Global Investigational New Drug CDMO Market Size is valued at USD 5.3 Billion in 2024 and is predicted to reach USD 9.6 Billion by 2034 at a 6.2% CAGR during the forecast period for 2025-2034.
Key Industry Insights & Findings from the Report:
A growing number of pharmaceutical companies have recognized the potential profitability in working with a CMDO for both clinical and commercial stage manufacturing due to the rising demand for generic drugs and biologics, the capital-intensive nature of the industry, and the complex manufacturing requirements. The market is expected to rise due to factors like pharmaceutical companies' greater reliance on outsourcing, more R&D spending, and stringent regulations for the conduct of clinical trials. When the drug's sponsor decides to look into the new molecule's diagnostic or therapeutic potential in humans, the FDA becomes involved in developing a novel drug. New molecules are initially screened for pharmacological activity and acute toxicity potential in animals. Following that, the molecule acquires a unique legal standing as a novel drug under the Federal Food, Drug, and Cosmetic Act, subject to the particular requirements of the drug regulatory system.
The pharmaceutical business will experience an increase in innovation, with cancer and rare diseases anticipated to profit the most, according to the post-pandemic pharmaceutical environment. Contract services are likely to significantly increase due to the recent spike in investigational new drug (IND) applications, with an estimated 75 yearly FDA approvals anticipated by 2025. 3,806 IND applications were submitted to the FDA between April 2020 and June 2020, surpassing the total for the previous eight years (3,576 from 2012-2019).
The Investigational New Drug CDMO market is segmented on the product, service and end-user. Based on product, the market is segmented into small and large molecules. Based on service, the market is segmented into 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))). Based on the end-user, the Investigational New Drug CDMO is segmented into Pharmaceutical Companies, Biotech Companies and Others (Government, Research Institutes, Academic Institutes, etc.).
Based on product, the market is segmented into small and large molecules. The small molecule category dominated the market, and the growing number of small molecules under research is partly to blame for this. More than 90% of the medications available today are small molecules. Throughout the forecast period, the large molecule category is predicted to grow fastest. This is essentially a result of pharmaceutical and biotech firms spending more money on the discovery and development of large molecule therapeutic proteins because of their specificity, which enables the targeting of disease states like oncology, neurology, and metabolic disease that were previously challenging to treat.
Based on service, the market is segmented into Contract Development and Contract Manufacturing. The contract development category dominated the market. Contrary to internal drug development, contract development has several advantages, including easier access to industry specialists, a quicker time to market, lower costs, and a stronger emphasis on core skills. Due to a lack of internal resources, most small pharmaceutical and biopharmaceutical companies seek to outsource their drug development efforts. Over the projected period, this is anticipated to boost the market.
The North American Investigational New Drug CDMO market is expected to register the highest market share shortly. This can be linked to the rise in R&D expenditures by pharmaceutical and life sciences firms, which are anticipated to raise the demand for contract manufacturing in the area. An investigational drug must travel an average of 12 years in the United States before it reaches the pharmacy. Only five of 5,000 drugs that go through preclinical research reach human clinical trials. One of the five drugs that have undergone human testing has received FDA approval. As a result, only 1 in 5,000 innovative drugs make it to the market. In addition, Asia Pacific is projected to grow rapidly in the global Investigational New Drug CDMO market. The region will probably increase substantially because of the quick expansion of pharmaceutical companies and contract manufacturing organizations in developing nations like China and India. Businesses involved in biotech are growing in the area. Principal Investigators (PIs) and well-known opinion leaders have also increased.
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Report Attribute |
Specifications |
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Market Size Value In 2024 |
USD 5.3 Billion |
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Revenue Forecast In 2034 |
USD 9.6 Billion |
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Growth Rate CAGR |
CAGR of 6.2% from 2025 to 2034 |
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Quantitative Units |
Representation of revenue in US$ Bn,and CAGR from 2025 to 2034 |
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Historic Year |
2021 to 2024 |
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Forecast Year |
2025-2034 |
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Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments Covered |
Product, Service, End-User |
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Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico ;The UK; France; Italy; Spain; China; Japan; India; South Korea; South East Asia; South Korea; South East Asia |
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Competitive Landscape |
