Lithotripsy Device Market Size and Share
Lithotripsy Device Market Analysis by Mordor Intelligence
The lithotripsy device market size is estimated at USD 1.75 billion in 2025, and is expected to reach USD 2.25 billion by 2030, at a CAGR of 5.16% during the forecast period (2025-2030). The value trajectory signals an industry pivot from traditional extracorporeal shock-wave systems toward precision-guided, minimally invasive platforms that simplify workflows and raise stone-clearance rates. Growth is reinforced by advanced imaging integration, the commercial rollout of thulium-fiber and other next-generation lasers, and expanding ultrasound-based technologies that permit anesthesia-free treatment. Portable solutions are broadening point-of-care capacity, while favorable reimbursement revisions in large economies continue to shift volumes from inpatient suites to ambulatory surgical centers. Asia Pacific’s infrastructure build-out, combined with regulatory modernization, is unlocking new demand pockets and diversifying geographic revenue streams within the lithotripsy device market.
Key Report Takeaways
- By device type, extracorporeal shock-wave lithotripters led with 53.16% of lithotripsy device market share in 2024, while intracorporeal platforms are projected to grow at a 5.89% CAGR through 2030.
- By modality, stand-alone systems held a 65.42% share of the lithotripsy device market size in 2024, whereas portable units are advancing at a 6.25% CAGR to 2030.
- By application, kidney stones accounted for 58.23% of the lithotripsy device market size in 2024; pancreatic stone treatment is the fastest-growing application at a 6.88% CAGR through 2030.
- By end user, hospitals commanded 51.63% of the lithotripsy device market size in 2024, but ambulatory surgical centers are expanding at a 7.15% CAGR to 2030.
- By geography, North America captured 32.56% of lithotripsy device market share in 2024, while Asia Pacific is forecast to accelerate at a 7.53% CAGR through 2030.
Global Lithotripsy Device Market Trends and Insights
Drivers Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Growing global incidence of kidney and urinary tract stones | +1.2% | Global, with higher impact in North America and Europe | Long term (≥ 4 years) |
| Continuous technology evolution toward non-invasive, high-precision lithotripsy platforms | +1.8% | Global, led by North America and Asia Pacific | Medium term (2-4 years) |
| Rising adoption of day-care/ambulatory stone-management procedures | +1.1% | North America and Europe, expanding to Asia Pacific | Medium term (2-4 years) |
| Expansion of healthcare infrastructure and surgical capacity in emerging economies | +0.9% | Asia Pacific core, spill-over to MEA and South America | Long term (≥ 4 years) |
| Broadening reimbursement coverage for stone-fragmentation treatments across major markets | +0.7% | North America and Europe primarily | Short term (≤ 2 years) |
| Integration of advanced imaging and navigation systems enhancing procedural success | +0.6% | Global, with early adoption in developed markets | Medium term (2-4 years) |
| Source: Mordor Intelligence | |||
Growing Global Incidence of Kidney and Urinary Tract Stones
Stone disease prevalence is climbing across every major region due to diet shifts, sedentary habits, and dehydration patterns that potentiate mineral crystallization in urinary tracts. Shock-wave lithotripsy still posts 50–75% success among eligible patients, yet its limitations open room for modern devices that can address harder stones and wider patient profiles. Clinical trials report 88% fragmentation and nearly 49% stone-free status with burst-wave ultrasound, illustrating efficacy gains over legacy systems.[1]Source: Applied Radiology, “Portable Ultrasound Technology Found Safe, Effective for Treating Urinary Stones,” appliedradiology.com Market demand consequently favors solutions that secure higher clearance in fewer sessions, reinforcing steady volume growth within the lithotripsy device market.
