Evolving Landscape of Excipients
According to the International Pharmaceuticals Excipients Council, “Pharmaceutical excipients are essentially substances apart from the active pharmaceutical ingredient (API) that are rigorously tested for safety and deliberately incorporated into drug delivery systems to:
- Facilitate the drug delivery system’s production process.
- Safeguard, support, or improve the product’s stability, bioavailability, and patient satisfaction.
- Assist in product recognition and enhance overall safety.
- Enhance the drug’s effectiveness and/or delivery during usage.
- Preserve the drug product’s integrity during storage.
Beyond pharmaceuticals, excipients are also integral to cosmetics, cosmeceuticals, herbal remedies, phytopharmaceuticals, nutraceuticals, healthcare 3D printing, along with traditional and alternative medical industries. Their roles in these sectors often align with their purpose in pharmaceuticals.
Indian Excipients Sector: A Growing Industry
Turning to the Indian excipients industry, market dynamics and future forecasts in pharmaceutical and related sectors are influential. The reverse is equally true, with the Indian pharma sector expected to reach a market value of $130 billion by 2030. The cosmetics market is set to expand to $18.4 billion by 2032, while the nutraceutical sector forecasts a 3.5% growth rate from 2024 to 2030.
Certain ayurvedic products, like churnas, tailas, and tablets, use excipients, with the Ayurveda market anticipated to hit Rs 3.2 billion by 2032. Emerging fields in therapeutics also include biologics, herbals, and phytopharmaceuticals, which highlight the increased demand for excipients.
Excipient Classification and Supply to Meet Industry Needs
Excipients are organized based on multiple criteria, well known to the industry. They are classified by product use such as pharmaceutical, cosmetic, or nutraceutical, or by the route of administration like oral or topical applications. Functionality and chemical structure, such as polymers or lipids, also play a role in their categorization.
Manufacturers and suppliers are pivotal in addressing product sector demands. A flourishing excipients market could reach $21.1 billion by 2030, with prominent global companies such as Ashland Inc, Roquette Freres, and Merck KGaA in play.
India’s Role in Excipients Manufacturing and Import Dynamics
Despite existing excipient manufacturers, India heavily relies on imports, ranking among the top three countries in pharmaceutical excipient imports. Countries like the USA, China, and France are major exporters to India, contributing to price inflation due to shipping costs and a lack of local production.
**Research, Technology, and Future Growth **
India’s advantageous low production costs, combined with its established chemical industries, present opportunities for excipient manufacturing innovation. Cutting-edge research focuses on novel excipients, particularly for biologics and 3D printed products, demanding companies to expand their capabilities.
Safety remains paramount, with regulatory bodies enforcing strict standards for excipients used in drug products. National and global guidelines guide excipient qualification and safety.
Collaborative potential, government initiatives like production-linked schemes, and the development of excipient hubs can enhance India’s position in the global excipients market, spurring job creation and educational growth in excipient science.
India’s pharmaceutical ecosystem is robust, offering a favorable environment for advancing excipient manufacturing domestically, thus reducing costs and ensuring medicine affordability. Emphasis on quality assurance remains crucial to prevent health risks associated with excipient use.