High Potency APIs /HPAPI Market- Growth, Trends, COVID-19 Impact, and Forecast (2022 - 2027)

The High-Potency APIs /HPAPI Market is Segmented by Product Type (Innovative High-Potency Active Pharmaceutical Ingredients and Generic High-Potency Active Pharmaceutical Ingredients), Application (Oncology, Hormonal Imbalance, Glaucoma, and Other Therapeutic Applications), Synthesis (Synthetic High-Potency Active Pharmaceutical Ingredients and Biotech High-Potency Active Pharmaceutical Ingredients), Manufacturer (Captive HPAPI Manufacturers and Merchant HPAPI Manufacturers), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

high potency apis market
Study Period: 2019-2027
Base Year: 2021
Fastest Growing Market: Asia-Pacific
Largest Market: North America
CAGR: 8.5 %

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Market Overview

The high-potency APIs/HPAPI market is projected to register a CAGR of 8.5% during the forecast period (2022-2027).

During the COVID-19 pandemic, the high-potency APIs/HPAPI market was adversely affected. The COVID-19 outbreak primarily affected the supply chain of the API market. Since Southeast Asia (specifically China and India) is the hub for the production of API, the market was severely hampered as COVID-19 increased in the region. According to the Germany Trade & Invest (GTAI) article titled "Covid-19 Fuels Debate over API Production Locations" published in April 2020, around 60% of APIs, including high-potency APIs of the world, are manufactured in India or China. India alone accounts for 18% of the global generic drug manufacturing market, most of which is exported to other countries. China is a major manufacturing location and produces 70% of the APIs, including high-potency APIs, for India's generics industry. This situation makes these two countries the biggest players in the global market for generic medicines. However, these countries were the most affected by the pandemic. As the virus spread globally, India temporarily placed an export curb on 26 drugs and various high-potent APIs, which accounted for around 10% of the country's pharmaceutical exports, to avoid domestic shortages. This factor further fueled the adversity in the market. However, various APIs are used in the production of COVID-19 vaccines. Overall, the market was considered to be hindered in the short term. However, the market may grow significantly once the industry reinforces its supply chain with modern advancements and protocols.

Certain factors driving the market’s growth include increasing demand for drugs (oncology and antibody-drug conjugates), increasing focus on precision medicine and high potency APIs, and technological advancements in high-potency API manufacturing. The International Agency for Research on Cancer (IARC) updated GLOBOCAN 2020 with new estimates about the global cancer burden, indicating that the cancer burden rose to 19.3 million cases and 10 million cancer deaths in 2020. This new study suggests that more than 50 million people will be diagnosed with cancer within five years. The use of high potency APIs in various drug therapies are also adding to the market growth. For instance, the United States Center for Drug Evaluation and Research (CDER) approved new therapies in 2020 for various cancers, particularly lung, thyroid, and breast cancers. These therapies included small and large API molecules for treatments. High-potency APIs are the primary constituents of these drugs. With the growing number of cancer cases, the market will simultaneously grow to provide solutions for the disease. Similarly, according to Parkinson’s Foundation's article published in July 2020, around 60,000 Americans are diagnosed with Parkinson's disease each year. There has been a focus on precision medicine in the past few years. The need for personalized medicine with higher efficacy is increasing. These generic drugs are known as pharmacogenetics. In 2020, the US Food and Drug Administration listed information relating to 200 pharmacogenetic drugs. In the United Kingdom, the National Health Scheme aims to integrate genomic medicines into its routine care by 2025. Therefore, owing to the increase in the research on the precision medicine and the utilization of high potency APIs for drug development, the studied market is estimated to witness a healthy growth rate during the forecast period.

Scope of the Report

As per the scope of the report, highly potent APIs are compounds that evoke a biological response at a very low dose. Some examples of high-potency APIs are cytotoxic compounds and hormones such as estrogen. The High-Potency APIs /HPAPI Market is Segmented by Product Type (Innovative High-Potency Active Pharmaceutical Ingredients and Generic High-Potency Active Pharmaceutical Ingredients), Application (Oncology, Hormonal Imbalance, Glaucoma, and Other Therapeutic Applications), Synthesis (Synthetic High-Potency Active Pharmaceutical Ingredients and Biotech High-Potency Active Pharmaceutical Ingredients), Manufacturer (Captive HPAPI Manufacturers and Merchant HPAPI Manufacturers), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries globally. The report offers the value (in USD million) for the above segments.

