Investigational New Drug CDMO Market Size, Share & Trends Analysis Report By Product (Small Molecule, Large Molecule), By Service (Upstream, Downstream), By End-use, By Region, And Segment)- Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

Investigational New Drug CDMO Market Size and Forecast 2024 to 2033

The global investigational new drug CDMO market size was valued at USD 5.18 billion in 2023 and is anticipated to reach around USD 9.92 billion by 2033, growing at a CAGR of 6.71% from 2024 to 2033.

Investigational New Drug CDMO Market Size, 2024 to 2033

Investigational New Drug CDMO Market Key Takeaways

  • Small molecule dominated the market and accounted for a share of 88.14% in 2023.
  • Large molecule is expected to register the fastest CAGR during the forecast period.
  • Contract development accounted for the largest market revenue share in 2023. The segment is also projected to expand at the fastest CAGR during the forecast period.
  • The contract manufacturing segment is anticipated to witness lucrative growth over the forecast period.
  • The Pharmaceuticals companies dominated the market in 2023.
  • The biotic firms is projected to grow at the fastest CAGR over the forecast period.
  • North America held the largest share of 43.19% in 2023.
  • Asia Pacific is anticipated to register the fastest growth rate of 7.8% throughout the forecast period.

The Pharmaceutical companies' significant use of outsourcing services, increased spending on research and development, and stricter laws governing clinical study conduct can all be credited with the market's growth.

The globali sing world with health-care needs more new drugs and therapies. Among them the rise in incidences of chronic diseases, evolution of the population with extensive aging, the development of new diseases requires new treatment options. Consequently, the number of Investigational New Drugs (IND) has continued to increase and this is accompanied by the need to seek the services of CDMOs in managing the development process.

The industry is increasingly experiencing pressure to get treatments to the patients faster due to recent improvements in the technologies hence faster drug discovery and development. The capability to complete IND development efficiently and quickly is an advantage for CDMOs within this market.

Investigational New Drug CDMO Market Report Scope

Report Attribute Details
Market Size in 2024 USD 5.53 Billion
Market Size by 2033 USD 9.92 Billion
Growth Rate From 2024 to 2033 CAGR of 6.71%
Base Year 2023
Forecast Period 2024 to 2033
Segments Covered Product, service, end-use, region
Market Analysis (Terms Used) Value (US$ Million/Billion) or (Volume/Units)
Report Coverage Revenue forecast, company ranking, competitive landscape, growth factors, and trends
Key Companies Profiled Lonza; Catalent,Inc; Recipharm AB; Siegfried Holding AG; Thermo Fisher Scientific Inc.; Charles River Laboratories; Cambrex Corporation;IQVIA Inc,; Syneous Health

Global Investigational New Drug CDMO Market Report Segmentation

Product Insights & Trends

Small molecule dominated the market and accounted for a share of 88.14% in 2023. This high percentage can be attributed to small molecules that constitutes more than 90% of the drugs currently in the market. Their simpler structure allows for easier development, potentially lower production complexities, and faster R&D, making them a cost-effective choice for pharmaceutical companies.

Large molecule is expected to register the fastest CAGR during the forecast period. This is mostly because large molecule therapeutic proteins are more specific than smaller molecules, making it possible to target previously hard-to-treat disease states such as oncology, neurology, and metabolic disease. As a result, pharmaceutical and biotech companies have been investing more in the discovery and development of large molecule therapeutic proteins.

Service Insights & Trends

Contract development accounted for the largest market revenue share in 2023. The segment is also projected to expand at the fastest CAGR during the forecast period. Compared to internal drug development, contract development has a number of advantages, including cost-effectiveness, faster time to market, access to industry expertise, and a stronger emphasis on key capabilities. Due to a lack of internal resources, the majority of small pharmaceutical and biopharmaceutical businesses chose to outsource their drug development operations.

The contract manufacturing segment is anticipated to witness lucrative growth over the forecast period. The sponsor companies that are creating the treatments are under tremendous pressure to reduce expenses and expedite the approval process for the market. The cost and duration of a drug development programme can be significantly impacted by various factors, such as manufacturing strategy and execution, even if safety and efficacy ultimately determine a new medicine's success. Therefore, it is crucial that a sponsor choose a CMO who is fully conversant with the IND submission procedure.

