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Ambu A/S: The Single-Use Revolution in Endoscopy
I. Introduction: A Danish Company Reinventing Medical History
In the sterile corridors of hospitals worldwide, a fundamental shift is underway—one that challenges nearly a century of medical orthodoxy. The reusable endoscope, long considered an indispensable tool of modern medicine, faces an existential question: What if the very instruments designed to save lives are silently spreading infections between patients?
Enter Ambu A/S, a Danish medical device company with roots stretching back to 1937, now at the forefront of what may be the most significant transformation in endoscopy since the invention of fiber optics. Today, Ambu employs approximately 5,700 people worldwide and reported revenue of 6,037 million Danish kroner for fiscal year 2024/25, with organic growth of 13.1%.
The numbers tell only part of the story. What makes Ambu remarkable is not its size—with a market capitalization hovering around $3.37 billion, it remains a relative minnow compared to giants like Olympus and Medtronic—but its audacity. Ambu has a 10-year head start on competitors, having introduced the first single-use bronchoscope in 2009; the company is now on its 4th-generation technology platform.
The central question for investors and industry observers alike: How did a small Danish company that invented the resuscitation bag become the global leader disrupting a multi-billion dollar endoscopy market dominated by some of the world's most formidable medical device giants?
The global endoscopy market was valued at USD 29.5 billion in 2024 and is expected to reach USD 56.9 billion by 2034, growing at a CAGR of 6.9% during the forecast period. Yet within this enormous market, Ambu has carved out a strategic position in the fastest-growing segment. The global disposable endoscopes market was valued at USD 1.9 billion in 2024 and is expected to reach USD 8.5 billion in 2034, growing at a CAGR of 16.4% during the forecast period.
This is not merely a story of market share capture—it's a story of structural disruption, regulatory tailwinds, and the economics of single-use versus reusable medical devices. The themes that emerge are universal to business strategy: how a focused innovator can challenge entrenched incumbents, how regulatory pressure can accelerate market transitions, and how manufacturing scale creates competitive moats in medical devices.
II. Founding Origins & The Ambu Bag Breakthrough (1937–1980s)
The Founder's Vision: A Refugee's Innovation
The story of Ambu begins not with corporate ambition but with personal crisis and ingenuity. As a young man, Holger Hesse went to the United States for a specialized training program with General Electric. Upon returning to Germany, he earned a doctorate in engineering. Hesse, of Jewish descent, fled Nazi Germany in 1935 and relocated to Denmark.
In 1937, two years after arriving in his adoptive country, Holger Hesse founded Ambu, initially naming the company Testa Laboratory. His first product was characteristically practical: Hesse's first invention enabled private practitioners to measure the amount of haemoglobin in the blood without having to send a blood sample to an external laboratory. The Sicca Haemometer is a core example of Hesse's dedication to rethink traditional medical approaches and replace them with smarter and simpler solutions.
This founding philosophy—questioning established medical practices and finding more efficient alternatives—would prove prescient decades later when Ambu challenged the reusable endoscope paradigm.
The Breakthrough: Inventing the Self-Inflating Resuscitator
The real breakthrough came from an unlikely partnership and a national crisis. In the early 1950s, Denmark was among the hardest-hit countries in Europe by the polio epidemic. The product was developed in Denmark at a time when the country was devastated by the polio epidemic and hospitals relied on medical students, volunteers, and relatives to manually ventilate ill patients 24 hours a day. The manual ventilators required an oxygen source, a truck drivers' strike hampered oxygen deliveries to Danish hospitals and hospitals needed a way to ventilate patients without oxygen.
In 1953, Dr. Holger Hesse met the Danish physician Dr. Henning Ruben and a fruitful teamwork began. Together they invented the Ambu Ventilation Bag, which was a revolution within resuscitation.
Dr. Henning Ruben himself was a remarkable figure. Ruben, born in Copenhagen in 1914 as the eldest son of an orthodox Jewish family, was a man of many talents. He was a member of the Danish fencing team, a professional dancer, magician, thought reader, dentist, doctor, and inventor. During the Nazi occupation of Denmark, Ruben escaped at night on a fishing boat to Sweden. He studied for two years to become a dentist in Stockholm. He returned to Denmark in 1945 and graduated medical school in 1946.
The collaboration between the refugee engineer and the polymath physician produced something extraordinary. The real breakthrough came in 1956, when the Ambu ventilation bag reached the market, developed together with anesthetist Henning Ruben. It was the world's first self-inflating resuscitator and a major milestone in emergency medical equipment. The Ambu Bag quickly became a permanent part of hospitals' and emergency services' product range.
Hesse is credited with suggesting self-expanding foam rubber to replace the bicycle spokes in Ruben's original model of the Ambu Bag. This seemingly small innovation—recognizing that foam rubber could replace mechanical components—exemplified Ambu's approach to rethinking medical solutions from first principles.
