High Potency APIs Market Size, Share & Trends Analysis By Type, By Synthesis, By Manufacturers, By Application, Regional Outlook, Competitive Strategies and Segment Forecasts to 2030
High Potency APIs Market is projected to be worth USD 37.0 billion by 2030.
According to SPER Market Research, High Potency APIs Market is estimated to reach USD 37.0 billion by 2030 with a CAGR of 6.9%. Expanding need for oncology medications, increasing adoption for antibody-drug conjugates, increased attention of prominent pharmaceutical companies on High Potency APIs, developments in High Potency APIs manufacturing methods, and growing focus on precision medicine are all driving this market forward.
Impact of COVID-19 on the High Potency APIs Market
High Potency APIs market was negatively impacted by the COVID-19 outbreak. COVID-19 significantly impacted this market supply chain. The economic scenario induced by the COVID-19 pandemic in 2020 has hindered the development of this market severely. As the share of enterprises outsourcing to countries with low-cost production technology grows at a rapid rate, companies are expected to benefit.
Scope of the report:
Market size available for years 2019-2030
Base year considered 2021
Forecast period 2022-2030
Segments covered By Type, By Synthesis, By Manufacturers, By Application
Geographies covered North America, Europe, Asia Pacific, Latin America, Middle East, Africa
Companies Covered
AbbVie, Albany Molecular Research Inc., BASF SE, Bayer AG, Boehringer Ingelheim International GmbH., Bristol-Myers Squibb Company, Carbogen Amcis, Cipla Inc., CordenPharma International, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, F. Hoffmann-La Roche, Lonza, Merck & Co. Inc., Novartis International AG, Pfizer Inc.,
Sanofi, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., Viatris Inc.
Driver: Rising demand for cancer medications
Rising cancer medicine demand is expected to open up a wide range of prospects in the worldwide High Potency API market. High Potency APIs are highly effective pharmacologically active compounds that provide significant action and efficiency even at low dosages. Because of the increasing incidence and prevalence of cancer, there is an increase in need for more effective cancer therapies, such as High Potency APIs. To meet the rising demand, pharmaceutical companies such as Pfizer, Sanofi, F. Hoffmann-La Roche, and others are putting more effort into developing pipelines for innovative cancer therapies.
Restraint: Cross-contamination is a major concern
Cross-contamination is one of the most serious concerns connected with High Potency API production. Mounting emphasis on the pharmaceutical business to minimise costs and make biopharmaceuticals more affordable to users are important factors encouraging the industry to use as many effective and efficient multi-product and multi-purpose facilities as possible. High Potency APIs frequently demonstrate high cytotoxicity in addition to high potency, so measures to minimise cross-contamination are critical to a safe production process that ensures the wellness of staff, the surroundings, and the patient.
Opportunity: Opportunities for CMOs and CDMOs are expanding
A complete High Potency API production plant necessitates thorough planning, the use of risk mitigation and assessment techniques, and a process for determining which compounds are eligible for production in each facility. The manufacture of such chemicals is hazardous to employees and the environment. Pharmaceutical companies must also be able to safely produce, store, and transport a growing number of strong substances. This demonstrates that building an effective High Potency API production plan necessitates substantial time and investment. As a result, many sponsor firms choose to seek assistance from CMOs and CDMOs for the development, production, and distribution of High Potency APIs and their formulated medicinal products, as some of these organizations have the proper equipment.
Challenges: Processes must be designed correctly
Among the most important needs for High Potency API production process is process design. The majority of High Potency APIs must be manufactured in tiny clinical and commercial quantities. However, producing gram scale GMP APIs and payloads is difficult. Ensuring containment control while using flexible and tiny equipment, especially glass equipment, is a significant problem that necessitates a customised method for each process and unit operation. It is also critical to retain proper process designs at the developmental size to guarantee that the process suits the plant equipment and capacities when scaled up. Furthermore, there is confusion in the business regarding the types of High Potency APIs. Because of an insufficient data, the classification of new APIs is uncertain due to the use of proprietary systems by various pharmaceutical corporations. These problems can be avoided with proper process designs and containment controls, which most businesses lack. All of these reasons, taken together, are expected to pose a considerable challenge to High Potency API market participants.
