- At present, innovative APIs remain the most popular drug type due to the advancements in technology.
- Captive manufacturers account for the largest market share.
- Demand for active pharmaceutical ingredients (APIs) is presently rising across the globe.
Active pharmaceutical ingredients (APIs) refer to the components that are biologically active within the drug and are responsible for the desired effect on the individuals. These ingredients are manufactured through a variety of processes, including chemical synthesis, recombinant DNA, fermentation processes, and isolation and recovery from natural sources.
With the rapid expiration of patented blockbuster drugs, there has been a rise in the demand for generic APIs worldwide. According to IMARC Group, the market size reached $176.3 billion in 2018. The market is fragmented in nature due to the presence of a large number of key players operating in the industry. Some of the leading active pharmaceutical ingredients companies are Pfizer, Inc., Novartis International AG, Sanofi S.A., Boehringer Ingelheim Group, Bristol-Myers Squibb Company, Teva Pharmaceutical Industries Ltd., Eli Lilly and Company, GlaxoSmithKline plc, Merck & Co., Inc. and AbbVie Inc.
Nowadays, several pharmaceutical companies are outsourcing API manufacturing to increase production, as well as introduce APIs which are more effective and cost-efficient to ensure their global access. Owing to this, several manufacturers are producing more effective APIs that can treat diseases beyond the scope of small molecule drugs.
Other than this, with the rising healthcare expenditure, governments of several second wave countries are encouraging domestic production of APIs by offering incentives to manufacturers. Looking forward, the global active pharmaceutical ingredients market is projected to reach a value of $247.2 billion by 2024, expanding at a CAGR of around 5.8% during 2019-2024.
Innovative APIs Lead the Market
The market has been segmented based on the drug type into innovative and generic APIs. At present, innovative APIs remain the most popular drug type due to the advancements in technology and an increasing number of research activities for drug discovery and development.
Captive Manufacturers Dominate the Market
Based on the type of manufacturer, captive manufacturers account for the largest market share as these manufacturers develop APIs for in-house drug formulation and have more control over the production process. They can also purchase raw materials directly from the producers, thereby reducing management and production costs. Captive manufacturers are followed by merchant API manufacturers, which are further segregated as innovative and generic merchant API manufacturers. Among these, generic merchant API manufacturers represent the largest segment, holding the majority of the total market share.
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Synthetic APIs: The Most Preferred Segment
On the basis of the type of synthesis, the market has been segregated as synthetic and biotech APIs. Presently, synthetic APIs account for the largest market share owing to the abundant availability of raw materials and easier synthesis protocols. These ingredients are further bifurcated based on the type into innovative and generic synthetic APIs.
On the other hand, biotech APIs are classified on the basis of the type as innovative biotech APIs and biosimilars. On the basis of the product, they are segmented into monoclonal antibodies, vaccines, cytokines, fusion proteins, therapeutic enzymes and blood factors. The biotech APIs market has also been divided based on the expression system into mammalian, microbial, yeast, transgenic and other expression systems.
Oncology: The Largest Application Segment for APIs
The market has been segregated on the basis of the therapeutic application into oncology, cardiovascular and respiratory, diabetes, central nervous system, neurological and other disorders. Amongst these, oncology accounts for the majority of the total market share. A considerable rise in the prevalence of cancer cases due to the rising tobacco and alcohol abuse and changing lifestyles of consumers, which have boosted the sales of oncology APIs.
North America Exhibits a Clear Dominance in the Market
North America currently enjoys the leading position in the market due to the well-established research and development (R&D) infrastructure, along with the availability of advanced technologies in the region. Also, the US Government has increased the overall healthcare expenditure in the region owing to the presence of a large geriatric population and rising prevalence of chronic diseases such as diabetes and cancer. North America is followed by Europe, Asia Pacific, Middle East and Africa, and Latin America.