The Ambu bag revolutionized manual resuscitation. To this day, the Ambu bag continues to make a difference and save millions of lives around the world. The idea was so brilliant and so simple that you could squeeze the bag, ventilate the patient with air, and then it would entrain its own air and spring back into shape again.
The "Ambu Bag" achieved what few medical devices ever do: it became so ubiquitous that the brand name became the generic term for self-inflating resuscitators, much like Kleenex for tissues or Band-Aid for adhesive bandages. This brand equity, built over nearly seven decades, continues to support Ambu's credibility in healthcare markets worldwide.
Building an International Foundation
Following Holger Hesse's death, during the 60s and 70s, the growth at Testa, which was now led by the late Holger Hesse's wife, Ruth Hesse, continued. Important products were launched, including manikins, the PEEP valve, the ECG Simulator and many more. By the late 70s, the demand for Ambu's products was overwhelming. A global distribution network and sales companies strengthened Ambu's position on the global medical care and training scene.
In 1986, Testa Laboratory changed its name to Ambu International, and six years later, a long awaited stock exchange listing officially marked Ambu as an international company.
The transition from Testa Laboratory to Ambu International was more than symbolic—it signaled the company's ambition to expand beyond Denmark's borders and compete on the global stage. The IPO in 1992 provided the capital foundation for what would become a decades-long transformation.
III. Building the Foundation: Electrodes & Manufacturing Scale (1992–2008)
The Medicotest Acquisition and Asian Manufacturing
The 1992 stock exchange listing marked Ambu's transformation into a publicly traded international company, but the decade that followed would prove equally consequential. The pivot from pure resuscitation and training products to broader medical device categories began with a strategic acquisition.
In 2001, Ambu acquired Medicotest, the largest European manufacturer of electrodes. With the acquisition came a large portfolio of quality electrodes called BlueSensor.
This acquisition was significant for several reasons beyond the immediate product portfolio expansion. And the first steps to gradually move Ambu's production from Denmark to Malaysia and China are taken. It's also at this stage that Ambu begins to focus more on advancing single-use devices. The medical community and several markets are in demand for single-use devices, and the single-use aspect gradually becomes an integrated part of our strategy.
The decision to establish manufacturing operations in Asia would prove crucial to Ambu's later success in single-use endoscopes. The cost economics of disposable medical devices demand manufacturing efficiency at scale—something that would have been difficult to achieve with purely Danish operations.
Building the Manufacturing Platform
Today, Ambu is headquartered in Denmark, with its workforce spread across North America, Europe, Asia Pacific and Latin America, with production sites in the USA, China, Malaysia and Mexico. North America is the biggest market, representing more than 50% of annual revenue.
Today, Ambu owns and operates manufacturing facilities in China, Malaysia, the U.S., and Mexico, totaling a production space of nearly 1.1 million square feet across continents.
The manufacturing footprint expansion accelerated significantly in 2022. Ambu hosted a grand opening of its new manufacturing plant, located in Ciudad Juárez, Mexico, on Oct. 11. With a total capacity of nearly 323,000 square feet, the new factory is Ambu's largest plant, allowing the company to ramp up its future production and supply of products. Securing a growing manufacturing capacity is imperative following a period of instability in the global supply chain.
The new manufacturing facility in Mexico was built in less than two years. The foundation stone was laid in March 2021, and the first products — SPUR resuscitators — have been shipped to the U.S. At the plant, Ambu will produce single-use endoscopes within the four major endoscopy segments — pulmonology, urology, ENT, and GI — as well as parts of our anesthesia portfolio. Furthermore, the company anticipates the creation of a total of 2,000-3,000 new jobs as it ramps up production in the coming years.
The strategic rationale is clear: proximity to North America, Ambu's largest market, combined with competitive labor costs and favorable trade arrangements. This manufacturing footprint creates both scale economies and supply chain resilience—competitive advantages that smaller competitors cannot easily replicate.
Additionally, As of September 19, 2023, Ambu opened the doors to a new R&D centre in Penang, Malaysia. Due to Ambu's 20+ years of success driving manufacturing and R&D activities in the country, the company's footprint has grown significantly, and the new centre will thus enable Ambu to further enhance its presence and engineering competences going forward. Ambu's R&D activities in Penang constitute an integral part of the company's endoscope development setup and revolve around the enhancement of products already in the market, as well as new product development.
IV. Inflection Point #1: The aScope Launch – Inventing Single-Use Endoscopy (2009)
Understanding the Problem with Reusable Endoscopes
To appreciate what Ambu accomplished in 2009, one must first understand the fundamental problem with reusable endoscopes. These devices—complex, flexible instruments with intricate internal channels—represent one of medicine's most challenging reprocessing challenges.
Advanced reusable medical devices – like endoscopes – pose a contamination risk to patients as the devices are difficult to sterilise between uses. Single-use scopes, on the other hand, are sterile straight from the pack to the patient. This means that single-use scopes eliminate the risk of device-related infections and – because they do not require cleaning or reprocessing – they can improve workflow.
