Boston, MA, June 17, 2016 --(PR.com
)-- This report analyzes the API global market in terms of market revenue ($ million) for all segments and it enables API manufacturers, pharma & biotech companies, academics, Research institutes and CRM’s to identify and analyze market expansion opportunities, manufacturing landscape and competition in API global market.
Active Pharmaceutical Ingredients/bulk drug is an active substance in drug with biological activity intended for diagnosis, treatment or prevention of disease status by altering physiological condition. API can be synthesized either chemically or biotechnological means through mammalian cell culture or fermentation process which are used for wide range of therapeutic applications. The API market is highly competitive with >3,000 firms and >5,500 manufacturing plants across the world with a higher proportion of players located in emerging regions due to favourable cost conditions and man power availability, thus leading to increased export of API products from these regions to various parts of the world. Limited number of finished pharmaceutical product manufacturers has their own in-house API manufacturing units. API manufacturers in developing countries face major challenges to develop product with quality at an affordable price, due to lower price of API and huge number of producers, which creates a price sensitive market. Some manufacturers may compromise the quality of product in order to keep prices low and boost sales, while some of the manufacturers having a larger market for their products, can sell their higher volume API’s at a slightly lower price. The average capacity utilization rate for active pharmaceutical ingredients (APIs) manufacturing facilities is estimated to be in range of 50-55%.
Patent expiration of prominent drugs led to increased generic drug sales, government initiatives for biomedical research, increasing scope of the HPAPI market, increasing aged population and regional penetration, local manufacturer expansion and high uptake of biologics are some of the factors that are driving the market growth. Whereas financial crisis, stringent regulatory policies, less investment in API pharmaceutical industry and fragmented markets are the factors that are hindering API market growth.
The global API market is segmented based on synthesis, customer base, business type and therapeutic applications. Depending on synthesis the market is classified into synthetic chemical API, biotech API and HPAPI (Highly Potent Active Pharmaceutical Ingredient). Synthetic chemicals API accounted for largest share and biotech API is the fastest growing segment. Biotech API is further segmented into monoclonal antibodies, recombinant proteins, vaccines and others. The HPAPI segment account for 9.7% share in the overall API market. HPAPI’s are the one is fastest growing segment as they can target cells in more precise manner and require relatively low doses. The majority of the highly potent drugs under development are mainly focused on oncology therapeutic applications.
By-customer base the API market is segmented into synthetic chemicals API, biotech API and HPAPI. Synthetic chemical API is further classified into branded/innovative and generic/non-branded API. Biotech API is further divided into biologics and biosimilars where biologics accounted for the largest share.
Depending on business type the API market is segmented into captive and merchant. Captive market accounted for the largest revenue, while merchant market is growing at a faster pace. Based on the therapeutic applications the global API market is categorized into eleven crucial application areas such as anti-infectives, oncology, cardiovascular and hematopoietic system, central nervous system, gastrointestinal disorder, respiratory system, hormonal-related disorder, metabolic disorder, genito-urinary disorder, musculo-skeletal disorder and others. Anti-infectives segment dominated the application market with a largest share in 2015 whereas oncology segment will be the fastest growing segment by 2022. Patent expiration of major drugs, increased incidence of various cancer diseases and aged population, high government investments for cancer research and healthcare awareness are the factors that drives the market whereas stringent regulations, failure of crucial drugs in last stage of clinical trial, and economical crisis are the factors that hampers the market growth.
Geographically API market is segmented into North America, Asia-Pacific, Europe and Rest of the world regions. North America dominated the global API market. Asia Pacific region is the fastest growing market due to low operating costs, Contract Manufacturing Organizations (CMO) services and high investments in medical research. Moreover, the high cost of skilled labor and energy are the major factors that forced European market to shift their base to countries such as India and China.
Major players in the API market include Teva Active Pharmaceutical Industries Limited (Israel), Boehringer Ingelheim GmbH (Germany), Lonza group (Switzerland), Lupin (India), Novartis (Switzerland), Aurobindo pharma (India), and Albemarle Corporation (U.S.).