Global Investigational New Drug CDMO Market

Report ID : 1367 | Published : 2022-09-24 | Pages: | Format: PDF/EXCEL

The market size of the global Investigational New Drug CDMO market in the year 2021 is valued at 4.69 billion and is predicted to reach 7.47 billion by the year 2030 at an 5.56% CAGR during the forecast period.

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).

Market Segmentation:

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 small molecules segment is accounted as a major contributor to the Investigational New Drug CDMO market.

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.

The contract development segment witnessed growth at a rapid rate.

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.

In the region, the North America Investigational New Drug CDMO market holds a significant revenue share.

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.

Competitive Landscape

The key players in the Investigational New Drug CDMO market have shifted their focus toward product manufacturing and are initiating significant strategies such as mergers, acquisitions, and joint ventures of major and domestic players to enhance their product portfolio and strengthen their global market footprint. Some key players in the Investigational New Drug CDMO market are Lonza; Catalent; Recipharm AB; Siegfried Holding AG; Thermo Fisher Scientific Inc.; Covance Inc.; Charles River Laboratories; Cambrex Corporation; IQVIA Holdings Inc.; Syneous Health.

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, 2019 & 2030

5.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2030 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, 2019 & 2030

6.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2030 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, 2019 & 2030

7.2. Market Size (Value (US$ Mn)) & Forecasts and Trend Analyses, 2019 to 2030 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, 2022-2030

8.1.2. North America Investigational New Drug CDMO Market Revenue (US$ Million) Estimates and Forecasts by Service, 2022-2030

8.1.3. North America Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2022-2030

8.1.4. North America Investigational New Drug CDMO Market Revenue (US$ Million) Estimates and Forecasts by country, 2022-2030

8.2. Europe

8.2.1. Europe Investigational New Drug CDMO Market revenue (US$ Million) by Product Type, 2022-2030

8.2.2. Europe Investigational New Drug CDMO Market revenue (US$ Million) by Service, 2022-2030

8.2.3. Europe Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2022-2030

8.2.4. Europe Investigational New Drug CDMO Market revenue (US$ Million) by country, 2022-2030

8.3. Asia Pacific

8.3.1. Asia Pacific Investigational New Drug CDMO Market revenue (US$ Million) by Product Type, 2022-2030

8.3.2. Asia Pacific Investigational New Drug CDMO Market revenue (US$ Million) by Service, 2022-2030

8.3.3. Asia-Pacific Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2022-2030

8.3.4. Asia Pacific Investigational New Drug CDMO Market revenue (US$ Million) by country, 2022-2030

8.4. Latin America

8.4.1. Latin America Investigational New Drug CDMO Market revenue (US$ Million) by Product Type, 2022-2030

8.4.2. Latin America Investigational New Drug CDMO Market revenue (US$ Million) by Service, 2022-2030

8.4.3. Latin America Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2022-2030

8.4.4. Latin America Investigational New Drug CDMO Market revenue (US$ Million) by country, 2022-2030

8.5. Middle East & Africa

8.5.1. Middle East & Africa Investigational New Drug CDMO Market revenue (US$ Million) by Product Type, 2022-2030

8.5.2. Middle East & Africa Investigational New Drug CDMO Market revenue (US$ Million) by Service, 2022-2030

8.5.3. Middle East & Africa Investigational New Drug CDMO Market revenue (US$ Million) by End-user, 2022-2030

8.5.4. Middle East & Africa Investigational New Drug CDMO Market revenue (US$ Million) by country, 2022-2030

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-

  • Small Molecule
  • Large Molecule

By 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
      • 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

By End-Users-

  • Pharmaceutical Companies
  • Biotech Companies
  • Others (Government, Research Institutes, Academic Institutes, Etc.)

By Region-

North America-

  • The US
  • Canada
  • Mexico

Europe-

  • Germany
  • The UK
  • France
  • Italy
  • Spain
  • Rest of Europe

Asia-Pacific-

  • China
  • Japan
  • India
  • South Korea
  • South East Asia
  • Rest of Asia Pacific

Latin America-

  • Brazil
  • Argentina
  • Rest of Latin America

 Middle East & Africa-

  • GCC Countries
  • South 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:

  • Company websites, financial reports, annual reports, investor presentations, broker reports, and SEC filings.
  • External and internal proprietary databases, regulatory databases, and relevant patent analysis
  • Statistical databases, National government documents, and market reports
  • Press releases, news articles, and webcasts specific to the companies operating in the market

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: 

  • Industry participants: CEOs, CBO, CMO, VPs, marketing/ type managers, corporate strategy managers, and national sales managers, technical personnel, purchasing managers, resellers, and distributors.
  • Outside experts: Valuation experts, Investment bankers, research analysts specializing in specific markets
  • Key opinion leaders (KOLs) specializing in unique areas corresponding to various industry verticals
  • End-users: Vary mainly depending upon the market

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.

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