Xenografts, an Emerging Space within the Expansive Bone Graft Substitute Market

The bone graft substitute market, a market of products used to repair damaged bone by filling bone voids or acting as bone extenders as a substitute for autograft harvesting, is a massively growing and established one within the medical world. This market as a whole sits at a whopping US$1.7 billion in 2023 and is expected to continue growing steadily over the upcoming years to reach over US$2 billion by 2030 (Figure 1) (iData Research 2024). Over the years, the bone graft substitute products have broken out to include a large number of different delivery systems (e.g., powders, putty, pellets, coatings, etc.) to accommodate a wide variety of procedural and indication types (e.g., large joint, spine, small joint, etc.) (Roberts & Rosenbaum 2012; iData Research 2024). Similarly, bone graft substitutes have expanded into various material types, such as allografts, demineralized bone matrices (DBMs), synthetic grafts and xenografts. DBMs represented the largest portion of the market, followed by synthetic grafts, then allografts, and finally xenografts. 

Xenografts are made of bone procured from animal products (e.g., bovine, etc.) and work very similarly to allografts (i.e., bone procured from cadaveric donation). Xenografts have a number of advantages over autograft and allografts; they do not require a second procedure to harvest autologous bone and do not have to navigate the complications related to procuring donations from cadaver specimens. Despite these advantages, the market currently sits, by far, as the smallest material market of the bone graft substitute space. 

The xenograft market saw a spike in growth in 2022 following the recovery from the impact of COVID-19 and is expected to grow consistently across the forecast period (2024-2030). The current leaders in this space benefiting from this growth include Biogennix with their Agilon product line and Xtant Medical Holding’s Tutopatch line (iData 2024). Xenografts are slowly but surely solidifying their place within the bone graft substitute market. There are a number of factors that have contributed to the market starting out much smaller, but can thank tissue supplies and demographic factors for its steady growth in the coming years.

The Factors That Have Held Xenografts Back

Xenografts have many potential benefits. So why have they been slower to incorporate into the regular practice of physicians? Some of the reasons could be lower incorporation rates and reduced osteoinductive properties.

Xenografts have very similar structures to autografts and allografts, but they have been shown to be more likely to improperly incorporate into the body of patients. This lower efficacy has acted as a barrier for entry for xenograft products, given the history and trust of the medical industry in alternative bone graft substitute products. Increasing the incorporation rates is an excellent strategy for new xenograft products coming into the market.

Another complication of xenograft products is the degree of sterilization required for its use. As they come from animal donations, a more thorough sterile processing is required. This is a necessary practice to ensure safety of use, but the con to this practice is that the processing also removes the osteoinductive benefits of the graft itself. This contributes to the lower incorporation rate of xenografts as well.

Tissue Supply as a Driver of Growth

Although lower incorporation rates and reduced osteoinductive properties have made it more difficult for xenografts to enter the bone graft substitute space, the availability of tissue supply for xenografts is one of various factors driving the market to have a steady growth throughout the forecast period (2024-2030) (Figure 2). 

As xenografts are animal derived, there is a much larger amount of donor tissue readily available for use. Even more than that, a benefit to the sterilization process is that it extends the shelf life of these products as well, even further expanding its tissue supply availability. Demographic factors will likely exacerbate these factors as well, resulting in xenografts becoming an increasingly popular choice among the bone graft substitute landscape. 

How Demographic Factors Are in Xenografts’ Favor

The first of the baby boomers began retiring in 2008, and as this generation ages, an increase in osteoarthritis and related bone repair and spinal fusion procedures will follow. In the bone graft substitute space, this means an increased demand for allografts, while the number of viable donors decreases. These two factors will make xenografts a more appealing choice as the population continues to age. 

More generally, an aging population will drive the need for bone graft substitutes more broadly, which is expected to benefit the market as a whole as well.

Conclusion

There are a number of factors that are predicted to drive the growth in the xenograft bone graft substitute market within the next few years. These factors include an increase in the elderly population in the U.S., the readily available nature of xenografts as a product (e.g., increased shelf life, higher number of potential donors, etc.), not requiring a second procedure to harvest autologous bone and not needing to navigate complications from cadaver donations. Despite these advantages and drivers of growth, xenografts have had several barriers to entry and to further growth. These include lower incorporation rates as well as reduced osteoinductive properties in xenografts due to increased sanitation practices required. 

As the very well-established bone graft substitute market continues to expand across the forecast period (2024-2030), it will be exciting to follow the xenograft space as it steadily establishes itself as a viable option for non-autologous procedures. As the market grows, and companies such as Biogennix and Xtant Medical Holdings continue to see increased growth in their xenograft products, this will also make the market increasingly attractive to new competitors and novel products. 

About the Authors

Alycea Wood is an analyst manager at iData Research. She develops and composes syndicated research projects regarding the medical device industry, publishing the U.S. Orthopedic Biomaterials report series.

Kamran Zamanian, Ph.D., is CEO and founding partner of iData Research. He has spent over 20 years working in the market research industry with a dedication to the study of medical devices used in the health of patients all over the globe.