Investigational New Drug CDMO Market Poised for Growth with North America Leading the Way by 2031

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 2031."

The global Investigational New Drug CDMO market is estimated to reach over 8.12 Billion by the year 2031, exhibiting a CAGR of 6.12% during the forecast period.

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The increasing demand for generic medications and biologics, coupled with the capital-intensive nature of the industry and the complex manufacturing processes, has led a growing number of pharmaceutical companies to recognize the profitability of collaborating with Contract Manufacturing and Development Organizations (CMDOs) for both clinical and commercial-stage manufacturing. The expansion of this market is driven by factors such as the rising reliance on outsourcing by pharmaceutical companies, increased investments in research and development (R&D), and the implementation of stringent regulatory requirements for conducting clinical trials. The involvement of the U.S.

Food and Drug Administration (FDA) in the development of a novel drug begins when a new molecule is tested for pharmacological activity and acute toxicity in animals, and continues when the drug's sponsor seeks to investigate its diagnostic or therapeutic potential in humans. At this point, the molecule assumes a new legal status under the Federal Food, Drug, and Cosmetic Act as a novel drug, subject to the unique requirements of the drug regulatory system. While the COVID-19 pandemic significantly impacted the global economy in 2020 and continues to influence various industries, it has also presented opportunities for growth in the Investigational New Drug (IND) CDMO market. Prior to the pandemic, potential sponsors often conducted facility evaluations to ensure that CDMOs had the necessary capacity, equipment, and personnel to execute their projects. In response to the changing landscape, CDMOs have adopted innovative strategies, including the use of virtual tools such as videos and virtual reality, to engage potential sponsors and offer virtual tours of their facilities.

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Market Dynamics:
Drivers:
The primary factor driving the growth of the Investigational New Drug (IND) CDMO market in the pharmaceutical industry is the increasing demand for advanced manufacturing techniques that effectively meet regulatory requirements. Pharmaceutical companies are expected to increasingly rely on outsourcing services, with rising investments in research and development (R&D) further contributing to the expansion of this market.

Challenges:
A significant challenge to the growth of the IND CDMO market is the limited availability of high investment capital. Additionally, the lack of awareness in emerging economies about the benefits of such services impedes market expansion. Furthermore, underinvestment by governments in medical infrastructure, particularly in developing countries, further constrains growth opportunities.

Regional Trends:
The North American market for IND CDMOs is projected to hold the largest market share in the near future due to its substantial patient population and favorable reimbursement policies. This is coupled with the increasing R&D expenditure by pharmaceutical and life sciences companies, which is expected to drive greater demand for contract manufacturing in the region. Market participants are adopting various strategic initiatives, such as forming new partnerships, collaborations, mergers, and acquisitions, to enhance their manufacturing capabilities and service offerings, thereby gaining a competitive advantage.

In parallel, the IND CDMO market in the Asia Pacific region is anticipated to experience rapid growth. This expansion is largely driven by the burgeoning pharmaceutical and contract manufacturing sectors in countries such as China and India. The region is seeing the rise of biotech companies, as well as a growing number of leading opinion leaders and principal investigators (PIs). Recent reforms in China aimed at improving drug review processes, accelerating the development of new medications, and reducing the time required for Investigational New Drug (IND) and New Drug Application (NDA) approvals are expected to further fuel market growth in 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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