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) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook 2021 2030

The global high potency active pharmaceutical ingredients market size is expected to be worth around US$ 44.8 billion by 2030, according to a new report by Vision Research Reports.

The global high potency active pharmaceutical ingredients market size was valued at US$ 24.4 billion in 2020 and is anticipated to grow at a CAGR of 20.3% during forecast period 2021 to 2030.

High Potency Active Pharmaceutical Ingredients Market Size 2021 to 2030

Report Coverage

Report Scope Details
Market Size USD 44.8 billion by 2030
Growth Rate CAGR of 20.3% From 2021 to 2030
Base Year 2021
Historic Data 2017 to 2020
Forecast Period 2021 to 2030
Segments Covered Product, Manufacturer,Drug Type, Application 
Regional Scope North America, Europe, Asia Pacific, Latin America, Middle East & Africa
Companies Mentioned

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, and Sanofi Aventis. 

Growth Factors

 Increasing number of new entrants producing fast relief therapeutics in emerging countries of India and China is anticipated to boost the demand for High potency active pharmaceutical ingredients (HPAPIs) over the forecast period. 

In addition, supportive government regulations for commercialization and research and development of novel drug molecules are projected to drive the industry growth. Extensive capital investments required for development of production facility has lead to increase in contract manufacturing activities for HPAPIs during the forecast period.

Report Highlights

Segmentation of high potency API market on the basis of products is done in to synthetic and biotech. Synthetic molecules is considered to be the largest market in 2016 in terms of revenue share owing to the easier protocols for synthesis of these molecules coupled with higher availability of raw material. The biotech segment is expected to witness lucrative growth owing to the technological advancements in this segment and high level of efficacy of these ingredients.

Biotech products are expected to show significant growth during the forecast period owing to increasing demand for biologics and associated benefits such as minimum side effects and higher efficacy levels. In addition, shifting of consumer preference from synthetic to biotech molecules is factor attributing towards the higher penetration rate of biologics.

Biotech HPAPI mainly consists of drug molecules obtained after usage of molecular techniques such as recombinant DNA technology. The genes expressing these molecules are transferred into expression vector for synthesis of the higher amount of drug molecule in less time.

Biotech HPAPI is mostly peptides and other forms of enzymes. The market for Biotech HPAPI is expected to witness lucrative growth owing to the technological advancements in this segment and high level of efficacy of these ingredients.

Increasing incidence of chronic disorders such as cancer and others along with patent expiration of blockbuster drugs thereby boosting generics drug manufacturing.  Rising demand for biotech synthesis drugs and introduction of innovative therapeutics are the key factors favoring competitive growth.

Incorporation of continuous process technology for the production of petrochemicals and polymers are further contributing toward the market growth. Emergence of multiple separation technology including filtration, purification and fermentation processes with advanced technology to provide growth platform to this market over the forecast period.

Manufacturers in High potency API include in-house and outsourced. In-house market dominated the overall industry in terms of revenue share owing to the higher availability of raw material and intensive capitalization of major key players in development of high end manufacturing facility. HPAPI molecules are manufactured by some pharmaceutical companies in their own manufacturing facilities. Pharmaceutical companies have made huge amount of investments in developing in house capabilities and specialized requirements for in house HPAPI investments.

Contract manufacturing services are also increasing in this field and are expected to witness lucrative growth.Contract manufacturing and outsourcing of HPAPI molecule development is growing trend in pharmaceutical sector. Companies such as Evonik and Lonza are actively involved in providing contract manufacturing services to other companies.Introduction of advancements in manufacturing technology such as single use production and batch culture fermentation for separating molecules is anticipated to offer opportunities for contract manufactures in coming years.

HPAPI drugs are segmented as innovative and generic. Innovative drugs segment dominated the drug type in terms of revenue share owing to the rising research and development activities for novel drug development coupled with favorable government initiatives. Expiration of patents of branded drug molecules is expected to increase the growth of generic drugs over the forecast period.

Established R&D facilities, increasing amount of funding and favorable regulatory structure are key factors for growth of innovative HPAPI market. Owing to extensive research in this field many novel innovative products are in pipeline and are expected to launch in the forecast period.

New entrants in this segment are expected to fuel the growth of this market. Introduction of advancements in the manufacturing of novel molecules with better efficacy and lower dosage for cancer treatment is another factor contributing toward the segment growth.