Global High Potency APIs Market, By Type:
Based on the Type, Global High Potency APIs Market is segment as; Innovative High Potency APIs, Generic High Potency APIs.
Global High Potency APIs Market, By Synthesis:
Based on the Synthesis, Global High Potency APIs Market is segment as; Synthetic APIs (Synthetic APIs Market By Type), Biotech APIs (Biotech APIs Market By Type, Biotech APIs Market By Product, Vaccines, Recombinant Proteins).
Global High Potency APIs Market, By Manufacturer:
Based on the Manufacturer, Global High Potency APIs Market is segment as; Captive High Potency APIs Manufacturers, Merchant High Potency APIs Manufacturers (Merchant High Potency APIs Manufacturers Market By Type, Merchant High Potency APIs Manufacturers Market By Type of Synthesis, Synthetic APIs, Biosynthetic APIs).
Global High Potency APIs Market, By Application:
Based on the Application, Global High Potency APIs Market is segment as; Oncology, Hormonal Imbalance, Glaucoma, Other Therapeutic Applications.
Global High Potency APIs Market, By Region:
North America owns the prime share of this market; this is due to the increasing prevalence of cancer, also China is growing faster in the Asia-Pacific region.
According to SPER Market Research, High Potency APIs Market is estimated to reach USD 37.0 billion by 2030 with a CAGR of 6.9%. Expanding need for oncology medications, increasing adoption for antibody-drug conjugates, increased attention of prominent pharmaceutical companies on High Potency APIs, developments in High Potency APIs manufacturing methods, and growing focus on precision medicine are all driving this market forward.
Impact of COVID-19 on the High Potency APIs Market
High Potency APIs market was negatively impacted by the COVID-19 outbreak. COVID-19 significantly impacted this market supply chain. The economic scenario induced by the COVID-19 pandemic in 2020 has hindered the development of this market severely. As the share of enterprises outsourcing to countries with low-cost production technology grows at a rapid rate, companies are expected to benefit.
Scope of the report:
Market size available for years 2019-2030
Base year considered 2021
Forecast period 2022-2030
Segments covered By Type, By Synthesis, By Manufacturers, By Application
Geographies covered North America, Europe, Asia Pacific, Latin America, Middle East, Africa
Companies Covered
AbbVie, Albany Molecular Research Inc., BASF SE, Bayer AG, Boehringer Ingelheim International GmbH., Bristol-Myers Squibb Company, Carbogen Amcis, Cipla Inc., CordenPharma International, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, F. Hoffmann-La Roche, Lonza, Merck & Co. Inc., Novartis International AG, Pfizer Inc.,
Sanofi, Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., Viatris Inc.
Driver: Rising demand for cancer medications
Rising cancer medicine demand is expected to open up a wide range of prospects in the worldwide High Potency API market. High Potency APIs are highly effective pharmacologically active compounds that provide significant action and efficiency even at low dosages. Because of the increasing incidence and prevalence of cancer, there is an increase in need for more effective cancer therapies, such as High Potency APIs. To meet the rising demand, pharmaceutical companies such as Pfizer, Sanofi, F. Hoffmann-La Roche, and others are putting more effort into developing pipelines for innovative cancer therapies.
Restraint: Cross-contamination is a major concern
Cross-contamination is one of the most serious concerns connected with High Potency API production. Mounting emphasis on the pharmaceutical business to minimise costs and make biopharmaceuticals more affordable to users are important factors encouraging the industry to use as many effective and efficient multi-product and multi-purpose facilities as possible. High Potency APIs frequently demonstrate high cytotoxicity in addition to high potency, so measures to minimise cross-contamination are critical to a safe production process that ensures the wellness of staff, the surroundings, and the patient.
