Digital Bone Health - An Emerging Market Sector

GE医疗 Hologic, Inc. OSTEOSYS undefined 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: I created this Map 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. ?I hope readers find this useful and I welcome feedback and collaboration on my approach for all the listed products and sector assumptions.

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.

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. Quantifying market size of this sector is of ongoing analysis and will be presented in a future writing. But for general comparison, there are roughly 10-15 million DXA scans done annually in the US versus 180 million x-rays and 80 million CT scans.

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.

I've segmented the technologies 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, I've created sub-categories 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 I'll address 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 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, and 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.

I predict that 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. Only one or two companies on this map seem to be positioning for this eventuality, whether they realize it or not.

I hope those interested find this useful. I make no warranties regarding the accuracy of the content, as this is just my seasoned opinion based on my experience in trying to bring a solution to market in this space. I've learned a lot the hard way and am happy to share my views in the hope that a successful solution will ultimately benefit patients suffering from this horrific, under appreciated condition.

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