Investigational New Drug CDMO Market Size, Share, and Outlook, 2025 Report- By Product (Small Molecule, Large Molecule), By Service (By Small MoleculeContract Development (Bioanalysis and DMPK studies, Toxicology Testing, Pathology and safety pharmacology

Investigational New Drug CDMO Market Outlook

Investigational New Drug CDMO Market Size is forecast to register an optimistic growth rate of 7.5% from 2025 to 2032.. The Investigational New Drug CDMO market is a thriving business that is poised to keep growing and presents potential growth opportunities for companies across the industry value chain.

The comprehensive market research report presents 12-year historic and forecast data on Investigational New Drug CDMO segments across 22 countries from 2021 to 2032. Key segments in the report include By Product (Small Molecule, Large Molecule), By Service (By Small MoleculeContract Development (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), By Large Molecule Contract Development (Cell Line development, Process Development), By Small Molecule Contract Manufacturing (Oral Solids, Liquid and Semi-solids, Injectables, Others), By Large Molecule Contract Manufacturing (MABs, Recombinant proteins, Others), By End-User (Pharmaceutical Companies, Biotech Companies, Others). Over 70 tables and charts showcase findings from our latest survey report on Investigational New Drug CDMO markets.

Investigational New Drug CDMO Market Insights, 2025

The investigational new drug (IND) CDMO market is growing as pharmaceutical companies increasingly outsource drug development and manufacturing to contract development and manufacturing organizations (CDMOs). IND CDMOs provide formulation development, analytical testing, and clinical trial material production for small molecules and biologics. The demand for specialized CDMO services is rising due to the complexity of cell and gene therapies, mRNA vaccines, and monoclonal antibodies. Companies are investing in advanced biomanufacturing technologies, including single-use bioreactors and continuous manufacturing, to enhance efficiency and scalability. Additionally, regulatory expertise and global expansion strategies are driving CDMO partnerships for faster IND approvals and market entry.

Five Trends that will define global Investigational New Drug CDMO market in 2025 and Beyond

A closer look at the multi-million global market for Investigational New Drug CDMO identifies rapidly shifting consumer preferences across categories. By focusing on growth and resilience, leading Investigational New Drug CDMO companies are prioritizing their investments across categories, markets, and geographies. The report analyses the most important market trends shaping the new landscape to support better decisions for the long and short-term future.

What are the biggest opportunities for growth in the Investigational New Drug CDMO industry?

The Investigational New Drug CDMO sector demonstrated remarkable resilience over the past year across developed and developing economies. Further, the market presents significant opportunities to leverage the existing momentum towards actions by 2030. On the other hand, recent macroeconomic developments including rising inflation and supply chain disruptions are putting pressure on companies. The chapter assists users to identify growth avenues and address business challenges to make informed commercial decisions with unique insights, data forecasts, and in-depth market analyses.

Investigational New Drug CDMO Market Segment Insights

The Investigational New Drug CDMO industry presents strong offers across categories. The analytical report offers forecasts of Investigational New Drug CDMO industry performance across segments and countries. Key segments in the industry include- By Product (Small Molecule, Large Molecule), By Service (By Small MoleculeContract Development (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), By Large Molecule Contract Development (Cell Line development, Process Development), By Small Molecule Contract Manufacturing (Oral Solids, Liquid and Semi-solids, Injectables, Others), By Large Molecule Contract Manufacturing (MABs, Recombinant proteins, Others), By End-User (Pharmaceutical Companies, Biotech Companies, Others). The largest types, applications, and sales channels, fastest growing segments, and the key factors driving each of the categories are included in the report.

Forecasts of each segment across five regions are provided from 2021 through 2032 for Asia Pacific, North America, Europe, South America, Middle East, and African regions. In addition, Investigational New Drug CDMO market size outlook is provided for 22 countries across these regions.

Market Value Chain

The chapter identifies potential companies and their operations across the global Investigational New Drug CDMO industry ecosystem. It assists decision-makers in evaluating global Investigational New Drug CDMO market fundamentals, market dynamics, and disruptive trends across the value chain segments.