Opportunity: Opportunities for CMOs and CDMOs are expanding
A complete High Potency API production plant necessitates thorough planning, the use of risk mitigation and assessment techniques, and a process for determining which compounds are eligible for production in each facility. The manufacture of such chemicals is hazardous to employees and the environment. Pharmaceutical companies must also be able to safely produce, store, and transport a growing number of strong substances. This demonstrates that building an effective High Potency API production plan necessitates substantial time and investment. As a result, many sponsor firms choose to seek assistance from CMOs and CDMOs for the development, production, and distribution of High Potency APIs and their formulated medicinal products, as some of these organizations have the proper equipment.
Challenges: Processes must be designed correctly
Among the most important needs for High Potency API production process is process design. The majority of High Potency APIs must be manufactured in tiny clinical and commercial quantities. However, producing gram scale GMP APIs and payloads is difficult. Ensuring containment control while using flexible and tiny equipment, especially glass equipment, is a significant problem that necessitates a customised method for each process and unit operation. It is also critical to retain proper process designs at the developmental size to guarantee that the process suits the plant equipment and capacities when scaled up. Furthermore, there is confusion in the business regarding the types of High Potency APIs. Because of an insufficient data, the classification of new APIs is uncertain due to the use of proprietary systems by various pharmaceutical corporations. These problems can be avoided with proper process designs and containment controls, which most businesses lack. All of these reasons, taken together, are expected to pose a considerable challenge to High Potency API market participants.
Global High Potency APIs Market, By Type:
Based on the Type, Global High Potency APIs Market is segment as; Innovative High Potency APIs, Generic High Potency APIs.
Global High Potency APIs Market, By Synthesis:
Based on the Synthesis, Global High Potency APIs Market is segment as; Synthetic APIs (Synthetic APIs Market By Type), Biotech APIs (Biotech APIs Market By Type, Biotech APIs Market By Product, Vaccines, Recombinant Proteins).
Global High Potency APIs Market, By Manufacturer:
Based on the Manufacturer, Global High Potency APIs Market is segment as; Captive High Potency APIs Manufacturers, Merchant High Potency APIs Manufacturers (Merchant High Potency APIs Manufacturers Market By Type, Merchant High Potency APIs Manufacturers Market By Type of Synthesis, Synthetic APIs, Biosynthetic APIs).
Global High Potency APIs Market, By Application:
Based on the Application, Global High Potency APIs Market is segment as; Oncology, Hormonal Imbalance, Glaucoma, Other Therapeutic Applications.
Global High Potency APIs Market, By Region:
North America owns the prime share of this market; this is due to the increasing prevalence of cancer, also China is growing faster in the Asia-Pacific region.
1. INTRODUCTION
1.1. Scope of the report
1.2. Market segment analysis
2. RESEARCH METHODOLOGY
2.1 Research data source
2.1.1 Secondary data
2.1.2 Primary data
2.1.3 SPER’s internal database
2.1.4 Premium insight from KOL’s
2.2 Market size estimation
2.2.1 Top-down and Bottom-up approach
2.3 Data triangulation
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1. Driver, Restraint, Opportunity and Challenges analysis
