Emerging Digital Bone Health Market - Part II

GE医疗 Hologic, Inc. OSTEOSYS CO., LTD DMS Imaging | DMS Group Swissray US Medimaps Group 3D-Shaper Medical Nanox AI ImageBiopsy Lab @Avicenna.AI Mindways Software, Inc. @HeartLung.AI bonescreen CurveBeam AI PROMEDIUS IBEX Innovations Naitive 16 Bit Bone Index Ltd. (Bindex) BeamMed LTD. Echolight

Overview:

Integrating AI into fracture risk assessment within existing clinical workflows has the potential to revolutionize the management of osteoporosis by enabling opportunistic detection at the point of care. Despite the advancements in AI technologies for X-ray and CT scans now available in the US, the fee-for-service model and reimbursement challenges present significant barriers to their widespread adoption. Despite the proven capability of being integrated non-disruptively into existing clinical work flows in markets outside the US, there currently is little incentive in US healthcare to prioritize adoption of these technologies where they could have the most effect.

Despite the potential benefits of these innovations—including enhanced diagnostic accuracy, improved patient outcomes, and more personalized treatment plans—their widespread adoption remains limited. Key barriers include a lack of standardized protocols, insufficient awareness among healthcare providers and allied medical professionals, regulatory complexities, and fragmented healthcare ecosystems.

To address these obstacles, it is essential to rethink the current status quo of osteoporosis screening and lack of clinical and financial incentives, focusing on where and how these new technologies can be most effectively utilized. Orthopedic surgeons, in particular, are in a prime position to impact the detection of undiagnosed osteoporosis patients, as millions pass through orthopedic clinics each year, undergo routine imaging now capable of easily identifying those at risk. However, orthopedic surgeons have little to no incentive to drive adoption and integration of these new technologies into their workflows where they could have the most impact on bending the curve on the emerging global health fragility fracture epidemic.

However, the current lack of incentives and concerns of increasing complexity and workload for orthopedists to identify and refer these patients for comprehensive bone health evaluations limits the potential benefits. By expanding beyond secondary fracture care and incorporating primary fracture prevention into routine clinical management, a new standard of care can be established and leverage AI’s capabilities to enhance osteoporosis detection on a large scale.

Background

Osteoporosis and fragility fractures are significant global health concerns (1), affecting millions of individuals and placing a substantial burden on healthcare systems worldwide. Osteoporosis, a condition characterized by reduced bone mass and deterioration of bone tissue, leads to increased bone fragility and a higher risk of fractures, particularly in the hip, spine, and wrist. Globally, it is estimated that 200 million people suffer from osteoporosis, with one in three women and one in five men over the age of 50 experiencing osteoporotic fractures (2,3). In the United States alone, approximately 10 million people have osteoporosis, and another 44 million have low bone density, putting them at risk for the disease. Each year, osteoporosis causes over 2 million fractures in the U.S., resulting in healthcare costs exceeding $19 billion (4). These fractures often lead to severe disability, reduced quality of life, and increased mortality, particularly among the elderly.

Despite the significant impact of osteoporosis and fragility fractures, there are substantial deficiencies in the screening and identification of at-risk patients. Current screening methods, such as dual-energy X-ray absorptiometry (DXA) scans, are underutilized, with less than 25% of eligible women in the U.S. receiving a bone density test (5). Moreover, many individuals at risk remain undiagnosed until they suffer a fracture. This gap in early detection is exacerbated by a lack of awareness and education among both patients and healthcare providers, insufficient access to screening facilities, and inadequate integration of osteoporosis management in routine clinical practice (6). As a result, many at-risk individuals do not receive the preventive care or timely interventions needed to reduce their fracture risk, highlighting the urgent need for improved screening strategies and public health initiatives to address this growing epidemic.

The Digital Bone Health Market

DXA is well-established and the dominant densitometer technology for screening low bone density with a market size of $300 million of equipment and software sales in 2022 and expected to grow to over $460 million by 2033 at an annual growth rate > 4.2% (7).

