The global high potency APIs market was valued at $19,693.65 million in 2021, and is projected to reach $41,373.34 million by 2031, registering a CAGR of 7.7% from 2022 to 2031.
High potency APIs are the substances that elicit a biological response even at very low doses. Cytotoxic substances and sex hormones like oestrogen are the common examples of HPAPIs which are highly selective in nature and show response at low doses. Moreover, the API development sector including the development of the HPAPIs, is the fastest expanding area of the pharmaceutical industry due to the development of the highly potent drugs such as fentanyl, alprazolam, risperidone, bumetanide, bisoprolol that evokes response at low concentrations and are into the market for the treatment of various ailments. In addition, more than 1,000 highly potent small molecules are under development that have their applications in the treatment of diseases like cancer, diabetes, glaucoma, and others.
According to the National Glaucoma Research, more than three million Americans have glaucoma, and 2.7 million of these patients are aged 40 and older and are affected by its most common form, open-angle glaucoma. Also, in 2020, about 80 million people have glaucoma globally, and this number is expected to increase to over 111 million by 2040. This rise in the number of the glaucoma patients, along with the prevalence of other multi-genetic disorders such as cancer, diabetes, and others around the globe, propel the growth of the high potency APIs market.
Furthermore, the key market players in the market are focusing on the emerging economies such as India, China and the Middle East Asia for investment and expansion of their business. The rise in the population in this region, along with prevalence of the excessive raw materials for the manufacturing and funding offered by the government are the factors driving the growth of the market in this region. In addition, NCBI states that the primary angle closure glaucoma (PACG) is higher in Asians than Europeans and Africans, with over 80% of the total cases globally, which highlights the investment opportunities for the key market players in the high potency APIs market during the forecast period.
In addition, there is an increase in the demand for oncology drugs due to the prevalence of the cancer cases around the globe. Also, advancements in HPAPI manufacturing technologies along with the rise in the number of contract manufacturing organization (CMOs) and contract development and manufacturing organization (CDMOs) are the factors driving the growth of the market. On the other hand, the patent expiry and launch of the generic versions of the highly potent APIs are projected to provide lucrative opportunity for the pharmaceutical companies to enhance product portfolio and expand their business.
However, the market is expected to be significantly constrained in the near future due to the high risk of cross-contamination and high development cost associated with the manufacturing process. The market is capital intensive and requires skilled technical human capital. This is projected to be a major barrier for new entrants entering the market.
The high potency APIs market is segmented on the basis of product type, application, type of synthesis and region. By product type, it is divided into innovative high-potency API and generic high-potency API. On the basis of application, the market is segmented into oncology, hormonal imbalance, glaucoma, and others. According to the type of synthesis, the market is segmented into synthetic and biotech. The biotech is further divided into merchant and captive. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.
The major companies profiled in this report include Abbvie Inc., Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Novartis AG, Pfizer Inc., Sanofi, Teva Pharmaceutical Industries Ltd. and others.
High potency APIs are the substances that elicit a biological response even at very low doses. Cytotoxic substances and sex hormones like oestrogen are the common examples of HPAPIs which are highly selective in nature and show response at low doses. Moreover, the API development sector including the development of the HPAPIs, is the fastest expanding area of the pharmaceutical industry due to the development of the highly potent drugs such as fentanyl, alprazolam, risperidone, bumetanide, bisoprolol that evokes response at low concentrations and are into the market for the treatment of various ailments. In addition, more than 1,000 highly potent small molecules are under development that have their applications in the treatment of diseases like cancer, diabetes, glaucoma, and others.
According to the National Glaucoma Research, more than three million Americans have glaucoma, and 2.7 million of these patients are aged 40 and older and are affected by its most common form, open-angle glaucoma. Also, in 2020, about 80 million people have glaucoma globally, and this number is expected to increase to over 111 million by 2040. This rise in the number of the glaucoma patients, along with the prevalence of other multi-genetic disorders such as cancer, diabetes, and others around the globe, propel the growth of the high potency APIs market.
Furthermore, the key market players in the market are focusing on the emerging economies such as India, China and the Middle East Asia for investment and expansion of their business. The rise in the population in this region, along with prevalence of the excessive raw materials for the manufacturing and funding offered by the government are the factors driving the growth of the market in this region. In addition, NCBI states that the primary angle closure glaucoma (PACG) is higher in Asians than Europeans and Africans, with over 80% of the total cases globally, which highlights the investment opportunities for the key market players in the high potency APIs market during the forecast period.
