The global small molecule innovator API CDMO market accounted for USD 30.03 billion in 2023 and is expected to reach at USD 60.41 billion by 2034 with a CAGR of 6.56% during the forecast period 2024-2034. Increasing demand for small molecule drugs, an increase in the incidence of chronic diseases, increased pharmaceutical R&D investments, stringent regulatory requirements, and increased strategic alliances and partnerships will all fuel market expansion.
The expanding number of drug development pipelines, particularly in therapeutic areas including oncology, central nervous system disorders, and rare diseases, is driving up demand for CDMO services. Small molecule developers frequently lack the infrastructure or skills to efficiently develop and produce APIs in-house, resulting in a growing reliance on CDMOs. For instance, in October 2023, Cambrex Corp. completed a USD 38 million expansion of their small molecule API production facility in North Carolina. This expansion doubled the facility's manufacturing capacity.
By stage type, the clinical segment accounted for the highest revenue-grossing segment in the global small molecule innovator API CDMO market in 2023 owing to the increasing demand for contract development and manufacturing services to support the rapid progression of drug candidates through early-stage clinical trials, driven by the expanding pipeline of novel therapeutics and the need for efficient, cost-effective development solutions. For instance, in March 2023, Catalent, Inc. worked with Grünenthal on an orally administered small molecule in Grünenthal's pipeline. This relationship expanded the company's operational capabilities in the marketplace. Additionally, the preclinical segment is predicted to grow at the fastest CAGR during the forecast period owing to the escalating emphasis on early-stage drug discovery and development, coupled with the rising adoption of outsourcing strategies by pharmaceutical and biotechnology companies to leverage the specialized expertise and infrastructure offered by CDMOs in accelerating preclinical research, optimizing lead compounds, and expediting the transition of promising drug candidates from bench to clinic.
By customer type, the pharmaceutical segment accounted for the highest revenue-grossing segment in the global small molecule innovator API CDMO market in 2023 owing to the continuous demand for outsourcing services from pharmaceutical companies seeking to enhance efficiency, reduce costs, and expedite the development and manufacturing processes of small molecule drugs. For instance, Piramal Pharma Solutions announced in February 2023 that the first few batches of APIs would be manufactured in its Michigan facility in Riverview, Michigan. Additionally, the biotechnology segment is predicted to grow at the fastest CAGR during the forecast period owing to the burgeoning biopharmaceutical industry's escalating need for specialized API development and manufacturing services, driven by the rapid advancement in biotechnological innovations, increasing investments in biologics research and development, and the rising prevalence of complex diseases that require targeted therapeutic interventions.
By therapeutic area, the oncology segment accounted for the highest revenue-grossing segment in the global small molecule innovator API CDMO market in 2023 owing to the escalating prevalence of cancer worldwide, the continuous expansion of oncology drug pipelines, and the increasing complexity of oncology therapies, which necessitate specialized expertise and capabilities offered by CDMOs in API development and manufacturing to meet the growing demand for novel cancer treatments. For instance, Catalent, Inc. announced in August 2023 that it would purchase Metrics Contract Services (Metrics), a CDMO, from Mayne Pharma Group Limited for USD 475 million. Additionally, the infectious diseases segment is predicted to grow at the fastest CAGR during the forecast period owing to the heightened global focus on combating infectious disease outbreaks, the urgent need for novel antiviral and antimicrobial therapies to address emerging infectious pathogens and drug-resistant strains, and the increasing investment in research and development of innovative treatments and vaccines targeting infectious diseases.
By end-user, the pharmaceutical companies segment accounted for the highest revenue-grossing segment in the global small molecule innovator API CDMO market in 2023 owing to the continued reliance of pharmaceutical companies on outsourcing partners for API development and manufacturing services. For instance, BioVaxys announced in February 2024 that it has acquired the IMV portfolio of clinical development, preclinical, and discovery stages from IMV USA, Immunovaccine Technologies, and IMV Inc. Additionally, the biotechnology companies’ segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing investment in biotechnological research and development, the rising demand for biopharmaceutical products, and the expanding pipeline of novel biologic therapies, driving biotechnology companies to seek specialized API development and manufacturing services from CDMOs to expedite the development process.
