Delray Beach, FL, Jan. 30, 2026 (GLOBE NEWSWIRE) -- The global drug device combination products market is projected to reach USD 379.17 billion by 2030, from USD 243.02 billion in 2025, at a CAGR of 9.3% during the forecast period. The convergence of pharmaceuticals and medical technology is rapidly redefining how chronic diseases are treated worldwide.
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Market Overview: What is Driving Growth and Why It Matters Now
Drug-device combination products—integrating therapeutic drugs with delivery devices such as insulin pens, autoinjectors, inhalers, wearable injectors, and drug-eluting stents—are becoming essential to modern healthcare delivery.
What is driving this acceleration? The answer lies in the rising prevalence of chronic diseases, an expanding geriatric population, and increasing demand for precise, patient-friendly drug delivery systems.
Why does this matter now for business leaders? Healthcare systems are under pressure to reduce hospital dependency, improve patient adherence, and manage long-term treatment costs—making combination products a strategic priority for pharmaceutical companies, medtech manufacturers, and investors alike.
In parallel, favorable reimbursement policies, enhanced healthcare infrastructure, and government initiatives supporting access to advanced therapeutics are strengthening market fundamentals globally.
Market Dynamics
Driver: Rising prevalence of chronic diseases
The growing global burden of diabetes, obesity, cancer, respiratory disorders, and cardiovascular disease is a primary catalyst for market expansion.
- According to the International Diabetes Federation (IDF, 2025), adults living with diabetes are projected to increase from 588.7 million to 853 million by 2050.
- In 2024 alone, diabetes accounted for approximately 3.4 million deaths and USD 1.015 trillion in global healthcare spending.
- The World Health Organization (WHO, 2024) reports more than 1 billion people worldwide are obese, including 650 million adults, 340 million adolescents, and 39 million children, with 167 million expected to face obesity-related health complications by 2025.
These conditions demand reliable, targeted, and user-friendly drug delivery. Combination products improve therapeutic precision, enable self-administration, and enhance adherence—directly influencing clinical outcomes and long-term healthcare costs.
Restraint: Stringent regulatory requirements
How does regulation impact market growth? Drug-device combination products must comply with both pharmaceutical and medical device regulations, creating complex and time-intensive approval pathways.
Agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require manufacturers to navigate overlapping frameworks. The FDA’s Office of Combination Products determines whether a product is regulated as a drug, device, or biologic—affecting whether Premarket Approval (PMA) or a New Drug Application (NDA) is required.
- The FDA’s 2023 Annual Report shows nearly 30% of submissions face delays due to classification disputes, often extending approval timelines by 12–18 months (Deloitte, 2022).
- McKinsey (2023) reports that 30–40% of companies struggle to align regulatory submissions across regions, including the EU MDR, China’s NMPA, and India’s CDSCO.
This regulatory complexity increases development costs and slows patient access, presenting a strategic challenge for global market players.
Opportunity: High-growth potential in emerging markets
Where is the next wave of growth expected? Emerging economies—particularly China, India, and Brazil—represent the most compelling expansion opportunity.
Rising healthcare expenditure, aging populations, and growing awareness of chronic disease management are driving rapid adoption of advanced combination products. Asia Pacific markets benefit from expanding healthcare infrastructure and comparatively lower production costs, offering attractive conditions for manufacturing investment and regional distribution.
For multinational corporations, these markets offer both volume growth and long-term strategic positioning in the evolving global healthcare ecosystem.
Challenge: Product malfunction and drug wastage
Product reliability remains a critical operational and reputational risk.
According to BD’s whitepaper, “The Value of an Integration System for Combination Products,” design flaws, poor component integration, and usability issues can lead to:
- Drug wastage of 5%–10% per dose due to leakage, blockages, or incomplete delivery
- Mechanical failures such as autoinjector clogs or needle retraction issues
- Increased recall, replacement, and liability costs potentially reaching millions of dollars
Regulators, including the FDA, have intensified oversight of malfunctioning products, further affecting approval timelines.
How are manufacturers responding? By prioritizing design optimization, system integration, and comprehensive user training to improve safety, reduce waste, and protect long-term commercial viability.
Market Ecosystem: Who Is Shaping the Industry
The market spans pharmaceutical companies, medical device manufacturers, contract development organizations, and regulatory authorities. Hospitals, pharmacies, healthcare providers, caregivers, and patients serve as critical end users.