The economics of reusable endoscopes created significant barriers to access. A typical reusable bronchoscope costs $30,000 or more—a capital investment that limits the number of devices a hospital can maintain. Combined with complex reprocessing requirements and the reality that scopes are frequently out of service for cleaning or repair, workflow bottlenecks are endemic.
The aScope Revolution
Since 2009, when we launched the world's first single-use flexible videoscope, we have shown the way in single-use endoscopy. The Ambu® aScope™ is an advanced platform for improving patient care, optimizing the workflows of health care professionals and reducing health care costs.
This launch was audacious for several reasons. First, Ambu was challenging incumbents with decades of experience in endoscope design—companies like Olympus, which still enjoys an 85% share of endoscopes used for gastrointestinal examination, ahead of a 70% share globally.
Second, Ambu was proposing a fundamentally different business model. Traditional endoscopy economics resembled the printer industry: relatively expensive capital equipment paired with recurring service and maintenance revenue. Ambu's model was closer to "razor and blades"—reusable display units paired with single-use scopes.
In 2009, Ambu introduced the world's first single-use flexible videoscope to the market, the Ambu aScope. Although initially targeted at difficult airway management, Ambu quickly saw the potential and need for more advanced single-use flexible endoscopy products. Access to flexible bronchoscopes was severely limited in many hospitals because of the high capital, maintenance and repair costs. In addition, more complex and time-consuming reprocessing guidelines were being implemented to address increasing evidence of endoscope contamination.
Iterating Toward Market Fit
The initial aScope was not perfect, but Ambu demonstrated the rapid iteration capability that would become a key competitive advantage. With focus and dedication, Ambu quickly iterated and improved scope performance and in 2013 launched the aScope 3 Broncho, which quickly gained momentum and adoption in the market. Seven years later, Ambu's fourth-generation single-use bronchoscope is used in one-third of all U.S. bronchoscopy procedures in the OR and ICU.
This progression from first-generation product to one-third market share in a specific segment illustrates the typical pattern of disruptive innovation: initial products that underperform on traditional metrics but excel on dimensions that matter to overlooked customer segments, followed by rapid improvement until the disruptive product competes directly with incumbents.
V. Inflection Point #2: The Invendo Medical Acquisition – Expanding the TAM (2017)
The Strategic Bet on Gastrointestinal Endoscopy
By 2017, Ambu had established leadership in single-use pulmonary endoscopy—but this market represented only approximately 5 million procedures annually. The real prize lay in gastrointestinal endoscopy, a vastly larger market.
With the acquisition of Invendo Medical, Ambu enters the field of gastrointestinal endoscopy (visualisation of the stomach and intestines) of which there are approximately 70 million procedures annually. Ambu already operates in the field of single-use pulmonary endoscopy (visualisation of the airways) of which there are approximately 5 million procedures annually.
This wasn't merely a market expansion—it was a fourteenfold increase in addressable procedures.
The Deal Structure
The acquisition demonstrated disciplined financial engineering. The up-front payment for Invendo Medical is EUR 115 million on a debt and cash free basis. Contingent payments up to additional EUR 110 million consist of EUR 70 million in milestone payments based on FDA clearance of future products and EUR 40 million in earn-out over a four-year period. We currently expect that EUR 10 million of milestone payments will be due in the current financial year 2017/18 when the colonoscope receives FDA clearance. A committed financing structure is in place to cover the full purchase price of EUR 225 million.
Invendo medical is a leading developer of sterile, single-use HD endoscopy products in the field of gastroenterology and gastrointestinal surgery. Started in 2002, invendo medical is a privately held medtech company that employs 35 people and is located in Kissing, Germany. Invendo has developed the world's first single-use gastrointestinal platform of which the second version of the first product – a HD colonoscope – is expected to be CE marked and have FDA clearance in 2018.
CEO Lars Marcher's Vision
Then-CEO Lars Marcher articulated the strategic logic clearly: "This acquisition is a massive upgrade of our business potential. We introduced single-use endoscopy for airway procedures with the Ambu aScope, and now, we will get ready to introduce single-use for the gastrointestinal procedures," said Lars Marcher, CEO of Ambu. "This is an important acquisition that puts Ambu in an ideal position to further disrupt the reusable market within endoscopy."
The "Big Five 2020" Strategy
The Invendo acquisition was part of a broader strategic plan. In October 2017, Ambu announced a three-year strategy plan called "Big Five 2020". The Big Five strategy set the direction for further growth through a pipeline of new single-use endoscopes for a broad range of medical fields.
"We have been on a four-year journey that has transformed Ambu," said CEO Lars Marcher. "Today, 25% of our revenue come from products that we did not have before 2013. That, to me, is testament to the power of innovation. We have proven that our new solutions are relevant to hospitals around the globe. Now, we look towards 2020. It took 75 years to reach 1 billion. Four years to reach 2 billion. Now, we will try to reach 5 billion in three years. It's a stretch, but we aim for the Big Five."