Scenario Analysis and Forecasts

Strategic decision-making in the Investigational New Drug CDMO industry is multi-faceted with the increased need for planning across scenarios. The report provides forecasts across three case scenarios- low growth, reference case, and high growth cases.

Asia Pacific Investigational New Drug CDMO Market Analysis- A Promising Growth Arena for Business Expansion

As companies increasingly expand across promising Asia Pacific markets with a combined population of over 4.5 billion, the medium-to-long-term future remains robust. The presence of the fastest-growing economies such as China, India, Thailand, Indonesia, and Vietnam coupled with strengthening middle-class populations and rising disposable incomes drive the market. In particular, China and India are witnessing rapid shifts in consumer purchasing behavior. China is recovering steadily with optimistic forecasts for 2025. Further, Japanese and South Korean markets remain stable with most companies focusing on new product launches and diversification of sales channels.

The State of Europe Investigational New Drug CDMO Industry 2025- Focus on Accelerating Competitiveness

As companies opt for an integrated agenda for competitiveness, the year 2025 presents optimistic scenarios for companies across the ecosystem. With signs of economic recovery across markets, companies are increasing their investments. Europe is one of the largest markets for Investigational New Drug CDMO with demand from both Western Europe and Eastern European regions increasing over the medium to long-term future. Increasing omnichannel shopping amidst robust consumer demand for value purchases shapes the market outlook. The report analyses the key Investigational New Drug CDMO market drivers and opportunities across Germany, France, the United Kingdom, Spain, Italy, Russia, and other Europe.

The US Investigational New Drug CDMO market Insights- Executives are most excited about opportunities for the US Investigational New Drug CDMO industry.

Easing inflation coupled with strengthening consumer sentiment is encouraging aggressive actions from the US Investigational New Drug CDMO companies. Market players consistently focusing on innovation and pursuing new ways to create value are set to excel in 2025. In addition, the Canadian and Mexican markets offer lucrative growth pockets for manufacturers and vendors. Focus on private-brand offerings and promotions, diversified sales channels, expansion into niche segments, adoption of advanced technologies, and sustainability are widely observed across the North American Investigational New Drug CDMO market.

Latin American Investigational New Drug CDMO market outlook rebounds in line with economic growth.

Underlying demand remains higher among urban consumers with an optimistic economic outlook across Brazil, Argentina, Chile, and other South and Central American countries. Increased consumer spending has been reported since H2-2024 and the prospects remain strong for 2025. Aggressive ecosystem moves to create new sources of income are widely observed across markets in the region. Marketing activities focused on customer insights, operations, and support functions are quickly gaining business growth in the region.

Middle East and Africa Investigational New Drug CDMO Markets- New Opportunities for Companies Harnessing Diversity

Rapid growth in burgeoning urban locations coupled with a young and fast-growing population base is attracting new investments in the Middle East and African Investigational New Drug CDMO markets. Designing expansion and marketing strategies to cater to the local consumer base supports the market prospects. In addition to Nigeria, Algeria, South Africa, and other markets, steady growth markets in Ethiopia, Rwanda, Ghana, Tanzania, the Democratic Republic of Congo, and others present significant prospects for companies. On the other hand, Middle Eastern Investigational New Drug CDMO markets including the UAE, Saudi Arabia, Qatar, and Oman continue to offer lucrative pockets of growth.

Competitive Landscape- How Investigational New Drug CDMO companies outcompete in 2025?

The ability to respond quickly to evolving consumer preferences and adapt businesses to niche consumer segments remains a key growth factor. The report identifies the leading companies in the industry and provides their revenue for 2024. The market shares of each company are also included in the report. Further, business profiles, SWOT analysis, and financial analysis of each company are provided in detail. Key companies analyzed in the report include Cambrex Corp, Catalent, Charles River Laboratories Inc, Covance Inc, IQVIA Holdings Inc, Lonza, Recipharm AB, Siegfried Holding AG, Syneos Health, Thermo Fisher Scientific Inc.