End-use Insights

The Pharmaceuticals companies dominated the market in 2023. This can be attributed to the increasing investments in the pharmaceutical sector. There are roughly 7,000 different rare diseases that affect 350 million people worldwide, and more research is being done than ever before.

The biotic firms is projected to grow at the fastest CAGR over the forecast period. The basic research is done both alone and in conjunction with scientists and other members of the biomedical research ecosystem from different backgrounds, including venture capital, pre-competitive consortia, patient organisations, and illness foundations. It has a protracted development phase that is particular to the industry. The typical timeframe for a new medicine to go from IND submission to market entry after receiving regulatory approval is eight years.

Regional Insights

North America held the largest share of 43.19% in 2023. This can be attributed to money that pharmaceutical and life sciences firms are spending on research and development, which is anticipated to increase the need for contract manufacturing in the area.

Investigational New Drug CDMO Market Share, By Region, 2023 (%)

U.S. Investigational New Drug CDMO Market Trends

The investigational new drug CDMO market in the U.S. dominated the market with a share of 80.6% in 2023 due to U.S. has a well-established pharmaceutical industry with a strong focus on innovation leading to high demand.

Asia Pacific Investigational New Drug CDMO Market Trends

Asia Pacific is anticipated to register the fastest growth rate of 7.8% throughout the forecast period. This surge is due to booming pharmaceutical industries, government support for R&D, cost-effective manufacturing, a massive patient pool for trials, and a rapidly growing scientific workforce. These factors position Asia Pacific as a prime location for developing the next generation of life-saving drugs.

China investigational new drug CDMO market held a substantial market share in 2023 owing to its lower operational cost as compared to established markets, offering cost-effective solutions for CDMO services.

Investigational New Drug CDMO Market Company Insights

A variety of strategic initiatives, including new partnership agreements, collaborations, and mergers & acquisitions, are being carried out by market participants in an effort to obtain a competitive edge by expanding their services and manufacturing services.

  • IQVIA Holdings Inc, is a contract research organization (CRO) providing outsourced services to the healthcare industry. They design and conduct clinical trials and studies to support the development and commercialization of drugs, biologics, and medical devices.
  • Thermo Fisher Scientific Inc. offers a wide range of instruments, consumables, and services for research, healthcare, and education. With a global presence, the company supports advancements across various scientific fields.

Investigational New Drug CDMO Market Top Key Companies:

The following are the leading companies in the investigational new drug CDMO market. These companies collectively hold the largest market share and dictate industry trends.

  • Catalent, Inc.
  • Lonza
  • Recipharm AB
  • Siegfried Holding AG
  • Patheon Inc.
  • Covance
  • IQVIA Holdings Inc.
  • Cambrex Corporation
  • Charles River Laboratories International, Inc.
  • Syneous Health

Investigational New Drug CDMO Market Recent Developments

  • In April 2024, Recipharm announced that they are selling seven of its manufacturing sites to private equity firm Blue Wolf Capital. This is likely to allow Recipharm to focus on its core business of developing and manufacturing drugs, especially new drugs and high potency drugs.
  • In March 2024, Cambrex, a drug development and manufacturing company announced that they are nearing completion of a USD 100 million investment plan a year ahead of schedule. This is anticipated to add 150,000 square feet of manufacturing space and new technologies across North America and Europe. The expansion is expected to allow them to better support the development of complex drugs and improve patient health.
  • In March, 2024 Lonza signed an agreement for the acquisition of the manufacturing facility of Genentech in Vacaville, U.S. from Roche for USD 1.2 billion. This is expected to significantly increase Lonza's capacity to produce biologic drugs and expand their presence in the U.S. Lonza plans to invest an additional USD 500 million to upgrade the facility and meet the demand for next-generation biologic therapies.
  • In February 2024, Novo Holdings, acquired Catalent for USD16.5 billion. This deal is expected to allow Novo Holdings to leverage Catalent's expertise in developing and supplying drugs while Novo Nordisk is set to acquire three of Catalent's manufacturing sites.

Investigational New Drug CDMO Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Investigational New Drug CDMO market.