4.1.1 Drivers
4.1.2 Restraints
4.1.3 Opportunities
4.1.4 Challenges
4.2. COVID-19 Impacts of the High Potency APIs Market
5. MARKET VARIABLES AND OUTLOOK
5.1. SWOT analysis
5.1.1 Strengths
5.1.2 Weaknesses
5.1.3 Opportunities
5.1.4 Threats
5.2. PESTEL analysis
5.2.1 Political landscape
5.2.2 Economic landscape
5.2.3 Social landscape
5.2.4 Technological landscape
5.2.5 Environmental landscape
5.2.6 Legal landscape
5.3. PORTER’S five forces analysis
5.3.1 Bargaining power of suppliers
5.3.2 Bargaining power of Buyers
5.3.3 Threat of Substitute
5.3.4 Threat of new entrant
5.3.5 Competitive rivalry
5.4. Heat map analysis
6. GLOBAL HIGH POTENCY APIS MARKET, BY TYPE, 2019-2030 (USD MILLION)
6.1. Introduction
6.2. Innovative High Potency APIs
6.3. Generic High Potency APIs
7. GLOBAL HIGH POTENCY APIS MARKET, BY SYNTHESIS, 2019-2030 (USD MILLION)
7.1. Introduction
7.2. Synthetic APIs
7.2.1. Synthetic APIs Market, By Type
7.3. Biotech APIs
7.3.1 Biotech APIs Market, By Type
7.3.2 Biotech APIs Market, By Product
7.3.3 Vaccines
7.3.4 Recombinant Proteins
8. GLOBAL HIGH POTENCY APIS MARKET, BY MANUFACTURER, 2019-2030 (USD MILLION)
8.1. Introduction
8.2. Captive High Potency APIs Manufacturers
8.3. Merchant High Potency APIs Manufacturers
8.3.1 Merchant High Potency APIs Manufacturers Market, By Type
8.3.2 Merchant High Potency APIs Manufacturers Market, By Type of Synthesis
8.3.3 Synthetic APIs
8.3.4 Biosynthetic APIs
9. GLOBAL HIGH POTENCY APIS MARKET, BY APPLICATION, 2019-2030 (USD MILLION)
9.1. Introduction
9.2. Oncology
9.3. Hormonal Imbalance
9.4. Glaucoma
9.5. Other Therapeutic Applications
10. GLOBAL HIGH POTENCY APIS MARKET, BY REGION, 2019-2030 (USD MILLION)
10.1. North America
10.1.1. United States
10.1.2. Canada
10.1.3. Mexico
10.2. Europe
10.2.1. Germany
10.2.2. United Kingdom
10.2.3. France
10.2.4. Italy
10.2.5. Spain
10.2.6. Rest of Europe
10.3. Asia-Pacific
10.3.1. China
10.3.2. Japan
10.3.3. India
10.3.4. Australia
10.3.5. South Korea
10.3.6. Rest of Asia-Pacific
10.4. South America
10.4.1. Brazil
10.4.2. Argentina
10.4.3. Rest of South America
10.5. Middle East & Africa
10.5.1. Kingdom of Saudi Arabia
10.5.2. United Arab Emirates
10.5.3. Rest of Middle East & Africa
11. COMPANY PROFILES
11.1. AbbVie
11.1.1. Company details
11.1.2. Financial outlook
11.1.3. Product summary
11.1.4. Recent developments
11.2. Albany Molecular Research Inc.
11.2.1. Company details
11.2.2. Financial outlook
11.2.3. Product summary
11.2.4. Recent developments
11.3. BASF SE
11.3.1. Company details
11.3.2. Financial outlook
11.3.3. Product summary
11.3.4. Recent developments
11.4. Bayer AG
