Germany is Poised to Drive Demand for Small Molecule API

Small Molecule API Market Analysis by Standard API and In-House Small Molecule API from 2023 to 2033

The Global Small Molecule API Industry is poised for significant growth, with projections indicating a substantial increase in revenue. According to the latest industry insights, the market is expected to generate US$ 116 billion in 2023, and the revenue is forecasted to reach an impressive US$ 174 billion by 2033.

The compound annual growth rate (CAGR) for the Global Small Molecule API Industry is anticipated to be 4.1% during the forecast period, reflecting sustained and robust expansion in the sector. This steady growth underscores the market’s resilience and its ability to adapt to evolving healthcare needs.

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. The high-potency drug market is a growing pharmaceutical segment. The increasing prevalence of cancer and other chronic diseases owes to the need for oncology drugs 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.

Global Small Molecule API Industry Key Takeaways:

  1. Revenue Surge: Projections reveal a substantial growth trajectory, with the market expected to generate US$ 116 billion in 2023, climbing to an impressive US$ 174 billion by 2033.
  2. Steady Expansion: The compound annual growth rate (CAGR) for the small molecule API market is anticipated to be 4.1% during the forecast period, reflecting sustained and robust expansion.
  3. Resilience and Adaptability: The market’s steady growth underscores its resilience and its ability to adapt to evolving healthcare needs, reinforcing its pivotal role in the pharmaceutical sector.
  4. Small Molecule Drug Advantages: Small molecule drugs, with their low molecular weight, easily enter cells, impacting molecules like proteins and potentially leading to the demise of cancer cells.
  5. Research Boosting Market Growth: Increasing research on small molecule APIs and novel Biologics APIs is expected to propel market growth, indicating a growing focus on innovation and advancement.
  6. High-Potency Drug Market Growth: The high-potency drug market, a burgeoning pharmaceutical segment, is contributing to the overall expansion of the small molecule API industry.
  7. Rising Demand for Oncology Drugs: The increasing prevalence of cancer and other chronic diseases is fueling the demand for oncology drugs and antibody-drug conjugates, further driving market growth.

 “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 drugs manufacturing.

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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 Global 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.,

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Global Small Molecule API Industry by Category Molecule 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

Rahul Palan

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