Executive Summary

Combination products-integrating drugs, devices, and often biologics-have transformed the medical devices industry, driving innovation, partnerships, and new regulatory frameworks. Since the early 2010s, this sector has experienced exponential growth, fueled by technological advances, the rise of chronic diseases, and patient-centric care models. Today, the market is characterized by dynamic collaboration between pharmaceutical and device companies, rapid product development cycles, and complex regulatory landscapes. This report provides a comprehensive update on the combination products market, significant industry partnerships, development challenges, and strategic imperatives for success in 2025 and beyond.

Market Overview

Definition and Scope

Combination products are therapeutic or diagnostic healthcare solutions that physically or chemically integrate drugs, medical devices, and sometimes biologics into a single entity or co-packaged system. Examples include drug-eluting stents, prefilled syringes, smart inhalers, insulin pumps, and transdermal patches.

Market Size and Growth Trajectory

2025 Market Size: The global drug-device combination products market is valued at approximately $165.26 billion in 2025, with forecasts suggesting it will reach $355.84 billion by 2034, reflecting a CAGR of 8.91%

Historical Growth: The market has more than doubled since the early 2010s, valued at just over $10 billion.

Key Drivers:

• Increasing prevalence of chronic diseases (diabetes, cardiovascular, respiratory, cancer)
• Aging populations demanding advanced, home-based healthcare solutions
• Technological innovation in drug delivery and device design
• Favorable regulatory and reimbursement environments in North America and Europe

Market Segmentation

Segment	Key Products/Applications	2025 Trends
Product Type	Infusion pumps, drug-eluting stents, inhalers, wound care products, autoinjectors, prefilled syringes, microneedle patches	Infusion pumps and diabetes management products lead the market.
Application	Diabetes, cardiovascular, respiratory, oncology, orthopedics, wound care	Diabetes and cardiovascular dominate, but oncology and neurology are growing rapidly
End User	Hospitals, ambulatory surgical centers, and home care	Hospitals remain dominant, but home care and ambulatory centers are the fastest-growing
Geography	North America, Europe, Asia-Pacific, Emerging Markets	North America leads, but Asia-Pacific is the fastest-growing region

 

Industry Dynamics and Strategic Partnerships

Shifting Industry Focus

The convergence of pharmaceuticals and medical devices has required device manufacturers to develop expertise in biology and vice versa. This shift has led to:

• Increased cross-disciplinary R&D teams
• Accelerated product innovation cycles
• Expansion into new therapeutic areas, including neurology and advanced wound care

Major Players and Competitive Landscape

The market is highly fragmented, with both global conglomerates and specialized firms:

Company	Strengths and Strategies
Abbott Laboratories	Advanced diagnostics and drug delivery integration
Medtronic Plc	Chronic disease management, diversified product portfolio
Boston Scientific Corp	Cardiac and vascular combination products
Becton, Dickinson and Company	Integrated syringes, strong R&D
Novartis AG	Biologics-device integration, digital health partnerships

Other notable players: GlaxoSmithKline, Stryker, Terumo, Mylan, Cook Medical, W.L. Gore & Associates

Recent Partnerships and M&A Activity

• Johnson & Johnson’s $13.1B acquisition of Shockwave Medical (2024): Expanded portfolio in vascular intervention
• Boston Scientific’s acquisition of Silk Road Medical: Strengthened position in carotid artery disease devices
• Medtronic and Bayer HealthCare: Joint development of next-gen diabetes management solutions
• Medtronic and Lilly: Collaboration for Parkinson’s drug delivery systems

Strategic collaborations are increasingly common, with pharmaceutical and device companies pooling resources to accelerate innovation and market access.

