Transparency Market Research (TMR) has published a new report titled, ‘High Potency Active Pharmaceutical Ingredients (HPAPI) Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019–2027’. According to the report, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market was valued at US$ 17.46 Bn in 2018 and is projected to expand at a CAGR of over 8.7% from 2019 to 2027. Overview
High-potency active pharmaceutical ingredients (HPAPIs) are a niche but growing area for pharmaceutical manufacturers and contract manufacturing organizations (CMOs). Specialized considerations in facility design, equipment, operation, and process safety are needed to achieve the desired level of containment of the drug substance or finished-drug product. For drugsubstance manufacturing, the HPAPI may be a small-molecule, biologic, or a hybrid of the two such as an antibody–drug conjugate, which links a cytotoxic small-molecule to a monoclonal antibody. High potency active pharmaceutical ingredients (HPAPI) form a significant proportion of new drugs under development. Production of HPAPI presents various challenges due to its cytotoxic nature; thus, it requires heavy investment to ensure safe environment for employees. Contract manufacturing of HPAPI has been preferred over captive production due to high degree of competition and reduced profitability. Contract manufacturing is also preferred due to geographical advantage and cost-effectiveness.
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North America dominate the global High Potency Active Pharmaceutical Ingredients (HPAPI) market in 2019 and the trend is anticipated to continue during the forecast period. High demand for biological HPAPI, technological development in the pharmaceutical industry, and large number of manufacturing facilities are major factors driving the market growth in these regions. Asia Pacific is likely to be a highly lucrative region for the High Potency Active Pharmaceutical Ingredients (HPAPI) market and is expected to expand at a high CAGR during the forecast period due to rising focus on contract manufacturing and contract research organizations. Low labor cost, well-equipped manufacturing plants, and favorable foreign exchange policies in countries such as China have created lucrative opportunities for outsourcing businesses. Additionally, pharmaceutical manufacturers are currently focusing on countries in Latin America for contract manufacturing.
Growing preference for outsourcing of HPAPI manufacturing and Patent expiry of blockbuster drugs to Drive Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market
Pharmaceutical companies started to expand geographical boundaries, they started experiencing shortage of HPAPIs. Furthermore, increasing cost of drug development and commercialization added to the financial burden. With developing regulatory and legal framework, outsourcing proved to be the most optimal option for HPAPI manufacturing.