The global small molecule API market size was estimated to be USD 157.33 billion in 2023 and is expected to reach at USD 329.12 billion by 2034 with a CAGR of 6.94% during the forecast period 2024-2034. Increasing demand for small molecule drugs, rise in outsourcing & the patent expirations of key compounds, growing prevalence of chronic diseases, surge in research & development activities, increasing launch of novel products, rising use of novel technologies, growing collaboration within market players for the discovery of small molecules using AI-based technology, and surge in approvals by regulatory bodies, are some of the leading factors fuelling the market growth.
Surge in approvals of targeted therapies by regulatory bodies is predicted to boost the market growth during the forecast period. The growing occurrence of chronic illnesses worldwide has prompted pharmaceutical makers to develop a greater number of therapeutic drugs. For instance, in December 2022, The U.S. FDA has granted KRAZATI (adagrasib) expedited approval as a targeted treatment option for adult patients with KRAS mutations and locally advanced or metastatic non-small cell lung cancer. This information was released by Mirati Therapeutics, Inc.
By type, synthetic was the highest revenue-grossing segment in the global small molecule API market in 2023 owing to the low cost of making these compounds and their remarkable efficacy, rising prevalence of synthetic pharmaceuticals in the pharmaceutical sector, which drives demand for production-related raw materials such small molecule APIs, presence of major market players. Additionally, biotech is predicted to grow at fastest CAGR during the forecast period owing to the growing number of firms are looking for backward integration & creating new factories to boost productivity, increasing focus on targeted therapies, rising demand for biotech-based products, and growing investment by major market players. For instance, in April 2022, AVM biotechnology has initiated a study involving its small molecule, AVM0703, for the purpose of reversing Type 1 diabetes. This effort has been facilitated by the reception of a Phase II Small Business Innovation Research (SBIR) award amounting to USD 1.6 million from the National Institute of Diabetes and Digestive Kidney Disease (NIDDK).
By manufacturer, in-house was the highest revenue-grossing segment in the global small molecule API market in 2023 owing to a large number of businesses manufacture their own API, reducing their reliance on raw material sources and rising investment by key market players. For instance, in September 2022, Cambrex has finished the initial stage of its $30 million investment in its manufacturing facility for small molecule active pharmaceutical ingredients located in High Point, North Carolina. Additionally, outsourcing is predicted to grow at fastest CAGR during the forecast period owing to the surge in numerous compounds that need sophisticated production procedures are being authorized, major firms have improved their capabilities to fulfil market needs as the CDMO business has experienced significant mobility.
By application, cardiology was the highest revenue-grossing segment in the global small molecule API market in 2023 owing to rising prevalence of cardiovascular conditions, surge in adoption of sedentary lifestyle & food habits, and growing product approvals by regulatory bodies. Additionally, oncology is predicted to grow at fastest CAGR during the forecast period owing to the growing prevalence of cancer, rising demand for cancer drugs, and increasing partnerships & collaborations within market players. For instance, in June 2022, Dr. Reddy's Laboratories Ltd. has reported that one of its subsidiaries has entered into a collaboration with Olema Pharmaceuticals, a U.S.-based company. This collaboration involves joint efforts in researching, developing, and marketing new small molecule inhibitors targeting an undisclosed oncology objective.
North America region is anticipated for the highest revenue share during the forecast period owing to the rising government initiatives, growing demand for small molecules, increasing focus on expansion by key market players, and surge in collaborations within market players. For instance, in January 2022, Pfizer Inc. and Biohaven have finalized a collaborative transaction aimed at marketing small molecule migraine medications, specifically rimegepant and zavegepant, in regions beyond the United States. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the growing healthcare infrastructure, the presence of major manufacturers, rising government support for investing in API business, and increasing initiatives by leading market players. For instance, in March 2022, Lonza has announced that the expansion project for the laboratory housed within its active pharmaceutical ingredient (API) production plant in China has been completed successfully. This expansion has enabled the company to concentrate on producing high potency APIs for small molecules.
Surge in approvals of targeted therapies by regulatory bodies is predicted to boost the market growth during the forecast period. The growing occurrence of chronic illnesses worldwide has prompted pharmaceutical makers to develop a greater number of therapeutic drugs. For instance, in December 2022, The U.S. FDA has granted KRAZATI (adagrasib) expedited approval as a targeted treatment option for adult patients with KRAS mutations and locally advanced or metastatic non-small cell lung cancer. This information was released by Mirati Therapeutics, Inc.
