Tag Archives: Breast Imaging

Breast imaging market to exceed $1.3 billion by 2026: What is the role of 3D mammo and AI?

16th December 2022 – By Matthew Watson – in Healthcare Business News

The breast imaging market in 2022, like most healthcare technology markets, is not yet free of the turmoil induced by the COVID-19 pandemic. Backlogs in breast cancer screening and rising costs remain pressing concerns for healthcare systems around the world. Breast cancer was the most common cancer globally in 2021, accounting for 12% of all new cases, with disruptions resulting in higher proportions of women presenting cancer symptoms in advanced stages. Hence, alongside efforts to expand access to breast imaging for screening purposes, governments, particularly in developed economies, have increasingly considered prioritising higher-risk patients. Better-designed, more inclusive screening programmes are by no means the only way to address breast cancer mortality, however. Improving the accuracy of breast imaging equipment so that missed lesions and false positives are less frequent is also of central importance for healthcare providers, supporting improved treatment quality and cost-efficiency of services

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Signify Premium Insight: Is Patent 99 the Key to Increasing Volpara’s ARPU?

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Breast imaging software vendor Volpara Health recently announced that it was awarded a US patent for a new method of the detection and quantification of breast arterial calcifications (BACs), taking Volpara’s total number of patents to 99.

The detection of breast arterial calcification is usually considered as benign and merely an incidental finding from an oncological perspective. However, with elevated levels of calcification associated with a range of conditions, including coronary artery disease, strokes, hypertension, chronic kidney disease and others, Volpara believes that offering an AI-based tool, which can detect and quantify BACs during routine mammographic screening, can ultimately improve patient outcomes. The vendor acknowledges that a commercial product for use in routine screening is still some way off, but the latest patent, which identifies BACs from a mammogram, and offers a score indicating a patient’s risk of heart disease resulting from the calcifications, is a significant step.

The Signify View

In some countries, more than 70% of women participate in routine breast screening examinations. At present these examinations are focused solely on the early identification of breast cancers. However, some vendors, including Volpara, see potential in such a large patient cohort already undergoing medical imaging exams, and believe that maximising the utility of these exams by using any incidental findings, could, over the long term, become increasingly beneficial to patients.

This approach to AI is not unique, but it does highlight a stage in the evolution of the technology. Many of the AI-based tools that are currently available to providers seek to improve the already established pathways. Many of the workflow tools, for example, reduce the time it takes to conduct and interpret certain types of medical imaging exams or look to ensure that patients’ scans are done correctly first time. These are valuable tools, but they don’t offer fundamental change, they improve practices that already exist. Volpara’s patent, conversely, offers a glimpse of a different approach with a new diagnosis and treatment pathway, and AI being able to create new opportunities to attend to patients with potentially symptomless conditions, with potentially no additional stages at the time of capture.

Efficiency has been relatively low-hanging fruit for AI, and has subsequently been the area where it has gained most traction, but moves like that of Volpara show that the technology is moving, albeit slowly, to a more significant realisation of its potential; to tangibly improve patient outcomes.

Practical Problems

Despite this theoretical progress there are still numerous practicalities that must be addressed for such tools to gain any ground commercially. One of the challenges is that new AI tools don’t exist in isolation. As helpful as it is for a patient to receive a BACs score alongside their mammography report, without an additional workflow being established, such as those patients with a higher score being automatically referred for further imaging or consultation, the benefit of such a tool will be moot.

This integrated post-mammography workflow is best suited to single-payor markets, where health networks are incentivised to identify and treat conditions such as heart disease early. Such a diagnosis could, after all, leave patients requiring little more than lifestyle changes and medication to stave off the worst effects of their heart health issues, compared to bypass surgeries and costly rehabilitation if the signs were ignored. In a single-payor market this calculation makes sense, with the upfront cost of acquiring a population health tool such as that patented by Volpara offset over the patient’s lifetime thanks to the significant savings made.

