The global high potency API contract manufacturing market is estimated to be USD 8.08 billion in 2024. It is expected to reach USD 25.52 billion by 2035, with a CAGR of 11.02% from 2025-2035. The market will grow due to factors such as the growing need for cancer medications, improvements in manufacturing technology, a greater emphasis on precision medicine, the outsourcing of the production of high-potency APIs, and increased investments in this area.
The pharmaceutical industry is increasingly relying on outsourcing to manufacture high-potency active pharmaceutical ingredients (HPAPIs) to contract manufacturing organizations (CMOs). This strategic shift enables pharmaceutical companies to reduce operational costs, enhance efficiency, and focus on their core competencies such as drug discovery and commercialization. According to a September 2024 article published by Wiley, high-potency compounds play a pivotal role in the pharmaceutical landscape, driven predominantly by advancements in oncology. Approximately 40%-50% of drugs under development target cancer, with 75% comprising high-potency APIs. This underscores the growing demand for CMOs with specialized expertise and robust infrastructure to handle these potent compounds safely and efficiently.
By product, the innovative segment accounted for the highest revenue-grossing segment in the global high-potency API contract manufacturing market in 2024 owing to the increasing demand for novel therapies targeting complex diseases, particularly in oncology, and the rising investment in R&D for high-potency drugs. For instance, Aurigene Pharmaceutical Services Limited established a biologics factory in Hyderabad, India, in June 2024. This facility is intended to assist clients with small-scale production of antibodies and other recombinant proteins for preclinical and early-phase clinical requirements, as well as process and analytical research. Additionally, the generic segment is predicted to grow at the fastest CAGR during the forecast period owing to its cost-effectiveness, the patent expiration of blockbuster drugs, and increasing demand in emerging markets.
By synthesis, the synthetic segment accounted for the highest revenue-grossing segment in the global high-potency API contract manufacturing market in 2024 owing to the widespread use of chemical synthesis processes, cost advantages, and established manufacturing capabilities for high-potency APIs. For instance, Lonza announced the opening of the Innovaform Accelerator, a French innovation and formulation center, in September 2024. For the development and innovation of capsule-based production and delivery systems for oral and pulmonary administration, the new facility will serve as a center of excellence. Additionally, the biotech segment is predicted to grow at the fastest CAGR during the forecast period owing to its rising application in targeted biologics, advancements in biopharmaceutical technology, and increasing focus on personalized medicine.
By application, the oncology segment accounted for the highest revenue-grossing segment in the global high potency API contract manufacturing market in 2024 owing to the high prevalence of cancer, the growing pipeline of oncology drugs, and the demand for targeted and potent therapies. For instance, according to data released by Botshilu Hospital in March 2024, 80% of people worldwide suffer from glaucoma, and 50% of those affected are not aware that they have the condition. Additionally, the glaucoma segment is predicted to grow at the fastest CAGR during the forecast period owing to its expanding prevalence among the aging population and increased demand for effective treatments with high-potency formulations.
By dosage form, the injectables segment accounted for the highest revenue-grossing segment in the global high-potency API contract manufacturing market in 2024 owing to the superior efficacy, rapid onset of action, and suitability of injectables for administering high-potency drugs. For instance, CordenPharma stated in March 2024 that it will introduce an integrated offering that consists of injectable therapeutic products and IND-targeted peptide APIs by expanding its early clinical peptide production capabilities. Additionally, the oral segment is predicted to grow at the fastest CAGR during the forecast period owing to its patient-friendly nature, ease of administration, and technological advancements in oral drug delivery systems.
By end-user, the pharmaceutical companies segment accounted for the highest revenue-grossing segment in the global high-potency API contract manufacturing market in 2024 owing to the increasing outsourcing of high-potency API manufacturing to focus on core competencies and reduce production costs. For instance, Piramal Pharma Limited declared in October 2024 that it will invest USD 80 million to develop its facilities in Kentucky. This website specializes in lyophilization, liquid filling, and sterile compounding for sterile injectable medicinal products. Additionally, the contract research organizations segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising need for specialized services, including high-potency API development and testing, and the trend toward strategic partnerships in drug development.
