The global high potency active pharmaceutical ingredients (APIs) market was valued at USD 14.4 billion in 2016 and is expected to grow at a CAGR of 10.3% over the forecast period. Highly potent APIs are capable of targeting diseased cell selectively and more precisely than other compounds. Increasing incidence of cancer resulted in increasing R&D pertaining to anticancer drugs which thereby propelling the demand for HPAPIs over the forecast period.
The rising number of biotech & pharmaceutical industry and increasing investments in R&D sector in developing economies such as Asia and Latin America regions are key factors expected to provide growth platform over the forecast period.
U.S. HPAPIs market revenue by product, 2014 - 2025 (USD billion)
Rising incidence of cancer is expected to drive the HPAPI market over the forecast period. Side effects related to chemotherapy such as it also affects non cancerous cells hence targeted therapy approach is gaining popularity as it does not harm non cancerous cells. This is attributed to the rising demand of HPAPI in the future.
The characteristics possessed by these anticancerous drugs such as minimum exposure of drug to the non cancerous cell & effectiveness are the factor contributing to the market growth. In addition HPAPI are also used as antibody drug conjugates (ADCs). ADC are the most important & effective treatment in combination with monoclonal antibodies & biologically active drug for the cancer.
The drug’s use for cancer treatment is cytotoxic in nature and is harmful to the non cancerous cells which cause extensive damage to patient’s health. Pharmaceutical industry is facing challenge related to harmful side effects of these drugs on normal cells of the body. While use of less effective drug is ineffective in cancer treatment hence the need for targeted therapy approach came into existence. HPAPI target cancer tissue effectively coupled with minimum exposure of drugs to healthy tissues
HPAPI are most commonly used in hormonal drugs which are used in treatment of breast cancer. Glaucoma is the other most important application of HPAPI. Increasing demand of drugs for the treatment of glaucoma is expected to drive the market growth. The HPAPIs also found application in cardiovascular drugs, central nervous system drugs and musculoskeletal drugs.
Increasing demand for these drugs during the forecast period is anticipated to propel the market growth in coming years. In addition, rising usage of HPAPI in gynecology & cosmetics are accounted for the further growth
Segmentation of high potency API market on the basis of products is done in to synthetic and biotech. Synthetic molecules is considered to be the largest market in 2016 in terms of revenue share owing to the easier protocols for synthesis of these molecules coupled with higher availability of raw material. The biotech segment is expected to witness lucrative growth owing to the technological advancements in this segment and high level of efficacy of these ingredients.
Biotech products are expected to show significant growth during the forecast period owing to increasing demand for biologics and associated benefits such as minimum side effects and higher efficacy levels. In addition, shifting of consumer preference from synthetic to biotech molecules is factor attributing towards the higher penetration rate of biologics.
Biotech HPAPI mainly consists of drug molecules obtained after usage of molecular techniques such as recombinant DNA technology. The genes expressing these molecules are transferred into expression vector for synthesis of the higher amount of drug molecule in less time.
Biotech HPAPI is mostly peptides and other forms of enzymes. The market for Biotech HPAPI is expected to witness lucrative growth owing to the technological advancements in this segment and high level of efficacy of these ingredients.
Increasing incidence of chronic disorders such as cancer and others along with patent expiration of blockbuster drugs thereby boosting generics drug manufacturing. Rising demand for biotech synthesis drugs and introduction of innovative therapeutics are the key factors favoring competitive growth.
Incorporation of continuous process technology for the production of petrochemicals and polymers are further contributing toward the market growth. Emergence of multiple separation technology including filtration, purification and fermentation processes with advanced technology to provide growth platform to this market over the forecast period.
Manufacturers in High potency API include in-house and outsourced. In-house market dominated the overall industry in terms of revenue share owing to the higher availability of raw material and intensive capitalization of major key players in development of high end manufacturing facility. HPAPI molecules are manufactured by some pharmaceutical companies in their own manufacturing facilities. Pharmaceutical companies have made huge amount of investments in developing in house capabilities and specialized requirements for in house HPAPI investments.
Contract manufacturing services are also increasing in this field and are expected to witness lucrative growth.Contract manufacturing and outsourcing of HPAPI molecule development is growing trend in pharmaceutical sector. Companies such as Evonik and Lonza are actively involved in providing contract manufacturing services to other companies.Introduction of advancements in manufacturing technology such as single use production and batch culture fermentation for separating molecules is anticipated to offer opportunities for contract manufactures in coming years.
HPAPI drugs are segmented as innovative and generic. Innovative drugs segment dominated the drug type in terms of revenue share owing to the rising research and development activities for novel drug development coupled with favorable government initiatives. Expiration of patents of branded drug molecules is expected to increase the growth of generic drugs over the forecast period.
Established R&D facilities, increasing amount of funding and favorable regulatory structure are key factors for growth of innovative HPAPI market. Owing to extensive research in this field many novel innovative products are in pipeline and are expected to launch in the forecast period.