By Poduct Type
Innovative High-potency Active Pharmaceutical Ingredients
Generic High-potency Active Pharmaceutical Ingredients
By Application
Oncology
Hormonal Imbalance
Glaucoma
Other Applications
By Synthesis
Synthetic High-potency Active Pharmaceutical Ingredients
Biotech High-potency Active Pharmaceutical Ingredients
By Manufacturer
Captive HPAPI Manufacturers
Merchant HPAPI Manufacturers
By Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle-East and Africa
GCC
South Africa
Rest of Middle-East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

Generic High-potency Active Pharmaceutical Ingredients Segment is Expected to Record Significant Growth

The high-potency APIs/HPAPI market is broadly segmented into innovative high-potency active pharmaceutical ingredients and generic high-potency active pharmaceutical ingredients. The primary factor for the growth is the patent expiration of various drugs and increasing demand for cancer treatment, along with the huge number of cancer treatment drugs in the pipeline for the future. According to the report published by the American Journal of Managed Care in June 2021, by 2023, patents of around 20 oncology biologics will expire, which may lead to the production of more biosimilars in cancer care and reduce costs. Due to these reasons, the market may see a high growth rate during the forecast period.

Also, the government initiatives focusing on active pharmaceutical ingredient production are adding to the growth of the studied market. In June 2021, the Indian Finance Minister announced an additional outlay of INR 197,000 crore for utilization over five years for the pharmaceutical Production Linked Incentive (PLI) Scheme in 13 key sectors such as active pharmaceutical ingredients, drug intermediaries, and key starting materials. The large incentives being allocated to the active pharmaceutical ingredient segment would greatly boost the market growth over the forecast period.​

Several key market players are also adding to the growth of the market over the forecast period. For instance, in April 2021, Pfizer acquired Amplyx Pharmaceuticals Inc., a privately-held company dedicated to developing therapies. The company makes several drugs, such as Fosmanogepix (a fungal inhibitor), which require high-potency APIs to manufacture. Such acquisitions are expected to boost the growth of the market over the forecast period.

Number of Estimated New Cancer Cases (in Millions), Global, 2020-2040

North America is Expected to Hold a Major Share in the Market

North America is expected to hold a significant share in the market during the forecast period

The United States was the most affected country in the world, with the prevalence of disorders such as cancer and neurological disorders. These disorders are increasing in prevalence, thus increasing the production of HPAPIs in the region. HPAPIs are widely used in many therapeutic, drug discovery, or other research studies related to oncology and other major disorders. Thus, the demand for the same will be significantly higher in the North American region as the patient population is increasing compared to other countries.

North America is expected to hold a major share in the high-potency APIs/HPAPI market due to the rising geriatric population and increasing prevalence and incidence of infectious diseases in this region. The incidence of chronic diseases, like cancer, is also high in the United States. As per the 2020 report by the American Cancer Society journal, there were an estimated 1.8 million new cancer cases diagnosed and 606,520 cancer deaths in 2020. According to the 2020 data by Parkinson’s Foundation, around 1 million people in the United States are living with Parkinson's disease, more than the combined number of people diagnosed with muscular dystrophy, multiple sclerosis, and Amyotrophic Lateral Sclerosis. This number is expected to increase to 1.2 million by 2030.

According to GLOBOCAN 2020, in Canada, around 225,800 new cancer cases and 83,300 cancer deaths were recorded in the year 2020. Around 30% of all deaths in Canada are caused by cancer. However, Canada has a universal healthcare system for its citizens. This factor creates an even demand in the region. Due to this factor, the market may register positive growth during the forecast period.

Moreover, the increasing R&D activities and the presence of favorable healthcare infrastructure are fueling the growth of the overall regional market. ​

High Potency APIs /HPAPI Market

Competitive Landscape

The high-potency APIs/HPAPI market is fragmented, competitive, and consists of several major players. In terms of market share, a few major players are currently dominating the market, including Thermo Fisher Scientific Inc., Merck KGaA, Pfizer, Novartis International AG, and Teva Pharmaceutical Industries.

