The global controlled release drug delivery market size was valued at USD 31.96 billion in 2017. It is expected to witness a CAGR of 14.0% during the forecast period. Increasing acceptance of these dosage forms, ease of administration, and necessity of geriatric and pediatric dosage forms are among the primary growth stimulants for the market.
Upsurge in usage of these delivery systems has been witnessed in geriatric and pediatric population as ease of administration can be effectively achieved. Major pharmaceutical and biopharmaceutical companies are investing in research and development to design therapeutics that are delivered with benefits of these systems.
Controlled release drug delivery systems allow reduction in amount of dose and dosage frequency, enhanced patient compliance and acceptance, less fluctuation in plasma drug levels, uniform drug effect, and improved efficacy ratio of administered therapeutic. In comparison to conventional delivery, these systems achieve a prolonged therapeutic effect, increase predictability in drug release kinetics, and bring about delivery at a pre-determined rate locally or systematically. Thus, with several added advantages offered by these systems, their adoption is slated to increase at a noteworthy rate over the coming years.
Oral controlled drug release systems are unique in formulation and are meticulously developed for usage in treatment and management of disorders. Since these require minimal dosage frequency, they are easy to administer to patients. Since these therapeutics provide increased compliance, treatment of chronic diseases also prove to be simplified with their adoption. Thus, many developers in the market are focusing on systems that cater to such specific therapeutics intended for use in geriatric and pediatric patients. The trend is estimated to fuel growth prospects.
On the basis of technology, the market has been segmented into Wurster technique, coacervation, micro encapsulation, implants, transdermal, targeted delivery, and others. Targeted delivery held the largest share in the market in 2017 as a large number of market participants have a strong portfolio for the technology.
Targeted delivery offers preferred site of action and can aid in allowing drugs to be away from sites that might lead to drug toxicity. Since these systems provide increased patient compliance, targeted technologies provide localization of drug, which leads to uniform effect, reduced fluctuation in circulating drug levels, and low risk of side-effects.
Microencapsulation has been gaining traction owing to increasing number of companies adopting this method to alter delivery mechanism. Microencapsulation offers reduced toxicity in comparison to conventional delivery systems, therefore they are preferred by doctors for geriatric and pediatric populations.
Implantable systems provide improved efficiency, reduced side-effects, convenience, and ensure linear delivery of drugs over a specified period of time. Coacervates represent a novel class of drug delivery vehicles, developed in the past decade as carriers of small molecule therapeutics and proteins. These include heparin-based coacervates with synthetic polycations for controlled growth factor delivery. With an increasing usage of these systems, they are anticipated to command considerable share in the market in near future.
The market, on the basis of release mechanism, has been divided into activation modulated, micro reservoir feedback regulated, partition controlled, polymer matrix systems, and chemically activated systems. Polymer matrix systems accounted for a large share in the market in 2017 owing to their ability to be loaded with therapeutics enabling controlled and spatial release.
Rate of dissolution and ability to control drug diffusion are some of the prominent factors contributing to the growth of the segment. Micro reservoir partition delivery consists of a drug reservoir in a suspension of drug solid particles in an aqueous solution of a water miscible polymer such as polyethylene and glycols. Usage of this release mechanism allows enhanced drug diffusion and uniform dispersal.
Chemically activated systems consist of pH activated, hydrolysis activated, and enzyme activated systems. OROS extended-release technology is an osmotic pressure activated drug delivery system developed by Alza Corporation that delivers INVEGA over an extended period of time in patients.
In recent past, chemically activated delivery systems have gaining tremendous popularity. Market players are also investing in the segment in order to strengthen their portfolio. For instance, LYRICA Pregabalin and QuilliChew ER chewable tablets, marketed by Pfizer, Inc., are chemically activated delivery systems that offer controlled release. The segment is projected to represent sizeable share in the controlled release drug delivery market throughout the forecast horizon.
Based on application, the market has been classified into injectables, drug eluting stents. oral controlled, transdermal and ocular patches, infusion pumps, and metered dose inhalers. The oral controlled segment was the leading revenue contributor in the market in 2017 owing to its frequent usage and availability.
In recent past, metered dose inhalers that make use of nanoparticles and polymeric materials are being used on an increasing scale to administer therapeutics in a controlled form. Controlled drug release in treatment of pulmonary diseases aids in more ways than one as it allows therapeutic to be delivered at desired site of action, thus ensuring significant reduction in frequency of dosage.