Now, with the advent of artificial intelligence and the development of digital bone health applications for other established modalities, the opening to make screening “opportunistic” and widely available, while moving it closer to the point-of-care, is becoming a reality. This new sector of digital bone health represents a potentially significant expansion of the current bone densitometer market beyond DXA technologies as imaging modalities like CT scans and X-Ray are ubiquitous and routinely ordered for other medical conditions further upstream in the clinical workflow. For general comparison, there are roughly 10-15 million DXA scans done annually in the US versus 275 million diagnostic x-rays and 80 million CT scans (8,9).

Excluding ultrasound capital equipment (covered in a later writing), there are currently 2 types of FDA cleared fixed radiology imaging products for estimating bone health available in the US beyond current DXA:

1. CT scans indicated for detecting vertebral compression fractures and low BMD in the spine using either chest or abdominal images (estimated subset between 10-12 million images according to the American College of radiology.)
2. Standard X-Rays indicated for pelvis, knee, chest, lumbar spine, thoracic spine, and hand/wrist.

There are several approaches to estimating the market value of these technologies, as full CMS reimbursement is currently only partially accessible for CT applications in the existing landscape. Without reimbursement, marketers of commercially available products are striving to showcase their value to health systems and practices by emphasizing return on investment. They do this by identifying patients early and directing new patient traffic to enhance DXA utilization, which could lead to increased reimbursement revenues. While defining a clear market opportunity can be difficult, the chart below suggests a potentially significant opportunity based on plausible assumptions.

These emerging AI imaging applications are based on algorithmic analysis and reporting technologies utilizing either X-Rays or CT scans being acquired for another indication. These methods aim to automatically detect and confirm undiagnosed patients with low bone mass to flag and refer them for preventive intervention of either primary or secondary fractures.

Why Orthopedics?

The orthopedic surgeon community is uniquely positioned to lead the transformation in identifying previously undiagnosed osteoporosis patients within their routine clinical workflow. Orthopedic surgeons frequently encounter patients with fractures, joint issues, and other musculoskeletal conditions, many of which are closely linked to underlying bone health problems, including osteoporosis. These touch-points offer a pivotal opportunity to integrate advanced diagnostic tools—such as AI-powered imaging, bone density assessments, and fracture risk evaluations—into standard practice.

By adopting these emerging technologies, orthopedic surgeons can provide added risk management by identifying surgical candidates who may benefit from osteoporosis treatment preoperatively thereby reducing postoperative complications. This early detection not only improves patient outcomes by enabling timely intervention but also positions orthopedic surgeons as key leaders in addressing a global public health issue. Furthermore, integrating osteoporosis screening into routine workflows enhances the value of surgical care by preventing future peri-prosthetic fractures and reducing readmissions and long-term healthcare costs overall. Leading this transformation empowers orthopedic surgeons to set new standards of care, improve patient safety, and play a critical role in combating the growing burden of osteoporosis.

According to the AAOS, approximately 40-50 million women and 20 to 30 million men experience musculoskeletal issues annually, which may lead them to seek care from orthopedic specialists. In addition, The number of women seeking total joint replacements in the U.S. has been steadily increasing. Women make up a significant portion of joint replacement surgeries, particularly for hip and knee replacements.

• Knee replacements: Approximately 60-65% of all knee replacement surgeries are performed on women. In 2020, more than 1 million knee replacements were performed in the U.S., meaning around 600,000 to 650,000 were likely for women.
• Hip replacements: Women account for roughly 55-60% of hip replacement surgeries. With over 500,000 hip replacements performed annually in the U.S., about 275,000 to 300,000 were for women.
• A study published in Osteoporosis International in 2017 found that up to 40% of patients undergoing hip replacement had undiagnosed osteoporosis.

This patient population presents an ideal early application to apply opportunistic screening with the highest impact.

