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Global Markets for Drug-Device Combinations

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    Report

  • 101 Pages
  • January 2022
  • Region: Global
  • BCC Research
  • ID: 5531022
UP TO OFF until Aug 31st 2033

The current report will provide a detailed introduction to and exploration of the drug-device combination market. This report analyzes the market trends of drug-device combination products with data from 2020, estimates from 2021, projections of compound annual growth rates through 2026 (forecast period 2021-2026) and regional markets of the drug-device combination product market. This report will highlight the current and future market potential of drug-device combinations along with a detailed analysis of the competitive environment. Regulatory scenario, drivers, restraints and opportunities will be covered in the current report. The report also covers market projections for 2026, and the market share for key market players.




The market has been segmented based on product type, application and geography. Based on product type, the market in this report is segmented into drug-device combination products such as drug eluting stents (DES), antimicrobial catheters, photodynamic therapy, autoinjectors, transdermal patches, metered dose inhalers and others), device/biologic drug-device combination products (microneedles, prefilled syringe (PFS), nasal inhalers, nanotechnology generated, implants and others), drug/biologic drug-device combination products (monoclonal antibodies, antibody-drug conjugates (ADC), wound care and others) and drug and device and biologic. Based on application, the drug-device combination product market is segmented by treatment of the following diseases: oncology, cardiovascular diseases, metabolic disorders, respiratory diseases, orthopedic diseases and others.

The regional market analysis of drug-device combination is also covered in this report. The market has been segmented into various major geographies, including the North America, Europe, Asia-Pacific and the Rest of the World regions. Detailed analysis of major countries such as the U.S., Germany, the U.K., Italy, France, Japan, China and India are going to be covered within the regional segment. For market estimates, data are going to be provided for 2020 as the base year, with estimates for 2021 and forecast values for 2026.


Report Includes


  • 47 tables
  • An overview of the global market for drug-device combination products
  • Estimation of the market size and analyses of global market trends, with data from 2019 to 2020, 2021 and projections of compound annual growth rates (CAGRs) through 2026
  • Characterization and quantification of market potential for drug-device combinations by type, application, and region
  • Coverage of regulatory landscape, product recalls, pipeline products, and discussion on future perspective, strategies, and developments of the industry
  • Identification of market drivers, restraints and other forces impacting the global market and evaluation of current market trends, market size, and market forecast
  • Market share analysis of the key companies of the industry and coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies and a relevant patent analysis
  • Company profiles of major players, including Abbott, Boston Scientific Corp., Johnson & Johnson Services Inc. and Sanofi S.A.

Table of Contents

Chapter 1 Introduction


  • Study Goals and Objectives
  • Reasons for Doing This Study
  • What's New in This Update?
  • Scope of Report
  • Information Sources
  • Methodology
  • Geographic Breakdown
  • Analyst's Credentials

Chapter 2 Summary and Highlights

Chapter 3 Market Dynamics


  • Drivers
  • Wide Range of Potential Applications of Combinations Products
  • Increasing Number of Diseases
  • Recent Approvals and Launch of Novel Drug-device Combination Products
  • Restraints
  • Limitations Associated with Drug-Device Combination Products
  • Regulatory Challenges
  • Opportunities
  • Key Players Focusing on Inorganic Strategies in the Drug-Device Combination Products Market

Chapter 4 Market Overview


  • Market Insights
  • Regulatory Landscape
  • Patent Review
  • Product Recalls
  • Product Pipeline
  • Market Trends
  • Future Perspective
  • Strategies and Developments

Chapter 5 Impact of COVID-19


  • Overview
  • COVID-19 Crisis
  • Impact on Market for Drug-Device Combination Products
  • Current Outlook

