• 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
fa global high potency active pharmaceutical ingredients market

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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.
  • 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.

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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.

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.

Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market: Key Developments

Key players in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market are engaged in regulatory approvals, technologically advanced products, launch of new products, and acquisition & collaborative agreements with other companies. These strategies are likely to fuel the growth of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market. A few expansion strategies adopted by players operating in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market are:

  • In April 2019, U.S. based Cambrex Corporation expanded its new facility high-potency API production in U.S.
  • In 2018, FDA approved 59 drugs, of that 42 were small molecules and 17 were biologics which accounts to about 28.8% of total approvals which has risen from 26.1% from the year 2017. Few biologic drugs approved in 2018 are Trogarzo, Ilumya, Crysvita, Aimovig, Poteligeo, Emgality, Libtayo and Takyzyro.

The report on the global High Potency Active Pharmaceutical Ingredients (HPAPI) market discussed individual strategies, followed by company profiles of manufacturers of High Potency Active Pharmaceutical Ingredients. The competitive landscape section has been included in the report to provide readers with a dashboard view and a company market share analysis of key players operating in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market

TMR’s report on the global High Potency Active Pharmaceutical Ingredients (HPAPI) market studies past as well as current growth trends and opportunities to gain valuable insights of these indicators of the market during the forecast period from 2019 to 2027. The report provides revenue of the global High Potency Active Pharmaceutical Ingredients (HPAPI) Market for the period 2017–2027, considering 2018 as the base year and 2027 as the forecast year. The report also provides the compound annual growth rate (CAGR) for the global High Potency Active Pharmaceutical Ingredients (HPAPI) Market during the forecast period.

The report has been prepared after an extensive primary and secondary research. Primary research involved bulk of research efforts, wherein analysts carried out interviews with industry leaders and opinion makers. Extensive secondary research involved referring to key players’ product literature, annual reports, press releases, and relevant documents to understand the global High Potency Active Pharmaceutical Ingredients (HPAPI) market.

Secondary research also included Internet sources, statistical data from government agencies, websites, company presentations, sales data, and trade associations. Analysts have employed a combination of top-down and bottom-up approaches to study various phenomenon in the global High Potency Active Pharmaceutical Ingredients (HPAPI) Market.

The report includes an elaborate executive summary, along with a snapshot of the growth behavior of various segments included in the scope of the study. Furthermore, the report sheds light on the changing competitive dynamics in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market. These indices serve as valuable tools for existing market players as well as for entities interested in entering the global High Potency Active Pharmaceutical Ingredients (HPAPI) market.

The report delves into the competitive landscape of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market. Key players operating in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market have been identified, and each one of these has been profiled for distinguishing business attributes. Company overview, financial standings, recent developments, and SWOT are some of the attributes of players in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market that have been profiled in this report.          

Key Questions Answered in Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market Report

  • What is the scope of growth for product companies in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market?
  • What will be the Y-o-Y growth of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market between 2019 and 2027?
  • What is the influence of changing trends in technologies on the global High Potency Active Pharmaceutical Ingredients (HPAPI) market?
  • Will North America continue to be the most profitable market for High Potency Active Pharmaceutical Ingredients (HPAPI) providers?
  • Which factors are anticipated to hamper the growth of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market during the forecast period?
  • Which are the leading companies in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market?

Research Methodology

A unique research methodology has been utilized by TMR to conduct comprehensive research on the growth of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market and arrive at conclusions on its growth prospects. This research methodology is a combination of primary and secondary research, which helps analysts warrant the accuracy and reliability of the drawn conclusions.

Secondary research sources referred to by analysts during the production of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market report include statistics from company annual reports, SEC filings, company websites, investor presentations, regulatory databases, government publications, and industry white papers. Analysts have also interviewed senior managers, product portfolio managers, CEOs, VPs, and market intelligence managers, who contributed to the production of TMR’s study on the High Potency Active Pharmaceutical Ingredients (HPAPI) market as primary methods.

These primary research respondents have provided exclusive information during interviews, which serves as a validation from the High Potency Active Pharmaceutical Ingredients (HPAPI) market leaders. Access to an extensive internal repository and external proprietary databases enabled this report to address specific details and questions about the global High Potency Active Pharmaceutical Ingredients (HPAPI) market with accuracy. The study also uses the top-down approach to assess the revenues for each segment and the bottom-up approach to counter-validate them. This has helped in reaching TMR’s estimates on future prospects of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market more reliably and accurately.

Regional Segmentation of High Potency Active Pharmaceutical Ingredients (HPAPI) market

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • Australia & New Zealand
    • Rest of Asia Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest of Latin America
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Rest of Middle East & Africa

Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market – Segmentation

API Type

Synthetic

Biological

Manufacture Type

Captive

Contract

Drug Type

Branded

Generic

Therapeutic Application

Oncology Drugs

Anti-diabetic Drugs

Cardiovascular Drugs

Academic & Research Centers

Pharmaceutical Companies

Others

Region

North America

Europe

Asia Pacific

Latin America

Middle East & Africa

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