Technological Innovation and Market Trends

Key Technological Advancements

• Smart Drug Delivery: Integration of IoT and AI enables real-time monitoring, dose adjustment, and improved patient adherence
• Wearable Devices: Continuous glucose monitors, wearable injectors, and connected inhalers are transforming chronic disease management
• Personalized Medicine: Customizable drug-device combinations for individualized therapy
• 3D Printing: Enables rapid prototyping and patient-specific device design
• Advanced Materials: Use of biocompatible polymers, hydrogels, and bioresorbable materials improves safety and efficacy

Market Trends

• Shift to Home-Based Care: COVID-19 accelerated adoption of combination products for at-home use, reducing hospital burden and improving patient convenience
• Digital Health Integration: Connected health solutions facilitate remote monitoring and data-driven care
• Minimally Invasive Therapies: Demand for less invasive procedures is driving innovation in drug-device delivery systems
• Regulatory Evolution: The FDA and EMA are streamlining approval pathways and embracing real-world evidence, expediting market access for novel products

Regulatory and Development Challenges

Regulatory Complexity

Combination products must comply with both drug and device regulations, requiring:

• Determination of Principal Mode of Action (PMOA) to establish the primary regulatory pathway (drug GMPs vs. device QSRs)
• Adherence to evolving FDA and EMA guidelines, including those for digital health and real-world evidence
• Navigating global variations in reimbursement and market access requirements

Development and Manufacturing Challenges

• Cross-Disciplinary R&D: Integrating drug and device development cycles, materials compatibility, and human factors engineering
• Product Integrity and Quality: Ensuring stability, sterility, and consistent performance of both drug and device components
• Clinical Study Design: Complex inclusion/exclusion criteria, enrollment challenges, and demonstration of combined efficacy and safety
• Manufacturing and Packaging: Managing extractables/leachable, sterilization, and protection of sensitive components from environmental factors
• Project Management: Coordinating cross-company teams, intellectual property protection, and vendor management

Reimbursement and Market Access

• Economic Justification: Premium-priced combination products often face hurdles in obtaining favorable reimbursement, as payers become the primary economic beneficiaries
• Coding and Coverage: Initial assignment to existing procedure codes can limit reimbursement, requiring sustained advocacy for new codes and payment models

Strategic Imperatives for Success

Identifying Unmet Needs

The most successful combination products address clear, unmet clinical needs within specific patient populations, leveraging the synergies of drug-device integration for superior therapeutic outcomes.

Collaboration Over Competition

• Effective partnerships- often more critical than in-house innovation key to bridging knowledge gaps between pharma and device sectors
• Outsourcing and collaboration with external engineering and design firms can accelerate development and ensure regulatory compliance

Investing in R&D and Digital Health

• Continuous investment in R&D, especially in digital health and personalized medicine, is essential to maintain a competitive advantage
• Embracing AI, IoT, and data analytics will drive the next wave of combination product innovation

Navigating Regulatory Change

• Proactive engagement with regulators and adaptation to evolving guidelines (including those for digital health and real-world evidence) will streamline approvals and reduce time to market

Future Outlook

Market Expansion

• The combination products market is expected to nearly double over the next decade, driven by demographic shifts, technological innovation, and the global burden of chronic disease
• Emerging markets in Asia-Pacific and Latin America offer significant growth opportunities as healthcare infrastructure and regulatory frameworks mature

Technological Disruption

• The convergence of biotechnology, materials science, and digital health will enable the development of next-generation combination products, including smart implants, connected injectors, and AI-powered monitoring devices
• Personalized, patient-centric solutions will become the norm, with real-time data guiding therapy adjustments and improving outcomes

Industry Consolidation and Collaboration

• Expect continued M&A activity as companies seek to expand portfolios, access new technologies, and achieve scale
• Strategic alliances and consortia will be critical for addressing complex development, regulatory, and market access challenges

Conclusion

Combination products have redefined the boundaries of the medical devices industry, driving unprecedented innovation and reshaping patient care. Success in this dynamic sector requires a deep understanding of market needs, a collaborative approach to R&D and commercialization, and agility in navigating regulatory and reimbursement landscapes. As technology and healthcare converge, the next decade will see combination products play an even greater role in delivering safer, more effective, and more personalized treatments worldwide.

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Disclaimer: The views expressed in the article are those of the authors and not of the organizations they represent.