Patent expiration of drugs and rising prevalence of chronic diseases are likely to propel the growth of high potency active pharmaceutical ingredient (HPAPI) market

High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Products (Synthetic and Biotech), Drug Type (Generic and Innovative), Manufacturer Type (Captive HPAPI Manufacturer and Contract HPAPI Manufacturer), Application (Oncology, Hormonal Disorders, and Glaucoma) – Global Outlook & Forecast 2021-2031

According to the deep-dive market assessment study conducted by Growth+ Reports, the global high potency active pharmaceutical ingredient (HPAPI) market was pegged at ~US$ 21.0 billion in 2020. The market is expected to witness a CAGR of ~8.4% from 2021 to 2031.

Factors contributing to the growth of high potency active pharmaceutical ingredients market include increasing number of patent expiration, rising incidence of chronic diseases, increasing demand for HPAPI, and stronger HPAPI pipeline. However, one of the major challenges faced by the manufacturers of high potency active pharmaceutical ingredients is the specialized handling considerations that are required during the manufacturing process.

Cancer is second leading of death worldwide and burden of disease is constantly increasing. According to American Cancer Society’s Cancer Statistics Center, in the U.S., almost 1.9 million new cancer cases are expected to be diagnosed in 2021 and approximately 608,570 Americans are expected to die of cancer in 2021. Therefore, many pharmaceutical companies are focused on developing highly potent oncology drugs, which in turn driving the growth of the HPAPI market.

In the past few years, patents for various drugs have been expired. Many more drug patents are about to expire in the coming years. According to the the Ministry of Food and Drug Safety (MFDS)’s Green List, a total of 62 drug-related patents covering 158 products are scheduled to expire in 2021. This has created lucrative opportunities for various drug manufacturers to develop similar potent drugs and thus, demand for HPAPIs is likely to increase.

Players in the high potency active pharmaceutical ingredients market are focused on adopting various strategies such as expanding their manufacturing capabilities. For instance, in September 2020, MilliporeSigma announced a US$ 65 million expansion of its HPAPI and antibody-drug conjugate manufacturing capacity at its facility near Madison in Wisconsin, the U.S. This expansion will allow the large-scale manufacturing of highly potent compounds for use in cancer therapies. Such strategies help in the organic growth of the individual companies, which in turn also drives the market growth. 

However, as these compounds should be manufactured under specialized conditions, the investments required for developing such sites is quite high which could challenge the entry of new players and restrain the market growth.

Regionally, the global high potency active pharmaceutical ingredients market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). Asia Pacific region is expected to grow at a higher CAGR during the forecast period. Factors contributing to the growth of the market in this region include the increasing incidence of chronic diseases, increasing R&D activities for developing new drugs, low costs of raw materials, and low manufacturing cost for HPAPIs.

Some of the prominent players operating in the global high potency active pharmaceutical ingredients market include Pfizer Inc., Merck & Co., Inc., Teva Pharmaceutical Industries Ltd, Sanofi, Mylan N.V., AbbVie Inc., Eli Lilly and Company, Bristol-Myers Squibb Company, F. Hoffmann-La Roche Ltd., and AstraZeneca, among others.

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