Unfortunately for Volpara, which, as detailed in Signify Research’s AI in Medical Imaging report, drew 90% of sales from the US in FY21, these sums break down in private healthcare markets. In the US, a breast screening clinic would likely to be unwilling to invest in software that gives a patient a BACs score, as that clinic may not be associated with any hospitals in which such a score could be followed up, or even if it did have the requisite connections, the patient may choose to follow up at a competitor’s hospital. In this instance the breast screening clinic would have, in effect, invested its resource in a tool that simply brought revenue into another health network. The lack of a single, cohesive health system is also likely to compound the difficulties in following up after a BACs score is given, raising further questions about their usefulness.

There could be some upside, though. Offering a BACs score may enable one screening centre to differentiate itself from its competition, an effect that isn’t likely to be overly significant, but it may be enough to persuade some screening clinics to invest.

Future Focus

These difficulties aside, developing such tools is a sound strategy for Volpara. While the vendor has the opportunity to sell its software to more screening centres and to increase revenues from additional geographic markets, arguably the most cost-effective way to do more business is to increase the average revenue per user (ARPU) that is brought in. The importance of this metric is clear. A year ago, when Volpara acquired CRA Health, CEO Ralph Higham stressed that the genetic testing capability of the acquired vendor had increased Volpara’s ARPU from $1.22 to $1.40. The newly patented BACs identification and quantification tool could increase this further, enabling Volpara to derive additional revenues from its existing customer base, effectively making each scan more valuable to the vendor.

This increase in ARPU is one that can’t come soon enough. For all of Volpara’s strengths, it does find itself in a challenging situation. The vendor’s full year 2021 results show that Volpara had $NZ32.2m in cash and cash equivalents at the end of that financial year. While this is a reasonable amount, the vendor had also made an operating loss for the year of almost NZ$20m. Such a rate is not sustainable, and leaves Volpara with short-term headaches and a need for cash that must be dealt with before its longer term visions can be realised.

At its current rate of cash burn, Volpara is likely to need to raise additional funds in the next 12-18 months. However, this will further dilute its share price, which has already had a tough ride over the last year, currently trading at around 70 cents from a high of 1.45 AUD in April 2021.

As such, the company needs to quickly improve revenues. While some expansion is possible, this road seems increasingly difficult. In FY21 a Volpara product was used on approximately 32% of scans up from 27% in FY20. While this is trending in the right direction, it hardly seems enough to stem the losses in the near term. In parallel, the vendor must seek to take additional revenues from existing customers by offering new tools and capabilities such as the BACs assessment, although the impact of these tools could be years away.

In the shorter term, Volpara will likely have to issue new shares and seek fresh investment. Even this path is fraught with difficulty, however. Convincing investors to pump in the required funds after the share price has underperformed will still be challenging, particularly given the associated dilution a new issue will cause. Volpara is doing a lot of things right, but, like other medical imaging AI vendors, it faces significant headwinds. As several of its peers are realising, success in AI is a long-term objective, with the key technologies and successful R&D only a small part of the equation.

The Road Ahead

Assuming Volpara can navigate these near-term challenges, however, then over the longer-term it could quietly establish itself as an AI screening powerhouse. The company is best known for its breast density analysis tools. This functionality has taken a long while to gain traction, with a combination of market reticence and the long-term nature of clinical validation studies both holding it back. However, these barriers are being eroded, especially in the US, leaving Volpara to focus on the next stages of its development. Capitalising on its strength in screening and leveraging its experience in promoting additional screening metrics could prove very valuable to the firm and give it an advantage when it comes to commercialising such tools.

Furthermore, while there are presently no plans for the sale of Volpara, the company remains an attractive acquisition target for several larger vendors with strong mammography portfolios such as Hologic and Fujifilm. Adding to its patent portfolio only bolsters this appeal, with Volpara demonstrating its value with each of its 99 patents, offering any potential suitor tangible IP, a rarity among AI developers.

Overall, this longer-term outlook is where Volpara’s latest patent will have the most impact. Assessing breast calcification is not a new idea, but effectively quantifying it as part of a routine scan does offer new opportunities, even if the immediate realities of the market may somewhat limit them. But, away from these practicalities, the patent’s repercussions could be quietly significant, slowly facilitating the adoption of population-based care, and teasing a future in which prevention really can compete with cure.

