How Buy and Bill is Breaking Bone Health — and What Providers Can Do to Improve Access and Outcomes
The global osteoporosis drug market is already a multi-billion-dollar opportunity. In 2024, the worldwide market for osteoporosis drugs is estimated at roughly $15–16 billion, and it is projected to grow steadily over the next decade as populations age and awareness of fracture prevention increases [1]. Within this market, denosumab —sold as Prolia® , Amgen, Inc. (NASDAQ: AMGN) — has emerged as a dominant product, generating between $4.0 and $4.5 billion annually by 2024 [2,3]. Prolia alone accounts for over $1.17 billion per quarter in U.S. sales, while Evenity (romosozumab) continues to grow quickly, adding nearly half a billion dollars per quarter.
This concentrated market share has created a near-monopoly in the injectable osteoporosis space. That monopoly has come at a cost to providers, who have had little negotiating power on price or purchasing terms. In addition, the buy-and-bill model requires practices to purchase costly inventory upfront, take on reimbursement risk, and manage tight cash flow. These barriers have long discouraged many bone health care practices from offering in-office treatment, limiting access for patients who could benefit.
However, the landscape is set to change. With biosimilar versions of denosumab expected to enter the U.S. market as early as 2025 or 2026, multiple manufacturers will soon be competing for provider business [4]. These biosimilars are likely to launch at 20–30% lower prices than branded Prolia and will be eager to gain share in a lucrative, underpenetrated market [4].
Prolia Economics Over Time: Trends in Costs, Reimbursement, and Margins
Since its introduction in 2010, Prolia (denosumab 60 mg) has seen a consistent increase in its estimated acquisition cost to providers, while reimbursement and provider margins have fluctuated, reflecting both rising drug prices and changes in Medicare payment policy.
In 2010, the estimated cost of a Prolia injection was about $599, with providers earning an average margin of roughly $36 per injection. At the time, the Medicare conversion factor for RVU-based reimbursement was 36.08, and providers recouped approximately 6% over their acquisition cost through reimbursement.
By 2011 and 2012, the cost to providers rose steadily, to $647 and then $699, respectively, while margins grew slightly in absolute terms (to $38.82 and $41.94). This suggests that reimbursement levels kept pace with price increases early in the product’s life cycle, maintaining roughly the same margin percentage (about 6%).
However, by 2013 and 2014, the dynamics shifted. The Prolia acquisition cost rose to $755 in 2013 and $815 in 2014, yet the provider margins decreased to $32.47 in 2013 before rebounding slightly in 2014. At the same time, the Medicare conversion factor declined to 34.02 in 2013 before slightly recovering in 2014 to 35.82. The percentage of reimbursement over cost also dropped, falling below 4.5% in both 2013 and 2014, compared to 6% in earlier years.
This downward trend continued over the next decade, as Prolia’s acquisition cost climbed steadily to $1,900 by 2025, more than tripling since 2010. Over the same period, provider margins increased only modestly in absolute dollars to about $81.70 per injection, and the percentage reimbursement over acquisition cost remained essentially flat since 2014 at roughly 4.3% — well below earlier levels. This equates to an average annual growth rate of nearly 8% in Prolia’s price between 2010 and 2025, far outpacing the average U.S. inflation rate of approximately 2–3% per year over the same period.
The widening gap between drug costs and stagnant reimbursement rates highlights an economic trajectory that is increasingly unsustainable for providers, who must front ever-larger sums to stock the drug under the traditional buy and bill model while receiving diminishing returns relative to their risk.
Without reform, this compounding financial strain threatens to discourage provider participation and limit patient access to necessary osteoporosis care.
The End of Prolia’s Monopoly
The long-running dominance of Prolia has been a double-edged sword. On one hand, it brought a highly effective, convenient therapy to millions of patients at risk for fracture [5]. On the other, it entrenched a single supplier in a position of power, leaving providers with little leverage to negotiate price or terms — especially in a market constrained by the burdens of the traditional buy-and-bill model. The anticipated entry of biosimilar competitors presents an important opportunity for bone health providers to rethink how they organize themselves and how they secure access to therapy for their patients.
