Global High Potency Active Pharmaceutical Ingredients Market

Global High Potency Active Pharmaceutical Ingredients Market- By Product (Synthetic, Biotech), By Manufacturer (In-house, Outsourced), By Drug Type (Innovative, Generic), By Application (Oncology, Hormonal, Glaucoma, Others), and By Region (North America, Europe, Asia Pacific, South America, and Middle East, & Africa)- Global forecast from 2020-2027.

Global High Potency Active Pharmaceutical Ingredients Market Overview:

High-potency active pharmaceutical ingredients (HPAPIs) is a cranny yet opportunistic area for contract manufacturing organizations (CMOS) and pharmaceutical manufacturers. Specialized considerations in equipment, facility design, operation, and process safety are needed to achieve the desired level of containment of the drug substance or finished-drug product.

Global High Potency Active Pharmaceutical Ingredients Market Insights

The global high potency active pharmaceutical ingredients market expected to increase market value by USD 30.52 billion with exponential CAGR in the forecast period from 2020-2027. The market demand for high potency active pharmaceutical ingredients is growing due to the lower clinical dosage, and fewer side effects of HP API drugs have attracted market attention in recent years. It has become a research and development hotspot.

API is a critical link in pharmaceutical production and is closely related to public health. And specific APIs are different from batch APIs. They have reliable growth attributes, high customer stickiness, and non-standard characteristics.

High-efficiency APIs (HPAPI), intermediates, and finished dosage forms require specialized facility design, equipment, operation, and process safety throughout the drug development process and commercial-scale production to achieve the necessary level of control and ensure operator safety. As a result, HPAPIs increasingly outsourced to professional contract development and production organizations (CDMOs) with such infrastructure, expertise, and tracking opportunities.

Moreover, in recent years, with the increasing number of patented drug varieties due to patent expiration, the type and number of generic drugs have risen rapidly, which has brought substantial market opportunities to the API market, and the output of APIs has continued to increase.

Growth Driver

Emerging Contract Manufacturing

High potency active pharmaceutical ingredients (HPAPI) construct a notable proportion of new drugs under development. Production of HPAPI involves various challenges due to its cytotoxic nature. Therefore, it requires a substantial investment to ensure a safe environment for employees. Contract manufacturing of HPAPI has preferred over captive production due to the reduced profitability and high degree of competition. Contract manufacturing is also preferred due to cost-effectiveness and geographical advantage.

Rising Incidence of Cancer

The rising incidence of cancer and its side effects related to chemotherapy also affect noncancerous cells. Hence targeted therapy approach is gaining popularity as it does not harm noncancerous cells. HP API also used in ADC drugs. ADC is a new variety formed by combining monoclonal antibodies for cancer treatment with highly effective biologically active ingredients. The highly active toxic components of HP API selectively delivered to specific tumor cells through monoclonal antibodies. Treatments that physically attack cancer cells protect non-cancer cells from toxic damage.

By Product Segmental Analysis

Based on the product, the global high potency active pharmaceutical ingredients market is bifurcated into Synthetic, Biotech. The biotech segment estimated to dominate the maximum share of the global high potency active pharmaceutical ingredients market. It is mainly due to the changing preference of consumers shifting from synthetic to biotech molecules as it penetrates a higher rate of biologics. Also, biotech HPAPI mainly consists of drug molecules obtained after usage of molecular techniques such as recombinant DNA technology. The genes expressing these molecules transferred into an expression vector for the synthesis of the higher amount of drug molecule in less time.

By Manufacturer Segmental Analysis

Based on the manufacturer, the global high potency active pharmaceutical ingredients market classified into In-house, Outsourced. The in-house segment dominated the largest market share in the global high potency active pharmaceutical ingredients market. It is mainly due to the increased availability of raw material, and the high-end manufacturing facility is investing high capitalization in developing in-house capabilities and specialized requirements.

By Drug Type Segmental Analysis

Based on drug type, the global high potency active pharmaceutical ingredients market segmented into Innovative, Generic. The Innovative segment holds the largest share in the global high potency active pharmaceutical ingredients market. It is mainly due to the rising research and development of the novel drug that drives the market share for high potency active pharmaceutical ingredients. Moreover, an increasing amount of funding and favorable regulations are fueling the market growth for developing the innovative drug. The expiry of the branded drug molecules is bolstering the adoption of the innovative medicine in global high potency active pharmaceutical ingredients market.

