The global active pharmaceutical ingredient market is expected to reach approximately $175 billion by 2020, growing at a CAGR of around 6% during forecast period. Active pharmaceutical ingredient is any substance or mixture of substances used in a finished pharmaceutical product with pharmacological activity used for diagnosis, cure, mitigation, treatment and prevention of diseases. Very less number of finished pharmaceutical product manufacturers has their own API manufacturing unit and nobody can make all required APIs in-house. It is basically not easy for API manufacturers in developing countries to ensure a product with quality at a reasonable price. API manufacturing involves conversion of raw materials into API and mixing API and excipients for final formulations. These formulations in the form of tablets, capsules or solutions are packaged and then marketed.
Patent expiration of major drugs that increased generic drug sales, government initiatives, 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 pharmaceutical industry and fragmented market 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). Biotech API is further segmented into mammalian cell culture, monoclonal antibodies, recombinant proteins, vaccines, insulin analog, growth hormones and interferons. Mammalian cell culture accounted for the largest share in 2013, while monoclonal antibody segment is the fastest growing segment by 2020. Despite low production yields, high manufacturing cost and highly unstable cell culturing method mammalian culture is the largest due to post-translational mechanism present in living cells. Monoclonal antibodies are growing at a faster pace due to demand for biotech APIs and increasing venture capital investments that drives the market.
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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. Branded API accounted for the largest share whereas, generic is the fastest growing segment. 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 in 2013. 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 in 2013 whereas oncology segment is the fastest growing segment with a CAGR of approximately 8% by 2020. 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 during the forecast period. Asia Pacific region is the fastest growing with a CAGR of more than 7.5% by 2020 due to patent expirations of drugs, low operation costs, services of Contract Manufacturing Organizations (CMO) 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), Ranbaxy Laboratories (India), Dr. Reddy’s Lab (India), Boehringer Ingelheim GmbH (Germany), Lonza group (Switzerland), Lupin (India), Novartis (Switzerland), Aurobindo pharma (India), and Albemarle Corporation (U.S.).
1 EXECUTIVE SUMMARY 19
2 INTRODUCTION 23
2.1 KEY TAKE AWAYS 23
2.2 REPORT DESCRIPTION 23
2.3 MARKETS COVERED 25
2.4 STAKEHOLDERS 26
2.5 RESEARCH METHODOLOGY 27
2.5.1 MARKET SIZE ESTIMATION 28
2.5.2 MARKET CRACK DOWN & DATA TRIANGULATION 31
2.5.3 SECONDARY RESEARCH RESOURCES 32
2.5.4 PRIMARY RESEARCH RESOURCES 33
2.5.5 ASSUMPTIONS 33
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