In addition, there is an increase in the demand for oncology drugs due to the prevalence of the cancer cases around the globe. Also, advancements in HPAPI manufacturing technologies along with the rise in the number of contract manufacturing organization (CMOs) and contract development and manufacturing organization (CDMOs) are the factors driving the growth of the market. On the other hand, the patent expiry and launch of the generic versions of the highly potent APIs are projected to provide lucrative opportunity for the pharmaceutical companies to enhance product portfolio and expand their business.
However, the market is expected to be significantly constrained in the near future due to the high risk of cross-contamination and high development cost associated with the manufacturing process. The market is capital intensive and requires skilled technical human capital. This is projected to be a major barrier for new entrants entering the market.
The high potency APIs market is segmented on the basis of product type, application, type of synthesis and region. By product type, it is divided into innovative high-potency API and generic high-potency API. On the basis of application, the market is segmented into oncology, hormonal imbalance, glaucoma, and others. According to the type of synthesis, the market is segmented into synthetic and biotech. The biotech is further divided into merchant and captive. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.
The major companies profiled in this report include Abbvie Inc., Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, Novartis AG, Pfizer Inc., Sanofi, Teva Pharmaceutical Industries Ltd. and others.
KEY BENEFITS FOR STAKEHOLDERS
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the high potency apis market analysis from 2021 to 2031 to identify the prevailing high potency apis market opportunities.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the high potency apis market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global high potency apis market trends, key players, market segments, application areas, and market growth strategies.
Key Market Segments
By Application
- Oncology
- Hormonal Imbalance
- Glaucoma
- Others
By Type of Synthesis
- Synthetic
- Biotech
- Type
- Merchant
- Captive
By Product Type
- Innovative High-Potency API
- Generic High-Potency API
By Region
- North America
- U. S.
- Canada
- Mexico
- Europe
- Germany
- France
- UK
- Italy
- Spain
- Rest Of Europe
- Asia-Pacific
- Japan
- China
- Australia
- India
- South Korea
- Rest Of Asia-Pacific
- LAMEA
- Brazil
- Saudi Arabia
- South Africa
- Rest Of LAMEA
Key Market Players
- AbbVie Inc.
- Bayer AG
- Boehringer Ingelheim International GmbH
- Bristol-Myers Squibb Company
- Eli Lilly and Company
- F. Hoffmann-La Roche
- Novartis International AG
- Pfizer, Inc.
- Sanofi
- Teva Pharmaceutical Industries Ltd.
