Investigational New Drug CDMO Market Worth $6.8 Billion By 2028

Investigational New Drug CDMO Market Growth & Trends

The global investigational new drug CDMO market size is expected to reach USD 6.8 billion by 2028, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 6.9% from 2021 to 2028. 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 89.0% in 2020. 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 with a revenue share of 85.5% in 2020. 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 of 69.4% in 2020. 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 7.7% 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 based on product, service, end user, and region:

IND CDMO Product Outlook (Revenue, USD Million, 2016 - 2028)

• Small Molecule

• Large Molecule

IND CDMO Service Outlook (Revenue, USD Million, 2016 - 2028)

• Contract Development

  • Small Molecule

    • Bioanalysis and DMPK Studies

    • Toxicology Testing

    • Pathology and Safety Pharmacology Studies

    • Drug Substance Synthetic Route Development

    • Drug Substance Process Development

    • Form Selection Crystallization Process Development

    • Scale-up of Drug Substance

    • Preformulation

    • Preclinical Formulation Selection

    • First In Man Formulation/ Process Development

    • Analytical Method Development / Validation

    • Release Testing of Drug Substance and Drug Product

    • Work Up Purification Steps

    • Telescoping & Process Refining

    • Initial Optimization

    • Formal Stability of Drug Substance and Drug Product

  • Large Molecule

    • Cell Line Development

    • Process Development

      • Upstream

        • Microbial

        • Mammalian

        • Others

      • Downstream

        • Mabs

        • Recombinant Proteins

        • Others

• Contract Manufacturing

  • Small Molecule

    • Oral Solids

    • Liquid and Semi-solids

    • Injectables

    • Others

  • Large Molecule

    • MABs

    • Recombinant Proteins

    • Others

IND CDMO End-user Outlook (Revenue, USD Million, 2016 - 2028)

• Pharmaceutical Companies

• Biotech Companies

• Others (Government, Research Institutes, Academic Institutes, etc.) 

IND CDMO Regional Outlook (Revenue, USD Million, 2016 - 2028)

• North America

  • U.S.

  • Canada

• Europe

  • U.K.

  • Germany

  • France

  • Italy

  • Spain

• Asia Pacific

  • Japan

  • China

  • India

  • Australia

  • South Korea

• Latin America

  • Brazil

  • Mexico

  • Argentina

• Middle East & Africa

  • South Africa

  • Saudi Arabia

  • UAE

List of Key Players of Investigational New Drug (IND) CDMO Market

• Lonza

• Catalent

• Recipharm AB

• Siegfried Holding AG

• Thermo Fisher Scientific Inc.

• Covance Inc.

• Charles River laboratories Inc.

• Cambrex Corporation

• IQVIA Holdings Inc.

• Syneous Health