The Global High Potency Active Pharmaceutical Ingredients Market is estimated to be USD 32.96 Bn in 2023 and is expected to reach USD 61.54 Bn by 2028 growing at a CAGR of 13.3%.Market players are integrating continuous manufacturing and containment technologies for enhanced safety and efficiency
Highly potent active pharmaceutical ingredients (HPAPIs) are pharmacologically active substances that exhibit biological activity at extremely low concentrations, such as a daily therapeutic dose of < 10 mg or an occupational exposure limit (OEL) of < 10 μg/m3 at an eight-hour time-weighted average. HPAPIs are classified based on their toxicity through occupational exposure limits (OELs). Some examples of HPAPIs are cytotoxic compounds and hormones such as estrogen. COVID-19 witnessed a positive impact on the high potency APIs market. The pandemic has provided opportunities for the key market players to invest and develop innovative HPAPIs for the treatment of infectious diseases.
The demand for high-potency active pharmaceutical ingredients is due to the increasingly adopting of targeted medicines because they are more effective and have fewer side effects than traditional chemotherapy. Targeted medicines are aimed at the disease while minimizing the off-target side effects caused to the normal cells. This leads to their higher adoption among other drugs in the market. The rising requirement for targeted medicines by the oncology sector is driven by increasing volumes and prices of oncology medicines. Furthermore, ongoing research and development activities for novel HPAPIs are being conducted to improve drug efficacy and reduce toxicity. The growing preference for outsourcing HPAPI manufacturing and the rich pipeline with targeted therapeutic drugs are likely to boost the market's growth.
Furthermore, the high risk of cross-contamination, huge capital investment, and high technical skills required for production are expected to hinder the market.
Market Segmentations
- The Global High Potency Active Pharmaceutical Ingredients Market is segmented based on Synthesis, Drug Type, Manufacturer Type, Applications, and Geography.
- By Synthesis, the market is classified into Biotech API and Synthetic API.
- The demand for Synthetic API is predicted to hold the largest market share in the forecasting period due to the higher effectiveness in treatment offered by synthetic HPAPI for a wide range of diseases at very small dosages. Moreover, with the expiry of patents associated with synthetic molecules, generics are increasingly entered into the market.
- By Drug Type, the market is classified into Innovative and Generic.
- The Generic segment is predicted to grow with the highest CAGR in the forecasting period, due to the low cost of generics as an alternative to branded drugs, a large number of patents expired branded drugs, and initiatives by governments and other regulatory bodies across the globe expecting to rise demand for generic drugs. As of 2021, more than 10,000 FDA-approved generic medications are on the market, with generics filling nine out of ten prescriptions in the U.S.
- By Manufacturer Type, the market is classified into In-house and Outsourced.
- The Outsourced segment is expected to grow fastest during the forecast period due to manufacturing reducing the company's risk, product complexity, and resource commitment, which allows for which further is expected to rise in the demand of the market.
- By Applications, the market is classified into Oncology, Hormonal Disorders, and Glaucoma.
- The Oncology segment is predicted to grow with the highest CAGR in the forecasting period due to the increasing prevalence of cancer worldwide. According to WHO 2022 updates, Cancer is a leading cause of death worldwide, accounting for nearly 10 Mn deaths in 2020, or nearly one in six deaths. The most common cancers are breast, lung, colon and rectum, and prostate. Due to the rise in cancer incidence, key market players are expanding their manufacturing capabilities to meet unmet needs.
- By Geography, the market is classified into Americas, Europe, Middle-East & Africa, and Asia-Pacific.
- America is expected to hold a major share in the high-potency APIs/HPAPI market. Chronic diseases, like cancer, are also high in the United States. According to the American Cancer Society estimation, in 2022, 1.9 Mn new cancer cases were diagnosed and 609,360 cancer deaths in the United States. The rising geriatric population and increasing prevalence and incidence of infectious diseases in this region.
