High potency APIs market Size was valued at USD 22.18 billion in 2021 and is projected to grow from USD 24.15 billion in 2022 to USD 49.1 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 9% during the forecast period (2023 - 2032).The rise in the incidences of cancer, technological advancements in HPAPI manufacturing technologies and growing focus on precision medicine are driving the market growth.
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
Sai Life Sciences successfully built a new High Potency API (HPAPI) manufacturing facility at its cGMP API Manufacturing site in Bidar, India, by January 2023. This motion enhances Sai Life’s aptitude and capability to develop and manufacture high-potency APIs, which provide clients with a faster route to NCE development.
In July 2022– Albany Molecular Research, Inc. (AMRI)set out to partner with Biasing Technologies, Inc. on merimepodib supply for SARS-CoV-2 antiviral production; this ensures the company maintains market position and earns more revenue through this supply agreement.
Almac’s multi-million-pound investment program enabled it to complete phase one of GMP active pharmaceutical ingredient (API) facility expansion in December 2022.
In October 2022, Asymchem Inc., a renowned global contract development and manufacturing organization provider, and AUM Biosciences (AUM), a clinical-stage global biotech specializing in the discovery, acquisition, and development of next-generation targeted oncology therapeutics, jointly announced the successful completion of their first-ever GMP production campaign for AUM601.
Asymchem Inc. disclosed the construction of another center within the Dunhua site in China on April 13, 2022, which will focus on the wider application of continuous flow technologies in manufacturing processes.
In October 2023, Axplora’s subsidiary Farmabios received cGMP approval from AIFA for expanded HPAPI and steroid production capacity.
In Jauary 2022 saw Helsinn and Immedica enter into an exclusive agreement for commercializing cancer-supportive care products in key European markets.
High Potency APIs Market Trends
The rising occurrence of various types of cancer around the world is propelling the market forward. For instance, according to the World Cancer Research Fund, it is estimated that there were around 18.1 million cancer cases worldwide in 2020. The rise of targeted therapy approaches in the treatment of cancer is projected to boost the market for high-potency APIs significantly. The growing demand for high potency APIs in emerging economies like China, Japan, and India might be attributed to increased awareness and evolving healthcare systems. Increased demand for pharmaceuticals (oncology and antibody-drug conjugates), increased focus on precision medicine and high-potency APIs, and technological developments in high potency API manufacturing are some of the reasons driving market expansion.
Aging populations and socioeconomic risk factors are two of the most common causes of cancer cases worldwide. The fundamental components of these medications are high-potency APIs. As the number of cancer cases increases, so will the demand for cancer treatments. For instance, it is estimated that around 290 small-molecule targeted therapies are currently under development for the treatment of cancer. The above mentioned factors are driving the growth of the market.
The high potency APIs market segmentation, based on product, includes biotech APAPI and synthetic HPAPI. The synthetic HPAPI segment had the largest share in 2021. This is due to the ease of production of synthetic HPAPI, rise in the number of new APIs and approval from government authorities.
June 2022: MilliporeSigma (US) opened new CDMO facility in US for cancer therapies. The company has doubled its high-potent active pharmaceutical ingredients (HPAPI) production capacity.
Figure 2: High potency APIs market, by Product, 2021 & 2030 (USD Billion)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
Based on type, the global High Potency APIs (HPAPI) industry has been segmented into innovative and generic. The innovative segment held the largest share in 2021, due to the increased investments in R&D for novel drug development, favorable government initiatives and increased focus on precision medicines.
Based on therapeutic area, the global High Potency APIs (HPAPI) industry has been segmented into oncology, glaucoma, hormonal disorders and others. The oncology segment held the largest market in 2021. This is attributed to the increased number of cancer cases worldwide and launch of innovative drugs. For instance, according to Centers for Disease Control and Prevention, in 2019, 1,752,735 new cancer cases were reported in the US.
By Region, the study segments the market into North America, Europe, Asia-Pacific, and the Rest of the World. The growth of North America High potency APIs market is attributed to presence of key players in the region and advanced technological infrastructure.
Further, the major countries studied are: the U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 3: HIGH POTENCY APIS MARKET SHARE BY REGION 2021 (%)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
North America market of High potency APIs accounts for the largest market share due to presence of key players in the region, advanced technological infrastructure, growing demand for oncology drugs and growing demand for high-potency APIs. Furthermore, the US market of High potency APIs held the largest market share and Canada market of High potency APIs accounting for the second largest market in North America.