Reasons to Buy the report

  • Make informed decisions through long and short-term forecasts across 22 countries and segments.
  • Evaluate market fundamentals, dynamics, and disrupting trends set to shape 2025 and beyond.
  • Gain a clear understanding of the competitive landscape, with product portfolio and growth strategies.
  • Get an integrated understanding of the entire market ecosystem and companies.
  • Stay ahead of the competition through plans for growth in a changing environment for your geographic expansion.
  • Assess the impact of advanced technologies and identify growth opportunities based on actionable data and insights.
  • Get free Excel spreadsheet and PPT versions along with the report PDF.


1. Table of Contents
List of Figures and Tables
2. Executive Summary
2.1 Key Highlights
2.1.1 Investigational New Drug CDMO Market Size Outlook, 2018-2024 and 2025-2032
2.1.2 Largest Investigational New Drug CDMO Market Types and Applications
2.1.3 Fastest Growing Segments
2.1.4 Potential Markets
2.1.5 Market Concentration
2.2 Market Scope and Segmentation
2.2.1 Market Scope- Segments
2.2.2 Market Scope- Countries
2.2.3 Macroeconomic and Demographic Outlook
2.2.4 Abbreviations
2.2.5 Units and Currency Conversions
3. Research Methodology
3.1 Primary Research Surveys
3.2 Secondary Data Sources
3.3 Data Triangulation
3.4 Forecast Methodology
3.5 Assumptions and Limitations
4. Introduction to Global Investigational New Drug CDMO Market in 2025
4.1 Industry Panorama
4.2 Leading Companies Profiled in the Study
4.3 Asia Pacific Markets offer Robust Market Prospects for New Entrants
4.4 Market Dynamics
4.4.1 Market Dynamics- Trends and Drivers
4.4.2 Market Dynamics- Opportunities and Challenges
4.5 Regional Analysis
4.6 Porter’s Five Force Analysis
4.6.1 Intensity of Competitive Rivalry
4.6.2 Threat of New Entrants
4.6.3 Threat of Substitutes
4.6.4 Bargaining Power of Buyers
4.6.5 Bargaining Power of Suppliers
4.7 Investigational New Drug CDMO Industry Value Chain Analysis
4.7.1 Stage of Value Chain
4.7.2 Key Activities of Companies
4.7.3 Companies Included in Each Stage
4.7.4 Key Insights
5. Investigational New Drug CDMO Market Outlook to 2032
5.1 Market Size Forecast by Type, 2021-2024 and 2025-2032
5.2 Market Size Forecast by Application, 2021-2024 and 2024-2032
5.3 Market Size Forecast by Geography, 2021-2024 and 2024-2032
By Product
Small Molecule
Large Molecule
By Service
By 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
By Contract Development (Large Molecule)
Cell Line development
Process Development
-Upstream
-Downstream
By Contract Manufacturing (Small Molecule)
Oral Solids
Liquid and Semi-solids
Injectables
Others
By Contract Manufacturing (Large Molecule)
MABs
Recombinant proteins
Others
By End-User
Pharmaceutical Companies
Biotech Companies
Others
6. Global Investigational New Drug CDMO Market Outlook across Growth Scenarios
6.1 Low Growth Scenario
6.2 Base/Reference Case
6.3 High Growth Scenario
6. North America Investigational New Drug CDMO Market Size Outlook
6.1 Key Market Statistics, 2024
6.2 North America Investigational New Drug CDMO Market Trends and Growth Opportunities
6.2.1 North America Investigational New Drug CDMO Market Outlook by Type
6.2.2 North America Investigational New Drug CDMO Market Outlook by Application
6.3 North America Investigational New Drug CDMO Market Outlook by Country
6.3.1 The US Investigational New Drug CDMO Market Outlook, 2021- 2032
6.3.2 Canada Investigational New Drug CDMO Market Outlook, 2021- 2032
6.3.3 Mexico Investigational New Drug CDMO Market Outlook, 2021- 2032
7. Europe Investigational New Drug CDMO Market Size Outlook
7.1 Key Market Statistics, 2024
7.2 Europe Investigational New Drug CDMO Market Trends and Growth Opportunities
