The size of the North American High Potency API Market was valued at USD 7.05 billion in 2022 and estimated to be growing at a CAGR of 8.9%, to reach USD 10.79 billion by 2027.
High Potency Active Pharmaceutical Ingredients (HPAPI) are pharmacological substances or intermediates which are active at concentrations of 150 micrograms per kilogram of body weight or below. They have high selectivity and usually bind to specific receptors or bind to enzymes which can lead to cancer, reproductive problems, and developmental disorders at low doses. Many new drugs in the market have these high potency active pharmaceutical ingredients leading to the high growth of the market.
These High Potency Active Pharmaceutical Ingredients have a wide range of applications, including cancer. After the mapping of the human genome, cancer drugs could be made not only for different patients but also for different cancers. The production of these drugs is difficult since they are active at very low concentrations and can cause health problems to workers during production and monitoring must be done against contamination of HPAPI production with contaminants. Hence it requires specialized equipment for managing air quality and handling HPAPI’s.
The North America High Potency API (HPAPI) Market has driving factors such as their low price, rising number of pharmaceutical manufacturers and patients, increasing government initiatives to expand the usage of generic medicines to cut down healthcare costs and growing healthcare prices. Some of the constraints faced by this market are the high price of equipment, lack of skilled workers and stringent regulatory requirements.
This research report on the North America HPAPI Market has been segmented and sub-segmented into the following categories:
By Type:
By Synthesis:
By Therapeutic Application:
By Country:
Regionally, North America has the largest market in this region is expected to be the fastest-growing. Factors such as the rising incidence of cancer, increasing demand for cancer research and rising funding for cancer-treating HPAPI’s are expected to propel the growth of this market.
Major Companies leading the North America High Potency API Market profiled in this report are Pfizer, Inc. (U.S.), Novartis International AG (Switzerland), Sanofi (France), F. Hoffmann-La Roche Ltd. (Switzerland), Eli Lilly and Company (U.S.), Bristol-Myers Squibb (U.S.), Boehringer Ingelheim (Germany), Teva Pharmaceutical Industries Ltd. (Israel), Merck & Co., Inc. (U.S.), AbbVie Inc. (U.S.), and Mylan Inc. (U.S.).
1.Introduction
1.1 Market Definition
1.2 Study Deliverables
1.3 Base Currency, Base Year and Forecast Periods
1.4 General Study Assumptions
2. Research Methodology
2.1 Introduction
2.2 Research Phases
2.2.1 Secondary Research
2.2.2 Primary Research
2.2.3 Econometric Modelling
2.2.4 Expert Validation
2.3 Analysis Design
2.4 Study Timeline
3. Overview
3.1 Executive Summary
3.2 Key Inferences
3.3 Epidemology
4. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
4.1 Market Drivers
4.2 Market Restraints
4.3 Key Challenges
4.4 Current Opportunities in the Market
5. Market Segmentation
5.1 Type
5.1.1 Innovative HPAPI's
5.1.2 Generic HPAPI's
5.1.3 Y-o-Y Growth Analysis, By Type
5.1.4 Market Attractiveness Analysis, By Type
5.1.5 Market Share Analysis, By Type
5.2 Synthesis
5.2.1 Biotech HPAPI's
5.2.1.1 Biotech High- otency Active Pharmaceutical Ingredients Market, By Type
5.2.1.1.1 Innovative Biotech HPAPIs
5.2.1.1.2 Biosimilars
5.2.2 Synthetic HPAPI's
5.2.2.1 Synthetic High Potency Active Pharmaceutical Ingredients Market, By Type
5.2.2.1.1 Innovative Synthetic HPAPIs
5.2.2.1.2 Generic Synthetic HPAPIs
5.2.3 Y-o-Y Growth Analysis, By Synthesis
5.2.4 Market Attractiveness Analysis, By Synthesis
5.2.5 Market Share Analysis, By Synthesis
5.3 Therapeutic Application
5.3.1 Oncology
5.3.2 Glaucoma
5.3.3 Hormonal Balance
5.3.4 Other therapeutic applications
5.3.5 Y-o-Y Growth Analysis, By Therapeutic Application
5.3.6 Market Attractiveness Analysis, By Therapeutic Application
5.3.7 Market Share Analysis, By Therapeutic Application
5.4 Manufacturer
5.4.1 Captive Manufacturers
5.4.2 Merchant Manufacturers
5.4.2.1 Merchant HPAPI Manufacturers Market, By Type
5.4.2.1.1 Innovative Merchant HPAPI Manufacturers
5.4.2.1.2 Generic Merchant HPAPI Manufacturers
5.4.2.2 Merchant HPAPI Manufacturers Market, By Type of Synthesis
5.4.2.2.1 Synthetic HPAPIs
5.4.2.2.2 Biotech HPAPIs
5.4.3 Y-o-Y Growth Analysis, By Manufacturer
5.4.4 Market Attractiveness Analysis, By Manufacturer
5.4.5 Market Share Analysis, By Manufacturer
6. Geographical Analysis
6.1 Introduction
6.1.1 Regional Trends
6.1.2 Impact Analysis
6.1.3 Y-o-Y Growth Analysis
6.1.3.1 By Type
6.1.3.2 By Synthesis
6.1.3.3 By Therapeutic Application
6.1.3.4 By Manufacturer
6.1.4 Market Attractiveness Analysis
6.1.4.1 By Type
6.1.4.2 By Synthesis
6.1.4.3 By Therapeutic Application
6.1.4.4 By Manufacturer
6.1.5 Market Share Analysis
6.1.5.1 By Type
6.1.5.2 By Synthesis
6.1.5.3 By Therapeutic Application
6.1.5.4 By Manufacturer
6.2 United States
6.3 Canada
7.Strategic Analysis
7.1 PESTLE analysis
7.1.1 Political
7.1.2 Economic
7.1.3 Social
7.1.4 Technological
7.1.5 Legal
7.1.6 Environmental
7.2 Porter’s Five analysis
7.2.1 Bargaining Power of Suppliers
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