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
      • 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
  • Contract Manufacturing
    • Small Molecule
      • Oral Solids
      • Liquid and Semi-solids
      • Injectables
      • Others
    • Large Molecule
      • MABs
      • Recombinant Proteins
      • Others

By End-use 

  • Pharmaceutical Companies
  • Biotech Companies
  • Others

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

Chapter 1 Methodology and Scope
                  1.1 Market Segmentation & Scope
                      1.1.1 Estimates And Forecast Timeline
                  1.2 Research Methodology
                  1.3 Information Procurement
                      1.3.1 Purchased Database
                      1.3.2 nova one advisor’s Internal Database
                      1.3.3 Secondary Sources
                      1.3.4 Primary Research
                      1.3.5 Details of Primary Research
                  1.4 Information or Data Analysis
                      1.4.1 Data Analysis Models
                  1.5 Market Formulation & Validation
                  1.6 Region Wise Market Calculation
                      1.6.1 Region Wise Market: Base Estimates
                      1.6.2 Global Market: CAGR Calculation
                  1.7 List of Secondary Sources
                  1.8 Objectives
                      1.8.1 Objective - 1: Understanding market dynamics
                      1.8.2 Objective - 2: Understanding market estimates and forecasts
                      1.8.3 Objective - 3: Understanding attributes such as strategy framework and competitor categorization
                      1.8.4 Objective - 4: Understanding the key service and application scopes to conclude on the market size.
Chapter 2 Executive Summary
                  2.1 Market Outlook
Chapter 3 Global Investigational New Drug CDMO Market: Variables, Trends, & Scope
                  3.1 Market Segmentation and Scope
                  3.2 Market Dynamics
                      3.2.1 Market Driver Analysis
                          3.2.1.1 Increasing outsourcing services by pharmaceutical companies
                          3.2.1.2 Rising investment in R&D
                          3.2.1.3 Growing pharmaceutical industry
                          3.2.1.5 Stringent regulatory requirements
                      3.2.2 Market Restraint Analysis
                          3.2.2.1 Compliance issues while outsourcing
                          3.2.2.2 Changing scenario in developing countries
                  3.3 Penetration & Growth Prospect Mapping
                  3.4 COVID-19 Impact on the Market
                  3.5 Major Deals and Strategic Alliances Analysis
                  3.6 Global Investigational New Drug CDMO: Market Analysis Tools
                      3.6.1 Industry Analysis - Porter’s
                      3.6.3 PESTEL Analysis
Chapter 4 Global Investigational New Drug CDMO Market: Product Segment Analysis
                  4.1 Global Investigational New Drug CDMO Market: Product Market Share Analysis, 2023 & 2030
                  4.2 Small Molecule
                      4.2.1 Small Molecule Market, 2021 - 2033 (USD Million)
                  4.3 Large Molecule
                      4.3.1 Large Molecule Market, 2021 - 2033 (USD Million)
Chapter 5 Global Investigational New Drug CDMO Market: Service Segment Analysis
                  5.1 Global Investigational New Drug CDMO Market: Service Market Share Analysis, 2023 & 2030
                  5.2 Contract Development
                      5.2.1 Contract Development market, 2021 - 2033 (USD Million)
                      5.2.2 Small Molecule
                          5.2.2.1 Small Molecule market, 2021 - 2033 (USD Million)
                              5.2.2.2.1 Bioanalysis and DMPK studies
                              5.2.2.2.2 Bioanalysis and DMPK studies market, 2021 - 2033 (USD Million)
                              5.2.2.2.3 Toxicology Testing
                              5.2.2.2.4 Toxicology Testing market, 2021 - 2033 (USD Million)
                              5.2.2.2.5 Pathology and safety pharmacology studies
                              5.2.2.2.6 Pathology and safety pharmacology studies market, 2021 - 2033 (USD Million)
                              5.2.2.2.7 Drug substance synthetic route development
                              5.2.2.2.8 Drug substance synthetic route development market, 2021 - 2033 (USD Million)
                              5.2.2.2.9 Drug substance process development
                              5.2.2.2.10 Drug substance process development market, 2021 - 2033 (USD Million)
                              5.2.2.2.11 Drug substance synthetic route development
                              5.2.2.2.12 Drug substance synthetic route development market, 2021 - 2033 (USD Million)
                              5.2.2.2.13 Form selection crystallization process development
                              5.2.2.2.14 Form selection crystallization process development market, 2021 - 2033 (USD Million)
                              5.2.2.2.15 Scale up of drug substance
                              5.2.2.2.16 Scale up of drug substance market, 2021 - 2033 (USD Million)
