Active Pharmaceutical Ingredient (API) refers to a substance or substance combination used in manufacturing a drug product. The active pharmaceutical ingredient market has been categorized by manufacturing process, API type, drug type, therapeutic area and geography. Manufacturing processes in the global API market include captive and contract manufacturing. The captive API manufacturing segment comprises the active pharmaceutical ingredients produced for internal consumption of a pharmaceutical company. Captive manufacturing accounted for the highest market share in 2014, however the share of this market segment is expected to witness a decline due high degree of competition from contract manufacturing and reduced profitability and thus increased preference for outsourcing API production over captive production. Outsourcing production helps pharmaceutical companies focus on their core business of developing new drug products. Contract manufacturing is being preferred because of its advantage in terms of capital and labor costs, access to advanced manufacturing technologies, and benefits from the global distribution network.
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The global active pharmaceutical market is segmented into API types: synthetic chemical API and biological API. The synthetic chemical API segment held the largest share of more than 70% of active pharmaceutical market in 2014. This market segment has evolved in the past few years due to innovations in the methods of synthesizing chemical APIs, which improves their stability and potency. The large volume of the demand is an important reason for the larger share of synthetic chemical API segment. On the other hand, the biological API market segment is expected to have the highest growth rate of 8.1% during the forecast period of 2015-2023. Large pharmaceutical companies are scaling down their small molecule manufacturing facilities to focus on biologic drugs, thereby presenting greater opportunities for contract manufacturing companies. The overall cost of drug development program for biologics is less as compared to chemical APIs, primarily because of high success rates in the pipeline phase. This factor has attracted higher investments in the biologics and biosimilars market.
Drug types in the global API market include branded prescription drug, generic prescription drug and OTC drugs. The branded API segment accounted for the largest share of 76% in the global API market in 2014. The factors driving the branded prescription drugs include government initiatives that has lowered the copayment on generics while raising it on the branded drugs. The increasing demand for biological drugs and supportive policies of the European Union toward biosimilars is also one of the major driving factors to boost branded API market. Moreover, the generic prescription drugs segment is expected to grow at the highest rate of 7.3% during the forecast period. With the rising cost of healthcare, governments and payers are pushing for the increasing generics consumption over branded drugs, thus driving growth of the generic APIs market. Over-the-counter (drugs) are considered sufficiently safe and effective for use without prescriptions from health care professionals and hence would continue to grow at a steady rate during the forecast period.
Based on the therapeutic area, the global API market is segmented into various disorders such as cardiovascular, metabolic, disorders, oncology, musculoskeletal, non-steroidal anti-inflammatory drugs (NSAIDs), and others. The cardiovascular disorder segment held the largest share of global active pharmaceutical ingredient market during the forecast period. Cardiovascular, metabolic, and neurological disorders held a combined market share of over 50% in 2014 due to the rising geriatric population, increasing prevalence of cardiovascular diseases, diabetes and neurological disease globally. Whereas, the oncology segment is expected to grow at the highest rate of 8.2% during the forecast period owing to the rising prevalence of cancer. The significant growth observed in oncology API has helped companies to prefer specialized manufacturing plants for oncology drugs. The musculoskeletal disorders, NSAIDs and other therapeutics area is anticipated to grow at a steady rate during the forecast period of 2015 to 2023.
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Geographically, North America dominated the active pharmaceutical ingredient market in 2014 with a share of 35.1% owing to factors such as higher consumption of API due to the presence of major pharmaceutical companies in this region. Biologics have become one of the top-selling drugs in North America. Thus, the expected market entry of biosimilars with flexible regulatory process would further boost the API market in North America. Japan, China, India and South Korea, the leading pharmaceutical hubs in Asia are majorly responsible for almost 30% of the total market share placing the region at the second position in the world. Major factors driving the API markets in China and India are the availability of low cost production facilities and labor cost. Other factors driving the market in the region include the tax incentives, rising government expenditure on health care and government plans to restructure the fragmented industry. Europe accounted for a market share of 21.6% in 2014. The governments of various countries in Europe have started supporting the manufacture of generic drugs post the financial crisis. Patent expirations of major blockbuster drugs in Europe would fuel the growth of the API market in the near future. Demand for generic drugs is increasing not only in developed countries, but also in developing and underdeveloped countries in South America and Africa. Brazil and South Africa are the important centers of pharmaceutical manufacturing in this regional segment. Factors boosting the growth of the market in developing regions are cost-efficient manufacturing, large number of patients, rising demand for generic drugs, and improvement in the healthcare infrastructure.
Teva Pharmaceutical Industries Ltd dominated active pharmaceutical ingredients market in 2014. Major factors attributed to its dominance are broad product portfolio and high market penetration. Zhejiang Medicine Co., Ltd. and Zhejiang NHU Co., Ltd secured the second market position in 2015. North China Pharmaceutical Group Corp. (NCPC) and Northeast Pharmaceutical Group Co., Ltd. held the third position in 2015. Other players in the active pharmaceutical ingredients market include Dr.Reddy’s Laboratories Limited, Sandoz (Novartis AG), Aurobindo Pharma Limited, Zhejiang Hisun Pharmaceutical Co., Ltd. and Zhejiang Huahai Pharmaceuticals Co., Ltd. and others.