Drug Device Combination Products Market Size and Outlook 2031

Report Description

Forecast Period	2027-2031
Market Size (2025)	USD 120.45 Billion
CAGR (2026-2031)	8.81%
Fastest Growing Segment	Transdermal Patches
Largest Market	North America
Market Size (2031)	USD 199.91 Billion

Market Overview

The Global Drug Device Combination Products Market will grow from USD 120.45 Billion in 2025 to USD 199.91 Billion by 2031 at a 8.81% CAGR. The Global Drug Device Combination Products Market encompasses therapeutic or diagnostic entities that physically or chemically integrate a pharmaceutical or biologic agent with a medical delivery device, such as prefilled syringes, inhalers, or drug-eluting stents. The market is primarily driven by the increasing prevalence of chronic diseases requiring consistent long-term management and the rising demand for self-administration technologies that facilitate home healthcare. These fundamental drivers foster patient autonomy and reduce reliance on clinical settings, establishing a growth trajectory distinct from transient industry trends.

However, the market encounters a significant challenge regarding complex regulatory frameworks, as manufacturers must satisfy rigorous compliance standards for both drug and device components simultaneously. This duality often results in extended approval timelines and elevated development costs. According to the 'Regulatory Affairs Professionals Society', in '2025', the FDA’s Office of Combination Products reported receiving 645 original premarket submissions during the 2024 fiscal year, reflecting the intense volume of regulatory activity. Consequently, navigating these intricate and resource-intensive submission processes remains a substantial barrier that could impede rapid market expansion.

Key Market Drivers

The rapid expansion of the biologics market is a primary engine for growth, necessitating specialized delivery systems for complex molecules. As chronic conditions surge, pharmaceutical entities are aggressively scaling injectable combination products to meet global volume requirements. This trend is underscored by the performance of leading therapies; according to Eli Lilly and Company, October 2024, in the 'Third Quarter 2024 Financial Results', worldwide revenue for the injectable product Mounjaro reached $3.11 billion in the third quarter alone. To support this trajectory, manufacturers are committing substantial resources to infrastructure; according to Novo Nordisk, November 2024, in the 'Financial Report for the period 1 January 2024 to 30 September 2024', the company forecasted full-year capital expenditures of DKK 45 billion to expand manufacturing capacity.

Technological advancements in smart and connected drug delivery systems are simultaneously revolutionizing the sector by addressing the demand for enhanced adherence. These innovations integrate connectivity into delivery devices, enabling patients to self-manage chronic illnesses while generating actionable data. This shift towards digital health is evidenced by the robust adoption of sensor-based technologies. According to Abbott, October 2024, in the 'Abbott Reports Third-Quarter 2024 Results' press release, sales of FreeStyle Libre continuous glucose monitors exceeded $1.6 billion for the quarter, achieving a reported growth rate of 19.1 percent. Such data confirms that the integration of diagnostic capabilities is becoming a critical differentiator.

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Key Market Challenges

The complex regulatory landscape constitutes a substantial barrier to the expansion of the Global Drug Device Combination Products Market. Manufacturers are compelled to navigate a bifurcated compliance framework that demands adherence to rigorous safety and efficacy standards for both pharmaceutical agents and medical devices simultaneously. This duality necessitates extensive cross-disciplinary validation and documentation, significantly extending the product development lifecycle. The lack of harmonized global standards regarding the "Primary Mode of Action" further exacerbates these delays, as companies often face conflicting classification rulings that stall commercialization and inflate capital expenditure.

These regulatory bottlenecks directly impact strategic market entry decisions and innovation rates. When compliance costs outweigh projected returns, manufacturers may delay or abandon product launches in key regions. According to 'MedTech Europe', in '2025', 'survey data indicated that the preference for the European Union as the first launch geography for large medical device manufacturers declined by approximately 33% compared to historic levels, largely attributed to the unpredictable timelines and resource demands of the Medical Device Regulation'. This trend demonstrates how intricate compliance requirements actively suppress market growth by disincentivizing rapid global accessibility.

Key Market Trends

The adoption of wearable on-body injectors is significantly altering the delivery landscape for therapeutics requiring continuous administration or large-volume dosing. Unlike traditional prefilled syringes, these devices adhere directly to the skin, offering a hands-free mechanism that supports the delivery of viscous biologics outside clinical environments. This transition towards wearable mechanical systems is validated by the performance of specialized device manufacturers who focus on tubeless delivery technologies. According to Insulet Corporation, November 2024, in the 'Insulet Reports Third Quarter 2024 Financial Results', the company achieved quarterly revenue of $543.9 million, driven primarily by the market demand for its proprietary on-body pod platform. This revenue volume underscores the growing patient and provider preference for form factors that physically integrate medication storage and actuation into a single unit.