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Table of Contents
CHAPTER 1: INTRODUCTION1.1. Report description
1.2. Key market segments
1.3. Key benefits to the stakeholders
1.4. Research Methodology
1.4.1. Secondary research
1.4.2. Primary research
1.4.3. Analyst tools and models
CHAPTER 2: EXECUTIVE SUMMARY
2.1. Key findings of the study
2.2. CXO Perspective
CHAPTER 3: MARKET OVERVIEW
3.1. Market definition and scope
3.2. Key findings
3.2.1. Top investment pockets
3.3. Porter’s five forces analysis
3.4. Top player positioning
3.5. Market dynamics
3.5.1. Drivers
3.5.2. Restraints
3.5.3. Opportunities
3.6. COVID-19 Impact Analysis on the market
3.7. Patent Landscape
CHAPTER 4: HIGH POTENCY APIS MARKET, BY PRODUCT TYPE
4.1 Overview
4.1.1 Market size and forecast
4.2 Innovative High-Potency API
4.2.1 Key market trends, growth factors and opportunities
4.2.2 Market size and forecast, by region
4.2.3 Market analysis by country
4.3 Generic High-Potency API
4.3.1 Key market trends, growth factors and opportunities
4.3.2 Market size and forecast, by region
4.3.3 Market analysis by country
CHAPTER 5: HIGH POTENCY APIS MARKET, BY APPLICATION
5.1 Overview
5.1.1 Market size and forecast
5.2 Oncology
5.2.1 Key market trends, growth factors and opportunities
5.2.2 Market size and forecast, by region
5.2.3 Market analysis by country
5.3 Hormonal Imbalance
5.3.1 Key market trends, growth factors and opportunities
5.3.2 Market size and forecast, by region
5.3.3 Market analysis by country
5.4 Glaucoma
5.4.1 Key market trends, growth factors and opportunities
5.4.2 Market size and forecast, by region
5.4.3 Market analysis by country
5.5 Others
5.5.1 Key market trends, growth factors and opportunities
5.5.2 Market size and forecast, by region
5.5.3 Market analysis by country
CHAPTER 6: HIGH POTENCY APIS MARKET, BY TYPE OF SYNTHESIS
6.1 Overview
6.1.1 Market size and forecast
6.2 Synthetic
6.2.1 Key market trends, growth factors and opportunities
6.2.2 Market size and forecast, by region
6.2.3 Market analysis by country
6.3 Biotech
6.3.1 Key market trends, growth factors and opportunities
6.3.2 Market size and forecast, by region
6.3.3 Market analysis by country
6.3.4 Biotech High Potency APIs Market by Type
6.3.4.1 Merchant Market size and forecast, by region
6.3.4.2 Captive Market size and forecast, by region
CHAPTER 7: HIGH POTENCY APIS MARKET, BY REGION
7.1 Overview
7.1.1 Market size and forecast
7.2 North America
7.2.1 Key trends and opportunities
7.2.2 North America Market size and forecast, by Product Type
7.2.3 North America Market size and forecast, by Application
7.2.4 North America Market size and forecast, by Type of Synthesis
7.2.4.1 North America Biotech High Potency APIs Market by Type
7.2.5 North America Market size and forecast, by country
7.2.5.1 U. S.
7.2.5.1.1 Market size and forecast, by Product Type
7.2.5.1.2 Market size and forecast, by Application
7.2.5.1.3 Market size and forecast, by Type of Synthesis
7.2.5.2 Canada
7.2.5.2.1 Market size and forecast, by Product Type
7.2.5.2.2 Market size and forecast, by Application
7.2.5.2.3 Market size and forecast, by Type of Synthesis
7.2.5.3 Mexico
7.2.5.3.1 Market size and forecast, by Product Type
7.2.5.3.2 Market size and forecast, by Application
7.2.5.3.3 Market size and forecast, by Type of Synthesis
7.3 Europe
7.3.1 Key trends and opportunities
7.3.2 Europe Market size and forecast, by Product Type
7.3.3 Europe Market size and forecast, by Application
7.3.4 Europe Market size and forecast, by Type of Synthesis
7.3.4.1 Europe Biotech High Potency APIs Market by Type
7.3.5 Europe Market size and forecast, by country
7.3.5.1 Germany
7.3.5.1.1 Market size and forecast, by Product Type
7.3.5.1.2 Market size and forecast, by Application
7.3.5.1.3 Market size and forecast, by Type of Synthesis
7.3.5.2 France
7.3.5.2.1 Market size and forecast, by Product Type
7.3.5.2.2 Market size and forecast, by Application
7.3.5.2.3 Market size and forecast, by Type of Synthesis
7.3.5.3 UK
7.3.5.3.1 Market size and forecast, by Product Type
7.3.5.3.2 Market size and forecast, by Application
7.3.5.3.3 Market size and forecast, by Type of Synthesis
7.3.5.4 Italy
7.3.5.4.1 Market size and forecast, by Product Type
7.3.5.4.2 Market size and forecast, by Application
7.3.5.4.3 Market size and forecast, by Type of Synthesis
7.3.5.5 Spain
7.3.5.5.1 Market size and forecast, by Product Type
7.3.5.5.2 Market size and forecast, by Application
7.3.5.5.3 Market size and forecast, by Type of Synthesis
7.3.5.6 Rest of Europe
7.3.5.6.1 Market size and forecast, by Product Type
7.3.5.6.2 Market size and forecast, by Application
7.3.5.6.3 Market size and forecast, by Type of Synthesis
7.4 Asia-Pacific
7.4.1 Key trends and opportunities
7.4.2 Asia-Pacific Market size and forecast, by Product Type
7.4.3 Asia-Pacific Market size and forecast, by Application
7.4.4 Asia-Pacific Market size and forecast, by Type of Synthesis
7.4.4.1 Asia-Pacific Biotech High Potency APIs Market by Type
7.4.5 Asia-Pacific Market size and forecast, by country