North American region is anticipated to have the highest revenue share during the forecast period owing to the presence of a robust pharmaceutical and biotechnology industry ecosystem, significant investments in drug research and development, advanced healthcare infrastructure, favorable regulatory policies, and a large market for innovative therapies. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the region's expanding pharmaceutical and biotechnology sector, increasing outsourcing of drug development and manufacturing activities to lower-cost destinations, rising investments in healthcare infrastructure and research capabilities, growing demand for generic drugs, and the presence of a large pool of skilled workforce. For instance, in June 2022, Lonza opened a new clinical phase development and production facility at its Bend, Oregon, small molecules site. It is committed to producing intermediates for drug products and completed dosage forms with spray-dried dispersion (SDD) that enhance bioavailability.
This extensive research report concentrates on the size and projections of the global and regional markets from 2023 to 2034.
The expanding number of drug development pipelines, particularly in therapeutic areas including oncology, central nervous system disorders, and rare diseases, is driving up demand for CDMO services. Small molecule developers frequently lack the infrastructure or skills to efficiently develop and produce APIs in-house, resulting in a growing reliance on CDMOs. For instance, in October 2023, Cambrex Corp. completed a USD 38 million expansion of their small molecule API production facility in North Carolina. This expansion doubled the facility's manufacturing capacity.
By stage type, the clinical segment accounted for the highest revenue-grossing segment in the global small molecule innovator API CDMO market in 2023 owing to the increasing demand for contract development and manufacturing services to support the rapid progression of drug candidates through early-stage clinical trials, driven by the expanding pipeline of novel therapeutics and the need for efficient, cost-effective development solutions. For instance, in March 2023, Catalent, Inc. worked with Grünenthal on an orally administered small molecule in Grünenthal's pipeline. This relationship expanded the company's operational capabilities in the marketplace. Additionally, the preclinical segment is predicted to grow at the fastest CAGR during the forecast period owing to the escalating emphasis on early-stage drug discovery and development, coupled with the rising adoption of outsourcing strategies by pharmaceutical and biotechnology companies to leverage the specialized expertise and infrastructure offered by CDMOs in accelerating preclinical research, optimizing lead compounds, and expediting the transition of promising drug candidates from bench to clinic.
By customer type, the pharmaceutical segment accounted for the highest revenue-grossing segment in the global small molecule innovator API CDMO market in 2023 owing to the continuous demand for outsourcing services from pharmaceutical companies seeking to enhance efficiency, reduce costs, and expedite the development and manufacturing processes of small molecule drugs. For instance, Piramal Pharma Solutions announced in February 2023 that the first few batches of APIs would be manufactured in its Michigan facility in Riverview, Michigan. Additionally, the biotechnology segment is predicted to grow at the fastest CAGR during the forecast period owing to the burgeoning biopharmaceutical industry's escalating need for specialized API development and manufacturing services, driven by the rapid advancement in biotechnological innovations, increasing investments in biologics research and development, and the rising prevalence of complex diseases that require targeted therapeutic interventions.
By therapeutic area, the oncology segment accounted for the highest revenue-grossing segment in the global small molecule innovator API CDMO market in 2023 owing to the escalating prevalence of cancer worldwide, the continuous expansion of oncology drug pipelines, and the increasing complexity of oncology therapies, which necessitate specialized expertise and capabilities offered by CDMOs in API development and manufacturing to meet the growing demand for novel cancer treatments. For instance, Catalent, Inc. announced in August 2023 that it would purchase Metrics Contract Services (Metrics), a CDMO, from Mayne Pharma Group Limited for USD 475 million. Additionally, the infectious diseases segment is predicted to grow at the fastest CAGR during the forecast period owing to the heightened global focus on combating infectious disease outbreaks, the urgent need for novel antiviral and antimicrobial therapies to address emerging infectious pathogens and drug-resistant strains, and the increasing investment in research and development of innovative treatments and vaccines targeting infectious diseases.
