The global High Potent Active Pharmaceutical Ingredient (HPAPI) Market accounted for US$ 21.5 Billion in 2020 and is likely to increase at a CAGR of 8.2% from 2021 to 2028.

High potent active pharmaceutical ingredients (HPAPIs) are a fast-increasing division of the pharmaceutical industry. A chemical having an occupational exposure limit (OEL) of less than 10 g/m3 of air as an 8-hour time-weighted average is considered powerful by the pharmaceutical industry. As API is considered highly potent it has biological activity at a smaller dose. The increase of biological activity and specificity of highly potent drug substances results in an increased risk of occupational handling of drug substances during product manufacturing. As the use of high potent active pharmaceutical substances grows more common in medication manufacture, effective engineering controls or 'containment systems' are more important than ever to ensure operator safety.

Market Dynamics

The increasing prevalence of cancer is the prime factor fueling the growth of high potent API market. High potent APIs find major applications in target therapies for cancer because of their target release characteristics. Cancer is the biggest cause of mortality worldwide, according to the World Health Organization (WHO), with approximately 10 million deaths were recorded in 2020. The most common cancer cases in 2020 (in terms of new cases of cancer) were breast (2.3 million cases); lung (2.2 million cases); colon and rectum (1.9 million cases); prostate (1.4 million cases); skin (non-melanoma) (1.2 million cases); and stomach (1.1 million cases).

Growing inclination towards oncology drugs is also supporting the growth of the market. The necessity for targeted medications in the oncology field is driving up demand for highly potent active pharmaceutical ingredients (HPAPIs). HPAPI development and manufacturing necessitate high-containment facilities staffed by skilled employees due to their strong pharmacological activity. HPAPIs are often complicated compounds by nature, necessitating the use of specialized methods for multi-step synthesis and purification. There are already 586 oncology drugs in development, with over 70 new cancer treatments (for more than 20 tumor types) entering the market in the last five years, increasing the demand for HPAPIs.

Innovative therapies accelerate the demand for the global high potency active pharmaceutical ingredients market. With the advent of pharmaceutical ingredients gradually moving toward innovative therapies focusing on customized and patient-centric treatment, pharmaceutical manufacturers are focusing on a smaller batch size of more complex and potent compounds triggering high-quality standards. However, HPAPI faces a big challenge regarding containment. Effective engineering controls or 'containment systems' are more necessary than ever to ensure operator safety as the usage of high potent APIs becomes more frequent in medication manufacturing. Efficient containment of HPAPI is also important as it could potentially result in undesired health effects and/or sensitization for the workers handling them. Furthermore, growing opportunities from the emerging market are expected to gain a significant impetus throughout the forecast period 2021 – 2028. Emerging economies such as China, India, the Middle East, and African countries offer significant growth potential for HPAPIs players. Because of their large populations, rising income, and better longevity, the market in most of these geographies is likely to develop rapidly in the future years.

Market Insights

Product type, manufacturer type, drug type, application, and region are the five segments of the global high potent active pharmaceutical ingredient (HPAPI) industry. The product type segment is further bifurcated into biotech and synthetic. Based on manufacturer type, the segmentation includes in-house, outsourced. The drug type segment is categorized into generic and innovative. Furthermore, the application segment includes oncology, glaucoma, hormonal disorders, and others.

Global High Potent Active Pharmaceutical Ingredient (HPAPI) Market Regional Competition

North America, Europe, Latin America, Asia-Pacific, and the Middle East & Africa are the segmentation of the global high potent active pharmaceutical ingredient (HPAPI) industry. Among all the regions, North America acquired the lion’s share in 2020. This is due to the expansion of a facility dedicated to the production of HPAPIs and complicated antibody-drug conjugates (ADCs). However, the Asia-Pacific region is likely to attain a significant growth rate during the forecast period. This is assessed because of the significant number of patients suffering from chronic diseases, the rise in healthcare spending, and the presence of major HPAPI manufacturers in this region.

Global High Potent Active Pharmaceutical Ingredient (HPAPI) Industry Segment Analysis

Product Type Segments

·         Synthetic

·         Biotech

Manufacturer Type Segments

·         In-house

·         Outsourced

Drug Type Segments

·         Innovative

·         Generic

Application Segments

·         Oncology

·         Hormonal Disorders

·         Glaucoma

·         Others

High Potent Active Pharmaceutical Ingredient (HPAPI) Market Prominent Players

This section of the report identifies the market's major players. BASF SE, Cipla Inc., Dr. Reddy’s Laboratories Ltd., Pfizer, Inc., Merck & Co., Inc., Novartis AG, Sanofi S.A., Bristol-Myers Squibb Company, Boehringer Ingelheim International GmbH, F. Hoffmann-La Roche Ltd., and Cambrex are the key companies mentioned in the research.

High Potent Active Pharmaceutical Ingredient (HPAPI) Market Regions

North America

·         U.S.

·         Canada

Europe

·         U.K.

·         Germany

·         France

·         Spain

·         Rest of Europe

Latin America

·         Brazil

·         Mexico

·         Rest of Latin America

Asia-Pacific

·         China

·         Japan

·         India

·         Australia

·         South Korea

·         Rest of Asia-Pacific

Middle East & Africa

·         GCC

·         South Africa

·         Rest of Middle East & Africa