7.4.5.1 Japan
7.4.5.1.1 Market size and forecast, by Product Type
7.4.5.1.2 Market size and forecast, by Application
7.4.5.1.3 Market size and forecast, by Type of Synthesis
7.4.5.2 China
7.4.5.2.1 Market size and forecast, by Product Type
7.4.5.2.2 Market size and forecast, by Application
7.4.5.2.3 Market size and forecast, by Type of Synthesis
7.4.5.3 Australia
7.4.5.3.1 Market size and forecast, by Product Type
7.4.5.3.2 Market size and forecast, by Application
7.4.5.3.3 Market size and forecast, by Type of Synthesis
7.4.5.4 India
7.4.5.4.1 Market size and forecast, by Product Type
7.4.5.4.2 Market size and forecast, by Application
7.4.5.4.3 Market size and forecast, by Type of Synthesis
7.4.5.5 South Korea
7.4.5.5.1 Market size and forecast, by Product Type
7.4.5.5.2 Market size and forecast, by Application
7.4.5.5.3 Market size and forecast, by Type of Synthesis
7.4.5.6 Rest of Asia-Pacific
7.4.5.6.1 Market size and forecast, by Product Type
7.4.5.6.2 Market size and forecast, by Application
7.4.5.6.3 Market size and forecast, by Type of Synthesis
7.5 LAMEA
7.5.1 Key trends and opportunities
7.5.2 LAMEA Market size and forecast, by Product Type
7.5.3 LAMEA Market size and forecast, by Application
7.5.4 LAMEA Market size and forecast, by Type of Synthesis
7.5.4.1 LAMEA Biotech High Potency APIs Market by Type
7.5.5 LAMEA Market size and forecast, by country
7.5.5.1 Brazil
7.5.5.1.1 Market size and forecast, by Product Type
7.5.5.1.2 Market size and forecast, by Application
7.5.5.1.3 Market size and forecast, by Type of Synthesis
7.5.5.2 Saudi Arabia
7.5.5.2.1 Market size and forecast, by Product Type
7.5.5.2.2 Market size and forecast, by Application
7.5.5.2.3 Market size and forecast, by Type of Synthesis
7.5.5.3 South Africa
7.5.5.3.1 Market size and forecast, by Product Type
7.5.5.3.2 Market size and forecast, by Application
7.5.5.3.3 Market size and forecast, by Type of Synthesis
7.5.5.4 Rest of LAMEA
7.5.5.4.1 Market size and forecast, by Product Type
7.5.5.4.2 Market size and forecast, by Application
7.5.5.4.3 Market size and forecast, by Type of Synthesis
CHAPTER 8: COMPANY LANDSCAPE
8.1. Introduction
8.2. Top winning strategies
8.3. Product Mapping of Top 10 Players
8.4. Competitive Dashboard
8.5. Competitive Heatmap
8.6. Key developments
CHAPTER 9: COMPANY PROFILES
9.1 AbbVie Inc.
9.1.1 Company overview
9.1.2 Company snapshot
9.1.3 Operating business segments
9.1.4 Product portfolio
9.1.5 Business performance
9.1.6 Key strategic moves and developments
9.2 Bayer AG
9.2.1 Company overview
9.2.2 Company snapshot
9.2.3 Operating business segments
9.2.4 Product portfolio
9.2.5 Business performance
9.2.6 Key strategic moves and developments
9.3 Boehringer Ingelheim International GmbH
9.3.1 Company overview
9.3.2 Company snapshot
9.3.3 Operating business segments
9.3.4 Product portfolio
9.3.5 Business performance
9.3.6 Key strategic moves and developments
9.4 Bristol-Myers Squibb Company
9.4.1 Company overview
9.4.2 Company snapshot
9.4.3 Operating business segments
9.4.4 Product portfolio
9.4.5 Business performance
9.4.6 Key strategic moves and developments
9.5 Eli Lilly and Company
9.5.1 Company overview
9.5.2 Company snapshot
9.5.3 Operating business segments
9.5.4 Product portfolio
9.5.5 Business performance
9.5.6 Key strategic moves and developments
9.6 F. Hoffmann-La Roche
9.6.1 Company overview
9.6.2 Company snapshot
9.6.3 Operating business segments
9.6.4 Product portfolio
9.6.5 Business performance
9.6.6 Key strategic moves and developments
9.7 Novartis International AG
9.7.1 Company overview
9.7.2 Company snapshot
9.7.3 Operating business segments
9.7.4 Product portfolio
9.7.5 Business performance
9.7.6 Key strategic moves and developments
9.8 Pfizer, Inc.
9.8.1 Company overview
9.8.2 Company snapshot
9.8.3 Operating business segments
9.8.4 Product portfolio
9.8.5 Business performance
9.8.6 Key strategic moves and developments
9.9 Sanofi
9.9.1 Company overview
9.9.2 Company snapshot
9.9.3 Operating business segments
9.9.4 Product portfolio
9.9.5 Business performance
9.9.6 Key strategic moves and developments
9.10 Teva Pharmaceutical Industries Ltd.
9.10.1 Company overview
9.10.2 Company snapshot
9.10.3 Operating business segments
9.10.4 Product portfolio
9.10.5 Business performance
9.10.6 Key strategic moves and developments
Executive Summary
According to this report, titled, 'High Potency APIs Market,' the high potency apis market size was valued at $19.7 billion in 2021, and is estimated to reach $41.4 billion by 2031, growing at a CAGR of 7.7% from 2022 to 2031.A significant aspect of the pharmaceutical manufacturing industry is high-potency active pharmaceutical ingredients (HPAPIs). The high potency APIs market analysis offers a range of different products from clinical domains, including drugs having application in oncology and hormonal imbalance. Nevertheless, the majority of HPAPIs are utilized for the production of anti-cancer drugs with a number of innovations, including packaging, which are fostering the market's expansion.