Continuous Technology Evolution Toward Non-Invasive, High-Precision Platforms
Thulium-fiber lasers, vortex-beam ultrasound, and optimized energy-delivery algorithms are rewriting device specifications and clinical protocols. Olympus’s SOLTIVE platform lowers procedure time by 20% and boosts fragmentation efficiency by 33% compared with Holmium YAG lasers.[2]Source: Olympus Medical Americas, “SOLTIVE SuperPulsed Laser System Shortens Kidney Stone Procedure Time,” medical.olympusamerica.com Boston Scientific’s MOSES 2.0 reduces retropulsion by 50% and enables 90% same-day discharge, making it attractive for outpatient workflows.[3]Source: Boston Scientific, “MOSES 2.0 Technology for Lithotripsy,” bostonscientific.com Academic prototypes such as Lithovortex showcase low-cost ultrasound designs that promise non-invasive fragmentation for broader patient cohorts. These advances help providers elevate outcomes while trimming anesthesia use, fueling premium-priced system demand across the lithotripsy device market.
Rising Adoption of Day-Care/Ambulatory Stone-Management Procedures
Ambulatory surgical centers (ASCs) receive incremental reimbursement support, including new pass-through codes for single-use ureteroscopes, which make outpatient stone removal economically viable. Ultrasound modalities capable of anesthesia-free treatment suit emergency departments and rapid-turnover clinics, slashing resource utilization while preserving outcomes. Consequently, device vendors are intensifying R&D into compact, plug-and-play systems that migrate lithotripsy volumes from inpatient suites to ASCs, expanding the lithotripsy device market footprint.
Expansion of Healthcare Infrastructure and Surgical Capacity in Emerging Economies
China’s policy drive to resolve hospital debt and revive procurement is restoring device purchasing budgets. India’s 2024 marketing code introduces clearer compliance standards, encouraging foreign entrants and transparent competition. Japan’s rapid uptake of thulium-fiber lasers underscores how Asia Pacific buyers adopt advanced platforms soon after launch. Robust infrastructure investment thus helps lift procedural capacity, drawing global manufacturers deeper into emerging-market channels and reinforcing CAGR expansion for the lithotripsy device market.
Restraints Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Adverse post-ESWL complications | -0.8% | Global, with higher impact in cost-sensitive regions | Medium term (2-4 years) |
| Availability of URS / PCNL alternatives | -1.1% | Global, led by North America and Europe | Medium term (2-4 years) |
| High upfront and lifecycle costs of lithotripsy systems limiting capital purchases | -1.2% | Global, particularly emerging markets and smaller healthcare facilities | Long term (≥ 4 years) |
| Reimbursement disparities and budget constraints in cost-sensitive regions | -0.9% | Asia Pacific, MEA, and South America primarily | Long term (≥ 4 years) |
| Source: Mordor Intelligence | |||
Adverse Post-ESWL Complications
Stone street formation and other side effects from shock-wave therapy remain clinical concerns, especially for lower-pole renal stones where flexible ureteroscopy achieves 90.2% stone-free rates versus ESWL’s 61.5%. Manufacturer exits from the ESWL segment and clinician shifts toward endoscopic modalities illustrate growing selectivity. Although burst-wave refinements may revitalize extracorporeal offerings, safety perceptions continue to cap ESWL spend within the lithotripsy device market.
High Upfront and Lifecycle Costs of Lithotripsy Systems
Capital intensity restricts procurement, with small hospitals deferring purchases or opting for rental models. EDAP TMS sold only 2 lithotripters in Q1 2024 versus 4 in the prior year, underscoring budget headwinds. The NIH summarizes that device reimbursement demands robust clinical evidence, adding time and expense to market entry. Leasing services, such as HealthTronics’ fleet, partly mitigate barriers but underline persistent affordability challenges that drag on lithotripsy device market growth.
Segment Analysis
By Device Type: Intracorporeal Systems Gain Precision Edge
Extracorporeal shock-wave units captured 53.16% of lithotripsy device market share in 2024, yet intracorporeal platforms are forecast to rise at 5.89% CAGR through 2030. Laser-based systems, especially thulium-fiber models, fragment stones twice as quickly at half the power of earlier lasers, a performance win that has shifted hospital investment priorities. Electromagnetic ESWL devices keep traction in high-volume centers because of their procedural familiarity, while piezoelectric variants carve out specialized niches where precise energy targeting is essential.
