Co-Processed Excipients Benefit Market, Offer Opportunity

The excipients market is pharmaceutical manufacturing dependent, and the demand for excipients is constantly changing according to the production needs of manufacturers’ business strategies, marketing environments, and consumer demand. BCC Research reveals in its new report, Excipients in Pharmaceuticals, that as new chemical entities are produced, co-processed excipients represent a significant market opportunity for producers.

Pharmaceutical excipients are natural or synthetic ingredients used along with the active ingredient in a drug formulation. Pharmaceutical excipients are used as fillers and diluents, binders, suspension and viscosity agents, coatings, flavoring agents, disintegrants, colorants, lubricants and glidants, and preservatives. There are three classes of excipients: organic excipients, inorganic excipients, and USP water (purified water produced per United States Pharmacopeia {USP} standards).

The global excipients market should reach nearly $6.9 billion by 2020 from approximately $6.3 billion in 2015, reflecting a 5-year compound annual growth rate (CAGR) of 1.9%. The organic excipients market should reach $6.3 billion by 2020 from nearly $5.8 billion in 2015, demonstrating a 5-year CAGR of 1.7%. The inorganic excipients market should grow from $351.9 million in 2015 to $433.7 million in 2020, thanks to a five-year CAGR of 4.3%.

Growth in the demand for pharmaceuticals and biopharmaceuticals, in turn, should drive market growth in the excipients market. Also, development of innovative drugs for chronic diseases and an increase in generic drug production should accelerate demand. Increased research and development spending, growing competition, looming patent expiries, new technologies, and upcoming product launches are key market drivers, as well.

There is a need for new excipients to increase options for the formulation and delivery of the newer molecules coming through the development pipelines, including both small molecule and biologic drugs. However, in recent years, few new excipients have reached the market due to high development costs and stringent regulatory requirements.

Developing new excipients requires expensive and time-consuming safety evaluations. As a result, some manufacturers are concentrating on co-processing existing approved excipients. Innovative co-processed excipients, or excipient composites, are being engineered to achieve the properties of key components of the tableting blend in a single, highly flowable and compressible granular material.

“With the increasing development of new chemical entities, there is a huge opportunity for the development of co-processed excipients and development of such innovative co-processed excipients with multi-functionality is beneficial for the market,” says BCC Research analyst Shalini S. Dewan. “Yet co-processed excipients have yet to find their way into official monographs, which is one of the major obstacles to their success in the marketplace.”

Excipients in Pharmaceuticals (PHM010J) analyzes the market, including examinations of the effects of a crisis in the global supply chain, the demands of quality by design (QbD), and concerns about drug safety. Analyses of global market drivers and trends, with data from 2014, estimates for 2015, and projections of CAGRs through 2020 also are provided.

For more information, contact BCC Research LLC, 49 Walnut Park, Building 2, Wellesley, MA 02481, Telephone: 866-285-7215; Email: editor@bccresearch.com.