11.4.1. Company details
11.4.2. Financial outlook
11.4.3. Product summary
11.4.4. Recent developments
11.5. Boehringer Ingelheim International GmbH.
11.5.1. Company details
11.5.2. Financial outlook
11.5.3. Product summary
11.5.4. Recent developments
11.6. Bristol-Myers Squibb Company
11.6.1. Company details
11.6.2. Financial outlook
11.6.3. Product summary
11.6.4. Recent developments
11.7. Carbogen Amcis
11.7.1. Company details
11.7.2. Financial outlook
11.7.3. Product summary
11.7.4. Recent developments
11.8. Cipla Inc.
11.8.1. Company details
11.8.2. Financial outlook
11.8.3. Product summary
11.8.4. Recent developments
11.9. Corden Pharma International
11.9.1. Company details
11.9.2. Financial outlook
11.9.3. Product summary
11.9.4. Recent developments
11.10. Dr. Reddy’s Laboratories Ltd.
11.10.1. Company details
11.10.2. Financial outlook
11.10.3. Product summary
11.10.4. Recent developments
11.11. Eli Lilly and Company
11.11.1. Company details
11.11.2. Financial outlook
11.11.3. Product summary
11.11.4. Recent developments
11.12. F. Hoffmann-La Roche
11.12.1. Company details
11.12.2. Financial outlook
11.12.3. Product summary
11.12.4. Recent developments
11.13. Lonza
11.13.1. Company details
11.13.2. Financial outlook
11.13.3. Product summary
11.13.4. Recent developments
11.14. Merck & Co., Inc.
11.14.1. Company details
11.14.2. Financial outlook
11.14.3. Product summary
11.14.4. Recent developments
11.15. Novartis International AG
11.15.1. Company details
11.15.2. Financial outlook
11.15.3. Product summary
11.15.4. Recent developments
11.16. Pfizer, Inc.
11.16.1. Company details
11.16.2. Financial outlook
11.16.3. Product summary
11.16.4. Recent developments
11.17. Sanofi
11.17.1 Company details
11.17.2 Financial outlook
11.17.3 Product summary
11.17.4 Recent developments
11.18. Sun Pharmaceutical Industries, Ltd.
11.18.1. Company details
11.18.2. Financial outlook
11.18.3. Product summary
11.18.4. Recent developments
11.19. Teva Pharmaceutical Industries Ltd.
11.19.1. Company details
11.19.2. Financial outlook
11.19.3. Product summary
11.19.4. Recent developments
11.20. Viatris Inc.
11.20.1. Company details
11.20.2. Financial outlook
11.20.3. Product summary
11.20.4. Recent developments
1.1. Scope of the report
1.2. Market segment analysis
2. RESEARCH METHODOLOGY
2.1 Research data source
2.1.1 Secondary data
2.1.2 Primary data
2.1.3 SPER’s internal database
2.1.4 Premium insight from KOL’s
2.2 Market size estimation
2.2.1 Top-down and Bottom-up approach
2.3 Data triangulation
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1. Driver, Restraint, Opportunity and Challenges analysis
