Endoscope Reprocessing Market

Market Overview

The global endoscope reprocessing market size was valued at USD 2,199 million in 2022. It is estimated to reach USD 4,609 million by 2031, growing at a CAGR of 8.57% during the forecast period (2023–2031).

Endoscope reprocessing is a process that involves multiple steps, such as effective cleaning, disinfection, and sterilization of endoscopes and related accessories. The endoscope reprocessing tag can be used for endoscopes that follow the endoscope reprocessing process. The high risk of infections occurring due to the improper sterilization of endoscopic devices drives the demand for reprocessing equipment. The endoscope reprocessing market will flourish due to the focus on high cleaning standards and the need for sterilized and disinfected medical devices in hospitals and clinics.

Market Dynamics

Global Endoscope Reprocessing Market Drivers

Intensifying Need for Endoscopic Procedures among Target Population

Endoscopy is one of the most performed procedures in healthcare settings. It is a powerful diagnostic tool used in the early detection, diagnosis, and treatment of gastrointestinal diseases. The rise in the prevalence of gastro-related disorders increases the number of endoscopy procedures performed and, eventually, the demand for reprocessing endoscopes to avoid infection risks in patients and physicians.

Additionally, gastrointestinal tract cancer represents over one-quarter (26%) of the global cancer incidence and one-third (35%) of all cancer-related deaths. The number of endoscopic procedures performed rapidly increases with the prevalence of cancers related to the gastrointestinal tract. In addition, endoscopy is needed a lot more than it used to be because more and more people are getting stomach problems. This rise in the number of endoscopes used frequently increases the risk of biofilm formation on endoscopes. Therefore, reprocessing equipment is widely used, and its high demand contributes to the market's growth.

Regulatory Guidelines Promoting Endoscope Reprocessing

Guidelines for multiple reprocessing are present to give endoscopy units explicit instructions on reprocessing endoscopes safely and in compliance with legislative laws. These reprocessing guidelines are formulated by international and various national medical societies that include multiple stakeholders, such as nurses, physicians, infection control and medical instrumentation experts, and government agencies. 

Recent infectious outbreaks attributed to endoscopes brought an increased awareness of infection control programs to mitigate future risks. Hence, proper reprocessing of endoscopes and their accessories is imperative in ensuring patient safety while complying with federal and state regulatory bodies. Such guidelines are widely promoting the need for appropriately reprocessing endoscopes to reduce the incidence of infections due to improper endoscope reprocessing, thereby lowering the risk to patients. Adhering to such guidelines will also provide accreditations and certifications ideal for endoscope reprocessors and drive market growth.

Global Endoscope Reprocessing Market Restraint

High Cost of Endoscope Reprocessing Equipment

Several organizations publish stringent reprocessing guidelines due to outbreaks of infections tied to contaminated flexible endoscopes. The guidelines are made to reduce disease risk and improve patient safety. Compliance with these recommendations will require institutions to invest more resources into endoscope reprocessing. In addition, the cost of reprocessing a flexible endoscope in the US can range from USD 114.07 to USD 280.71. The average hands-on time for reprocessing one endoscope is 76 minutes, and the personnel reprocessing endoscopes include surgical and patient care technicians, registered nurses, respiratory therapists, and others. Also, the personnel is paid on an hourly basis. Thus, such high costs associated with endoscope reprocessing hinder the use of reprocessing equipment.

Global Endoscope Reprocessing Market Opportunities

Technological Advancements in Endoscope Reprocessing Methods

In 2008, the Centers for Disease Control and Prevention (CDC) stated that flexible endoscopes and AERs needed to be improved and redesigned to make disease transmission less likely. The CDC report states that AERs offer advantages over endoscope reprocessing manual methods as these devices automate several reprocessing steps and minimize personnel exposure to high-level disinfectants.

In addition, cleaning endoscopes was complex because they could only recently clean the insides of their lumens. Latest technological advances led to the development of flexible inspection camera systems that can inspect the internal channels of an instrument for debris and damage, which could help reduce infection rates. Several manufacturers emphasize the automation of their disinfection workflows, defining their production advances and innovation strategies. Thus, the technological advances in endoscope reprocessing methods create opportunities for the market to grow.

Segmental Analysis

The global endoscope reprocessing market is segmented into product and end-user.