By Application Segmental Analysis

Based on the application, the global high potency active pharmaceutical ingredients market categorized into Oncology, Hormonal, Glaucoma, Others. Oncology dominates the largest end-use segment in the global high potency active pharmaceutical ingredients market in the forecast period from 2020-2027. HPAPI is widely used in drug therapy, commonly used in cancer treatment such as breast cancer. At present, more and more pharmaceutical products contain HPAPI, which has scientifically proved to be more effective than traditional API at lower dose levels. The small-molecule targeted drugs and ADC in HPAPI mainly treat cancer. Compared with conventional chemotherapy, targeted therapy does not damage healthy cells and has fewer side effects, making it more widespread.

By Region Segmental Analysis

Based on geography, the global high potency active pharmaceutical ingredients market segmented into North America, Europe, Asia Pacific, South America, and Middle East & Africa. The Asia Pacific is the world’s fastest-growing global high potency active pharmaceutical ingredients market, accounting for the largest share. It is mainly due to an emerging focal point on contract manufacturing and contract research organizations. It helps reduce labor costs, well-equipped manufacturing plants, and favorable foreign exchange policies in countries.

Competitor Analysis

Companies such as Lonza, Novartis International AG, BASF AG, Carbogen Amcis AG, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd Bristol-Myers Squibb, Pfizer Inc., Roche Diagnostics., Hospira Inc, Boehringer Ingelheim, Covidien Plc, Merck & Co, Bayer AG, Sigma-Aldrich Corporation, Sanofi Aventis and others are key players in the global high potency active pharmaceutical ingredients market.

Key Stakeholders                                     

  • Market research and consulting firms
  • Industry associations
  • Global high potency active pharmaceutical ingredients manufacturing companies
  • Research organizations and consulting companies’ high potency active pharmaceutical ingredients
  • Regulatory bodies

The objective of the Research

  • Market modeling starts with identifying a target market where historical data exists. A Market can include prediction problems, economic factors, analyzing customer behavior, and identifying new patterns from past events, which helps our client to have deep dive into the market.
  • Product analysis involves steps such as examining product features, costs, availability, quality, and other aspects. Product analysis is conducted to understand potential buyers and measure competition in the market.
  • Market Trend and Economic Factors Analysis helps in assessing potential changes to an economy’s inflation rate, taxes, interest rates, exchange rates, trading regulations, and excise duties that can or have a major effect on the target market.
  • Market Segmental Analysis defines in-depth scenario of the target market by the process of grouping consumers into naturally existing created segments of consumers who share similar product preferences or characteristics
  • The geographical mapping approach helps our clients to understand national or international markets because different consumers in different regions have different needs wants, and cultural characteristics that can be specifically targeted.

Market Modelling

By Product

  • Synthetic
  • Biotech

By Manufacturer       

  • In-house
  • Outsourced

By Drug Type

  • Innovative
  • Generic

By Application

  • Oncology
  • Hormonal
  • Glaucoma
  • Others

By Region

  • Europe
  • North America
  • Asia Pacific
  • South America
  • Middle East & Africa

