Drug-Device Combination Products Market (2026-2036)

The growth of this market is mainly driven by the rapid growth of injectable GLP-1 therapies for diabetes and obesity delivered in prefilled pens, the shift of biologic treatments for autoimmune, inflammatory, and other chronic diseases from hospital infusion to self-injection at home, the rising prevalence of diabetes, respiratory, cardiovascular, and other chronic diseases, the development of new delivery platforms such as wearable on-body injectors for large-volume biologics, and the growing focus on patient convenience, adherence, and lower total cost of care. However, factors such as complex and lengthy regulatory pathways that require both drug and device evidence, high development and manufacturing costs, supply constraints for primary containers and devices, pricing pressure on high-cost drugs, and the risk of device-related recalls are expected to restrain the growth of this market to some extent.

Drug-device combination products are therapeutic products that combine a drug or biological product with a medical device in a single product or package, where the device is used to deliver, administer, or release the drug, or where the drug enhances the function of the device. Common examples include prefilled syringes, pen injectors, and autoinjectors containing biologics, insulin, or GLP-1 therapies; metered-dose and dry powder inhalers for asthma and chronic obstructive pulmonary disease; transdermal and microneedle patches; drug-eluting coronary stents, balloons, and ophthalmic implants; antimicrobial catheters, wound dressings, and bone cements; and wearable on-body injectors that deliver large volumes of biologics under the skin.

This market covers the global sales of drug-device combination products, measured in value at manufacturers' selling prices of the finished products. It is segmented by product type, therapeutic area, end user, and geography. Stand-alone drugs supplied in vials or ampoules and administered with separate syringes, stand-alone medical devices without a drug component, empty delivery devices and primary containers sold to drug manufacturers, and contract manufacturing services are not included.

Combination products have become central to modern medicine and to the commercial strategies of pharmaceutical companies. Many of the fastest-growing drugs, including GLP-1 therapies for diabetes and obesity and biologics for autoimmune and inflammatory diseases, are delivered by patients themselves at home using prefilled pens and autoinjectors, which allows treatment outside hospitals and improves convenience and adherence. Inhalers remain the main way to treat asthma and chronic obstructive pulmonary disease, and drug-eluting stents are the standard of care in coronary interventions. As more drugs are designed for self-administration, the device has become an important part of a drug's commercial success and patient experience.

The value of combination products is concentrated in a small number of very large therapeutic franchises. GLP-1 therapies and insulin in pens, biologics for immunology in autoinjectors and prefilled syringes, and maintenance inhalers for respiratory diseases together account for most of the market. At the same time, the device-led part of the market, including drug-eluting stents, balloons, ophthalmic implants, and antimicrobial devices, is important for cardiovascular and surgical care. Growth in the market is therefore closely linked to the success of leading drug classes and to the adoption of new delivery formats.

Combination products are regulated differently from stand-alone drugs or devices, which adds complexity for developers. In the U.S., the FDA assigns each combination product to a lead center based on its primary mode of action, and the Office of Combination Products coordinates reviews between the drug, biologics, and device centers. Manufacturers must comply with both drug and device quality requirements under 21 CFR Part 4, conduct human factors studies to show that patients can use the device safely, and manage device design controls and risk management. In Europe, the Medical Device Regulation requires a notified body opinion for integral drug-device combinations, while drug-eluting devices are regulated as medical devices with consultation of medicines regulators.

Regulators have issued extensive guidance on combination products, covering topics such as human factors engineering, bridging studies when device changes are made, postmarketing safety reporting, and the essential performance outputs of delivery devices. These requirements increase the importance of device expertise within pharmaceutical companies and of partnerships with specialist device developers.

The market includes pharmaceutical and biotechnology companies that develop and sell drug-led combination products, and medical device companies that develop and sell device-led products such as drug-eluting stents. Leading drug-led companies include Novo Nordisk, Eli Lilly, Sanofi, AbbVie, Amgen, AstraZeneca, GSK, and Teva, while leading device-led companies include Medtronic, Boston Scientific, and Abbott. Specialist device developers and component suppliers, such as Ypsomed, SHL Medical, BD, and West Pharmaceutical Services, design and supply pens, autoinjectors, prefilled syringe systems, and wearable injectors used in combination products.

The supply chain for combination products involves many specialized partners across components, devices, and filling. Glass and polymer primary containers are supplied by companies such as BD, West Pharmaceutical Services, Gerresheimer, Schott, and Stevanato, device platforms by Ypsomed, SHL Medical, and others, and aseptic filling and device assembly are performed in-house by pharmaceutical companies or by contract manufacturers. Capacity across this supply chain has become a strategic issue as demand for GLP-1 therapies and biologics has grown.

Over the forecast period, the drug-device combination products market is expected to grow strongly, driven by GLP-1 therapies, biologics, the shift to home care, and new delivery technologies. North America is expected to remain the largest market, while Asia-Pacific is expected to grow fastest as access to biologics and GLP-1 therapies expands and generic versions become available.

Our next antibody needs a 5-milliliter dose. An on-body injector lets patients take it at home instead of coming in for an infusion.

This explains why on-body injectors and oncology are growing fastest.

For biotechnology companies developing large-dose biologics, on-body injectors open the possibility of home treatment that standard autoinjectors cannot provide.

This also shows why device developers are investing in large-volume platforms that can be used across multiple drugs and therapeutic areas.

Respiratory Physician - university hospital, U.K.

Inhaler technique is still the biggest problem we see. Simpler devices and connected sensors help patients use their inhalers correctly.

This explains why inhalers remain a large product type and why connected and easier-to-use devices are a key opportunity for respiratory companies.

When semaglutide comes off patent, we will launch in pens. The device has to be as good as the originator's, at a much lower cost.

This explains why Asia-Pacific is the fastest-growing region and why device platforms for generic and biosimilar manufacturers are a major opportunity.

Diabetes and obesity are expected to account for the largest share of the market in 2026, driven by GLP-1 therapies and insulin delivered in pens, while oncology is projected to register the highest CAGR.

In the U.S., the FDA's Office of Combination Products assigns each product to a lead center based on its primary mode of action, and manufacturers must meet both drug and device requirements under 21 CFR Part 4. In the EU, integral drug-device products require a notified body opinion on the device part under Article 117 of the Medical Device Regulation.

Wearable and on-body injectors are projected to register the highest CAGR, driven by large-volume biologics, subcutaneous versions of infused drugs, and the shift of treatment from hospitals to homes and community settings.

Wearable on-body injectors are devices attached to the skin that deliver larger volumes of drugs, typically several milliliters, over minutes or hours, allowing patients to take biologics at home that would otherwise require infusion.

Semaglutide patents began to expire in markets such as India, Canada, China, and Brazil from 2026, and generic pens are expected to expand access and volumes, particularly in emerging markets, while increasing price competition.