A vast range of bone grafts and substitutes is available for clinical use. As per Inkwood Research, the global bone graft and substitute market is projected to register a CAGR of 5.40% during the forecast period, 2023-2032. Yet, effective reconstructive device development is extremely challenging. The translational pathway for novel technologies is slow and only facilitates minor enhancements in established clinical treatments. Safety concerns, high economic requirements, and scalability constitute the major impediments to bone graft product development.
Over the years, advancements in technology and biomaterial science have facilitated several bone graft types from different sources, such as synthetic materials (alloplastic graft), human cadavers (allograft), and animals (xenograft). For instance, the development of the synthetic bone graft, Inductigraft™ (AltaPore™ in the United States), built on the pioneering research of the Queen Mary University of London by Dr Karin Hing.
The research encompassed a wide range of academics and scientists across the University and other institutions. Inductigraft™ is acknowledged as an effective autograft with the bigger advantage of not needing additional surgery to harvest the autograft. Consequently, lesser anesthesia and a shorter operation time for the patient. (Source)
Accordingly, rigorous research efforts have been centered on developing innovative bone substitutes that offer immediate mechanical support alongside ensuring appropriate graft anchoring. At the same time, out of the innumerable studies associated with bone graft development, only a few have stood the test of time, regulations, and safety. This impediment is accredited to several factors, as found out by various studies undertaken.
The following sections shed light on the same –
Global Bone Graft and Substitute Market: Navigating An Uneven Product Landscape
A clinician might prefer a certain graft type based on various reasons like the material’s performance & safety, the amount of bone to be regenerated, economic evaluations, expertise, etc. However, the patient may not approve of the clinician’s decision, irrespective of the scientific evidence.
The patient’s disapproval has to be seriously considered, given their right to autonomy and to reinforce the surgeon-patient relationship. Moreover, the patient is an entity with religious or ethical concerns. At the same time, the rejection of a bone graft type can be based on unfounded fears.
For instance, in a study published by Dove Medical Press Ltd, a percentage of patients rejected the allograft or xenograft due to the fear of disease transmission possibility from the donor. Whereas the general disease transmission risk is significantly low, attributed to the quality care administered during the bone graft-obtaining procedure, which has considerably improved over the years.
Similarly, another multicentre study by Dove Medical Press Ltd surveyed patients from five countries to analyze their opinion on the bone graft source commonly used in dental treatments. The study aimed to evaluate whether the acceptance or rejection of certain bone graft types was based on variables like country of origin, religion, education, age and gender.
The study found that allogenic bone grafts faced the highest rejection percentage (40.5%), followed by autologous bone grafts from the extraoral donor site (34%) and xenografts (32.7%). Whereas autologous bone graft from intraoral donor site and alloplastic bone graft received the lowest rejection rates, at 24.5% and 6.3%, respectively. (Source)
For alloplastic bone graft and xenograft, the country of origin was the major predictor for rejection. While for autologous bone graft, the rejection reasons were religion and country affiliations. However, the primary cause for autologous rejection was the fear of pain & discomfort.
Furthermore, the relevant predictors for allograft rejection were country & religious affiliation and education levels. Moreover, xenograft was rejected due to the fear of disease transmission and dissent against the use of animals for human benefit.
Commercial Challenges in Bone Graft Development for Dentistry
Although bone grafting is a large-scale practice in dentistry, implant failure due to loosened or poor fixation of implanted grafts is a common complication. Containment materials are deployed to expand the contact interface with the graft and enable targeted high-quality bone formation to minimize such complications. Tissue grafts employed in such clinical scenarios include xenografts or allografts. The examples include BioGuide® (Geistlich) or CreosTM Xenoprotect (Nobel BiocareTM), which have proven to promote implant support and bone gain in patients undergoing dental surgery.
Special attention is accorded to the source and processing of such products for their clinical translation in dentistry. For instance, the raw material needs extensive screening to minimize the disease risk transmission in xenografts and allografts, as mandated by the Food and Drug Administration (FDA).
Bone Graft and Substitute Market’s Resolution for Cost-Effective and Safe Products
Despite consequential rejection parameters, the product landscape of the bone graft and substitute market is obstinately resilient. There have been some therapies that serve as models in bone tissue engineering’s clinical translation, successfully reaching the clinic. These center around platelet-rich plasma (PRP), collagen sponges and hydrogels, and BMP-2 and BMP-7.
By Akhil Nair
The bone graft and substitute market’s resilience can be attributed to ongoing advancements in regenerative medicine, innovative product development, and a growing aging population. Despite rejection parameters, the market remains robust due to the increasing demand for orthopedic procedures, a rise in musculoskeletal disorders, and the continual exploration of novel therapies in bone tissue engineering.
Successful therapies in bone tissue engineering serve as pivotal models for clinical translation, demonstrating the feasibility and efficacy of innovative approaches. These breakthroughs not only inspire confidence in the market but also drive investment and research. By reaching the clinic, these therapies validate the potential for addressing unmet medical needs, influencing the market landscape by fostering a climate of innovation and adaptability.