Patent expiry of branded drug molecules is primary factor attributing to lucrative growth of generic HPAPI drugs. Generic drug market is expected to show lucrative growth in countries such as India and Brazil owing to presence of unmet clinical needs in this area and high acceptance levels for OTC drugs.

HPAPI are used majorly in treatment of hormonal imbalance, oncology, glaucoma and others.  Oncology segment dominated the overall industry owing to the rising cancer incidences worldwide. Cancer is estimated to be second most common cause for mortality in the U.S. Extensive R&D is also undertaken by many companies for development of drugs specific to novel biomarkers. These molecules are also widely used in Antibody Drug Conjugates (ADCs) form which is an effective and important development in the field of cancer treatment.

Hormonal followed oncology owing to increasing hormonal imbalance cases mainly in female population. Sedentary lifestyle has increased prevalence of metabolic disorders. Hormonal imbalance is growing concern in majority of countries. The disorders include sexual hormone imbalance and thyroid problems.

Glaucoma is primarily caused due to increase in blood sugar levels. Increasing lifestyle changes and growing obese population are key factors increasing the usage of glaucoma drugs.The applications of HPAPIs are developing in the treatment of neurological, cardiovascular and musculoskeletal drugs. These molecules are also find applications in certain gynecological, high potency analgesics, and cosmetic applications.

North America recorded the largest revenue of the overall industry as of 2020. The growth is primarily due to the rising chronic disease patients coupled with increasing demand for fast acting and higher efficacy drugs. Furthermore, increasing awareness pertaining to highly potent drugs, rising demand for anti-cancerous therapeutics and growing number of biotechnology industries are the factors attributing to dominant share.

North America have highly regulated and developed pharmaceutical industry. Incidence of cancer is higher, in this region hence, cancer therapy drugs show lucrative growth and is expected to be the same during the future period. Increasing incidence of older age diseases with changing lifestyle are the key contributing factors for growing demand for HPAPIs in this region.

The U.S. held the dominant market share of high potency APIs in North America. The key industry players holding majority of market share in this region are SAFC, Teva Pharmaceuticals, Bristol Myers Squibb, Cambrex Ferro, and Carbogen Amcis.

Asia Pacific region is expected to register high growth owing to the flourishing generic drug market, developing healthcare infrastructure and presence of untapped opportunities. Growing investments in biotechnology sector, supportive government initiatives and rapidly growing oncology market are the factors expected to propel the industry growth in this region.

In addition, growing generic sector business and improving healthcare facilities is anticipating the further growth in the near future. Healthcare infrastructure is growing rapidly in Asian countries, especially in India & China. The demand for oncology drugs & is expected to fuel the market growth over the forecast period.

Key Players

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, and Sanofi Aventis. 

Market Segmentation

  • Product Outlook

    • Synthetic

    • Biotech

  • Manufacturer Outlook 

    • In-house

    • Outsourced

  • Drug Type Outlook 

    • Innovative

    • Generic

  • Application Outlook 

    • Oncology

    • Hormonal

    • Glaucoma

    • Others

  • Regional Outlook

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • UK

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Brazil

      • Mexico

    • The Middle East and Africa

      • South Africa

The High Potency Active Pharmaceutical Ingredients market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of High Potency Active Pharmaceutical Ingredients market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global High Potency Active Pharmaceutical Ingredients market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the High Potency Active Pharmaceutical Ingredients market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted High Potency Active Pharmaceutical Ingredients market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the High Potency Active Pharmaceutical Ingredients capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of High Potency Active Pharmaceutical Ingredients by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global High Potency Active Pharmaceutical Ingredients market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major High Potency Active Pharmaceutical Ingredients market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of High Potency Active Pharmaceutical Ingredients market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the High Potency Active Pharmaceutical Ingredients industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The High Potency Active Pharmaceutical Ingredients market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to High Potency Active Pharmaceutical Ingredients market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of High Potency Active Pharmaceutical Ingredients market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new High Potency Active Pharmaceutical Ingredients market. These factors have benefited the growth of the global market for High Potency Active Pharmaceutical Ingredients. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for High Potency Active Pharmaceutical Ingredients. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of High Potency Active Pharmaceutical Ingredients are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2021
  • Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market

To strategically profile the key players and comprehensively analyze their growth strategies.

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