Chapter 6 Market Breakdown by Product Type


  • Drug/Biologic-Device Combination Products
  • Drug Eluting Stents (DES)
  • Prefilled Syringe (PFS)
  • Inhalers
  • Nebulizer
  • Wound Care Products
  • Implants
  • Antimicrobial Catheters
  • Photodynamic Therapy (PDT)
  • Transdermal Patches
  • Others
  • Drug-Biologic Drug-Device Combination Products
  • Antibody-Drug Conjugates (ADC)
  • Monoclonal Antibodies (mAbs)
  • Others
  • Drug and Device and Biologic Combination Products

Chapter 7 Market Breakdown by Application


  • Cardiovascular Diseases
  • Metabolic Disorders
  • Respiratory Diseases
  • Wound Care
  • Orthopedic Conditions
  • Oncology
  • Others

Chapter 8 Market Breakdown by Region


  • Overview
  • North America
  • Europe
  • Asia-Pacific
  • Rest of the World

Chapter 9 Competitive Landscape


  • Company Share Analysis

Chapter 10 Company Profiles


  • Company Profiles
  • 3M
  • ABBOTT
  • B. BRAUN MELSUNGEN AG
  • BD
  • BOSTON SCIENTIFIC CORP.
  • COSMED PHARMACEUTICAL CO., LTD.
  • JOHNSON & JOHNSON SERVICES INC.
  • MEDTRONIC INC.
  • SANOFI S.A.
  • SMITH & NEPHEW PLC
  • STRYKER CORP.
  • TERUMO CORP.

Chapter 11 Appendix: List of Acronyms

List of Tables
Summary Table : Global Market for Drug-Device Combination Products, by Product Type, Through 2026
Table 1 : EU Combination Product Regulation
Table 2 : Patents on Drug-Device Combination Products, 2011-2021
Table 3 : Recalled Drug-Device Combination Products
Table 4 : Drug-Device Combination Product Pipeline
Table 5 : Recent Strategies and Developments, 2018-2021
Table 6 : Global Market for Drug-Device Combination Products, by Product Type, Through 2026
Table 7 : Global Market for Drug/Biologic-Device Combination Products, by Product Type, Through 2026
Table 8 : Global Market for Drug/Biologic-Device Combination Products, by Region, Through 2026
Table 9 : Global Market for Drug-Biologic Combination Products, by Product Type, Through 2026
Table 10 : Global Market for Drug-Biologic Combination Products, by Region, Through 2026
Table 11 : Global Market for Drug and Device and Biologic Combination Products, by Region, Through 2026
Table 12 : Global Market for Drug-Device Combination Products, by Application, Through 2026
Table 13 : Global Market for Drug-Device Combination Products for Cardiovascular Diseases, by Region, Through 2026
Table 14 : Global Market for Drug-Device Combination Products for Metabolic Disorders, by Region, Through 2026
Table 15 : Global Market for Drug-Device Combination Products for Respiratory Diseases, by Region, Through 2026
Table 16 : Global Market for Drug-Device Combination Products for Wound Care, by Region, Through 2026
Table 17 : Global Market for Drug-Device Combination Products for Orthopedic Conditions, by Region, Through 2026
Table 18 : Global Market for Drug-Device Combination Products in Oncology, by Region, Through 2026
Table 19 : Global Market for Drug-Device Combination Products for Other Chronic Diseases, by Region, Through 2026
Table 20 : Global Market for Drug-Device Combination Products, by Region, Through 2026
Table 21 : U.S. Estimates for Influenza Disease Burden, by Age Group, 2019-2020
Table 22 : North American Market for Drug-Device Combination Products, by Country, Through 2026
Table 23 : European Market for Drug-Device Combination Products, by Country, Through 2026
Table 24 : Asia-Pacific Market for Drug-Device Combination Products, by Country, Through 2026
Table 25 : Estimation of New Cancer Cases in Africa, by Cancer Type, 2020 and 2024
Table 26 : Market Players and the Products They Offer for Various Applications
Table 27 : Terumo Corp.: R&D Investment, 2018-2020
Table 28 : 3M: Drug-Device Combination Products
Table 29 : 3M: Key Developments
Table 30 : Abbott: Drug-Device Combination Products
Table 31 : Abbott: Key Developments
Table 32 : B. Braun Melsungen AG: Drug-device combination products
Table 33 : BD: Combination Product
Table 34 : BD: Key Development
Table 35 : Boston Scientific Corp.: drug-Device Combination Products
Table 36 : CosMED Pharmaceutical Co., Ltd.: Combination Product
Table 37 : Johnson & Johnson Services Inc.: Combination Product
Table 38 : Medtronic: Drug-device combination products
Table 39 : Medtronic: Key Developments
Table 40 : Sanofi S.A.: Combination Product
Table 41 : Sanofi S.A.: Key Development
Table 42 : Smith & Nephew: Combination Product
Table 43 : Stryker Corp.: Drug-Device Combination Products
Table 44 : Terumo Corp.: Combination Product
Table 45 : Terumo Corp.: Key Developments
Table 46 : Acronyms Used in This Report