Intracorporeal advances dovetail with the broader surgical trend toward precision and minimal tissue insult. Laboratory evidence shows 92% fragmentation under optimized settings, widening clinical acceptance of these tools. Ultrasonic lithotrites with aspiration enhance percutaneous workflows, and pneumatic devices persist in difficult cases needing mechanical impact. Collectively, these dynamics lift the intracorporeal portion of the lithotripsy device market while pushing vendors to diversify portfolios beyond legacy extracorporeal units.
Note: Segment shares of all individual segments available upon report purchase
By Modality: Portable Systems Transform Point-of-Care Treatment
Stand-alone suites held 65.42% of the lithotripsy device market size in 2024, anchored by well-equipped hospital units handling complex cases with integrated imaging. Yet portable and tabletop designs are pacing the modality race with a 6.25% CAGR. Break Wave ultrasound shows how mobility and anesthesia-free performance can broaden access to emergency departments and rural clinics. The Lithovortex prototype amplifies this shift by packaging vortex-beam capability into an affordable footprint suited for budget-restricted settings.
Operational flexibility is critical. Portable systems shorten room turnover, fit multi-department use, and lower facility overhead, making them popular with ASC administrators aiming for strong throughput. Vendors are thus engineering hybrid configurations—compact enough for transport yet robust enough to integrate with fluoroscopy—ensuring continued relevance across multiple care environments within the lithotripsy device market.
By Application: Pancreatic Stones Drive Specialized Growth
Kidney stones accounted for 58.23% of the lithotripsy device market size in 2024, but pancreatic stone treatment is advancing quickest at 6.88% CAGR as gastroenterologists embrace endoscopic ultrasound-guided lithotripsy. Bile-duct management also benefits from electrohydraulic energy delivered via cholangioscopes, adding procedure types to hospital offerings.
Ureteral and bladder applications remain staples in urology departments, where flexible scopes and laser fibers yield high stone-free ratios. Salivary-duct stone removal, though niche, is gaining traction in ENT settings thanks to miniaturized lithotripters. The widening array of anatomical indications is expanding device utilization hours, underpinning broader revenue prospects for the lithotripsy device market.
Note: Segment shares of all individual segments available upon report purchase
By End User: Ambulatory Centers Lead Migration Trend
Hospitals retained 51.63% usage share in 2024, but ambulatory surgical centers (ASCs) are on a 7.15% CAGR trajectory. Transitional Pass-Through payments for single-use scopes lower capital thresholds, helping ASCs add stone-management lines without ballooning budgets. Specialty clinics concentrate domain expertise, streamlining scheduling and post-operative care.
Hospital systems are responding with hybrid care models that intertwine inpatient resources and outpatient efficiency, ensuring they remain referral hubs for complex presentations. Urgent-care sites and mobile units, grouped under “Others,” extend reach into communities with limited specialist access. Across these settings, demand converges on devices that marry clinical sophistication to workflow simplicity, reinforcing the growth outlook for the lithotripsy device market.
Geography Analysis
North America accounted for 32.56% of lithotripsy device market share in 2024, supported by transparent reimbursement pathways and a dense ASC network. Hospitals exploit Medicare coding stability to justify equipment refresh cycles, while vendors enjoy receptive early-adopter physician bases. The region’s robust after-sales service networks further safeguard utilization uptime, sustaining replacement demand.
Europe follows with mature yet steadily modernizing health systems. National health funds encourage minimally invasive interventions, accelerating adoption of newer lasers and portable ultrasound. Cross-border purchasing frameworks support multicountry tenders that often favor vendors offering comprehensive training and maintenance, a factor strengthening pan-regional product footprints.
Asia Pacific is forecast to grow at 7.53% CAGR thanks to infrastructure expansion, regulatory reforms, and rising per-capita income. Japan’s USD 40 billion medical-device sector is investing heavily in IoT-enabled equipment that maximizes operating-room productivity. China’s debt-relief strategy is unblocking hospital CAPEX budgets, and India’s conduct code is fostering market transparency. Middle East & Africa plus South America trail in absolute value but are accelerating as new private hospitals and public-sector projects equip operating theaters, broadening the global footprint of the lithotripsy device market.