Strategic co-development partnerships between pharmaceutical companies and medical device specialists are simultaneously emerging to mitigate technical development risks. As combination products become mechanically intricate, pharmaceutical firms are increasingly outsourcing the design and manufacturing of device components to established medtech partners rather than maintaining vertical integration. This collaborative model allows drug manufacturers to leverage external engineering expertise, thereby ensuring component compatibility and accelerating commercialization timelines. The scale of this supplier-dependency is evident in recent industrial financial performance. According to West Pharmaceutical Services, Inc., October 2024, in the 'West Announces Third-Quarter 2024 Results' press release, net sales reached $746.9 million, highlighting the substantial capital flowing into specialized containment and delivery system providers. This reliance on expert partners is fundamentally reshaping the industry supply chain.

Segmental Insights

Transdermal patches represent the fastest-growing segment within the Global Drug Device Combination Products Market. This expansion is primarily driven by the rising demand for self-administered therapies that improve patient compliance through non-invasive delivery. These devices provide controlled drug release, which is advantageous for managing chronic conditions such as cardiovascular diseases and pain management. Furthermore, agencies like the US FDA have established clear guidance for combination product approvals, encouraging manufacturers to develop alternative delivery systems. Consequently, the shift toward home-based care continues to fuel the rapid adoption of patch technologies globally.

Regional Insights

North America maintains a dominant position in the Global Drug Device Combination Products Market, primarily driven by an established healthcare infrastructure and the presence of key industry players. The region experiences a high prevalence of chronic conditions requiring self-administration, such as diabetes and respiratory disorders, which fuels demand for inhalers and injectors. Furthermore, the United States Food and Drug Administration provides a structured regulatory framework that supports product development and approval. Favorable reimbursement policies and substantial healthcare expenditure also contribute significantly to the market expansion in this region.

Recent Developments

In October 2024, Ypsomed and Becton, Dickinson and Company announced a strategic collaboration to develop self-injection systems for high-viscosity biologic drugs. The partners focused on integrating the BD Neopak XtraFlow Glass Prefillable Syringe with Ypsomed’s YpsoMate 2.25 autoinjector platform to enable the delivery of formulations with higher viscosities. This joint initiative aimed to address current technical limitations in subcutaneous drug delivery and streamline the development process for pharmaceutical companies. By leveraging shared expertise, the companies sought to provide reliable, patient-centric solutions for administering chronic condition therapeutics, such as antibodies and next-generation biologics.
In October 2024, invoX Pharma established a strategic partnership with H&T Presspart to manufacture device sub-assemblies for the commercialization of the Softhaler, a proprietary soft mist inhalation device. Under the agreement, H&T Presspart was tasked with moulding components and producing sub-assemblies at its facility in Spain to support the industrialization of the propellant-free device. This collaboration aimed to leverage specialized manufacturing expertise to bring the mechanical inhaler to the global market. The device is designed to convert water-based formulations into an ultra-fine mist, optimizing drug delivery to the lungs for patients with respiratory diseases.
In February 2024, Coherus BioSciences launched Udenyca OnBody, a novel on-body injector presentation of its pegfilgrastim biosimilar, in the United States. This product utilizes the LTS Sorrel wearable drug delivery platform to administer medication the day after chemotherapy, aiming to decrease the incidence of infection manifested by febrile neutropenia. The device features a five-minute injection time and a retractable needle mechanism designed to enhance patient safety and convenience. The Chief Commercial Officer of Coherus BioSciences stated that this innovative delivery system provides patients and healthcare providers with a valuable hands-free administration option aligned with individual treatment needs.
In January 2024, FUJIFILM Biotechnologies entered a strategic partnership with SHL Medical to expand its capabilities in finished goods autoinjector assembly. This non-exclusive agreement allowed the contract development and manufacturing organization to provide final assembly services for SHL Medical’s Molly autoinjector platform. The collaboration was established to meet the growing market demand for autoinjector medicines and to offer pharmaceutical customers a streamlined path to clinic and market. Executive leadership noted that accessing SHL Medical’s solutions would enhance the company’s ability to support clients in improving patient access to advanced self-administration therapies.

