Drug device combination products are the amalgamation of certain medical devices and drugs or biological products to facilitate enhanced drug delivery. These products act as a single entity to meet desirable efficacy, typically lacking in traditional methods of drug delivery. The combination products are required to go through stringent regulatory process to ensure high safety standards.
These products are needed to be monitored consistently during the regulatory approvals owing to incorporation of components belonging to multiple regulatory categories with distinct requirements. As a consequence of the aforementioned, the review of drug-device combination products typically requires an involvement of multiple FDA centers. These centers include Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Office of Combination Products.
"Current and future trends in drug device combination market"
Drug device combination products are gaining popularity and importance globally as a consequence of the lucrative benefits associated with it. These products are anticipated to represent a versatile, highly sophisticated clinical technology and functional improvements in the implants. In the present scenario, antimicrobial catheters as well as drug eluting stents are steadily being approved by the regulatory authorities and increasingly being involved in the clinical practice.
New product development in this realm is believed to provide boost to the adoption rate of drug device combination products in wide range of therapeutics applications. Currently, cardiovascular and orthopedic implants, possessing on-board or direct drug delivery systems are in the product pipeline, which are expected to herald the FDA approval over the coming years.
Recent developments in cell-based therapeutics, formulation strategies, and progenitor cell exploitation are presumed to provide high probability of development of advanced combination strategies. The aforementioned is further expected to facilitate enhanced functional tissue regeneration and improve tissue device integration, thus resulting in heightened drug delivery capabilities.
In future, it is presumed that, with the help of drug device combination products, delivery of numerous bioactive agents over the temporal and spatial scale will improve the prosthetic function.
The market is competitive in nature and is dominated by major players such as Medtronic and Boston Scientific Corporation. The sector participants are attaining consistent growth through geographical expansions, new product development initiatives, and mergers & acquisitions. The other major players include Terumo Corporation, Stryker Corporation, Mylan N.V., and Teleflex Incorporated, Novartis AG.
"Drug device combination market outlook"
Rapid growth in the medical devices sector, soaring prevalence of chronic diseases, and the rising number of innovative product launches are primary factors believed to heighten the demand for the drug device combination products. In addition, government and private funding in clinical research, increasing R&D investment, and heightening healthcare awareness levels in the emerging economies, are some of the key factors presumed to be the growth of the global drug device combination market.
However, high associated operational costs and follow-ups and stringent regulatory framework with respect to drug device combination products are believed to be critical growth restraining factor of the market.
In-depth report on global drug device combination market by Grand View Research: