The value chain of the active pharmaceutical ingredient (API) market is supported by players who specialize in specific technologies, and as a result are maintaining an edge on the back of their expertise in production. Companies such as BASF, DuPont, Dow Chemicals, and Bayer are some of the leading chemical manufacturers. API manufacturing is gradually being concentrated in the Asia-Pacific countries, particularly India, with companies such as Sun Pharma, Teva, Takeda, Orchid Pharma, and Cipla being prominent players. Demand for specialized APIs for biological drugs is increasing gradually too, which makes for a segment that is dominated by players such as PolyPeptide Group, Bachem Group, Otsuka Chemicals, and Lonza.
Major challenge for specialized active pharmaceutical ingredient manufacturers is the optimization of economies of scale through application of sophisticated technologies and enter into long-term contracts with western drug manufacturers. Through time, API manufacturers have forward integrated to manufacture their own drugs in order to expand profit margins and better explore the pharmaceutical landscape.
The global market for active pharmaceutical ingredients will be worth USD 219,601.9 by the end of 2023, mounting from its evaluated worth of USD 151,591.7 as of 2017, showcasing a CAGR of 6.4 percent during the period of 2017 to 2023. Captive manufacturing is a stronger segment than contract manufacturing in the API market, whereas synthetic chemical API are in greater demand than biological APIs. Additionally, branded prescription drugs are the leading drug type segment. The potential of demand can be expected from the therapeutic areas of cardiovascular, NSAIDs, metabolic, neurological, oncology, musculoskeletal, and other usages as well as in the regions of North America, Asia-Pacific, Europe, and the Rest of the World (RoW). Availability of technically efficient manpower and cost effectiveness is poised to turn India and thereby Asia Pacific a highly lucrative region in the near future.
The healthcare industry has been on an upward curve in the past couple of decades as a result of economic growth of a number of developing countries and robust reimbursement mandates in developed nations. As a result, the pharmaceutical manufacturers are busier than ever, catering to expanding demand generated by the prevalence of chronic diseases. In addition to that, lifestyle inflicted diseases are on the rise too, apart from increasing percentage of geriatrics in the world’s population. The analyst of the report also has highlighted the strengthening presence of Indian drug manufacturers in the API market. Indian API manufacturers have been investing to comply with the USFDA regulations, and to win contracts from the US based companies, and have been filing the drug master file (DMF) applications. All these factors are expected to reflect positively on the global active pharmaceutical ingredients market in the near future.
On the other hand, compliance with regulatory is the primary hurdle challenging the API market at every step of the way. The exporters of active pharmaceutical ingredients now have to abide by the good manufacturing practice (GMP) in the European region, while FDA is regulating quality assurance in the US and other regions. According to the analyst, while these regulations are helping to improve and maintain quality of drugs, they are also restricting the API manufacturing market especially in developing economies from Asia-Pacific. – Transparency Market Research