Pharmaceutical Excipients – Paving the way for Low-cost Pharmaceuticals
Pharmaceutical excipients are crucial contents of a formulation that enable effective drug absorption. Excipients must suit the intended dosage form and comply with regulatory requirements i.e. pharmacopeial standards to ensure finished product quality. Moreover, their compatibility is crucial in dosage forms that involves taste masking, coating, controlled and sustained release, and oil base (emulsifiers). The International Pharmaceutical Excipient Councils (IPE) governs the global pharmaceutical excipient manufacturing by providing harmonized excipient guidelines to manufacturers.
Excipients used in drug manufacturing serve as binders, diluents, glidents, or disintegrants. Thus, multifunctional excipients can lower the drug development and manufacturing cost of the product. Generics market has witnessed robust growth in recent times, owing to patent expiries, in turn acting as a major factor driving demand for pharmaceutical excipients. Moreover, meeting growing demand for pharmaceutical products and large patient population base would propel growth of pharmaceutical excipients market. However, stringent regulations, especially inspection of manufacturing sites by the regulatory authorities such as the FDA, MHRA and TGA has impacted the supply of pharmaceutical excipients globally.
China and India are the major suppliers of pharmaceutical excipients outside the U.S. and European markets. China is the largest supplier of low cost API and excipients. Demand for high-quality and functional excipients is high in developed markets, while emerging economies tend to prefer low cost alternatives.
The global pharmaceutical excipients market was valued at US$ 5,394.2 million in 2015 and is expected to witness a robust CAGR of 6.9% during the forecast period (2016 – 2024).
Figure 1. Global Pharmaceutical Excipients Market Size and Forecast, US$ Million and Y-o-Y Growth (%), 2014–2024
Source: Coherent Market Insights Analysis (2017)
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Oral and topical dosage forms driving the pharmaceutical excipients market growth
Consumption of excipients is very high in production of oral dosage forms such as tablets, capsules and liquids, compared to parenteral. The growth of excipients usage in oral dosage forms is expected to be 7.2% during the forecast period. Local players entering the pharmaceutical industry mark their entry with oral dosage forms, which are easier to manufacture. India, Brazil, China and U.S. are few major pharmaceutical excipients markets in terms of presence of regional pharmaceutical players. Thus, demand for excipients is projected to be high in such economies. Moreover, with growing topical solutions (cream, gel, eye drops, skin patch) in dermatology, and pain management categories, demand for excipients is also expected to grow consequently.
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Patent expiries to provide opportunities for pharmaceutical excipient manufacturers
Symbicort (Budesonide/Formoterol Fumarate Dihydrate), Cialis (Tadalafi), Velcade (Bortezomib), Alimta (Pemetrexed), Vytorin (Ezetimibe and Simvastatin), Cubicin (Daptomycin), Reyataz (Atazanavir) and Sandostatin LAR (Octreotide Acetate) are some of the major blockbuster brands going off-patent in 2017. This will pave way for generic brands boosting the demand for respective pharmaceutical excipients. According to the McKinsey’s Global Generics report, nearly US$ 97 billion of drugs will go off-patent during 2017 – 2019.
In addition, advent of biosimilars would further propel growth of the pharmaceutical excipients market. Companies are investing in development of biosimilars to capitalize on this billion dollar market opportunity. However, strict regulatory hold over approval of biosimilars is slowing the approval of biosimilars being developed, in turn hampering growth of the pharmaceutical excipients market.
Growing demand for low cost medicines
Affordable healthcare is the primary objective of health regulators globally, something that is propagated by various such initiatives in place such as Obama Care Act and the actions of Drug Price Control Order (DPCO) in India. The DPCO has capped the prices of over 467 drugs to cater to unmet need of population with low income levels. According to the IMS Health 2015 data, average price of branded products has increased from US$ 71.91 in 2010 to US$ 91.92 in 2015. On the other hand, average price of generic products has declined from US$ 26.23 in 2010 to US$ 20.92 in 2015. Pricing pressure and high competition are major attributable factors to this decline. This has further contributed to wards the growth of pharmaceutical excipients market.
Increase in preferences for low cost medicine will drive the demand for pharmaceutical excipients, especially the on form natural sources to reduce production cost of the product.
Pharmaceutical excipients are critical components of a pharmaceutical dosage form, ensuring drug safety and efficacy. Therefore, compatibility with API, adjacent excipients and dosage form are essential factors that need to be considered while selecting an excipient. Various types of excipients are used in a pharmaceutical formulations. This includes binders, diluents, glidents, disintegrants, emulsifiers, compressing agents, taste masking agents, lubricants, coating agents, sweeteners, and vehicles (base). Use of excipients is high in oral and topical dosage forms compared to parenteral. These excipients are extracted from different sources such as plant, animals, and minerals or are synthetically developed. The International Pharmaceutical Excipients Council (IPEC), formed in 1991, focuses on harmonizing manufacturing standards for pharmaceutical excipients globally.
Demand for high-quality excipients is more in developed economies, while affordability is the key criteria considered for price sensitive emerging economies. China has emerged as the largest supplier of low-cost pharmaceutical API and excipients. India is the other fast emerging market to which production of excipients is outsourced owing to lower labor and production costs. North America and Europe lead the market for excipients as the number of excipient manufacturers are high in these regions. Moreover, high cost of manufactured excipients generates higher revenue for these regions compared to cost of material produced by manufacturers in Asia Pacific. However, growing pharmaceutical drug price pressure across the globe is expected to drive growth of the markets in China and India characterized by high supply of low cost excipients.
Increasing demand for oral dosage forms is projected to propel the market growth for pharmaceutical excipients in oral application during the forecast period. Moreover, patent expiry of blockbuster drugs would fuel demand for pharmaceutical excipients in the near future. However, regular inspection of FDA approved manufacturing sites by local regulatory authorities is impacting supply of pharmaceutical excipients globally.
This report segments the global pharmaceutical excipients market on the basis of chemistry, functionality, application, and geography. On the basis of chemistry, the market is categorized into plants, animals, minerals and synthetic sources. On the basis of functionality, the market is segmented into binders, diluents, glidents, disintegrants, and others. The application segment is divided into oral, parenteral, topical and others. For comprehensive understanding of market dynamics, the global pharmaceutical excipients market is analyzed across key geographical regions namely North America, Europe, Asia Pacific, Latin America, Africa, and Middle East. Each of these regions is analyzed on basis of market findings across major countries in these regions for a macro-level understanding of the market.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.
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