High Potency Active Pharmaceutical Ingredient (HPAPI) Market: Synthetic Segment to Dominate the Global Market

According to Transparency Market Research’s latest report on the global High Potency Active Pharmaceutical Ingredients (HPAPI) market for the historical period 2017–2018 and forecast period 2019–2027, growing preference for outsourcing of HPAPI manufacturing and rich pipeline with targeted therapeutic drugs are the factors likely to boost the growth of High Potency Active Pharmaceutical Ingredients (HPAPI) market. However, containment of technical expertise in the hands of few major players and lack of universal regulatory policies and standards is poised to escalate the growth of High Potency Active Pharmaceutical Ingredients (HPAPI) market.

According to the report, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market was valued at US$ 17.45 Bn in 2018 and is anticipated to expand at a CAGR of over 8.7% from 2019 to 2027

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Growing preference for outsourcing of HPAPI manufacturing and rich pipeline with targeted therapeutic drugs: Key Drivers of Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

  • Pharmaceutical companies were skeptical in outsourcing manufacture of high potency APIs, and majority of the manufacturing was confined to captive or in-house. Major factor behind this was risk of patent infringement. However, as 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.
  • Pharmaceutical companies can now focus on core business activities such as drug development and commercialization, while also take advantage of technical expertise at CMOs instead of investing in expensive HPAPI manufacturing setup.

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  • Pharmaceutical companies have made significant investments in development of innovative drugs with targeted mode of action. Specific action and little or no side effects are major advantages for preference of such drugs. Various research articles published suggest that over 25% of the drugs in pipeline incorporate high potency active pharmaceutical ingredient (HPAPI). Currently only two antibody-drug conjugated drugs have been approved: Adcertis (Brentuximab vedotin) and Kadcyla (Trastuzumab emtansine). There are two other late stage candidates Inotuzumab ozogamicin (by, Pfizer) and IMMU-107 (by, Immunomedics). Several monoclonal antibody drugs are also expected to hit the market in the near future. Palivizumab, ofatumumab, KW-0761, and pembrolizumab are only a few examples of monoclonal antibody drugs in phase 3.
  • With increasing number of potential phase 3 drug candidates, demand for contract manufacturing of HPAPIs has increased significantly in the recent past, and is one of the major drivers of the global HPAPI market.

Patent Expiry of Blockbuster Drugs Propel Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market Growth

  • Patent expiry and subsequent launch of generic versions is a lucrative opportunity for pharmaceutical companies to expand product portfolio and tap profitable market segments in this technology driven market. Various biosimilar have been approved in Europe, while the U.S. FDA has approved only one biosimilar to date. Increase in research and development activities and constant attempts toward mimicking branded biological drugs would pave the way for introduction of cost-effective treatment alternatives.
  • Various blockbuster drugs are expected to loose patent protection in the near future, providing large opportunities in the biosimilar market. 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.

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Containment of Technical Expertise in the Hands of Few Major Players to Hamper Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

  • High potency API manufacturing is capital intensive and requires skilled technical know-how; this has been a major barrier for new entrants who wish to tap the lucrative HPAPI market. Currently, few major players exist who have built their own capabilities through mergers, acquisitions, partnerships, and research and development.
  • Hence, the global HPAPI manufacturing market is leaning toward consolidation of expertise in the hands of few global players. Lonza, Novasep, SAFC, Cambrex, Teva API, Dr. Reddy’s Laboratories, and WuXi are key players in the HPAPI market.

Lack of Universal Regulatory Policies and Standards to Restrain Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

  • The high potency API market is a rapidly growing market with large numbers of players looking to invest in building capabilities for manufacturing of HPAPIs. HPAPIs are highly toxic to human body. Hence, high level of care is taken during manufacturing of these compounds. Despite these complications, there does not exist any specific occupational health, safety, and environmental protection regulations that cover manufacturing of HPAPIs.
  • Private organizations such as Merck, Lonza, and SafeBridge have taken initiative to classify HPAPIs and (occupational exposure limits) OELs. However, CMOs need to maintain manufacturing standards as per client requirements due to lack of a universal guidelines. Introduction of universal guidelines and manufacturing policies would also provide credibility to CMOs, thus helping pharmaceutical companies in outsourcing business.

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Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market: Competitive Landscape

This report profiles major players in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments

The global High Potency Active Pharmaceutical Ingredients (HPAPI) market is highly fragmented, with the presence of a number of international as well as regional players

Leading players operating in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market are

  • Alkermes plc
  • Cambrex Corporation
  • Dr. Reddy's Laboratories
  • Lonza Group
  • Novasep
  • Novartis AG
  • Pfizer
  • Sigma-Aldrich Co. LLC.
  • WuXi AppTec
  • Bristol-Myers Squibb
  • F. Hoffmann-La Roche
  • Teva Pharmaceutical Industries
  • Eli Lilly and Company
  • Abbvie.

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