The global Investigational New Drug CDMO market is expected to grow at a CAGR of around 12.9% over the forecast period 2021 to 2030 and expected to reach the market value of around US$ 13.8 billion by 2030.
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Growth Factors
The market growth can be attributed to factors such as the increasing outsourcing services by pharmaceutical companies, rising R&D investments, and stringent regulations for conducting clinical studies. The FDA’s role in the development of a novel drug begins when the drug’s sponsor decides to test the new molecule’s diagnostic or therapeutic potential in humans after screening it for pharmacological activity and acute toxicity potential in animals. The molecule then changes its legal position under the Federal Food, Drug, and Cosmetic Act, becoming a new drug subject to the drug regulatory system’s specific requirements.
Report Coverage
| Report Scope | Details |
| Market Size | USD 13.8 billion by 2030 |
| Growth Rate | CAGR of 12.9% From 2021 to 2030 |
| Base Year | 2020 |
| Historic Data | 2017 to 2020 |
| Forecast Period | 2021 to 2030 |
| Segments Covered | Product, Service, End-user |
| Regional Scope | North America, Europe, Asia Pacific, Latin America, Middle East & Africa |
| Companies Mentioned | Lonza; Catalent; Recipharm AB; Siegfried Holding AG; Thermo Fisher Scientific Inc.; Covance Inc.; Charles River Laboratories; Cambrex Corporation; IQVIA Holdings Inc.; Syneous Health |
Report Highlights
The small molecule segment held the largest share of 90.0% in 2020 and is likely to remain dominant over the forecast period. This is largely due to the increasing number of small molecules in development. Small molecules constitute more than 100% of the drugs currently in the market.
The large molecule segment is anticipated to register the fastest CAGR of 10.8% throughout the forecast period. This is largely due to pharmaceutical and biotech companies investing more in the discovery and development of large molecule therapeutic proteins due to their specificity, which allows for the targeting of previously difficult-to-address conditions in disease states, such as oncology, neurology, and metabolic disease.
The contract development segment dominated the market with a revenue share of 95.5% in 2020. The segment is also projected to expand at the fastest CAGR during the forecast period. The contract development offers several benefits over in-house development of drugs, such as access to industry experts, less time to market, cost-effectiveness, and more focus on core competencies.
The pharmaceutical companies segment led the market and accounted for 79.4% in 2020. This can be attributed to the increasing investments in the pharmaceutical sector. There are roughly 7,000 different rare diseases that impact 350 million people worldwide, and more research is being done than ever before.
The biotech companies segment is anticipated to register a lucrative growth rate of 10.0% over the forecast period. The basic research is carried out both independently and in collaboration with researchers and others from various parts of the biomedical research ecosystem, such as disease foundations and patient organizations, venture capital, and pre-competitive consortia.
North America held the largest share of 51.1% in 2020. This can be attributed to the increased R&D investments by life sciences and pharmaceutical companies, which are expected to boost the demand for contract manufacturing in the region. In the U.S, it takes an investigational drug an average of 12 years to get from the lab to the medicine cabinet.
Key Players
- Covance Inc.
- Charles River Laboratories Inc.
- Cambrex Corporation
- IQVIA Holdings Inc.
- Syneos Health
- Lonza
- Catalent
- Recipharm AB
- Siegfried Holding AG
- Thermo Fisher Scientific Inc.
Market Segmentation
- Product
- Small Molecule
- Large Molecule
- Service
- 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
- Pre Formulation
- 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
- Upstream
- Small Molecule
- Contract Manufacturing
- Small Molecule
- Oral Solids
- Liquid and Semi-solids
- Injectables
- Others
- Large Molecule
- MABs
- Recombinant Proteins
- Others
- Small Molecule
- Contract Development
- End-user
- Pharmaceutical Companies
- Biotech Companies
- Others (Government, Research Institutes, Academic Institutes, etc.)
- Regional
- North America
- U.S.
- Canada
- Europe
- U.K.
