The Small Molecule API Market is poised to display a solid 5% Compound Annual Growth Rate (CAGR) from 2022 to 2032, ultimately reaching a substantial valuation of US$ 216.97 billion by the end of the forecast period. According to the report, while in-house manufacturing currently holds a dominant position in the market, the pharmaceutical industry’s evolving inclination towards outsourcing is rendering outsourced production increasingly lucrative. As a result, the outsourcing segment is expected to claim a significant 50% share of production within the market throughout the forecast period. The global demand for Small Molecule API is anticipated to experience a consistent year-on-year growth rate of 5.0%, culminating in a valuation of US$ 216.97 billion in 2032.
Small molecule drugs, characterized by their low molecular weight, possess the ability to easily penetrate cells, where they can interact with various molecules, including proteins, potentially leading to the demise of cancer cells. The market’s growth is further propelled by the escalating research initiatives in the realm of small molecule APIs and innovative Biologics APIs. Additionally, the increasing prevalence of cancer and other chronic diseases, necessitating the development of oncology drugs, drives the high-potency drug market, which is witnessing substantial expansion, and antibody-drug conjugates.
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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 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
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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 several 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, 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 drug 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.,
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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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