Global Market Trends For Drug–Device Combination Products

By Aditi Shivarkar, insightSLICE

Drug–device combination products, also known simply as combination products, are therapeutic or diagnostic products that combine drugs or biologics (such as vaccines or blood products), and a medical device into a single entity. The field’s wide range of applications include drug-eluting stents, prefilled syringes with medications, inhalers with drugs, and transdermal patches with therapeutic agents, among others. These products are designed to provide a more integrated and effective approach to patient care by combining the benefits of both drugs and medical devices in a single treatment, improving treatment effectiveness, enhancing patient compliance, and streamlining healthcare delivery.

The global drug-device combination products market was valued at $109.17 billion in 2022 and is estimated to be around $117.93 billion by the end of 2023. Furthermore, it is expected to reach $236.36 billion by 2033 at a CAGR of 7.2%, according to our new market research. Let’s look at the three largest growth drivers, segment analysis, and geographic insights.

3 Growth Drivers Of Combination Products Globally

Advancements in Technology and Medical Innovation

One of the primary driving factors behind the growth of the global drug-device combination products market is the continuous advancements in technology and medical innovation. As researchers and healthcare companies strive to develop more effective and patient-friendly treatment options, they are increasingly exploring the potential of combining drugs and medical devices. These innovations have led to the creation of novel combination products that offer enhanced therapeutic benefits, improved drug delivery mechanisms, and better patient outcomes. From smart inhalers and drug-eluting stents to wearable devices that deliver medications, the integration of cutting-edge technologies with pharmaceuticals is reshaping the landscape of healthcare, driving the demand for drug-device combination products worldwide.

Growing Prevalence of Chronic Diseases

The rising prevalence of chronic diseases, such as cardiovascular disorders, diabetes, respiratory illnesses, and cancer, is another key driver of the global drug-device combination products market. These conditions often require long-term and targeted treatments involving both drugs and medical devices to manage symptoms effectively, control disease progression, and enhance patient quality of life. Combination products offer a valuable solution by providing a streamlined approach to therapy, reducing the need for multiple interventions, and ensuring better patient compliance.

Regulatory Support and Expedited Approval Processes

The development and approval process for drug-device combination products can be complex, as it involves the regulatory requirements for both drugs and medical devices. The responsibility for reviewing and regulating combination products often falls under a collaboration between different regulatory agencies, such as the U.S. FDA’s Center For Devices & Radiological Health (CDER) and Center For Biologics Evaluation and Research (CBER) and/or Center for Drug Evaluation and Research (CDER). Governments and regulatory agencies around the world have recognized the potential benefits of drug-device combination products and have shown increasing support for their development and commercialization. Efforts to streamline the regulatory pathways and provide clearer guidelines for combination products have facilitated faster approval processes, encouraging pharmaceutical and medical device companies to invest in this market segment. Expedited approval pathways, such as the FDA's Combination Product Agreement Meetings and the European Medicines Agency's (EMA) Scientific Advice for Combination Products, have incentivized innovation in this field. The regulatory backing and simplified approval processes have not only accelerated market entry for new combination products but have also encouraged collaborations between drug and medical device manufacturers, fostering a dynamic and competitive market landscape.

Which Product Segment Holds The Largest Share?

Based on product type, the market is segmented into:

• drug-eluting stents,
• infusion pumps,
• photodynamic therapy,
• antimicrobial wound dressings,
• prefilled syringes,
• drug-eluting balloons,
• nebulizers,
• inhalers,
• transdermal delivery systems, and
• other products.

Among these, drug-eluting stents have been one of the largest segments in the drug-device combination products market. These stents are used in interventional cardiology to treat coronary artery disease by propping open narrowed or blocked arteries and slowly releasing drugs to prevent restenosis (re-narrowing). The prevalence of cardiovascular diseases, such as coronary artery disease, has been substantial globally, and drug-eluting stents have become a standard treatment option due to their ability to reduce the chances of repeat blockages.

Therapeutic Indications

Based on indication, the market is segmented into:

• cardiovascular disorders,
• diabetes,
• respiratory problems,
• cancer treatment,
• antimicrobial application, and
• other indications.

Among these, the cardiovascular disorders segment holds the largest market share for combination products. Cardiovascular diseases, such as coronary artery disease, heart failure, and arrhythmias, have been among the leading causes of morbidity and mortality worldwide for several years. Combination products play a crucial role in the treatment of cardiovascular disorders, with examples such as drug-eluting stents, pacemakers with drug delivery capabilities, and implantable defibrillators.

Geographic Market Trends

Geographically, the global drug-device combination products market is segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and South America, with North America being largest segment. This is primarily due to several factors:

• North America, especially the United States, is home to a robust and innovative healthcare industry, including both pharmaceutical and medical device sectors. This fosters a conducive environment for research, development, and commercialization of drug-device combination products.
• The region has a large patient population with a significant prevalence of chronic diseases, creating a substantial demand for integrated and advanced treatment options.
• North America's regulatory agencies, such as the U.S. FDA, have been proactive in supporting the development of combination products, offering expedited approval pathways and clear guidelines.
• North America is also seeing a rise in telehealth and remote patient monitoring, leading to higher demand for connected drug-device combination products.

In Europe, there’s a surge in demand for wearable combination products and smart delivery systems, with many market players investing in digital health technologies to enhance treatment outcomes.

In the Asia-Pacific region, there’s a shift toward self-administration devices and targeted drug delivery systems. There is also an increasing number of collaborations between global and local companies to address market needs.

The key players of the global drug-device combination products market are:

• Abbott Laboratories (U.S.)
• Baxter International Inc. (U.S.)
• Bayer AG (Germany)
• Becton, Dickinson and Company (U.S.)
• Boston Scientific Corporation (U.S.)
• GlaxoSmithKline plc (United Kingdom)
• Johnson & Johnson (U.S.)
• Medtronic plc (Ireland)
• Novartis International AG (Switzerland)
• Smith & Nephew plc (United Kingdom)

About The Author:

Aditi Shivarkar is principal consultant at insightSLICE, a market intelligence and strategy consulting company. She has been a part of the research industry for 13 years. She joined insightSLICE in 2021 and she works with clients to design studies that generate the data needed to answer their strategic market analysis, segmentation, brand equity, and pricing questions. She works across various domains, including healthcare, industrial automation, consumer goods, IT, and telecom.