The Small Molecule API Industry is poised for impressive growth in the coming decade, with a projected Compound Annual Growth Rate (CAGR) of 5% between 2022 and 2032. According to the latest industry report, the market is expected to reach an estimated US$ 216.97 billion by the end of the forecast period.
In a pharmaceutical landscape marked by innovation and dynamic shifts, the report highlights a significant trend toward outsourcing in the industry. While in-house manufacturing currently dominates the market, the allure of outsourced production is rapidly gaining momentum. This trend is expected to see the outsourcing segment capturing a substantial 50% share of the small-molecule API production during the forecast period.
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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 Industry. 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 Industry 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 Industry
- 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
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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 Industry 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 with the goal of accelerating 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.
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Key players in the Small Molecule API Industry 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 Industry 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
Author
Sabyasachi Ghosh (Associate Vice President at Future Market Insights, Inc.) holds over 12 years of experience in the Healthcare, Medical Devices, and Pharmaceutical industries. His curious and analytical nature helped him shape his career as a researcher.
Identifying key challenges faced by clients and devising robust, hypothesis-based solutions to empower them with strategic decision-making capabilities come naturally to him. His primary expertise lies in areas such as Market Entry and Expansion Strategy, Feasibility Studies, Competitive Intelligence, and Strategic Transformation.
Holding a degree in Microbiology, Sabyasachi has authored numerous publications and has been cited in journals, including The Journal of mHealth, ITN Online, and Spinal Surgery News.
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 5,000 analysts worldwide, FMI provides global, regional, and local expertise on diverse domains and industry trends across more than 110 countries.
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