Prolonged drug release and cell-specific targeted delivery are some of the other advantages offered by usage of these devices. Aradigm Corporation’s current product pipeline consists of three drugs for treatment of bronchiectasis, cystic fibrosis, and smoking cessation that make use of metered dose inhalers as they are a relatively easy way to administer drugs.
Injectables held a considerably large share in the market in 2017 owing to a wide product diversity and usage in treatment of various diseases. Long acting injectables are preferred to conventional forms of delivery as they offer several advantages, including predictable drug release profile during a definite period of time, enhanced patient compliance, improved systemic availability of drugs, ease of application, and thus an overall reduction on medical costs incurred.
In 2017, North America was the leading regional market in the global arena. Supportive government initiatives pertaining to development of controlled release drug delivery and growing investments in R&D are supplementing the growth of the market in the region. Besides this, domicile of prominent market players is promoting the adoption of controlled release drug delivery systems.
Rising number of NDA and ANDA applications in the region is also playing an important role in the development of the regional market. Apart from this, increasing burden of chronic diseases such as cancer, diabetes, and cardiac disorders is stimulating the growth of the North America market. Spiraling utilization of controlled release drug delivery systems for treatment of hypertension is one of the key trends escalating the growth of the regional market.
Europe accounted for the second largest share in 2017 owing to increasing research and developmental activities and presence of major pharmaceutical companies in the region. With significant rise in patients suffering from chronic diseases such as cancer, diabetes and COPD diseases, the regional market is poised to tread along a healthy growth track over the coming years.
Asia Pacific is likely to witness the highest CAGR during the forecast period. The region has been gaining global attention due to increasing development in the pharmaceutical industry. Rapid expansion in the Indian and Chinese pharmaceutical industry is positively affecting the market in the region. Presence of large geriatric population in Japan is another major factor triggering product adoption.
Key market participants include Orbis Biosciences, Inc.; Merck and Co., Inc.; Alkermes plc; Johnson and Johnson; Coating Place, Inc.; Corium International, Inc.; Depomed, Inc.; Pfizer, Inc; Aradigm Corporation; and Capsugel. The market is highly fragmented as several developers are engaged in development of drugs that cater to specific patient requirements.
Various companies make use of a wide range of technologies that ensure controlled release. Major pharmaceutical companies are also indulged in implementing controlled release to increase consumer base and product penetration. Thus, the market consists of various players facing intense competition from other players and new entrants.
In addition, key participants are indulged in mergers and acquisitions to expand their existing product portfolios. For instance, in January 2016, Capsugel announced completion of acquisition of Xcelience and Powdersize, which aided the company to expand its existing resources with respect to its dosage form solutions business segment.
Major players are also engaged in launch of controlled release drug delivery technologies, which are novel and unique in nature. For instance, in October 2015, Capsugel announced launch of enTRinsic drug delivery technology that provides complete enteric protection along with targeted release into upper gastrointestinal tract for a variety of compounds.
Base year for estimation
Actual estimates/Historical data
2014 - 2016
2018 - 2025
Revenue in USD Billion and CAGR from 2014 to 2025
North America, Europe, Asia Pacific, Latin America, Middle East & Africa
U.S., Canada, U.K., Germany, France, Italy, Spain, Japan, China, India, Brazil, Mexico, South Africa, Saudi Arabia
Revenue forecast, company share, competitive landscape, growth factors and trends
15% free customization scope (equivalent to 5 analyst working days)
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global controlled release drug delivery market report on the basis of technology, release mechanism, application, and region:
Technology Outlook (Revenue, USD Billion, 2014 - 2025)
Release Mechanism Outlook (Revenue, USD Billion, 2014 - 2025)
Polymer Based Systems
Micro Reservoir Partition Controlled Drug Delivery Systems
Feedback Regulated Drug Delivery Systems
Activation-modulated Drug Delivery Systems
Osmotic Pressure Activated
Hydrodynamic Pressure Activated
Vapor Pressure Activated
Application Outlook (Revenue, USD Billion, 2014 - 2025)
Metered Dose Inhalers
Transdermal and Ocular Patches
Oral Controlled-drug delivery Systems
Drug Eluting Stents
Regional Outlook (Revenue, USD Billion, 2014 - 2025)
Middle East and Africa
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