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Small Molecule API Market is expected to exhibit a CAGR of 5% through 2031.

[300 Pages Report]  Increasing demand of high potency drugs and increasing cases of chronic diseases are expected to boost small molecule active pharmaceutical ingredient (API) Market. In a study, Future Market Insights (FMI) has forecast the small molecule API market to exhibit 5% CAGR between 2021 and 2031. According to the report, although in-house manufacturing is currently leading the market, the trend towards outsourcing in the pharmaceutical industry makes outsourced production more lucrative. The outsource segment is therefore likely to account for 50% of production in the market during the forecast period.

A small molecule drug can enter cells easily because it has a low molecular weight. Once inside the cells, it can affect other molecules, such as proteins, and may cause cancer cells to die. Increasing research on small molecule APIs and novel Biologics APIs will boost the market growth. High potency drug market is a growing pharmaceutical segment. Increasing prevalence of cancer and other chronic diseases owe to the need of oncology drugs and antibody drug conjugates.

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The oncology market is growing enormously. High potency drugs constitute significantly to the new drugs that are under development. Small molecule demand still dominates the API market, however new biological entity demand is also growing rapidly growing 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 to API manufacturing units is also increase 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

Coronavirus pandemic has changed the public medical care needs and spending however this is viewed as transient effect on the Small Molecule API market. The immense COVID-19 patient pool attracted 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 North America small molecule API market
  • Rising focus on health and wellness will enable the U.K. exhibit a little below 4% y-o-y growth in 2021
  • Germany will account for maximum sales in Europe. Besides this, the demand from France too is expected to rise
  • Increasing investment in research and development within pharmaceutical 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 Ingredient (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 was 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 which have no internal GMP manufacturing capabilities whatsoever (e.g. biotech companies), outsourcing is, of course, a necessity. However, companies which have some level of internal manufacturing capacity may have options to use outsourcing to their strategic advantage. This outsourcing capability has increase the source of generating more revenue for new emerging companies. For fast growth of 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 advance technology for manufacturing, acquisitions, in order to create a strong position into the market is leading into vigorous developments which is helping the market to grow at a considerable rate.

For Instance, In January 2020, Novartis acquisition of operations of Aspen in Japan. This acquisition strengthened Sandoz’s position in world market of off-patent medicines and generic drugs manufacturing.

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Key Participant InsightsVarious 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 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 its demand across various therapeutic area. 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.,

Want more insights?Future Market Insights brings the comprehensive research report on forecasted revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2031. The global Small Molecule API market is segmented in detail to cover every aspect of the market and present a complete market intelligence approach to the reader. The study provide compelling insights on Small Molecule API market on basis of Molecule by (Standard API, High Potency API), By Production (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) across seven major regions.

Small Molecule API Market by CategoryMolecule Type

  • Standard API


  • Captive/In-House
  • Out Source


  • 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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  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Middle East and Africa (MEA)
  • Oceania

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Last Updated: 05-Apr-2022