Moving Beyond Secondary Fracture Care

The current focus in osteoporosis care tends to prioritize “secondary fracture prevention”, which involves identifying and treating patients after they have already experienced a fracture. This approach, while essential, addresses the problem too late—often after bone loss has already advanced significantly. Secondary fracture prevention programs, such as fracture liaison services, aim to ensure that patients who have suffered a fracture receive appropriate bone health assessment and treatment to prevent subsequent fractures. However, these efforts, while impactful, miss the opportunity to intervene earlier, potentially before the first fracture occurs.

In contrast, “primary fracture prevention” focuses on identifying and treating patients at high risk of fracture before they experience one. Despite its importance, primary prevention has been less emphasized, largely due to the challenges in early diagnosis and proactive management of osteoporosis in patients who may not show overt symptoms. Many individuals with low bone density remain undiagnosed until their first fracture, representing a critical gap in care.

Emerging “point-of-care imaging technologies”—such as AI-driven x-ray analysis, quantitative ultrasound, CT, and portable bone density scanners—can dramatically shift the focus toward primary fracture prevention. By integrating these tools into routine orthopedic and primary care workflows, clinicians can assess bone health more easily and accurately at the point of care, identifying patients at risk of osteoporosis and fracture before a serious event occurs. This enables earlier intervention through lifestyle changes, pharmacological treatments, and other preventive measures, reducing the likelihood of fractures and the associated complications.

These technologies offer several advantages:

1. Accessibility: Point-of-care devices bring bone health assessment into clinical settings where it may not have been previously available, such as general practice offices or outpatient orthopedic clinics.

2. Efficiency: They enable rapid, on-the-spot assessments, allowing healthcare providers to make immediate decisions about further diagnostics, treatment, or referrals.

3. Improved outcomes: Early diagnosis and management through primary prevention can significantly reduce the burden of osteoporosis-related fractures, improving patient quality of life and reducing healthcare costs related to fracture treatment and long-term care.

Can these Technologies Ultimately Replace DXA?

Not in the near term. DXA will hold a dominant position in the market for some time as the only proven diagnostic modality for osteoporosis that both CMS and private insurers will accept towards an osteoporosis diagnosis satisfying pre-authorization requirements for reimbursement for prescribed therapeutic interventions like Prolia or Evinity. However, over time it is predicted these AI driven technologies will reach the diagnostic accuracy necessary to supplant DXA but will require long-term longitudinal studies to ultimately demonstrate diagnostic efficacy. However, this emerging technology sector can provide significant near term value as an adjunct feeder to DXA through upstream point-of-care applications to flag otherwise undiagnosed patients warranting a more extensive bone health work up that would include DXA.

Conclusion

Shifting from a reactive model focused on secondary prevention to a proactive, primary fracture prevention strategy could transform osteoporosis care. Orthopedic surgeons and allied healthcare providers equipped with point-of-care imaging technologies have the potential to lead this shift, intervening earlier and preventing the devastating first fracture, ultimately reshaping how bone health is managed.

Background: Digital Bone Health Market

Overview: This map was created to begin outlining the emerging commercial efforts to address the global epidemic of low bone mass and fragility fractures through algorithmic diagnostic imaging analysis and reporting technologies. These efforts mainly aim to detect and confirm undiagnosed patients with low bone mass and flag them for preventive intervention of either primary or secondary fractures.

This sector is just beginning to catalyze as a small group of companies of varying sizes have successfully reached the clinic with revenue generating products, while others are still in the early stages of pre-revenue commercialization. However, the fragmented and slow development nature of the current space reflects the long-standing clinical challenges of a condition that is considered a “silent disease” and disincentivized to treat or widely prioritized within the global healthcare system.

Rationale: Inclusion criteria for this Map were based on subjective and actual knowledge of commercial status and momentum—whether already in the market with FDA clearances, clinical use, and revenue, or progressing towards these milestones. A handful of entities were excluded due to a lack of apparent developmental traction and high likelihood of failure.

