Investigational New Drug CDMO Market Grows on the Back of Virtual Engagement Tools and Post-Pandemic Manufacturing Innovation

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Investigational New Drug CDMO Market By Product (Small Molecule, Large Molecule), 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))), End-user (Pharmaceutical Companies, Biotech Companies, Others (Government, Research Institutes, Academic Institutes, Etc.))- Trends, Industry Competition Analysis, Revenue and Forecast To 2034."

The global Investigational New Drug CDMO market is estimated to reach over USD 9.6 Billion by 2034, exhibiting a CAGR of 6.2% during the forecast period.

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The growing demand for generic drugs and biologics, combined with the capital-intensive nature of pharmaceutical production and the complexity of manufacturing processes, has prompted an increasing number of pharmaceutical companies to engage Contract Development and Manufacturing Organizations (CDMOs) for both clinical and commercial-scale operations. This market expansion is primarily fueled by the pharmaceutical industry's rising dependence on outsourcing, increased investment in research and development (R&D), and the enforcement of stringent regulatory standards governing clinical trials.

The U.S. Food and Drug Administration (FDA) becomes involved in the development process of a novel drug at the preclinical stage, when a new compound undergoes pharmacological and toxicity evaluations in animal models. Once a sponsor intends to assess the compound's diagnostic or therapeutic potential in humans, the substance is classified as a new drug under the Federal Food, Drug, and Cosmetic Act, thereby becoming subject to comprehensive regulatory oversight.

While the COVID-19 pandemic had a substantial impact on global economic activities in 2020 and continues to affect various sectors, it also created new opportunities within the Investigational New Drug (IND) CDMO market. Historically, potential sponsors would conduct on-site evaluations to assess a CDMO's capabilities, including facility capacity, equipment, and technical staff. However, in response to pandemic-related restrictions, CDMOs have adopted innovative approaches-such as leveraging digital platforms, videos, and virtual reality tools-to provide remote facility tours and maintain engagement with prospective clients.

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Market Dynamics
Drivers:
The growth of the Investigational New Drug (IND) Contract Development and Manufacturing Organization (CDMO) market is primarily driven by the rising demand for advanced manufacturing solutions that align with stringent regulatory standards. Pharmaceutical companies are increasingly turning to outsourcing models to enhance operational efficiency and reduce time-to-market. In addition, heightened investment in research and development (R&D) activities is significantly contributing to the expansion of this sector.

Challenges:
One of the main obstacles impeding the growth of the IND CDMO market is the substantial capital investment required to establish and maintain compliant manufacturing infrastructure. Moreover, limited awareness of the advantages offered by CDMO services in emerging markets presents a barrier to adoption. Insufficient public investment in healthcare infrastructure, particularly across developing economies, further restricts the market's potential for expansion.

Regional Trends:
North America is anticipated to dominate the IND CDMO market in the foreseeable future, owing to its large patient base, well-established reimbursement frameworks, and growing R&D spending by pharmaceutical and life sciences companies. Market players in this region are actively pursuing strategic initiatives-such as mergers, acquisitions, collaborations, and partnerships-to strengthen their production capacities and broaden their service portfolios, thereby enhancing their competitive positioning.

Simultaneously, the Asia Pacific region is projected to witness significant growth, propelled by the rapid development of pharmaceutical and contract manufacturing industries, particularly in China and India. The emergence of numerous biotech firms, along with an increasing number of key opinion leaders and principal investigators (PIs), is fostering a robust clinical research ecosystem. Additionally, regulatory reforms in China aimed at streamlining drug evaluation processes, expediting new drug development, and shortening IND and New Drug Application (NDA) approval timelines are expected to further stimulate market expansion across the region.

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Major market players operating in the Investigational New Drug CDMO market include Lonza, Catalent, Recipharm AB, Siegfried Holding AG, Thermo Fisher Scientific Inc., Covance Inc., Charles River Laboratories, Societal CDMO, Inc., Cambrex Corporation, FUJIFILM Diosynth Biotechnologies, Minakem, Regis Technologies Inc., Samsung Biologics, Shanghai Medicilon Inc., and TaiMed Biologics, IQVIA Holdings Inc., Syneous Health, and other prominent players.

Key developments in the market:
• In Aug 2022, Good Manufacturing Practice (GMP) accreditation has been granted to Charles River Laboratories, International Inc. Charles River's Memphis contract development and manufacturing (CDMO) facility's GMP accreditation supplements an existing GMP licence for Investigational Medicinal Product (IMP) manufacture.
• In July 2022, Lonza proposes to invest $518 million in a new fill-finish production facility in Stein, Switzerland. This project will represent the culmination of Lonza's objective to provide fully integrated CDMO services. This investment improves the company's position as a leading CDMO with an unmatched breadth of services across scales and technologies.
• In June 2021, the purchase of Vigene Biosciences, Inc. by Charles River Laboratories International, Inc. The acquisition increased its current cell and gene therapy contract manufacturing capacity and offered a comprehensive gene-modified cell treatment option in the United States.
• In Aug 2019, Permira acquired Cambrex to accelerate growth in the contract development and manufacturing organisation (CDMO) industry, which is consolidating. The investment by the Permira funds will support the continued growth of Cambrex's integrated services offering by enhancing the company's ability to service its global customer base and broadening its capabilities to provide additional world-class services to support the analysis, development, and manufacturing of drug substances and products, from preclinical through commercial phases.

Market Segments
Global Investigational New Drug CDMO Market, by Product, 2020-2030 (Value US$ Mn)
• Small Molecule
• Large Molecule
Global Investigational New Drug CDMO Market, by Service, 2020-2030 (Value US$ Mn)
• Contract Development
o 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
o Large Molecule
 Cell Line development
 Process Development
• Upstream
o Microbial
o Mammalian
o Others
• Downstream
o MABs
o Recombinant proteins
o Others
• Contract Manufacturing
o Small Molecule
 Oral Solids
 Liquid and Semi-solids
 Injectables
 Others
o Large Molecule
 MABs
 Recombinant proteins
 Others
Global Investigational New Drug CDMO Market, by End-Users, 2020-2030 (Value US$ Mn)
• Hospitals & Surgical Centers
• Ambulatory Care Centers
• Research Laboratories & Academic Institutes
Global Investigational New Drug CDMO Market, by Region, 2020-2030 (Value US$ Mn)
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa
North America Investigational New Drug CDMO Market, by Country, 2020-2030 (Value US$ Mn)
• U.S.
• Canada
Europe Investigational New Drug CDMO Market, by Country, 2020-2030 (Value US$ Mn)
• Germany
• France
• Italy
• Spain
• Russia
• Rest of Europe
Asia Pacific Investigational New Drug CDMO Market, by Country, 2020-2030 (Value US$ Mn)
• India
• China
• Japan
• South Korea
• Australia & New Zealand
Latin America Investigational New Drug CDMO Market, by Country, 2020-2030 (Value US$ Mn)
• Brazil
• Mexico
• Rest of Latin America
Middle East & Africa Investigational New Drug CDMO Market, by Country, 2020-2030 (Value US$ Mn)
• GCC Countries
• South Africa
• Rest of Middle East & Africa

Why should buy this report:
 To receive a comprehensive analysis of the prospects for the global Investigational New Drug CDMO market
 To receive an industry overview and future trends of the Investigational New Drug CDMO market
 To analyze the Investigational New Drug CDMO market drivers and challenges
 To get information on the Investigational New Drug CDMO market size (Value US$ Mn) forecast to 2030
 Major investments, mergers & acquisitions in the Investigational New Drug CDMO market industry

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