Report Overview
The global biopharmaceutical excipients market size was valued at USD 2.60 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 5.4% from 2024 to 2030. Increasing R&D investments in biosimilars, coupled with the patent expiration of top-selling biologics, are projected to propel the market. The chemical and physical instability of biopharmaceuticals and stringent manufacturing requirements need to be fulfilled for consistent yield of biologics and to ensure high cell viability are boosting the market. Moreover, the increasing adoption of multifunctional excipients, patent expiry of biological actives, and growing focus of pharmaceutical players on the generic market are factors expected to offer lucrative opportunities in the market for biopharmaceutical excipients during the forecast period.
COVID-19 Impact: Vital role of excipients in therapeutics is set to propel market demand. Pandemic Impact Post COVID Outlook Multi-functional excipients have gained significant popularity in recent years, expected to drive the market. Biopharmaceutical excipients are expected to gain traction post the pandemic outbreak, with high demand across re-purposing existing drugs & vaccine development for the management of SARS-COV-2 infection. Market participants are focusing on the development of co-processed multifunctional excipient formulations anticipated to propel market expansion. An array of effective excipient formulations are being introduced for the stabilization of vaccines and biologics during storage & processing, which is set to offer new opportunities to the market players, particularly post the pandemic outbreak.
Biopharmaceutical manufacturers are engaged in improving the administration of biologics as compared to conventional dosage forms (currently available in parental formulations). Growing demand for excipients with improved properties for biologic formulations drives the market. Polyols, glycerol, surfactants, and buffers are the most used excipients for the formulation of biologics. Moreover, companies operating in the market are developing new process development technologies.
For instance, in June 2020, Evonik launched the RESOMER Precise platform for custom manufacturing of functional polymeric excipients to allow pharmaceutical companies to control the release of their parenteral drug products with accuracy and precision. The process technology will help in optimizing drug product stability, which will reduce regulatory risk for a wide range of parenteral drug products.
Moreover, operating players are launching innovative biopharmaceutical excipients to maintain the stability of pharmaceutical products. For instance, in May 2023, Roquette introduced the novel excipient PEARLITOL ProTec in Europe . It is a unique, plant-based co-processed blend of maize starch & mannitol and can be used for stabilizing and protecting sensitive active ingredients such as probiotics.
Furthermore, an increasing number of programs to advance innovative biopharmaceutical excipients are expected to open new avenues for the market. For instance, in September 2022, the Office of New Drugs and the Center for Drug Evaluation and Research launched a voluntary Pilot Program for the Review of Innovation and Modernization of Excipients (PRIME). This program is intended to allow biopharmaceutical manufacturers to obtain FDA review of novel excipients. Such initiatives are driving the biopharmaceutical excipients market.