The global small molecule API (Active Pharmaceutical Ingredient) market is poised for significant growth, with estimated sales valued at USD 120,376.6 million in 2024. The market is projected to expand at a CAGR of 4.5% during the forecast period from 2024 to 2034, ultimately reaching an estimated USD 186,941.2 million by 2034. In 2023, the small molecule API market generated USD 114,517.3 million in revenue, reflecting a year-over-year growth of 4.6% in 2024.
The growth of the small molecule API market is primarily driven by the increasing demand for pharmaceutical products, particularly for the treatment of chronic diseases. Small molecule APIs are essential components in drug formulation, and their versatility and effectiveness make them a staple in the pharmaceutical industry.
The oncology market is growing enormously. High-potency drugs constitute significant new drugs that are under development. Small molecule demand still dominates the API market, however, new biological entity demand is also growing rapidly healthcare expenditure is resulting in new molecule discovery, the evaluation of various molecules for possible disease treatment, and the adoption of an innovative approach to these studies.
As increasing prevalence of chronic disorders like cardiovascular diseases, diabetes, cancer, and infectious diseases, and increasing research on small molecule APIs will boost the market growth. Besides this, government funding for API manufacturing units is also increasing in developing countries like India, Israel, and China. In May 2020, AstraZeneca recovered the global rights to brazikumab from Allergan. Small molecule monoclonal antibody is developed for Crohn’s Disease and Ulcerative Colitis and adds to their growing presence in Immunology
The coronavirus pandemic has changed public medical care needs and spending however this is viewed as a transient effect on the Small Molecule API market. The immense COVID-19 patient pool attracted the spotlight on the treatment of these patients, in turn increasing the demand for small molecule API.
Key Takeaways from Small Molecule API Market Study
- As a result of increasing healthcare spending and favorable reimbursement policies, the U.S. accounts for over 87% of the North American small molecule API market
- A rising focus on health and wellness will enable the U.K. to exhibit a little below 4% y-o-y growth in 2021
- Germany will account for the maximum sales in Europe. Besides this, the demand from France is expected to rise
- Increasing investment in research and development within pharmaceuticals will drive sales in China
“The market is highly competitive, compelling the key players to aim at strategic partnerships. Some of the leading players have been focusing on strategic collaborations to expand their footprint and portfolio” says the FMI Analyst
The use of external resources (people, equipment, and/or expertise) to facilitate the preparation of Active Pharmaceutical Ingredients (API) or advanced intermediates has become a common practice for most pharmaceutical development organizations. In early development, the reasons to seek external support for the manufacture of API were attributed to a number of factors, including a lack of sufficient internal capacity, a need to source unique technical expertise, or a desire to achieve overall cost reductions.
For organizations that have no internal GMP manufacturing capabilities whatsoever (e.g. biotech companies), outsourcing is, of course, a necessity. However, companies that have some level of internal manufacturing capacity may have options to use outsourcing to their strategic advantage. This outsourcing capability has increased the source of generating more revenue for new emerging companies. For the fast growth of the industry, they follow outsourcing strategies.
In addition, key players in the Small Molecule API market are keenly focusing on carrying out strategic activities such as advanced technology for manufacturing, and acquisitions, in order to create a strong position in the market is leading to vigorous developments which is helping the market to grow at a considerable rate.
For Instance, In January 2020, Novartis acquired of operations of Aspen in Japan. This acquisition strengthened Sandoz’s position in the world market of off-patent medicines and generic drugs manufacturing.
Key Participant Insights
Various manufacturers are undergoing partnerships, collaborations, acquisitions, and distribution agreements to improve their market footprint.
For Instance, in December 2020, Pfizer Inc. and PostEra announced a strategic partnership to accelerate small molecule drug discovery by developing a platform technology based on generative chemistry.
Also, in January 2020, Merck announced its strategic collaboration for an oncology platform with Taiho Pharmaceutical Co, Ltd. And Taiho Pharmaceutical Co., Ltd to expand its focus on small molecule inhibitors for cancer research.
Key players in the Small Molecule API market are focusing on developing novel drugs due to their demand across various therapeutic areas. Some of the key players are
Hoffmann-La Roche Ltd, Albany Molecular Research Inc., AstraZeneca, Merck & Co., Inc., BASF SE, Teva Pharmaceutical Industries Ltd., Sanofi S.A., Pfizer Inc., Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd., Novartis AG, Bristol-Myers Squibb, Boehringer Ingelheim GmbH, GlaxoSmithKline PLC, GILEAD Science Inc.,
Small Molecule API Market by Category Molecule Type
- Standard API
- HPAPI
Production
- Captive/In-House
- Out Source
Application
- Clinical
- Commercial
Therapeutic Area
- Cardiovascular Diseases
- Respiratory Disorders
- Infectious Diseases
- Metabolic Disorders
- Oncology
- Immunology
- Neurology
- Urology
- Dermatology
- Ophthalmology
- General Health
- Others
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Key Segments Profiled in the Small Molecule API Market Industry Survey
By Molecule Type:
- Standard API
- HPAPI
By Production:
- Captive/In-House
- Outsourced
By Application:
- Clinical
- Commercial
By Therapeutic Area:
- Cardiovascular Diseases
- Respiratory Disorders
- Infectious Diseases
- Metabolic Disorders
- Oncology
- Immunology
- Neurology
- Urology
- Dermatology
- Ophthalmology
- General Health
- Others
By Region:
- North America
- Latin America
- Western Europe
- Eastern Europe
- South Asia and Pacific
- East Asia
- Middle East and Africa
About Future Market Insights (FMI)
Future Market Insights, Inc. (ESOMAR certified, recipient of the Stevie Award, and a member of the Greater New York Chamber of Commerce) offers profound insights into the driving factors that are boosting demand in the market. FMI stands as the leading global provider of market intelligence, advisory services, consulting, and events for the Packaging, Food and Beverage, Consumer Technology, Healthcare, Industrial, and Chemicals markets. With a vast team of over 400 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.
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