agency (EMA) published updated GMP guidelines for ATMPs (Advanced Therapy Medicinal Products), emphasizing manufacturing consistency, patient safety, and robust quality controls. As sponsors face increasingly complex compliance requirements, partnering with experienced CRDMOs mitigates regulatory risks and accelerates approvals. Many players, such as Syngene International Limited, have expanded their regulatory advisory and GMP-certified service offerings to align with these evolving standards, making them preferred partners for global biopharmaceutical clients.

Growth of Precision Medicine and Personalized Therapeutics Creating New Opportunities

The shift toward precision medicine and personalized therapeutics is reshaping drug development, creating demand for CRDMOs with flexible, small-batch, and patient-specific capabilities. With therapies increasingly tailored to genetic profiles or rare diseases, manufacturing requires highly adaptable processes and rapid turnaround times. In April 2024, the U.S. National Cancer Institute (NCI) reported that over 50% of ongoing oncology trials involve biomarker-driven or targeted therapies, underlining this paradigm shift. CRDMOs that can support these niche, high-complexity projects gain a competitive edge.

For instance, in January 2024, Catalent, Inc. expanded its gene therapy manufacturing footprint in Harmans, Maryland, to provide modular, flexible solutions for personalized therapies, enabling biopharmaceutical innovators to meet fast-evolving clinical demands. This reflects the growing reliance on CRDMOs to support the dynamic and customized nature of modern drug pipelines.

North America Dominates the Global CRDMO Services Market Size

North America holds the largest share of the global CRDMO services market, driven by its advanced life sciences ecosystem, significant R&D investments, and presence of major biopharmaceutical companies. The region benefits from a robust regulatory framework, skilled workforce, and continuous innovation in drug development. U.S.-based companies, particularly in hubs like Boston and San Francisco, are key contributors to demand, leveraging CRDMOs to accelerate pipelines while managing costs.

According to the NIH, U.S. federal funding for biomedical research rose by 7% in 2024, signaling sustained investment in innovation. Companies such as Jubilant Biosys and Eurofins have expanded their U.S. operations to cater to growing demand for integrated R&D and manufacturing services. Additionally, a strong focus on cell & gene therapies, as well as personalized medicine, further cements North America's leadership position, making it the preferred region for biopharma outsourcing partnerships globally.

Future Market Scenario: Integration of AI and Digital Technologies Reshaping the CRDMO Landscape

The global CRDMO services market is poised for transformational growth, underpinned by the integration of artificial intelligence (AI), machine learning (ML), and digital twins into drug development and manufacturing workflows. These technologies enable predictive modeling, process optimization, and real-time monitoring, reducing development timelines and improving outcomes. By 2030, it is anticipated that a significant share of CRDMOs will adopt AI-driven platforms for target discovery, adaptive trial design, and automated manufacturing.

Companies such as Aragen Life Sciences Inc. and Esco Aster Pte. Ltd. are already investing in digital transformation initiatives to enhance efficiency and competitiveness. Regulatory agencies are also supportive of innovation, with the FDA issuing draft guidance in late 2023 on the use of AI in pharmaceutical manufacturing. This convergence of technology and outsourcing services will expand market opportunities, attract new entrants, and deliver better value to sponsors, solidifying the role of CRDMOs as integral partners in the future of precision healthcare.

Key Players Landscape and Outlook

The CRDMO Services Market is highly competitive and dynamic, with continuous innovation, strategic partnerships, and capacity expansions shaping the landscape. Key players leverage their global presence, regulatory expertise, and specialized platforms to cater to growing demand across biologics, advanced therapies, and personalized medicine. Leading CRDMOs are enhancing capabilities through acquisitions and investments in digital transformation, enabling more agile and efficient delivery services.

For instance, in August 2024, Sai Life Sciences Limited expanded its Pune facility with a new dedicated biologics R&D unit, highlighting the growing focus on advanced modalities. Similarly, in February 2024, WuXi AppTec opened a fully integrated discovery-to-commercialization campus in the U.S. to serve global customers more effectively. These moves illustrate how players continue to strengthen their positions through geographic expansion and service diversification.

