PHARMACEUTICAL EXCIPIENTS MARKET ANALYSIS

Stringent regulatory framework across various countries can hamper the pharmaceutical excipients market growth. Regulations around drug development and approval have become quite complex, necessitating extensive documentation and clinical trial protocols by manufacturers. Compliance with various global guidelines such as the International Council on Harmonization (ICH) has increased the cost and timelines associated with new product development and existing product upgrades. Excipients used in drug formulations are also subjected to thorough safety and toxicity evaluations. Any changes to excipient sourcing or manufacturing processes require lengthy re-validation and re-approval procedures from regulatory bodies. This poses a practical challenge for pharmaceutical companies as it does not allow for flexibility in quickly responding to market demands or disruptions in supply chains. A significant number of clinical trials and pipeline drugs had been delayed or cancelled due to long review periods and inability to make formulation changes on time. For example, according to the Government of India's Central Drugs Standard Control Organization (CDSCO) annual report for 2021-22, nearly 30% of new drug applications did not get approved primarily owing to non-compliance issues.

Market Opportunities: Potential of 3D printing in pharmaceutical manufacturing

3D printing can offer growth opportunities for the pharmaceutical excipients market by facilitating personalized drug development. Using 3D printing, customized drugs can be produced directly at the site of care for individual patient needs. This personalized approach has potential to revolutionize drug therapy by improving efficacy and compliance. Several pharmaceutical companies are actively exploring use of 3D printing for developing specialized drugs with precise release profiles or complex internal structures not possible through conventional methods. For example, trials show 3D printed medicines can be designed to release drug at different rates based on diseased area's pH or other environmental factors in the body. This targeted delivery helps improve drug performance while reducing unwanted side effects. 3D printing also allows producing patient-specific medications shaped to their unique anatomy. According to the data published by National Institutes of Health, 3D printed drugs individually tailored for each asthmatic patient resulted in 57% higher lung deposition as compared to commercially available inhalers. This can significantly improve treatment of respiratory diseases. The technology provides flexibility to alter drug formulations quickly based on latest clinical research. As per World Health Organization Report in 2021, 3D printing can address medicine shortages and affordability issues, especially for chronic therapies in developing nations.