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Signify Premium Insight: Breast Imaging: A Market Set for Change

This Insight is part of your subscription to Signify Premium Insights – Medical Imaging. This content is only available to individuals with an active account for this paid-for service and is the copyright of Signify Research. Content cannot be shared or distributed to non-subscribers or other third parties without express written consent from Signify Research. To view other recent Premium Insights that are part of the service please click here.

The nature of the breast imaging market makes it unlike almost all others. The fact that it is a market centred around national guidelines and screening programmes, which were almost universally paused as part of providers’ responses to the coronavirus pandemic, means that it has been disrupted more so than most others.

This disruption, and the long-term effect it is set to have on the market, as well as the impact of developing trends are detailed in the recently released Breast Imaging – World Market Report 2021.

For providers, the response to this disruption is likely to be varied.

“One statistic in the report,” says Senior Research Analyst and co-author Graham Cooke, “is that the UK’s National Health Service (NHS) expects it to take ten years to clear the backlog.”

“Because of this, if a healthcare provider does have the money to invest in new equipment and upgrade to new technologies then dealing with this backlog provides an incentive to do so. However, it could be the opposite. Breast imaging clinics could well have been stretched with regards to available budget over the previous year, and with restricted funds, they could continue to use the ageing installed base of equipment until there are funds available to replace them.”

 A Digital Direction

For some of these providers, however, the answer may not necessarily lie in the replacement of breast imaging hardware, but could focus on maximising the use of existing systems.  “That is really where AI could come in,” continues Cooke. “AI isn’t just about finding abnormalities on a mammogram that the human eye may miss, more practically some AI tools could help radiologists detect abnormalities more quickly, or rapidly give some cases a green light where no further attention is needed. This will mean that radiologists can focus their time on more urgent cases.”

While these tools could relate directly to image analysis, in practice, many of the solutions that are set to be of most use in clearing the backlog of postponed breast imaging exams focus their efforts elsewhere. Tools that facilitate operational workflow improvements or triage tools that help prioritise suspicious scans in the worklist are among those that offer the greatest benefit.

“Another interesting tool that will help in this regard is personalised screening and having AI assess a woman’s individual cancer risk, including factors like family history of breast cancer, genetics, lifestyle factors which make some people more at risk, or physiological factors like dense breast tissue.”

This will help providers manage their screening programmes, prioritising those who are most at risk, while individuals at lower risk of breast cancer can wait longer between mammography appointments, thereby reducing the provider’s workload.

This, however, will not happen immediately, cautions Senior Research Analyst Bhvita Jani. “At the moment there are still three main barriers to the widespread use of AI in breast imaging. Firstly, until it is included and recommended in national screening guidelines it is not going to make as much impact as it should.

“Secondly there is a lack of representation in the validation studies. There is, for example, an underrepresentation of some ethnic minorities which makes it impossible to extrapolate the findings to women of different backgrounds.

“The third problem is reimbursement. Unless AI is reimbursed the only way that providers would be convinced to use it is if it will reduce their costs.”

The breast imaging AI market is set to grow rapidly as the barriers to its adoption are overcome

Starting Screening

Another factor that could dramatically impact the breast imaging market is the establishment of screening programmes in countries that don’t yet have them. The growth potential for different vendors in the breast imaging market is highly dependent on the country dynamics.

“China, for instance, is quite a price-sensitive market,” notes Cooke, “so even if it were to introduce a screening programme, that screened millions of women, providers would overwhelmingly purchase their systems locally. Not only do Chinese vendors have lower price points than international vendors, but Chinese hospitals often have partnerships with local vendors. Going with a local brand will also often be seen favourably, compared to using an American or European brand for example.”

Jani adds: “But, this would only be the case for 2D mammography systems. Any demand for 3D systems will still primarily be captured by global vendors as Chinese vendors don’t extensively offer 3D systems.

“In some areas that are on the cusp of establishing screening programmes global vendors will be preferred. In the Middle East region, for example, where brand reputation is very important. Screening programmes in other areas could also benefit global vendors, including several CIS (Commonwealth of Independent States) countries. However, within this market, there is a stronger preference for low to mid-range breast imaging systems.

“It is worth noting though, that when it comes to large government tenders, price is often the most important consideration. So, companies that are more flexible when it comes to price negotiations have tended to do well. One company that has been particularly successful is Fujifilm. It has increased its share of the mammography market, through, in part, its aggressive pricing strategy.”

