The Global HPAPI Market size is forecasted to value USD 32.17 billion by 2026 and be worth USD 21.20 billion in 2021, registering a CAGR of 8.7% from 2021 to 2026.
High Potency API (HPAPI) can be defined as pharmacologically intermediates or substances, active at concentrations of 150 micrograms per kilogram of body weight or below. They are usually highly selective and can bind to specific receptors or bind to specific enzymes, which can cause cancer, developmental disorders, and reproductive problems at low doses. Many new drugs have these high potency active pharmaceutical ingredients; hence the growth of this market is high.
These High Potency API (HPAPI) have new cures to many diseases, especially cancer. After the human genome was mapped, cancer drugs were made not only for different cancers but also for other patients. However, the production of these drugs is challenging since they are active at low concentrations. They can pose health hazards to workers if leakage during production and monitoring has to be done mostly against the contamination of drugs with foreign substances. Hence it requires specialized equipment for handling HPAPI’s and managing air quality.
MARKET DRIVERS:
The global High Potency API market is driven by factors such as their low price, a growing number of pharmaceutical manufacturers and patients, rising healthcare prices, and government initiatives to expand the usage of generic medicines to cut down healthcare costs.
The global high potency active pharmaceutical ingredients market is further growing due to a growing number of new entrants in developing countries generating quick relief therapeutics. Additionally, favorable government regulations for commercialization and research and production of novel drug molecules are expected to drive market expansion. Other factors driving market growth include the demand for oncology drugs, the demand for antibody-drug conjugates, and advances in HPAPI manufacturing technologies.
Companies in the HPAPIs market should leverage emerging economies such as India, China, and the Middle East for high-growth opportunities. Due to their large population, growing stability, and improving longevity, the demand in most of these geographies is expected to expand rapidly in the coming years. Diseases such as musculoskeletal disorders, glaucoma, and, in particular, cancer have a huge effect on people's health around the world, with developed countries experiencing faster growth rates. According to the WHO, developing countries accounted for approximately 66 percent of all cancer-related deaths in 2014. Furthermore, according to GLOBOCAN 2012, 6.8 million new cancer cases were registered in Asia in 2012; this figure is projected to grow to 8.4 million cases by 2020, suggesting a 24 percent increase. Furthermore, emerging areas have more lenient and flexible laws, making these markets highly profitable for providers unable to meet the federal government's stringent requirements. Besides that, developing countries such as India and China deliver extremely low manufacturing and labor costs and highly skilled labor, enticing players from developed regions to enter the market.
MARKET RESTRAINTS:
High equipment costs, a scarcity of skilled workers, and stringent regulatory criteria are all stumbling blocks for the high-potency API industry.
Manufacturers will also be expected to invest in advanced HPAPI-antibody conjugation facilities that include potent compound handling and biologics processing. For example, ADC Biotechnology (UK) invested USD 10 million in October 2015 to construct a manufacturing facility for advanced anti-cancer drugs. This market's growth is likely to be hindered by the need for major investments.
Even though the demand for high-potency APIs is new and increasing, pharmaceutical companies face major challenges in updating their current facilities, which can only accommodate low- or medium-potency APIs. A significant portion of the budget is allocated to specialized containment to shield workers and their surroundings from exposure. Apart from the normal GMP production facilities, contract manufacturers are expected to invest extensively in constructing new facilities that are specifically built for HPAPI manufacturing; these expenditures can often amount to millions of dollars.
Impact of COVID-19 on the global high potency API market:
COVID-19 has had a negative influence on the global economy and has affected every sector. Pharmaceuticals are one of the industries that COVID-19 has hit. High potency APIs, or HPAPIs, are extremely efficient and pharmacologically active ingredients. The high potency APIs have an exact action and can provide substantial efficacy even at low daily therapeutic doses. The COVID-19 virus has wreaked havoc on the pharmaceutical industry's manufacturing and supply chain. China is a big source of active pharmaceutical ingredients. Since China was at the epicenter of the epidemic, all production and export were stopped, and factories were shut down to prevent the virus from spreading further. These firms have been shut down due to lockdown, preventing API manufacturing and import-export in and around China. The disruption of logistic and transportation networks, which limited access and movement of goods to and from ports, further affected supplies. These demand and supply disruptions will inevitably affect production, which will affect the High Potency API market's growth.
REPORT COVERAGE:
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REPORT METRIC |
DETAILS |
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Market Size Available |
2020 to 2026 |
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Base Year |
2020 |
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Forecast Period |
2021 to 2026 |
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Segments Analysed |
By Type, Synthesis, Therapeutic Application, and Region. |
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Various analyses covered |
Global, Regional & Country Level Analysis, Segment-Level Analysis, DROC, PESTLE Analysis, Porter’s Five Forces Analysis, Competitive Landscape, Analyst Overview on Investment Opportunities |
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Regions Analysed |
North America, Europe, Asia Pacific, Latin America, Middle East, and Africa |
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Companies Analysed |
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.), Mylan Inc. (U.S.) |
This research report on the global High Potency API market has been segmented and sub-segmented based on type, synthesis, therapeutic application, and region.
High Potency API Market – By Type:
Based on type, Innovative HPAPI’s has the largest market share due to factors like many numbers of them being patented, higher price compared to generics, pharmaceutical manufacturers focusing on the production of new drugs, and demand for novel anti-cancer medicines.
High Potency API Market – By Synthesis:
Based on the synthesis, Synthetic HPAPI’s have a larger market share due to the rise of new drugs in the market, ease of production, technological improvements in synthesis, and approval for new drugs.
High Potency API Market – By Therapeutic Application:
Based on therapeutic application, the market is segmented into oncology, glaucoma, hormonal balance, etc. Oncology has the largest share in the market. Factors such as the rising incidence of cancer and the launch of new target therapies are the reason for the rise in the therapeutic segment.
High Potency API Market – By Region:
Geographically, North America had the largest share in the world market in 2019, followed by Europe. Asia-Pacific is the fastest-growing market in the world. Factors like the rising incidence of cancer increased cancer research funding, and growing demand for cancer HPAPI’s are the essential factors that are likely to propel this market's growth in the future.
KEY MARKET PLAYERS:
Some of the most promising companies in the Global High Potency API Market 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.).
RECENT MARKET HAPPENINGS:
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 &am
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