Recent Development
- The Indian Minister of Health & Family Welfare and Chemical and Fertilizers announced that India had started manufacturing 35 pharmaceutical ingredients, which had been imported earlier. - 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.- March 2022
Company Profiles
The report provides a detailed analysis of the competitors in the market. It covers the financial performance analysis for the publicly listed companies in the market. The report also offers detailed information on the companies' recent development and competitive scenario. Some of the companies covered in this report are API Pharmatech, BASF SE, Pfizer Inc., Teva Pharmaceutical Industries Ltd., Viatris Inc., etc.Countries Studied
- America (Argentina, Brazil, Canada, Chile, Colombia, Mexico, Peru, United States, Rest of Americas)
- Europe (Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom, Rest of Europe)
- Middle-East and Africa (Egypt, Israel, Qatar, Nigeria, Saudi Arabia, South Africa, United Arab Emirates, Rest of MEA)
- Asia-Pacific (Australia, Bangladesh, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Sri Lanka, Thailand, Taiwan, Rest of Asia-Pacific)
Competitive Quadrant
The report includes Competitive Quadrant, a proprietary tool to analyze and evaluate the position of companies based on their Industry Position score and Market Performance score. The tool uses various factors for categorizing the players into four categories. Some of these factors considered for analysis are financial performance over the last 3 years, growth strategies, innovation score, new product launches, investments, growth in market share, etc.Ansoff Analysis
- The report presents a detailed Ansoff matrix analysis for the Global High Potency Active Pharmaceutical Ingredients Market. Ansoff Matrix, also known as Product/Market Expansion Grid, is a strategic tool used to design strategies for the growth of the company. The matrix can be used to evaluate approaches in four strategies viz. Market Development, Market Penetration, Product Development and Diversification. The matrix is also used for risk analysis to understand the risk involved with each approach.
- The publisher analyses the Global High Potency Active Pharmaceutical Ingredients Market using the Ansoff Matrix to provide the best approaches a company can take to improve its market position.
- Based on the SWOT analysis conducted on the industry and industry players, the publisher has devised suitable strategies for market growth.
Why buy this report?
- The report offers a comprehensive evaluation of the Global High Potency Active Pharmaceutical Ingredients Market. The report includes in-depth qualitative analysis, verifiable data from authentic sources, and projections about market size. The projections are calculated using proven research methodologies.
- The research report also provides a detailed market size analysis and projections in volume and value terms. The projections are calculated using verified research methodologies.
- Excel data sheet for the market size will also be provided with the report.
- The report has been compiled through extensive primary and secondary research. The primary research is done through interviews, surveys, and observation of renowned personnel in the industry.
- The report includes an in-depth market analysis using Porter’s 5 forces model, PESTLE Analysis, and the Ansoff Matrix. In addition, the impact of COVID-19 on the market is also featured in the report.
- The report includes the regulatory scenario in the industry, which will help you make a well-informed decision. The report discusses major regulatory bodies and major rules and regulations imposed on this sector across various geographies.
- The report includes Self-Assessment Form, which helps customers evaluate their position in the market compared to their competitors
- The report offers customized research - tailored uniquely to our customers with a quick turnaround time. We offer a 15% customization option at no extra charge to all our clients for any of our syndicated reports.
Report Highlights:
- A complete analysis of the market, including the parent industry
- Important market dynamics and trends
- Impact Analysis - a comprehensive assessment to confront risk and make strategic & operational decisions to counter the changes in the market environment.
- Market segmentation
- Competitive Analysis: Comparative analysis of competitor
- Historical, current, and projected size of the market based on value and volume
- Market size of the US states
- Market shares and strategies of key players
- Recommendations to companies for strengthening their foothold in the market
Table of Contents
1 Report Description
2 Research Methodology
3 Executive Summary
4 Market Dynamics
5 Market Analysis
6 Global High Potency Active Pharmaceutical Ingredients Market, By Synthesis
7 Global High Potency Active Pharmaceutical Ingredients Market, By Drug Type
8 Global High Potency Active Pharmaceutical Ingredients Market, By Manufacturer Type
9 Global High Potency Active Pharmaceutical Ingredients Market, By Applications
10 Americas' High Potency Active Pharmaceutical Ingredients Market
11 Europe's High Potency Active Pharmaceutical Ingredients Market
12 Middle East and Africa's High Potency Active Pharmaceutical Ingredients Market
13 APAC's High Potency Active Pharmaceutical Ingredients Market
14 Competitive Landscape
15 Company Profiles
16 Appendix
Companies Mentioned
- AbbVie Inc.
- API Pharmatech
- Asymchem Inc.
- BASF SE
- Bayer Ag
- Boehringer Ingelheim
- Carbogen Amcis Ag
- CordenPharma International
- Dr. Reddy’s Laboratories Ltd.
- Evonik Industries
- Lonza Ag
- Lonza Group Ag
- Pfizer Inc.
- Piramal Pharma Solutions
- Sanofi S.A.
- Sigma-Aldrich (Merck KGaA)
- Sun Pharmaceutical Industries
- Teva Pharmaceutical Industries Ltd.
- Thermo Fisher Scientific Inc.
- Viatris Inc.