The Orthopedic Industry Offers a Roadmap for How Providers Can Harness This Moment
For decades, hospitals and ambulatory surgery centers have relied on a sophisticated contracting and consignment model for orthopedic implants and instruments. In that system, manufacturers deliver a broad range of prosthetic components and specialized tools directly to hospitals on a consignment basis, retaining ownership of the inventory until it is used. Hospitals only pay for what they actually implant in a procedure, while manufacturers and their field representatives manage the stock, restock as needed, and track usage for compliance and recall purposes.
This system solves the fundamental problem of variability: no single patient or procedure is alike, and providers cannot afford to tie up capital in an exhaustive inventory that may never be used. The consignment model enables hospitals to keep the full array of options available without assuming substantial financial risk, while still giving manufacturers a way to secure volume and loyalty.
New Competition, New Leverage: Will Biosimilars Change the Game?
The emergence of biosimilar denosumab introduces a similar variability and opportunity into bone health care. With multiple manufacturers entering the market, there will finally be competition for the right to supply clinics and hospitals — competition that can be leveraged [6]. For the first time, bone health providers are positioned to organize themselves into collaborative buyer groups, aggregating their purchasing power and creating meaningful volume commitments that biosimilar manufacturers will compete to win.
Just as implant makers have done in orthopedics, biosimilar suppliers can and should offer consignment-based distribution as a standard part of these agreements.
Why Buyer Groups and Consignment Make Sense
This approach carries clear benefits. By negotiating collectively, providers can lower the unit cost of therapy, secure inventory without upfront payment, and ensure they always have product on hand to treat patients when they’re identified. A consignment model minimizes the risk of unused inventory sitting in the refrigerator and allows smaller practices to enter the market without tying up scarce capital.
It also creates the potential for manufacturers to add value beyond the drug itself — supplying refrigeration equipment, training, digital inventory tracking systems, and patient support services — all in the name of winning a share of the group’s business. For providers and patients, the result is expanded access to effective fracture prevention therapies and a stronger incentive to integrate bone health services into routine orthopedic, rheumatology, and primary care workflows. By acting now, marketers of competitive products can secure exclusive agreements with providers and health systems, essentially locking out competition.
Reimbursement Misalignment: Medicare vs. Medicare Advantage
One of the most frustrating barriers for providers offering injectable osteoporosis treatment is the misalignment of reimbursement between traditional Medicare and Medicare Advantage (MA) plans. For patients on original Medicare Part B, in-office administered biologics like Prolia are covered with predictable, fee-for-service reimbursement [6]. Providers are paid based on a transparent schedule, and patients often face manageable out-of-pocket costs with supplemental coverage.
However, for patients enrolled in MA plans, the experience can be very different. Drug benefits for MA plans treat Prolia as a Part D liability, implementing formulary restrictions, prior authorizations, and alternative payment structures that result in delayed reimbursement, lower payment rates to providers, and higher out-of-pocket costs to patients [6]. The transition of coverage from Part B to Part D effectively removes the incentive for in-office treatment.
This misalignment creates administrative burden, unpredictable cash flow, and inequities in access. It also disincentivizes providers from building bone health programs that include in-office injectables, since a growing share of their patients — now over 50% in many markets — are covered by MA rather than traditional Medicare.
A properly negotiated consignment and collective buying arrangement could help mitigate some of this misalignment by reducing upfront risk, enabling providers to carry stock regardless of payer mix, and giving them leverage to advocate for more consistent MA reimbursement policies.
Still, aligning payer incentives with fracture prevention remains a necessary longer-term policy goal.
Understanding Organizational Incentives: 340(b) Hospital Drug Pricing Programs vs. Non-340(b) Providers
An important distinction in how this opportunity is perceived lies in the differing incentives between the 340(b) Drug Pricing Programs for nonprofit health systems and private, non-340(b) (for-profit or physician-owned) organizations [7].