7.2.1 Europe Investigational New Drug CDMO Market Outlook by Type
7.2.2 Europe Investigational New Drug CDMO Market Outlook by Application
7.3 Europe Investigational New Drug CDMO Market Outlook by Country
7.3.2 Germany Investigational New Drug CDMO Market Outlook, 2021- 2032
7.3.3 France Investigational New Drug CDMO Market Outlook, 2021- 2032
7.3.4 The UK Investigational New Drug CDMO Market Outlook, 2021- 2032
7.3.5 Spain Investigational New Drug CDMO Market Outlook, 2021- 2032
7.3.6 Italy Investigational New Drug CDMO Market Outlook, 2021- 2032
7.3.7 Russia Investigational New Drug CDMO Market Outlook, 2021- 2032
7.3.8 Rest of Europe Investigational New Drug CDMO Market Outlook, 2021- 2032
8. Asia Pacific Investigational New Drug CDMO Market Size Outlook
8.1 Key Market Statistics, 2024
8.2 Asia Pacific Investigational New Drug CDMO Market Trends and Growth Opportunities
8.2.1 Asia Pacific Investigational New Drug CDMO Market Outlook by Type
8.2.2 Asia Pacific Investigational New Drug CDMO Market Outlook by Application
8.3 Asia Pacific Investigational New Drug CDMO Market Outlook by Country
8.3.1 China Investigational New Drug CDMO Market Outlook, 2021- 2032
8.3.2 India Investigational New Drug CDMO Market Outlook, 2021- 2032
8.3.3 Japan Investigational New Drug CDMO Market Outlook, 2021- 2032
8.3.4 South Korea Investigational New Drug CDMO Market Outlook, 2021- 2032
8.3.5 Australia Investigational New Drug CDMO Market Outlook, 2021- 2032
8.3.6 South East Asia Investigational New Drug CDMO Market Outlook, 2021- 2032
8.3.7 Rest of Asia Pacific Investigational New Drug CDMO Market Outlook, 2021- 2032
9. South America Investigational New Drug CDMO Market Size Outlook
9.1 Key Market Statistics, 2024
9.2 South America Investigational New Drug CDMO Market Trends and Growth Opportunities
9.2.1 South America Investigational New Drug CDMO Market Outlook by Type
9.2.2 South America Investigational New Drug CDMO Market Outlook by Application
9.3 South America Investigational New Drug CDMO Market Outlook by Country
9.3.1 Brazil Investigational New Drug CDMO Market Outlook, 2021- 2032
9.3.2 Argentina Investigational New Drug CDMO Market Outlook, 2021- 2032
9.3.3 Rest of South and Central America Investigational New Drug CDMO Market Outlook, 2021- 2032
10. Middle East and Africa Investigational New Drug CDMO Market Size Outlook
10.1 Key Market Statistics, 2024
10.2 Middle East and Africa Investigational New Drug CDMO Market Trends and Growth Opportunities
10.2.1 Middle East and Africa Investigational New Drug CDMO Market Outlook by Type
10.2.2 Middle East and Africa Investigational New Drug CDMO Market Outlook by Application
10.3 Middle East and Africa Investigational New Drug CDMO Market Outlook by Country
10.3.1 Saudi Arabia Investigational New Drug CDMO Market Outlook, 2021- 2032
10.3.2 The UAE Investigational New Drug CDMO Market Outlook, 2021- 2032
10.3.3 Rest of Middle East Investigational New Drug CDMO Market Outlook, 2021- 2032
10.3.4 South Africa Investigational New Drug CDMO Market Outlook, 2021- 2032
10.3.5 Egypt Investigational New Drug CDMO Market Outlook, 2021- 2032
10.3.6 Rest of Africa Investigational New Drug CDMO Market Outlook, 2021- 2032
11. Company Profiles
11.1 Leading 10 Companies
Cambrex Corp
Catalent
Charles River Laboratories Inc
Covance Inc
IQVIA Holdings Inc
Lonza
Recipharm AB
Siegfried Holding AG
Syneos Health
Thermo Fisher Scientific Inc
11.2 Overview
11.3 Products and Services
11.4 SWOT Profile
12. Appendix
12.1 Subscription Options
12.2 Customization Options
12.3 Publisher Details

Download our eBook: How to Succeed Using Market Research

Learn how to effectively navigate the market research process to help guide your organization on the journey to success.

Download eBook
Cookie Settings