                              5.2.2.2.17 Preformulation
                              5.2.2.2.18 Preformulation market, 2021 - 2033 (USD Million)
                              5.2.2.2.19 Preclinical formulation selection
                              5.2.2.2.20 Preclinical formulation selection market, 2021 - 2033 (USD Million)
                              5.2.2.2.21 First in Man Formulation/ Process Development
                              5.2.2.2.22 First in Man Formulation/ Process Development market, 2021 - 2033 (USD Million)
                              5.2.2.2.23 Analytical method development / validation
                              5.2.2.2.24 Analytical method development / validation market, 2021 - 2033 (USD Million)
                              5.2.2.2.25 Release testing of drug substance and drug product
                              5.2.2.2.25 Release testing of drug substance and drug product market, 2021 - 2033 (USD Million)
                              5.2.2.2.26 Work up Purification Steps
                              5.2.2.2.27 Work up purification steps market, 2021 - 2033 (USD Million)
                              5.2.2.2.28 Telescoping & Process Refining
                              5.2.2.2.29 Telescoping & Process Refining market, 2021 - 2033 (USD Million)
                              5.2.2.2.30 Initial Optimization
                              5.2.2.2.31 Initial Optimization market, 2021 - 2033 (USD Million)
                              5.2.2.2.32 Formal stability of drug substance and drug product
                              5.2.2.2.33 Formal stability of drug substance and drug product market, 2021 - 2033 (USD Million)
                      5.2.3 Large Molecule
                          5.2.3.1 Large Molecule market, 2021 - 2033 (USD Million)
                          5.2.3.2 Cell Line development
                          5.2.3.3 Cell line development market, 2021 - 2033 (USD Million)
                          5.2.3.4 Process development
                          5.2.3.5 Process development market, 2021 - 2033 (USD Million)
                              5.2.3.4.1 Upstream
                                  5.2.3.4.1.1 Upstream market, 2021 - 2033 (USD Million)
                                  5.2.3.4.1.2 Microbial
                                  5.2.3.4.1.3 Microbial market, 2021 - 2033 (USD Million)
                                  5.2.3.4.1.4 Mammalian
                                  5.2.3.4.1.5 Mammalian market, 2021 - 2033 (USD Million)
                                  5.2.3.4.1.6 Others
                                  5.2.3.4.1.7 Others market, 2021 - 2033 (USD Million)
                                  5.2.3.4.1.8 Upstream
                                  5.2.3.4.1.9 Upstream market, 2021 - 2033 (USD Million)
                              5.2.3.4.2 Downstream
                                  5.2.3.4.2.1 Downstream market, 2021 - 2033 (USD Million)
                                  5.2.3.4.2.2 MABs
                                  5.2.3.4.2.3 MABs market, 2021 - 2033 (USD Million)
                                  5.2.3.4.2.4 Recombinant Proteins
                                  5.2.3.4.2.5 Recombinant Proteins market, 2021 - 2033 (USD Million)
                                  5.2.3.4.2.6 Others
                                  5.2.3.4.2.7 Others market, 2021 - 2033 (USD Million)
                  5.3 Contract Manufacturing
                      5.3.1 Contract Manufacturing market, 2021 - 2033 (USD Million)
                          5.3.1.1 Small Molecule
                          5.3.1.2 Small Molecule market, 2021 - 2033 (USD Million)
                              5.3.1.1.1 Oral Solids
                              5.3.1.1.2 Oral Solids market, 2021 - 2033 (USD Million)
                              5.3.1.1.1 Liquid & Semi-solids
                              5.3.1.1.2 Liquid & Semi-solids market, 2021 - 2033 (USD Million)
                              5.3.1.1.3 Injectables
                              5.3.1.1.4 Injectables market, 2021 - 2033 (USD Million)
                              5.3.1.1.5 Others
                              5.3.1.1.6 Others market, 2021 - 2033 (USD Million)
                      5.3.2 Large Molecule
                          5.3.2.1 Large Molecule market, 2021 - 2033 (USD Million)
                              5.3.2.1.1 MABs
                              5.3.2.1.2 MABs market, 2021 - 2033 (USD Million)
                              5.3.2.1.3 Recombinant Proteins
                              5.3.2.1.4 Recombinant Proteins market, 2021 - 2033 (USD Million)
                              5.3.2.1.5 MABs
                              5.3.2.1.6 MABs market, 2021 - 2033 (USD Million)
                              5.3.2.1.7 Others
                              5.3.2.1.8 Others market, 2021 - 2033 (USD Million)
Chapter 6 Global Investigational New Drug CDMO Market: End-user Segment Analysis
                  6.1 Global Investigational New Drug CDMO Market: End-user Market Share Analysis, 2023 & 2030
                  6.2 Pharmaceutical Companies
