Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market: Opportunities and Challenges

Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Global Market Report 2025

The Business Research Company's Investigational New Drug CDMO Global Market Report 2025 – Market Size, Trends, And Global Forecast 2025-2034

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What Is The Expected Cagr For The Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Through 2025?
In recent years, the market for the development and manufacturing of investigational new drugs under contract (CDMO) has seen significant expansion. From $5.53 billion in 2024, it is anticipated to rise to $5.91 billion in 2025, with a compound annual growth rate (CAGR) of 7.0%. Factors such as the escalating demand for initial-phase clinical trials, heightened outsourcing by pharmaceutical firms, an increase in the development of biologics and complex molecules, amplified regulatory backing for fast-tracked drug approvals, as well as an increased emphasis on cost-efficiency and quick market entry, have all contributed to this historic growth.

Anticipations are high for substantial expansion in the upcoming years for the market size of the research-based new medicinal contract development and manufacturing organizations (CDMO). The market is set to reach $7.67 billion in 2029 with a compound annual growth rate (CAGR) of 6.7%. Factors contributing to this growth during the forecast period include the amplified emphasis on rare and orphan drug development, heightened requirement for integrated preclinical to clinical services, the increasing complexity of biologics and gene therapies, elevated investment in small molecule innovation, and rising implementation of virtual pharmaceutical business models. Notable trends to watch in the forecast period are progress in integrated drug development platforms, the advent of AI-controlled clinical trial designs, evolution in personalized medicine production, improvements in regulatory compliance technologies, and the creation of adaptable and modular manufacturing facilities.

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What Are The Driving Factors Impacting The Investigational New Drug CDMO Market?
The escalating number of clinical trials is predicted to accelerate the expansion of the investigational new drug contract development and manufacturing organization (CDMO) market in the future. Clinical trials, conducted meticulously with human participants, are utilized to validate the safety and effectiveness of medical procedures, treatments, or interventions within well-managed circumstances. This increase in clinical trials is largely due to the rising demand for novel treatments, as pharmaceutical and biotech corporations are pressured to develop and test fresh therapies due to a marked increase in chronic and complex diseases. Investigational new drug CDMOs play a crucial role in clinical trials by efficiently coordinating the development and manufacturing of trial-ready drug formulations, thereby ensuring that investigational products are supplied punctually and in compliance with each study phase. To illustrate, as per the Association of the British Pharmaceutical Industry, a UK-based trade association, the UK experienced a 4.3% yearly increase in company-initiated clinical trials in November 2023, rising from 394 in 2021 to 411 in 2022. Consequently, the escalating number of clinical trials is triggering the expansion of the investigational new drug contract development and manufacturing organization (CDMO) market.

Which Players Dominate The Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Industry Landscape?
Major players in the Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Global Market Report 2025 include:
• Thermo Fisher Scientific Inc.
• Fresenius Kabi AG
• Lonza Group Ltd.
• Catalent Inc.
• Samsung Biologics Co. Ltd.
• Fareva SA
• Recipharm AB
• PCI Pharma Services
• Vetter Pharma
• Delpharm.

What Are The Future Trends Of The Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market?
Leading firms in the investigational new drug contract development and manufacturing organization (CDMO) market are putting emphasis on establishing strategic alliance to enhance their development capabilities and speed up market entry. Such alliances refer to official partnerships formed between two or more organizations which work together to accomplish mutual goals, using each other's strengths, resources, or expertise to reap shared benefits while maintaining their independence. For example, in August 2023, a crucial step was taken by Sartorius AG, a life science enterprise based in Germany, when it formed a partnership with Repligen Corporation, an American life sciences firm. The partnership is intended to introduce an integrated system that brings together BIOSTAT STR and XCell ATF technologies to intensify upstream process. The goal of this combined effort is to simplify biopharmaceutical production by improving efficiency and scalability. This approach is a clear indicative of Sartorius’ ongoing innovation in the field of bioprocessing solutions, exhibiting its dedication towards the progression of the biomanufacturing industry.

Global Investigational New Drug CDMO Market Segmentation By Type, Application, And Region
The investigational new drug contract development and manufacturing organization (cdmo) market covered in this report is segmented –
1) By Product: Small Molecules, Large Molecules
2) By Formulation Type: Solid Formulations, Liquid Formulations, Injectable Formulations
3) By Service Type: Clinical Trial Material Supply, Regulatory Support Services, Manufacturing Services
4) By End-User: Biotechnology Companies, Academic And Research Institutes, Other End-Users

Subsegments:
1) By Small Molecules: Synthetic Small Molecules, Semi-synthetic Small Molecules, Peptide-based Small Molecules, Oligonucleotides
2) By Large Molecules: Monoclonal Antibodies (mAbs), Recombinant Proteins, Vaccines, Cell Therapy Products, Gene Therapy Products, RNA-based Therapeutics

View the full investigational new drug contract development and manufacturing organization (cdmo) market report:
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Which Region Holds The Largest Market Share In The Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market?
In 2024, North America held the dominant position in the global market of Contract Development And Manufacturing Organization (CDMO) for Investigational New Drugs. However, over the forecast period, the Asia-Pacific region is anticipated to witness the fastest growth. The comprehensive market report includes an analysis of various regions such as Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.

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