Competitive Landscape
The lithotripsy device market shows moderate fragmentation with technology-rich incumbents and a pipeline of venture-backed challengers. Olympus booked JPY 175,038 million (USD 1.17 billion) in Therapeutic Solutions revenue in Q2 FY2025 on strong SOLTIVE sales that captured hospital attention for shorter case times.
EDAP TMS channels roughly 10% of revenue into R&D, nurturing high-frequency ESWL refinements and next-generation focal therapy platforms. Dornier MedTech, Karl Storz, Cook Medical, Siemens Healthineers, and Storz Medical all hedge portfolios across extracorporeal and intracorporeal solutions, ensuring coverage of diverse procedural segments.
White-space innovators include Avvio Medical and Stone Clear. Portfolio breadth, M&A agility, and post-purchase service capabilities remain decisive factors as competitors jostle for mindshare among surgeons and procurement committees.
Lithotripsy Device Industry Leaders
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EDAP TMS
-
DirexGroup
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Boston Scientific Corporation
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Cook Medical LLC
-
Olympus Corp.
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- May 2025: Avvio Medical announced successful first-patient treatments with its investigational Enhanced Lithotripsy System (ELS) following FDA IDE approval.
- December 2024: Shvabe Holding unveiled a certified extracorporeal shock-wave lithotripter aimed at substituting imported systems in Russian clinics.
- November 2024: SonoMotion received FDA de-novo clearance for the Stone Clear device, the first ultrasound platform that externally mobilizes residual fragments post-lithotripsy.
Research Methodology Framework and Report Scope
Market Definitions and Key Coverage
Our study defines the lithotripsy devices market as the value of newly manufactured extracorporeal shock-wave and intracorporeal systems, laser, ultrasonic, pneumatic, and electrohydraulic that fragment urinary tract stones in hospitals, ambulatory surgery centers, and specialist urology clinics worldwide. According to Mordor Intelligence, the base year is 2025, when sales reached about USD 1.75 billion.
Scope exclusion: devices used solely for intravascular or gall-stone lithotripsy fall outside this analysis.
Segmentation Overview
- By Device Type
- Extracorporeal Shock-Wave Lithotripters
- Electrohydraulic ESWL
- Electromagnetic ESWL
- Piezoelectric ESWL
- Intracorporeal Lithotripters
- Laser Lithotripters
- Ultrasonic Lithotripters
- Pneumatic/Ballistic Lithotripters
- Electrohydraulic Intracorporeal
- Extracorporeal Shock-Wave Lithotripters
- By Modality
- Stand-alone Systems
- Portable / Table-top Systems
- By Application
- Kidney Stones
- Ureteral Stones
- Bladder Stones
- Bile-duct Stones
- Pancreatic Stones
- Salivary-gland Stones
- By End User
- Hospitals
- Ambulatory Surgical Centers
- Specialty Clinics
- Others
- By Geography
- North America
- United States
- Canada
- Mexico
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Russia
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of Asia Pacific
- Middle East and Africa
- GCC
- South Africa
- Middle East and Africa
- South America
- Brazil
- Argentina
- Rest of South America
- North America
Detailed Research Methodology and Data Validation
Primary Research
Mordor analysts interviewed practicing urologists, biomedical engineers, supply-chain managers, and procurement heads across North America, Europe, and high-growth Asia Pacific markets. These discussions validated annual procedure counts, average selling prices, and service-contract ratios, while short surveys of ASC administrators clarified emerging demand for portable table-top units.
Desk Research
We gathered baseline figures from public sources such as the World Health Organization, the National Kidney Foundation, Eurostat procedure registries, and UN Comtrade shipment codes, which outline kidney-stone prevalence, hospital procedure volumes, and global trade in HS 901890. Peer-reviewed evidence from journals like Journal of Endourology and Urology helped trace efficacy trends of thulium-fiber and burst-wave platforms, while association portals, European Association of Urology and American Urological Association, provided guideline updates that influence device adoption. Financial filings accessed through D&B Hoovers and news archives on Dow Jones Factiva rounded out vendor pricing and replacement-cycle patterns. This list is illustrative; many other sources informed interim checks and clarifications.