By product, the global market is divided into disinfectants, reprocessing equipment, detergents, drying, storage, and transport systems, and others. 

The disinfectants segment owns the highest market share and is anticipated to grow at a CAGR of 9.23% over the forecast period. Disinfectants are chemical substances used to inactivate or destroy microbes on inert substances. These substances differ from antiseptics that destroy microorganisms in living tissues. Disinfectants are classified into low-level disinfectants, intermediate-level disinfectants, and high-level disinfectants. Low-level disinfectants can rapidly kill most vegetative bacteria and lipid-containing viruses. Although intermediate-level disinfectants and high-level disinfectants kill all microbes, they differ based on their ability to destroy bacterial endospores. One of the advantages associated with disinfectants is that they are inexpensive and widely available. 

The other benefits of disinfectants include effective bactericidal, cleansing, tuberculocidal, and virucidal activity. Furthermore, disinfectants have a pleasant odor and are non-staining as they evaporate without leaving residues. These properties of disinfectants accelerate their adoption in healthcare settings. The use of disinfectants to disinfect various healthcare areas, such as scanners, imaging devices, high-touch surfaces, and bedding instruments, increased considerably during the COVID-19 outbreak. Chemical disinfectants are highly toxic and widely used in clinical and surgical practices. Thus, the high demand for disinfectants during the pandemic encouraged significant vendors, such as STERIS, 3M, The Clorox Company, and others, to increase the production of disinfectants.

The other segment includes brushes, pre-cleaning kits, bedside kits, cleaning adapters, soak shields, endoscope reprocessing sinks and flushing aids, visual inspection and leak testers, and tracking software used during the endoscope reprocessing process. Endoscopic accessories are critical devices that breach sterile body sites. They have unique reprocessing difficulties compared with other medical and surgical instruments due to their complex structure, narrow lumens, thermolabile construction materials, and applications in semicritical endoscopic devices. Many global guidelines focus on hygiene and infection control in endoscopy. These guidelines focus only on flexible endoscopes and the accessories used in gastrointestinal endoscopy. They address several essential safety aspects in gastrointestinal endoscopy, mainly focusing on avoiding infections resulting from improper reprocessing of endoscopes or endoscopic accessories.

By end-user, the global market is divided into hospitals, specialty clinics and medical office suites, standalone reprocessing service facilities, and others. 

The hospital segment is the highest contributor to the market and is expected to grow at a CAGR of 7.98% during the forecast period. Hospitals must ensure the highest level of disinfection and sterilization of their medical devices with the growth in infectious diseases, epidemics, and pandemics. These must also guarantee the effectiveness of their disinfection and sterilization protocols for medical devices. To reduce the risk of infections, healthcare facilities should have a reliable, high-quality way to clean and sterilize medical instruments like endoscopes. 

Hospitals also need to re-examine their endoscope reprocessing protocols to meet the highest standards, thereby reducing the potential for a disease outbreak. The infection risk with high-level disinfected endoscopes is a significant concern in hospitals. Endoscopes that remain wet pose a severe contamination risk. Many hospital outbreaks are associated with the improper drying of flexible endoscopes, including those caused by Mycobacterium tuberculosis, Serratia marcescens, Pseudomonas aeruginosa, and Mycobacterium chelonae. In 2017, researchers examined three hospitals where 62% of the disinfected endoscopes at the top-performing hospitals in the US tested positive for bacteria, including potential pathogens. The other two hospitals had an even worse case, where 85% and 92% of disinfected endoscopes tested positive for bacteria. Hence, there is a high demand for endoscope processing in hospitals.

Specialty clinics treat infants, children, adolescents, and some adults with medically complex conditions. These clinics are often associated with a healthcare system or hospital group, but they can also be standalone practices. Patients at specialty medical clinics have access to extraordinary expertise, resources, and therapy programs that are not often available at general hospital centers. Specialty clinics often have years of experience and provide patients with improved treatments using advanced surgical equipment and emotional support. Specialty clinics perform a wide range of endoscopic techniques that allow both diagnosis and treatment of GI disorders, such as peptic ulcers, cancers, polyps, and others. These clinics require endoscopes to perform various procedures and use endoscope reprocessing systems to reduce the risk of endoscope-associated infections. Many endoscopy centers employ ventilated scope storage cabinets. 

