Urethral Dilators Market Size, Share & Trends Analysis Report By Usage (Disposable, Reusable), By Application (Urethral Stricture, Meatal Stenosis, Kidney Stone Removal), By End-user, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global urethral dilators market size was valued at USD 218.71 million in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 5.7% from 2022 to 2030. The demand for urethral dilators is increasing owing to the high prevalence of chronic kidney diseases, rise in the cases of urinary stones and urinary tract infections, and the rapidly growing baby boomer population. Urethral dilators are commonly used to treat urethral strictures, which means narrowing of the urethra that makes it difficult for urine to pass. This condition accounts for nearly 1.5 million office visits annually in the U.S. This is done by passing a thin rod into the urethra to widen the urethral passage. In a few cases, dilation may be necessary before inserting large instruments such as a resectoscope into the urethra. Also, people who suffer from fibrosis, inflammation, trauma, and birth defects use urethral dilators to expand the urinary tract. Moreover, surgical-related infections, risk of recurrence, and ease to perform dilation at home are expected to propel the industry growth in the coming years.

The COVID-19 pandemic is expected to have a short-term and moderate impact on market growth. All urological surgeries were considered non-urgent during the pandemic. Due to this, all outpatient and elective interventional procedures were reduced or interrupted for reducing the risk. According to the African Journal of Urology in 2021, all types of elective urological procedures have decreased significantly. In particular, ureteroscopic lithotripsy, percutaneous nephrolithotomy, transurethral resection of the prostate, urethroplasty, and renal transplant had the highest cut-down. For instance, according to early urologic recommendations issued in April 2021, from weeks 8–9 to weeks 11–13, the trend for 2020 urologic activity dropped steadily. Additionally, as per the same source, one-third of uro-oncologic procedures may have been postponed. As a result, due to the outbreak of the COVID-19 pandemic in 2020, sales of urethral dilators dropped dramatically.

However, as lockdown restrictions are being lifted in most countries, the supply chains of most healthcare companies are expected to work effectively and smoothly over the forecast period. Thus, the global market is expected to grow at a significant rate in the coming years. Key players intend to expand their enterprises regionally, build new warehouses in new places, and run their operations through multiple channels in the worst-affected areas. For instance, between the fourth quarter of 2020 and the first quarter of 2021, most elective surgeries were resumed as the regulations imposed by the governments were relaxed in various countries. This has increased the patient volume in hospitals and outpatient centers and has partially regulated the sale of urethral dilators. To cite an example, Boston Scientific Corporation's 2021 revenue was USD 11,888 million, an increase of 19.9% compared to 2020 revenue. The sales were primarily driven by the resumption of urological care and surgeries worldwide. Moreover, the COVID-19 outbreak has created opportunities for local manufacturers.

Increasing incidence of urethral strictures, prostate cancer, injuries, kidney stones, and medical conditions requiring urethral dilators is expected to drive the market over the forecast period. According to data published by Laborie Medical Technologies Inc. (Laborie), a leading diagnostic and therapeutic medical technology company, the urethral stricture is a common disease in men with an incidence of about 1 in every 10,000 at 25 years old to about 1 in every 1,000 men at 65 or older. Moreover, as per the study published in the National Center for Biotechnology Information (NCBI), in 2018, an estimated 12% of the Indian population is suffering from urolithiasis, out of which, 50% may end up with loss of kidney functions and urethral obstructions. Similarly, it is estimated that around 600,000 people in the U.S. suffer from urinary stones every year, which represents 1 in 11 people suffering from kidney stones. All these aforementioned factors are expected to boost the sale of urethral dilators over the forecast period.

Additionally, prostate cancer is the second most commonly occurring cancer in men and the fourth most commonly occurring cancer overall. As per the report published by the National Cancer Institute (part of the NIH), in the U.S., there were 191,930 estimated new cases of prostate cancer reported in 2020. This is expected to boost the demand for urethral dilators during the forecast period. Because these devices may be effective in relieving bladder outlet obstruction caused by prostate cancer, they are most useful for patients who are at high surgical risk and have limited life expectancy. Similarly, urinary incontinence (UI) is one of the major medical conditions in which urethral dilators play a major role in regulating urine flow. UI is an extremely common condition throughout the world. According to a study published in the NCBI, the prevalence of urinary incontinence in pregnant women ranges from 32.0% to 64.0%. Thus, rising incidence of urological dysfunctions has surged the demand for urethral dilators for post-operative convenience. This is expected to positively impact the industry growth.

