Drug Device Combination Products Market

Market Overview

The global Drug Device Combination Products Market was valued at approximately USD 132.4 billion in 2024 and is projected to reach USD 236.8 billion by 2033, growing at a CAGR of 6.7% during the forecast period (2025–2033).

Drug device combination products incorporate a medical device with included pharmaceutical ingredient, to provide targeted therapy, with improved safety, efficacy, and patient compliance. Examples include drug eluting stents, pre-filled syringes, transdermal patches, and inhalers that also deliver drugs while performing a device function. As an example, drug eluting stents provide medication that inhibits the artery from re-narrowing after angioplasty. Inhalers deliver bronchodilators directly to lungs for people living with asthma or chronic obstructive pulmonary disease (COPD). The increasing burden of chronic diseases like cardiovascular diseases, diabetes and cancer, leads to increased growth opportunities. Furthermore, there is an increasing market demand for minimally invasive drug delivery systems. Product innovation, emphasis on patient-oriented design and protocols from regulatory bodies to support approval of various combination products will help strengthen and propel growth globally. The trend toward home health care, self-administration of drugs and user-friendly combination drug/device products such as auto-injectors and wearable pumps are also likely to increase use and consumption of drug device combination products.

Market Dynamics

Market Drivers

Increasing Burden of Chronic Diseases Driving Demand for Targeted Drug Delivery Systems

The increasing global burden of chronic diseases such as diabetes, cardiovascular disease, asthma, and cancers are significant reasons for the increasing need for drug device combination products. This group of products (e.g., drug-coated stents, insulin delivery systems, inhalers, etc.) combines medicines with enhanced therapeutic control mechanisms to provide a valuable combination modality for accurate medication delivery.

Non-communicable diseases (NCDs), according to the World Health Organization (WHO), caused 74% of deaths worldwide, with cardiovascular disease accounting for 17.9 million deaths annually, diabetes affecting 422 million people, and cancer accounting for 9.3 million deaths, in 2020. The burden of chronic conditions causes ongoing therapies, often requiring self-managed, continuous therapies—this is where combination products such as insulin pens, prefilled unit dose biologics syringes, and transdermal patches become necessary.

Medtronic’s launch of the next-generation MiniMed™ 780G insulin pump system in Europe and other parts of Asia in September 2023, combined continuous glucose monitoring, with automated insulin delivery systems; as both device and drug technologies converge more to manage chronic illnesses, patients are seeking out more convenient, safer, and home-managed therapy; the need for combination products that provide familiarized and expedited long-term treatment structures are expected to accelerate.

Technological Advancements and Regulatory Approvals Fueling Product Innovation

Medical technologies are advancing, creating advanced combination products that are safer, easier to use, and deliver drugs with more precision. This is clearly being seen with the evolution of inhalation devices, drug eluting implantables, and wearable injectors. For example, Propeller Health’s digital inhaler sensors track medications use in asthma and COPD patients to provide real-time medication use data to providers while patients are in the home setting to help enhance adherence.

This smart inhaler is the first of what will surely be a wave, of connected drug-device combination platforms technology has enabled to better clinical outcomes. Additionally, from a regulatory perspective, the pathways available at the U.S. FDA and EMA have considerably improved the processes for combination products approval and have encouraged combination product manufacturers to invest in R&D for combination products. In April 2024, the FDA approved Aptar Pharma’s connected prefilled syringe platform which incorporates sensors to track injection events, and provides scientific data for the purposes of improved pharmacovigilance and patient monitoring.

This type of innovation is shaping drug delivery and enabling treatment that is increasingly personalized and data-driven in the pharmaceutical and medical device industry. With the shift in focus to combination therapies, particularly in oncology, respiratory care, and autoimmune diseases, regulatory and technical innovations will continue to be significant drivers of growth.

Market Restraint

Stringent Regulatory Framework and Complex Approval Pathways

One of the key limitations to the drug device combination products market is a complicated regulatory environment. Unlike a standalone drug or a standalone device, combination products adhere to both drug and device regulation, presenting complexities in its development and commercialization. These products will need to adhere to the requirements of the pharmaceutical and medical device components, often involving multiple regulatory authorities and conflicting guidelines.

For example, in the United States, the FDA will assign the lead review center based on a Primary Mode of Action (PMOA) for the combination product which can lead to increased project timelines from intercenter collaboration between the Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

In a similar manner, the European Medicines Agency (EMA) and other national authorities are required to evaluate the device components separately under the new regulations as outlined in the EU MDR (Medical Device Regulation) in 2021.

Segmental Analysis

The Drug Device Combination Products Market is segmented by product type and end-user. Each segment plays a vital role in enhancing patient compliance, ensuring accurate delivery, and improving therapeutic outcomes across various clinical conditions.

By Product Type

Drug-Eluting Stents (DES) had the most significant market share in 2024 as the increase in worldwide coronary artery disease rates and percutaneous coronary interventions (PCI) were driving factors. DES are stents that release antiproliferative drugs to prevent restenosis, and utilized globally in developed and developing markets because proven results. Abbott’s Xience and Medtronic’s Resolute Onyx stents have made a successful dent in the market demonstrating significant clinical outcomes within DES and having FDA approvals. 

Prefilled Syringes and Auto-injectors were also being driven by the strong demand in the delivery of biologics for conditions like rheumatoid arthritis, diabetes and multiple sclerosis. These devices provide benefits such as ease of use, accuracy of dose, and reduced risk of contamination, which were appealing to home care patients. Also, inhalers, such as dry powder and metered-dose inhalers are expected to have a high growth rate due to the increasing prevalence of asthma and chronic obstructive pulmonary disease.

