High Potency APIs /HPAPI Market- Growth, Trends, COVID-19 Impact, and Forecast (2022 - 2027)

The high-potency APIs/HPAPI market is projected to register a CAGR of 8.5% during the forecast period.

During the COVID 19 pandemic, the high potency APIs/HPAPI market was adversely affected. The COVID-19 outbreak primarily affected the supply chain of the API market. Since Southeast Asia (specifically China and India) is the hub for the production of API, the market was severely hampered as COVID-19 increased in the region. According to the Germany Trade & Invest (GTAI), around 60% of APIs, including high-potency APIs of the world, 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 is a major manufacturing location and produces 70% of the APIs, including high-potency APIs, for India's generics industry. This situation makes these two countries the biggest players in the global market for generic medicines. However, these countries were the most affected by the pandemic. As the virus spread globally, India temporarily placed an export curb on 26 drugs and various high-potent APIs, which account for around 10% of the country's pharmaceutical exports, to avoid domestic shortages. This factor further fueled the adversity in the market. However, various APIs are used in the production of COVID-19 vaccines. Overall, the market may be hindered in the short term. However, the market may grow significantly once the industry reinforces its supply chain with modern advancements and protocols.

Certain factors driving the market’s growth include increasing demand for drugs (oncology and antibody-drug conjugates), increasing focus on precision medicine and high potency APIs, and technological advancements in high-potency API manufacturing. The International Agency for Research on Cancer (IARC) updated GLOBOCAN 2020 with new estimates about the global cancer burden, indicating that the cancer burden rose to 19.3 million cases and 10 million cancer deaths in 2020. This new study suggests that more than 50 million people will be diagnosed with cancer within five years. The aging population and socio-economic risk factors are common for increasing cancer cases. For instance, the US Center for Drug Evaluation and Research (CDER) approved new therapies in 2020 for various cancers, particularly lung, thyroid, and breast cancers. These therapies include small and large molecules for treatments. High-potency APIs are the primary constituents of these drugs. With the growing number of cancer cases, the market will simultaneously grow to provide solutions for the disease. Similarly, according to Parkinson’s Foundation, around 60,000 Americans are diagnosed with Parkinson's disease each year. There has been a focus on precision medicine in the past few years. The need for personalized medicine with higher efficacy is increasing. These generic drugs are known as pharmacogenetics. In 2020, the US Food and Drug Administration listed information relating to 200 pharmacogenetic drugs. In the United Kingdom, the National Health Scheme aims to integrate genomic medicines into its routine care by 2025. Due to such factors, the studied market is estimated to witness a healthy growth rate during the forecast period.

Key Market Trends

Generic High-potency Active Pharmaceutical Ingredients Segment is Expected to Record Significant Growth

The high-potency APIs/HPAPI market is broadly segmented into innovative high-potency active pharmaceutical ingredients and generic high-potency active pharmaceutical ingredients. The primary factor for the growth is the patent expiration of various drugs and increasing demand for cancer treatment, along with the huge number of cancer treatment drugs in the pipeline for the future. According to the report published by the American Journal of Managed Care in June 2021, by 2023, patents of around 20 oncology biologics will expire, which may lead to the production of more biosimilars in cancer care and reduce costs. According to Roche, Rituxan (a drug for blood cancer) is already facing competition due to the loss of its patent in 2018. Loss of patents leads to low manufacturing costs, further increasing competition and propelling the market. Due to these reasons, the market may see a high growth rate during the forecast period.

North America is Expected to Hold a Major Share in the Market

North America is expected to hold a significant share in the market during the forecast period

The United States was the most affected country in the world, with 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. HAAPIs are widely used in many therapeutic, drug discovery, or other research studies related to oncology and other major 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.

North America is expected to hold a major share in the high-potency APIs/HPAPI market due to the rising geriatric population and increasing prevalence and incidence of infectious diseases in this region. The incidence of chronic diseases, like cancer, is also high in the United States. As per the 2020 report by the American Cancer Society journal, there were an estimated 1.8 million new cancer cases diagnosed and 606,520 cancer deaths in 2020. In addition, as per a 2018 report by the Centers for Disease Control and Prevention, around 60% of Americans are living with at least one chronic disease, and chronic diseases are the leading cause of death and disability in the United States. According to the Parkinson’s Foundation, around 1 million people in the United States are living with Parkinson's disease, more than the combined number of people diagnosed with muscular dystrophy, multiple sclerosis, and Amyotrophic Lateral Sclerosis. This number is expected to increase to 1.2 million by 2030. In Canada, in 2020, around 225,800 new cancer cases and 83,300 cancer deaths were recorded. Around 30% of all deaths in Canada are caused by cancer. However, Canada has a universal healthcare system for its citizens. This factor creates an even demand in the region. Due to this factor, the market may register positive growth during the forecast period.

Moreover, the increasing R&D activities and the presence of favorable healthcare infrastructure are fueling the growth of the overall regional market. ​

Competitive Landscape

The high-potency APIs/HPAPI market is fragmented, competitive, and consists of several major players. In terms of market share, a few major players are currently dominating the market, including Thermo Fisher Scientific Inc., Merck KGaA, Pfizer, Novartis International AG, and Teva Pharmaceutical Industries.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

This product will be delivered within 2 business days.