Combining a drug component and a device component into a single product creates a drug-device combination product. These products are used in various medical treatments and are made up of pharmaceutical substances and medical devices that help deliver the drug to the patient’s body in the intended location. Examples of drug delivery systems include pre-filled medicine delivery systems, surgical trays, monoclonal antibodies mixed with therapeutic drugs, pacing leads, catheters, and first-aid kits.
The global drug-device combination products market was valued at US$ 123.9 billion in 2022 and is anticipated to reach US$ 190.1 billion by the end of 2030 with a CAGR of 5.5% from 2023 to 2030.
Manufacturers of drug-device combination products must seek a Notified Body Opinion before releasing them as integral devices and marketing them as “medicinal products” under Article 117 of the Medical Equipment Regulation. The notifying body assesses compliance with the relevant General Performance and Safety Standards (GSPR) and provides the manufacturer with an NBOP Report for inclusion in the Marketing Authorization Application (MAA).
The market for drug-device combinations is expanding due to the increasing prevalence of chronic diseases and technological advancements. However, there are restrictions and issues associated with these products that could hinder their future growth. The stringent regulatory environment creates a barrier to the global market for drug-device combinations, but collaborations and partnerships among major market players can create opportunities for growth.
Global Drug-Device Combination Products Market Amid COVID-19 Pandemic
The COVID-19 pandemic has affected various sectors of the economy, including the market for drug-device combination products worldwide. Governments implemented strict regulations to curb the spread of the virus, creating obstacles for some markets while providing opportunities for others. Lockdowns and restrictions on movement impacted drug-device combination products’ market dynamics in developed and emerging economies alike. However, all economies have since experienced a slow recovery, leading to a positive impact on the market for drug-device combinations.
Drug delivery devices are expected to play a crucial role in providing effective medical care to COVID-19 patients during the pandemic. For instance, Europe issued new guidelines in April 2021 outlining quality specifications that industries must address in their marketing authorization reports for drug-device combination products used in COVID-19 testing. These guidelines help improve drug-device combination products for COVID-19 testing, stimulating market growth during the pandemic.
Increasing Prevalence of chronic diseases, and adoption of novel drug delivery systems & technological trends to boost Drug-Device Combination Products
The market for innovative drug delivery methods is growing due to the rise in chronic diseases like cancer, diabetes, and respiratory illnesses. Reports show that 537 million adults have diabetes and 643 million will have it by 2030. The market is projected to grow as a result of the increased use of drug delivery combination products for consistent drug delivery, which is expected to be driven by the rise in metabolic illnesses.
The market for drug-device combination products will benefit from technical trends brought on by increasing R&D expenditures and a growing industry focus on innovation, leading to groundbreaking discoveries. This will increase competition as new competitors enter the market.
The prevalence of chronic illnesses and the desire for new approaches to disease treatment are driving the adoption of medical device combination products worldwide. These products benefit patients with significant illnesses like spinal cord injuries, diabetes, rheumatoid arthritis, hepatitis, multiple sclerosis, heart disease, cerebral palsy, and anemia. They offer benefits such as reduced side effects, regulated medication delivery, enhanced patient compliance, and focused drug delivery.
Inhalers, autoinjectors, pre-filled pens, pre-filled nebulizers, pre-filled syringes, and transdermal patches are becoming more common due to their associated advantages, including decreased pain levels, improved patient outcomes, shorter hospital stays, and overall healthcare cost-effectiveness. They also offer benefits such as improved tolerance levels, a simpler dosage regimen, and enhanced symptomatic and pharmacokinetic profiles. Synergistic effects that facilitate multi-target treatment are another advantage, which should boost the market for all these systems and open up room for market expansion.
Industry participants are combining technology for monitoring and tracking medicinal device combination goods. They are launching high-end goods developed with sophisticated active ingredients, formulations, delivery methods, and dosage forms like liposomes, transdermal patches, and peptides. They are also focusing on creating formulations, new classes of biologics, and next-generation goods with high viscosity to provide patients with treatments and solutions that will help them adhere to their therapy better.
Expanding healthcare infrastructure and improvements in drug delivery technologies are anticipated to support market expansion throughout that time. However, the industry is anticipated to be hampered by strict regulatory guidelines, product recalls, and issues related to certain drug-device combinations.
North America to spearhead the Global Drug-Device Combination Products Market
North America is expected to have a significant market share in the drug-device combination products industry due to the region’s strong healthcare infrastructure and the adoption of these goods. This is mainly due to the efforts of well-known firms in the area that carry out extensive new product development operations. One of the potential growth factors for this market is the increasing prevalence of chronic diseases in the region, which creates a clinical urgency to use these products. This, in turn, aids in the expansion of the North American market.
There are several reasons for the growth of the drug-device combination products market in North America. Firstly, the region has a favorable regulatory environment, with regulatory agencies creating clear policies and procedures for the clearance of these therapies. Secondly, major industries are adopting new technologies to develop effective medical equipment. Thirdly, there is intensive new product development activity to meet the people’s demands for treatment. Lastly, there is an increase in investment in the healthcare infrastructure, which is further contributing to North America’s leadership in the drug-device combination products market.
Numerous companies in the Drug-Device Combination Products industry are striving to expand their market share and revenue through various growth strategies. Among these companies are Medtronic, Zimmer Biomet, Amgen Inc., Mediprint, Propeller Health, Ypsomed, CosMED Pharmaceutical Co. Ltd., Micron Biomedical, Inc., Findair Sp. z o. o., VAXXAS, MetP Pharma AG, SONCEBOZ, Eitan Medical, Vaxess Technologies Inc., Subcuject Aps, E3D Elcam Drug Delivery Devices, OcuMedic, GlaxoSmithKline plc, Bayer AG, NanoPass, Sensirion AG Switzerland, Janssen Pharmaceuticals, Inc. (a subsidiary of Johnson & Johnson Services, Inc.), Insulet Corporation, TheraJect, Otsuka America Pharmaceutical Inc., Raphas Co. Ltd., and EOFLOW CO., LTD.
To achieve their goals, these companies have implemented several strategies, including partnerships and collaborations, new product development, geographical expansion, acquisitions and mergers, and increased investment. Through partnerships and collaborations, companies can leverage each other’s resources and expertise to develop new treatments quickly. New product development is another strategy that companies are using to improve existing interventional radiology drainage procedures and launch new items to broaden their product offerings and gain a competitive edge. Geographical expansion is another growth strategy that companies are using to attract new customers and increase revenue by opening operations in new markets with promising growth prospects. Additionally, businesses can acquire new technology by making purchases or collaborating with other businesses. Finally, increased investment to produce cost-effective items is another way to expand and grow in the competitive market.