By type, synthetic was the highest revenue-grossing segment in the global small molecule API market in 2023 owing to the low cost of making these compounds and their remarkable efficacy, rising prevalence of synthetic pharmaceuticals in the pharmaceutical sector, which drives demand for production-related raw materials such small molecule APIs, presence of major market players. Additionally, biotech is predicted to grow at fastest CAGR during the forecast period owing to the growing number of firms are looking for backward integration & creating new factories to boost productivity, increasing focus on targeted therapies, rising demand for biotech-based products, and growing investment by major market players. For instance, in April 2022, AVM biotechnology has initiated a study involving its small molecule, AVM0703, for the purpose of reversing Type 1 diabetes. This effort has been facilitated by the reception of a Phase II Small Business Innovation Research (SBIR) award amounting to USD 1.6 million from the National Institute of Diabetes and Digestive Kidney Disease (NIDDK).
By manufacturer, in-house was the highest revenue-grossing segment in the global small molecule API market in 2023 owing to a large number of businesses manufacture their own API, reducing their reliance on raw material sources and rising investment by key market players. For instance, in September 2022, Cambrex has finished the initial stage of its $30 million investment in its manufacturing facility for small molecule active pharmaceutical ingredients located in High Point, North Carolina. Additionally, outsourcing is predicted to grow at fastest CAGR during the forecast period owing to the surge in numerous compounds that need sophisticated production procedures are being authorized, major firms have improved their capabilities to fulfil market needs as the CDMO business has experienced significant mobility.
By application, cardiology was the highest revenue-grossing segment in the global small molecule API market in 2023 owing to rising prevalence of cardiovascular conditions, surge in adoption of sedentary lifestyle & food habits, and growing product approvals by regulatory bodies. Additionally, oncology is predicted to grow at fastest CAGR during the forecast period owing to the growing prevalence of cancer, rising demand for cancer drugs, and increasing partnerships & collaborations within market players. For instance, in June 2022, Dr. Reddy's Laboratories Ltd. has reported that one of its subsidiaries has entered into a collaboration with Olema Pharmaceuticals, a U.S.-based company. This collaboration involves joint efforts in researching, developing, and marketing new small molecule inhibitors targeting an undisclosed oncology objective.
North America region is anticipated for the highest revenue share during the forecast period owing to the rising government initiatives, growing demand for small molecules, increasing focus on expansion by key market players, and surge in collaborations within market players. For instance, in January 2022, Pfizer Inc. and Biohaven have finalized a collaborative transaction aimed at marketing small molecule migraine medications, specifically rimegepant and zavegepant, in regions beyond the United States. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the growing healthcare infrastructure, the presence of major manufacturers, rising government support for investing in API business, and increasing initiatives by leading market players. For instance, in March 2022, Lonza has announced that the expansion project for the laboratory housed within its active pharmaceutical ingredient (API) production plant in China has been completed successfully. This expansion has enabled the company to concentrate on producing high potency APIs for small molecules.
Segmentation: Small Molecule API Market Report 2022 - 2033
Small Molecule API Market Analysis & Forecast by Type 2023 - 2034 (Revenue USD Bn)
- Biotech
- Synthetic
Small Molecule API Market Analysis & Forecast by Manufacturer 2023 - 2034 (Revenue USD Bn)
- Outsourced
- In-house
Small Molecule API Market Analysis & Forecast by Application 2023 - 2034 (Revenue USD Bn)
- Nephrology
- Gastroenterology
- Cardiology
- Pulmonology
- Orthopedic
- Oncology
- Ophthalmology
- Endocrinology
- CNS and Neurology
- Others
Small Molecule API 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 API Market: Type Estimates & Trend Analysis
8. Small Molecule API Market: Manufacturer Estimates & Trend Analysis
9. Small Molecule API Market: Application Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Small Molecule API Market
12. Europe Global Small Molecule API Market
13. Asia Pacific Global Small Molecule API Market
14. Latin America Global Small Molecule API Market
15. MEA Global Small Molecule API Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Sun Pharmaceutical Industries Ltd.
- Boehringer Ingelheim International GmbH
- Celgene Corporation
- BASF SE
- Teva Pharmaceutical Industries Ltd.
- Baxter International Inc.
- Pfizer Inc.
- Cambrex Corporation
- Sanofi S.A.
- AstraZeneca Plc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 145 |
| Published | October 2023 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 157.33 Billion |
| Forecasted Market Value ( USD | $ 329.12 Billion |
| Compound Annual Growth Rate | 6.3% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