Key Market Players

Abbott Laboratories Inc.
Medtronic plc
Boston Scientific Corporation
Becton, Dickinson and Company
Novartis AG
GlaxoSmithKline plc
AbbVie Inc.
W. L. Gore & Associates, Inc.
Stryker Corporation
Terumo Corporation

By Application	By End User	By Region
Cardiovascular Diabetes Cancer Treatment Respiratory Diseases Others	Hospitals Ambulatory Surgical Centers Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Drug Device Combination Products Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Drug Device Combination Products Market, By Application:

Cardiovascular
Diabetes
Cancer Treatment
Respiratory Diseases
Others

Drug Device Combination Products Market, By End User:

Hospitals
Ambulatory Surgical Centers
Others

Drug Device Combination Products Market, By Region:

North America

United States
Canada
Mexico

Europe

France
United Kingdom
Italy
Germany
Spain

Asia Pacific

China
India
Japan
Australia
South Korea

South America

Brazil
Argentina
Colombia

Middle East & Africa

South Africa
Saudi Arabia
UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Drug Device Combination Products Market.

Available Customizations:

Global Drug Device Combination Products Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

Detailed analysis and profiling of additional market players (up to five).

Global Drug Device Combination Products Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]

Table of content

1. Product Overview

1.1. Market Definition

1.2. Scope of the Market

1.2.1. Markets Covered

1.2.2. Years Considered for Study

1.2.3. Key Market Segmentations

2. Research Methodology

2.1. Objective of the Study

2.2. Baseline Methodology

2.3. Key Industry Partners

2.4. Major Association and Secondary Sources

2.5. Forecasting Methodology

2.6. Data Triangulation & Validation

2.7. Assumptions and Limitations

3. Executive Summary

3.1. Overview of the Market

3.2. Overview of Key Market Segmentations

3.3. Overview of Key Market Players

3.4. Overview of Key Regions/Countries

3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Drug Device Combination Products Market Outlook

