U.S. Continuous Renal Replacement Therapy (CRRT) Market Outlook to 2030

The report titled “U.S. Continuous Renal Replacement Therapy (CRRT) Market Outlook to 2030 - By Product Type, By Modality, By End User, By Clinical Indication, By Technology Tier, and By Region” provides a comprehensive analysis of the CRRT market in the United States. The report covers an overview and genesis of the industry, overall market size in terms of revenue, market segmentation; trends and developments, regulatory landscape, customer level profiling, issues and challenges, and competitive landscape including competition scenario, cross-comparison, opportunities and bottlenecks, and company profiling of major players in the CRRT market. The report concludes with future market projections based on procedure volumes, product categories, regions, cause-and-effect relationships, and success case studies highlighting the major opportunities and cautions.

U.S. Continuous Renal Replacement Therapy (CRRT) Market Overview and Size

The U.S. CRRT market is valued at USD 408.1 million, based on a five-year historical analysis, with growth propelled by higher ICU admissions for acute kidney injury (AKI) and sepsis, plus increased use of automated CRRT platforms and premixed fluids. The current period points to ~USD 418.9 million in revenue, indicating continued purchasing of consumables and connected systems. Key references: Fortune Business Insights for the U.S. value, and Grand View Research for the latest directional update and growth contours. 

CRRT demand is concentrated around large tertiary ecosystems with Level I trauma centers, ECMO programs, and high ICU bed density—New York, Los Angeles, Houston, Chicago, Boston—where patient acuity, KOL presence, and procurement via IDNs/GPOs accelerate adoption. North America’s leadership in CRRT reflects dense critical-care infrastructure and established OEM service networks; within it, the U.S. leads due to scale, payer mix, and FDA-cleared portfolios across systems and consumables. Sources highlight North America’s primacy and U.S. hospital drivers.

What Factors are Leading to the Growth of the U.S. Continuous Renal Replacement Therapy (CRRT) Market:

Critical‐illness throughput that directly feeds CRRT starts (U.S. hospitals, beds, admissions).: CRRT demand scales with the size of the acute-care system absorbing high-acuity cases. The United States operates 6,093 hospitals and 5,112 community hospitals, with 787,987 staffed beds and 34,011,386 total admissions in acute facilities—each a direct feeder for ICU renal replacement episodes. Concentration in large IDNs and trauma centers accelerates protocolized CRRT use and recurring filter/fluids consumption. The macro base (beds and admissions) underwrites procedure volume stability across seasons and geographies, sustaining utilization of CVVHDF, CVVHD, CVVH, and SCUF in hemodynamically unstable patients.

Sepsis burden in inpatient care—primary clinical trigger for CRRT.: Sepsis is a leading driver of AKI requiring continuous therapies. There are 1,700,000 adult sepsis hospitalizations each year in the U.S., with 350,000 ending in death or discharge to hospice; this single syndrome permeates ICU caseloads where CRRT is chosen for hemodynamic stability. Sepsis’ contribution to over a third of hospital deaths underscores the necessity of around-the-clock clearance and fluid management, anchoring demand for filters, lines, and replacement fluids and favoring integrated CRRT platforms in tertiary centers.

Population and payer scale supporting sustained ICU volumes.: Macro population size and coverage keep critical-care pipelines active. The U.S. population stands at 340,110,988, reinforcing absolute numbers of cardiovascular, hepatic, and septic cases arriving at ICUs where CRRT is indicated. On the coverage side, nationwide Medicare enrollment and inpatient hospital participation guide discharge and DRG-based planning, essential for capital and disposable provisioning at hospital level. This large demographic and payer base sustains consistent demand for CRRT systems, consumables, and associated fluids.

Which Industry Challenges Have Impacted the Growth of the U.S. Continuous Renal Replacement Therapy (CRRT) Market:

ICU capacity strain versus admissions throughput.: High admissions against finite staffed beds complicate scheduling and circuit availability for continuous therapies. Nationally, hospitals logged 34,011,386 admissions against 787,987 staffed beds, forcing frequent triage of capital systems and allocation of filters and fluids during peaks. Community hospitals (5,112) manage surges with limited on-site CRRT expertise, raising dependence on transfer pathways to tertiary centers—each transfer adding logistics time to initiate CVVHDF/CVVHD and anticoagulation. These capacity ratios challenge consistent uptime and filter life in real-world ICUs.

Workforce pressure in critical-care nursing and dialysis specialists.: CRRT requires trained ICU nurses and dialysis/acute-program specialists to manage circuits, anticoagulation, alarms, and documentation. There are 189,100 registered-nurse openings projected per year through the current cycle, intensifying staffing gaps at bedside where continuous therapies run 24×7. Replacement hiring and turnover at this magnitude stretch training pipelines for CRRT competencies, raising variability in filter-life hours and downtime across hospitals and shifts.

