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Technological developments in recent years, which include advances in image quality and improved diagnostic sensitivity, are broadening the options for diagnosing gastrointestinal (GI) conditions.

Traditional endoscopy has long been viewed as the gold standard for screening and diagnosis.

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Most commonly deployed in the GI tract, endoscopy is used for diagnostic applications such as evaluating lesions or monitoring and diagnosing conditions such as Crohn’s disease and Barrett’s oesophagus. 

Endoscopy is considered to be a minimally invasive procedure. Yet while sedation is not mandatory in all cases, for most endoscopies, it is often the prescribed standard of care.

Research indicates that GI in low-risk patient populations, resulting in unnecessary patient discomfort, risks for infirm patients undergoing the procedure, and contributing towards .

Other studies have found that , with 83% of patients diagnosed with indigestion, and that from a total of 459,503 colonoscopies performed in the US, of which 242,756 were screening colonoscopies, the

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Capsule endoscopy, wherein a small capsule affixed with a camera is placed into a patient’s digestive tract, presents an alternative to traditional endoscopy – one potentially more desirable for patients and which could lead to a more efficient diagnosis.

Capsule endoscopy was first introduced following the US Food and Drug Administration’s (FDA) approval of Given Imaging’s PillCam in 2001. However, widespread adoption of the technology was initially hindered by factors such as low diagnostic yield, poor battery life, and low image quality. But as more entrants have entered the space and technology has advanced, many of these limitations have been overcome, and the capsule endoscopy market is showing signs of growth.

GlobalData analysis reveals that the capsule endoscopy market is primarily growing due to the increasing US population and the rising incidence of GI diseases. The North American capsule endoscopy market is projected to grow at a CAGR of 6.2% between 2024 and 2034, with market growth of 6.1% in the US.

Subsequent versions of PillCam added functionality and expanded the technology’s indications into colon and oesophageal imaging. Spurred by the Covid-19 pandemic, Medtronic, which inherited PillCam in 2015 when it acquired Covidien (which acquired Given Imaging in 2014), currently holds the largest share of the US market at 89.4%. More recently, Medtronic introduced AI tools to improve image interpretation and ‘at-home ingestion’ protocols for PillCam.

Other companies investing in capsule endoscopy R&D and liable to benefit from the field’s growth include Olympus, which is focused on advancing optics for GI diagnostics, and China’s Chongqing Jinshan Science & Technology group, with its development of magnetically controlled capsule endoscopes.

The advantages of capsule endoscopy

Dr Andrew S Thompson, director of therapy research and analysis in medical devices for GlobalData, says that while the first capsule endoscopes were ineffective with respect to sensitivity and specificity, the latest generation are producing readings “in the ”.

CapsoVision received 510(k) clearance from the FDA for its CapsoCam capsule endoscope in 2016. This year, the company received further clearances for the tool in remote ingestion (use at home with virtual supervision) and for patients aged two and above.

CapsoCam is primarily used for small bowel evaluation in cases of obscure gastrointestinal bleeding, suspected Crohn’s disease, iron-deficiency anaemia, and other conditions where traditional endoscopy has proven inconclusive.

According to CapsoVision’s global head of sales, Doug Atkinson, CapsoCam reduces the need for repeat procedures, which can be common with traditional endoscopy, thereby helping to optimise clinical efficiency and resource use.

In addition, CapsoCam’s recent clearance for remote ingestion expands its market potential, Atkinson says, to rural, mobility-limited, and paediatric populations over traditional endoscopy.

Other alternatives to traditional endoscopy

In much of Europe, colonoscopy for colorectal cancer (CRC) is being used less frequently, with faecal immunochemical tests (FIT) for CRC becoming more widely promoted due to their .

“Instead, faecal immunochemical tests (FIT) are used for screening, creating the referral for procedural colonoscopy,” Thompson explains.

While FIT tests, along with liquid biopsy testing for cancer, may indeed supersede traditional endoscopy in indications such as CRC, the capsule sponge is a further alternative in GI screening.