The strategy encompassed aggressive expansion into new endoscopy segments. The ENT endoscopy market represents a significant opportunity with its 11m procedures. Ambu has recently launched two ENT scopes (aScope™ 4 RhinoLaryngo Intervention and Slim). We received FDA approval for the Slim version in May, 2019, and we are currently launching the product globally. The slim version targets 95% of the ENT market so this is a very important milestone for Ambu.
Urology represents another important market for Ambu with total procedures of 8m. We have shared before that we are developing a cystoscope to target bladder and urethra procedures which accounts for 6m out of the total 8m urology procedures.
VI. Inflection Point #3: FDA Regulatory Tailwinds (2015–2020)
The Contamination Crisis
What Ambu could not have fully anticipated when launching the aScope in 2009 was that regulatory pressure would become one of its most powerful tailwinds. Beginning in 2015, a series of contamination crises forced regulators to confront uncomfortable truths about reusable endoscopes.
Awareness of the risk of post-endoscopic infections caused by contaminated duodenoscopes has increased significantly over the recent years. On the 19 February 2015, the Food & Drug Administration (FDA) published the first duodenoscope-related Safety Communication; this stated that the design of duodenoscopes may impede effective cleaning, and therefore lead to the potential transmission of microorganisms in the patient-ready high-level-disinfected (HLD) duodenoscopes used for ERCP. From 2015 to 2019, 17 out of 85 (20%) of the FDA's Medical Device Safety Communications have been related to endoscopes, predominantly targeting contaminated reusable duodenoscopes. In October 2015, the FDA ordered manufacturers of duodenoscopes sold in the United States to conduct post-market surveillance studies.
The statistics were alarming. Between January 2015 and June 2019, the Manufacturer and User Facility Device Experience (MAUDE) database of the FDA shows a total of 1115 medical device reports associated with duodenoscopes related to device contamination, exposure, and patient infection. Despite manufacturer recommended reprocessing with HLD, the rate of contamination in reprocessed duodenoscopes have been reported to be around 13% to 15%. While these include nonpathogenic organisms, studies and post-market surveillance by duodenoscope manufacturers have reported contamination with high-risk microorganisms to be around 2% to 5%.
Three people died and 45 people developed infections from contaminated endoscopes, the US Food and Drug Administration said in April 2019. "Our analysis of medical device reports associated with patient infections for duodenoscope indicates that the number of medical device reports peaked in 2015 at 250 reports and declined 62% to fewer than 100 reports per year in 2017," according to a safety communication issued by the FDA.
The FDA's Pivotal 2019 Recommendation
The FDA recommended that duodenoscope manufacturers and health care facilities transition to different types of duodenoscopes that may pose less risk to patient safety. Specifically, because of challenges with cleaning these devices for reuse (reprocessing) and persistent high levels of contamination, the agency is recommending moving away from using duodenoscopes with fixed endcaps to those with disposable components that include disposable endcaps—or to fully disposable duodenoscopes when they become available. Disposable designs simplify or eliminate the need for reprocessing, which may reduce between-patient duodenoscope contamination as compared to reusable, or fixed endcaps.
This recommendation represented an extraordinary regulatory endorsement of the single-use concept—the core of Ambu's strategy.
Ambu's Regulatory Wins
Ambu moved aggressively to capitalize on these tailwinds. The Ambu® aScope™ Duodeno received 510(k) clearance from the U.S. Food and Drug Administration (FDA) on 17 July 2020 and is now ready for commercial launch as planned.
Danish medtech Ambu said Friday it received FDA clearance and is ready to launch a single-use duodenoscope. The 510(k) clearance comes about seven months after the agency greenlit a device from Boston Scientific it said was the first fully disposable duodenoscope to come to market. FDA last year encouraged healthcare providers to make the switch to single-use duodenoscopes from reusable versions of the devices, used in procedures to diagnose and treat pancreas and bile duct problems, after reviewing evidence that the latter can cause infections. The typically reusable flexible tube devices used in GI procedures — half a million endoscopic retrograde cholangiopancreatography, or ERCP, procedures per year, according to FDA — can be a host for potentially deadly infection.
The aScope Duodeno was designed with input from a global gastroenterologist consultant board along with engineering expertise from the team of Invendo Medical acquired by Ambu in 2017.
The reimbursement environment also turned favorable. Payers are already recognizing the value of single-use duodenoscopes. The Centers for Medicare & Medicaid Services (CMS) recently announced a new Transitional Pass-Through (TPT) payment category for single-use endoscopes used in outpatient ERCP procedures. With this decision, CMS recognizes that single-use duodenoscopes are essential to improving patient safety.
VII. Inflection Point #4: COVID-19 – The Accelerant (2020–2021)
The Pandemic as Catalyst
The COVID-19 pandemic created conditions that dramatically accelerated adoption of single-use endoscopes. Infection control, always important, became paramount.
