Lithotripsy Devices Market

Market Overview

The global lithotripsy devices market size has valued at USD 1.08 billion in 2022. It is estimated to reach 1.65 billion by 2031, growing at a CAGR of 4.87% during the forecast period (2023–2031). The global incidence of urolithiasis is increasing, and this can be associated with a range of factors such as dietary habits, shifts in lifestyle, and demographic features. This is expected to drive the global lithotripsy device market. Moreover, due to its huge advantages, the rising demand for non-invasive or minimally invasive surgery is further fueling the global lithotripsy devices market growth.

Lithotripsy is a medical procedure employed to treat kidney stones and other urinary tract stones. Lithotripsy devices are medical instruments that have been specifically designed to perform lithotripsy. The etymology of the name "lithotripsy" can be traced back to its Greek origins, where "lithos" denotes stone and "tripsis" signifies the act of crushing. The objective of lithotripsy is to shatter kidney stones or other urinary stones into smaller particles, facilitating their natural expulsion from the body.

Although various varieties of lithotripsy devices exist, applying shock waves is a prevalent technique. The technique described is called extracorporeal shock wave lithotripsy (ESWL). Other types of lithotripsy, such as intracorporeal lithotripsy, may entail direct contact with the stone through specialized instruments. This may encompass methodologies such as laser lithotripsy, which utilizes a laser to fragment the stone, or ultrasonic lithotripsy, which employs high-frequency sound vibrations to accomplish the identical objective.

Market Dynamics

Lithotripsy Devices Market Drivers

Increasing Incidence of Urolithiasis

Urolithiasis is a pathological disorder characterized by the migration of stones from the renal pelvis to the other parts of the urinary collecting system, encompassing the ureters, bladder, and urethra. The prevalence of urolithiasis is surging worldwide, which can be attributed to various factors, including dietary patterns, changes in lifestyle, and demographic characteristics.

According to an article published in NLM, the prevalence of stone disease in the global adult population ranges from 1% to 13%. As per an article published in the International Journal of Clinical Practice, the incidence of urolithiasis climbed to 116 million in 2019 from 78 million in 1990 globally, an increase of 48.57%. According to the same source, mortality because of urolithiasis has increased by 17.12%, from 11,338 in 1990 to 13,227 in 2019. Consequently, there is a growing need to develop efficacious treatments, augmenting the global lithotripsy device market.

Rising Preference for Minimally Invasive Procedures

Lithotripsy is a non-invasive or minimally invasive technique that is patient-preferred compared to conventional surgical approaches. The utilization of non-surgical methods can mitigate the necessity for surgical intervention, expedite the recuperation process, and diminish the likelihood of complications commonly connected with surgical procedures.

Minimally invasive interventions are becoming increasingly common due to the decreased risk and trauma involved in these treatments. Such procedures require limited anesthesia and can be a possible option for many who are not candidates for surgery. Minimally invasive surgeries provide several advantages, such as faster recovery time, smaller incisions, reduced scarring and pain, increased accuracy, and shorter hospital stays. Such advantages propel the lithotripsy devices market demand for lithotripsy devices as medical professionals strive to provide alternatives to invasive procedures.

Lithotripsy Devices Market Restraint

High Cost of Lithotripsy Therapy and Devices

The purchase and maintenance costs associated with lithotripsy devices might be enormous. Moreover, the financial implications of lithotripsy therapy for individuals can pose a constraint, particularly in areas with constrained healthcare funding or where patients bear a substantial burden of the costs. As per the article published by the Australian Institute of Health and Welfare in 2023, it has been reported that the average cost associated with the lithotripsy procedure for bile duct stones falls within the range of USD 2,100 to USD 3,300. This is expected to restrict market expansion.

Lithotripsy Devices Market Opportunities

Rapid Advancements

In recent years, there has been a rapid advancement in lithotripsy procedures. For instance, in October 2017, Lumenis Ltd., a manufacturer of medical devices, introduced the revolutionary Moses holmium technology for urology applications in India. With the aid of Moses technology, stones in difficult-to-reach areas can be surgically treated, and initial fiber insertion is facilitated via an entirely deflected scope. This technology is specifically engineered to substantially diminish the retropulsion that occurs during lithotripsy, thereby facilitating a considerably reduced migration of stones and a more streamlined procedure.

Furthermore, in May 2021, UCI Health urologists tested a new laser technology, "super-pulsed thulium fiber laser," capable of reducing kidney stones the size of a thumb into dust particles of 100 microns or less. The thulium fiber laser consistently breaks kidney stones into fragments ten times smaller than the holmium laser, the latter of which is presently employed by most urologists. Therefore, advancements in such laser technologies can help develop novel lithotripsy devices, thereby creating opportunities for market expansion.

Regional Analysis

Based on region, the global lithotripsy devices market share is bifurcated into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global lithotripsy device market shareholder and is expected to expand substantially during the forecast period. North America is a developed region with advanced and smart healthcare services, excellent infrastructure, and a high adoption rate of advanced products, which drives market growth in the region. The primary factor driving the lithotripsy device market in the region is the surging prevalence of kidney stones. For instance, according to UCI Health, the incidence of kidney stones in the American population has exhibited a significant two-fold increase in recent decades. More than 10% of the United States population may encounter kidney stones at some point during their lifetime. Moreover, the U.S. has the highest per capita GDP of over USD 46,760 and per capita health expenditure of USD 7,720. This also drives the lithotripsy device market in North America.