In contrast, other healthcare facilities, such as physician practices and specialty clinics, store their processed instruments in a clean storage room. Many doctors globally invest in proper equipment, build offices that can accommodate procedure rooms, attain accreditation for ambulatory procedures, and hire staff to provide office-based endoscopy procedures. Market dynamics, reimbursement, and other policy changes combined motivate the shift of endoscopy services into physicians' office settings, increasing medical office suites' need to adopt endoscope reprocessor systems.

Regional Analysis

By region, the global endoscope reprocessing market is divided into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant shareholder in the global endoscope reprocessing market and is anticipated to grow at a CAGR of 8.01% during the forecast period. The demand for disinfection systems in North America is majorly driven by the increased prevalence of chronic diseases, HAIs, stringent regulations, and favorable government initiatives related to disinfection and sterilization. Advances in the healthcare infrastructure in the US and Canada are expected to propel the demand for disinfectants and detergents in healthcare settings during the coming years. The ease and convenience of using these products have led to an increase in the market for these products in various end-user application segments. 

Additionally, there is a steady growth in the volume of endoscopic minimally invasive surgeries. With the change in the number of endoscopic surgeries performed, the demand for automated endoscope reprocessors that facilitate high-level disinfection of endoscopes is set to rise. Furthermore, regulatory guidelines that support the reprocessing of medical devices and growth in the number of product approvals for automated endoscope reprocessors increase the demand for endoscope reprocessors and related accessories in the region.

Europe is expected to grow at a CAGR of 8.30% over the forecast period. Due to the growth in the aging population with chronic diseases and the prevalence of HAIs and hospitalizations, the market in the region is growing. Advanced healthcare infrastructure, technological advances in the medical industry, and the development of smart devices for disinfection systems contribute to regional market growth. The COVID-19 outbreak necessitated the disinfection of healthcare settings and hand hygiene for physicians and patients, which drove the regional market's growth. In addition, digestive cancers represent 28% of all cancer-related deaths in the region. Therefore, the number of patients needing endoscopic interventions is high, which drives market growth in the region.

In Asia-Pacific, the rise in the aging population, chronic diseases, healthcare expenditure, technological developments, and the COVID-19 outbreak are significant factors that contribute to the market's growth. The prevalence of HAIs contributes to using disinfection systems in healthcare settings. The WHO noted in its 2015 factsheet that 5.7%–19.1% of HAIs occurred in low- and middle-income countries (LMICs). Also, the frequency of intensive care unit (ICU)-acquired infections is at least 2–3 fold higher in LMICs compared with high-income countries. Furthermore, the risk of HAIs in Asia-Pacific countries is estimated to be 2–20 times higher than in developed countries globally.

The increased prevalence of HAIs in Latin America is associated with the large aging population, which will likely offer growth opportunities to the manufacturers of healthcare disinfection systems during the forecast period. The prevalence of chronic diseases and outbreaks of epidemics and pandemics increase the use of disinfectants and detergent products across the region. This is majorly driven by the rise in initiatives by governments that ensure proper disinfection practices, especially in healthcare settings. The market's growth rate in the Middle East and Africa is slower than in other regions due to a large and undertreated patient population requiring hygienically advanced treatment procedures, increased government initiatives and healthcare funding, and improved healthcare infrastructure. The incidence of infections in the region is anticipated to increase over the coming years. 

Recent Developments

• December 2022- PENTAX Medical America introduced the new PlasmaTYPHOONdry endoscope drying solution. The new fast endoscope drying solution is a patented, completely automated process that uses an advanced technique to dry with two different airflow levels.
• March 2022- The Association for the Advancement of Medical Instrumentation issued its long-awaited update to its guidance on cleaning and storing flexible and semi-rigid endoscopes.

Endoscope Reprocessing Market Segmentation

By Product

• Disinfectants
• Reprocessing Equipment
• Detergents
• Drying, Storage, and Transport Systems
• Others

By End-User

• Hospitals
• Specialty Clinics and Medical Office Suites
• Standalone Reprocessing Service Facilities
• Others

By Regions

• North America
• Europe
• Asia-Pacific
• Latin America
• The Middle East and Africa