In 2020, more than 1 million Ambu single-use endoscopes were used in more than 6,000 hospitals, making Ambu the world's largest supplier of single-use endoscopes. In the spring of 2020, as the novel coronavirus raged around the world, Ambu realized it had a responsibility – and an opportunity. Our bronchoscopes and resuscitators were needed to treat COVID-19 patients, and we would fulfill that responsibility no matter the roadblocks.
In 2020 Ambu sold more than 1 million single use endoscopes — more than twice the volume of competitors. COVID-19, meanwhile, is accelerating the development of the single-use market as both healthcare professionals and patients gain new awareness of infection control and patient safety strategies.
In early 2020, the American Society for Gastrointestinal Endoscopy's Infection Control Summit reviewed endoscope disinfection and reprocessing and recommended, among other solutions, expanded use of single-use duodenoscopes. When the COVID-19 pandemic began to surge in mid-March 2020, the American Association for Bronchology and Interventional Pulmonology released guidelines recommending that, if bronchoscopy is warranted during testing or treatment, physicians should use a disposable bronchoscope to protect patients and staff.
Stock Price Surge and Subsequent Correction
The pandemic-driven enthusiasm was reflected in Ambu's stock price. The all-time high Ambu stock closing price was 57.45 on April 27, 2021. However, the post-pandemic period brought challenges as pandemic-era tailwinds subsided and the company faced the task of meeting elevated expectations.
"Since Juan Jose Gonzalez joined as CEO in 2019, Ambu has made good progress and achieved important milestones on the strategic transformation into the world's largest single-use endoscopy company," Ambu Chair Jørgen Jensen said in a news release. "However, the COVID-19 pandemic, the recent macroeconomic headwind and a weaker than originally expected financial performance require that we execute differently on our strategy."
This underscores an important distinction for investors: structural tailwinds (infection control concerns, regulatory pressure, workflow benefits) persist, but pandemic-era demand surges represented temporary boosts that created unsustainable expectations.
VIII. Modern Era: Leadership Transition & Scaling (2022–Present)
New CEO: Britt Meelby Jensen
In May 2022, Ambu underwent another leadership transition. The Board of Directors of Ambu A/S appointed Britt Meelby Jensen as new Chief Executive Officer (CEO). Britt Meelby Jensen served as board member of Ambu since 2019, a position she stepped down from when she took over as CEO on 20 May 2022.
Jensen brought substantial healthcare industry experience. Britt Meelby Jensen, born in 1973, has more than 20 years of experience from the life science industry. From 2019 Britt Meelby Jensen served as CEO of Swedish Atos Medical until she led the sale of the company to Coloplast in early 2022. From 2015 to 2019, Britt Meelby Jensen was CEO of Zealand Pharma. Prior to this, Britt Meelby Jensen served as CEO of Dako and had several leadership positions in Novo Nordisk.
Between 2000-2002, Britt Meelby Jensen worked as a Management Consultant in McKinsey & Company. She joined Novo Nordisk A/S in 2002 where she held several leadership roles, including being Corporate Vice President of Global Marketing, Market Access & Commercial Excellence. In 2013, Britt Meelby Jensen was appointed CEO of Dako A/S, a global cancer diagnostics company owned by Agilent Inc.
Her leadership philosophy emphasizes the connection between culture and performance. "I have a strong belief in the connection between leadership, culture, and performance. When organisations get these elements right, and when people understand the impact of their work while feeling supported in their development, the results speak for themselves. That is why, from the beginning, we approached Ambu's transformation not only as a financial revitalisation, but also as a cultural shift."
Current Business Structure
Net sales break down by family of products as follows: single-use endoscopes (59.2%); emergency care and resuscitation devices (21.4%): mechanical ventilation devices (insufflators, laryngeal masks, facial masks and respiratory bags), secretion aspirators, immobilization devices, etc.; monitoring and diagnostic devices (19.4%): including electrodes used in the fields of cardiology, neurophysiology and first aid.
Today, Ambu is a global company of 5,000 dedicated employees, with a market leader position in single-use endoscopy across the four major endoscopy segments and with a strong track record of innovative solutions in anaesthesia as well as cardiology and neurology.
Innovation Pipeline
In the last three years Ambu introduced five single-use endoscopy products; that number will jump to 20 in the next 3 years. Our investments in research and development are increasing in areas such as image processing and AI. New manufacturing capacity is continuously being added; our fourth manufacturing facility is slated to be built in Mexico to support the U.S.
Ambu has built on over a decade of single-use endoscopy know-how to place a reliable, sterile and cost-effective solution in your hands. We launched the world's first single-use flexible bronchoscope in 2009, and in 2022, over 1.7 million of our single-use endoscopes were used in more than 6,500 hospitals.
