Investigational New Drug CDMO Market To Reach $10.40 Billion By 2033

Investigational New Drug CDMO Market Growth & Trends

The global investigational new drug CDMO market size is anticipated to reach USD 10.40 billion by 2033, according to a new report by Grand View Research, Inc. The market is projected to grow at a CAGR of 8.66% from 2025 to 2033. This is largely due to the increased R&D investments, along with stringent regulations pertaining to IND.

The U.S. FDA and the European Medicines Agency (EMA) are health authority bodies that regulate the use of investigational drugs in the U.S. and the European Union, respectively. In addition, investigational review boards (IRBs) in the U.S. and ethics committees (ECs) in the European Union must approve the use of drugs in humans.

It is the requirement of a federal law that a drug be the subject of an approved marketing application prior to it is distributed or transported across the state lines. Hence, sponsors aiming to conduct clinical studies that involve an IND should gain exemption from the FDA to permit the shipping of the investigational drug to clinical investigators in several states.

The pandemic has significantly impacted the global economy in 2020 and has an ongoing impact on various industries. However, the market for IND CDMO has benefited from the pandemic. Prior to COVID-19, prospective sponsors demanded facility audits to ensure CDMOs had the required capacity, equipment, and personnel to undertake their projects. Nowadays, CDMOs should find new ways to attract new sponsors, such as through videos, virtual reality, and other technologies that allow sponsors to virtually experience the site.

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Investigational New Drug CDMO Market Report Highlights

• In terms of product, the small molecule segment dominated the market with a revenue share of 88.4% in 2024. This is largely due to the increasing number of small molecules in development. Besides, in 2019, the small molecules dominated the new drug approvals accounting for 79% of all the NME approvals.

• Based on service, the contract development segment led the market in 2024. The contract development offers several benefits over in-house development of drugs, such as access to industry experts, less time to market, cost-effectiveness, and more focus on core competencies.

• By end user, pharmaceutical companies accounted for the largest share in 2024. This is due to the changes in the pharmaceutical industry that have an impact on research and development strategies, which, in turn, influence new drug approval trends.

• Asia Pacific to register the fastest growth rate of 8.9% over the forecast period. Due to the rapid growth of pharmaceutical firms and contract manufacturing organizations in developing countries, such as India and China, the region is likely to overtake Europe and North America in the near future.

Investigational New Drug CDMO Market Segmentation

Grand View Research has segmented the global investigational new drug CDMO market report based on service, end use, and region. 

Investigational New Drug CDMO Service Outlook (Revenue, USD Million, 2021 - 2033)

• Contract Development

  • Small Molecule

    • Bioanalysis and DMPK Studies

    • Toxicology Testing

    • Pathology and Safety Pharmacology Studies

    • Drug Substance Development

      • Synthetic Route Development

      • Process Development

      • Form Selection Crystallization Process Development

      • Scale-up of Drug Substance

    • Formulation Development

      • Pre Formulation

      • Preclinical Formulation Selection

      • First In Man Formulation/ Process Development

    • Analytical & Quality Services

      • Analytical Method Development / Validation

      • Release Testing of Drug Substance and Drug Product

      • Formal Stability of Drug Substance and Drug Product

    • Process Optimization

      • Work Up Purification Steps

      • Telescoping & Process Refining

      • Initial Optimization

  • Large Molecule

    • Cell Line Development

    • Process Development

      • Upstream

        • Microbial

        • Mammalian

        • Others

      • Downstream

        • MABs

        • Recombinant Proteins

        • Others

• Contract Manufacturing

  • Small Molecule

    • Oral Solids

    • Semi-Solids

    • Liquids & Injectables

    • Others

  • Large Molecule

    • MABs

    • Recombinant Proteins

    • Others

Investigational New Drug CDMO End Use Outlook (Revenue, USD Million, 2021 - 2033)

• Pharmaceutical Companies

• Biotech Companies

• Others

Investigational New Drug CDMO Regional Outlook (Revenue, USD Million, 2021 - 2033)

• North America

  • U.S.

  • Canada

  • Mexico

• Europe

  • UK

  • Germany

  • France

  • Italy

  • Spain

  • Denmark

  • Sweden

  • Norway

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • Thailand

  • South Korea

• Latin America

  • Brazil

  • Argentina

• Middle East & Africa

  • South Africa

  • UAE

  • Saudi Arabia

  • Kuwait

  • Qatar

  • Oman

List of Key Players in the Investigational New Drug CDMO Market

• 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