Smart inhalers with embedded digital sensors and technology such as those offered from Propeller Health and GSK, are gaining traction as connected health for inhale medications. Transdermal patches and wearable infusion pumps are also have a steady rate of growth and gaining traction with the increasing use in chronic pain, hormone replacement therapy and diabetes management. The non-invasive, and controlled release delivery features make these devices desirable for both patients and providers.

By End-User

Hospitals and Clinics dominate the market with the highest revenue share in 2024. This segment performs the most surgical procedures, infusions, and emergency procedures using combinations of products requiring advanced combinations such as drug-eluting stents, infusion pumps, and implantable devices. There are unique staff resources and infrastructure to support the opportunities; Therefore, the agreements of drug-device combinations in these environments would be high.

Home Care Settings, are a rapidly emerging segment toward which we expect drug-device combination products to be moving rapidly, as this represents a global trend away from inpatient care and the self-administration of therapies. This is illustrated by the increasing use of auto-injectors, wearable insulin pumps, and pre-filled syringes that help patients become independent and also decrease the risk of re-admission to hospitals.

With the increasing aging population and rising costs of healthcare, adoption of homecare will further accelerate, particularly in the North America and Europe. Ambulatory Surgical Centers ( ASC) are also using more drug-device combinations of products specifically for minor procedures within the fields of cardiovascular and orthopedics. ASC significantly lower cost structure, reduce time to recovery, and patient’s convenience makes ASC very attractive alternatives to traditional hospitals for elective nature interventions.

Diagnostic centers and specialty clinics for example continue to help drive additional growth in the market, particularly in terms of conditions within the respiratory, neurological, and oncological fields which may require some level of therapeutic intervention on a regular basis through an advanced delivery system.

Regional Analysis

North America

North America has the largest share of the Drug Device Combination Products Market accounting for an estimated 38.6% share in 2024. It has strong growth in the region due to a well-developed health care system, regulatory policies, and the early adoption of new drug-delivery technologies.

The market is driven predominantly by the United States which is a major contributor with the use of drug-eluting stents, insulin pumps, auto-injectors, and digital inhalers. There are also a number of leading manufacturers in North America including Medtronic, Abbott, and Boston Scientific that have R&D investment along with a prevalent burden of chronic diseases which is fueling growth.

Chronic diseases such as type 1 and type 2 diabetes (high), asthma (high ; approximately 8% of the population represents) and cardiovascular diseases (also high in prevalence), along with reimbursement policies for clinical and home-care uses, is a healthy market looking to sustain demand as chronic disease burden is increasing.

Europe

Europe remains an important market for drug device combination products, which is reinforced by established healthcare systems and an aging population. Germany, France, the UK, and the Netherlands play a major part in this market. More specifically, it is driven by the increase in prevalence of chronic respiratory disease, diabetes, and cancer, as well as the increase in adoption of prefilled syringes and transdermal patches, and wearable infusion devices.

In addition, as noted above, the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are designed to stimulate innovation among manufacturers while promoting patient safety standards. Furthermore, with Home based care and minimally invasive demand in Europe also increasing, this will lead to further market expansion in drug device combination products.

Asia-Pacific

The Asia-Pacific region is expected to grow the fastest, with a projected CAGR of 7.9% during the forecast period (2025-2033). The region is undergoing rapid market expansion due to increased urbanization rate, increased health care spend, and a growing prevalence of chronic diseases, including diabetes, hypertension, and respiratory illnesses.

The most significant growth engines will be China, India, Japan, and South Korea; all of them have invested heavily in digital health and devices. Programs such as Ayushman Bharat in India and Healthy China 2030 are planning to improve access to modern treatment options, including combination products. Additionally, the growing middle-class population and increased access to health insurance will increase the demand for portable, user friendly drug delivery devices, including auto-injectors and insulin pens.

Latin America and Middle East & Africa (MEA)

The drug device combination market is experiencing moderate but steady growth in the MEA and Latin America regions. The rising adoption of combination therapies for chronic disease management in Latin America (mainly Brazil, Mexico, and Argentina) is primarily the result of improved access to healthcare and increased public awareness. In the MEA region, countries (e.g. Saudi Arabia, South Africa, and UAE) are increasingly investing in healthcare modernization.

This activity is resulting in innovative drug-delivery systems in hospitals and outpatient clinics. Economic disparity, lack of advancement in infrastructure, and complexity of regulations surrounding drugs and devices remain obstacles to discovering viable market opportunities in some markets. Nevertheless, with further government efforts and alliances with international medtech companies, the adoption barriers of combination products will likely diminish.

Recent Development

1. April 2025 – Medtronic received FDA approval for its Simplera Sync™ sensor, compatible with the MiniMed® 780G insulin pump system. This integration allows users to maintain >70% time-in-range with fewer infusion set changes, as the Simplera™ infusion set lasts up to seven days, enhancing both convenience and glycemic control.
2. August 2024 – Medtronic also secured FDA approval to initiate the pivotal IDE clinical trial for its Prevail™ paclitaxel drug-coated balloon, aimed at treating in-stent restenosis and small-vessel de novo coronary disease. This trial sets the stage for future device authorization in the U.S. and Japan.
3. March 2025 – Boston Scientific presented 12-month positive safety and efficacy outcomes from its PERSEUS clinical program for the TAXUS® Element™ platinum-chromium paclitaxel‑eluting stent. Data, shared at the ACC annual meeting, indicate superior efficacy and comparable safety in small vessels compared to prior-generation stents.