Dublin, Oct. 21, 2025 (GLOBE NEWSWIRE) -- The "Investigational New Drug CDMO Market Size, Share & Trends Analysis Report by Service (Contract Development, Contract Manufacturing), End Use (Pharmaceutical Companies, Biotech Companies), and Region with Growth Forecasts, 2025-2033" report has been added to ResearchAndMarkets.com's offering.
The global investigational new drug CDMO market size was estimated at USD 5.35 Billion in 2025 and is projected to reach USD 10.40 billion by 2033, growing at a CAGR of 8.66% from 2025 to 2033. The investigational new drug (IND) CDMO market has been driven by rising outsourcing demand from pharmaceutical & biotechnology companies, increasing pipeline complexity, and growing need for cost efficiency among companies.
Besides, increased emphasis on accelerating time-to-market, while early-phase development risks have been managed through partnerships with specialized CDMOs. In addition, growing therapeutic focus on oncology, rare diseases, and advanced biologics has further fueled IND new drug CDMO services.
Moreover, growing technological advancements have been adopted to strengthen CDMO service offerings across the IND space. Besides, artificial intelligence, advanced analytical platforms, organoid-based preclinical models, and digital regulatory systems have been integrated into operations to enable faster, data-rich development. Single-use bioprocessing and continuous manufacturing have provided flexibility in early-stage production, ensuring scalability and efficiency. Furthermore, investments have been directed toward expanding laboratory infrastructure, specialized bioassay capabilities, and digital quality systems to capture higher-value IND projects. In addition, strategic capital allocated to mergers, acquisitions, and alliances are enabling CDMOs to broaden service portfolios and expand global footprints. Private equity and venture capital activity has continued to support niche CDMOs, particularly those focused on biologics and cell and gene therapy.
Furthermore, the regulatory landscape has remained a critical determinant of IND CDMO performance. Increased scrutiny from the U.S. FDA, EMA, and other regional agencies has been observed, requiring adherence to evolving quality standards. Data integrity, transparency in early toxicology and bioanalytical submissions, and compliance with good laboratory and manufacturing practices have been emphasized, creating challenges and opportunities for differentiation.
Overall, the IND CDMO market has been characterized by rising demand, rapid technological adoption, and strategic expansion. In addition, market participants have been operating under competitive pressures to provide integrated, end-to-end solutions while balancing cost efficiency and compliance. This growth has been supported by globalized operations, diversified portfolios, and a focus on collaborative innovation, positioning CDMOs as indispensable partners in the early stages of drug development.
Global Investigational New Drug CDMO Market Report Segmentation
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented the global investigational new drug CDMO market report based on service, end use, and region.
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 120 |
| Forecast Period | 2025 - 2033 |
| Estimated Market Value (USD) in 2025 | $5.35 Billion |
| Forecasted Market Value (USD) by 2033 | $10.4 Billion |
| Compound Annual Growth Rate | 8.6% |
| Regions Covered | Global |
Key Topics Covered:
Chapter 1. Research Methodology and Scope
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.3. Competitive Insights
Chapter 3. Investigational New Drug CDMO Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Increasing outsourcing services by pharmaceutical companies
3.2.1.2. Rising investment in R&D
3.2.1.3. Growing pharmaceutical industry
3.2.1.4. Stringent regulatory requirements
3.2.2. Market Restraint Analysis
3.2.2.1. Compliance issues while outsourcing
3.2.2.2. Changing scenario in developing countries
3.3. Technology Landscape
3.4. Pricing Model Analysis
3.5. Tariff Impact Analysis
3.6. Value Chain Analysis
3.7. Market Analysis Tools
3.7.1. Porter's Five Force Analysis
3.7.2. PESTEL by SWOT Analysis
Chapter 4. Investigational New Drug CDMO Market: Service Estimates & Trend Analysis
4.1. Investigational New Drug CDMO Market, by Service: Segment Dashboard
4.2. Investigational New Drug CDMO Market, by Service: Movement Analysis
4.3. Investigational New Drug CDMO Market Estimates & Forecasts, by Service, 2021-2033 (USD Million)
4.4. Contract Development
4.5. Contract Development
Chapter 5. Investigational New Drug CDMO Market: by End Use Estimates & Trend Analysis
5.1. Investigational New Drug CDMO Market, by End Use: Segment Dashboard
5.2. Investigational New Drug CDMO Market, by End Use: Movement Analysis
5.3. Investigational New Drug CDMO Market Estimates & Forecasts, by End Use, 2021-2033 (USD Million)
5.4. Pharmaceutical Companies
5.5. Biotech Companies
5.6. Others
Chapter 6. Investigational New Drug CDMO Market: Regional Estimates & Trend Analysis
6.1. Regional Market Dashboard
6.2. Regional Market Share Analysis, 2024 & 2033
Chapter 7. Competitive Landscape
7.1. Key Participant Categorization
7.1.1. Market Leaders
7.1.2. Emerging Players
7.2. Market Share/Assessment Analysis, 2024 (Heat Map Analysis)
7.3. Company Profiles
- Catalent, Inc.
- Lonza
- Recipharm AB
- Siegfried Holding AG
- Patheon Inc.
- Covance
- IQVIA Holdings Inc.
- Cambrex Corporation
- Charles River Laboratories International, Inc.
- Syneos Health
- Syngene International
- Jubilant Pharmova
- Piramal Pharma Solutions
- Dr. Reddy's CPS
- Dishman Carbogen Amcis Ltd.
- Biocon Biologics
- Laurus Labs
For more information about this report visit https://www.researchandmarkets.com/r/rqxjvp
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