Europe High Potency API’s Market Introduction and Overview
According to SPER Market Research, the Europe High Potency API’s Market is estimated to reach USD 16.68 billion by 2033 with a CAGR 10.8%.
The report includes an in-depth analysis of the Europe High Potency API’s Market, including market size and trends, product mix, distribution channels, and supplier analysis. The active pharmacological compounds with high potency are those that show results at extremely low dosages. They have a large stake in the novel medications that are being developed, which emphasizes their significance and potential uses soon. Furthermore, compared to conventional APIs, high potency active pharmaceutical ingredients (HPAPI) are effective at far lower dosage levels, which is why the healthcare industry is increasingly using them to treat critical illnesses.
Market Opportunities and Challenges
Opportunities: The market's main drivers are the expiration of drug patents, the introduction of more affordable generic alternatives, the rise in demand for cancer treatment, the large number of cancer treatment drugs under development, the growth in contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDOs). The number of collaborations between CMOs, CDMOs, and pharmaceutical companies has increased recently. These companies often lack the resources necessary to move their products from the first stages of development to production and market launch. As a result, CMOs and CDMOs work with these organizations to advance the high potency API production phases, which expands the market.
Furthermore, the pharmacological effects of branded or novel API are equivalent to those of generic high-potency API. The growing need for generic pharmaceuticals and the requirement for generic HPAPI to produce high-quality medications at competitive costs are the main factors driving the generic HPAPI market. Growing company mergers and acquisitions have also contributed to the segment's expansion.
Challenges: One of the most essential requirements for HPAPI production operations is process designs. Small clinical and commercial volumes are required for the production of the majority of HPAPI and ADC drug payloads. It is difficult to produce gram-scale GMP APIs and payloads, nevertheless. It might be difficult to maintain containment control when employing small, flexible equipment, especially glass equipment. A customized strategy is needed for each process and unit operation. Maintaining suitable process designs during the developing stage is also crucial to making sure the process suits the facility's equipment and capabilities when it is scaled up. Moreover, there is confusion in the industry as a whole around HPAPI classification.
Market Competitive Landscape
The high potency API’s market in Europe is moderately consolidated. Some of the market key players are AbbVie Inc., Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, F. Hoffmann-La Roche Ltd., Merck & Co., Inc., Mylan Inc., Novartis International AG, Pfizer, Inc., and Sanofi.
Scope of the Report:
| Report Metric | Details |
Market size available for
years | 2020-2033 |
| Base year considered | 2023 |
| Forecast period | 2024-2033 |
| Segments covered | By Type, By Synthesis, By Therapeutic Application
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| Regions covered | France, Germany, Italy, Spain, United Kingdom, Rest of Europe
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| Companies Covered | AbbVie Inc., Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, F. Hoffmann-La Roche Ltd., Merck & Co., Inc., Mylan Inc., Novartis International AG, Pfizer, Inc., and Sanofi.
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COVID-19 Impact on Europe High Potency API’s Market
The European market for High Potency Active Pharmaceutical Ingredients (HPAPIs) was greatly affected by the COVID-19 epidemic. Production and delivery of HPAPIs throughout the region had difficulties during the pandemic because to reduced manufacturing capacities, lockdown measures, and disruptions in global supply chains. Logistics and the focus of resources on containing the virus caused delays for pharmaceutical companies in clinical trials and regulatory authorization. Furthermore, the implementation of strict safety regulations and social distancing measures in manufacturing facilities impeded the efficiency of operations.