Additionally, the increasing launch of new products and their approval by the key players in the market are also boosting market expansion. For instance, in January 2022, Applaud Medical disclosed that its Acoustic Enhancer technology had been granted FDA breakthrough device designation. Acoustic Enhancer technology, developed by Applaud Medical in San Francisco, is intended to integrate ureteroscopy with laser lithotripsy (URS-LL). Its purpose is to fragment calcium-based urinary stones (with a minimum diameter of 6mm and a maximum diameter of 20mm) that are obstructive or are determined by a urologist or other qualified physician to pose a substantial risk of future obstruction.

Europe is expected to expand at a significant rate. According to Eurostat data, the number of minimally invasive treatments increased in 20 of Europe's 21 member states from 2013 to 2018. The region's growing geriatric population is also encouraging the use of minimally invasive procedures. According to Eurostat, the proportion of the European population aged 65 and older has risen from 17.69% in 2010 to 20.69% in 2020. Therefore, this rise in the geriatric population and minimally invasive surgeries is driving the lithotripsy device market in the European region.

In addition, there has been a surge in regulatory approval for lithotripsy devices in the region. For instance, in March 2021, Dornier MedTech (Dornier) won the distinction of being the inaugural integrated urology company globally to obtain certification under the new medical device regulation (MDR) of the European Union. Dornier has received the MDR certification for two of its Class IIb products: the Dornier UIMSTM, a cutting-edge information management system that aids clinicians in the treatment of kidney stones, and the Dornier Delta® III, a highly effective lithotripter that leverages the company's Extracorporeal Shock Wave Lithotripsy (ESWL) technology. Such factors are anticipated to expedite market expansion in the region.

In the Asia-Pacific, strong economic growth is expected to play a key role in the market's growth. The growth in the number of minimally invasive surgeries in the region is expected to be strongly driven by the huge population and increasing affordability among the rising middle class. This growth in preference for minimally invasive surgeries further drives the lithotripsy devices market. In addition, the advancement in lithotripsy technology further stimulates the expansion of the Asia-Pacific market. For instance, in October 2020, the Department of Urology at Jipmer in Puducherry, India, commissioned an innovative extracorporeal shock-wave lithotripsy system, the Dornier Delta III. This state-of-the-art technology enables the department to provide non-surgical therapy for urinary stones.

Segmental Analysis

The global lithotripsy devices market is segmented by type, application, and end-user.

Based on type, the global lithotripsy device market is bifurcated into extracorporeal shock wave and intracorporeal lithotripsy devices. 

The extracorporeal shock wave lithotripsy device segment dominates the global market. Extracorporeal Shock Wave Lithotripsy (ESWL) is a minimally invasive medical intervention employed to fragment kidney stones into smaller fragments, facilitating their passage via the urinary tract. The methodology entails the application of externally generated shock waves that are directed toward the kidney stones. The generation of shock waves is conventionally accomplished through an extracorporeal shock wave lithotripsy device.

In addition, specialized instruments are utilized for ESWL to generate and concentrate shock waves with extreme precision. These apparatuses frequently comprise a patient positioning device, a shock wave generator, and imaging technology to guide the procedure. The procedure must be carried out under the strict supervision of medical professionals who have received the appropriate training.

Based on application, the global lithotripsy devices market is divided into kidney stones, ureteral stones, bile duct stones, and pancreatic stones. 

The kidney stone segment is the largest revenue contributor to the market. Kidney stones, sometimes called renal calculi, are solid concretions that develop within the renal system. Kidney stones form due to the heightened concentration and subsequent crystallization of chemicals such as calcium, oxalate, and phosphorus in the urine. The stones exhibit a range of sizes, spanning from minuscule grains of sand to enormous golf balls. The development of kidney stones is a multifaceted process that is impacted by a range of factors, encompassing genetic predisposition, dietary patterns, and hydration levels. Moreover, the development of kidney stones can be influenced by factors such as dehydration, specific medical disorders, and a diet that is rich in salt and certain minerals.

Based on the end-user, the global lithotripsy devices industry is segmented into hospitals, ambulatory surgical centers, and others. 

The hospital segment owns the highest market share. Hospitals can enhance awareness among patients and referring physicians regarding the availability and advantages of lithotripsy procedures. This, in turn, may result in more patients seeking lithotripsy treatment, thereby augmenting the demand for lithotripsy devices. Moreover, the growing number of hospitals across several countries positively impacts the demand for lithotripsy devices. For instance, as per the American Hospital Association Annual Survey 2021, in the United States, there were 1,805 rural community hospitals, 3,336 urban community hospitals, and 3,453 community hospitals in a system in 2019.

Recent Developments

• February 2023: Rhein Laser Technologies introduced the UroFiber 150Q SuperPulsed Thulium Fiber Laser (TFL) system for the purpose of stone lithotripsy treatment.
• April 2023: AVS, an early-stage medical device company whose PIVLTM (pulsatile intravascular lithotripsy) therapy is designed to treat severely calcified arterial disease safely and effectively, announced that it raised an additional USD 8.8 million in Series B funding, bringing the total to USD 28.8 million.