Disposable endoscopes set to disrupt the reusable market

While the COVID-19 pandemic negatively impacted many medical devices markets in 2020, sales for disposable endoscopes defied this trend and experienced significant YoY growth.

The COVID-19 pandemic had a vast impact and necessitated a worldwide response. However, getting things back to normal is likely to come on a country-by-country, state-by-state and in some cases, city-by-city basis.

Endoscopy falls squarely into that reality. Non-emergent, endoscopic procedures were among the many elective procedures suspended when the pandemic reached full fervor in mid-March. That meant the endoscopist’s bread-and-butter procedures, the screening colonoscopy, had to be put on the shelf until officials had a better grasp on the coronavirus disease, and the outlook for society improved.

Although the pandemic is still ongoing, endoscopists are already beginning to resume the urgent and elective procedures that had to be postponed during the worst of COVID-19. To get back to the point of treating their patients, gastroenterologists have had to navigate a network of society guidelines, as well as governmental directives.

The Indian endoscopes market in 2020-21 received a minor setback with the COVID outbreak. Sales fell by about 10 percent, by value. The drop in sales in 2020 was compensated by a surge in demand in JFM 2021 quarter, and the momentum continues, government buying being a major factor. The market in 2020-21 is estimated at ₹521.6 crore, at 3317 units, a new entry in the segment is the motorized spiral endoscopes, the latest product launched in 2020.

The three leading brands in the rigid endoscopes segment, Olympus, Stryker, and Karl Storz, together constitute 90 percent of the market. The local players continue to have a 10 percent market share. While the imported segment commands a unit price in the range of ₹12-15 lakhs, the local players have to make do with ₹7.5 lakhs. Refurbished models are no longer preferred and the Chinese players too lost ground this year.

The flexible endoscopes segment is dominated by Olympus, with Fujifilm also aggressive in the market. Pentax is continuing to lose market share, especially with the private sector. Karl Storz is more of a regional player.

Olympus has introduced the PowerSpiral Enteroscopy, a motorised type of endoscope, that allows for fast and gentle access to reach deep into the gastrointestinal tract by pleating the small bowel onto the enteroscope using a spiral segment. This is achieved via an integrated motor, which rotates the single-use PowerSpiral cover tube that is equipped with soft spiral-shaped fins that gently follow the mucosa. The enhanced insertion speed, easy advancement, controlled withdrawal- and improved maneuverability can substantially reduce the overall procedure time and allow time for effective treatment. The company had a sales of 12 units in 2020-21 and 17 units so far. It is being preferred over the balloon endoscopes, with which the same procedure takes almost double the time.

As India continues to battle the COVID-19 pandemic, new deadly complications of the infection have surfaced. Patients with suspected mucormycosis need to undergo nasal endoscopy, an endoscope from the rigid segment. This segment is expected to clock ₹430 crore in 2021-22, from ₹380 crore in 2019-20 and ₹340 crore in 2020-21.

The global endoscopes market was valued at USD 10.8 billion in 2020. The endoscopes market declined by 4.1 percent from 2019 to 2020; as per earlier projections the market was expected to be over USD 11.3 billion in 2020. The postponement of elective surgeries and the reduction in the number of elective surgeries performed during the pandemic have drastically impacted the market. In addition, changing regulations with a view to curtailing the infection due to virus, along with disruptions in the supply chain, have hampered the market growth during the pandemic.

With the easing of restrictions on elective procedures, the market is estimated to witness a year-over-year (Y-o-Y) growth of 8 percent over the next 5 years. The growth is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges.

Flexible endoscopes dominated the market with a share of 49.9 percent in 2020. This is attributed to the growing preference for flexible endoscopes among medical professionals, technological advancements, increased efficiency and safety, and ergonomic features of flexible endoscopes. In addition, these endoscopes are used in numerous procedures like upper gastrointestinal endoscopy, colonoscopy, bronchoscopy, sigmoidoscopy, laryngoscopy, pharyngoscopy, duodenoscopy, nasopharyngoscopy, and rhinoscopy, which increase their adoption, thereby fueling the segment’s growth.

Technological advancements with respect to endoscopes, and increasing applications in various diagnosis and treatment processes, are among the key trends boosting the demand for endoscopes globally. Furthermore, minimally invasive surgeries are driving the utilization of various endoscopic procedures for diagnosis like proctoscopy, cystoscopy, and gastroscopy.

A considerable rise in the prevalence of cancer and gastrointestinal disorders represents one of the primary factors driving the endoscopy devices market. Endoscopy devices can be used to investigate unusual symptoms like dysphagia, diarrhea, weight loss, heartburn, and stool blood. Consequently, the growing pediatric population, which is relatively more vulnerable to targeted diseases, is further influencing the utilization of flexible endoscopes for diagnosis and treatment. Apart from this, the leading players are introducing capsule or robot-assisted endoscopy devices with ultra-high-definition (UHD) visualization systems. These players are also offering easy-to-handle light sources and state-of-the-art video equipment to support the use of endoscopy devices in microsurgical techniques, which is contributing to the market growth. Furthermore, the growing adoption of modern endoscopy devices that incorporate distal lens designs to provide a wider field of view, in confluence with the increasing consumer preferences for minimal post-surgical complications, is anticipated to foster the market growth.

North America dominated the global market with a revenue share of 42.5 percent in 2020 owing to the improved healthcare infrastructure, the rising adoption of advanced technologies, and the growing preference for minimally invasive surgeries to curb healthcare spending. In addition, the growing burden of gastrointestinal disorders and cancer in the region is one of the significant factors propelling the market growth. For instance, according to the estimates of the National Cancer Institute (NCI), around 1,806,590 new cases were estimated to be diagnosed in the US in 2020.

The Asia-Pacific region is expected to witness lucrative growth over the next 5 years with high demand for endoscopic technologies in this region. Some of the other factors contributing to the regional market growth are improving health infrastructure and the growing geriatric population. In addition, rising economic development in the region is one of the major factors responsible for attracting foreign investments. The presence of key players in the region is boosting the visibility and adoption of endoscopes, thereby supporting the market growth.

Competition is strong among the existing players owing to the increase in demand for endoscopes for various diagnostic and treatment procedures, coupled with technological advancements. The increasing demand in the market is likely to boost the entry of new companies in the future, propelled by increasing awareness and acceptance of endoscopes and allied technologies.

Some prominent players in the global endoscopes market include Boston Scientific Corporation, Johnson & Johnson, Fujifilm Holdings Corporation, HOYA Corporation, Karl Storz SE & Co. KG, Machida Endoscope Co. Ltd., Medtronic Plc, Olympus Corporation, Richard Wolf GmbH, Smith & Nephew plc, and Stryker Corporation.

Disposable endoscopes are set to disrupt the reusable endoscopes market. The development and implementation of single-use, or disposable, medical devices is becoming more widespread. Disposable devices are being increasingly used at the expense of reusable counterparts across most markets and therapy areas. One of the major reasons for this shift has been to prevent the spread of infectious diseases and to reduce the logistics required to sterilize reusable equipment. Reasons not to use single-use devices include environment concerns (minimizing the production of waste) and the generally cheaper costs associated with reusable devices.

While the COVID-19 pandemic negatively impacted many medical devices markets in 2020, sales for disposable endoscopes, also known as single-use endoscopes, defied this trend and experienced significant Y-O-Y growth.

The disposable endoscopes market is set to grow at a remarkable CAGR of 29 percent, resulting in a global market value exceeding USD 6 billion by 2030. Sales for single-use bronchoscopes are growing at a CAGR of 124 percent, a 126-fold increase since 2014. In contrast, the global market for reusable bronchoscopes is expected to grow at only 2.7 percent over the next 10 years. Additionally, since the launch of single-use rhinoscope in 2019, sales have grown by 441 percent. This impressive growth rate is facilitated by the demand for healthcare systems to reduce time, costs, and cross-contamination potential when using more traditional, reusable endoscopes. Sales of disposable endoscopes spiked at the onset of the COVID-19 pandemic, as it became necessary for healthcare facilities to redirect their resources toward COVID-19 patients and to eliminate even the slightest chances of patient-to-patient cross-contamination from using sterilized reusable endoscopes.

The emerging market for disposable endoscopes is rapidly growing and new types of disposable devices and manufacturers enter the market every year. With high interest from healthcare professionals seeking alternatives to reusable endoscopes that at times resulted in cross-contamination issues, the market experienced double or triple-digit annual growth from 2015 to last year.

The rapid growth of this market is also attributed to simple economics. The cost of purchasing reusable endoscopes is often an order of magnitude or higher than the cost of their disposable counterparts, so the market growth of disposable devices is expected to be driven by both well-funded healthcare systems and more budget-conscious medical facilities worldwide.

