Drug Delivery Device Market, By Route of Administration (Oral, Parenteral, Transdermal, Ocular, Pulmonary), By Application (Oncology, Infectious Diseases, Respiratory Diseases, Diabetes, Cardiovascular Diseases, Autoimmune Diseases, Central Nervous System Disorders), By End User (Hospitals, Diagnostic Centers, Ambulatory Surgery Centers/Clinics, Home Care Settings, Others), By Geography (North America, Latin America, Europe, Asia Pacific, Middle East & Africa)

Published In : Aug 2024

Code : CMI5419

Pages :162

Formats :

Excel and PDF

Industry : Medical Devices

Market Challenges: Stringent regulatory policies for product approval

Global drug delivery device market growth can be hampered due to stringent regulatory policies for product approval. Devices used for drug delivery are classified as medical devices, and hence, require approvals from regulatory bodies like the U.S. FDA and European Medicines Agency before these can be commercialized. Getting these approvals is a complex, costly and time-consuming process. Medical device manufacturers need to present clinical data demonstrating safety and efficacy of their products to obtain regulatory clearances. This involves conducting lengthy clinical trials under Good Clinical Practices. Any changes to an approved device may require renewed testing and approvals. Such stringent norms increase the cost and time involved in launching new products. This poses a major bottleneck in translating innovative drug delivery technologies into commercially available products. The rigorous regulatory oversight also poses compliance challenges for manufacturers throughout the product life cycle.

Market Opportunities: Expanding biologics market

Expanding biologics market can offer growth opportunities for global drug delivery device market. Biologics such as monoclonal antibodies and recombinant proteins have revolutionized the treatment of complex diseases like cancer and rare genetic disorders. Biologics often require parenteral delivery such as injections owing to their structural complexity. This boosts demand for prefilled syringes, auto-injectors, drug reconstitution devices and wearable drug delivery systems. It is projected that biologics will account for over 50% of the pharmaceutical market by 2030. As more biologics receive regulatory approvals and enter clinical use, it will spur the development of advanced devices that can administer these drugs in user-friendly formats. Rising biologics offers scope for innovation across secondary packaging, delivery modalities and connectivity in drug delivery devices. Many existing as well as emerging players are strategically focusing on this vertical for future growth opportunities.