Specific focus on the quality-by-design (QbD) approaches for the robust design of dosage forms is expected to change the future landscape of controlled-release drug delivery technologies. While conventional hydrophilic matrix based technologies such as Accuform are being used in the market for several years, recent advancements in the development of oral drug delivery systems such as gastro-retentive drug delivery for controlled release, buoyant systems, mucoadhesive systems for regulated release of anti-viral medications etc. would increase the penetration of controlled-release drug delivery technologies in the global pharmaceuticals market. Acuform polymer-based patented technology is widely being used in a number of controlled-release formulations such as NUCYNTA ER, Gralise (Depomed Inc.), Janumet XR (Merck), Glumetza (Salix Pharmaceuticals) etc. Wurster coating technology is being used in the drug coating for controlled release of drug since 1976. Corplex transdermal technology has largely been commercialized in P&G’s Crest product line. Plenty of new controlled-release technologies are in phase to be commercialized in next few years. For instance, MicroCor PTH using MicroCor transdermal technology is being evaluated in phase IIa. OROS technology which delivers drug in controlled manneris being used in more than 17 commercially available drugs. In case of oral controlled drug delivery, elderly persons and pediatrics constitute the large proportion of consumers for controlled-release drugs due to increase adherence to dosage regime. Some of the commercially available medications using controlled-release drug delivery technology include Prozac (polymer matrix based system), Avinza (polymer coating), Capoten (enzyme activated system), GLUCOPHAGE XR (polymer matrix based system), Alza (osmotically activated system) etc.
Controlled-Release Drug Delivery Technology Market: Drivers and Restraints
The global market for controlled-release drug delivery technology is driven by increasing the need for pediatric controlled release dosage forms, high acceptance of CR dosage forms due to once-a-daily dosing nature, etc. However, some of the major factors restraining the global market for controlled-release drug delivery technology are fewer excipients are deemed acceptable for pediatric use, the requirement of a high dose of API, promising development of CR dosage forms that impart abuse resistance, a higher price of controlled-release systems compared with traditional pharmaceutical formulations, etc. Moreover, some of the biopharmaceutical challenges for development of controlled-release drug delivery systems such as establishing desired release profiles for new chemical entities, risk management of dose dumping, selection of biocompatible and biodegradable materials with desired controlled-release properties, etc.
Controlled-Release Drug Delivery Technology Market: Overview
The global market for controlled drug delivery technology is expected to gain traction during the forecast period due to increasing commercialization of new technologies by a number of modified release products launches. Loss of patents for some of the controlled-release drug delivery technologies would present an opportunity for generic players to penetrate the market. For instance, blockbuster osmotic delivery system OROS would be off patented by July 2017 and the technology will lose the pediatric exclusivity by January 2018. Allergan Plc. received FDA approval for Generic Cardizem extended release tablets indicated for the treatment of hypertension.
Controlled-Release Drug Delivery Technology Market: Regional Wise Outlook
Geographically, the global controlled-release drug delivery technology market is classified into regions viz. North America, Latin America, Western Europe, Eastern Europe, Asia-Pacific, Japan, Middle East and Africa. North America will continue to hold the largest share in the global controlled-release drug delivery technology market due to rising number of NDA and ANDA applications being filed by the key players. Europe is expected to hold second largest share in the global market for controlled-release drug delivery technology market. However, APAC is expected to witness highest growth rate due to expansion activities by the key players in the region.
Controlled-Release Drug Delivery Technology Market: Key Players
Some of the market players in the global controlled-release drug delivery technology market are Depomed, Inc., Coating Place, Inc., Corium International Inc., Alza Corporation (Johnson & Johnson), Pfizer Inc., SKY Pharmaceuticals Pvt. Ltd. and others. Global pharmaceutical companies are desperately looking for new strategies to increase profitability and in line with this number of companies are bringing in the market, the modified release formulations of existing drugs due to short pathway for approval while maintaining their market share.