On the other hand, biotechnological methods utilize living organisms or their components to produce APIs. This includes processes such as fermentation and cell culture, which are foundational for the production of biologics and advanced therapies. As the demand for biologics increases—growing at a rate significantly higher than that of traditional small molecules—biotechnology plays an increasingly pivotal role in API production.
An essential aspect of APIs is their role in generic medications. When the patent for a branded drug expires, other companies can produce generic versions of the drug using the same API, often at a lower cost. This process promotes competition in the pharmaceutical market, ultimately benefiting consumers by providing more affordable medication options. However, regulatory standards still apply to generic drugs, ensuring that they are equivalent in safety and efficacy to their branded counterparts.