Furthermore, the market is expected to be driven by a large geriatric population, which is highly susceptible to various diseases including kidney and urinary disorders. As per the WHO, the global population of 65 years and above is expected to rise from 7% in 2000 to 16% in 2050. Old age is considered one of the greatest risk factors for developing various medical conditions. Aging also weakens the immune system and consequently increases a patient’s susceptibility to various ailments such as renal disorders, diabetes, prostate cancer, and urinary retention. As a result, all these disorders may cause thinning of the urethra resulting in difficulties to pass urine. This is carried out by passing a thin rod (urethral dilators) into the urethra resulting in the widening of the urethral passage. According to the American Society of Nephrology, urologic diseases are the third most common concern among the geriatric population, and these account for approximately around 47% of physician visits. Thus, the increasing geriatric population is one of the significant drivers for the market.

The U.S. dominated the North American market with a revenue share of over 85.0% in 2021. Factors that are fueling the growth in the U.S. include the increasing prevalence of targeted diseases, such as UI, bladder obstruction, urinary retention, Benign Prostate Hyperplasia (BPH), and bladder cancer, and rising number of elderly people suffering from bladder problems. UI is prominently seen in the older population, resulting in high healthcare costs, poor quality of life, and high morbidity rates. According to the National Association for Continence, people aged 40 years and over are mostly affected by the Overactive Bladder (OAB) and urine urgency. Thus, rising incidence of kidney-related disorders is expected to drive the usage of urethral dilators over the forecast period. Moreover, the presence of a large number of urologists in the country and the rising preference for minimally invasive surgeries are further expected to boost the market growth in the country. According to the American Urological Association (AUA) in 2020, the U.S. urologist population totaled 13,352 urologists, an increase of 2.4% from 13,044 urologists in 2019. Thus, this is expected to boost industry growth.

Over the past decade, the demand for minimally invasive surgeries is increasing. According to The Mount Sinai Hospital in 2021, novel diagnostic techniques and less invasive therapies for prostate, kidney, bladder malignancies, and a wide range of urologic illnesses are becoming more widely used. Additionally, between 2019 and 2021, there was a 50% increase in the number of procedures for advanced bladder cancer, a 20% increase in procedure volume for the kidney cancer program, and a 34% increase in volume for the prostate cancer program, all of which are expected to boost the sale of urethral dilators in the near future. Urethral dilators are used in such procedures, thus the rising demand for minimally invasive procedures is expected to drive the market during the forecast period.

Usage Insights

In 2021, the disposable segment held the largest revenue share of over 60.0% and is expected to expand at the fastest CAGR during the forecast period. Disposable urethral dilators are intended for one-time use and are considered a cost-effective alternative to reusable ones. In terms of safety and quality, they are preferred over reusable ones. Additionally, these can help reduce the risk of contamination and transmission of infection from one patient to another. All these advantages are expected to boost segment growth over the forecast period.

Moreover, in the case of reusable dilators, proper cleaning and disinfection as per the FDA guidelines are very much necessary to avoid the transmission of any kind of infection from one patient to another. The risk of infection transmission is comparatively less than disposable ones owing to which healthcare professionals mostly prefer disposable urethral dilators. Furthermore, the presence of many key players that offer disposable urethral dilators is anticipated to drive the segment over the forecast period. Thus, all these aforementioned factors are contributing to the segment growth.

Additionally, rising cases of HAIs are another significant factor anticipated to propel industry growth during the forecast period. For instance, the WHO reports that 7 out of 100 hospitalized patients in developed countries and 10 in developing countries develop at least one HAI. In addition, roughly 30% of patients in ICU are affected by at least one HAIs in high-income countries. Hence, hospitals and other healthcare facilities are seeking the adoption of disposable medical devices to curb the infection rate in medical facilities, thereby contributing to the segment growth.

End-user Insights

The hospitals segment dominated the global market in 2021 and accounted for a revenue share of more than 40.0%. The segment growth is mostly due to an increase in the number of patients suffering from various urological diseases, which has resulted in an increase in surgical treatments. For instance, according to the Urology Care Foundation, around 33 million people are living with overactive bladder and a quarter to a third of men and women suffer from UI in the U.S. Hospitals provide efficient and effective patient care, maintain a safe environment, and offer extensive services. Thus, hospitals are expected to grow at a significant rate during the forecast period. Moreover, hospitals see a substantially higher inflow of patients for urological procedures or other treatments than other healthcare settings owing to the simplicity of managing any emergencies that may develop during surgical procedures and the availability of a wide range of treatment alternatives. As a result, the hospital segment is likely to be driven by the aforementioned variables.

The home care settings segment is expected to expand at the fastest CAGR of 6.5% from 2022 to 2030. The patient-friendliness, cost-effectiveness, and safety associated with these devices are contributing to their growing popularity at home. In addition, rising hospital costs make home care a better option, especially for the elderly population. According to a 2018 report by the WHO, the global population aged 60 years and older is expected to reach 2 billion by 2050. Since prostate cancer, urethral stricture, and bladder obstruction in the elderly are major health concerns globally, this is expected to present a significant growth opportunity for the market over the forecast period. A range of urethral or meatal dilators has been deployed to perform self-dilation at home or in privacy to keep the urethral passage open and prevent the recurrence of urethral stricture or other urethral obstructions. Thus, the advancements and availability of urethral dilators to use at home are boosting the demand for urethral dilators in home care settings. Its cost-effectiveness also makes it feasible for patients in developed and developing economies.

