Propelled by the developments in the bulk drugs and formulations industry, pharma excipients industry is on a high growth orbit, aver industry experts.
The increasing demand for pharmaceutical and biopharmaceutical drugs and growing demand for new excipients in drug manufacturing procedures are major driving factors for the global pharmaceutical excipients market. Also, technological advancement in drug delivery systems and the emergence of innovative drugs for the treatment of chronic diseases have fuelled the growth of this market. Moreover, the growing generics market due to patent expiries of various blockbuster drugs has increased the demand of excipients for their formulation.
Growing developments in the field of medicine formulation and rise in research in the field of dosage technology are expected to drive the global excipients industry through 2014 to 2020 according to a new report by Grand View Research, Inc. The global excipients market is anticipated to reach US$ 5.22 billion by 2020, growing at a CAGR of six per cent during this period.
Introduction of novel technologies for utilization of generic drugs in the development of new formulations is expected to boost growth of this industry over the forecast period. Furthermore, increasing global geriatric population base is anticipated to significantly raise demand for pharmaceuticals as this segment of the population is prone to high risk of organ disorders and infections, thereby propelling market growth.
Increasing demand for diverse excipients pertaining to interaction with active pharmaceutical ingredients and ongoing R&D for developing sustained and immediate drug delivery techniques for novel drugs is also expected to serve as high impact driver for the growth of this industry over the forecast period.
Polymer segment dominated with respect to market share in 2014 with over 45 per cent of global excipients revenue. Factors contributing towards high revenue share of this segment in 2014 include growing demand for major polymers such as lubricants, anti-adherents, fillers/diluents, binders, disintegrants, and coating materials in the pharmaceutical and cosmetic industries.
Sugar segment is expected to register fast growth of about seven per cent over the forecast period owing to higher consumption rate of sugar in different drug formulations. Benefits associated with use of sugars as sweetening agents and disintegrants such as longer disintegration times, odourless formulations even on long storage, inert nature, and low expenses are expected to fuel growth of this segment through to 2022.
Europe was observed to be the dominant region for excipients industry accounting for 32 per cent of global revenue in 2014 owing to the presence of a large number of pharmaceutical manufacturers, high demand for medicine products as a consequence of rising geriatric population base in the western European countries.
Asia Pacific region is expected to grow at lucrative rate and its revenue is estimated to reach over US$ 1,500 million in 2020. Presence of low cost manufacturing options and high unmet medical needs in countries of this region are factors that are anticipated to attribute to growth of this industry in the given region through to 2020.
This industry is competitive in nature marked by high industry rivalry levels. Players are striving to gain competitive advantage by focusing on stringent regulations issued by regulatory bodies pertaining to safety of finished products.
In terms of geography, North America dominates the global pharmaceutical excipients market. This is due to the growth in demand for pharmaceutical and biopharmaceutical drugs in the region. In addition, technological innovations in manufacturing procedures of excipients have also propelled the growth of the market in North America. The U.S. represents the largest market for pharmaceutical excipients in North America, followed by Canada. In Europe, Germany, France, and the U.K. hold major shares of the pharmaceutical excipients market.
The pharmaceutical excipients market in Asia too, is expected to show high growth rates in the next five years. This is due to increasing investments by many excipients manufacturing companies in the region. In addition, low manufacturing and labour costs also propelled the growth of the pharmaceutical excipients market in Asia. India, China, and Japan are expected to be the fastest-growing markets for pharmaceutical excipients in Asia.
However stringent regulatory requirements for the approval of excipients obstruct the growth of the global pharmaceutical excipients market. Rapid product launches and increasing numbers of mergers and acquisitions between excipients producers are major trends observed in the global pharmaceutical excipients market.
The major companies operating in this market are Ashland Inc., Lubrizol Corporation, Evonik Industries, BASF SE, the Dow Chemical Company, Roquette, FMC Corporation, Colorcon, Inc., and Avantor Performance Materials, Inc.
At the same time the global OSDF excipients market has been growing at a rapid pace. North America is leading the market, followed by APAC and Europe. The North American market has witnessed growth because of the growth in ageing population in the US. Though OSDF excipients are used only in oral medication drugs, the ongoing research to develop new excipients is still going on and will drive market growth further in the coming years. The pharmaceutical industry is the only user of OSDF excipients and with growing R&D in this sector, the growth of the market is inevitable.
OSDF excipients are chemical compounds that are added along with API and other chemicals during the manufacture of a drug. The sole purpose of the excipients is to hold the components together in the different forms of oral dosage. Sometimes, these excipients also act as drug releasers by releasing controlled amount of the medication after ingestion of the same.
At the same time the global binder excipients market has witnessed rapid growth over the past few years. The US and Germany accounted for the major shares because of the presence of a large number of excipient manufacturers. Pharmaceutical companies are the major consumers of binder excipients.
According to Technavio's analysts the global binder excipients market to grow at a CAGR of 4.93 per cent over the period 2015-2019.
Binders are used to hold or bind materials close enough so that they form a cohesive unit; binders also act as adhesives. Binder excipients are used during medicine or drug formulations. They are used to form granules of medical powders, which under compaction can take various shapes to form a compact mass, known as tablets.
In the meanwhile according to a new market report published by Transparency Market Research , the global albumin (excipient) market would be valued at US$828.2 million by 2020, increasing from US$704.9 million in 2013 at a CAGR of 2.3 per cent between 2014 and 2020.
Albumin, as an excipient, finds wide applications in drug development, vaccine manufacture, drug delivery, and media component in vaccine production, which collectively drive the albumin market. Due to chances of contamination of finished products, such as recent incidents of contamination of animal virus of pharmaceutical products, manufacturers are working on innovative ways to reduce such occurrences.
Excipients are inactive components of a drug that are used in conjunction with API. Though they are often referred to being inert, excipients play important functional roles in drug delivery.
Some of the key functions include binding, flavouring, colouring, lubricating, and enhancing solubility of the drug. Solubility enhancing excipients are relatively new compared to the aforementioned functionalities.
However, with the introduction of an increasing number of poorly soluble drugs, the demand for solubility enhancing excipients has been on the rise, especially for OSDF applications.
Excipients offer opportunities to introduce new dosage forms, enabling the extension of patent life and enhanced excipient-related functionality. For example, colour, shape and release profiles imparted by the selective use of excipients are seen increasingly as key elements in the creation of strong product branding and can assist the design of more patient-friendly dosage forms.
The establishment of an excipients formulary can lead to more efficient use of available assets, decreased development times, harmonized specifications, worldwide formulation acceptance, and economy in product manufacturing, stated industry experts. Therefore ensuring quality of pharmaceutical excipients and their regulatory issues are an indispensable initial step to the success of drug products, say industry sources.