North American region is anticipated to have the highest revenue share during the forecast period owing to the well-established pharmaceutical infrastructure, high prevalence of chronic diseases such as cancer, and significant investments in R&D for high-potency APIs. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the increasing outsourcing of pharmaceutical manufacturing to countries like India and China due to cost advantages, expanding healthcare infrastructure, and rising demand for generic and branded high-potency drugs. For instance, AbbVie expanded its manufacturing facility in Singapore in February 2024, investing USD 223 million to bolster its manufacturing capacity. The company's standing in the Asia Pacific area will be further enhanced by this.
This comprehensive research report focuses on the global and regional market size and forecasts from 2024 to 2035.
The pharmaceutical industry is increasingly relying on outsourcing to manufacture high-potency active pharmaceutical ingredients (HPAPIs) to contract manufacturing organizations (CMOs). This strategic shift enables pharmaceutical companies to reduce operational costs, enhance efficiency, and focus on their core competencies such as drug discovery and commercialization. According to a September 2024 article published by Wiley, high-potency compounds play a pivotal role in the pharmaceutical landscape, driven predominantly by advancements in oncology. Approximately 40%-50% of drugs under development target cancer, with 75% comprising high-potency APIs. This underscores the growing demand for CMOs with specialized expertise and robust infrastructure to handle these potent compounds safely and efficiently.
By product, the innovative segment accounted for the highest revenue-grossing segment in the global high-potency API contract manufacturing market in 2024 owing to the increasing demand for novel therapies targeting complex diseases, particularly in oncology, and the rising investment in R&D for high-potency drugs. For instance, Aurigene Pharmaceutical Services Limited established a biologics factory in Hyderabad, India, in June 2024. This facility is intended to assist clients with small-scale production of antibodies and other recombinant proteins for preclinical and early-phase clinical requirements, as well as process and analytical research. Additionally, the generic segment is predicted to grow at the fastest CAGR during the forecast period owing to its cost-effectiveness, the patent expiration of blockbuster drugs, and increasing demand in emerging markets.
By synthesis, the synthetic segment accounted for the highest revenue-grossing segment in the global high-potency API contract manufacturing market in 2024 owing to the widespread use of chemical synthesis processes, cost advantages, and established manufacturing capabilities for high-potency APIs. For instance, Lonza announced the opening of the Innovaform Accelerator, a French innovation and formulation center, in September 2024. For the development and innovation of capsule-based production and delivery systems for oral and pulmonary administration, the new facility will serve as a center of excellence. Additionally, the biotech segment is predicted to grow at the fastest CAGR during the forecast period owing to its rising application in targeted biologics, advancements in biopharmaceutical technology, and increasing focus on personalized medicine.
By application, the oncology segment accounted for the highest revenue-grossing segment in the global high potency API contract manufacturing market in 2024 owing to the high prevalence of cancer, the growing pipeline of oncology drugs, and the demand for targeted and potent therapies. For instance, according to data released by Botshilu Hospital in March 2024, 80% of people worldwide suffer from glaucoma, and 50% of those affected are not aware that they have the condition. Additionally, the glaucoma segment is predicted to grow at the fastest CAGR during the forecast period owing to its expanding prevalence among the aging population and increased demand for effective treatments with high-potency formulations.
By dosage form, the injectables segment accounted for the highest revenue-grossing segment in the global high-potency API contract manufacturing market in 2024 owing to the superior efficacy, rapid onset of action, and suitability of injectables for administering high-potency drugs. For instance, CordenPharma stated in March 2024 that it will introduce an integrated offering that consists of injectable therapeutic products and IND-targeted peptide APIs by expanding its early clinical peptide production capabilities. Additionally, the oral segment is predicted to grow at the fastest CAGR during the forecast period owing to its patient-friendly nature, ease of administration, and technological advancements in oral drug delivery systems.
