Active Pharmaceutical Ingredients (API) is estimated to be worth $388.0 billion by 2029

Generally, each drug made up of two components that are API and excipients, having curative activity. APIs are often known as bulk pharmaceuticals and most of all APIs are in powder form. Active Pharmaceutical Ingredients (APIs) are active substances in a drug intended to achieve pharmacological activity which is having a direct effect on disease treatment. APIs are synthesized based on chemical synthesis, fermentation, biotechnological methods or enhanced from the natural source.

The API global market is expected to grow at a high single digit CAGR from 2022 to 2029 to reach $388,002.4 million by 2029. The major factors driving the API market are increasing incidence and prevalence of various chronic diseases, adoption of biologics in disease management & increasing regulatory approvals and increasing R&D expenditure & expansion of manufacturing facilities. Whereas, growing scope for HPAPI and next generation therapeutics such as cell therapy and gene therapy, increasing patent expiration and trend of outsourcing are providing immense opportunity to the API market.  The high risk of contamination during the manufacturing of API, high cost for manufacturing of complex and advanced API’s, presence of alternatives and stringent regulations associated with pharma manufacturing are hindering the market growth.

The global API market is mainly segmented based on synthesis, business type, application, and geography. Based on synthesis, the API global market is segmented into synthetic API, biotech API and HPAPI. Among these, synthetic API accounted for the highest revenue in 2022 and is expected to grow at a mid single digit CAGR from 2022 to 2029. Biotech API is expected to grow at a double digit CAGR from 2022 to 2029. Based on product type, Biotech API is further segmented into antibodies, recombinant proteins, vaccines, cell therapy, gene therapy and others. Among these, antibodies segment accounted for the highest revenue in 2022 and is expected to grow at a double digit CAGR from 2022 to 2029. Gene Therapy is expected to grow at a mid teen CAGR from 2022 to 2029. Antibodies global market is further classified into monoclonal antibody, bispecific and others. Among these, Monoclonal Antibody segment is accounted for the highest revenue in 2022 and is expected to grow at a double digit CAGR from 2022 to 2029. Bispecific segment is expected to grow at an early teen CAGR from 2022 to 2029. Based on the customer base, the global biotech API is further segmented into biologics and biosimilars. Biologics accounted for the highest revenue in 2022 and is expected to grow at a high single digit CAGR from 2022 to 2029. Biosimilar API segment is expected to grow at a mid teen CAGR from 2022 to 2029.

Synthetic API global market based on customer base is further segmented into branded and generic synthetic API. Among these, branded synthetic AP global market accounted for the highest revenue in 2022 and is expected to grow at a mid single digit CAGR from 2022 to 2029. Generic synthetic API market is expected to grow at a high single digit CAGR from 2022 to 2029.

The HPAPI global market is estimated to be $XX million in 2022 and is expected to grow at a double digit CAGR from 2022 to 2029. The global HPAPI market based on customer base is further classified into branded and generic HPAPI. Among these, branded HPAPI accounted for the highest revenue in 2022 and is expected to grow at a high single digit CAGR from 2022 to 2029. Generic HPAPI is expected to grow at an early teen CAGR of 11.8% from 2022 to 2029.

Based on business type, the API global market is segmented into Captive and Merchant API. Among these, captive API accounted for the highest revenue in 2022 and is expected to grow at a mid single digit CAGR from 2022 to 2029. Merchant API segment is expected to grow at high single digit CAGR from 2022 to 2029. The Captive API global market is further segmented into branded and generic API. Among these, branded API accounted for the highest revenue in 2022 and is expected to grow at a mid single digit CAGR from 2022 to 2029. The merchant API global market is further segmented into branded and generic API. Among these, branded merchant API accounted for the highest revenue in 2022 and is expected to grow at a high single digit CAGR from 2022 to 2029. Generic Merchant API segment is expected to grow at early teen CAGR from 2022 to 2029.

The API global market based on application is segmented into infectious diseases, oncology, cardiovascular diseases, central nervous system, pulmonary diseases, gastrointestinal diseases, endocrine diseases, metabolic disorders, genito-urinary diseases, musculoskeletal diseases and others such as ophthalmology, nephrology, hepatology, ENT, dental, dermatology, and pain management. Among the application, the infectious disease segment accounted for the highest revenue in 2022 and is expected to grow at a mid single digit CAGR from 2022 to 2029. Oncology is expected to grow at a double digit CAGR from 2022 to 2029.

In synthetic API global market based on application, infectious disease segment accounted for the highest revenue in 2022 and is expected to grow at a mid single digit CAGR from 2022 to 2029. Oncology is expected to grow at a high single digit CAGR from 2022 to 2029. In Biotech API global market based on application, musculoskeletal diseases segment accounted for the largest revenue in 2022 and is expected to grow at a double digit CAGR from 2022 to 2029. The oncology segment is expected to grow at a strong early teen CAGR from 2022 to 2029. The HPAPI global market based on application, the oncology segment accounted for the largest revenue in 2022 and is expected to grow at a early teen CAGR from 2022 to 2029.

The active pharmaceutical Ingredients global market based on region is segmented as North America, Europe, Asia-Pacific, and the Rest of the world (ROW). Among the region, North America accounted for the highest revenue in 2022 and is expected to grow at a mid single digit CAGR from 2022 to 2029. Growing pharma R&D expenditure, increasing development of new drugs over the time, increasing approval of generics and biosimilars, growing biopharmaceutical drugs pipelines, presence of number of API manufacturing facilities for all regulated drug products, increasing scope of highly potent drugs, government support to expand the domestic pharmaceutical manufacturing facilities and increase in the prevalence of infectious diseases, cancer, central nervous system associated diseases, cardiac disease, and musculoskeletal disorder are some of the major diseases that are driving the market growth. Asia-Pacific is the fastest-growing region with a high single digit CAGR from 2022 to 2029. The factors such as increasing generic pharmaceuticals and vaccines production, number of pharma companies with a strong network of manufacturing facilities, increasing outsourcing with number of CMO’s and expanding manufacturing facilities, increasing development of new pharma and biopharma drugs, growing biotech R&D investment, presence of number of innovative biotech startups, presence of dedicated departments to support biotechnology research, increasing government investment to support the pharma and biotech industry, low labor cost, and increased prevalence of infectious and other chronic diseases are driving the market growth.

Some of the key players of Active pharmaceutical Ingredient (API) market are Catalent Inc (U.S.), Divis Laboratories (India), Lonza Group (Switzerland), Samsung Biologics, (South Korea), Wuxi Biologics (China), Wuxi Apptec (China), Pfizer Inc. (U.S.), EuroAPI (France), Thermo Fisher Scientific (Patheon N.V.) (U.S.) and Teva Pharmaceutical Industries Limited (Israel).

 

The report provides an in-depth market analysis of the above-mentioned segments across the following regions:

  • North America
  • U.S.
  • Rest of North America
  • Europe
  • Italy
  • Germany
  • France
  • Rest of Europe
  • Asia-Pacific
  • China
  • Japan
  • India
  • Rest of APAC
  • Rest of the World (RoW)
  • Brazil
  • Rest of Latin America
  • Middle East and Others