By definition, excipients are inactive substances that serve as a medium or vehicle for pharmaceutical active drug substances. Over the years, excipients have been increasingly developed to provide important functionalities to pharmaceutical formulations. The global pharmaceutical market is worth more than USD 1.1 trillion as of 2017 and expected to grow more than 4% annually over the next five years. The global market of specialty excipients in the overall pharmaceutical industry is estimated at about USD 6.8 billion in 2017.
Among the many routes of pharmaceutical drug administration, the oral route is the most widely used, accounting for around 55% of the global pharmaceuticals market value, while the parenteral route is the second most widely used one, accounting for around 30%. Within orals, solid formulations are the most preferred dosages for their ease of administration, dosage accuracy, stability, and cost-effectiveness. Tablets continue to be the dominant pharmaceutical dosage type globally, followed by capsules.
The consumption of specialty OSDF excipients in the key regions (India, Europe, China, North America, Japan, Southeast Asia, Brazil, the Middle East, Africa, and CIS) covered by Kline’s recently published Specialty Excipients for OSDFs Database is around USD 3.5 billion. In value terms, North America is the largest market, followed by Europe. However, in volume terms, India is the largest consumer. Low-cost generic medicines, combined with the trend of outsourcing drug production to lower-cost manufacturing destinations, has made India a large global hub for oral solid dose pharmaceuticals production. The four markets of India, Europe, China, and North America together make up over 80% of the global excipients consumption in oral solid doses by value.
Based on primary functionality, the OSDF excipients market is categorized into five main segments: binders and fillers, coatings, lubricants, matrix formers, and disintegrants. The largest functional category is binders and fillers, accounting for 57% in value terms, and 85% in volume terms of the oral solid excipients consumption. Within binders and fillers, starch is the most widely used excipient type, followed by cellulosics, lactose, and polyols. The market of co-processed excipients, providing combined benefits of two or more excipients, has slowed down in some regions due to the lack of flexibility they offer in the selection of excipients and suppliers.
Among OSDFs, coatings is the fastest growing functional category globally. The market for coating excipients is driven not only because a growing number of tablets/capsules are being coated for aesthetics, but also because coatings are increasingly used to control the release profile of the drugs along with bringing properties of moisture protection and taste/odor masking. Controlled release functions of coatings, including sustained release and enteric release, are especially key drivers, as they increase patient compliance by reducing the dosage frequency and lowering the cost of treatment. Ready-to-use formulated coatings are witnessing higher growth than coating film-formers, as they prove to be more cost-effective by reducing the production process steps for formulators. Hydroxypropyl methylcellulose is the most widely used coating polymer for its versatility in different application functions, followed by polymethacrylates for their increasing use in enteric release.
Despite oral solids being the most preferred route of drug administration, they face significant competition from injectables because of the increasingly difficult-to-formulate APIs in the drug pipeline. The market of parenteral pharmaceuticals has gained much momentum in the last few years, driven by the increasing number of large biologics and poorly soluble APIs that cannot be formulated into oral solids. According to Kline’s latest study, Specialty Excipients for Parenteral Pharmaceuticals: Market Analysis and Opportunities, the United States and Europe are by far the largest markets of specialty parenteral pharmaceutical excipients, together accounting for USD 0.5 billion, which makes around 80% of the global parenteral excipients market.
There are three primary types of parenteral formulations as classified by Kline: liquid solutions, lyophilization, and suspensions. Liquid injectable solution is the most common form, which has a share of 72% in the parenteral excipients market value. Specialty parenteral excipients, as studied by Kline, comprise of a large variety of excipients, including large volume excipients, such as sodium chloride and dextrose, as well as low volume but very high value excipients like trehalose.
While the global OSDF excipients market consists of many suppliers, including large multinationals and small regional producers, the parenteral excipients market is more consolidated. Globally, the largest suppliers of OSDF excipients are Colorcon, Evonik, Dow Chemical, BASF, and Shin-Etsu, while Roquette is the largest supplier of parenteral excipients.
The market growth is estimated to be higher in the parenteral segment than in the OSDF segment over the next five years. The reasons for this include growth in biologics, poorly soluble APIs, targeted therapy oncology drugs, the growing use of liposomes, proteins, etc. The expected annual growth in the market value of OSDF excipients is nearly 6% globally, and the parenteral segment is close to 8% through 2021.
To learn more about the specialty excipients market, please refer to our two studies Specialty Excipients for Oral Solid-Dosage-Form and Solubility Enhancement in Pharmaceutical Oral Solid Dosage Forms, covering the key market trends, such as the emergence of biologics, the impact of affordable healthcare, inter-product competition, and more.