Cyted’s EndoSign capsule sponge is a minimally invasive cell collection device for the monitoring and diagnosis of Barrett’s oesophagus.

EndoSign is attached to a string and swallowed by a patient. Once in the patient’s stomach, the device dissolves, collecting cells from the upper part of the stomach and the entire length of the oesophagus. The cells are subsequently analysed to determine whether Barrett oesophagus is present, or whether there are any indications that a given Barrett’s patient is at higher risk of their condition progressing to cancer.

While endoscopy is resource-intensive and requires multiple people in an operating theatre to carry out the procedure, Cyted CEO Marcel Gehrung says the company’s tests can be done in an office or outpatient setting within seven minutes and require no special equipment.

According to Gehrung, the bulk of endoscopy backlogs are for unnecessary endoscopies, because only around 20% to 25% of endoscopies for upper GI indications yield clinically significant findings.

EndoSign, which is currently primarily used in the UK National Health Service (NHS), although the company is also establishing a presence in the US, is therefore intended to reduce unnecessary endoscopies.

Gehrung concludes: “With the fact you could lose 75% to 80% of endoscopies without really changing any clinical outcomes, the question for us became one of how you could triage patients at the point at which they’re being referred, to know which ones need an endoscopy, and which can be safely discharged or managed without endoscopic investigation, at ideally half the cost.

“That tells you quite a bit about how good endoscopy is at the end of the day, which is that it’s only about as good as where you take biopsies from, and if the endoscopist finds the right lesion.”

Diagnostic only

The major drawback to capsule endoscopy and capsule sponge, notes Charlie Whelan, senior director of consulting for medical devices at GlobalData, is that the tools are “purely diagnostic”.

Whelan says: “They can be used, but traditional endoscopy would have to be reverted to, to carry out any specific treatment like a tumour removal.”

Jeremy Gurewitz, CEO at US patient advocacy company Solace Health, points to similar concerns likely to limit capsule endoscopy’s potential in superseding traditional endoscopy at this time.

He says: “Thus far, we have observed cases in which capsule endoscopy has detected concerning lesions. Still, these could not be acted upon without subsequent utilisation of traditional endoscopes.

“That being said, the convenience and comfort to the patient really make it an important option for wider availability in rural or lower-resource areas.”

While capsule endoscopy’s current limitations as a direct treatment tool are undeniable, regarding colonoscopy for the identification of colorectal (CRC) tumours, Dr Thompson’s view is that capsule endoscopy may end up positioned as a tool to “bridge the gap” between subjective colonoscopy exams and objective blood tests.

“But given only 5%-10% of polyps actually progress to cancer, there has to be a better way of early detection of CRC,” Thompson says.

“Hence, I think the long-term approach lies in liquid biopsy tests.”

The future outlook for capsule endoscopy

In the future, further technological disruption in the capsule endoscopy space may prove the decisive factor that supercharges its growth.

“Pair capsule visuals with a soft-robotic anchor and tissue sampler in real time, and you’ve really got something disruptive. This is a new space, but I believe the future of endoscopy will be hybrid, combining passive imaging with robotic precision,” says Gurewitz.

While capsule endoscopy today is primarily diagnostic, Atkinson says, research across the field is exploring therapeutic applications such as targeted drug delivery, micro-biopsy, and minimally invasive interventions.

“These innovations will require further validation and regulatory clearance, but industry-wide progress indicates a pathway toward multifunctional capsules in the future.” 

At this time, the capsule endoscopy market’s growth, especially in GI tract evaluation, suggests it may begin carving out a position in areas where the use of traditional endoscopy is dwindling or already viewed as a suboptimal diagnostic tool.

The cost-savings and efficiency potential held in capsule endoscopy as a diagnostic tool currently appear to be the key growth indicators for the space. As a near-term factor in the market’s development, more entrants propagating the space may prove the initial driving force behind the technology’s potential for greater disruption moving forward.  

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