Active Pharmaceutical Ingredient (API) Market by Type [Generic and Branded], Type Of Manufacturer [Merchant (Contract) Manufacturers and Captive (In-House) Manufacturers], Application [Cardiovascular Disease, Infectious Diseases, Oncology, Neurological Diseases, Diabetes, and Respiratory Diseases] – Global Outlook & Forecast 2021-2031
According to the deep-dive market assessment study conducted by Growth+ Reports, the global active pharmaceutical ingredient (API) market was pegged at ~US$ 186 billion in 2020. The market is expected to witness a CAGR of ~6% from 2021 to 2031.
Rising incidence of acute & chronic diseases, the outbreak of new disease cases, increasing launch of generics medicines & biosimilars, and growing R&D activities are some of the pivotal factors propelling the growth of the active pharmaceutical ingredient (API) market. However, high capital investment & production costs and stringent regulations for the safety & handling of APIs are likely to restrain the market growth to a certain extent.
Government bodies and numerous organizations across the globe are implementing several initiatives to fast-track the development of active pharmaceutical ingredient (API) by providing the necessary funding, grants, permissions, clearances & approvals to meet the needs of the healthcare sector. For instance, in Jun 2020, the government of India proposed to provide an incentive of US$1.3 billion (INR 10 crore) each to domestic companies setting up plants to produce 53 crucial active pharmaceutical ingredients (APIs) for which the domestic drug industry is vulnerably dependent on imports from China. This is expected to boost the domestic manufacturing of active pharmaceutical ingredients (API) in India.
Rising incidence of acute & chronic diseases and outbreak of new disease cases has increased the demand for new curable drugs for treatment. The prevalence of chronic diseases such as diabetes, cancer, coronary artery disease, chronic obstructive pulmonary disease (COPD), asthma, hepatitis, etc., has increased considerably globally in the last few decades. According to WHO, chronic diseases was estimated to account for over 73% of all deaths and 60% of the global burden of disease by 2020. The anticipated rise in patient pool is expected to raise the demand for effective treatment, which int turn is likely to boost the active pharmaceutical ingredient (API) market.
Over the past few years, clinical trials and the launch of biosimilar drugs has increased significantly. As biosimilars are generic version of patented biologic drugs, these drugs do not need to comply with the stringent requirements of various regulatory authorities. Biologics are cost-effective and have relatively shorter approval timeline as compared to patented biologics. By 2023, patents of nearly 20 oncology biologics are expected to expire, which may force many companies to invest further on biosimilar development process to develop new and more effective products thereby increasing biosimilars market, which in turn is expected to propel the active pharmaceutical ingredient (API) market.
However, high capital investment & production cost of API is expected to restrain the market to a certain extent. Construction of production facilities according to cGMP standards, its maintainance, and installation of technology & large equipments requires heavy investment which is likely to hamper the growth of the market.
The Asia Pacific region is projected to be the fastest growing active pharmaceutical ingredient (API) market. The high growth of region can mainly be attributed to developing healthcare infrastructure, availability of affordable labor force, and presence of a large number of domestic & international players . Pharmaceutical and biotechnology companies have shifted their focus to the emerging countries due to the increasing regulatory requirements and approval timeline in developed countries. Countries such as India and China in the APAC region are expected to offer significant growth opportunities owing to booming pharmaceutical industry and presence of large number of API manufacturers in the region.
Some of the prominent players operating in the active pharmaceutical ingredient (API) market are Sun Pharmaceutical Industries Ltd., Merck KGaA, GlaxoSmithKline plc., Cipla Inc., Pfizer Inc., Sanofi SAIS, Lilly, Bristol-Myers Squibb Company, Boehringer Ingelheim International GmbH, Teva Pharmaceutical Industries Ltd., among others.