New entrants in this segment are expected to fuel the growth of this market. Introduction of advancements in the manufacturing of novel molecules with better efficacy and lower dosage for cancer treatment is another factor contributing toward the segment growth.
Patent expiry of branded drug molecules is primary factor attributing to lucrative growth of generic HPAPI drugs. Generic drug market is expected to show lucrative growth in countries such as India and Brazil owing to presence of unmet clinical needs in this area and high acceptance levels for OTC drugs.
HPAPI are used majorly in treatment of hormonal imbalance, oncology, glaucoma and others. Oncology segment dominated the overall industry owing to the rising cancer incidences worldwide. Cancer is estimated to be second most common cause for mortality in the U.S. Extensive R&D is also undertaken by many companies for development of drugs specific to novel biomarkers. These molecules are also widely used in Antibody Drug Conjugates (ADCs) form which is an effective and important development in the field of cancer treatment.
Hormonal followed oncology owing to increasing hormonal imbalance cases mainly in female population. Sedentary lifestyle has increased prevalence of metabolic disorders. Hormonal imbalance is growing concern in majority of countries. The disorders include sexual hormone imbalance and thyroid problems.
Glaucoma is primarily caused due to increase in blood sugar levels. Increasing lifestyle changes and growing obese population are key factors increasing the usage of glaucoma drugs.The applications of HPAPIs are developing in the treatment of neurological, cardiovascular and musculoskeletal drugs. These molecules are also find applications in certain gynecological, high potency analgesics, and cosmetic applications.
North America recorded the largest revenue of the overall industry as of 2016. The growth is primarily due to the rising chronic disease patients coupled with increasing demand for fast acting and higher efficacy drugs. Furthermore, increasing awareness pertaining to highly potent drugs, rising demand for anti-cancerous therapeutics and growing number of biotechnology industries are the factors attributing to dominant share.
North America have highly regulated and developed pharmaceutical industry. Incidence of cancer is higher, in this region hence, cancer therapy drugs show lucrative growth and is expected to be the same during the future period. Increasing incidence of older age diseases with changing lifestyle are the key contributing factors for growing demand for HPAPIs in this region.
Global HPAPIs market revenue, by region, 2016 (%)
The U.S. held the dominant market share of high potency APIs in North America. The key industry players holding majority of market share in this region are SAFC, Teva Pharmaceuticals, Bristol Myers Squibb, Cambrex Ferro, and Carbogen Amcis.
Asia Pacific region is expected to register high growth owing to the flourishing generic drug market, developing healthcare infrastructure and presence of untapped opportunities. Growing investments in biotechnology sector, supportive government initiatives and rapidly growing oncology market are the factors expected to propel the industry growth in this region.
In addition, growing generic sector business and improving healthcare facilities is anticipating the further growth in the near future. Healthcare infrastructure is growing rapidly in Asian countries, especially in India & China. The demand for oncology drugs & is expected to fuel the market growth over the forecast period.
The key companies of this industry include Lonza, Novartis International AG, BASF AG, Carbogen Amcis AG, Eli Lilly and Company, Teva Pharmaceutical Industries Ltd Bristol-Myers Squibb, Pfizer Inc., Roche Diagnostics., Hospira Inc, Boehringer Ingelheim, Covidien Plc, Merck & Co, Bayer AG, Sigma-Aldrich Corporation, and Sanofi Aventis.
The market for branded HPAPIs is consolidated with few players involved in intense competition and rivalry. Increasing production of generics is expected to trigger the competition in this market place. In addition, manufactures focus is shifting toward the implementation of strategies such as product launch post patent expiration, mergers & acquisitions and collaborations activities, geographic expansion are anticipated to keep industry rivalry at higher levels.
Moreover, rising outsourcing activities due to high cost of investment and stringent regulations for the production of HPAPI drugs which is expected to keep the competition at higher level over the forecast period. Many pharmaceutical companies are investing in new HPAPIs production facilities; some are planning existing production capacity expansion in order to meet the fast growing demand.
Captive manufacturing for HPAPIs is cost intensive and requires a lot of safety and handling specifications. Owing to this many of the drug formulating companies are closing their in-house production facility and shifting towards contract outsourcing. The HPAPIs contract outsourcing is growing in India and China due to the cost advantage.
Base year for estimation
Actual estimates/Historical data
2014 - 2016
2017 - 2025
Revenue in USD Million and CAGR from 2017 to 2025
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, UK, Germany, Japan, China, India, Brazil, Mexico, South Africa
Revenue forecast, company share, competitive landscape, growth factors and trends
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This report forecasts revenue growth at global, regional, & country levels and provides an analysis of the industry trends in each of the sub segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global high potency APIs market on the basis of product, manufacturers, drug type, application, and region:
Product Outlook (Revenue, USD Million, 2014 - 2025)
Manufacturer Outlook (Revenue, USD Million, 2014 - 2025)
Drug Type Outlook (Revenue, USD Million, 2014 - 2025)
Application Outlook (Revenue, USD Million, 2014 - 2025)
Regional Outlook (Revenue, USD Million, 2014 - 2025)
The Middle East and Africa
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