The Asia-Pacific market of High potency APIs is expected to grow at a highest rate from 2022 to 2030. This is due to the growing geriatric population, unmet needs for the cancer treatment and rising healthcare expenditure. Moreover, the India market of High potency APIs held the largest market share, and the China market of High potency APIs was the fastest growing market in the Asia-Pacific region.
High Potency APIs (HPAPI) Key Market Players & Competitive Insights
Major market players are adopting several business strategies to increase their market presence. They are significantly investing in R&D activities to expand their product portfolio, further driving the market of High potency APIs. In addition, the market players are adopting several strategic initiatives, such as new product launches, contractual agreements, mergers & acquisitions, increasing investments, and partnering with other players to expand their global footprint. Some key players in the market are Teva Pharmaceuticals (Israel), Lilly (US), Pfizer Inc. (US), Carbogen Amcis (India), Bristol-Myers Squibb (US) and Asymchem Lab (China)
Pfizer, Inc. (Pfizer) is a leading research-based biopharmaceutical company that applies science and resources to inventive treatments that extend and significantly improve lives. Pfizer discovers, develops, manufactures, and sells healthcare products worldwide. It operates through two segments: Pfizer Innovative Health (IH) and Pfizer Essential Health (EH). It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs), and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies, and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. Furthermore, the company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa, and the Middle East.
Key Companies in the High potency APIs market includes
High Potency APIs (HPAPI) Industry Developments
October 2022: AUM Biosciences (Singapore), a global clinical-stage biotech company, focused on discovering, acquiring, and developing next-generation targeted oncology therapeutics, and Asymchem (China), a leading global contract development and manufacturing service provider, completed the Phase II API production campaign of the novel TRK inhibitor.
April 2021: Pfizer Inc. (US) has acquired Amplyx Pharmaceuticals, Inc. (US), a manufacturer of medications, including Fosmanogepix (a fungal inhibitor), which requires high-potency APIs, to increase and strengthen its position in the high-potency API (HPAPI) market.
High Potency APIs (HPAPI) Regional Outlook
| Report Attribute/Metric | Details |
| Market Size 2021 | USD 22.18 billion |
| Market Size 2022 | USD 24.15 billion |
| Market Size 2032 | USD 49.1 billion |
| Compound Annual Growth Rate (CAGR) | 9% (2023-2032) |
| Base Year | 2021 |
| Forecast Period | 2023-2032 |
| Historical Data | 2018 & 2020 |
| Forecast Units | Value (USD Billion) |
| Report Coverage | Revenue Forecast, Competitive Landscape, Growth Factors, and Trends |
| Segments Covered | Product, Type, Therapeutic Area, and Region |
| Geographies Covered | North America, Europe, Asia Pacific, and Rest of the World |
| Countries Covered | The U.S, Canada, Germany, France, UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil |
| Key Companies Profiled | Teva Pharmaceuticals (Israel), Lilly (US), Pfizer Inc. (US), Carbogen Amcis (India), Bristol-Myers Squibb (US), Asymchem Lab (China), Lonza Group (Switzerland), Bayer AG (Germany), Boehringer Ingelheim (Germany) and Sanofi (France) |
| Key Market Opportunities | ·        Growing opportunities for CMOs and CDMOs |
| Key Market Dynamics | ·        Rise in the incidences of cancer ·        Technological advancements in HPAPI manufacturing technologies ·        Growing focus on precision medicine |
Frequently Asked Questions (FAQ) :
The high potency APIs market is projected to grow at an 9% CAGR between 2023-2032.
The high potency APIs market predicted to touch USD 49.1 billion by 2030.
North America is projected to command the largest share in the high potency APIs market.
The biotech segment will lead the high potency APIs market.
Lack of regulatory framework may limit market growth.
Assistant Manager He holds an experience of about 7+ years in market research and business consulting, working under the spectrum of life sciences and healthcare domains. rahul conceptualizes and implements a scalable business strategy and provides strategic leadership to the clients. his expertise lies in market estimation, competitive intelligence, pipeline analysis, customer assessment, etc. in addition to the above, his other responsibility includes strategic tracking of high growth markets & advising clients on the potential areas of focus they could direct their business initiatives
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