Investigational New Drug CDMO Market Powering Drug Discovery Navigating the Early Stages How IND CDMOs Partner with Pharma to Develop New Drugs

Global Investigational New Drug CDMO Market worth $7.47 billion by 2030 - Exclusive Report by InsightAce Analytic

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 2030."

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The global Investigational New Drug CDMO market is estimated to reach over USD 7.47 billion by 2024-2031, exhibiting a CAGR of 5.56% during the forecast period.

The Rise of Contract Manufacturing in Pharma: A Lucrative Partnership
The pharmaceutical industry is increasingly turning to Contract Manufacturing and Development Organizations (CMDOs) for clinical and commercial-stage manufacturing. This trend is driven by several factors:
• Capital-intensive Nature of Pharma: The high costs of building and maintaining manufacturing facilities make partnering with a CMDO a financially attractive option.

• Growing Demand for Biologics and Generics: The rising demand for complex biologics and generic drugs creates additional pressure on in-house manufacturing capabilities.

• Intricate Manufacturing Requirements: Modern pharmaceuticals often require specialized expertise and facilities that CMDOs can provide.
Market Growth Fueled by Outsourcing Trends

The CMDO market is experiencing significant growth due to several positive forces:
• Increased Outsourcing by Pharma Companies: Pharmaceutical companies are recognizing the benefits of outsourcing and are focusing their resources on core competencies like drug discovery.

• Rising R&D Investments: Growing investments in research and development are leading to a larger pipeline of potential drugs, further fueling the demand for CMDO services.

• Stringent Regulatory Requirements: The complex and ever-evolving regulatory landscape for clinical trials necessitates expertise that CMDOs can offer.

The Impact of COVID-19
The global pandemic significantly impacted the overall economy, and its effects are still being felt across various industries. However, the IND-focused segment of the CMDO market actually benefited from the pandemic. Due to travel restrictions and social distancing measures, sponsors increasingly relied on virtual facility tours using innovative technologies like virtual reality and 360° videos to assess CMDO capabilities.

In conclusion, the CMDO market is thriving due to a confluence of factors, including the cost advantages of outsourcing, rising demand for complex drugs, and the increasing focus on R&D. While the pandemic presented challenges, it also accelerated the adoption of virtual technologies for CMDO selection. As the pharmaceutical industry continues to evolve, CMDOs are well-positioned to play an even greater role in drug development and manufacturing.

Market Dynamics:
Drivers-
The need for cutting-edge manufacturing methods that have proven to be very effective in satisfying regulatory standards is the primary driver influencing the expansion of Investigational New Drug CDMO in the pharmaceutical sector. Pharmaceutical companies are anticipated to use outsourcing services more frequently, and R&D spending is anticipated to rise.

Challenges:
Lack of high investments will constrain the market for Investigational New Drug CDMO market growth. Moreover, the lack of awareness among individuals in emerging economies limits the market growth. Governments' underinvestment constrains market expansion in medical infrastructure in developing and developing countries.

Regional Trends:
Due to its large patient population and favourable reimbursement policies, the North American market for Investigational New Drugs CDMO is anticipated to have the largest market share soon. This is related to the rise in pharmaceutical and life sciences companies' R&D spending, which is expected to increase the need for contract manufacturing in the region. Market participants are implementing various strategic initiatives, such as new partnership contracts, collaborations,

mergers, and acquisitions, intending to enhance their manufacturing and service offerings to achieve a competitive edge in this area. Additionally, the Investigational New Drug CDMO market in the Asia Pacific is anticipated to expand quickly. The rapid growth of pharmaceutical enterprises and contract manufacturing businesses in developing countries like China and India will likely force the region to grow significantly. Biotech-related companies are expanding there.

There have also been more renowned opinion leaders and principal investigators (PIs). Recently, a series of reforms with the goals of enhancing drug review procedures, speeding up the creation of novel new medications, and decreasing the time required to revise (IND) and NDA applications were announced in China.

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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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Advanced Therapy Medicinal Products CDMO Market
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Peptide CDMO (Pharmaceutical) Market

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