Global Active Pharmaceutical Ingredients (APIs) market was at US$ 190.5 Billion in 2022, and it will expand at a CAGR of 6.52 from 2022 to 2027. The API (active pharmaceutical ingredient) is the part of any medication that produces the intended health effects. The APIs are made from raw materials with a specified strength and chemical concentration. Some drugs, such as combination therapies, have multiple APIs that may act differently or treat different symptoms.
Active Pharmaceutical Ingredients (API) of good quality is core to manufacturing effective and safe essential drugs. The price of APIs is the main cost driver for manufacturing. Unfortunately, only a few large manufacturers of finished pharmaceutical products have their API manufacturing capabilities, and none can make all required APIs in-house. The API market provides a challenge, particularly to small manufacturers, who have limited means to verify the quality of the APIs they buy. One possible way to address this problem would be to broaden the WHO Prequalification system to include APIs for drugs on the WHO Model List for Essential Medicines.
Trends in Ageing Population
The global geriatric population is rising. According to the WHO, by 2030, every 1 out of 6 people worldwide will be 60 years or over. The population share of aged 60 years & above will increase to 1.4 billion from 1 billion in 2020. The global population aged 60 years and older will double by 2050. In addition, the number of people 80 years or older is anticipated to triple between 2020 and 2050 and reach 426 million. Aging weakens the immune system and increases a patient’s susceptibility to acquiring infectious diseases. Moreover, impairment in body functions enhances the chances of getting other conditions, such as CVD and diabetes.
Type of Molecule and Synthetic Insights
Active ingredients are the substances in drugs responsible for the beneficial health effects experienced by consumers. Based on Molecule, APIs are categorized into Small and Large. In addition, synthetic types have been classified into synthetic and biotech. Synthetic APIs, known as small molecules, constitute a large share of the pharmaceutical market, with many small-molecule drugs commercially available. On the other hand, Biotech APIs are used in biologics, which are increasingly becoming the top-selling drugs in the market. However, despite the growing demand, biologics are currently significantly fewer in number compared to small molecule drugs.
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Type Insights: Generic APIs will lead the global market
On the basis of type, the API market is categorized into generic and innovative APIs. Generic APIs will lead the global market because of promising government guidelines, recognized R&D facilities, and augmented subsidies for creative drug development. In addition, due to widespread research in this field, numerous novel, ground-breaking products are in the pipeline and are estimated to be introduced in future years. According to our research findings Worldwide Active pharmaceutical ingredients (APIs) market will surpass US$ 261.3 Billion by 2027.
Type of Manufacturers Insights
Among different types of manufacturers involved in the API market, Captive API occupied most of the revenue shares because of the stress-free obtainability of raw materials and thorough capitalization of foremost companies for the progress of high-end manufacturing facilities. Merchant API is projected to be the fastest-growing sector in the years to come. The segment development is compelled by influences like the high cost of in-house engineering of these molecules and the increasing demand for biopharmaceuticals.
Application Insights: Cardiology Dominates the Market Share
APIs find widespread application in Cardiology, Oncology, CNS & Neurology, Orthopaedics, Endocrinology, and Others. Cardiology occupied the majority share of the market due to escalating commonness of target diseases internationally. For example, as per the WHO, cardiovascular diseases may result in about 17.9 million deaths annually, where heart attacks and strokes instigate 85% of these deaths.
Regional Insights: North America Dominates the API Market Globally
API Market has been categorized geographically into North America, Latin America, Europe, Asia-Pacific, and Middle East & Africa. North America dominates in the global market and expected to increase its market in the future, owing to the rising aging population and the increasing incidences of disease. Driven by lower costs, API manufacturing has slowly shifted from the historical leaders in Western countries to newer firms in India and China.
In addition, several regulatory authorities are involved to ensure that firms manufacture APIs and final formulations in a quality manner. The geographic location of the manufacturer and market, as well as the financing source, determines which regulatory agencies are involved. For example, APIs intended for final formulations in sub-Saharan Africa are often less regulated due to weaker national regulatory agencies and cost-sensitive markets.
Key Companies & Market Share Insights
Generally speaking, the API market is very competitive with many producers. As a result, API manufacturers specialize and target their manufacturing based on market opportunities and firm skills. The presence of prominent players in this market space significantly diminishes the prospects for a new entry into the market, as it is challenging to match the high capital requirements. Some prominent players in the global active pharmaceutical ingredients market are Sanofi SA, F. Hoffmann-LA Roche Ltd, Pfizer, Abbott, Bayer AG, Merck & Co. Inc, Boehringer Ingelheim Gmbh, GlaxoSmithKline Plc, Novartis AG, Eli Lilly Company, and Teva Pharmaceutical.
- For instance, in August 2021, Teva Pharmaceutical and MED in Cell received approval from the U.S FDA for a new drug application to treat schizophrenia.
- In December 2021, Novasep invested around EUR 6 million in France to upgrade its capabilities to newer APIs in areas such as oncology, central nervous system (CNS), and infectious diseases.
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