Global High Potency Active Pharmaceutical Ingredients Market

Report Content

  1. Research Strategic Development
    • Market Modelling
    • Product Analysis
    • Market Trend and Economic Factors Analysis
    • Market Segmental Analysis
    • Geographical Mapping
    • Country Wise Segregation
  2. Research Methodology
    • Identification of Target Market
    • Data Acquisition
    • Refining of Data/ Data Transformations
    • Data Validation through Primary Techniques
    • Exploratory Data Analysis
    • Graphical Techniques/Analysis
    • Quantitative Techniques/Analysis
    • Visual Result/Presentation
  3. Executive Summary
  4. Market Insights
    • Economic Factor Analysis
      • Drivers
      • Trends
      • Opportunities
      • Challenges
    • Competitors & Product Analysis
    • Regulatory Framework
    • Company market share analysis, 2019
    • Porter’s Five forces analysis
    • New Investment Analysis
    • PESTEL Analysis
  5. Global High Potency Active Pharmaceutical Ingredients Market Overview
    • Market Size & Forecast, 2016-2027
      • Demand
        • By Value (USD Million)
      • Market Share & Forecast, 2016-2027
        • By Product
          • Synthetic
          • Biotech
        • By Manufacturer
          • In-house
          • Outsourced
        • By Drug Type
          • Innovative
          • Generic
        • By Application
          • Oncology
          • Hormonal
          • Glaucoma
          • Others
        • By Region
          • Europe
          • North America
          • Asia Pacific
          • South America
          • Middle East & Africa
  1. Europe High Potency Active Pharmaceutical Ingredients Market Overview
    • Europe High Potency Active Pharmaceutical Ingredients Market Size & Forecast, 2016-2027
      • Demand
        • By Value (USD Million)
      • Europe High Potency Active Pharmaceutical Ingredients Market Share & Forecast, 2016-2027
        • By Product
          • Synthetic
          • Biotech
        • By Manufacturer
          • In-house
          • Outsourced
        • By Drug Type
          • Innovative
          • Generic
        • By Application
          • Oncology
          • Hormonal
          • Glaucoma
          • Others
        • By Country
          • Germany
          • UK
          • France
          • Italy
          • Rest of Europe
        • Company Market Share (Top 3-5)
        • Economic Impact Study on Europe High Potency Active Pharmaceutical Ingredients Market
  1. North America High Potency Active Pharmaceutical Ingredients Market Overview
    • North America High Potency Active Pharmaceutical Ingredients Market Size & Forecast, 2016-2027
      • Demand
        • By Value (USD Million)
      • North America High Potency Active Pharmaceutical Ingredients Market Share & Forecast, 2016-2027
        • By Product
          • Synthetic
          • Biotech
        • By Manufacturer
          • In-house
          • Outsourced
        • By Drug Type
          • Innovative
          • Generic
        • By Application
          • Oncology
          • Hormonal
          • Glaucoma
          • Others
        • By Country
          • US
          • Canada
          • Mexico
        • Company Market Share (Top 3-5)
        • Economic Impact Study on North America High Potency Active Pharmaceutical Ingredients Market
  1. Asia Pacific High Potency Active Pharmaceutical Ingredients Market Overview
    • Asia Pacific High Potency Active Pharmaceutical Ingredients Market Size & Forecast, 2016-2027
      • Demand
        • By Value (USD Million)
      • Asia Pacific High Potency Active Pharmaceutical Ingredients Market Share & Forecast, 2016-2027
        • By Product
          • Synthetic
          • Biotech
        • By Manufacturer
          • In-house
          • Outsourced
        • By Drug Type
          • Innovative
          • Generic
        • By Application
          • Oncology
          • Hormonal
          • Glaucoma
          • Others
        • By Country
          • China
          • India
          • Japan
          • Australia
          • Rest of Asia Pacific
        • Company Market Share (Top 3-5)
        • Economic High Potency Active Pharmaceutical Ingredients Market Overview
      • South America High Potency Active Pharmaceutical Ingredients Market Size & Forecast, 2016-2027
        • Demand
          • By Value (USD Million)
        • South America High Potency Active Pharmaceutical Ingredients Market Share & Forecast, 2016-2027
          • By Product
            • Synthetic
            • Biotech
          • By Manufacturer
            • In-house
            • Outsourced
          • By Drug Type
            • Innovative
            • Generic
          • By Application
            • Oncology
            • Hormonal
            • Glaucoma
            • Others
          • By Country
            • Brazil
            • Argentina
            • Rest of South America
          • Company Market Share (Top 3-5)
          • Economic Impact Study on South America High Potency Active Pharmaceutical Ingredients Market
  1. Middle East & Africa High Potency Active Pharmaceutical Ingredients Market Overview
    • Middle East & Africa High Potency Active Pharmaceutical Ingredients Market Size & Forecast, 2016-2027
      • Demand
        • By Value (USD Million)
      • Middle East & Africa High Potency Active Pharmaceutical Ingredients Market Share & Forecast, 2016-2027
        • By Product
          • Synthetic
          • Biotech
        • By Manufacturer
          • In-house
          • Outsourced
        • By Drug Type
          • Innovative
          • Generic
        • By Application
          • Oncology
          • Hormonal
          • Glaucoma
          • Others
        • By Country
          • Saudi Arabia
          • UAE
          • South Africa
          • Rest of Middle East & Africa
        • Company Market Share (Top 3-5)
        • Economic Impact Study on Middle East & Africa High Potency Active Pharmaceutical Ingredients Market
  1. Competitor Analysis
    • Company Description
    • Financial Analysis
    • Key Products
    • Key Management Personnel
    • Contact Address
    • SWOT Analysis
    • Company Profile
      • Lonza
      • Novartis International AG
      • BASF AG
      • Carbogen Amcis AG
      • Eli Lilly and Company
      • Teva Pharmaceutical Industries Ltd Bristol-Myers Squibb
      • Pfizer Inc.
      • Roche Diagnostics.
      • Hospira Inc
      • Boehringer Ingelheim
      • Covidien Plc
      • Merck & Co
      • Bayer AG
      • Sigma-Aldrich Corporation
      • Sanofi Aventis
      • Other players