The global Active Pharmaceutical Ingredient (API) market is expected reach the value of USD 248.3 billion in 2025 and is expected to register CAGR of 6.8 % over the forecasted period.
Market Definition – A substance used in a finished pharmaceutical product (FPP), intended to furnish pharmacological activity or to otherwise have direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to have direct effect in restoring, correcting or modifying physiological functions in human beings.
Manufacturers use certain standards to determine how strong the API is in each drug. However, the standard can vary widely from one brand to another. Each brand might use different test methods, that can result in different potencies.
In all cases, manufacturers are required by the FDA to prove the potency of their products in real-life patients, as well as in laboratory conditions
Market Dynamics–
Rising prevalence of Chronic Diseases, rising consumption of biopharmaceuticals, similarly, rising demand of generics and Advanced API Manufacturing Active Pharmaceutical Ingredient (API) is boosting the growth of fueling the growth of the market.
However, unfavorable drug price control policies across various countries and rising penetration of counterfeit drugs are the factors restraining the growth of the market.
Market segmentation –
The Active Pharmaceutical Ingredient (API) market is divided by type, type of manufacturer, type of synthesis, and therapeutic application.
Based on the of type the market is broadly divided into Innovative APIs and Generic APIs
Based on the type of manufacturer the market is further bifurcated into Captive API Manufacturers and Merchant API Manufacturers
Based on the type of synthesis the market is further divided into Biotech APIs and Synthetic APIs. Biotech APIs are further divided into Vaccines, Monoclonal Antibodies, and Recombinant Proteins
Based on the therapeutic application the market is further divided into divided into respiratory diseases, communicable diseases, cardiovascular diseases, oncology, diabetes, pain management, and others.
Key Market players –
AstraZeneca plc (UK), Pfizer, Inc. (US), F. Hoffmann-La Roche Ltd. (Switzerland), Novartis AG (Switzerland), AbbVie Inc. (US), Sanofi (France), Merck & Co., Inc. (US), Boehringer Ingelheim (Germany), GlaxoSmithKline plc (UK), Bristol-Myers Squibb (US), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel) among others.
Questions Answered -
Where will all these developments take the industry in the mid-to-long term?
What are the recent trends affecting the market?
What are the major applications in the market?
Who are the key players in the market, and how intense is the competition?
What are the key types of Active Pharmaceutical Ingredient (API) in the market?
Key Market Development –
In March 2020, Thermo Fisher Scientific Inc. has acquired a drug substance manufacturing site in Cork, Ireland, from GlaxoSmithKline plc (GSK).
In Feb 2020, Sanofi to create leading European APIs company, the spinout would enter the market as the second largest API producer worldwide.
In May 2019, Thermo Fisher to acquired GlaxoSmithKline site for complex APIs
In Dec 2019, Alkem Labs to acquired API assets from American firm AbbVie