4.1.1 Drivers
4.1.2 Restraints
4.1.3 Opportunities
4.1.4 Challenges
4.2. COVID-19 Impacts of the High Potency APIs Market
5. MARKET VARIABLES AND OUTLOOK
5.1. SWOT analysis
5.1.1 Strengths
5.1.2 Weaknesses
5.1.3 Opportunities
5.1.4 Threats
5.2. PESTEL analysis
5.2.1 Political landscape
5.2.2 Economic landscape
5.2.3 Social landscape
5.2.4 Technological landscape
5.2.5 Environmental landscape
5.2.6 Legal landscape
5.3. PORTER’S five forces analysis
5.3.1 Bargaining power of suppliers
5.3.2 Bargaining power of Buyers
5.3.3 Threat of Substitute
5.3.4 Threat of new entrant
5.3.5 Competitive rivalry
5.4. Heat map analysis
6. GLOBAL HIGH POTENCY APIS MARKET, BY TYPE, 2019-2030 (USD MILLION)
6.1. Introduction
6.2. Innovative High Potency APIs
6.3. Generic High Potency APIs
7. GLOBAL HIGH POTENCY APIS MARKET, BY SYNTHESIS, 2019-2030 (USD MILLION)
7.1. Introduction
7.2. Synthetic APIs
7.2.1. Synthetic APIs Market, By Type
7.3. Biotech APIs
7.3.1 Biotech APIs Market, By Type
7.3.2 Biotech APIs Market, By Product
7.3.3 Vaccines
7.3.4 Recombinant Proteins
8. GLOBAL HIGH POTENCY APIS MARKET, BY MANUFACTURER, 2019-2030 (USD MILLION)
8.1. Introduction
8.2. Captive High Potency APIs Manufacturers
8.3. Merchant High Potency APIs Manufacturers
8.3.1 Merchant High Potency APIs Manufacturers Market, By Type
8.3.2 Merchant High Potency APIs Manufacturers Market, By Type of Synthesis
8.3.3 Synthetic APIs
8.3.4 Biosynthetic APIs
9. GLOBAL HIGH POTENCY APIS MARKET, BY APPLICATION, 2019-2030 (USD MILLION)
9.1. Introduction
9.2. Oncology
9.3. Hormonal Imbalance
9.4. Glaucoma
9.5. Other Therapeutic Applications
10. GLOBAL HIGH POTENCY APIS MARKET, BY REGION, 2019-2030 (USD MILLION)
10.1. North America
10.1.1. United States
10.1.2. Canada
10.1.3. Mexico
10.2. Europe
10.2.1. Germany
10.2.2. United Kingdom
10.2.3. France
10.2.4. Italy
10.2.5. Spain
10.2.6. Rest of Europe
10.3. Asia-Pacific
10.3.1. China
10.3.2. Japan
10.3.3. India
10.3.4. Australia
10.3.5. South Korea
10.3.6. Rest of Asia-Pacific
10.4. South America
10.4.1. Brazil
10.4.2. Argentina
10.4.3. Rest of South America
10.5. Middle East & Africa
10.5.1. Kingdom of Saudi Arabia
10.5.2. United Arab Emirates
10.5.3. Rest of Middle East & Africa
11. COMPANY PROFILES
11.1. AbbVie
11.1.1. Company details
11.1.2. Financial outlook
11.1.3. Product summary
11.1.4. Recent developments
11.2. Albany Molecular Research Inc.
11.2.1. Company details
11.2.2. Financial outlook
11.2.3. Product summary
11.2.4. Recent developments
11.3. BASF SE
11.3.1. Company details
11.3.2. Financial outlook
11.3.3. Product summary
11.3.4. Recent developments
11.4. Bayer AG
11.4.1. Company details
11.4.2. Financial outlook
11.4.3. Product summary
11.4.4. Recent developments
11.5. Boehringer Ingelheim International GmbH.
11.5.1. Company details
11.5.2. Financial outlook
11.5.3. Product summary
11.5.4. Recent developments
11.6. Bristol-Myers Squibb Company
11.6.1. Company details
11.6.2. Financial outlook
11.6.3. Product summary
11.6.4. Recent developments
11.7. Carbogen Amcis
11.7.1. Company details
11.7.2. Financial outlook
11.7.3. Product summary
11.7.4. Recent developments
11.8. Cipla Inc.
11.8.1. Company details
11.8.2. Financial outlook
11.8.3. Product summary
11.8.4. Recent developments
11.9. Corden Pharma International
11.9.1. Company details
11.9.2. Financial outlook
11.9.3. Product summary
11.9.4. Recent developments
11.10. Dr. Reddy’s Laboratories Ltd.
11.10.1. Company details
11.10.2. Financial outlook
11.10.3. Product summary
11.10.4. Recent developments
11.11. Eli Lilly and Company
11.11.1. Company details
11.11.2. Financial outlook
11.11.3. Product summary
11.11.4. Recent developments
11.12. F. Hoffmann-La Roche
11.12.1. Company details
11.12.2. Financial outlook
11.12.3. Product summary
11.12.4. Recent developments
11.13. Lonza
11.13.1. Company details
11.13.2. Financial outlook
11.13.3. Product summary
11.13.4. Recent developments
11.14. Merck & Co., Inc.
11.14.1. Company details
11.14.2. Financial outlook
11.14.3. Product summary
11.14.4. Recent developments
11.15. Novartis International AG
11.15.1. Company details
11.15.2. Financial outlook
11.15.3. Product summary
11.15.4. Recent developments
11.16. Pfizer, Inc.
11.16.1. Company details
11.16.2. Financial outlook
11.16.3. Product summary
11.16.4. Recent developments
11.17. Sanofi
11.17.1 Company details
11.17.2 Financial outlook
11.17.3 Product summary
11.17.4 Recent developments
11.18. Sun Pharmaceutical Industries, Ltd.
11.18.1. Company details
11.18.2. Financial outlook
11.18.3. Product summary
11.18.4. Recent developments
11.19. Teva Pharmaceutical Industries Ltd.
11.19.1. Company details
11.19.2. Financial outlook
11.19.3. Product summary
11.19.4. Recent developments
11.20. Viatris Inc.
11.20.1. Company details
11.20.2. Financial outlook
11.20.3. Product summary
11.20.4. Recent developments