5.1. Market Size & Forecast

5.1.1. By Value

5.2. Market Share & Forecast

5.2.1. By Application (Cardiovascular, Diabetes, Cancer Treatment, Respiratory Diseases, Others)

5.2.2. By End User (Hospitals, Ambulatory Surgical Centers, Others)

5.2.3. By Region

5.2.4. By Company (2025)

5.3. Market Map

6. North America Drug Device Combination Products Market Outlook

6.1. Market Size & Forecast

6.1.1. By Value

6.2. Market Share & Forecast

6.2.1. By Application

6.2.2. By End User

6.2.3. By Country

6.3. North America: Country Analysis

6.3.1. United States Drug Device Combination Products Market Outlook

6.3.1.1. Market Size & Forecast

6.3.1.1.1. By Value

6.3.1.2. Market Share & Forecast

6.3.1.2.1. By Application

6.3.1.2.2. By End User

6.3.2. Canada Drug Device Combination Products Market Outlook

6.3.2.1. Market Size & Forecast

6.3.2.1.1. By Value

6.3.2.2. Market Share & Forecast

6.3.2.2.1. By Application

6.3.2.2.2. By End User

6.3.3. Mexico Drug Device Combination Products Market Outlook

6.3.3.1. Market Size & Forecast

6.3.3.1.1. By Value

6.3.3.2. Market Share & Forecast

6.3.3.2.1. By Application

6.3.3.2.2. By End User

7. Europe Drug Device Combination Products Market Outlook

7.1. Market Size & Forecast

7.1.1. By Value

7.2. Market Share & Forecast

7.2.1. By Application

7.2.2. By End User

7.2.3. By Country

7.3. Europe: Country Analysis

7.3.1. Germany Drug Device Combination Products Market Outlook

7.3.1.1. Market Size & Forecast

7.3.1.1.1. By Value

7.3.1.2. Market Share & Forecast

7.3.1.2.1. By Application

7.3.1.2.2. By End User

7.3.2. France Drug Device Combination Products Market Outlook

7.3.2.1. Market Size & Forecast

7.3.2.1.1. By Value

7.3.2.2. Market Share & Forecast

7.3.2.2.1. By Application

7.3.2.2.2. By End User

7.3.3. United Kingdom Drug Device Combination Products Market Outlook

7.3.3.1. Market Size & Forecast

7.3.3.1.1. By Value

7.3.3.2. Market Share & Forecast

7.3.3.2.1. By Application

7.3.3.2.2. By End User

7.3.4. Italy Drug Device Combination Products Market Outlook

7.3.4.1. Market Size & Forecast

7.3.4.1.1. By Value

7.3.4.2. Market Share & Forecast

7.3.4.2.1. By Application

7.3.4.2.2. By End User

7.3.5. Spain Drug Device Combination Products Market Outlook

7.3.5.1. Market Size & Forecast

7.3.5.1.1. By Value

7.3.5.2. Market Share & Forecast

7.3.5.2.1. By Application

7.3.5.2.2. By End User

8. Asia Pacific Drug Device Combination Products Market Outlook

8.1. Market Size & Forecast

8.1.1. By Value

8.2. Market Share & Forecast

8.2.1. By Application

8.2.2. By End User

8.2.3. By Country

8.3. Asia Pacific: Country Analysis

8.3.1. China Drug Device Combination Products Market Outlook

8.3.1.1. Market Size & Forecast

8.3.1.1.1. By Value

8.3.1.2. Market Share & Forecast

8.3.1.2.1. By Application

8.3.1.2.2. By End User

8.3.2. India Drug Device Combination Products Market Outlook

8.3.2.1. Market Size & Forecast

8.3.2.1.1. By Value

8.3.2.2. Market Share & Forecast

8.3.2.2.1. By Application

8.3.2.2.2. By End User

8.3.3. Japan Drug Device Combination Products Market Outlook

8.3.3.1. Market Size & Forecast

8.3.3.1.1. By Value

8.3.3.2. Market Share & Forecast

8.3.3.2.1. By Application

8.3.3.2.2. By End User

8.3.4. South Korea Drug Device Combination Products Market Outlook

8.3.4.1. Market Size & Forecast

8.3.4.1.1. By Value

8.3.4.2. Market Share & Forecast

8.3.4.2.1. By Application

8.3.4.2.2. By End User

8.3.5. Australia Drug Device Combination Products Market Outlook

8.3.5.1. Market Size & Forecast

8.3.5.1.1. By Value

8.3.5.2. Market Share & Forecast

8.3.5.2.1. By Application

8.3.5.2.2. By End User

9. Middle East & Africa Drug Device Combination Products Market Outlook

9.1. Market Size & Forecast

9.1.1. By Value

9.2. Market Share & Forecast

9.2.1. By Application

9.2.2. By End User

9.2.3. By Country

9.3. Middle East & Africa: Country Analysis

9.3.1. Saudi Arabia Drug Device Combination Products Market Outlook

9.3.1.1. Market Size & Forecast

9.3.1.1.1. By Value

9.3.1.2. Market Share & Forecast

9.3.1.2.1. By Application

9.3.1.2.2. By End User

9.3.2. UAE Drug Device Combination Products Market Outlook

9.3.2.1. Market Size & Forecast

9.3.2.1.1. By Value

9.3.2.2. Market Share & Forecast

9.3.2.2.1. By Application

9.3.2.2.2. By End User

9.3.3. South Africa Drug Device Combination Products Market Outlook

9.3.3.1. Market Size & Forecast

9.3.3.1.1. By Value

9.3.3.2. Market Share & Forecast

9.3.3.2.1. By Application

9.3.3.2.2. By End User

10. South America Drug Device Combination Products Market Outlook

10.1. Market Size & Forecast

10.1.1. By Value

10.2. Market Share & Forecast

10.2.1. By Application

10.2.2. By End User

10.2.3. By Country

10.3. South America: Country Analysis

10.3.1. Brazil Drug Device Combination Products Market Outlook

10.3.1.1. Market Size & Forecast

10.3.1.1.1. By Value

10.3.1.2. Market Share & Forecast

10.3.1.2.1. By Application

10.3.1.2.2. By End User

10.3.2. Colombia Drug Device Combination Products Market Outlook

10.3.2.1. Market Size & Forecast

10.3.2.1.1. By Value

10.3.2.2. Market Share & Forecast

10.3.2.2.1. By Application

10.3.2.2.2. By End User

10.3.3. Argentina Drug Device Combination Products Market Outlook

10.3.3.1. Market Size & Forecast

10.3.3.1.1. By Value

10.3.3.2. Market Share & Forecast

10.3.3.2.1. By Application

10.3.3.2.2. By End User

11. Market Dynamics

11.1. Drivers

11.2. Challenges

12. Market Trends & Developments

12.1. Merger & Acquisition (If Any)

12.2. Product Launches (If Any)

12.3. Recent Developments

13. Global Drug Device Combination Products Market: SWOT Analysis

14. Porter's Five Forces Analysis

14.1. Competition in the Industry

14.2. Potential of New Entrants

14.3. Power of Suppliers

14.4. Power of Customers

14.5. Threat of Substitute Products

15. Competitive Landscape

15.1. Abbott Laboratories Inc.

15.1.1. Business Overview

15.1.2. Products & Services

15.1.3. Recent Developments

15.1.4. Key Personnel

15.1.5. SWOT Analysis

15.2. Medtronic plc

15.3. Boston Scientific Corporation

15.4. Becton, Dickinson and Company

15.5. Novartis AG

15.6. GlaxoSmithKline plc

15.7. AbbVie Inc.

15.8. W. L. Gore & Associates, Inc.

15.9. Stryker Corporation

15.10. Terumo Corporation

16. Strategic Recommendations

17. About Us & Disclaimer

Report Description

Table of content

Figures and Tables

Frequently asked questions

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