The largest R&D team within single-use endoscopy in the world: Over 400 engineers in 5 global single-use innovation centres work to develop new ways to improve patient care. Close collaboration with clinical specialists: We work with leading endoscopists in pulmonology, gastroenterology, urology and ENT to ensure that our single-use endoscopes both add value and meet your true requirements. A modular approach across clinical areas: Our innovation teams are set up to share components and technology across different single-use endoscope projects, which enables rapid iterations.
IX. The Single-Use Value Proposition Deep Dive
The Economic Argument
The economic case for single-use endoscopes challenges conventional wisdom that disposable products are inherently more expensive than reusable alternatives.
In fact, when you consider the recurring costs associated with reprocessing, maintenance and repairs and potential workflow improvements, Ambu single-use endoscopes may actually save money for your hospital as a whole.
When you consider all the costs related to reusable endoscopes, such as capital investments, maintenance and repairs, and reprocessing expenses, Ambu single-use endoscopes may save money for your hospital as a whole.
Remove hidden expenditures: Every step of reprocessing – from pre-cleaning, leak-testing, rinsing, disinfecting and/or sterilizing to drying storing and transporting the endoscopes – is another layer of expense to include in your cost calculations. The single-use concept not only eliminates these reprocessing costs, it also cuts material costs, such as cleaning detergents, water, brushes, and personal protective equipment.
Eliminate recurring costs: First, the cost and effort of maintenance and repairs, and resources spent on transportation, administration, and training are removed. Second, you are free from complex investment contracts and often binding long-term service contracts. Finally, you don't have to worry about damaging expensive endoscopes when performing procedures or training.
The reimbursement environment has improved significantly. NTAP is a financial game changer for healthcare organizations interested in making single-use endoscopy a part of their operations. The add-on payment is specifically designed to put cutting-edge technologies such as the Ambu aScope Duodeno on an even (or nearly even) financial level with traditional solutions. For healthcare providers, this means that they can unlock the benefits of single-use scopes without taking a financial hit. The specific figures will vary from case to case, but typically the NTAP reimbursement will make the use of single-use duodenoscopes essentially cost-neutral.
Quality & Consistency
This leads to wear and tear on the inner and outer surfaces, as well as degradation of mechanical performance and imaging. With Ambu single-use endoscopes, there is no deterioration because you use a new endoscope for every procedure.
Unlike with reusable endoscopes, there is no deterioration of the mechanical performance of Ambu single-use endoscopes. With Ambu, you get a brand new endoscope straight from the package for every procedure. What's more, our modular development approach and rapid implementation of user input mean you can count on the latest technology. Discover how our modular design approach, close collaboration with clinical specialists and single-use expertise enable us to develop high-quality innovations rapidly.
Workflow Benefits
The gastroscope — as well as a next-generation display unit — from Danish medical device company Ambu A/S is designed to be used once and discarded, protecting patients from possible device cross-contamination and addressing workflow challenges that arise when scopes are out of service being reprocessed or repaired. Those challenges have been exacerbated, company executives say, by the COVID-19 pandemic, which has caused staff shortages at overtaxed healthcare and hospital systems.
Over the long run, single-use endoscopes can not only improve patient care but can also insulate healthcare organizations from a number of financial risks. For instance, duodenoscopes such as the Ambu aScope Duodeno enable hospitals to use a variable, rather than a fixed, cost model. This becomes important when procedure counts fluctuate over time. Rather than running the risk of over- or under-investing in reusable scopes, administrators can be confident that every dollar they spend on flexible endoscopes will go to good use. And if organizations switch over to single-use endoscopes completely, they can recapture hospital space and staff time that are currently dedicated to reprocessing.
X. Competitive Landscape & Porter's Five Forces Analysis
The Competitive Arena
Ambu operates in a market with formidable competitors. The prominent players of global endoscopy equipment market are Olympus Corporation (Japan), KARL STORZ SE & Co. KG (Germany), Boston Scientific Corporation (US), JOHNSON & JOHNSON (US), Stryker Corporation (US), Medtronic, plc (Ireland), Fujifilm Holdings Corporation (Japan), HOYA Corporation (Japan), Nipro Corporation (Japan), Smith & Nephew plc (UK), Intuitive Surgical, Inc. (US), Richard Wolf GmbH (Germany), Cook Medical (US), B. Braun Melsungen AG (Germany), ConMed Corporation (US), Ambu A/S (Denmark), and others.
Olympus Corporation holds a prominent position in the endoscopy equipment market, largely due to its extensive range of endoscope-related products. The company boasts a diverse portfolio encompassing endoscopic systems, surgical endoscopes, gastrointestinal endoscopes, and repair services. The company is committed to innovation, allocating a significant portion of its revenue to research and development initiatives aimed at introducing cutting-edge products. For instance, in November 2023, the company introduced the EVIS X1, its most advanced endoscopy system to date. Through its offerings, including endoscopes and endotherapy devices, Olympus aims to facilitate early diagnosis and deliver minimally invasive treatments, ultimately enhancing patients' quality of life.