This market is currently dominated by just a few manufacturers, most notably Ambu and Boston Scientific. Since the launch of Ambu’s aScope disposable rhinoscope in 2019, its sales grew by 441 percent in 2020 despite the COVID-19 pandemic and its YoY sales of disposable aScope bronchoscope increased by 50 percent in 2020. The company launched its aScope disposable duodenoscope in 2020 and plans to release the aScope Duo2 in 2022. GlobalData expects other medical device manufacturers to continue entering this market as early as this year, thus increasing its competitiveness. These may include well-established, highly diversified manufacturers like Medtronic and Ethicon, as well as large manufacturers and startup companies that already specialize in endoscopic devices, such as Olympus.

For the market leaders to remain competitive in an increasingly disruptive market, they will need to begin manufacturing single-use endoscopes before the competitive landscape becomes overly crowded.

The future of endoscopy is sure to include a variety of both reusable and disposable technologies, enabled by new connectivity products proven to go the distance in terms of providing safe, effective care, whether that means withstanding advanced sterilization techniques or contributing to a single-patient-use solution.

Mergers and acquisitions and strategic alliances with other market players and increasing R&D in the area of endoscopic technologies are some of the initiatives being undertaken by key market players to increase their share in the market.

In August 2021, Boston Scientific secured 510(k) clearance from the US Food and Drug Administration (FDA) for its EXALT Model B single-use bronchoscope. The company has designed the new bronchoscope for use in bedside procedures within the intensive care unit (ICU) and operating room (OR). According to the company, more than 1.2 million bedside procedures involving a bronchoscope are performed in ICU and OR settings each year across the US and over three million are performed across the world.

In August 2021, 3NT Medical announced FDA clearance for its Peregrine Drivable ENT Scope, designed to provide ENT surgeons with unparalleled views of the sinus anatomy to enhance the surgical experience.

In July 2021, SonoScape secured CE mark approval for its linear-array echoendoscope called EG-UC5T. The approval of a new linear-array echoendoscope allows expanding the company’s endoscopic ultrasound (EUS) portfolio in the international market.

In May 2021, Pentax Medical Europe obtained a CE mark for its new single-use bronchoscope – the PulmoONE. The PulmoONE is a single-use bronchoscope with superior suction power and HD image quality.

In May 2021, China-based medical device company EndoFresh received the US Food and Drug Administration (FDA) 510(k) approval for its Disposable Digestive Endoscopy System.

In March 2021, Olympus announced FDA 510(k) clearance of narrow band imaging (NBI) to assess the neoplastic potential of colorectal polyps. In addition to the current indications for NBI, Olympus has received FDA clearance for the screening and surveillance of Barrett’s esophagus and is currently exploring other claims for NBI both in gynecology and general surgery.

In January 2021, Olympus Corporation entered into an agreement to acquire Quest Photonic Devices B.V. for up to € 50 million (USD 60.7 million) including milestone payments to strengthen its surgical endoscopy capabilities.

In October 2020, SourceMark has been awarded a video endoscopy contract for single-use video laryngoscopy and for video endoscopic systems by Premier Inc., a healthcare improvement company, uniting an alliance of approximately 4100 US hospitals and health systems and more than 200,000 other providers and organizations.

In recent years, endoscopic navigation systems have gradually become one of the core instruments in MIS. After a period of development, endoscopic navigation systems have effectively solved many issues encountered in the clinic. However, different clinical applications have diverse goals and encounter different challenges.

In cardiovascular endoscopy, advanced imaging technology has reached the stage of clinical trials in lesion identification. Instrument tracking technology has been widely used in vascular interventional surgery, which mostly uses radiography technology (such as ultrasound and MRI) and magnetic tracking technology. Future research should focus on ways to use endoscopic vision technology to guide and accurately track cardiovascular endoscopes.

Some clinical applications and commercial products have been developed in the application of endoscopic navigation to the respiratory tract. The branched structure of the respiratory tract is complex and narrow, and, therefore, the main concern in the endoscopic navigation of the respiratory tract is the guidance of the endoscope through the complex branches to reach the target, such as a biopsy location at the distal end of the bronchus. Currently, the most commonly used navigation system for the respiratory tract is based on electromagnetic tracking technology, which has high accuracy but is expensive. Navigation methods based on endoscopic vision technology are attractive, low-cost solutions. As developments in deep learning technology continue, this method will increasingly become the focus of research.