Application Insights

The urethral stricture segment held the largest revenue share of over 50.0% in 2021 owing to the rising cases of urinary tract infections, advances in the development of therapeutics to treat urinary strictures, and public-private partnerships to raise awareness, and increasing penetration of large companies in emerging markets. Urethral strictures are usually the result of inflammation and injury from repeated medical procedures such as catheters or surgery or infection, which cause scarring/ narrowing in or around the urethra that can block the flow of urine. Associated risk factors include urinary tract infections, wall thickening, hydronephrosis, and stone formation in the urinary bladder. This is expected to boost the segment growth over the forecast period.

The kidney stone removal segment is expected to grow at the fastest rate of 6.4% during the forecast period. The rising adoption of minimally invasive procedures and high-risk factors that cause kidney stones, such as diabetes, obesity, and renal dysfunction, are major contributors to the segment growth. For instance, over the last 30 years, the National Health and Nutrition Examination Survey (NHANES) has shown a rising trend in the prevalence of kidney stones. Renal dilators are used for the dilatation of nephrostomy tract before the percutaneous kidney stone removal. This, in turn, is anticipated to fuel the industry growth over the forecast period. Moreover, the ease of usage, noninvasive nature, cost-effectiveness, and great efficacy in the treatment of stones are the benefits of using dilators during the process. Furthermore, these procedures can be conducted in outpatient departments because of the shorter turnaround time. All these advantages are expected to propel the demand over the forecast period.

Regional Insights

North America held the largest revenue share of over 30.0% in 2021. The regional market is mainly driven by the rising incidence of targeted diseases, such as bladder obstruction, UI, Benign Prostate Hyperplasia (BPH), urinary retention, and bladder cancer. For instance, according to the American Academy of Family Physicians (AAFP), more than 250,000 patients with BPH undergo surgical procedures every year. This condition may occur due to aging or trauma/injury to the penis, urethra, or bladder, and is also associated with pregnancy. Moreover, the high purchasing power of consumers and increased adoption of advanced technologies and innovative medical devices are expected to drive the market. Also, the presence of public and private funding initiatives, especially in the U.S., to create awareness regarding advanced devices is a key growth factor. These initiatives, including the U.S. Affordable Care Act (ACA), focus on reducing the cost of medical devices. This is expected to drive the market in the region over the forecast period.

Asia Pacific is estimated to exhibit the highest CAGR of 6.3% over the forecast period. This can be attributed to the presence of a large population suffering from kidney and other urological diseases, improvement in medical facilities, and the availability of insurance policies. Moreover, the presence of a large patient pool and growing need for technologically advanced and cost-efficient healthcare solutions are expected to present significant regional growth opportunities. For instance, according to the Japan Times Ltd., in September 2021, the number of people aged 65 and up in Japan reached a new high of 36.4 million, resulting in hospitalization. Thus, these factors are expected to boost the growth of the industry in this region during the forecast period.

Key Companies & Market Share Insights

The market players are constantly launching new products and increasing their reach through geographical expansions to acquire a greater share. For instance, in June 2020, B. Braun Melsungen AG launched virtual support services during the COVID-19 crisis to help weak patients at home with acute bladder problems. This service delivers continence and ostomy care products to patients at home by providing FaceTime video tutorials and advice on distribution channels.

Moreover, numerous manufacturers in the urethral dilators industry work in partnership with key medical device distributors to market and supply their products globally or in certain countries. Therefore, strategic alliances are quite common among them. Such alliances not only help the manufacturers acquire the license to market their product but also reduce their liability in case of product recall and adverse events. For instance, in February 2019, Coloplast signed a three-year agreement with Premier Inc., a U.S.-based healthcare improvement company, for its urology products. The general urological products include drainage systems, dilators, catheters, and other accessories, thereby increasing penetration of the product in a new market. Some prominent players in the global urethral dilators market include:

• B. Braun Melsungen AG

• BD

• Cook Medical

• MED pro Medical BV

• Teleflex Inc.

• UROMED

• Boston Scientific Corporation

• Smiths Medical (ICU Medical)

• Urovision-Urotech

• Coloplast

Urethral Dilators Market Report Scope

Global Urethral Dilators Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2018 to 2030. For the purpose of this study, Grand View Research has segmented the global urethral dilators market report on the basis of usage, application, end-user, and region:

• Usage Outlook (Revenue, USD Million, 2018 - 2030)

  • Disposable

  • Reusable

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Urethral Stricture

  • Meatal Stenosis

  • Kidney Stone Removal

  • Others

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Clinics

  • Ambulatory Surgical Center

  • Home Care Settings

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • South Korea

    • Australia

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE