For medical-device original equipment manufacturers (OEMs), the intravenous (IV) disposables market continues to present a fast-expanding frontier — driven by clinical necessity, the increasing burden of chronic disease, heightened infection-control awareness and new care-delivery models. What was once often viewed as a purely commodity space is now undergoing rapid technological transformation — creating new white space for OEMs that can partner effectively with healthcare providers, distributors, and pharma companies to deliver value-based, technology-integrated solutions.
Market Size and Trajectory
According to a recent report by Future Market Insights (FMI), the global IV disposables market is projected to grow from about $21.2 billion in 2025 to roughly $64.8 billion by 2035, representing a CAGR of approximately 11.8 percent. 1
The market remains large and growing strongly — with an ~12 percent CAGR signaling that growth is accelerating over baseline commodity growth of the past decade. OEMs that move beyond volume to innovation are positioned for meaningful share capture.
Shifting from Commodity to Strategic Component
Traditionally, IV disposables (e.g., catheters, infusion sets, connectors) were considered low-margin/high-volume consumables. However, as you noted, the category is now evolving into smart, integrated delivery platforms.
Smart infusion systems increasingly require precision-engineered compatible disposables (needleless connectors, closed-system transfer devices (CSTDs), in-line filters) to meet the requirements of connected infusion pumps and data/monitoring systems.
OEMs that can integrate sensors, RFID/NFC tracking, cloud connectivity, or improve ergonomics and infection-control features (antimicrobial plastics, touch-free connectors) can create premium differentiators in what was traditionally a commoditized field.
Given how hospitals and outpatient care settings are under pressure to reduce adverse events, improve workflow efficiency, and support home/hybrid care, OEMs have the opportunity to reposition disposables not just as consumables but as part of the delivery ecosystem.
Growth Drivers: Where OEMs Can Lead the Charge
Chronic Disease Management and Care Migration. The global incidence and prevalence of chronic conditions (diabetes, cancer, renal disease, heart failure, etc.) continue to rise. This drives demand for IV therapies (hydration, biologic infusions, chemo, dialysis support) not only in inpatient but also outpatient/home settings.
With care shifting from inpatient to outpatient/at-home models, OEMs should consider modular, patient-centric IV kits or wearable/portable infusion sets that support self-administration or home infusion. Investment in home-infusion infrastructure is growing, which opens opportunities for OEMs to supply disposables designed for non-hospital settings with more patientfriendly design, connectivity and supply-chain support.
Infection Control, Sterility, and Single-Use Pressure. The residual effects of the COVID-19 pandemic and increased regulatory/institutional focus on hospital-acquired infection (HAI) prevention continue to push single-use, closed-system, and low-touch solutions.
Hospitals now favor disposables that reduce manual handling, simplify workflows, and integrate with closed-loop systems. OEMs with expertise in aseptic engineering, advanced polymers, and packaging/supply-chain simplicity can capture higher margin opportunities.
Smart Health, Connectivity, and Data Integration. Hospitals and home-care providers are increasingly adopting connected devices (infusion pumps that feed data to electronic health records (EHRs), dosing algorithms, remote monitoring). The disposables that interface with these systems must meet tighter tolerances, provide data capture (e.g., flow/pressure sensors embedded), and enable interoperability.
OEMs that embed traceability (barcode/NFC tags on disposables), analytics, and remote-monitoring capability (especially for home infusion) will differentiate. Note: Cybersecurity, interoperability standards (HL7/FHIR, device connectivity), and cloud compliance are increasingly important for this smart disposable angle.
Emerging Markets and Geographic Expansion. Emerging markets (Asia-Pacific, Latin America, Middle East, and Africa) continue to grow faster than mature markets, driven by rising healthcare investment, expanding hospital infrastructure, aging populations, and rising outpatient/home-care use. For example, the FMI report lists Asia-Pacific as a high-growth region.
OEMs that can deliver cost-effective, scalable manufacturing (potentially via regional manufacturing or partnerships) and adapt to local regulatory/clinical workflows will be well positioned. Key geographies, including China and India, remain priority markets, but Southeast Asia and Middle East are increasingly attractive for IV disposables.
Market Barriers and Considerations
Cost Sensitivity in Procurement. Hospitals and outpatient providers face budget pressure, GPO consolidation, and value-based purchasing. OEMs must convincingly demonstrate ROI (reduced adverse events, workflow improvement, cost savings) or integrate into service-models (e.g., managed-kits, subscription models) rather than pure consumables.
Regulatory and Quality Complexity. The regulatory and standards environment continues to tighten globally. For example, closed-system transfer devices (CSTDs) have more scrutiny, traceability requirements are increasing, and smart device/disposables may incur software/device regulatory combinations. OEMs that build robust quality systems, analytics for post-market surveillance, and supply-chain transparency will reduce recall/defect risk.
Product Recalls, Brand Risk. Product recalls and brand remains a real challenge. One failed batch or infection event associated with a disposable kit can damage both OEM and hospital-brand. Proactive risk-management (sterilization validation, supply-chain audits, redundancy) is key.
Disruption from Alternative Therapies and Settings. Growth of subcutaneous, oral, or other non-IV delivery routes in biologics and drugs may reduce some IV volumes in certain therapies. OEMs should therefore target the IV use-cases with strong clinical necessity (e.g., acute care, emergency hydration, high-volume infusion, home infusion of biologics) and monitor modality shifts.
Competitive Landscape and OEM Partnership Models
Key players in the market are focused on increasing their product portfolio for strengthening their position in the market and to expand their footprint in emerging markets. The key strategy adopted by manufacturers to gain a competitive edge in the market is pricing strategies, market strategies, technological advancements, and acquisition with other companies to expand their business.
Established major players include Becton Dickinson (BD), Baxter International, ICU Medical, Fresenius Kabi, B. Braun Melsungen, and Terumo Corporation. Many of these firms outsource via strategic OEM/contract-manufacturers for components, packaging, specialty tubing, etc.
For example, BD’s focus on polymer innovation (via acquisition of Tepha Inc.) remains aligned with advanced disposables.
Fresenius Kabi’s acquisition of Ivenix signals a strong push into software-integrated infusion platforms, thereby increasing downstream demand for interoperable high-quality disposables.
For smaller OEMs: There is opportunity in becoming specialized innovation engines (e.g., advanced tubing, sensor-embedded connectors, ergonomic handles, automated kit assembly). These can then partner in platform ecosystems rather than try to compete head-on with large vertically-integrated players.
Product Focus: Infusion Pumps and Disposable Sets
The FMI report indicates that in 2025 the intravenous administration set”product segment is expected to hold ~47.2 percent of total revenue. The end-user segment — hospitals — is projected to account for ~53.6 percent of market revenue in 2025.
Growth in home-infusion/outpatient settings remains strong (although fewer public numbers were found specifically for IV disposables versus broader disposables). OEMs should emphasize kitassembly capability, sterile packaging (especially for home/ambulatory settings), compatibility with connected infusion pumps, and modularity for home use.
The Bottom Line for OEMs
The IV disposables market remains a compelling multi-decade growth opportunity — but the nature of that opportunity is shifting: from pure volume/commodity to value-driven innovation, connectivity, service-oriented models, and global scale.
OEMs that bring the right blend of regulatory/quality rigor, user-centered design, scalable manufacturing, and digital integration (sensors, data, connectivity) are well positioned to gain share.
Key strategic imperatives for OEMs include:
Focus on differentiating features (connectivity, sensors, ergonomic design, infection-control).
Partner upstream with infusion-platform providers (pump makers, software providers) and downstream with providers/home-care networks.
Develop regional manufacturing/partnerships in emerging markets (to address cost and access).
Build supply-chain resilience and lifecycle tracking (traceability, post-market analytics).
Consider service-models/kit-bundles rather than pure consumables (e.g., subscription-based home-infusion kits).
Address sustainability concerns proactively (materials, waste-reduction).
Monitor modality shifts (e.g., subcutaneous versus IV) and pivot to IV use-cases with strong clinical necessity.
TRENDS TO CONSIDER
Connected/Home-Infusion Growth: As home-infusion becomes more prevalent, OEMs should emphasise disposable sets designed for minimal clinical oversight, intuitive use, remote monitoring, and patient engagement (alerts, safety lock-outs).
Interoperability and Software Integration: With infusion pumps becoming part of hospital device networks, disposables must play the system component role (flow sensors, smart connectors, data logging). Cybersecurity, software validation, and connectivity standards become relevant.
Materials Innovation and Sustainability: Pressure is increasing for disposables with lower environmental impact (recyclable plastics, reduced packaging, re-sterilizable components, carbon-footprint transparency). OEMs should factor this in.
Regional Supply-Chain Resilience: The pandemic and recent supply-chain disruptions have underscored the risk of single-source/long-lead manufacturing. OEMs offering diversified/regional manufacturing offer advantage.
Value-Based Procurement and Outcomes: Hospitals and providers increasingly expect disposables to contribute to clinical outcomes (reduced infection, fewer line-complications) or workflow savings (faster setup, fewer errors). OEMs need to gather evidence (clinical studies, workflow ROI) to support premium positioning.
Emerging-Market Nuances: While growth in China/India is strong, local regulatory/price dynamics differ (e.g., local sourcing, price pressures, import tariffs). OEMs may need to adapt product cost models and localization strategies.
Competitive New Entrants/Disruptors: Smaller specialized OEMs may begin capturing niche segments (smart connectors, sensor-embedded tubing, home-infusion kits) and partnering with large platform players.
References
- “IV Disposables Market Size and Share Forecast Outlook 2025 to 2035,” Future Market Insights.
This article was compiled by Sherrie Trigg, Editor and Director of Content, Medical Design Briefs. She can be reached at
