Global High Potency Active Pharmaceutical Ingredients Market: Growing Demand for Targeted Therapeutics to Boost Market Growth at 7.8% CAGR

High potency active pharmaceutical ingredients, better known as HPAPI, are extensively used in targeted therapeutics and deliver effective treatment even at low concentration. The global HPAPI market has been growing rapidly with increasing prevalence of cancer, diabetes, and cardiovascular diseases. The overall market was worth US$12.6 bn in 2014. Expanding at an estimated CAGR of 7.8% during the period between 2015 and 2023, the global HPAPI market is projected to be valued at US$25.1 bn by 2023. 


Lately, targeted therapeutics has gained high acceptance among the medical fraternity for critical conditions and this has significantly boosted the global HPAPI market. However, the high cost of development of HPAPI, along with the requirement of advanced technological expertise, has restrained the overall market.


Rising Cost of Drug Development Leads HPAPI Manufacturers to Outsource Production 


On the basis of type of HPAPI, the global HPAPI market has been categorized into biological and synthetic. As mimicking biological drugs is challenging and requires advanced technological expertise, synthetic high potency active pharmaceutical ingredients are mostly manufactured by pharmaceutical companies.


In terms of type of manufacturer, the global HPAPI market has been dominated by captive or in-house manufacturers to avoid risk of patent infringement. However, the increasing cost of drug development and commercialization have led pharmaceutical companies to outsource HPAPI manufacturing. The developing regulatory and legal framework has proved outsourcing to be the most optimal option for HPAPI manufacturing. In the near future, the trend for outsourcing HPAPI production to contract or third party manufacturers is expected to catch up. 


According to type of drug, the global HPAPI market has been segmented into branded and generic drugs. The demand for branded drugs has been significantly high especially for therapeutic areas such as oncology.


Oncology Drugs Segment to Dominate Global High Potency Active Pharmaceutical Ingredients Market


On the basis of therapeutic area, the global HPAPI market has been categorized into anti-diabetic drugs, cardiovascular drugs, oncology drugs, musculoskeletal drugs, central nervous system drugs, and others. Oncology drugs segment accounts for a market share of over 50% and is the fastest growing segment. Approval of innovative drugs with targeted therapy is expected to further propel the growth of the segment in the coming years. Synagis (palivizumab), Avastin (bevacizumab), Herceptin (trastuzumab), Humira (adalimumab), Erbitux (cetuximab), Remicade (infliximab), and Rituxan (rituximab) are some of the major drugs going off patent in the next couple of years. Patent expiry of some of these major cancer drugs would create new opportunities for contract manufacturing organizations (CMO) and generic drug manufacturers.


Key Regions in Global High Potency Active Pharmaceutical Ingredients Market


The global HPAPI market has been segmented into five key regions: Europe, North America, Asia Pacific, Middle East & Africa, and Latin America. Pharmaceutical firms located in North America and Europe have invested extensively in production of HPAPI and hence, the HPAPI market in these regions has grown significantly. However, rapid growth of contract manufacturing organizations in Asia Pacific will boost the regional HPAPI market. 


Prominent Players in Global High Potency Active Pharmaceutical Ingredients Market


The global HPAPI market has been dominated by a few players as mimicking biological drugs is a challenging task. There are no standardized or regulatory process policies in the market and hence, there is little guidance available for new entrants. Market players are trying to gain technological expertise and are building assets. Some of the prominent players operating in the global HPAPI market are Lonza Group, Pfizer Inc., Novasep, Alkermes plc, Dr. Reddy’s Laboratories, Cambrex Corporation, Sandoz International GmbH, Wuxi App Tec, and Sigma-Aldrich Co. LLC. 


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