Specialty Excipients for Oral Solid-Dosage-Form

The Expansion of Healthcare Will Drive the Demand for OSDF Excipients

The expansion of affordable healthcare and robust growth in generics due to increasing patent expirations of branded drugs are boosting consumption of specialty oral solid-dosage-form (OSDF) excipients globally. According to Kline’s recently published Specialty Excipients for OSDFs Database, the markets in China, CIS, Europe, India, Japan, and the United States are estimated at USD 3.5 billion and expected to grow at a compound annual growth rate (CAGR) of close to 6% during 2016-2021. While the growth is foreseen at all the industry levels, the key factors driving the growth in mature and “pharmerging” markets vary widely. In this blog, we look deeper into the most important market issues and trends affecting the industry and how suppliers can use them in their favor.

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.

Global Value Share of Specialty Excipients for
OSDFs by Key Geographic Markets, 2016

Note: All other includes Japan, Southeast Asia, Brazil, the Middle East, Africa, and CIS

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 five 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 up 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. Solubility enhancement is a key trend in the industry with the growing number of poorly soluble APIs, leading to growth in the demand of solubilizing excipients within the binders and fillers category, such as copovidone.

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.

The coating excipients market is further segmented into film-formers, which are polymer excipients used by the pharmaceutical formulators in-house to form films on the OSDFs; and ready-to-use formulated coatings, which are offered as complete coating solutions and include other ingredients, such as colors and additives for the coating media. Formulated coatings will be the faster-growing sub-segment in the global pharmaceutical coatings market 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.

Demand for the lubricant excipient, magnesium stearate, will grow in line with the global production growth of OSDFs for improving the process characteristics in the production. Disintegrant excipients, which enhance the rate at which the drug is made available for its activity, will find increased use in orally disintegrating tablets, which is an important trend stemming from the need of increased compliance with pediatric, geriatric, and psychiatric patients who have difficulty in swallowing or chewing solid medicines.

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.

All the emerging trends, trending product categories, and changes in regional market dynamics will be discussed during Kline’s free webinar – Excipients for OSDF: Where are the Growth Opportunities and What is Driving them?, which will take place on Thursday, September 7.

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