By end-user, the pharmaceutical companies segment accounted for the highest revenue-grossing segment in the global high-potency API contract manufacturing market in 2024 owing to the increasing outsourcing of high-potency API manufacturing to focus on core competencies and reduce production costs. For instance, Piramal Pharma Limited declared in October 2024 that it will invest USD 80 million to develop its facilities in Kentucky. This website specializes in lyophilization, liquid filling, and sterile compounding for sterile injectable medicinal products. Additionally, the contract research organizations segment is predicted to grow at the fastest CAGR during the forecast period owing to the rising need for specialized services, including high-potency API development and testing, and the trend toward strategic partnerships in drug development.
North American region is anticipated to have the highest revenue share during the forecast period owing to the well-established pharmaceutical infrastructure, high prevalence of chronic diseases such as cancer, and significant investments in R&D for high-potency APIs. Additionally, the Asia Pacific region is predicted to grow at the fastest CAGR during the forecast period owing to the increasing outsourcing of pharmaceutical manufacturing to countries like India and China due to cost advantages, expanding healthcare infrastructure, and rising demand for generic and branded high-potency drugs. For instance, AbbVie expanded its manufacturing facility in Singapore in February 2024, investing USD 223 million to bolster its manufacturing capacity. The company's standing in the Asia Pacific area will be further enhanced by this.
This comprehensive research report focuses on the global and regional market size and forecasts from 2024 to 2035.
Report Scope:
- Base Year: 2024
- Forecast Period: 2025-2035
- Study Coverage
- Market Forecast by Product, Synthesis, Application, Dosage Form, 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
- 20% Free Customization Available to Meet Your Exact Requirement.
Segmentation: High Potency API Contract Manufacturing Market Report 2024 - 2035
High Potency API Contract Manufacturing Market Analysis & Forecast by Product 2024 - 2035 (Revenue USD Bn)
- Innovative
- Generic
High Potency API Contract Manufacturing Market Analysis & Forecast by Synthesis 2024 - 2035 (Revenue USD Bn)
- Synthetic
- Biotech
High Potency API Contract Manufacturing Market Analysis & Forecast by Application 2024 - 2035 (Revenue USD Bn)
- Oncology
- Hormonal Disorders
- Glaucoma
- Others
High Potency API Contract Manufacturing Market Analysis & Forecast by Dosage Form 2024 - 2035 (Revenue USD Bn)
- Injectable
- Oral Solids
- Creams
- Others
High Potency API Contract Manufacturing Market Analysis & Forecast by End-User 2024 - 2035 (Revenue USD Bn)
- Pharmaceutical Companies
- Contract Research Organizations
- Academic Institutions
High Potency API Contract Manufacturing Market Analysis & Forecast by Region 2024 - 2035 (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. High Potency API Contract Manufacturing Market: Process Estimates & Trend Analysis
8. High Potency API Contract Manufacturing Market: Synthesis Estimates & Trend Analysis
9. High Potency API Contract Manufacturing Market: Application Estimates & Trend Analysis
10. High Potency API Contract Manufacturing Market: Dosage Form Estimates & Trend Analysis
11. High Potency API Contract Manufacturing Market: End-user Estimates & Trend Analysis
12. Regional Market Analysis
13. North America High Potency API Contract Manufacturing Market
14. Europe Global High Potency API Contract Manufacturing Market
15. Asia Pacific Global High Potency API Contract Manufacturing Market
16. Latin America Global High Potency API Contract Manufacturing Market
17. MEA Global High Potency API Contract Manufacturing Market
18. Competitor Analysis
19. Company Profiles
Companies Mentioned
- Lonza Group AG
- Cambrex Corporation
- Novasep
- Thermo Fisher Scientific Inc.
- Catalent, Inc.
- Pfizer CentreOne
- Carbogen Amcis AG
- Evonik Industries AG
- Patheon (A part of Thermo Fisher Scientific)
- Piramal Pharma Solutions
- Alcami Corporation
- Wuxi AppTec
- AMRI (Albany Molecular Research Inc.)
- Dishman Carbogen Amcis Ltd.
- CordenPharma
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | December 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 8.08 Billion |
| Forecasted Market Value ( USD | $ 25.52 Billion |
| Compound Annual Growth Rate | 11.0% |
| Regions Covered | Global |
| No. of Companies Mentioned | 15 |