Porter's Five Forces
1. Threat of New Entrants: MEDIUM-HIGH
While Ambu enjoys a significant first-mover advantage, the attractiveness of the single-use market is drawing major players. The 510(k) clearance for Ambu came about seven months after the agency greenlit a device from Boston Scientific it said was the first fully disposable duodenoscope to come to market.
In April 2024, Olympus received U.S. FDA 510(k) clearance for its first single-use flexible ureteroscope system, named RenaFlex. This innovative device is designed to assist healthcare professionals in diagnosing and treating urinary diseases and disorders, such as kidney stones. The RenaFlex system allows for visualization of the urinary tract, including the urethra, bladder, ureter, calyces, and renal papillae, through both transurethral and percutaneous access routes.
Barriers include regulatory expertise, manufacturing scale, and clinical relationships—all areas where Ambu has invested heavily. However, large incumbents have deep resources to enter aggressively.
2. Bargaining Power of Suppliers: LOW-MEDIUM
Ambu's products rely on relatively commoditized components—plastics, sensors, optics—from multiple suppliers. The geographic diversification of manufacturing across four countries provides optionality and reduces dependence on any single supplier base.
3. Bargaining Power of Buyers: MEDIUM-HIGH
Hospital systems are increasingly consolidated, creating larger negotiating entities through group purchasing organizations (GPOs). However, infection control pressures and regulatory recommendations shift some power back to single-use suppliers who can credibly address contamination concerns.
4. Threat of Substitutes: LOW-MEDIUM
Reusable endoscopes remain the primary alternative but face structural headwinds from regulatory pressure and contamination concerns. A wide range of product substitutes are available, as endoscopic devices is a rapidly evolving field in healthcare. For instance, the conventional endoscope can be replaced by an innovative capsule endoscopy technology. Three technological developments have been necessary for the development of the capsule endoscope: powerful, compact camera systems that are only a few millimeters in size, wireless technology that allows camera images to be transmitted in real-time, and sensor or actuator systems that allow intuitive control of the capsule inside the body.
5. Industry Rivalry: HIGH
Olympus Corporation, Karl Storz SE & Co. KG, Boston Scientific, FUJIFILM, and Stryker are the top five players, collectively accounting for nearly half of global market share.
Competition is intense, with incumbents defending territory while transitioning their own portfolios toward single-use offerings. The market is characterized by continuous innovation, strategic partnerships, and geographic expansion.
XI. Hamilton's 7 Powers Framework Analysis
1. Scale Economies: DEVELOPING
Ambu's manufacturing footprint—nearly 1.1 million square feet across four countries—creates meaningful scale advantages in production costs. Their high-scale, low-cost manufacturing capabilities make the transition to single-use endoscopy globally possible. However, larger competitors could achieve similar scale if they commit fully to single-use manufacturing.
2. Network Effects: LIMITED
Medical devices generally lack strong network effects. However, Ambu's ecosystem approach—compatible display units working across multiple scope types—creates mild switching costs and system-level value.
3. Counter-Positioning: STRONG
This is perhaps Ambu's most significant source of competitive power. Incumbents like Olympus derive substantial revenue from reusable endoscope sales, service contracts, and repair revenue. Aggressively promoting single-use alternatives would cannibalize their existing business models. Olympus still enjoys an 85% share of endoscopes used for gastrointestinal examination, ahead of a 70% share globally—a position built on reusable products that incumbents are reluctant to undermine.
4. Switching Costs: MODERATE
Once hospitals adopt Ambu's display units, there are modest switching costs associated with training, workflow integration, and inventory management. The standardization of display platforms across multiple scope types increases system-level switching costs.
5. Cornered Resource: MODERATE
Ambu has a 10-year head start on competitors, having introduced the first single-use bronchoscope in 2009; the company is now on its 4th-generation technology platform. This accumulated know-how, clinical data, and manufacturing expertise represents a cornered resource—though not an insurmountable one for well-funded competitors.
6. Process Power: DEVELOPING
Ambu's modular development approach and rapid iteration capability represent emerging process power. Our modular development approach and rapid implementation of user input mean you can count on the latest technology. Discover how our modular design approach, close collaboration with clinical specialists and single-use expertise enable us to develop high-quality innovations rapidly.
7. Branding: STRONG IN LEGACY, DEVELOPING IN ENDOSCOPY
The "Ambu Bag" brand carries enormous equity in emergency medicine. In single-use endoscopy, Ambu is building brand recognition as the category pioneer and innovation leader.
XII. Bull vs. Bear Case
The Bull Case
1. Structural Tailwinds Persist
Regulatory pressure on reusable endoscopes shows no signs of abating. The FDA's concerns about contamination, combined with growing awareness among healthcare providers and patients, create durable demand drivers.
2. Market Expansion Opportunity
The global disposable endoscopes market was valued at USD 1.9 billion in 2024 and is expected to reach USD 8.5 billion in 2034, growing at a CAGR of 16.4% during the forecast period. If Ambu maintains significant market share in a rapidly expanding category, revenue growth could be substantial.