Lonza; Catalent; Recipharm AB; Siegfried Holding AG; Thermo Fisher Scientific Inc.; Covance Inc.; Charles River Laboratories; Cambrex Corporation; IQVIA Holdings Inc.; Syneous Health. |
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Customization Scope |
Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing And Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Investigational New Drug CDMO Market Snapshot
Chapter 4. Global Investigational New Drug CDMO Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Industry Analysis – Porter’s Five Forces Analysis
4.7. Competitive Landscape & Market Share Analysis
4.8. Impact of Covid-19 Analysis
Chapter 5. Market Segmentation 1: by Product Type Estimates & Trend Analysis
5.1. by Product Type & Market Share, 2024 & 2034
5.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 for the following by Product Type:
5.2.1. Percutaneous Endovascular Aneurysm Repair (EVAR)
5.2.2. Fenestrated EVAR
5.2.3. Aortic Stents Biodegradable Stents
5.2.4. Self- Expanding Nitinol Stents
5.2.5. Thoracic Aortic Aneurysm Grafts
5.2.6. Other Devices
Chapter 6. Market Segmentation 2: by Service Estimates & Trend Analysis
6.1. by Service & Market Share, 2024 & 2034
6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 for the following by Service:
6.2.1. Contract Development
6.2.1.1. Small Molecule
6.2.1.1.1. Bioanalysis and DMPK studies
6.2.1.1.2. Toxicology Testing
6.2.1.1.3. Pathology and safety pharmacology studies
6.2.1.1.4. Drug substance synthetic route development
6.2.1.1.5. Drug substance process development
6.2.1.1.6. Form selection crystallization process development
6.2.1.1.7. Scale-up of drug substance
6.2.1.1.8. Preformulation
6.2.1.1.9. Preclinical formulation selection
6.2.1.1.10. First in Man Formulation/Process Development
6.2.1.1.11. Analytical method development/validation
6.2.1.1.12. Release testing of drug substance and drug product
6.2.1.1.13. Work up Purification Steps
6.2.1.1.14. Telescoping & Process Refining
6.2.1.1.15. Initial Optimization
6.2.1.1.16. Formal stability of drug substance and drug product
6.2.1.2. Large Molecule
6.2.1.2.1. Cell Line development
6.2.1.2.2. Process Development
6.2.1.2.2.1. Upstream
6.2.1.2.2.1.1. Microbial
6.2.1.2.2.1.2. Mammalian
6.2.1.2.2.1.3. Others
6.2.1.2.2.2. Downstream
6.2.1.2.2.2.1. MABs
6.2.1.2.2.2.2. Recombinant proteins
6.2.1.2.2.2.3. Others
6.2.2. Contract Manufacturing
6.2.2.1. Small Molecule
6.2.2.1.1. Oral Solids
6.2.2.1.2. Liquid and Semi-solids
6.2.2.1.3. Injectables
6.2.2.1.4. Others
6.2.2.2. Large Molecule
6.2.2.2.1. MABs
6.2.2.2.2. Recombinant proteins
6.2.2.2.3. Others
Chapter 7. Market Segmentation 3: by End-user Estimates & Trend Analysis
7.1. by End-user & Market Share, 2024 & 2034
7.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2021 to 2034 for the following by End-user:
7.2.1. Pharmaceutical Companies
7.2.2. Biotech Companies
7.2.3. Others (Government, Research Institutes, Academic Institutes, Etc.)
Chapter 8. Investigational New Drug CDMO Market Segmentation 4: Regional Estimates & Trend Analysis
8.1. North America
8.1.1. North America Investigational New Drug CDMO Market Revenue (US$ Million) Estimates and Forecasts by Product Type, 2021-2034
8.1.2. North America Investigational New Drug CDMO Market Revenue (US$ Million) Estimates and Forecasts by Service, 2021-2034
8.1.3. North America Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2021-2034
8.1.4. North America Investigational New Drug CDMO Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
8.2. Europe
8.2.1. Europe Investigational New Drug CDMO Market revenue (US$ Million) by Product Type, 2021-2034
8.2.2. Europe Investigational New Drug CDMO Market revenue (US$ Million) by Service, 2021-2034
8.2.3. Europe Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2021-2034
8.2.4. Europe Investigational New Drug CDMO Market revenue (US$ Million) by country, 2021-2034
8.3. Asia Pacific
8.3.1. Asia Pacific Investigational New Drug CDMO Market revenue (US$ Million) by Product Type, 2021-2034
8.3.2. Asia Pacific Investigational New Drug CDMO Market revenue (US$ Million) by Service, 2021-2034
8.3.3. Asia-Pacific Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2021-2034
8.3.4. Asia Pacific Investigational New Drug CDMO Market revenue (US$ Million) by country, 2021-2034
8.4. Latin America
8.4.1. Latin America Investigational New Drug CDMO Market revenue (US$ Million) by Product Type, 2021-2034
8.4.2. Latin America Investigational New Drug CDMO Market revenue (US$ Million) by Service, 2021-2034
8.4.3. Latin America Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2021-2034
8.4.4. Latin America Investigational New Drug CDMO Market revenue (US$ Million) by country, 2021-2034
8.5. Middle East & Africa
8.5.1. Middle East & Africa Investigational New Drug CDMO Market revenue (US$ Million) by Product Type, 2021-2034
8.5.2. Middle East & Africa Investigational New Drug CDMO Market revenue (US$ Million) by Service, 2021-2034
8.5.3. Middle East & Africa Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2021-2034
8.5.4. Middle East & Africa Investigational New Drug CDMO Market revenue (US$ Million) by country, 2021-2034
Chapter 9. Competitive Landscape
9.1. Major Mergers and Acquisitions/Strategic Alliances
9.2. Company Profiles
9.2.1. Covance Inc.
9.2.2. Charles River Laboratories Inc.
9.2.3. Cambrex Corporation
9.2.4. IQVIA Holdings Inc.
9.2.5. Syneos Health
9.2.6. Lonza
9.2.7. Catalent
9.2.8. Recipharm AB
9.2.9. Siegfried Holding AG
9.2.10. Thermo Fisher Scientific Inc.
9.2.11. Other Prominent Players
By Product-
By Service-
By End-Users-
By Region-
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
Rest of Middle East and Africa
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
To know more about the research methodology used for this study, kindly contact us/click here.