                      6.2.1 Pharmaceutical companies Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                  6.3 Biotech
                          6.3.2. Biotech Companies Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                  6.4 Others
                          6.4.2. Others Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
Chapter 7 Global Investigational New Drug CDMO Market: Regional Analysis
                  7.1 Global Investigational New Drug CDMO Market: Regional Market Share Analysis, 2023 & 2030
                  7.2 North America
                      7.2.1 North America Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.2.2 U.S.
                          7.2.2.1 U.S. Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.2.3 Canada
                          7.2.3.1 Canada Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                  7.3 Europe
                      7.3.1 Europe Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.3.2 U.K.
                          7.3.2.1 U.K. Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.3.3 Germany
                          7.3.3.1 Germany Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.3.4 France
                          7.3.4.1 France Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.3.5 Italy
                          7.3.5.1 Italy Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.3.6 Spain
                          7.3.6.1 Spain Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                  7.4 Asia Pacific
                      7.4.1 Asia Pacific Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.4.2 Japan
                          7.4.2.1 Japan Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.4.3 China
                          7.4.3.1 China Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.4.4 India
                          7.4.4.1 India Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.4.5 Australia
                          7.4.5.1 Australia Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.4.6 South Korea
                          7.4.6.1 South Korea Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                  7.5 Latin America
                      7.5.1 Latin America Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.5.2 Brazil
                          7.5.2.1 Brazil Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.5.3 Mexico
                          7.5.3.1 Mexico Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.5.4 Argentina
                          7.5.4.1 Argentina Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                  7.6 MEA
                      7.6.1 MEA Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.6.2 South Africa
                          7.6.2.1 South Africa Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.6.3 Saudi Arabia
                          7.6.3.1 Saudi Arabia Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
                      7.6.4 UAE
                          7.6.4.1 UAE Investigational New Drug CDMO Market, 2021 - 2033 (USD Million)
Chapter 8 Company Profiles
                  8.1 Catalent, Inc.
                      8.1.1 Company Overview
                      8.1.2 Service Benchmarking
                      8.1.3 Financial Performance
                      8.1.4 Strategic Initiatives
                  8.2 Lonza
                      8.2.1 Company Overview
                      8.2.2 Financial Performance
                      8.2.3 Service Benchmarking
                      8.2.5 Strategic Initiatives
                  8.3 Recipharm AB
                      8.3.1 Company Overview
                      8.3.2 Service Benchmarking
                      8.3.3 Strategic Initiatives
                  8.4 Siegfried Holding AG
                      8.4.1 Company Overview
                      8.4.2 Financial Performance
                      8.4.3 Service Benchmarking
                  8.5 Patheon Inc.
                      8.5.1 Company Overview
                      8.5.2 Financial Performance
                      8.5.3 Service Benchmarking
                  8.6 Covance
                      8.6.1 Company Overview
                      8.6.2 Financial Performance
                      8.6.3 Service Benchmarking
                  8.7 IQVIA Holdings Inc.
                      8.7.1 Company Overview
                      8.7.2 Financial Performance
                      8.7.3 Service Benchmarking
                      8.7.4 Strategic Initiatives
                  8.8 Cambrex Corporation
                      8.8.1 Company Overview
                      8.8.2 Financial Performance
                      8.8.3 Service Benchmarking
                  8.9 Charles River Laboratories International, Inc.
                      8.9.1 Company Overview
                      8.9.2 Financial Performance
                      8.9.3 Service Benchmarking
                      8.9.4 Strategic Initiatives
                  8.10 Syneous Health
                      8.10.1 Company Overview
                      8.10.2 Financial Performance
                      8.10.3 Service Benchmarking
                      8.10.4 Strategic Initiatives

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