The outlook remains optimistic as demand for outsourced R&D and manufacturing services rises alongside biopharma innovation, making the market attractive for both established players and emerging entrants.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global CRDMO Services Market Outlook, 2018-2032F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Service Type
    • 4.2.1.1. Research and Development Services
    • 4.2.1.2. Manufacturing Services
  • 4.2.2. By Product Type
    • 4.2.2.1. Biologics
    • 4.2.2.2. Chemicals
  • 4.2.3. By Therapeutic Area
    • 4.2.3.1. Oncology
    • 4.2.3.2. Cardiovascular
    • 4.2.3.3. Neurology
    • 4.2.3.4. Others
  • 4.2.4. By End-user
    • 4.2.4.1. Pharmaceutical Companies
    • 4.2.4.2. Biotechnology Companies
  • 4.2.5. By Region
    • 4.2.5.1. North America
    • 4.2.5.2. Europe
    • 4.2.5.3. Asia-Pacific
    • 4.2.5.4. South America
    • 4.2.5.5. Middle East and Africa
  • 4.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2024)
• 4.3. Market Map Analysis, 2024
  • 4.3.1. By Service Type
  • 4.3.2. By Product Type
  • 4.3.3. By Therapeutic Area
  • 4.3.4. By End-user
  • 4.3.5. By Region

5. North America CRDMO Services Market Outlook, 2018-2032F*

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Service Type
    • 5.2.1.1. Research and Development Services
    • 5.2.1.2. Manufacturing Services
  • 5.2.2. By Product Type
    • 5.2.2.1. Biologics
    • 5.2.2.2. Chemicals
  • 5.2.3. By Therapeutic Area
    • 5.2.3.1. Oncology
    • 5.2.3.2. Cardiovascular
    • 5.2.3.3. Neurology
    • 5.2.3.4. Others
  • 5.2.4. By End-user
    • 5.2.4.1. Pharmaceutical Companies
    • 5.2.4.2. Biotechnology Companies
  • 5.2.5. By Country Share
    • 5.2.5.1. United States
    • 5.2.5.2. Canada
    • 5.2.5.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. United States CRDMO Services Market Outlook, 2018-2032F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Service Type
        • 5.3.1.2.1.1. Research and Development Services
        • 5.3.1.2.1.2. Manufacturing Services
      • 5.3.1.2.2. By Product Type
        • 5.3.1.2.2.1. Biologics
        • 5.3.1.2.2.2. Chemicals
      • 5.3.1.2.3. By Therapeutic Area
        • 5.3.1.2.3.1. Oncology
        • 5.3.1.2.3.2. Cardiovascular
        • 5.3.1.2.3.3. Neurology
        • 5.3.1.2.3.4. Others
      • 5.3.1.2.4. By End-user
        • 5.3.1.2.4.1. Pharmaceutical Companies
        • 5.3.1.2.4.2. Biotechnology Companies
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe CRDMO Services Market Outlook, 2018-2032F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Poland

7. Asia-Pacific CRDMO Services Market Outlook, 2018-2032F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia

8. South America CRDMO Services Market Outlook, 2018-2032F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa CRDMO Services Market Outlook, 2018-2032F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa

10. Demand Supply Analysis

11. Value Chain Analysis

12. Porter's Five Forces Analysis

13. PESTLE Analysis

14. Pricing Analysis

15. Market Dynamics

• 15.1. Market Drivers
• 15.2. Market Challenges

16. Regulatory Framework

17. Patent Landscape

18. Case Studies

19. Competitive Landscape

• 19.1. Competition Matrix of Top 5 Market Leaders
• 19.2. SWOT Analysis for Top 5 Players
• 19.3. Key Players Landscape for Top 10 Market Players
  • 19.3.1. Catalent, Inc.
    • 19.3.1.1. Company Details
    • 19.3.1.2. Key Management Personnel
    • 19.3.1.3. Products and Services
    • 19.3.1.4. Financials (As Reported)
    • 19.3.1.5. Key Market Focus and Geographical Presence
    • 19.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisitions
  • 19.3.2. Lonza
  • 19.3.3. WuXi AppTec
  • 19.3.4. Sai Life Sciences Limited
  • 19.3.5. Syngene International Limited
  • 19.3.6. Jubilant Biosys Limited.
  • 19.3.7. Aragen Life Sciences Ltd.
  • 19.3.8. Eurofins Scientific
  • 19.3.9. Huayi Technology
  • 19.3.10. Esco Aster Pte. Ltd.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

20. Strategic Recommendations

21. About Us and Disclaimer