Regulatory agencies such as the FDA and EMA enforce dual oversight, reinforcing the importance of compliance-driven innovation and cross-sector collaboration.
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Segment Insights
Injectable drug delivery devices lead the market
Injectable drug delivery devices held the largest market share in 2024. Autoinjectors, prefilled syringes, and pen injectors are widely adopted for biologics and advanced therapies requiring precision dosing.
Key growth factors include:
- Rising prevalence of cancer, rheumatoid arthritis, and diabetes
- Increasing preference for self-administration
- Innovations such as needle safety systems, dose-accuracy technologies, and connected “smart” injectors
These advancements support patient-centric care models and reduce dependency on clinical settings.
Home care settings to record the highest CAGR
When and how are care models changing? Home care is expected to be the fastest-growing end-user segment during the study period.
Patients managing chronic diseases increasingly prefer home-based treatment to save time, reduce hospital visits, and lower costs. Portable autoinjectors, insulin wearables, and smart inhalers are enabling safe and effective self-care.
An aging population, institutional capacity constraints, and demand for personalized medicine are accelerating this structural shift.
North America leads market share
North America accounted for the largest market share in 2024 and is projected to maintain its leadership due to:
- Favorable reimbursement frameworks
- High healthcare spending per capita
- Strong R&D ecosystems
- Supportive government policies
Major companies including Abbott, Becton Dickinson and Company, and Eli Lilly and Company continue to drive innovation from the US, supported by advanced healthcare infrastructure and strong adoption of new technologies.
Asia Pacific emerges as the fastest-growing region
China and India are expected to drive the highest demand growth, supported by chronic disease prevalence, expanding healthcare systems, and rising adoption of self-administration technologies.
Key Market Players
Leading companies in the global drug device combination products market include:
Abbott (US), Boston Scientific Corporation (US), Medtronic (Ireland), Becton, Dickinson and Company (US), Novartis AG (Switzerland), Novo Nordisk A/S (Denmark), Sanofi (France), Eli Lilly and Company (US), Merck KGaA (Germany), AbbVie Inc. (US), Teva Pharmaceutical Industries Ltd. (Israel), Stryker (US), B. Braun SE (Germany), Terumo Corporation (Japan), and Kaleo, Inc. (US).
The market remains consolidated, with top players leveraging global distribution networks, high R&D spending, and strong brand equity, while smaller firms compete through pricing strategies and targeted innovation.
Recent Industry Developments
- March 2025: Terumo Europe received MDR approval for expanded indications of Ultimaster Nagomi and Ultimaster Tansei sirolimus-eluting coronary stents for high-bleeding-risk patients.
- January 2025: Eli Lilly and Company received FDA approval for Omvoh (mirikizumab-mrkz) to treat moderately to severely active Crohn’s disease in adults.
- July 2024: AbbVie secured European Commission approval for SKYRIZI for moderately to severely active ulcerative colitis.
- May 2024: Abbott launched the XIENCE Sierra Everolimus-Eluting Coronary Stent System in India.
- March 2024: Novo Nordisk received FDA approval for label expansion of Wegovy to reduce major adverse cardiovascular events (MACE).
Company Highlights
Abbott (US) maintains a leading position through its Medical Devices segment, offering drug-eluting stents and drug-coated balloons across cardiovascular and diabetes care. With R&D and manufacturing operations in over 100 countries and distribution in more than 160 markets, the company continues to expand its global footprint through innovation and strategic acquisitions.
Eli Lilly and Company (US) ranks second globally, supported by a biologics-focused pipeline and advanced injection systems for diabetes and other therapeutic areas. Operating in 14 countries with distribution across 125 markets, the company emphasizes digital delivery solutions such as the HumaPen smart insulin platform.
Medtronic (Ireland) dominated the market in 2024, backed by combination therapies including drug-eluting stents, implantable infusion pumps, and smart insulin pens. The company invested approximately USD 2.84 billion in R&D in fiscal year 2024 and operates in more than 160 countries.
Strategic Outlook for Decision-Makers
For CEOs, CFOs, CMOs, and healthcare strategists, the drug device combination products market represents a high-growth intersection of technology, therapeutics, and value-based care. Market success will increasingly depend on regulatory expertise, design excellence, emerging market penetration, and the ability to support decentralized healthcare models.
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Injectable Drug Delivery Market
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