- Pfizer Inc.
- Novartis International AG
- Sanofi
- Boehringer Ingelheim
- Bristol-Myers Squibb
- Teva Pharmaceutical Industries Ltd.
- Eli Lilly and Company
- GlaxoSmithKline plc
- Merck & Co., Inc.
- AbbVie Inc.
- F. Hoffmann-La Roche Ltd.
- AstraZeneca
- Cipla, Inc.
- Mylan N.V.
- Dr. Reddy’s Laboratories Ltd
- Sun Pharmaceutical Industries Ltd.
- API Pharma Tech
- BDR Pharmaceuticals Internationals Pvt. Ltd.
- Sreepathi Pharmaceuticals Limited
- Shilpa Medicare Limited
- Albemarle Corporation
- Viatris Inc.
- Aurobindo Pharma
- Biocon
(Note: The list of the major players will be updated with the latest market scenario and trends)
Recent developments by key players in the API Market:
A total of $9 billion has been invested in the Lebanon, Indiana site to increase the production of active pharmaceutical ingredients (APIs) for Zepbound and Mounjaro (tripeptide). This investment enhances the capacity for obesity and diabetes treatments, making it the largest synthetic API investment in the U.S. to date. Additionally, $1.6 billion has been allocated to the LEAP Innovation Park, further expanding the complex API manufacturing capabilities.
- Dr. Reddy’s Laboratories:
During GMP inspections in May 2025, the U.S. FDA issued two Form 483 observations at their API plant in Miryalaguda, Telangana; they are addressing the issues according to regulatory timelines.
Pfizer's CentreOne has completed a $120 million upgrade at its Active Pharmaceutical Ingredient (API) facility in Kalamazoo, Michigan. This enhancement increases the site’s production capacity to approximately 1,200 metric tons per year, highlighting the company's commitment to resilience in the treatment of COVID-19.
Sanofi is heavily investing in biotechnological API innovation, accelerating its pipeline with a 50% increase in Phase III studies by 2025, supported by collaborations with AI specialist Exscientia.
- In December 2021, the Novasep facility in Chasse-sur-Rhône, France, which offers services and technology to the life sciences sector, invested approximately EUR 6 million to update its capabilities about the newer generation APIs in areas such as cancer, the central nervous system (CNS), and infectious diseases.
- In August 2021, the US FDA authorized Teva Pharmaceutical and MEDinCell to market TV-46000/mdc-IRM as a new medication (risperidone extended-release injectable suspension for subcutaneous use). This drug is used to treat schizophrenia.
The demand for pharmaceutical products, especially APIs, is driven by rising healthcare costs, particularly in emerging economies. The need for APIs to make essential medications increases as nations invest more in their healthcare infrastructure and work to provide access to affordable healthcare. The growing prevalence of cancer, diabetes, cardiovascular disease, and respiratory disorders significantly influences the API market. APIs are the main ingredients in creating medications to address these chronic illnesses. The rising global toll of chronic diseases fuels the need for APIs. Generic medicine manufacturers can enter the market once the brand-name drug patents expire, necessitating the demand for API providers. APIs that are bioequivalent to the original branded pharmaceuticals are necessary for generic medications. Blockbuster medication patent expirations present opportunities for generic drug producers, which in turn increases the demand for APIs. For instance, Erenumab, a novel API by Dr. Reddy's Laboratories, was introduced as a migraine treatment in 2022. This API is administered as a subcutaneous injection once a month to prevent migraines. The FDA, EMA, and other national agencies, which set strict regulatory criteria and quality standards, are essential in developing the API business. The need for high-quality API producers is fueled by the assurance of safety, efficacy, and quality provided by compliance with these standards, which drives the API market. However, cost inflation is a significant barrier in the API business because it is fiercely competitive. When choosing API suppliers, pharmaceutical companies, especially those that manufacture generic medications, strongly emphasize the most affordable solutions, which pressures API producers to maintain low prices while upholding quality standards. The profitability of API manufacturers is also impacted by changes in the cost of raw materials, energy prices, and manufacturing costs, thereby limiting market growth.