 Demand for More Dimensions

For those countries that already have established breast screening programmes, there are still some large and impactful changes on the horizon.

“One of the biggest unanswered questions in the breast imaging market is when will 3D mammography be used outside of the US for screening, which is the only country to have so far really embraced the technology,” Jani explains. “Our prediction is maybe three to five years for Western Europe, which looks set to be one of the next markets to adopt 3D for breast screening.

“This rollout of 3D mammography can only take place when there is enough provision to read the 3D scans, with limited radiologist capacity being a challenge. Because of this, the rollout of 3D will likely go hand in hand with the increased adoption of AI, which will help providers make the transition by reducing the time required to read 3D scans.”

Digital Breast Tomosynthesis is forecast to grow strongly over the coming years

There could also be other technology changes afoot. “There are a number of different emerging breast imaging technologies becoming available,” notes Cooke, “but mammography is still the dominant, unthreatened modality by far.”

“Other modalities, such as ABUS or Cone Beam Computed Tomography have advantages compared to mammography in some ways, but it is difficult for them to penetrate the breast imaging market. “These technologies are not designed to replace mammography but are instead meant to supplement it. They must work alongside mammography to be part of patient pathways. If you consider automated breast ultrasound, for example, that has taken some 20 years or so to really be accepted, and even now there are only a handful of vendors that offer it.

“So, we could see some of these smaller and more niche breast imaging vendors getting acquired by larger breast imaging vendors. There are already examples of this, with Hologic, which dominates the mammography market, diversifying their hardware portfolio to include breast ultrasound, by recently acquired Supersonic Imagine, whose technology should complement Hologic’s own mammography systems.”

Women’s Priorities

There are other changes that will affect providers’ purchasing decisions in the nearer term. For screening mammography at least, screening centres are in competition with one another, in particular in the United States, for footfall of eligible women. Because of this, vendors will happily pay to purchase new and higher-end systems, with features which focus on the patient experience and comfort, if they will attract more women into their centres.

“One-way providers are encouraging more women into their screening programmes is by focusing on enhancing comfort levels, and reducing discomfort and pain,” notes Cooke. “That could have a large role in influencing what systems providers actually purchase.

“This is a prominent trend and as a result, instead of only marketing their systems to providers, breast imaging vendors are targeting women directly. The preferences of these women could then influence what systems providers purchase.”

The Market Matters

These sorts of strategies are only viable in countries where screening programmes are already established. While there will be effort expended to encourage women to participate in screening programmes, for vendors and providers in these countries the priority will be on improving the patient experience and the accuracy of first-time right screening and reducing the rate of rescans and recalls.

“Over the coming years, there will be more focus on personalised screening and risk-based screening, as well increased variation in the breast imaging modality used and the frequency of scans,” details Jani. “These changes could also be very much influenced by AI’s development in this market.

“In developing countries, the creation and establishment of screening programmes will be the biggest change. But this is itself dependent on the subsequent treatment plan that is available afterwards is a diagnosis is made”.

“Overall, though, the next 10 years could really shake up the breast imaging market. New emerging breast imaging technologies could gradually have increased market adoption where there are established screening programmes. Meanwhile there will be some opportunity for niche vendors to increase the uptake of their products and get their systems installed as part of new screening programmes where guidelines are yet to be established.

“It is, after all, easier to penetrate a new market with a lack of guidelines and recommendations, than it is to try and break a well-established market like the US right away.”

The breast imaging market is set for change. Technological developments, primarily in breast AI, will play a part in enabling this change and drive increased uptake of more advanced breast imaging hardware solutions. With current challenges such as the significant backlog of women requiring screening, a fundamental need to reduce the number of false positives or negatives and the need to increase early detection and more accurate diagnosis all being factors that will help drive this movement forward.

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This Insight is part of your subscription to Signify Premium Insights – Medical Imaging. This content is only available to individuals with an active account for this paid-for service and is the copyright of Signify Research. Content cannot be shared or distributed to non-subscribers or other third parties without express written consent from Signify Research. To view other recent Premium Insights that are part of the service please click here