Market Trends of High Potency APIs /HPAPI Industry
Generic High-potency Active Pharmaceutical Ingredients Segment is Expected to Record Significant Growth
Generic high-potency active pharmaceutical ingredients show the same pharmacological effects as branded or innovative API. The generic HPAPI segment is primarily driven by the rising demand for generic pharmaceuticals and the rising need for generic HPAPI to generate high-quality drugs at affordable prices. Rising mergers and acquisitions between businesses have also helped expand the segment.
Factors such as the expiration of patents on branded drugs and lower costs are also driving segment growth. According to the report published by the American Journal of Managed Care in June 2021, patents on around 20 oncology biologics will expire in 2023, which may lead to the production of more biosimilars in cancer care and reduce costs. Due to these reasons, the market may see a high growth rate during the forecast period.
Also, government initiatives focusing on active pharmaceutical ingredient production are contributing to the growth of the studied market. In June 2021, the Indian Finance Minister announced an additional outlay of INR 197,000 crore (USD 24,024 million) for utilization over five years for the pharmaceutical Production Linked Incentive (PLI) Scheme in 13 key sectors such as active pharmaceutical ingredients, drug intermediaries, and critical starting materials. The significant incentives allocated to the dynamic pharmaceutical ingredient segment would significantly boost market growth over the forecast period.
Furthermore, market players are also involved in expansion strategies to gain a competitive edge. For instance, in 2021, MoehsGroup announced the incorporation of the GMP-compliant Kilo Lab Unit for developing and commercially producing high-potency APIs (HPAPIs). Additionally, in November 2021, Hovione announced an investment of USD 170 million to increase its capacity and capabilities. This capacity and capability of Hovione will also upgrade the production of highly potent active pharmaceutical ingredients (HPAPI).
Thus, all the factors above, such as an increase in patent expirations and the launch of HPAPI manufacturing facilities, are anticipated to boost the segment's growth over the forecast period.
North America is Expected to Hold a Significant Market Share Over the Forecast Period
North America is expected to hold a significant share of the market owing to the prevalence of disorders such as cancer and neurological disorders. These disorders are increasing in prevalence, thus increasing the production of HPAPIs in the region. HPAPIs are widely used in many therapeutic, drug discovery, or other research studies related to oncology and other significant disorders. Thus, the demand for the same will be significantly higher in the North American region as the patient population is increasing compared to other countries.
The increasing prevalence and incidence of chronic diseases in this region are expected to boost the market over the forecast period. For instance, according to statistics published by the Government of Canada and released in May 2022, about 233,900 Canadians were diagnosed with cancer in 2022, and prostate cancer is expected to remain the most commonly diagnosed cancer. Thus, the growing burden of cancer in the region is expected to boost market growth over the forecast period.
Further, according to the World Alzheimer's Report 2023, an estimated 6.7 million Americans age 65 and older are expected to be living with Alzheimer's dementia in 2023. Thus, the growing burden of neurological diseases is expected to increase demand for effective treatment and management methods, thereby boosting the market for HPAPI over the forecast period.
The country's expansion by key market players is another factor in the market's growth. For instance, in August 2021, Curia, formerly AMRI, a leading contract research, development, and manufacturing organization, announced the expansion of its commercial manufacturing capacity at its Rensselaer, New York, facility. The increased capability to flexibly manufacture complex active pharmaceutical ingredients (APIs) will further strengthen Curia's ability to partner with customers.
Thus, owing to the factors above, the United States high-potency API (HPAPI) market is expected to witness a high growth rate over the forecast period.
