The global sustained release excipients market size was estimated at USD 865.9 million in 2017. Rising number of patent expirations and soaring need for pediatric and geriatric dosage forms are providing a boost to the growth of the market. Growing awareness regarding added benefits provided by sustained release formulations is also stimulating the growth of the market. Sustained release formulations significantly reduce dosage frequency and improve patient compliance.
Oral sustained drug release systems are unique in the formulation and are meticulously developed for treatment and management of various disorders. Since these drugs require fewer doses, they are easy to administer and one dose is usually sufficient for a day, which simplifies the treatment of chronic diseases. This has been a key factor promoting the adoption of these technologies. Introduction of sustained release drug delivery systems has encouraged patient-centric therapy and provided increased drug efficacy.
Sustained release systems require meticulous designing and development as they are more effective and easy to administer. Various attributes such as biocompatibility, dose titration & formulation, and type of drug release mechanism are taken into consideration while designing a particular drug delivery system.
As a majority of these require groundbreaking research and innovation, they are more expensive when compared to conventional pharmaceutical formulations. This factor is likely to restrain the growth of the market, as the affordability of these drugs may be limited to a specific set of individuals.
The oral route of delivery is the most preferred route of administration. The segment is expected to lead the market throughout the forecast period. The growth of the segment can be attributed to convenience in terms of storage, premeasured doses, portability, and noninvasive nature of the route. On the other hand, transdermal patches will emerge to be the fast-growing segment during the same period.
The intramuscular route provides rapid drug delivery and absorption, owing to which the segment is poised to represent a sizeable share in the market. Intravenous administration for sustained or prolonged acting drugs, such as long-acting injectable formulations, provide several advantages including assessed drug-release profile throughout a definite period of time, ease of application, better patient compliance, reduced dosage frequency, minimum adverse effects, and overall cost reduction of medical care
Ophthalmic route of delivery is also anticipated to post a noteworthy CAGR during the forecast period owing to the increasing number of product launches aiding treatment of cytomegalovirus, chronic non-infectious posterior uveitis, and diabetic macular edema.
Various manufacturers are developing products that help diabetic patients in managing the disease better. For instance, Bydureon BCise is an extended release system that delivers exenatide in patients and is indicated for weekly use. Also, Sustol (Granisetron) manufactured by Heron Therapeutics, Inc. is another example of a subcutaneously delivered drug that is an antiemetic used for management of nausea and vomiting, typically observed in cancer patients undergoing chemotherapy.
Polymers held the largest share in the sustained release excipients market in 2017 due to their wide usage in sustained release formulations. Higher contribution of sugars in sustained release formulations can be attributed to properties such as spherical shape and porous nature, which improves flowability and lowers friability. This makes it the choice of excipient for a wide range of pharmaceuticals.
Minerals are an important class of excipients owing to properties such as reactivity to acids, swelling capacity, specific surface area, and high absorption capacity. Use of titanium oxide in Amrix, Kadian, OxyContin, and Conzip as a major excipient is indicative of the increase in the utilization of minerals in various formulations, accelerating their growth.
Increasing use of gelatin, alcohol, and chitosan in sustained release formulations is also anticipated to propel segment growth. Use of gelatin in manufacturing powder, liquid, and oil-based pastes such as solids, semisolid, and liquid forms of formulations is expected to drive the gelatin segment in the future. Sugars used in drug formulations are also applicable as drug delivery agents in pulmonary route-based formulations.
Pharmaceutical companies are involved in developing extended drug delivery systems that would allow easy administration and improve drug efficacy. As sustained drug release systems are meticulously developed according to their usage, they prove to be beneficial for geriatric and pediatric populations. These factors are expected to impel segment growth over the forecast period.
Targeted drug delivery accounted for the largest market share in 2017, as a large number of market players have a strong product portfolio. Targeted delivery involves the delivery of the drug to a preferred site of action and prevents the drug from reaching unintended regions of the body. This averts the chances of drug toxicity. Lyrica (pregabalin) is one such drug by Pfizer, Inc. It is used for diabetic, peripheral neuropathic pain and postherpetic neuralgia.
The transdermal segment is expected to exhibit the fastest CAGR during the forecast period due to its rising use for the treatment of chronic diseases such as rheumatoid arthritis and asthma. For instance, Corplex technology by Corium International, Inc. delivers small-molecule drugs through the skin, providing a simplified way to deliver drugs.