The technologies were segmented primarily by imaging modality, focusing on the result rather than whether they are a combination of hardware and software or purely software or AI products. For DXA and CT, sub-categories were created that attempt to differentiate between deeper analytical functions of bone structure analysis and basic screens for fractures and low BMD. However, there are exceptions that will be addressed in future refinements to this map. For the X-Ray (DXR) category, there are subtle distinctions between the entities listed but this is still a very nascent area with great promise still in-formation, making it too early to try to segment further at this time. Further, many European companies are working on solutions that are either far from US commercialization or are currently in the EU market and are also included in this Market Map.

A special mention goes to MediMaps. They've defined a new category with their combination adjunct to DXA, widely recognized as Trabecular Bone Score (TBS), and have obtained full reimbursement for this service coupled with an impressive body of supporting peer-reviewed literature. This combination effectively revives reimbursement levels, offsetting declining rates for DXA alone. MediMaps stands out as the most commercially advanced digital application in bone health to date.

Key takeaways: This emerging sector represents a wide range of approaches to detecting at-risk patients and is generally a highly fragmented collection of digital point-solutions, limiting market penetration in an already crowded field of other point solutions for single medical conditions. Yet, the sheer volume of both X-rays and CT scans performed as compared to that of current DXA, and wider point of care applicability, indicates a significant digital bone health market opportunity if current limitations can be overcome.

Most available products in the US struggle to find a footing within the fee-for-service model due to lack of reimbursement and clinical evidence, often attempting a too-broad approach, or suffer from being a solution looking for a problem. Without clinical evidence, reimbursement, and focus, while solving a real problem, many products face challenges in demonstrating efficacy and ROI, further inhibiting widespread adoption.

Future implications: These applications are ideally suited for efficient delivery of preventive medicine approaches and could significantly contribute to the success of Value Based Care (VBC) delivery models, potentially altering the trajectory of this devastating and costly health crisis. However, given the continued dominance of the fee-for-service model in the US, it seems unlikely that the full potential of these products will be realized until reimbursement is obtained.

As more solutions enter the market and others fail, a consolidation opportunity into a comprehensive delivery platform will emerge. This platform approach is already revealing strategies to combine these technologies with other functionalities to address specific pain points in the orthopedic peri-operative workflow. This represents a potentially high-value application, supported by emerging evidence of the high prevalence of undiagnosed and at-risk orthopedic patients before surgery.

References:

1. Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosis-related fractures in the United States, 2005-2025. J Bone Miner Res. 2007 Mar;22(3):465-75. doi: 10.1359/jbmr.061113. PMID: 17144789.
2. Rashki Kemmak A, Rezapour A, Jahangiri R, Nikjoo S, Farabi H, Soleimanpour S. Economic burden of osteoporosis in the world: A systematic review. Med J Islam Repub Iran. 2020 Nov 12;34:154. doi: 10.34171/mjiri.34.154. PMID: 33437750; PMCID: PMC7787041.
3. Andrea Singer, Alex Exuzides, Leslie Spangler, Cynthia O’Malley, Chris Colby, Karissa Johnston, Irene Agodoa, Jessica Baker, Risa Kagan,
4. Burden of Illness for Osteoporotic Fractures Compared With Other Serious Diseases Among Postmenopausal Women in the United States
5. NOF. Osteoporosis Fast Facts.
6. Lewiecki EM, Wright NC, Curtis JR, Siris E, Gagel RF, Saag KG, et al. Hip fracture trends in the United States, 2002 to 2015. Osteoporosis Int. 2018 Mar;29(3):717–22.
7. Bone Densitometer Market Size, Trends and Recent Developments
8. Trends in the number of radiology studies and a decline in radiation dose, December 19, 2022, Health Imaging , Medical Imaging
9. Answers to Common Questions About the Use and Safety of CT Scans, Mayo Clinic Proceedings, Volume 90, Issue 10P1380-1392, October 2015