TheActive Pharmaceutical Ingredients (API) Marketis expected to reach USD 251.3 billion in 2028 from USD 182.5 billion in 2020 at a CAGR of 6.2% during the forecast period.An API is a component of any drug that produces its effects. Some medicines, such as combination therapies, have many active ingredients for treating different symptoms or targeting in different ways. They are manufactured using high-tech industrial processes, both during the R&D and commercial production phases.
The occurrence of chronic diseases such as diabetes, coronary heart disease, chronic obstructive pulmonary disease (COPD), asthma, hepatitis, arthritis, and cancer has increased worldwide in the last few decades. It is due to lifestyle changes, dietary changes due to rapid urbanization, lower mortality rate i.e., by 2050, more than 20% of the world's population is expected to be over 65-year-old and thus more prone to said health issues. The recent upsurge in infectious diseases is also set on creating a relying market.
The high cost of producing APIs is one of the biggest challenges market players face. Manufacturers often must invest expensively to upgrade their production facilities to ensure compliance with standards such as cGMP. This includes setting up production facilities, focusing on familiarity with educational requirements and procedures, and creating adoseof product testing that meets the requirements of regulatory authorities. Such cost of obtaining regulatory permits is excessive for small-scale firms. Chemical integration of APIs also often requires premium and unconventional building blocks as well as immature materials, which can further add to the production costs of the API.
The rising factors driving the growth of active pharmaceutical ingredients markets are the increasing number of off-patent biologic drugs and the demand for biosimilars in different therapeutic applications (such as rheumatoid arthritis and blood disorders). Biosimilars are standard versions of patented biology; therefore, they do not need to comply with the strict requirements of the various regulatory authorities. The expiration of patents and other intellectual property rights of the founder of biological sciences over the next decade is expected to open up opportunities for biosimilars to enter the market.
Based on the type, the active pharmaceutical market is divided into innovative and standard APIs. Increased FDA approvals for new cellular organizations, higher prices for generic APIs compared to generic drugs, increased focus on R&D by companies developing API are features that contribute to the growth of part of innovative APIs. Based on the application, the market for active pharmaceutical ingredients is divided into infectious diseases, oncology, heart disease, diabetes, pain management, chronic respiratory diseases, and other therapeutic applications, as well as, neurology, immunology, hematology, critical care, pulmonology, haemato-oncology, rheumatology, and other applications.
Geographically, the market for active pharmaceutical ingredients is divided into North America, Europe, Asia, and the rest of the world. North America, currently dominates the active pharmaceutical market and is expected to continue its strength for another few years. The United States owns most of the markets in the region. A large part of North America in the global market has been caused by an increase in the incidence of preventable diseases, government focus on generic drugs, demand for biologic drugs, and technological advances in API implementation processes.
Key market players in the active pharmaceutical ingredients market include Pfizer (USA), Novartis International AG (Switzerland), Merck & Co. (USA), Teva Pharmaceutical Industries (Israel), Mylan N.V. (USA), Boehringer Ingelheim (Germany), F. Hoffmann-La Roche AG (Switzerland), Sanofi (France), AbbVie (USA), Eli Lilly and Company (USA), AstraZeneca (UK), Bristol-Myers Squibb (USA) and GlaxoSmithKline (UK).