List of Figures
Summary Figure : Global Market Shares of Drug-Device Combination Products, by Product Type, 2020
Figure 1 : U.S. FDA Combination Product Approval Pathway
Figure 2 : Global Market for Drug-Device Combination Products, 2019-2026
Figure 3 : Global Market for Drug/Biologic-Device Combination Products, 2019-2026
Figure 4 : Global Market for Drug-Biologic Combination Products, 2019-2026
Figure 5 : Global Market for Drug and Device and Biologic Combination Products, 2019-2026
Figure 6 : Global Market for Drug-Device Combination Products, by Application, 2019-2026
Figure 7 : Global Market for Drug-Device Combination Products for Cardiovascular Diseases, 2019-2026
Figure 8 : Global Market for Drug-Device Combination Products for Metabolic Disorders, 2019-2026
Figure 9 : Global Market for Drug-Device Combination Products for Respiratory Diseases, 2019-2026
Figure 10 : Global Market for Drug-Device Combination Products for Wound Care, 2019-2026
Figure 11 : Global Market for Drug-Device Combination Products for Orthopedic Conditions, 2019-2026
Figure 12 : Global Market for Drug-Device Combination Products for Oncology, 2019-2026
Figure 13 : Global Market for Drug-Device Combination Products for Other Chronic Diseases, 2019-2026
Figure 14 : Global Market Shares of Drug-Device Combination Products, by Region, 2020
Figure 15 : North American Market for Drug-Devices Combination Product, by Country, 2019-2026
Figure 16 : North American Market for Drug-Devices Combination Product, by Country, 2019-2026
Figure 17 : European Market for Drug-Device Combination Products, by Country, 2019-2026
Figure 18 : European Market Shares of Drug-Device Combination Products, by Country, 2020
Figure 19 : Asia-Pacific Market for Drug-Device Combination Products, by Country, 2019-2026
Figure 20 : Asia-Pacific Market Shares of Drug-Device Combination Products, by Country, 2020
Figure 21 : Global Market Shares of Drug-Device Combination Products, by Company, 2020
Figure 22 : 3M: Annual Revenue, 2018-2020
Figure 23 : 3M: Revenue Share, by Business Segment, 2020
Figure 24 : 3M: Revenue Share, by Business Segment, 2020
Figure 25 : Abbott: Annual Revenue, 2018-2020
Figure 26 : Abbott: Revenue Share, by Business Segment, 2020
Figure 27 : Abbott: Medical Devices Revenue-Vascular (Coronary Endovascular), 2019 and 2020
Figure 28 : B. Braun Melsungen AG: Annual Revenue, 2018-2020
Figure 29 : B. Braun Melsungen AG: Revenue Share, by Division, 2020
Figure 30 : BD: Annual Revenue, 2018-2020
Figure 31 : BD: Revenue Share, by Business Segment, 2020
Figure 32 : BD: Medical Segment Revenue-Medication Delivery Solutions, 2019 and 2020
Figure 33 : BD: Combination Product
Figure 34 : BD: Key Development
Figure 35 : Boston Scientific Corp.: Cardiovascular Revenue (Interventional Cardiology), 2019 and 2020
Figure 36 : Johnson & Johnson Services Inc.: Annual Revenue, 2018-2020
Figure 37 : Johnson & Johnson Services Inc.: Revenue Share, by Business Segment, 2020
Figure 38 : Johnson & Johnson Services Inc.: Medical Devices Revenue Orthopedics, 2019 and 2020
Figure 39 : Medtronic: Annual Revenue, 2018-2020
Figure 40 : Medtronic: Revenue Share, by Business Segment, 2020
Figure 41 : Sanofi S.A.: Annual Revenue, 2018-2020
Figure 42 : Sanofi S.A.: Revenue Share, by Business Unit, 2020
Figure 43 : Smith & Nephew: Annual Revenue, 2018-2020
Figure 44 : Smith & Nephew: Revenue Share, by Business Segment, 2020
Figure 45 : Smith & Nephew: Advanced Wound Management Segment Revenue, Advanced Wound Care (AWC), 2019-2020
Figure 46 : Stryker Corp.: Annual Revenue, 2018-2020
Figure 47 : Stryker Corp.: Revenue Share, by Business Segment, 2020
Figure 48 : Terumo Corp.: Annual Revenue, 2018-2020
Figure 49 : Terumo Corp.: Revenue Share, by Business Segment, 2020
Figure 50 : Terumo Corp.: Cardiac and Vascular Company Revenue Interventional Systems (TIS), 2019 and 2020