The main goal of digestive endoscopy navigation systems at present is to help doctors comprehensively and accurately detect and characterize lesions in the gastrointestinal tract. This raises three key questions: how can the endoscope be made to traverse the entire gastrointestinal system completely, how can advanced sensor technology be used to obtain more information about the lesion, and how can the lesion be accurately detected, characterized, and located? Endoscopic vision technology has shown great potential in attempting to solve these problems. Deep-learning-based methods can effectively increase the detection rate of BE, ESCC, GC, and other lesions, and can reduce the number of blind spots in gastrointestinal endoscopy.

In laparoscopic navigation, methods based on the fusion of preoperative data (such as CT and MRI) cannot cope with the large-scale deformation of intraoperative organs. Intraoperative modalities, such as IOUS, may provide real-time structural details on deep tissues, but the image resolution is low, and therefore the doctor’s experience and spatial visualizing ability are required. ICG fluorescence endoscopes can perform high-resolution angiography, but the detection depth is only approximately 10 mm below the tissue. Navigation technologies focused on the multimodal image fusion of preoperative and intraoperative data could potentially solve the problem of lesion navigation under conditions of large-scale changes. The primary challenge is the high-precision registration between multiple modalities.

Endoscopic navigation systems have been widely used in clinical treatment during neurosurgery. Because of the strict safety requirements, the accuracy of the registration between preoperative data and the endoscopic visualization is a key indicator for evaluating the endoscopic navigation system. During navigation, changes in the anatomical structures during the operation could still affect the registration accuracy; however, the stiffness of the brain tissue is relatively high. As an evolving technology, the fusion of intraoperative data, such as CBCT and iMRI, with endoscopic images can potentially reduce the impact of intraoperative anatomical structure changes on registration accuracy, which can also be improved by the real-time identification of critical anatomical structures with endoscopic images.

Ureteroscopic navigation is currently in the research and development stage. The main problem lies in determining methods to completely traverse the endoscope through the renal pelvis structure to accurately identify, locate, and measure the lesion or stone. Future research should identify ways to improve the flexibility of the ureteroscope and ways to locate it in an environment with limited textures and feature points.
Multiple optical endoscopy technologies provide more information than ever before. Nevertheless, these technologies are currently limited to some departments. For example, binocular endoscopes are generally only used for laparoscopy, while EC is generally only used in GI applications. This is mainly limited by the sizes of the tips of different endoscopes. Miniaturization of these modules and wider application in other departments will significantly improve disease diagnosis.

In endoscopic navigation, many sensor modules, including the EM sensor and CLE probe, must pass through the instrument channel to function, which can affect the surgeon’s surgical procedures. For example, in urinary navigation surgery, these sensors and laser fibers have to be exchanged frequently through the instrument channel. Therefore, integrating these sensors into existing endoscopes may lead to greater convenience during the surgical procedure.

In 3D reconstruction, monocular endoscopes cannot measure scale without a fixed-size reference object. Therefore, it is necessary to use binocular cameras or external-positioning sensors to obtain scale information. However, this can lead to errors from just the initial calibration. High-precision camera and hand-eye calibration for endoscopes will effectively minimize these errors.

Deep learning has become an important technology in navigation systems. Today, it is extensively used in a variety of fields, and has achieved feasible performance. Constructing a standard dataset with a large number of labelled endoscopic images is important for the performance of endoscopic artificial intelligence-assisted diagnosis algorithms.

Finally, in MIS, movement interference and the large-scale deformation of soft tissue remain vital issues. Many previous studies were based on registration algorithms, using preoperative data. With the improvement in endoscopic imaging and fast MRI technology, combining intraoperative data to track and visualize lesions in real time is expected to be the primary research direction in the future.

Endoscopic navigation provides surgeons with more accurate, effective, and reliable diagnoses and treatments in MIS. Combined with advanced endoscopic vision technology, the next generation of endoscopic navigation systems is already under development. In this paper, we have summarized multiple optical endoscopy modalities, including white-light imaging, contrast-enhancement, and advanced endoscopic vision technologies that are currently or will potentially be used in endoscopic navigation systems. Endoscopic optical imaging modalities include white-light imaging, contrast-enhancement techniques, and technologies of magnifying observation. Meanwhile, endoscopic vision technologies consist of instrument tracking, endoscopic view expansion, and suspicious lesion tracking. All these technologies will bring changes to future surgical navigation systems. Combining diverse and complex clinical needs, it is necessary to integrate these advanced endoscopic technologies to achieve more precise navigation.