Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market to Grow at 6.7% CAGR, Reaching $7.67 Billion by 2029

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Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Outlook: How is the Market Expected to Grow by 2025?
The market size for the contract development and manufacturing organization (CDMO) for new investigational drugs has witnessed substantial growth recently. The market is projected to increase from $5.53 billion in 2024 to $5.91 billion in 2025, with a compound annual growth rate (CAGR) of 7.0%. The historical growth of this sector can be ascribed to several factors including the growing demand for initial-phase clinical trials, an increase in outsourcing from pharmaceutical firms, advancements in biologics and complex molecule development, enhanced regulatory support for swift drug approvals, and an increased emphasis on cost-effectiveness and expedited market introduction.

Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Forecast: What Size Will It Reach By 2029?
Anticipated robust expansion is predicted for the under trial new drug contract development and manufacturing organization (CDMO) market, with projections estimating it to reach $7.67 billion in 2029, accruing a compound annual growth rate (CAGR) of 6.7%. This growth over the period is associated with growing emphasis on developing rare and orphan drugs, escalating demand for all-round preclinical-to-clinical services, increased complexity in biologics and gene therapies, greater investments in small molecule innovation and rising acceptance of virtual pharma business models. The forecast period reflects significant trends such as advancements in comprehensive drug development platforms, the creation of AI-based clinical trial designs, the evolution in personalized medicine manufacturing, enhancement in technologies for regulatory compliance, and establishment of flexible and modular manufacturing setups.

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Which Key Market Drivers Will Shape Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Industry Trends in 2025-2029?
The growth of the investigational new drug contract development and manufacturing organization (CDMO) market is anticipated to be fueled by the increasing number of clinical trials. Clinical trials are meticulously structured studies, involving human subjects, with the aim to evaluate the safety and effectiveness of a specific medical treatment, procedure, or intervention under regulated settings. The surge in clinical trials is primarily due to the escalating demand for innovative medical treatments as the prevalence of complex and chronic diseases is on a rise, thus compelling pharmaceutical and biotech firms to invent and examine new therapies. The investigational new drug CDMOs aid in streamlining the development and manufacturing process of drug formulations ready for trials, thereby ensuring a timely and regulated supply of investigational products required for each study stage. For instance, according to the data from the UK's trade association, Association of the British Pharmaceutical Industry, the UK experienced a growth of 4.3% in industry-led clinical trials annually, escalating from 394 in 2021 to 411 in 2022. In conclusion, an increase in clinical trials is contributing towards the expansion of the investigational new drug contract development and manufacturing organization (CDMO) market.

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What Are the High-Growth Segments in the Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market?
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

Which Global Trends Are Driving Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market Expansion?
The leading players in the market for the development and manufacturing of investigational new drugs via Contract Development and Manufacturing Organizations (CDMOs) are focusing on strategic partnerships. These alliances, formal in nature, involve two or more organizations collaborating to achieve a common goal by utilizing each other's strengths, resources, or expertise, all while maintaining their independence. One such example occurred in August 2023, when German life sciences company Sartorius AG allied with American life sciences company Repligen Corporation. Together they launched an integrated system that combines BIOSTAT STR and XCell ATF technologies to intensify the upstream process. The goal of this partnership is to make biopharmaceutical production more efficient and scalable, showcasing Sartorius' ongoing innovation in bioprocessing solutions and a reiteration of its dedication to progressing the biomanufacturing industry.

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Who Are the Fastest-Growing Companies in the Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Industry?
Major companies operating in the investigational new drug contract development and manufacturing organization (cdmo) market are 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, Kindeva Drug Delivery LP, Ajinomoto Bio-Pharma Services, Cenexi SAS, Grand River Aseptic Manufacturing Inc., INCOG BioPharma Services, Aurigene Pharmaceutical Services, Jubilant HollisterStier LLC, Symbiosis Pharmaceutical Services Ltd., Afton Scientific Corp., Amaran Biotech Inc.

What Is the Regional Outlook for the Investigational New Drug Contract Development And Manufacturing Organization (CDMO) Market by 2029?
North America was the largest region in the investigational new drug contract development and manufacturing organization (CDMO) market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the investigational new drug contract development and manufacturing organization (cdmo) market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

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