Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry. In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. In fact, over 8,000 biological pharmaceutical products are currently under clinical investigation worldwide.
Given the evident benefits of biologics over small molecule drugs (including high efficacy, target specificity and favorable safety profiles), the biopharmaceutical market is poised to witness continued and consistent growth over the next several years. It is worth mentioning that some of excipients have their own effects. In order to make a stable and safer formulation it is important to reduce the exposure of excipient to make it pharmaceutical formulation compliant. The desired function of excipient in formulation of the medicinal product is to carry the active component to the target site with an active contribution in improving its biological effect, stability, appearance and patient compliance.
In addition to complexities in the manufacturing process, significant number of excipients are added in formulations and dosage forms to stabilize proteins and enhance intended properties in a biologic formulation. Further, excipients help to decrease developmental costs and provide huge opportunities to formulate products through new routes of drug delivery.
Diverse Landscape of Biopharmaceutical Excipient Manufacturers
During our research, we came across more than 40 players, which claim to offer manufacturing of biopharmaceutical excipients. As per our analysis, majority of the manufacturers are involved in the manufacturing of surfactants. This is followed by stabilizers and tonicity modifiers.
Company Competitiveness Analysis
Several biopharmaceutical excipient manufacturers are constantly making efforts to expand current capabilities to enhance their respective product portfolios and comply to evolving industry benchmarks.
Majority of the total installed capacity is dedicated to commercial scale manufacturing. Whereas rest of the capacity is being used for preclinical / clinical scale manufacturing of biopharmaceutical excipients. In addition, over 50% of the total current global, installed biopharmaceutical excipient manufacturing capacity is installed in Europe.
Considering the technical and routine operations-related challenges, an increasing number of biologics developers are increasingly relying on biopharmaceutical excipient manufacturers. The benefits of engaging such third-party service providers are numerous; for instance, contracting a supplier for medical grade biopharmaceutical excipients enables sponsors to leverage specialty biopharmaceutical excipients (available with the manufacturers), access larger capacities and achieve greater operational flexibility. Presently, there are several contract manufacturers that claim to have the required capabilities to manufacture a variety of biopharmaceutical excipients, including lipids, lactose, trehalose, mannitol, succinate, Tween 20 and benzyl alcohol. These companies are increasingly focusing on the development of co-processed multifunctional biopharmaceutical excipients to improve the stability and effectiveness of novel biotherapeutics. It is worth highlighting that biopharmaceutical excipient manufacturers are actively trying to consolidate their presence in this field by entering into strategic alliances, enhance their respective manufacturing capabilities in order to meet the growing demand for excipients used in biologics. In fact, recently, a number of deals were inked between vaccine developers and biopharmaceutical excipient manufacturers in order to cater to the urgent need for lipids for the formers’ respective COVID-19 vaccines. With outsourcing being increasingly accepted as a viable and beneficial business model within this field, we anticipate the biopharmaceutical excipient manufacturing market to grow at a steady pace in the coming years.
For more details on this emerging domain, check out the following report: