High Potency APIs /HPAPI Market Size (2024 - 2029)

High-Potency APIs /HPAPI Market Analysis

The High Potency APIs /HPAPI Market size is estimated at USD 26.85 billion in 2024, and is expected to reach USD 41.83 billion by 2029, growing at a CAGR of 9.27% during the forecast period (2024-2029).

During the COVID-19 pandemic, the high-potency API (HPAPI) market was adversely affected. The COVID-19 outbreak primarily affected the supply chain of the API market. China and India are the hubs for the production of API, and the market was severely hampered as COVID-19 increased in the region. According to the article published in the European Pharmaceutical Review in June 2022, 60% of APIs, including high-potency APIs, are manufactured in India or China. 

India alone accounts for 18% of the global generic drug manufacturing market, most of which is exported to other countries. China manufactures 70% of the APIs, including high-potency APIs, for India's generics industry. Due to stringent lockdown restrictions in China, 44 firms closed API manufacturing plants during the outbreak. As a result, access to critical APIs and medicines was severely limited. 

It is anticipated that 80 percent of APIs for vital medications in critical therapeutic areas in the United States do not have a domestic manufacturing source, which has significant global health consequences. Overall, the market was considered to be hindered in the short term. However, various APIs are used in producing COVID-19 vaccines, and the market is expected to grow significantly over the forecast period.

Factors driving the market's growth include increasing demand for drugs, increasing focus on precision medicine and high-potency APIs, and technological advancements in high-potency API manufacturing.

APIs are essential components of drugs used to treat chronic underlying health disorders like cancer, cardiovascular disease, strokes, heart attacks, diabetes, and others. The rising prevalence of these chronic diseases is likely to increase demand for HPAPI, increasing market growth. For instance, according to Cancer Facts and Figures 2023, published in January 2023 by the American Cancer Society, an estimated 1.9 million new cancer cases will be diagnosed in 2023, among which prostate cancer is estimated to be 288,300, followed by 238,340 cases of lung cancer, and 300,590 cases of female breast cancer. Thus, the growing burden of cancer in the country is expected to increase demand for advanced treatments that need HPAPI to produce effective medicine, which is likely to boost market growth.

Establishing HPAPI manufacturing facilities across the market will drive the market significantly. For instance, in May 2021, Novasep expanded its highly potent active pharmaceutical ingredients (HPAPIs) manufacturing capabilities on its Le Mans (France) site to produce innovative and targeted molecules to treat cancer by investing in additional capacity. Additionally, in March 2022, the Indian Minister of Health and Family Welfare and Chemicals and Fertilisers announced that India had started manufacturing 35 pharmaceutical ingredients that had been imported earlier from China. Such initiatives are expected to meet the unmet need of API in countries and, hence, boost the market over the forecast period.

Thus, all the factors above, such as the increasing burden of chronic diseases and the establishment of manufacturing facilities, are projected to drive market expansion. However, the high capital investment is expected to restrain the market over the forecast period.

High-Potency APIs /HPAPI Industry Segmentation

A highly potent active pharmaceutical ingredient (HPAPI) is generally defined as a pharmacologically active ingredient or intermediate that shows biological activity at approximately 150 µg/kg of body weight or below in humans.

The high-potency APIs (HPAPI) market is segmented by product type (innovative high-potency active pharmaceutical ingredients and generic high-potency active pharmaceutical ingredients), application (oncology, hormonal imbalance, glaucoma, and other therapeutic applications), synthesis (synthetic high-potency active pharmaceutical ingredients and biotech high-potency active pharmaceutical ingredients), manufacturer (captive HPAPI manufacturers and merchant HPAPI manufacturers), and geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries globally.

The report offers the value (in USD) for the above segments.