High Potency Active Pharmaceutical Ingredient (HPAPI) Market Size, Share, Growth, Trends, Consumption, Revenue, Company Analysis, Regional Insights and Forecast 2020-2027

Published Date : Nov 2020 | No. of Pages : 200 Pages | Category : Healthcare

According to Vision Research Reports, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market size surpassed at US$ 17.60 Bn in 2019 and is expected to grow at a CAGR of over 8.8% from 2020 to 2027.

Global High Potency Active Pharmaceutical Ingredients (HPAPI) market size is projected to surpass around US$ 37 billion by 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.

Overview

  • High-potency active pharmaceutical ingredients (HPAPIs) are a niche but growing area for pharmaceutical manufacturers and contract manufacturing organizations (CMOs). Specialized considerations in facility design, equipment, operation, and process safety are needed to achieve the desired level of containment of the drug substance or finished-drug product. For drug-substance manufacturing, the HPAPI may be a small-molecule, biologic, or a hybrid of the two such as an antibody–drug conjugate, which links a cytotoxic small-molecule to a monoclonal antibody.
  • High potency active pharmaceutical ingredients (HPAPI) form a significant proportion of new drugs under development. Production of HPAPI presents various challenges due to its cytotoxic nature; thus, it requires heavy investment to ensure safe environment for employees. Contract manufacturing of HPAPI has been preferred over captive production due to high degree of competition and reduced profitability. Contract manufacturing is also preferred due to geographical advantage and cost-effectiveness.
  • North America dominate the global High Potency Active Pharmaceutical Ingredients (HPAPI) market in 2019 and the trend is anticipated to continue during the forecast period. High demand for biological HPAPI, technological development in the pharmaceutical industry, and large number of manufacturing facilities are major factors driving the market growth in these regions.
  • Asia Pacific is likely to be a highly lucrative region for the High Potency Active Pharmaceutical Ingredients (HPAPI) market and is expected to expand at a high CAGR during the forecast period due to rising focus on contract manufacturing and contract research organizations. Low labor cost, well-equipped manufacturing plants, and favorable foreign exchange policies in countries such as China have created lucrative opportunities for outsourcing businesses. Additionally, pharmaceutical manufacturers are currently focusing on countries in Latin America for contract manufacturing.

Growing preference for outsourcing of HPAPI manufacturing and Patent expiry of blockbuster drugs to Drive Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

  • 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.
  • 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 biosimilars 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 biosimilars 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.

Synthetic Segment to Dominate High Potency Active Pharmaceutical Ingredients (HPAPI) Market

  • In terms of API type, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been segmented into Synthetic, Biological.
  • Synthetic segment dominated the global High Potency Active Pharmaceutical Ingredients (HPAPI) market in 2018 and the trend is projected to continue during the forecast period. Numerous drugs consisting synthetic HPAPI are slated to go off patent in the near future. This would unlock a huge market opportunity for generic drug manufacturers, resulting in augmented demand for synthetic HPAPIs.
  • Majority of the biologics are manufactured in-house due to intellectual property concerns and quality issues. However, the manufacture of biological HPAPIs is becoming an increasingly complex and challenging process. Hence, innovator companies are outsourcing to contract manufacturers with biological production expertise.

Captive Segment Hold a Major Share of Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

  • In terms of manufacture type, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been classified into captive and contract
  • The captive segment is likely to dominate the High Potency Active Pharmaceutical Ingredients (HPAPI) market during the forecast period. High potency active pharmaceutical ingredients (APIs) are manufactured either in-house (captive) by the innovator/formulator company, or outsourced to contract manufacturing organizations. In-house or captive facility is preferred by most companies in case of exclusive drugs or when the production is limited to a specific geography.

Branded Segment to Dominate Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

  • Based on drug type, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been segmented into branded and generic
  • Branded HPAPIs, which account for the larger share of the global HPAPI market, are expected to witness continued growth, albeit at a slower pace than the generic HPAPIs market

Oncology drugs Segment to Dominate Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

  • Based on therapeutic application, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been segmented into oncology drugs, anti-diabetic drugs, cardiovascular drugs, CNS drugs, musculoskeletal drugs and other drugs
  • The oncology drugs segment witnessed a steep rise in the introduction of innovative therapeutic options. Antibody-drug conjugates, monoclonal antibodies, and cytotoxic drugs account for the largest share and are considered to be the key drivers of the high potency active pharmaceutical ingredients (HPAPI) market. Patent expiry of blockbuster drugs such as Herceptin, Humira, and Rituxan has unlocked immense opportunities for generic HPAPI manufacturers.

North America to Dominate Global High Potency Active Pharmaceutical Ingredients (HPAPI) Market

  • In terms of region, the global High Potency Active Pharmaceutical Ingredients (HPAPI) market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global High Potency Active Pharmaceutical Ingredients (HPAPI) market in 2019, followed by Europe.
  • North America accounted for major share of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market in 2018. Demand for biological HPAPIs is high in North America, as technological developments in the pharmaceutical industry are paving the way for newer biotechnology drugs. Furthermore, biologics have replaced synthetic drugs as the top selling drugs in North America. Leading pharmaceutical companies also own manufacturing facilities in the region.
  •  The High Potency Active Pharmaceutical Ingredients (HPAPI) market in Asia Pacific is anticipated to expand at a high CAGR from 2019 to 2027. Well-equipped manufacturing plants, low labor costs, and favorable foreign exchange policies are the major factors driving outsourcing business to Asia Pacific.

Competitive Landscape

  • The global High Potency Active Pharmaceutical Ingredients (HPAPI) market is fragmented in terms of number of players. Key players in the global High Potency Active Pharmaceutical Ingredients (HPAPI) market include 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.  

Market Segmentation

By API Type

    • Synthetic
    • Biological

By Manufacture Type

    • Captive
    • Contract

By Drug Type

    • Branded
    • Generic

By Therapeutic Application

    • Oncology Drugs
    • Anti-diabetic Drugs
    • Cardiovascular Drugs
    • CNS Drugs
    • Musculoskeletal Drugs
    • Other Drugs

By Region

    • North America
      • U.S.
      • Canada
    • Europe
      • Germany
      • U.K.
      • France
      • Italy
      • Spain
      • Rest of Europe
    • Asia Pacific          
      • China
      • India
      • Japan
      • 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

Report Scope

VRR’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 2020 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

  • 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 VRR 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 VRR’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 VRR’s estimates on future prospects of the global High Potency Active Pharmaceutical Ingredients (HPAPI) market more reliably and accurately.


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