Microencapsulation has been gaining traction in the market with an increasing number of companies adopting this method to alter drug delivery mechanisms. It results in lower toxicity when compared to conventional drug delivery systems and these systems are, therefore, preferred for geriatric and pediatric patients.
The implant segment is projected to grow at a lucrative rate during the forecast period because of its advantages such as high efficiency and continuous maintenance of drug levels in a therapeutically desired range. Retisert is a sustained release implant designed by Bausch & Lomb Incorporated, which can be used for the treatment of glaucoma. The device provides ﬂuocinolone acetonide locally for a period of 2.5 years and allows a steady predetermined rate of drug to be released.
In terms of region, North America held the largest revenue share in the market owing to high investment in R&D and the availability of highly sophisticated technologies in the region. Well-developed research infrastructure and the presence of leading pharmaceutical and biopharmaceutical companies have also fueled the regional market. Moreover, the adoption of advanced technologies and growing focus on drug discovery drives this market.
There is a wide scope for growth of the market in Europe, which includes France, Spain, and Italy, due to the rising adoption of advanced drugs in these countries. Moreover, regulatory authorities, such as the European Medicines Agency (EMA) and Medicines and Healthcare Products Regulatory Agency (MHRA), are constantly working toward ensuring high safety standards and easy access to low-cost drugs.
The Asia Pacific market is expected to register the fastest growth rate due to factors such as developing healthcare infrastructure, increasing prevalence of chronic diseases, and rising demand for highly effective therapeutics. According to the Indian Council of Medical Research, in 2016, around 1.45 million new cases of cancer were diagnosed in India, and this number is estimated to reach 1.73 million by 2020.
Moreover, geographic expansion and launch of new products by leading drug manufacturers are expected to drive the Asia Pacific market. For instance, in September 2017, Dr. Reddy’s Laboratories Ltd. launched Bupropion Hydrochloride Extended-Release Tablets, 300 mg, and 150 mg, in India.
The market constitutes a large number of global as well as local players. Some of the key players in the industry are Depomed, Inc.; Coating Place, Inc.; Corium International, Inc.; Orbis Biosciences, Inc.; Capsugel; Aradigm Corporation; and Alkermes plc.
Leading players are involved in mergers and acquisitions, strategic collaborations, regional expansions, and new product development to gain a greater revenue share in the industry. Mergers and acquisitions and strategic collaborations help companies expand their existing business as well as geographical reach.
Major players are also engaged in the launch of controlled release drug delivery technologies that are novel and unique in nature. For instance, in October 2015, Capsugel announced the launch of enTRinsic drug delivery technology, which provides complete enteric protection along with targeted release into the upper gastrointestinal tract for a variety of compounds.
In addition, key participants are indulged in mergers and acquisitions to expand their existing product portfolios. For instance, in January 2016, Capsugel announced the completion of its acquisition of Xcelience and Powdersize, which was aimed at aiding the company in expanding its dosage form solutions business segment.
Base year for estimation
Actual estimates/Historical data
2015 - 2016
2018 - 2026
Revenue in USD Million & CAGR from 2018 to 2026
North America, Europe, Asia Pacific, Latin America, MEA
U.S., Canada, U.K., Germany, Japan, China, India, Brazil, Mexico, South Africa
Revenue forecast, company share, competitive landscape, growth factors and trends
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2015 to 2026. For the purpose of this study, Grand View Research has segmented the global sustained release excipients market report on the basis of product, route of administration, technology, and region:
Product Outlook (Revenue, USD Million, 2015 - 2026)
Route of Administration Outlook (Revenue, USD Million, 2015 - 2026)
Technology Outlook (Revenue, USD Million, 2015 - 2026)
Regional Outlook (Revenue, USD Million, 2015 - 2026)
Middle East & Africa
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Multiple therapeutic regimens are being followed across the globe in attempts to come up with a reliable treatment for Covid-19. One line of treatment includes the use of hydroxychloroquine, while a second treatment line focuses to use antiviral drugs used in the disease management of HIV. Both these approaches have surged demand from advanced antivirals and antimalarial drugs. This impacts the drug manufacturers as an off label indication for these drug classes has to be worked upon. At the moment, the WHO has not prescribed any of these approaches, neither they have commented if one is better than the other. The report will account for Covid19 as a key market contributor.