While developed pharmaceutical markets such as the US and EU are expected to emerge as the main sourcing markets for pharmaceutical excipients, economies such as India, China and Brazil are expected to emerge as the main supplying countries for raw materials such as cellulose, starch, lactose etc, according to a latest market report published by Persistence Market Research (PMR), a third-platform research firm.
Formalization of good manufacturing practices for excipients is an urgent need in the global excipients market, in order to cater to rising demand for higher purity excipients in applications such as parenteral forms. According to various trade associations and regulatory agencies, global acceptance of excipients by drug manufacturers is a relatively lengthy process, which takes around seven to 10 years. This factor is expected to prolong the revenue conversion period for excipients manufacturers.
North America is estimated to dominate the pharmaceutical excipients market accounting for a maximum revenue share of the overall market by the end of 2015. By 2021 end, North America and Europe markets are expected to account for over three-fifth share of the global pharmaceutical excipients market revenue. In terms of market share by value, North America is estimated to retain its dominant position, registering a CAGR of 6.9 per cent over the forecast period.
The revenue from the global pharmaceutical excipients market is expected to expand at a CAGR of 6.7 per cent during the forecast period 2015 – 2021.
In the overall market, oral solid dosage formulations are expected to witness increased uptake owing to the ease of consumption by patients globally. Accordingly, oral application type segment is expected to witness value increase from US$ 3,327.8 million in 2015 to US$ 5,094.2 million by the end of 2021.
The prime drivers of the market include rising demand for sustained-release and controlled-release formulations, especially in oral applications, and increased demand for generics. Sustained and extended release formulations are gaining popularity as they help in maintaining patient-safety through reduced number of medicine dosages, but having increased drug efficacy. Apart from these factors, increase in the incidence of chronic diseases across regions has been spurring demand for essential drugs, which is expected to fuel demand for excipients over the forecast period.
Frequent physical audits of excipients manufacturing facilities by officials from regulatory agencies lead to the imposition of substantial operating cost burdens on excipient manufacturers, thus hampering revenue growth for excipients over the forecast period. Other market deterrents include long gestation period before a novel excipient is formally accepted in the industry. However, the situation is expected to improve over the next few years, with individual economies formulating their own good manufacturing and good distribution practice guidelines in collaboration with the International Pharmaceutical Excipient Council(IPE).
At the same time according to an by an analysis Coherent Market Insights, the global pharmaceutical excipients market which was valued at US$ 5,394.2 million in 2015,is expected to witness a robust CAGR of 6.9 per cent during the forecast period of 2016 – 2024.
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.
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 per cent 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.
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.
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, the report adds.