The global Active Pharmaceutical Ingredient (API) market size was worth at USD 134.2 billion in the year 2015 which is anticipated to reach a value of USD 239.8 billion by 2025, with CAGR of 6.0%. Rising prevalence of chronic diseases such as neurological diseases, cardiovascular diseases, can lead to the growth.
The key drivers can be the rising demand of efficient and rapid acting drugs and introduction of innovative drug production facility. Major key players are choosing for outsourcing the product from the developing regions such as India, Brazil and China, which also anticipated to drive the market.
In addition, pharmaceutical companies face tremendous loss in terms of revenue owing to the patent expiration of blockbuster drugs. Expiration of patent results in increasing focus for development of generic versions of the molecules. The R&D investment of the company are no longer valuable after patent expiration. Thus, the API outsourcing trend in rising.
Synthesis Type Insights
Based on synthesis type, the market is categorized into synthetic and biotech. Various methods are adopted by the manufacturing companies depending up on the complexity of the molecule required. Synthetic drugs are manufactured on the basis of organic chemistry in contrast to biotechnology based drugs, which are produced by utilizing molecular techniques. Further classification of biotech segment is recombinant proteins, monoclonal antibodies and vaccines.
In 2015, synthetic segment held the largest share. The key factors for the biotech APIs segment growth are large R&D investment for new biosimilars, increasing demand for protein-based medicines, and rising focus of key manufacturers toward biological drugs.
Manufacturer Type Insights
Based on the type of manufacturer, it is categorized into outsourced or merchant or in-house or captive APIs. According to market estimates, in 2015, in-house APIs was the largest segment and outsourced APIs are anticipated to be the fastest growing market.
All pharmaceutical companies does not have separate unit for the formulation of API. This has led to rise in the outsourcing of the molecules from the production sites. The need of investment in expensive production processes is eliminated by the outsourcing.
Based on the type, APIs are classified into innovative and generics. Branded products come under innovative type, whereas the generic drugs are the ones, which are available OTC (over the counter). Owing of high rate of prescription, high drug development initiatives, and high price, the innovative APIs segment dominated in 2015.
Generic segment is anticipated to be fastest-growing type, due to expirations of patents of various blockbuster drugs. Patent expirations of branded drugs have very serious negative impacts on the drug producers, as the companies face the tremendous loss after expiration. Hence the drug manufacturers prefer more generic drugs than the branded ones.
Cancer, neurological disorders & CNS, endocrinal disorders and cardiovascular diseases are some of the major applications of the API. In 2015, CVD (cardiovascular diseases) dominated the market owing to its high rate of prevalence and high product availability. CVD has been reported as the major cause of death in the U.S since many years.
In addition, oncology is expected to be the fastest-growing segment and is estimated to witness the CAGR of 7% owing to high number of products waiting approval. Moreover, increasing prevalence of cancer worldwide is anticipated to further boost market.
In 2015, API market was dominated by the North America and is anticipated to retain its position in upcoming years owing to encouraging government initiatives for generic drug usage, rising R&D expenditure, and technological advancements in the drug manufacturing practices.
Asia Pacific is anticipated to be the region with fastest growth owing to the increasing availability of cheap and affordable labour. Hence, key major companies are setting up their API production plants in developing countries of Asia Pacific such as China and India.
One of the key manufacturers of the API (Active pharmaceutical ingredients) is Teva Pharmaceuticals Ltd. Some of the additional key players in this industry includes Boehringer Ingelheim GmbH, AbbVie, Inc., Merck & Co., Inc. and Cipla, Inc., New molecule launches, collaborations, acquisitions, and regional expansions are some strategic initiatives taken by these Key players to retain their position.
API Type of Synthesis Outlook (Revenue, USD Billion, 2014 - 2025)
• Monoclonal antibodies
• Recombinant proteins
API Type of Manufacturer Outlook (Revenue, USD Billion, 2014 - 2025)
• Captive APIs
• Merchant APIs
API Type Outlook (Revenue, USD Billion, 2014 - 2025)
• Generic APIs
• Innovative APIs
API Application Outlook (Revenue, USD Billion, 2014 - 2025)
• Cardiovascular Disease
• CNS & Neurological Disorders
• Orthopedic Disorders
• Gastrointestinal Disorders
API Regional Outlook (Revenue, USD Billion, 2014 - 2025)
• North America
• Asia Pacific
• Latin America
• South Africa
Research Support Specialist, USA