Drug-Device Combination Products Market to Soar $337.81 Bn by 2034

Drug-Device Combination Products Market Trends & Competitive Analysis

The drug-device combination products market size was estimated at US$ 150.3 billion in 2023 and is projected to grow to US$ 337.81 billion by 2034, rising at a compound annual growth rate (CAGR) of 7.64% from 2024 to 2034. The rising incidences of chronic disorders, demand for personalized medicines, and favorable government policies drive the market.

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Drug-Device Combination Products Market: Stimulating Effect

Drug-device combination products are therapeutic and diagnostic products that combine a drug and a device, leading to safer and more effective treatments. There are generally two main types of combination products: integral and co-packaged. In integral, the drug and device form a single integrated product. In co-packaged, the pharmaceutical and device are separate items but packaged together in the same secondary packaging. Examples of drug-device combination products include autoinjectors, inhalers, pre-filled nebulizers, pre-filled pens, pre-filled syringes, and transdermal patches.

The careful and precise drug targeting, local administration, and individualized therapy favor the development of drug-device combination products. The increasing incidences of chronic disorders and growing research & development activities potentiate market growth. Additionally, favorable government policies and increasing sophistication of the products drive the market. Rising investments & collaborations, and technological advancements also boost the market.

Drug-Device Combination Products Market Trends

• In September 2024, PCI Pharma Services announced an investment of more than $365 million in infrastructure supporting the clinical and commercial-scale final assembly and packaging of drug-device combination products.
• In June 2024, Freudenberg Medical, a global CDMO partner to the medical device and biopharma industry, announced plans to expand its drug-device combination products business. The company is investing more than $50 million in a new Hemotaq AG production facility in Aachen, Germany.
• In December 2023, Kindeva Drug Delivery and Orbia Advance Corporation announced a collaboration for the conversion from existing marketed pressurized Metered Dose Inhaler (pMDI) products to Koura’s more sustainable and environmentally-conscious medical propellant, HFA 152a, known as Zephex 152a.

Drug-Device Combination Products Market Growth Factors

• Rising Incidences of Chronic Disorders: The rising incidences of chronic disorders such as cancer, neurological, autoimmune, etc. drive the market.
• Growing Research and Development: The growing research and development leads to the development of novel drug-device combination products, thereby augmenting market growth.
• Suitable Regulatory Frameworks: Several regulatory agencies have suitable regulatory guidelines for approving drug-device combination products.
• Increasing Collaborations: The increasing collaborations among different organizations facilitate the production of drug-device combination products.

Technological Future of the Drug-Device Combination Products Market

The latest technological advancements like artificial intelligence (AI) and machine learning (ML) foster innovations in the development of drug-device combination products. AI can optimize the research and development process, thereby reducing development costs. ML algorithms can assist in experimental design and predict the pharmacokinetics and toxicity of drug candidates. AI can also aid the development of personalized medicines by analyzing real-world patient data. Additionally, AI can enable the drug to be compatible with the device, leading to more effective treatment outcomes. AI can also manipulate the drug release from the device at the precise time and location within the body. Favorable government policies boost the market. In September 2024, the US FDA established a new internal advisory body for regulating the use of AI during the manufacturing and testing of pharmaceutical products and in the development of complex drug-device combination products.

Regulatory Challenges and Drug-Device Integration

The major challenge of the market is the evolving regulatory standards for the approval of drug-device combination products. This poses a challenge for many manufacturers and distributors to stay abreast of regulatory changes and guidelines specific to these products. Another major challenge is the drug-device integration. The complex interaction between medications and devices presents a major challenge in product development. The drugs and devices should have precise coordination and compatibility to optimize performance and efficacy.

Regional Insights

Rising Incidences of Chronic Disorders Dominated North America

North America dominated the drug-device combination products market in 2023. The advanced healthcare infrastructure, state-of-the-art research and development facilities, technological advancements, and the presence of key players drive the market. Several government bodies, such as the Food and Drug Administration, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health, regulate the approval of drug-device combination products. The rising chronic disorders like cancer and diabetes promote the development of drug-device combination products. The US reported around 1.9 million new cancer cases in 2022, while in Canada, 0.23 million new cancer cases were reported.