3. First-Mover and Scale Advantages
Ambu A/S is a leading player in the global disposable endoscopes market due to its strong product lineup, ongoing innovation, and strategic regulatory progress. The company offers a broad range of single-use endoscopes for pulmonary, gastrointestinal, urology, and ENT applications, meeting diverse clinical needs across multiple specialties. Ambu's consistent focus on organic growth, including new product launches and regulatory approvals, has reinforced its market leadership.
4. Margin Expansion Potential
As manufacturing scales and the product mix shifts toward higher-value GI endoscopes, gross margins could expand. The transition from investment phase to harvesting phase could drive significant EBIT margin improvement.
The Bear Case
1. Competitive Response from Incumbents
Large incumbents have deep resources. In the Single-Use Flexible Endoscope Market, top players such as OTU Medical, KARL STORZ, COOPERSURGICAL, Olympus Corporation, HOYA Corporation, Ambu A/S, obp Surgical Corporation, Flexicare Medical Limited, Welch Allyn (Hill Rom), and Boston Scientific Corporation compete fiercely through continual innovation, product diversification, and strategic collaborations. If Olympus, Fujifilm, or Boston Scientific commit fully to single-use, Ambu could face formidable competition.
2. Price Pressure
Despite eliminating reprocessing costs, single-use endoscopes often present higher per-procedure expenses, especially in high-volume departments such as GI suites. As competition intensifies, price pressure could compress margins.
3. Execution Risk in GI Market
The GI market represents Ambu's largest growth opportunity but also its greatest challenge. GI procedures are more complex than pulmonary applications, and physician adoption in this segment may be slower than in bronchoscopy.
4. Environmental Pushback
These scopes are also facing backlash from different medical societies throughout Europe. There are many ongoing "green endoscopy" campaigns in western Europe to forbid hospitals from acquiring single-use scopes out of fear of plastic pollution. The most famous of these campaigns are run by the British Society of Gastroenterology (BSG), Joint Accreditation Group (JAG), and Centre for Sustainable Health (CSH) to minimize the environmental effect of endoscopy in general.
XIII. Key Performance Indicators to Monitor
For investors tracking Ambu's progress, three KPIs warrant particular attention:
1. Endoscopy Segment Organic Growth Rate
This metric captures the core growth engine of the business, stripping out currency effects and acquisitions. The fiscal year 2024/25 organic growth of 13.1% provides a baseline; sustained double-digit growth would validate the market expansion thesis.
2. Single-Use Endoscope Procedure Volume
In 2022, over 1.7 million of our single-use endoscopes were used in more than 6,500 hospitals. Tracking unit volume growth reveals market penetration independent of pricing dynamics.
3. EBIT Margin Before Special Items
In January 2025, Ambu raised guidance for organic revenue growth to 11-14%, from 10-13%, and for EBIT margin b.s.i. to 13-15%, from 12-14%, based on better-than-expected revenue growth in Anesthesia & Patient Monitoring. Margin trajectory indicates whether scale economics are materializing and whether the company is transitioning from investment mode to profitability.
XIV. Conclusion: The Long View
Ambu A/S represents a fascinating case study in disruptive innovation applied to medical devices. The company's journey from the Ambu Bag to single-use endoscopy illustrates how founding principles—rethinking traditional medical approaches—can guide strategic evolution across decades.
The structural forces favoring single-use endoscopy appear durable: regulatory pressure stemming from contamination concerns, healthcare systems prioritizing infection control, and workflow benefits that address chronic staffing challenges. Yet the competitive response from deep-pocketed incumbents remains the central risk to Ambu's leadership position.
For long-term investors, the key question is whether Ambu's first-mover advantage, accumulated know-how, and manufacturing scale constitute a defensible moat—or merely a head start that competitors can close. The answer will likely depend on execution: continued innovation velocity, successful expansion into GI, and margin trajectory as the business scales.
What began in 1937 with a refugee engineer's vision to "make life easier for doctors" has evolved into a company at the forefront of one of medicine's most significant technological transitions. Whether Ambu emerges as the category leader or merely the catalyst for industry transformation remains to be determined—but the journey from the Ambu Bag to the aScope represents one of medical device industry's most compelling strategic narratives.
Myth vs. Reality Box:
| Common Belief | Reality |
|---|---|
| Single-use is always more expensive | Total cost of ownership including reprocessing, maintenance, and repairs often favors single-use |
| Reusable endoscopes can be reliably sterilized | Reported duodenoscope contamination rates after reprocessing range from 0.4 to 35.8% |
| Ambu is a small niche player | In 2020, more than 1 million Ambu single-use endoscopes were used in more than 6,000 hospitals |
| The transition to single-use is temporary/pandemic-driven | Structural regulatory pressure predates COVID-19 and persists post-pandemic |
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