Recent Developments

  • In March 2022, the Indian Minister of Health & Family Welfare and Chemical and Fertilisers announced that India had started the manufacturing of 35 pharmaceutical ingredients, which had been imported earlier. 
  • In March 2022, Sumitomo Chemical Co., Ltd. started the construction of a new manufacturing plant for active pharmaceutical ingredients (APIs) and intermediates for small molecule drugs in Japan. This project was initiated to enhance the company’s capacity to supply a variety of high-quality APIs and intermediates in response to the increasing demand for small molecule drugs.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Increasing Demand for Drugs (Oncology and Antibody-drug Conjugates)

      2. 4.2.2 Increasing Focus on Precision Medicine and High-potency APIs

      3. 4.2.3 Technological Advancements in High-potency API Manufacturing

    3. 4.3 Market Restraints

      1. 4.3.1 Huge Capital Investment

      2. 4.3.2 Ever Changing Industry Standards and Guidelines

    4. 4.4 Porter's Five Forces Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION (Market Size by Value - in USD Millions)

    1. 5.1 By Poduct Type

      1. 5.1.1 Innovative High-potency Active Pharmaceutical Ingredients

      2. 5.1.2 Generic High-potency Active Pharmaceutical Ingredients

    2. 5.2 By Application

      1. 5.2.1 Oncology

      2. 5.2.2 Hormonal Imbalance

      3. 5.2.3 Glaucoma

      4. 5.2.4 Other Applications

    3. 5.3 By Synthesis

      1. 5.3.1 Synthetic High-potency Active Pharmaceutical Ingredients

      2. 5.3.2 Biotech High-potency Active Pharmaceutical Ingredients

    4. 5.4 By Manufacturer

      1. 5.4.1 Captive HPAPI Manufacturers

      2. 5.4.2 Merchant HPAPI Manufacturers

    5. 5.5 By Geography

      1. 5.5.1 North America

        1. 5.5.1.1 United States

        2. 5.5.1.2 Canada

        3. 5.5.1.3 Mexico

      2. 5.5.2 Europe

        1. 5.5.2.1 Germany

        2. 5.5.2.2 United Kingdom

        3. 5.5.2.3 France

        4. 5.5.2.4 Italy

        5. 5.5.2.5 Spain

        6. 5.5.2.6 Rest of Europe

      3. 5.5.3 Asia-Pacific

        1. 5.5.3.1 China

        2. 5.5.3.2 Japan

        3. 5.5.3.3 India

        4. 5.5.3.4 Australia

        5. 5.5.3.5 South Korea

        6. 5.5.3.6 Rest of Asia-Pacific

      4. 5.5.4 Middle-East and Africa

        1. 5.5.4.1 GCC

        2. 5.5.4.2 South Africa

        3. 5.5.4.3 Rest of Middle-East and Africa

      5. 5.5.5 South America

        1. 5.5.5.1 Brazil

        2. 5.5.5.2 Argentina

        3. 5.5.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 AbbVie Inc.

      2. 6.1.2 Merck & Co. Inc.

      3. 6.1.3 Corden Pharma International

      4. 6.1.4 Pfizer Inc.

      5. 6.1.5 Sanofi (EUROAPI)

      6. 6.1.6 SK Biotek

      7. 6.1.7 Sun Pharmaceutical Industries Ltd

      8. 6.1.8 Teva Pharmaceutical Industries Ltd

      9. 6.1.9 Thermo Fisher Scientific Inc.

      10. 6.1.10 Viatris Inc.

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Subject to Availability
**Competitive Landscape Covers - Business Overview, Financials, Products and Strategies, and Recent Development

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Frequently Asked Questions

The Global High Potency APIs /HPAPI Market market is studied from 2019 - 2027.

The Global High Potency APIs /HPAPI Market is growing at a CAGR of 8.5% over the next 5 years.

Asia-Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Pfizer Inc., Thermo Fisher Scientific Inc., Sanofi (EUROAPI), Merck & Co. Inc., Teva Pharmaceutical Industries Ltd are the major companies operating in Global High Potency APIs /HPAPI Market.

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