High-potency active pharmaceutical ingredients (HPAPIs) is a cranny yet opportunistic area for contract manufacturing organizations (CMOS) and pharmaceutical manufacturers. Specialized considerations in equipment, facility design, operation, and process safety are needed to achieve the desired level of containment of the drug substance or finished-drug product.
The global high potency active pharmaceutical ingredients market expected to increase market value by USD 30.52 billion with exponential CAGR in the forecast period from 2020-2027. The market demand for high potency active pharmaceutical ingredients is growing due to the lower clinical dosage, and fewer side effects of HP API drugs have attracted market attention in recent years. It has become a research and development hotspot.
API is a critical link in pharmaceutical production and is closely related to public health. And specific APIs are different from batch APIs. They have reliable growth attributes, high customer stickiness, and non-standard characteristics.
High-efficiency APIs (HPAPI), intermediates, and finished dosage forms require specialized facility design, equipment, operation, and process safety throughout the drug development process and commercial-scale production to achieve the necessary level of control and ensure operator safety. As a result, HPAPIs increasingly outsourced to professional contract development and production organizations (CDMOs) with such infrastructure, expertise, and tracking opportunities.
Moreover, in recent years, with the increasing number of patented drug varieties due to patent expiration, the type and number of generic drugs have risen rapidly, which has brought substantial market opportunities to the API market, and the output of APIs has continued to increase.
High potency active pharmaceutical ingredients (HPAPI) construct a notable proportion of new drugs under development. Production of HPAPI involves various challenges due to its cytotoxic nature. Therefore, it requires a substantial investment to ensure a safe environment for employees. Contract manufacturing of HPAPI has preferred over captive production due to the reduced profitability and high degree of competition. Contract manufacturing is also preferred due to cost-effectiveness and geographical advantage.
The rising incidence of cancer and its side effects related to chemotherapy also affect noncancerous cells. Hence targeted therapy approach is gaining popularity as it does not harm noncancerous cells. HP API also used in ADC drugs. ADC is a new variety formed by combining monoclonal antibodies for cancer treatment with highly effective biologically active ingredients. The highly active toxic components of HP API selectively delivered to specific tumor cells through monoclonal antibodies. Treatments that physically attack cancer cells protect non-cancer cells from toxic damage.
Based on the product, the global high potency active pharmaceutical ingredients market is bifurcated into Synthetic, Biotech. The biotech segment estimated to dominate the maximum share of the global high potency active pharmaceutical ingredients market. It is mainly due to the changing preference of consumers shifting from synthetic to biotech molecules as it penetrates a higher rate of biologics. Also, biotech HPAPI mainly consists of drug molecules obtained after usage of molecular techniques such as recombinant DNA technology. The genes expressing these molecules transferred into an expression vector for the synthesis of the higher amount of drug molecule in less time.
Based on the manufacturer, the global high potency active pharmaceutical ingredients market classified into In-house, Outsourced. The in-house segment dominated the largest market share in the global high potency active pharmaceutical ingredients market. It is mainly due to the increased availability of raw material, and the high-end manufacturing facility is investing high capitalization in developing in-house capabilities and specialized requirements.
Based on drug type, the global high potency active pharmaceutical ingredients market segmented into Innovative, Generic. The Innovative segment holds the largest share in the global high potency active pharmaceutical ingredients market. It is mainly due to the rising research and development of the novel drug that drives the market share for high potency active pharmaceutical ingredients. Moreover, an increasing amount of funding and favorable regulations are fueling the market growth for developing the innovative drug. The expiry of the branded drug molecules is bolstering the adoption of the innovative medicine in global high potency active pharmaceutical ingredients market.
Based on the application, the global high potency active pharmaceutical ingredients market categorized into Oncology, Hormonal, Glaucoma, Others. Oncology dominates the largest end-use segment in the global high potency active pharmaceutical ingredients market in the forecast period from 2020-2027. HPAPI is widely used in drug therapy, commonly used in cancer treatment such as breast cancer. At present, more and more pharmaceutical products contain HPAPI, which has scientifically proved to be more effective than traditional API at lower dose levels. The small-molecule targeted drugs and ADC in HPAPI mainly treat cancer. Compared with conventional chemotherapy, targeted therapy does not damage healthy cells and has fewer side effects, making it more widespread.
Based on geography, the global high potency active pharmaceutical ingredients market segmented into North America, Europe, Asia Pacific, South America, and Middle East & Africa. The Asia Pacific is the world’s fastest-growing global high potency active pharmaceutical ingredients market, accounting for the largest share. It is mainly due to an emerging focal point on contract manufacturing and contract research organizations. It helps reduce labor costs, well-equipped manufacturing plants, and favorable foreign exchange policies in countries.
Companies such as Lonza, Novartis International AG, BASF AG, Carbogen Amcis AG, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd Bristol-Myers Squibb, Pfizer Inc., Roche Diagnostics., Hospira Inc, Boehringer Ingelheim, Covidien Plc, Merck & Co, Bayer AG, Sigma-Aldrich Corporation, Sanofi Aventis and others are key players in the global high potency active pharmaceutical ingredients market.
By Drug Type