Sepsis mortality burden elevating acuity and protocol complexity.: There are 350,000 hospital deaths or hospice discharges annually from adult sepsis, highlighting extreme acuity and multi-organ failure where CVVHDF is often preferred. Managing anticoagulation (e.g., citrate) and maintaining circuit patency in these patients requires protocol discipline and sufficient staffing; mortality burden drives longer support runs and higher consumable draws per episode. This elevates strain on supply continuity and training across large systems and rural referrals alike.

What are the Regulations and Initiatives which have Governed the Market:

Device baseline classification—Hemodialysis systems and accessories: CRRT platforms share regulatory lineage with hemodialysis systems under gastroenterology/urology devices. The Code of Federal Regulations specifies device identification and performance controls in 21 CFR 876.5820, covering the extracorporeal blood circuit, dialysate delivery, and associated monitors/alarms—foundational for U.S. market access and hospital procurement. Hospitals use the CFR citation (876.5820) in value-analysis checklists for compliance documentation when onboarding CRRT modalities and accessories.

New classification for devices with expanded solute removal profile: The FDA codified the hemodialyzer with expanded solute removal profile under 21 CFR 876.5862, explicitly covering devices intended for hemodialysis, hemofiltration, and hemodiafiltration. This action formalizes expectations for technologies spanning diffusive and convective clearance—directly relevant to CVVH, CVVHD, and CVVHDF component performance and labeling at U.S. hospitals. The order documents the section number (876.5862) that procurement and regulatory teams cite in submissions.

Pediatric CRRT device classification order and accessory alignment: FDA issued a classification order for pediatric continuous renal replacement therapy systems, aligning blood-access devices under 21 CFR 876.5540 and clarifying therapeutic device scope for low-weight patients. Hospitals implementing neonatal/pediatric CRRT (e.g., NICU, PICU) must document these CFR references (876.5540) in equipment credentialing and IFU compliance packages, ensuring appropriate clinical indications and accessory controls across circuits and catheters.

U.S. Continuous Renal Replacement Therapy (CRRT) Market Segmentation

By Product Type: The U.S. CRRT market is segmented by product type into systems, consumables, fluids, and ancillaries. Recently, consumables have a dominant market share in the U.S. under this segmentation, due to their recurring use per therapy hour and the clinical push to maintain circuit patency and target clearances. Leading vendors bundle filters, hemofilters, bloodline sets, and access kits, strengthening attach rates. Research indicates U.S. purchasing committees favor reliable supply and filter life; this entrenches consumables as the revenue engine relative to less frequently replaced capital systems. 

By Modality: The U.S. CRRT market is segmented by modality into CVVH, CVVHD, CVVHDF, and SCUF. Recently, CVVHDF has a dominant market share in the U.S. under the modality segmentation, due to its combined convective-diffusive clearance breadth and alignment with ICU protocols for hemodynamically unstable patients. Multiple sources note CVVHDF as the preferred modality in U.S. critical care, with clinicians citing solute range coverage, fluid control, and protocol familiarity driving its leadership over purely convective or diffusive modes. 

Competitive Landscape in U.S. Continuous Renal Replacement Therapy (CRRT) Market

The U.S. CRRT market is consolidated around a few global OEMs—notably Baxter, Fresenius Medical Care, and B. Braun—with specialized players in membranes, access, and pediatric platforms (e.g., Medtronic’s Carpediem). This concentration reflects high regulatory barriers, deep service networks, and entrenched GPO contracts that reinforce incumbency, while new clearances (e.g., expanded CRRT/SCUF on modular systems) are intensifying feature-led competition.

Some of the Recent Competitor Trends and Key Information About Competitors Include:

Baxter International: A market leader in CRRT, Baxter launched the PrisMax 2 system in the U.S., enhancing usability with EMR integration and advanced data capture features. The company also expanded availability of premixed dialysis and replacement fluids, reducing compounding needs and improving workflow efficiency in critical care units.

Fresenius Medical Care: Building on its acute care portfolio, Fresenius received expanded FDA clearance for CRRT modalities integrated into its multiTHERA platform. The company is also investing in regional citrate anticoagulation compatibility, responding to U.S. clinical protocol shifts emphasizing safety and longer filter life.

B. Braun Melsungen AG: B. Braun has scaled adoption of its OMNI CRRT platform in U.S. hospitals, with a focus on flexible use across CVVH, CVVHD, and CVVHDF. The company’s strategy emphasizes bundled consumables supply and training partnerships with academic hospitals, strengthening its foothold in teaching and trauma centers.

Medtronic: With its Carpediem pediatric CRRT system, Medtronic is targeting a niche but growing segment of neonatal and pediatric ICUs in the U.S. Recent hospital partnerships underscore its focus on ultra-low-weight patient categories, an area underserved by larger CRRT platforms.

Outset Medical: Known for disruptive approaches in dialysis, Outset Medical is exploring CRRT applications of its Tablo Hemodialysis System within acute ICU settings. Pilot programs in U.S. hospitals highlight its ambition to diversify beyond chronic outpatient care and enter the critical care market.

