Active Pharmaceutical Ingredient (API) is described as an element or mixture of substances intended to be used in a drug product. These are the main components in the manufacturing process of a drug. Secondary components described as excipients help deliver the medication to the targeted human system. These secondary components are chosen carefully since a mismatch in API can result in poor efficacy of the drug product.
The production of APIs can be integrated with the in-house facilities or can be outsourced. Outsourcing the manufacturing of these products has resulted in low costs. Series of operations are undertaken to develop APIs which involve multi-step chemical synthesis, fermentation, purification, crystallization, drying, milling, packaging, labeling, and testing.
On a broad scale, the APIs are classified into two major categories which are innovative and generic type API.
The innovative type of APIs makes use of exhaustive research process and produce drug substances which undergo a series of clinical trials. They are considered more efficacious and get patented approvals from the respective regulatory bodies. Higher input costs are subjected to this type of API production process. The business outlook for innovative type API is expected to stay positive due to greater approvals and increased spending towards research. Generic API type makes use of the innovator APIs that are rebranded with different names. According to the market database, generic type requires fewer trials and is cost-effective.
The innovative API segment has experienced a greater share in the market. This is because several companies have invested in R&D capabilities to obtain the required patent.
The APIs are produced with different synthesis processes depending on the application. The synthetic process makes of multi-step organic and chemical products to protect and prevent diseases. The biotech process makes use of biological ingredients for therapeutic or vaccination applications. Companies have started to shift their focus towards the biotech process.
Range of Applications:
The APIs are consumed to prepare a great variety of drug products that serve different purposes. The various diseases for which it can be utilized include basic communicable diseases, oncology, cardiovascular diseases, diabetes, pain management, chronic respiratory diseases, dedicated therapeutic applications, neurology, immunology, and others. Among these, cardiovascular diseases have endured a greater share in the market. This is due to changes in lifestyles and increased cases of heart diseases. More inclusive awareness was promoted by different organizations such as the world heart federation, world stroke organization, and stoke association among a few.
According to the market database, a significant rise is also observed in oncology applications. The increased demand for high-potent API for the treatment of cancer has also supported the market growth. The Antibody-Drug Conjugates (ADCs) are important to provide effective treatment against cancer cells. This is used in combination with biologically active drugs for increased efficacy.
Increased R&D investments to produce innovative type APIs have contributed significantly towards growth for this market. The global market database can be used to study other drivers associated with this market.
Further application cases of generics as an alternative in the preventive measure have acted as a catalyst for emerging economies. Increased cases of chronic diseases such as diabetes, coronary artery disease, asthma, hepatitis, and others have led to further transformations in the production process. For instance, according to the international diabetes federation in 2019, 463 million people worldwide were diagnosed with diabetes.
COVID-19 induced pandemic disrupted manufacturing processes and research activities. The business recovery is expected to be driven by the Asian countries due to low-cost manufacturing infrastructure. Wide-scale production of effective drugs before the vaccine approval was witnessed in this region.
The North America Market:
According to the market database, the region has experienced a greater share in the API market. Increased government initiatives and policies have contributed significantly towards improved safety and quality of drug products. A greater number of cardiovascular diseases in the region have led to greater awareness and the need for efficacious drug products. For instance, according to the 2019 report by the Centre for Disease Control & Prevention (CDC), close to 92.1 million in the U.S have been diagnosed with some sort of cardiovascular disease.
The region has enhanced its focus on Good Manufacturing Practices (GMP) across the market. The outsourced drug products are also verified by the Food and Drug Administration (FDA) on arrival. Improved and robust mechanisms have been installed to tackle adverse drug experiences after using specific drug products.
APAC Region Analysis:
The region has drawn increased attention due to low manufacturing costs and easy availability of labor. According to the market database, India and China are anticipated to propel growth in this region. Favorable government policies have attracted major market players to set R&D manufacturing units. In 2020, India was a key supplier of hydroxychloroquine to major countries across the world.
The region is a center for significant pharmaceutical players and has produced a holistic research environment. Continuous developments in the administrative structures for this region have contributed towards enhanced quality standards of the drug products.
Active Pharmaceutical Committee (APIC) is an essential body that serves as an intermediary for various players in the market. Under this, many companies are of the pharmaceutical sector, involved in the production activity of APIs. Standard protocols and mechanisms are supervised by APIC which strengthens the effectiveness of the drug products.