In 340(b) eligible nonprofit hospital systems, revenue from professional fees may flow to physicians, while the hospital bears much of the cost and risk of drugs and supplies. This misalignment can dampen enthusiasm for initiatives like in-office bone health optimization, because the hospital’s incentive to invest in the infrastructure is weak, while the physicians may not directly benefit [7]. Large nonprofits are also more risk-averse and slower to adapt new care models, given their bureaucracy and their focus on compliance and mission-driven care rather than margin expansion.
By contrast, non-340(b) organizations — including private orthopedic practices, physician-owned ASCs, and for-profit multi-specialty groups — have clearer financial alignment. They tend to retain the revenue from in-office treatment and have more flexibility to innovate operationally. For these organizations, the combination of lower biosimilar costs, consignment inventory to eliminate upfront risk, and new revenue streams is a far more compelling business case. They are well-positioned to take the lead in forming buyer groups, negotiating favorable contracts, and delivering integrated bone health services efficiently.
Orthopedic Surgeons Can Lead the Charge
This opportunity is even more compelling when we recognize who is best positioned to lead bone health optimization: orthopedic surgeons. As the physicians most likely to see the devastating consequences of untreated osteoporosis — in the form of fragility fractures, failed implants, and compromised surgical outcomes — orthopedic surgeons are uniquely situated to identify high-risk patients and coordinate comprehensive bone health care [8].
Embedding bone health and fracture prevention treatment into orthopedic practice not only improves surgical outcomes but also aligns with the growing emphasis on value-based care and population health. For orthopedic surgeons to take the lead, the model must make sense clinically, financially, and operationally. The combination of biosimilar competition, consignment-based inventory, and collective bargaining does exactly that. It lowers the economic barriers that could keep many surgeons and orthopedic groups from offering in-office treatment while creating an ecosystem of support and sustainability. It allows orthopedic practices to extend their role beyond acute fracture repair to ongoing prevention and optimization — a natural evolution of their mission.
A Call to Action: Organize, Negotiate, Transform
The end of Prolia’s monopoly is more than just a price story. It is a chance to redefine the economics of in-office osteoporosis treatment, making it more sustainable, more accessible, and more attractive to providers. Borrowing from the lessons of orthopedic implants, bone health practices — led by orthopedic surgeons — can finally shift from being price takers in a buy-and-bill world to being active participants in a competitive, service-oriented marketplace.
If they organize, they can make consignment the standard and bring about a long-overdue transformation in the way bone health is delivered — with orthopedic surgeons at the helm, where they belong.
Contact:
Peter T. Bianco, MBA
References:
Grand View Research. Osteoporosis Drugs Market Size & Share Report, 2024–2030. 2024. Available at: https://www.grandviewresearch.com/industry-analysis/osteoporosis-drug-market
Amgen, Inc. Amgen Reports Fourth Quarter and Full Year 2024 Financial Results. February 2025. Available at: https://www.amgen.com
The Business Research Company. Denosumab Global Market Report 2024. 2024. Available at: https://www.thebusinessresearchcompany.com/report/denosumab-global-market-report
DelveInsight. Emerging Drugs Bring a Positive Shift in Global Osteoporosis Market. 2024. Available at: https://www.delveinsight.com/blog/emerging-drugs-bring-a-positive-shift-in-global-osteoporosis-market
National Osteoporosis Foundation. Clinician’s Guide to Prevention and Treatment of Osteoporosis. 2024 Update.
U.S. Centers for Medicare & Medicaid Services. Medicare Advantage in 2024: Enrollment Trends and Policy Considerations. CMS.gov, 2024.
U.S. Department of Health and Human Services, HRSA. 340B Drug Pricing Program. 2024. Available at: https://www.hrsa.gov/opa/index.html
Pre-Operative Bone Health Optimization as a Trojan Horse, Unlocking the Orthopedic Platform and Reclaiming the Patient Funnel, Digital Bone Health Study Group Blog Post, Peter Bianco, May 18, 2025 (www.digitalbonehealth.org)
