CDMO (Contract Development and Manufacturing) Industry Report 2025, Clinical Trials, Emerging Players - Helix Biotech, Andelyn Biosciences, and Celloid

contract development and manufacturing (CDMO) market reached US$ 150.19 billion in 2024 and is expected to reach US$ 280.07 billion by 2033, growing at a CAGR of 7.4% during the forecast period 2025-2033

DataM Intelligence has published a new research report on "Contract Development and Manufacturing Market Size 2025". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

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Clinical Approvals in October 2025 & Ongoing Approvals

October 2025 clinical approvals linked to CDMOs primarily involved novel drug formulations, including the FDA approval of Cosmo Pharmaceuticals' Winlevi (for acne) with EU regulatory endorsement shortly after, showcasing effective contract manufacturing partnerships for quick market access.​

Ongoing CDMO-supported clinical trials span various therapeutic areas including oncology, rare diseases, and biosimilars, with emphasis on advanced modalities such as gene and cell therapies benefiting from specialist contract development expertise.​

IASO Biotherapeutics received Clinical Trial Notification approval in Japan for its anti-BCMA CAR-T therapy, leveraging manufacturing partnerships across Asia and the US to expedite global clinical development.

Latest Mergers & Acquisitions (M&A)

The CDMO industry continues strong consolidation as pharma and biotech companies outsource drug development and manufacturing to specialists to reduce costs and speed time to market. Notable recent M&A includes strategic acquisitions targeting biologics and advanced therapy CDMOs that offer flexible and continuous manufacturing capabilities.​

Mid-2025 saw increased activity in acquiring regional CMOs with specialty manufacturing capabilities in emerging markets including India and Southeast Asia, helping global firms regionalize supply chains and meet local regulatory requirements.​

Several deals focus on integrating advanced AI-driven process analytics and digital twins for optimizing manufacturing scale-up and quality control.

Key Players:

Catalent Inc, Recipharm AB, Jubilant Pharmova Limited, Thermo Fisher Scientific Inc., Boehringer Ingelheim International GmbH, IQVIA, Syneos Health, Parexel International (MA) Corporation, Curia Global, Inc., NextPharma Technologies among others.

Emerging Players

Helix Biotech, Andelyn Biosciences, and Celloid among others

Key Development:

In March 2024, Eurofins CDMO Alphora Inc., a global Contract Development & Manufacturing Organization within the Eurofins laboratory network, announced a major expansion of its Drug Product Analytical Services Laboratory in Mississauga, Canada. The upgraded facility now features advanced equipment and analytical capabilities, enabling comprehensive support for drug product analysis.

In September 2024, Serán Bioscience, an emerging CDMO, announced plans to accelerate the transition from clinic to market for its clients through a substantial investment backed by Bain Capital and the construction of a new commercial facility. With $200 million in funding from Bain's Life Science subsidiary, Serán aims to establish its first commercial manufacturing plant by 2026.

Growth Forecast Projected:

The Global Contract Development and Manufacturing Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Contract Development and Manufacturing Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

By Service Type: (Active Pharmaceutical Ingredient (API) Manufacturing, Finished Dosage Formulation (FDF) Development and Manufacturing, Secondary Packaging)

By Research Phase: (Pre-Clinical, Phase I, Phase II, Phase III, Phase IV)

By End User: (Pharmaceutical Companies, Contract Research Organizations (CROs), Generic Pharmaceutical Companies)

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FDA Approvals

FDA approvals in 2025 depend heavily on partnership models involving CMOs and CDMOs to meet stringent regulatory guidelines, with several new molecular entity (NME) approvals showcasing successful outsourcing collaboration.​

The FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot Program launched in 2025 incentivizes innovation in manufacturing process development, promoting quality and regulatory adherence.

FAQ's

Q1: What is the current size of the Contract Development and Manufacturing Market?

A: The Contract Development and Manufacturing Market stood at US$ 150.19 billion in 2024 and is set to experience remarkable growth, reaching US$ 280.07 billion by 2033

Q2: How fast is the Contract Development and Manufacturing Market growing?

A: The Market is on an impressive growth trajectory, expected to expand at a CAGR of 7.4% from 2025 to 2032

Regulatory Updates

The FDA expanded its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot Program in August 2025 to accelerate innovation adoption among CDMOs. This program supports pilot projects aimed at developing advanced manufacturing analytical technologies and digital tools, improving quality and compliance readiness for drug substance and drug product manufacturing.​

The EPA introduced stricter environmental requirements targeting chemical manufacturing waste, driving CDMOs to adopt greener manufacturing processes and enhanced sustainability protocols to maintain regulatory compliance.​

The European Medicines Agency (EMA) increased scrutiny on supply chain transparency and traceability, requiring CDMOs supplying API and drug substances to demonstrate end-to-end data integrity and compliance with serialization and anti-counterfeit regulations.​

Reimbursement & Payer Policies

Globally, payers are increasingly linking reimbursement to product quality and manufacturing reliability, incentivizing pharmaceutical companies to partner with CDMOs recognized for superior process controls, robust supply chains, and compliance performance.​

Value-based reimbursement frameworks favor therapies manufactured with advanced continuous processing and real-time release testing (RTRT), both byproducts of CDMO technological innovation.​

New reimbursement codes and enhanced coverage policies were implemented in some regions to cover patient access programs and post-market monitoring activities linked with advanced biologics, indirectly support CDMO roles in lifecycle management.​

Impact and Outlook

These regulatory and reimbursement updates emphasize quality by design (QbD), data integrity, and sustainability, making digital transformation and environment-friendly investments essential in CDMO strategic roadmaps.

CDMOs aligning early with these evolving frameworks are better positioned to attract high-value contracts and ensure faster regulatory approvals for their pharmaceutical partners.

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