A second sweep cross-referenced customs data with voluntary recall notices and patent counts from Questel, giving our team early signals on model anomalies and pipeline shifts that pure sales data miss.
Market-Sizing & Forecasting
We start with a top-down reconstruction that multiplies country-level stone-surgery volumes by device penetration and replacement cadence. We then validate totals with selective bottom-up roll-ups of leading manufacturers' revenues spotted in filings. Key variables like kidney-stone incidence, elective-surgery recovery rates, portable-unit share, ASP erosion curves, and reimbursement coverage ratios feed a multivariate regression that projects demand through 2030. Gaps in country data are bridged with regional proxies adjusted by GDP per capita and health-expenditure elasticities.
Data Validation & Update Cycle
Outputs move through automated variance scans, paired-analyst reviews, and senior sign-off. We refresh every twelve months, with off-cycle updates triggered by regulatory approvals or material recalls. Before delivery, an analyst re-runs the latest data pass to ensure clients receive the current view.
Why Mordor's Lithotripsy Device Baseline Inspires Confidence
Published estimates often differ because each firm chooses its own device mix, price assumptions, and refresh rhythm.
Key gap drivers include whether intravascular and gall-stone systems are combined with urology units, how aggressively portable ASPs are deflated, and if post-pandemic backlog procedures are front-loaded or smoothed. Mordor reports only urinary-stone devices, applies real-world ASP erosion drawn from service contracts, and updates annually, making our 2025 baseline balanced and timely.
Benchmark comparison
| Market Size | Anonymized source | Primary gap driver |
|---|---|---|
| USD 1.75 B (2025) | Mordor Intelligence | - |
| USD 1.60 B (2024) | Global Consultancy A | Includes limited portable-unit data and uses three-year refresh cycle |
| USD 1.40 B (2024) | Industry Journal B | Combines biliary and intravascular devices within total |
| USD 1.69 B (2024) | Regional Consultancy C | Applies flat ASP across regions, understating price dispersion |
Taken together, the comparison shows that when scope, variables, and cadence align with real buying patterns, Mordor's baseline presents the most reproducible platform for strategic planning.
Key Questions Answered in the Report
What technology innovations are most influencing new lithotripsy systems?
Next-generation thulium-fiber lasers, vortex-beam ultrasound, and advanced imaging integration are improving fragmentation efficiency, shortening procedure time, and reducing the need for anesthesia. These capabilities appeal to surgeons who seek faster, more predictable stone-clearance outcomes.
Why are ambulatory surgical centers increasingly choosing portable lithotripsy platforms?
Portable units fit smaller procedure rooms, require minimal setup, and allow facilities to schedule same-day cases without tying up fixed hospital theatre space. Their mobility and lower overhead align with the cost-containment goals driving outpatient care.
How are reimbursement policies shaping purchasing decisions for lithotripsy devices?
Expanded coding for single-use endoscopes and clearer payment pathways for ultrasound-based stone management are helping providers justify capital investment. Conversely, gaps in coverage for older extracorporeal systems can delay replacement cycles.
Which clinical applications are expanding beyond traditional kidney-stone treatment?
Providers are increasingly applying lithotripsy to pancreatic, bile-duct, and salivary-gland stones. Success in these niche areas is encouraging vendors to design accessories and energy-delivery modes tailored to gastroenterology and ENT workflows.
What role does device service and maintenance play in vendor selection?
Hospitals and clinics favor manufacturers with reliable service networks and flexible leasing or rental options. Strong after-sales support minimizes downtime, which is critical for high-volume stone-management programs.
How are emerging markets influencing product design?
Facilities in developing regions prioritize systems that are compact, energy-efficient, and easy to operate without extensive infrastructure. Manufacturers are responding by offering hybrid platforms that combine robust performance with simplified user interfaces.
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