Rising Geriatric Population Drives Asia-Pacific

Asia-Pacific is anticipated to grow at the fastest rate in the drug-device combination products market during the forecast period. The increasing investments & collaborations, growing research and development, rising chronic disorders, and increasing geriatric population drive the market. In China, approximately 280 million people will be 60 years or older in 2022. In India, around 149 million were above 60 years old in 2022, while in Japan, 36.25 million are currently 65 years and above. The geriatric population is more vulnerable to chronic disorders, necessitating the development of novel drug-device combination products to enhance patient adherence.

Segmental Insights

By product, the drug-eluting stents segment held the largest share of the drug-device combination products market in 2023. Drug-eluting stents are tubes used to treat narrowed or blocked arteries by gradually releasing the drug. They can act both mechanically by opening the arteries and pharmacologically by targeted drug delivery. The rising incidences of cardiovascular disorders and heart attacks potentiate the segment growth.

The infusion pumps segment is expected to grow at the fastest rate in the market during the forecast period. Infusion pumps are medical devices that deliver fluids, such as nutrients and drugs, into a patient’s body in controlled amounts. They are used to self-administer drugs in hospitalized patients or cancer patients for sustained release.

By application, the cardiovascular segment accounted for a considerable share of the drug-device combination products market in 2023. The rising incidences of cardiovascular diseases drive the segment growth. The most common combination product for cardiovascular disease drug-eluting stent provides the desired effect, giving targeted drug delivery.

The cancer treatment segment is anticipated to grow with the highest CAGR in the market during the studied years. The rising cases of cancer disorders and lack of effective treatment for late-stage cancer promote the segment growth. In 2022, approximately 20 million new cancer cases were reported globally.

By end-user, the hospital segment registered its dominance over the global drug-device combination products market in 2023. The increasing number of patients and surgeries, technical expertise, and favorable reimbursement policies in hospitals boost the segment growth.

The ambulatory surgical centers segment is projected to expand rapidly in the market in the coming years. The increasing awareness and demand for same-day discharge are responsible for the use of drug-delivery combination products.

Latest Announcement by Industry Leaders

Dr. Mark Ostwald, CEO of Freudenberg Medical, commented that the drug-device combination products are inspiring a new generation of innovative products to improve patients’ outcomes. He added that the company’s investment of $50 million will strengthen its position as a strategic partner to their customers, offering vertically integrated solutions along the entire supply chain.

Recent Developments in the Drug-Device Combination Products Market

• In October 2024, SHL Medical adopted a novel reusable electromechanical autoinjector, Elexy, that changes how new drugs are trailed and commercialized. It consists of a reusable power unit and an interchangeable drug cassette that can accommodate both prefilled syringes and cartridges, as well as various viscosities and volumes.
• In March 2022, the US FDA approved the generic product Breyna (Budesonide and Formoterol Fumarate), a complex drug-device combination product, which is a metered-dose inhaler for the treatment of asthma and COPD. It is the first generic product of Symbicort by AstraZeneca.

Top Companies in the Drug-Device Combination Products Market

• Abbott Laboratories
• AbbVie, Inc.
• AstraZeneca
• Freudenberg Medical
• Kindeva Drug Delivery
• Medtronic Plc
• Novartis AG
• PCI Pharma Services
• SHL Medical
• Stryker Corporation
• The Lubrizol Corporation
• Terumo Corporation
• Teva Pharmaceuticals
• Viatris

Segments Covered in the Report

By Product

• Drug Eluting Stents
• Infusion Pumps
• Transdermal Patches
• Drug Eluting Balloon
• Inhalers
• Others

By Application

• Cardiovascular
• Cancer Treatment
• Diabetes
• Respiratory Diseases
• Others

By End-User

• Hospitals
• Ambulatory Surgical Centers
• Others

By Region

• North America
  • US
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Thailand
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Sweden
  • Denmark
  • Norway
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • UAE
  • Saudi Arabia
  • Kuwait