The drug device combination products market, focusing on services related to development, testing, and commercialization, is a rapidly growing sector projected to reach significant milestones by 2035. According to a detailed market report by Roots Analysis, the market for service providers in this space was valued at approximately $252 million in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 10% through the forecast period.
Market Growth Drivers
Several factors are driving this growth. A major challenge in pharmaceutical treatment is patient non-adherence to prescribed medication regimens, which not only adversely affects patient health but also imposes a substantial financial burden on drug developers—estimated at over $250 billion annually. Additionally, conventional drug delivery methods often fail to provide sustained or controlled release of active pharmaceutical ingredients (APIs) at targeted sites, leading to fluctuating plasma drug levels and side effects.
Drug device combination products address these issues by integrating two or more FDA-regulated components—such as drugs and devices—to enable controlled release of APIs. This approach enhances drug delivery efficiency and patient compliance. However, developing these combination products is complex, requiring advanced technologies, significant capital investment, and expertise. Challenges include ensuring drug-device compatibility, meeting user needs, conducting release and performance testing, and managing production and packaging requirements.
Market Segmentation and Service Focus
The market report segments the drug device combination products market by type of device, service focus area, company size, and geography:
- Types of Devices: Autoinjectors, prefilled syringes, large volume wearable injectors, and other device types.
- Service Focus Areas: Particle testing, performance testing, and product development.
- Company Size: Ranges from very small to very large companies.
- Geographical Regions: North America, Europe, Asia, and the rest of the world.
Service providers offer a range of specialized services including chemical characterization/testing, closure integrity testing, packaging validation, process development and validation, and stability studies. These services support manufacturers throughout the product lifecycle, from development to commercial manufacturing.
Key Industry Players
Several prominent service providers are active in this market, including EKG LABS, Eurofins Medical Device Testing, Exponent, Kymanox, Medical Engineering Technologies, Pace Analytical Services, Suttons Creek, and West Pharmaceutical Services. These companies often provide access to GMP-certified facilities, advanced technologies, larger capacities, and operational flexibility to meet the complex demands of combination product development.
URL: https://www.rootsanalysis.com/reports/combination-product-services-market.html
Recent Industry Developments
Recent strategic collaborations and expansions highlight the dynamic nature of the market. For example:
- In March 2024, SHL partnered with Swiss CDMO ten23 to offer sterile drug/device combination product services by combining manufacturing capabilities with autoinjector technology.
- In January 2025, CVS Caremark added Zydus Lifesciences’ combination products to its diabetes drug formulary.
- Resyca obtained a medical device regulation (MDR) certificate from TÜV SÜD in January 2025, enhancing support for medical devices and drug-device combination products.
- Sandoz opened a new Device Development Center in Cambridge, UK, in November 2024 to advance global development of drug-device combination products.
Challenges and Market Outlook
Despite the promising growth, the development and commercialization of drug device combination products remain challenging due to the need for novel technologies, regulatory compliance, and significant investment. To mitigate these challenges and improve patient outcomes, many developers are outsourcing testing and validation services to specialized providers.
Service providers are actively expanding their geographical reach and broadening their service portfolios to meet increasing demand for effective drug delivery solutions. The market report also includes detailed company competitiveness analyses, recent expansion activities, and case studies on advanced combination products such as large volume wearable injectors and prefilled syringes.
Conclusion
The drug device combination products market is poised for substantial growth driven by the need for improved medication adherence and controlled drug delivery. With a diverse range of devices and specialized services, supported by key industry players and ongoing innovations, this market is expected to evolve significantly through 2035, offering enhanced therapeutic options and improved patient experiences.
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