Executive Summary

Growth of the global market is attributed to the factors such as the wide range of potential applications of drug-device combinations, the increasing number of diseases and the recent approvals of novel drug-device combination products.

Drug-device combinations are used in drug delivery in various disease treatments. Thus, the increasing prevalence of chronic diseases is another factor driving this market. According to U.S. Census estimates, people aged 65+ will make up nearly a quarter of the U.S. population by 2060. Studies show that nearly 60% (150 million) of Americans have at least one chronic disease, and 45% (100 million) have more than one. It is estimated that by 2023, the number of chronic disease cases will increase to 230 million (42% of the total U.S. population).

The global market for drug-device combination products is segmented based on product type, application and region.


Reasons for Doing This Study


The first drug-device combination product was conceptualized in the 1970s, and it was regulated under FDA authority. Within next two decades, drug-device combination product drug-device combination products were regulated by the agencies the Office of Combination Products (OCP) through the use of inter-agency agreements. In the 1990s, a provision for the regulation of drug-device combination products, the Safe Medical Devices Act (SMDA), was adopted. In 1991, the product authority regulation, 21 CFR Part 3 was introduced. This eventually fell under the FDA Modernization Act (FDMA), which was fully enacted in 1997. The FDMA addressed pre-market approval, notification, classification, labeling, tracking, surveillance and establishment registration, to name a few of its areas of focus. The drug device combination products market is still evolving, expanding its fields for better outcomes.

A combination product is a composite of two or more distinct products, called constituent parts, that are different product types. Drug-Device combination products are comprised of two or more regulated components that are physically, chemically or otherwise combined or mixed as a “single entity.” Two or more separate products that are packaged together in a single package or sold as a unit are referred as “co-packaged” products. Where drugs, devices, or biological products are packaged separately, which is used to plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, this is often referred to as a “cross-labeled” combination product. These products are regulated under 21 CFR Part 3.2.

Companies Mentioned

  • 3M
  • Abbott
  • B. Braun Melsungen AG
  • Bd
  • Boston Scientific Corp.
  • Cosmed Pharmaceutical Co. Ltd.
  • Johnson & Johnson Services Inc.
  • Medtronic Inc.
  • Sanofi S.A.
  • Smith & Nephew plc
  • Stryker Corp.
  • Terumo Corp.

Table Information