Market Challenges: Stringent regulatory requirements

Stringent regulatory requirements from various regulatory bodies across the globe can hamper the global controlled release drug delivery market growth. Obtaining approval for new drug delivery systems has become a lengthy and complex process, owing to rising safety concerns. Regulatory agencies are enforcing more rigorous evaluation procedures to assess the efficacy, long-term safety and quality of novel drug delivery mechanisms before granting approvals. This has compelled pharmaceutical manufacturers to spend considerable time and resources on extensive clinical trials and demonstrations to comply with evolving guidelines. For example, it took almost 4 years for the U.S FDA to review and approve an extended-release combination of morphine and naltrexone for management of severe chronic pain in 2021. Approval for a once-weekly formulation of risperidone for treatment of schizophrenia took over 2 years of review by the European Medicines Agency in 2020. The prolonged review and assessment cycles have deterred investments in development of advanced drug delivery technologies.

Market Opportunities: Emerging economies

Emerging economies can offer lucrative opportunities for the global controlled release drug delivery market growth in the near future. With rising health awareness and economic growth in developing nations, more patients are accessing advanced treatment options. This widening access to healthcare is benefiting the controlled release drug delivery industry. Controlled release drug delivery systems allow for targeted medication over extended periods, enhancing patient compliance and clinical effectiveness. These offer convenience by eliminating the need for frequent dosing, which is particularly valuable in markets with challenges around continuous care. As emerging nations tackle non-communicable diseases and seek to strengthen their healthcare infrastructures, controlled release technologies can help address issues of treatment affordability and provider shortages. International organizations project rapid increases in the disease burden from chronic conditions in the developing world. For instance, according to the data published by World Health Organization, cardiovascular deaths in Africa had increased by over 100% from 2015 to 2030 if prevention and management efforts are not scaled up. Controlled release formulations improving medication adherence play a significant role in achieving better health outcomes on the continent. Increasing diagnosis rates and access to sophisticated treatment methods can offer opportunities for sustained delivery drug devices in these populations.