Number of pages: 100-120 | Report Format: PDF | Published date: 01 January, 2020
Historical Years – 2018 & 2019 | Base Year – 2020 | Forecasted Years – 2021 to 2031
High potency active pharmaceutical ingredients are pharmacologically active substances that exhibit biological activity at extremely low concentrations. Each HPAPI has a limit of daily therapeutic dose of <10 mg or an occupational exposure limit (OEL) of < 10Â¼g/m3 at an 8-hour average. In order to manufacture these compounds, specialized considerations must be made for the facility design, equipment, operation, and safety processes to achieve the best level of containment of the drug product. HPAPI can be a small-molecule, biologic, or a hybrid of the two such as an Antibody-drug conjugates, which links a cytotoxic small-molecule to a monoclonal antibody. Examples of HPAPIs include cytotoxic compounds as well as sex hormones such as estrogen.
The shift towards the use of HPAPIs has led to a stronger pipeline of HPAPIs. The rising incidence of diseases such as cancer, growing number of drugs patent expiration, and increasing demand for contract manufacturing of HPAPIs are some of the other factors playing a pivotal role in propelling the global high potency active pharmaceutical ingredients market growth. However, one of the major challenges faced by the manufacturers of high potency active pharmaceutical ingredients is the specialized handling considerations that are required during the manufacturing process.
The global high potency active pharmaceutical ingredients market has been analyzed from five perspectives: Product, Drug Type, Manufacturer Type, Application, and Region.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Product
Based on product, the high potency active pharmaceutical ingredients market has been segmented into synthetic HPAPI and biotech HPAPI. Biotech HPAPI segment is anticipated to be the fastest growing segment in the HPAPI market. Several factors such as increasing demand for biologics, advancements in HPAPI manufacturing technology, and rising investment for R&D of new drugs are contributing to the growth of this segment.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Drug Type
Based on drug type, the market has been segmented into generics and innovative. Innovative drug segment dominated market in 2020. High demand and the rising R&D activities for development of innovative drugs are driving the growth of innovative drug segment.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Manufacturer Type
Based on manufacturer type, the market has been segmented into captive HPAPI manufacturer and contract HPAPI manufacturer. Captive HPAPI manufacturer held the largest share of the market in 2020. Large share of this segment is attributed the factors such as high preference for in-house manufacturing and the rising investments by pharmaceutical companies to develop in-house capabilities for manufacturing HPAPIs.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Application
Based on application, the market has been segmented oncology, hormonal disorders, glaucoma, and other disorders. Oncology segment held the largest share of the HPAPI market in 2020 and is also expected to continue dominate the market during the forecast period. The major factors attributing to the growth of oncology segment include the rising burden of cancer, increasing focus of companies for manufacturing oncology drugs, and stronger product pipeline of oncology HPAPIs.
High Potency Active Pharmaceutical Ingredient (HPAPI) Market by Region
Regionally, the global high potency active pharmaceutical ingredients market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). North America dominated the market for high potency active pharmaceutical ingredients holding the largest share of the market in 2020. The rising prevalence of various diseases such as cancer, growing investments by regional pharmaceutical companies for R&D activities for new drugs, and the increasing demand for fast acting drugs are some of the factors driving the growth of HPAPI market in North America.
Some of the prominent players operating in the global high potency active pharmaceutical ingredients market includes:-