Novel Drug Delivery Systems Market Trends

Growth Drivers

• Health Care quality improvement & hospitalization reduction: Improve treatment efficacy, minimize complications, and boost patient outcomes. NDDS formulations, such as sustained-release formulations/transdermal patches/targeted drug delivery, result in more accurate dosing, fewer hospital visits, and fewer hospital admissions. This benefits the patient and results in increased compliance and decreased pressure on healthcare facilities. NDDS solutions could reduce hospital acute care admissions, reduce the length of treatment, and improve care quality relative to traditional methods of management at a reasonable cost, which contributes to NDDS.

• Government spending via CMS / Medicare: Broader ticked Medicare Innovation awards guarantee that care delivery models reduce avoidable admissions in clinically complex populations. NDDS platforms that fit within these models. Systematic reviews show that quality improvement interventions that engage patients and clinics reduce readmission and general patient populations. While not NDDS specific, these findings support industry demand for delivery systems that support reliable outpatient therapy, and greater regimen adherence for which NDDS technologies can provide quantifiable returns.
• Patient pool & disease prevalence: The chronic disease counts reported by government bodies in North America and Europe indicate that there is a larger eligible population desirable of NDDS interventions. Targeted pain delivery in advanced cancer intervention is consistent with expanding the patient population, requiring a better framework for chronic care. Adoption continues to be particularly high in oncology and neurological disciplines. By creating access gaps for potential NDDS beneficiaries, generated by cost barriers and lagging coverage. Manufacturers delivering more affordable and coverage-friendly NDDS solutions can meet that unmet demand especially with smaller practices and self-pay patients.

Challenges

• Pricing restraints and government-imposed price caps: The high prices of NDDS products frequently result in price caps set by the government. This leads to costly development programs with larger R&D expenses, as well as longer clinical programs. Ultimately, when a government limits the price of a new DDT or gives explicit constraints on any ingenious pricing strategy, pharmaceutical companies are limited in the price that they can sell at for these new NDDS. Therefore, if the products are sold at lower prices than expected, the profitability of that product decreases. This lack of profit will result in reduced investment in NDDS innovation and perhaps reduce overall market growth.

• Regulatory approval delays: The authorization of NDDS technologies could involve a prolonged approval process due to their complexity and unfamiliarity. Regulatory governing bodies (e.g., the FDA), require extensive clinical trial data to assess safety and effectiveness of new delivery systems. Additionally, Global Supply disruption is impacting the availability of the active pharmaceutical ingredient (API). We have witnessed the vulnerabilities and challenges within the pandemic when there was a 4-month backlog and counting of worldwide availability of NDDS products.