- Germany
- France
- Italy
- Spain
- Asia Pacific
- Japan
- China
- India
- Australia
- South Korea
- Latin America
- Brazil
- Mexico
- Argentina
- Middle East & Africa
- South Africa
- Saudi Arabia
- UAE
- North America
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Reasons to Purchase this Report:
– Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
– Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
– Market value USD Million and volume Units Million data for each segment and sub-segment
– Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
– Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
Table of Contents
Chapter 1. Introduction
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
Chapter 2. Research Methodology
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
Chapter 3. Executive Summary
3.1. Market Snapshot
Chapter 4. Market Variables and Scope
4.1. Introduction
4.2. Market Classification and Scope
4.3. Industry Value Chain Analysis
4.3.1. Raw Material Procurement Analysis
4.3.2. Sales and Distribution Channel Analysis
4.3.3. Downstream Buyer Analysis
Chapter 5. Market Dynamics Analysis and Trends
5.1. Market Dynamics
5.1.1. Market Drivers
5.1.2. Market Restraints
5.1.3. Market Opportunities
5.2. Porter’s Five Forces Analysis
5.2.1. Bargaining power of suppliers
5.2.2. Bargaining power of buyers
5.2.3. Threat of substitute
5.2.4. Threat of new entrants
5.2.5. Degree of competition
Chapter 6. Competitive Landscape
6.1.1. Company Market Share/Positioning Analysis
6.1.2. Key Strategies Adopted by Players
6.1.3. Vendor Landscape
6.1.3.1. List of Suppliers
6.1.3.2. List of Buyers
Chapter 7. Global Investigational New Drug CDMO Market, By Product
7.1. Investigational New Drug CDMO Market, by Product, 2021-2030
7.1.1. Small Molecule
7.1.1.1. Market Revenue and Forecast (2017-2030)
7.1.2. Large Molecule
7.1.2.1. Market Revenue and Forecast (2017-2030)
Chapter 8. Global Investigational New Drug CDMO Market, By Service
8.1. Investigational New Drug CDMO Market, by Service, 2021-2030
8.1.1. Contract Development
8.1.1.1. Market Revenue and Forecast (2017-2030)
8.1.2. Contract Manufacturing
8.1.2.1. Market Revenue and Forecast (2017-2030)
Chapter 9. Global Investigational New Drug CDMO Market, By End User
9.1. Investigational New Drug CDMO Market, by End User, 2021-2030
9.1.1. Pharmaceutical Companies
9.1.1.1. Market Revenue and Forecast (2017-2030)
9.1.2. Biotech Companies
9.1.2.1. Market Revenue and Forecast (2017-2030)
9.1.3. Others (Government, Research Institutes, Academic Institutes, etc.)
9.1.3.1. Market Revenue and Forecast (2017-2030)
Chapter 10. Global Investigational New Drug CDMO Market, Regional Estimates and Trend Forecast
10.1. North America
10.1.1. Market Revenue and Forecast, by Product (2017-2030)
10.1.2. Market Revenue and Forecast, by Service (2017-2030)
10.1.3. Market Revenue and Forecast, by End User (2017-2030)
10.1.4. U.S.
10.1.4.1. Market Revenue and Forecast, by Product (2017-2030)
10.1.4.2. Market Revenue and Forecast, by Service (2017-2030)
10.1.4.3. Market Revenue and Forecast, by End User (2017-2030)
10.1.5. Rest of North America
10.1.5.1. Market Revenue and Forecast, by Product (2017-2030)
10.1.5.2. Market Revenue and Forecast, by Service (2017-2030)
10.1.5.3. Market Revenue and Forecast, by End User (2017-2030)
10.2. Europe
10.2.1. Market Revenue and Forecast, by Product (2017-2030)
10.2.2. Market Revenue and Forecast, by Service (2017-2030)
10.2.3. Market Revenue and Forecast, by End User (2017-2030)
10.2.4. UK
10.2.4.1. Market Revenue and Forecast, by Product (2017-2030)
10.2.4.2. Market Revenue and Forecast, by Service (2017-2030)
10.2.4.3. Market Revenue and Forecast, by End User (2017-2030)
10.2.5. Germany
10.2.5.1. Market Revenue and Forecast, by Product (2017-2030)
10.2.5.2. Market Revenue and Forecast, by Service (2017-2030)
10.2.5.3. Market Revenue and Forecast, by End User (2017-2030)
10.2.6. France
10.2.6.1. Market Revenue and Forecast, by Product (2017-2030)
10.2.6.2. Market Revenue and Forecast, by Service (2017-2030)
10.2.6.3. Market Revenue and Forecast, by End User (2017-2030)
10.2.7. Rest of Europe
10.2.7.1. Market Revenue and Forecast, by Product (2017-2030)
10.2.7.2. Market Revenue and Forecast, by Service (2017-2030)