What Lies Ahead for U.S. Continuous Renal Replacement Therapy (CRRT) Market?

The U.S. CRRT market is expected to sustain steady growth through the end of the decade, driven by rising ICU admissions, increasing incidence of acute kidney injury (AKI), and strong regulatory frameworks that support advanced critical-care technologies. Growth momentum is reinforced by the country’s large hospital base, with over 6,093 hospitals and 787,987 staffed beds supporting critical-care throughput, and by the clinical preference for CRRT in hemodynamically unstable patients. Source: American Hospital Association

Rise of Hybrid Organ-Support Platforms: The future of CRRT in the U.S. is likely to see integration with other organ-support technologies, such as ECMO and apheresis. With 1,700,000 sepsis hospitalizations annually in the U.S., a large proportion involving multi-organ dysfunction, hospitals are demanding multifunctional systems that can handle simultaneous therapies, reducing equipment footprint and staff burden.

Focus on Outcomes and Filter Life Optimization: Hospitals will increasingly measure CRRT success in terms of patient outcomes like survival, renal recovery, and ICU length of stay. Given the 34,011,386 hospital admissions annually across U.S. hospitals, even small improvements in filter longevity or downtime translate into significant efficiency gains. Vendors that can document outcome-linked improvements in filter hours and uptime will gain procurement preference in value analysis committees.

Expansion into Pediatric and Neonatal Care: There is expected to be a growing demand for pediatric and neonatal CRRT systems, addressing the needs of the 3,623,046 births recorded in the U.S. in 2022, many requiring NICU admission. Specialized circuits like Medtronic’s Carpediem align with the unmet needs of low-weight patients where standard CRRT platforms are not feasible. Hospitals with high NICU throughput are expected to prioritize pediatric-ready CRRT systems in procurement cycles.

Leveraging Digital Health and Connectivity: The use of digital health, EMR integration, and predictive analytics in CRRT management is expanding, with over 340 million people in the U.S. generating substantial health data that supports digital ICU workflows. Real-time connectivity will enhance protocol compliance, filter performance tracking, and adverse event reporting, ultimately improving patient outcomes and hospital operational efficiency.

U.S. Continuous Renal Replacement Therapy (CRRT) Market Segmentation

By Product Type (In Value %)

• CRRT Systems / Machines

• Disposable Consumables (hemofilters, bloodlines, cartridges)

• Dialysate & Replacement Fluids

• Catheters & Vascular Access

• Ancillary Devices (anticoagulation modules, sensors, software add-ons)

By Modality (In Value %)

• Continuous Venovenous Hemofiltration (CVVH)

• Continuous Venovenous Hemodialysis (CVVHD)

• Continuous Venovenous Hemodiafiltration (CVVHDF)

• Slow Continuous Ultrafiltration (SCUF)

By End User (In Value %)

• Tertiary / Academic Hospitals

• Community & Regional Hospitals

• Specialty Critical Care Centers (e.g., trauma, burn units)

• Pediatric & Neonatal Intensive Care Units (NICUs/PICUs)

• Ambulatory / Satellite Critical Care Facilities

By Clinical Indication (In Value %)

• Sepsis-Induced Acute Kidney Injury (AKI)

• Multi-Organ Failure (MOF)

• Cardio-Renal Syndrome / Heart Failure–related AKI

• Hepatic Failure / Hepatorenal Syndrome

• Drug & Toxin-Induced AKI

By Region (In Value %)

• Northeast (New York, Boston, Philadelphia hubs)

• Midwest (Chicago, Cleveland, Minneapolis hubs)

• South (Houston, Dallas, Atlanta, Miami hubs)

• West (Los Angeles, San Francisco, Seattle hubs)

• Rural vs Urban hospital segmentation

Players Mentioned in the Report:

• Baxter International

• Fresenius Medical Care

• B. Braun

• Nikkiso Co.

• Asahi Kasei Medical

• Toray Medical

• Nipro Corporation

• Medtronic

• BD (Becton, Dickinson and Company)

• Teleflex

• Medical Components, Inc. (Medcomp)

• Infomed SA

• Outset Medical

• Quanta Dialysis Technologies

• Fresenius Kabi. 

Key Target Audience

• Integrated Delivery Networks (IDNs) and hospital procurement committees (Value Analysis Committees)

• Tertiary/Academic Medical Centers (critical-care & nephrology service line heads)

• Community Hospital Systems (ICU directors; critical care nursing leadership)

• Dialysis Providers & ICU Services Partners (in-hospital acute programs)

• Investments and Venture Capitalist Firms (healthcare devices & supplies investors)

• Group Purchasing Organizations (GPOs) (category managers for renal therapies)

• Government & Regulatory Bodies — U.S. FDA (CDRH), Centers for Medicare & Medicaid Services (CMS), CDC, AAMI/ISO committees

• Health Insurers / Payers

Key Target Audience

Time Period:

Historical Period: 2019-2024

Base Year: 2025

Forecast Period: 2025-2030