High potency active pharmaceutical ingredients (HPAPIs) are small-molecule, biologic, or hybrids of antibody–drug conjugates, which link a cytotoxic small-molecule to a monoclonal antibody. Demand for high potency active pharmaceutical ingredients (HPAPIs) is rapidly increasing due to its ability to target diseased cells more precisely and selectively than other APIs and is regarded as a relatively more efficient treatment for cancer and chronic diseases such as diabetes and heart diseases, worldwide. According to estimates from the International Agency for Research on Cancer (IARC), in 2012, 14.1 million new cancer cases and 8.2 million cancer deaths were recorded worldwide. This global burden of cancer is expected to account for 21.7 million new cancer cases and cause 13 million deaths by 2030.
High Potency Active Pharmaceutical Ingredients Market Taxonomy
By Synthesis Route
By Drug Type
By Manufacturer Type
By Therapeutic Applications
Growing demand for Antibody Drug Conjugates (ADC) is expected to augment market growth
High potency active pharmaceutical ingredients is considered as a growing area for pharmaceutical manufacturers and contract manufacturing organizations (CMOs) with much R&D focusing on more specialized medicines especially in the field of oncology. According to IMS institute of healthcare informatics, 2016, 586 drugs are under development for oncology treatment, with over 70 new cancer treatments (for over 20 tumor types), entering the market over the past five years (2010-2015). HPAPIs are also increasingly being used in the form of Antibody Drug Conjugates (ADCs), which is an important and effective breakthrough in cancer treatment. However, high capital costs associated with the specialized containment technology required to protect both employees and the environment, as well as lack of harmonization in GMP regulations preventing cross contamination in some countries may hamper growth of the high potency active pharmaceutical ingredients market.
Increasing investment in research and development by manufacturers is expected to propel high potency active pharmaceutical ingredients market growth
Increasing number of major pharmaceutical companies are continuously focusing on expansion of their product line in HPAPIs or considering investing in new HPAPIs production facilities, further outsourcing the manufacturing of HPAPIs to contract manufacturers. This in turn will increase the benefits from the latter’s competency and expertise, as captive manufacturing of HPAPIs is expensive and requires stringent safety and handling specifications. This is thus expected to boost growth of the high potency active pharmaceutical ingredients market. The outsourcing of HPAPIs manufacturing is increasing in India, China, and Eastern European countries due to the low cost of manufacturing as compared to North America and Western Europe regions. For instance, in Oct 2017, Piramal Pharma Solutions (PPS), a contract development and manufacturing organization invested US$ 55 million across its sites in Asia, to expand its API manufacturing capabilities and capacities. Furthermore, companies such as Evonik and Lonza are actively involved in providing contract manufacturing services to other companies.
Among regions, North America holds the largest market share, followed by Europe in the global high potency active pharmaceutical ingredients market. The dominance of this region is due to high prevalence rate of cancer in the region, which in turn is increasing the potential of oncology drugs. For instance, according to an American Cancer Society estimations, 2017, 1,688,780 people are estimated to be diagnosed with cancer and 600,920 cancer deaths are estimated to occur in the US. Furthermore, increasing incidence of age related diseases associated with changing lifestyle and eating habits is also expected to boost growth of the high potency active pharmaceutical ingredients market. As the nature and extents of HPAPIs is different for the ageing population than that for a younger population thus, HPAPIs have become a mitigating factor in reducing the disease burden especially in geriatric population. According to the U.S. census bureau, 2014, 46.2 million people aged 65 years and above, accounted for 14.5% of the total population, which is projected to be 98.2 million by 2060. Moreover, market in Asia Pacific is also gaining significant traction, owing to growing API manufacturing sectors in countries such as China and India, due to expansion of low cost manufacturing facilities by manufacturers/CMOs to produce generic HPAPIs.
Key players in the high potency active pharmaceutical ingredients market include Lonza, Novartis International AG, BASF AG, Carbogen Amcis AG, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd Bristol-Myers Squibb, Pfizer Inc., Roche Diagnostics., Boehringer Ingelheim, Covidien Plc, Merck & Co, Bayer AG, Sigma-Aldrich Corporation, and Sanofi Aventis.
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