10.2.7.3. Market Revenue and Forecast, by End User (2017-2030)
10.3. APAC
10.3.1. Market Revenue and Forecast, by Product (2017-2030)
10.3.2. Market Revenue and Forecast, by Service (2017-2030)
10.3.3. Market Revenue and Forecast, by End User (2017-2030)
10.3.4. India
10.3.4.1. Market Revenue and Forecast, by Product (2017-2030)
10.3.4.2. Market Revenue and Forecast, by Service (2017-2030)
10.3.4.3. Market Revenue and Forecast, by End User (2017-2030)
10.3.5. China
10.3.5.1. Market Revenue and Forecast, by Product (2017-2030)
10.3.5.2. Market Revenue and Forecast, by Service (2017-2030)
10.3.5.3. Market Revenue and Forecast, by End User (2017-2030)
10.3.6. Japan
10.3.6.1. Market Revenue and Forecast, by Product (2017-2030)
10.3.6.2. Market Revenue and Forecast, by Service (2017-2030)
10.3.6.3. Market Revenue and Forecast, by End User (2017-2030)
10.3.7. Rest of APAC
10.3.7.1. Market Revenue and Forecast, by Product (2017-2030)
10.3.7.2. Market Revenue and Forecast, by Service (2017-2030)
10.3.7.3. Market Revenue and Forecast, by End User (2017-2030)
10.4. MEA
10.4.1. Market Revenue and Forecast, by Product (2017-2030)
10.4.2. Market Revenue and Forecast, by Service (2017-2030)
10.4.3. Market Revenue and Forecast, by End User (2017-2030)
10.4.4. GCC
10.4.4.1. Market Revenue and Forecast, by Product (2017-2030)
10.4.4.2. Market Revenue and Forecast, by Service (2017-2030)
10.4.4.3. Market Revenue and Forecast, by End User (2017-2030)
10.4.5. North Africa
10.4.5.1. Market Revenue and Forecast, by Product (2017-2030)
10.4.5.2. Market Revenue and Forecast, by Service (2017-2030)
10.4.5.3. Market Revenue and Forecast, by End User (2017-2030)
10.4.6. South Africa
10.4.6.1. Market Revenue and Forecast, by Product (2017-2030)
10.4.6.2. Market Revenue and Forecast, by Service (2017-2030)
10.4.6.3. Market Revenue and Forecast, by End User (2017-2030)
10.4.7. Rest of MEA
10.4.7.1. Market Revenue and Forecast, by Product (2017-2030)
10.4.7.2. Market Revenue and Forecast, by Service (2017-2030)
10.4.7.3. Market Revenue and Forecast, by End User (2017-2030)
10.5. Latin America
10.5.1. Market Revenue and Forecast, by Product (2017-2030)
10.5.2. Market Revenue and Forecast, by Service (2017-2030)
10.5.3. Market Revenue and Forecast, by End User (2017-2030)
10.5.4. Brazil
10.5.4.1. Market Revenue and Forecast, by Product (2017-2030)
10.5.4.2. Market Revenue and Forecast, by Service (2017-2030)
10.5.4.3. Market Revenue and Forecast, by End User (2017-2030)
10.5.5. Rest of LATAM
10.5.5.1. Market Revenue and Forecast, by Product (2017-2030)
10.5.5.2. Market Revenue and Forecast, by Service (2017-2030)
10.5.5.3. Market Revenue and Forecast, by End User (2017-2030)
Chapter 11. Company Profiles
11.1. Covance Inc.
11.1.1. Company Overview
11.1.2. Product Offerings
11.1.3. Financial Performance
11.1.4. Recent Initiatives
11.2. Charles River Laboratories Inc.
11.2.1. Company Overview
11.2.2. Product Offerings
11.2.3. Financial Performance
11.2.4. Recent Initiatives
11.3. Cambrex Corporation
11.3.1. Company Overview
11.3.2. Product Offerings
11.3.3. Financial Performance
11.3.4. Recent Initiatives
11.4. IQVIA Holdings Inc.
11.4.1. Company Overview
11.4.2. Product Offerings
11.4.3. Financial Performance
11.4.4. Recent Initiatives
11.5. Syneos Health
11.5.1. Company Overview
11.5.2. Product Offerings
11.5.3. Financial Performance
11.5.4. Recent Initiatives
11.6. Lonza
11.6.1. Company Overview
11.6.2. Product Offerings
11.6.3. Financial Performance
11.6.4. Recent Initiatives
11.7. Catalent
11.7.1. Company Overview
11.7.2. Product Offerings
11.7.3. Financial Performance
11.7.4. Recent Initiatives
11.8. Recipharm AB
11.8.1. Company Overview
11.8.2. Product Offerings
11.8.3. Financial Performance
11.8.4. Recent Initiatives
11.9. Siegfried Holding AG
11.9.1. Company Overview
11.9.2. Product Offerings
11.9.3. Financial Performance
11.9.4. Recent Initiatives
11.10. Thermo Fisher Scientific Inc.
11.10.1. Company Overview
11.10.2. Product Offerings
11.10.3. Financial Performance
11.10.4. Recent Initiatives
Chapter 12. Research Methodology
12.1. Primary Research
12.2. Secondary Research
12.3. Assumptions
Chapter 13. Appendix
13.1. About Us
13.2. Glossary of Terms
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