By end-user, the pharmaceutical companies segment accounted for the highest revenue-grossing segment in the global small molecule innovator API CDMO market in 2023 owing to the continued reliance of pharmaceutical companies on outsourcing partners for API development and manufacturing services. For instance, BioVaxys announced in February 2024 that it has acquired the IMV portfolio of clinical development, preclinical, and discovery stages from IMV USA, Immunovaccine Technologies, and IMV Inc. Additionally, the biotechnology companies’ segment is predicted to grow at the fastest CAGR during the forecast period owing to the increasing investment in biotechnological research and development, the rising demand for biopharmaceutical products, and the expanding pipeline of novel biologic therapies, driving biotechnology companies to seek specialized API development and manufacturing services from CDMOs to expedite the development process.
North American region is anticipated to have the highest revenue share during the forecast period owing to the presence of a robust pharmaceutical and biotechnology industry ecosystem, significant investments in drug research and development, advanced healthcare infrastructure, favorable regulatory policies, and a large market for innovative therapies. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the region's expanding pharmaceutical and biotechnology sector, increasing outsourcing of drug development and manufacturing activities to lower-cost destinations, rising investments in healthcare infrastructure and research capabilities, growing demand for generic drugs, and the presence of a large pool of skilled workforce. For instance, in June 2022, Lonza opened a new clinical phase development and production facility at its Bend, Oregon, small molecules site. It is committed to producing intermediates for drug products and completed dosage forms with spray-dried dispersion (SDD) that enhance bioavailability.
This extensive research report concentrates on the size and projections of the global and regional markets from 2023 to 2034.
Report Scope:
- Base Year: 2023
- Forecast Period: 2024-2034
- Study Coverage
- Market Forecast by Stage Type, Customer Type, Therapeutic Area, and End-User
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of the Top 10+ Major Market Players
Segmentation: Small Molecule Innovator API CDMO Market Report 2023 - 2034
Small Molecule Innovator API CDMO Market Analysis & Forecast by Stage Type 2023 - 2034 (Revenue USD Bn)
- Preclinical
- Clinical
- Commercial
Small Molecule Innovator API CDMO Market Analysis & Forecast by Customer Type 2023 - 2034 (Revenue USD Bn)
- Pharmaceutical
- Biotechnology
Small Molecule Innovator API CDMO Market Analysis & Forecast by Therapeutic Area 2023 - 2034 (Revenue USD Bn)
- Cardiovascular Diseases
- Oncology
- Respiratory Disorders
- Neurology
- Metabolic Disorders
- Infectious Diseases
- Others
Small Molecule Innovator API CDMO Market Analysis & Forecast by End-User 2023 - 2034 (Revenue USD Bn)
- Pharmaceutical Companies
- Biotechnology Companies
- Generic Drug Manufacturers
Small Molecule Innovator API CDMO Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Small Molecule Innovator API CDMO Market: Stage Type Estimates & Trend Analysis
8. Small Molecule Innovator API CDMO Market: Customer Type Estimates & Trend Analysis
9. Small Molecule Innovator API CDMO Market: Therapeutic Area Estimates & Trend Analysis
10. Small Molecule Innovator API CDMO Market: End-user Estimates & Trend Analysis
11. Regional Market Analysis
12. North America Small Molecule Innovator API CDMO Market
13. Europe Global Small Molecule Innovator API CDMO Market
14. Asia Pacific Global Small Molecule Innovator API CDMO Market
15. Latin America Global Small Molecule Innovator API CDMO Market
16. MEA Global Small Molecule Innovator API CDMO Market
17. Competitor Analysis
18. Company Profiles
Companies Mentioned
- Lonza Group AG
- Cambrex Corporation (Now part of Thermo Fisher Scientific)
- Evonik Industries AG
- Siegfried Holding AG
- Wuxi AppTec
- Recipharm AB
- Piramal Pharma Solutions
- Almac Group
- Patheon (Part of Thermo Fisher Scientific)
- AMRI (Albany Molecular Research Inc.)
- Syngene International Limited
- Siegfried AG
- AbbVie Contract Manufacturing
- Fujifilm Diosynth Biotechnologies
- Hovione.
