Pharmaceuticals is one of the largest and most essential industries worldwide. The global pharmaceutical market is worth over USD 1.1 trillion as of 2016 and is expected to grow in the range of 4%-7% annually over the next five years. Among the several routes of drug administration prevalent in the pharmaceutical industry, oral route is the most widely used, accounting for around 55% of the global pharmaceuticals market value. Furthermore, within orals, solid formulations are the most preferred dosages for their ease of administration, dosage accuracy, stability, and cost-effectiveness. OSDFs is a key growth segment for the global healthcare industry, especially with the growing emphasis on expanding affordable healthcare. However, the oral solid doses industry faces some competition from injectables because of the increasingly difficult-to-formulate APIs in the drug pipeline.
The consumption of specialty OSDF excipients in the key regions (see figure 1) 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.
NOTE: All other includes Japan, Southeast Asia, Brazil, the Middle East, Africa, and CIS.
Based on their primary functionality, the excipients market is categorized into four broad segments: binders and fillers, coatings, lubricants, matrix formers, and disintegrants. The most important functional category in the OSDF excipients market is binders and fillers. They account for 57% in value terms, but in volume terms, they make around 85% of the oral solid excipients consumption. Within binders and fillers, starch is the most widely used excipient type, followed by cellulosic, lactose, and polyols. The market of co-processed excipients, which are combinations of two or more excipients to provide better functional attributes than the individual excipients, was anticipated to be a high growth sub-segment a few years back; however, its growth has slowed down in some regions due to the lack of flexibility allowed by them in the selection of excipients for formulations, and in the selection of suppliers.
Figure 2: Global Value Share of Specialty Excipients for OSDFs by Functional Category, 2016
Different functionality trends and product specific trends shape the market dynamics of individual excipient chemistries in the pharmaceutical industry. The pharmaceutical coating excipients is the fastest growing functional category of excipients globally. Its market is driven not only because increasing 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.
Growth in the demand of sustained-release drugs also gives rise to the use of matrix formers, which is another effective method of retarding the drug release in solid dose formulations. This retarding of drug release is an important trend, allowing reduction in drug dosage frequency for many treatments. The main matrix former excipients include HPMC and ethyl cellulose.
The market of specialty excipients in the key regions, taken together, is forecast to grow at an annual rate close to 6% through 2021. Southeast Asia will witness the fastest growth in the consumption of OSDF excipients, followed by India. The developed markets of the United States and Europe will witness slow growth. The continued trend of outsourcing of pharmaceutical oral solid doses manufacturing, such as from the United States to India, especially for generics, will widen the gap in growth rates between the different regional markets.
After oral solids, the parenteral route is the second most widely used method for pharmaceutical drug administration, accounting for around 30% of the global pharmaceuticals market by value. The United States and Europe are by far the largest markets, together accounting for USD 0.5 billion worth of specialty parenteral pharmaceutical excipients. Since the last few years, the market of parenteral pharmaceuticals has gained much momentum driven by the increasing number of large biologics and poorly soluble APIs that cannot be formulated into oral solids. The specialty pharmaceutical parenteral excipients markets in the United States and Europe combined are expected to grow at 7.5% annually by value over the next five years.
The data is based on Kline’s two recently published studies Specialty Excipients for Oral Solid-Dosage-Form Pharmaceuticals Global Series: Market Analysis and Opportunities and Specialty Excipients for Parenteral Pharmaceuticals: Market Analysis and Opportunities.
Read full article written by Shilpi Mehrotra, Kline’s Project Manager, for Pharma Horizon > http://bit.ly/2zOZ88X