High Potency Active Pharmaceutical Ingredient Market - Global Segments and Forecasts up to 2023: Transparency Market Research

The Global high potency active pharmaceutical ingredients (HPAPI) market was valued at US$12.6 bn in 2014 and is projected to reach US$25.1 bn by 2023 at a CAGR of 7.8% from 2015 to 2023.

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High potency active pharmaceutical ingredients are used in targeted therapeutics and show effective treatment even at extremely low concentration. These APIs are difficult to manufacture and require technological expertise and sophisticated manufacturing setup. HPAPI market currently accounts for a small portion of overall API market, however is a rapidly growing segment. The global high potency active pharmaceutical ingredients (HPAPI) market is a major therapeutic area covering oncology, anti-diabetic, cardiovascular, central nervous system, musculoskeletal and others. Oncology leads the market with more than 50% market share and is also the fastest growing segment. This segment is also expected to witness approval of innovative drugs with targeted therapy in the near future. Furthermore, patent expiry of blockbuster cancer drugs would create new opportunities for generic drug manufacturers and contract manufacturing organizations (CMOs). Avastin (bevacizumab), Herceptin (trastuzumab), Synagis (palivizumab), Erbitux (cetuximab), Humira (adalimumab), Remicade (infliximab), and Rituxan (rituximab) are some of the major drugs going off patent in the near future. In spite of the anticipated steep patent cliff, global branded HPAPI market would still lead throughout the forecast period.

Majority of the high potency API manufacturing is confined to captive production to avoid risk of patent infringement. 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. Hence trend for outsourcing HPAPI production is expected to grow rapidly in the near future.

Mimicking biological drugs is a challenging task, and technology and ability for cost effective and high quality HPAPI lies in the hands of few major players. Furthermore, as no regulatory and standardized process policy exists, there is a little guidance available for new entrants. CMOs across the globe are trying to gain technological expertise and are building assets and become ready for lucrative HPAPI market. Key players in the market include Alkermes plc, Cambrex Corporation, Dr. Reddy's Laboratories, Lonza Group, Novasep, Sandoz International GmbH, Pfizer, Inc., Sigma-Aldrich Co. LLC., WuXi AppTec.

Global HPAPI market has been segmented as below:
Global HPAPI Market, by Type of HPAPI
Synthetic
Biological

Global HPAPI Market, by Type of Manufacturer
Captive or In-house HPAPI manufacturers
Contract or Third Party HPAPI manufacturer

Global HPAPI Market, by Type of Drug
Branded
Generic

Global HPAPI Market, by Therapeutic Area
Oncology Drugs
Anti-diabetic Drugs
Cardiovascular Drugs
Central Nervous System Drugs
Musculoskeletal Drugs
Other Drugs

Global HPAPI Market, by Geography
Introduction
North America
U.S.
Canada

Europe
U.K.
Germany
Rest of Europe

Asia Pacific
Japan
China
Rest of Asia Pacific

Latin America
Brazil
Rest of Latin America

Middle East & Africa
GCC Countries
Rest of Middle East and Africa

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