Market Challenges And Opportunities

Global Drug Device Combination Product Market– Driver

Increased product launches

The rising burden of chronic disorders, such as cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes, is fueling the growth of the drug device combination product market. For instance, on January 4^th 2023, Valencell is a leading innovator in wearable biometric sensor technology, specializing in accurate and reliable physiological monitoring for a range of applications. Valencell has announced plans to launch its own branded product line in the digital health sector as it concentrates efforts to bring solutions to market to manage chronic diseases.

Government Initiatives Driving Market Growth

Governments around the world are implementing various initiatives to address the rising burden of chronic disorders and promote patient safety. These initiatives are playing a crucial role in driving the growth of the global drug device combination product market. For instance, In September 2021, the US FDA recognized the significant impact of AI/ML in drug development. Over 100 drug and biologic submissions with AI/ML components were reported this year. AI/ML is employed in various stages of drug development, including drug discovery, clinical research, safety surveillance, and manufacturing. The FDA acknowledges the potential of AI/ML in Digital Health Technologies and Real-World Data analytics

Global Drug Device Combination Product Market: Restraint

Product Recalls and Stringent Regulations Pose Challenges to Global Drug Device Combination Product Market

The growth of the global drug device combination product market faces obstacles as product recalls and associated complications arise. Instances of adverse events and harm have led to recalls of certain drug device combination products, impacting market growth. Additionally, stringent government regulations and policies aimed at ensuring safety and efficacy have been introduced, creating hurdles for the development and marketing of these products. These challenges emphasize the importance of quality control and regulatory compliance in the industry.

Risk of Infections

The risk of infections associated with drug-device combination products poses a significant constraint on market growth. For instance, a 66-year-old woman who underwent knee replacement surgery developed a recurring infection, resulting in multiple surgeries and ultimately the amputation of her leg. This case underscores the widespread problem of infections related to implanted medical devices. To address this issue, researchers from Binghamton University, Stevens Institute of Technology, Syracuse University, and City College of New York are collaborating to develop infection-resistant tissue scaffolds that can prevent biofilm formation and eliminate medical device-associated infections.

Strict Regulations

Strict and non-specific regulatory pathways for drug-device combination product approval further hinder market growth. In the United States, pharmaceutical products and medical devices follow separate regulatory approval processes. For instance, in September 4, 2020, The U.S. FDA's Center for Devices and Radiological Health (CDRH) regulates medical devices and radiation-emitting electronic products in the United States. It oversees requirements for establishment registration, device listing, premarket notification (510(k)), quality system regulation, labeling, and medical device reporting. The CDRH ensures the safety and effectiveness of these products.