According to the NCBI, National Center for Biotechnology Information, atrial fibrillation is the most frequent cardiac arrhythmia and is estimated that 6-12 million people worldwide will suffer with this condition in the U.S. by 2050 and 17.9 million people in Europe by 2060. Also, people of European descent are more likely to have atrial fibrillation than African Americans. Thus, the prevalence of the cardiovascular disease cases around the globe along with rise in the number of other multi-genetic disorders, is projected to lead towards the growth of the high potency APIs market trends.
Furthermore, the rise in the outsourcing process for HPAPI production, along with the developments in favorable regulatory frameworks, production of extremely effective high potency APIs, surge in demand for antibody-drug conjugates, and government initiatives to expand the usage of the generic drugs are the factors accelerating the growth of the high potency APIs market size.
Also, the high potency drugs hold the larger percentage of medicines, including both that are being developed and innovated recently and those that are already available in the market. The patent expiry of the drugs available in the market provides lucrative opportunities for the market players to enter this market. This is boosting the ability and capacity of the key market players to produce highly potent APIs (HPAPIs), especially for the contract manufacturing businesses (CMOs), and thus leading to the expansion of the market.
Furthermore, rise in the advancements in the high potency APIs manufacturing technologies will favor the growth of the high potency APIs industry during the forecast period. These advancements offer faster results, accuracy and better efficacy than the existing technologies. In addition, a growing digital toolbox is enabling pharmaceutical developers to advance the high potency API production. Digital modelling and simulation, process analytical technology (PAT), automated visual assessment and documentation, virtual and augmented reality, and machine learning and data analysis are the digital technologies that helps to safely and effectively advance HPAPI production at various points in the development process, which further propels the growth of the market
However, the market is expected to be significantly constrained in the near future due to high risk of cross-contamination and high development cost associated with the manufacturing process.
By product type, the innovative high-potency API segment was the largest segment in the 2021 and is expected to grow at a highest CAGR during the high potency APIs market forecast period, due to increase in the number of patents approvals, rise in patients’ trust in the branded drugs, and surge in the investment by the key market players in research and development of new HPAPIs.
By application, the oncology segment held a dominant portion in the global high potency APIs industry in 2021 and is expected to grow at the fastest CAGR during the forecast period due to the new innovations in the oncology sector and the advantages that the HPAPIs provides in the cancer treatment.
By type of synthesis, the biotech segment held the largest high potency APIs market share in 2021 and is expected to grow at the highest CAGR during the forecast period, because of the adoption of advanced and precise techniques by the pharmaceutical manufacturers for synthesizing APIs on the large scale and rising awareness about the biotechnology sector in the treatment of disease.
Region wise, North America acquired a major high potency APIs market share in 2021, due to the manufacturers in this region, who have been concentrating on creating innovative and effective solutions using HPAPIs. However, Asia-Pacific is expected to witness the highest CAGR for the high potency APIs market throughout the forecast period due to increase in innovations in the high potency APIs, rise in number of the hormonal imbalance diseases, and surge in number of cancer patients in the region.
KEY FINDINGS OF THE STUDY
By product type, the innovative high-potency API segment was the highest contributor to the market in 2021.By application, the oncology segment was the highest contributor to the market in 2021, and is expected to continue this trend during the forecast period.
Depending on type of synthesis, the biotech segment was highest contributor in 2021 and is expected to grow at the fastest CAGR during the forecast period.
Region wise, North America garnered the largest revenue share in 2021, whereas Asia-Pacific is anticipated to grow at the highest CAGR during the forecast period.
Companies Mentioned
- Abbvie Inc.
- Bayer AG
- Boehringer Ingelheim International GmbH
- Bristol-Myers Squibb Company
- Eli Lilly and Company
- F. Hoffmann-La Roche
- Novartis International AG
- Pfizer, Inc.
- Sanofi
- Teva Pharmaceutical Industries Ltd.
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 310 |
| Published | October 2022 |
| Forecast Period | 2021 - 2031 |
| Estimated Market Value ( USD | $ 19693.65 million |
| Forecasted Market Value ( USD | $ 41373.34 million |
| Compound Annual Growth Rate | 7.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