Key Target Audience:
- Pharmaceutical Companies
- Contract Manufacturing Organizations (CMOs)
- Biotechnology Companies
- Research Institutes and Academic Institutions
- Regulatory Authorities
- Investors and Financial Institutions
- Healthcare Providers and Hospitals
Our in-depth analysis of the Europe High Potency API’s Market includes the following segments:
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By Type:
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Innovative high potency API’s
Generic high potency API’s
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By Synthesis:
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Biotech high potency API’s
Synthetic high potency API’s
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By Therapeutic Application:
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Oncology
Glaucoma
Hormonal Balance
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Key Topics Covered in the Report:
- Europe High Potency API’s Market Size (FY’2024-FY’2033)
- Overview of Europe High Potency API’s Market
- Segmentation of Europe High Potency API’s Market By Type (Innovative high potency API’s, Generic high potency API’s)
- Segmentation of Europe High Potency API’s Market By Synthesis (Biotech high potency API’s, Synthetic high potency API’s)
- Segmentation of Europe High Potency API’s Market By Therapeutic Application (Oncology, Glaucoma, Hormonal Balance)
- Expansion Analysis of Europe High Potency API’s Market
- Problems and Obstacles in Europe High Potency API’s Market
- Competitive Landscape in the Europe High Potency API’s Market
- Impact of COVID-19 and Demonetization on Europe High Potency API’s Market
- Details on Current Investment in Europe High Potency API’s Market
- Competitive Analysis of Europe High Potency API’s Market
- Prominent Players in the Europe High Potency API’s Market
- SWOT Analysis of Europe High Potency API’s Market
- Europe High Potency API’s Market Future Outlook and Projections (FY’2024-FY’2033)
- Recommendations from Analyst
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 Europe High Potency API’s Market
5. Market variable 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
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. Competitive Landscape
6.1. Europe High Potency API’s Market Manufacturing Base Distribution, Sales Area, Product Type
6.2. Mergers & Acquisitions, Partnerships, Product Launch, and Collaboration in Europe High Potency API’s Market
7. Europe High Potency API’s Market, By Type (USD Million) 2020-2033
7.1. Europe High Potency API’s Market Size, Share and Forecast, By Type, 2020-2026
7.2. Europe High Potency API’s Market Size, Share and Forecast, By Type, 2027-2033
7.3. Innovative high potency API’s
7.4. Generic high potency API’s
8. Europe High Potency API’s Market, By Synthesis (USD Million) 2020-2033
8.1. Europe High Potency API’s Market Size, Share and Forecast, By Synthesis, 2020-2026
8.2. Europe High Potency API’s Market Size, Share and Forecast, By Synthesis, 2027-2033
8.3. Biotech high potency API’s
8.4. Synthetic high potency API’s
9. Europe High Potency API’s Market, By Therapeutic Application (USD Million) 2020-2033
9.1. Europe High Potency API’s Market Size, Share and Forecast, By Therapeutic Application, 2020-2026
9.2. Europe High Potency API’s Market Size, Share and Forecast, By Therapeutic Application, 2027-2033
9.3. Oncology
9.4. Glaucoma
9.5. Hormonal Balance
10. Europe High Potency API’s Market Forecast, 2020-2033 (USD Million)
10.1. Europe High Potency API’s Market Size and Market Share
11. Europe High Potency API’s Market, By Region, 2020-2033 (USD Million)
11.1. Europe High Potency API’s Market Size and Market Share By Region (2020-2026)
11.2. Europe High Potency API’s Market Size and Market Share By Region (2027-2033)
11.3. France
11.4. Germany
11.5. Italy
11.6. Spain
11.7. United Kingdom
11.8. Rest of Europe
12. Company Profile
12.1. AbbVie Inc.
12.1.1. Company details
12.1.2. Financial outlook
12.1.3. Product summary
12.1.4. Recent developments
12.2. Boehringer Ingelheim
12.2.1. Company details
12.2.2. Financial outlook
12.2.3. Product summary
12.2.4. Recent developments
12.3. Bristol-Myers Squibb
12.3.1. Company details
12.3.2. Financial outlook
12.3.3. Product summary
12.3.4. Recent developments
12.4. Eli Lilly and Company
12.4.1. Company details
12.4.2. Financial outlook
12.4.3. Product summary
12.4.4. Recent developments
12.5. F. Hoffmann-La Roche Ltd.
12.5.1. Company details
12.5.2. Financial outlook
12.5.3. Product summary
12.5.4. Recent developments
12.6. Merck & Co., Inc
12.6.1. Company details
12.6.2. Financial outlook
12.6.3. Product summary
12.6.4. Recent developments
12.7. Mylan Inc.
12.7.1. Company details
12.7.2. Financial outlook
12.7.3. Product summary
12.7.4. Recent developments
12.8. Novartis International AG
12.8.1. Company details
12.8.2. Financial outlook
12.8.3. Product summary
12.8.4. Recent developments
12.9. Pfizer, Inc.
12.9.1. Company details
12.9.2. Financial outlook
12.9.3. Product summary
12.9.4. Recent developments
12.10. Sanofi
12.10.1. Company details
12.10.2. Financial outlook
12.10.3. Product summary
12.10.4. Recent developments
12.11. Others
13. Conclusion
14. Reference Links
15. List of Abbreviations
SPER Market Research’s methodology uses great emphasis on primary research to ensure that the market intelligence insights are up to date, reliable and accurate. Primary interviews are done with players involved in each phase of a supply chain to analyze the market forecasting. The secondary research method is used to help you fully understand how the future markets and the spending patterns look likes.
The report is based on in-depth qualitative and quantitative analysis of the Product Market. The quantitative analysis involves the application of various projection and sampling techniques. The qualitative analysis involves primary interviews, surveys, and vendor briefings. The data gathered as a result of these processes are validated through experts opinion. Our research methodology entails an ideal mixture of primary and secondary initiatives.
