Global bone grafts and substitutes market size was valued at USD $2.85 billion in 2021. It is expected to reach USD $4.7 billion by 2030, growing at a CAGR of 5.9% during the forecast period (2022–2030). Increased synthetic bone grafts drive the growth with HAp and TCP, demonstrating superior biocompatibility to others. The bone morphogenic proteins for spine surgery are humans' only approved bone-inducing growth factors (BMP 2 and 7). In addition, allograft and xenograft procedures were estimated to have the highest refusal rates among the patients surveyed for spinal infusion surgery, according to a 2015 BMC Med Ethics study. This ethical concern is hampering the growth of the market.
Biologics, known as "bone graft substitutes" can be used in place of autologous bone grafts. Allograft, demineralized bone matrix, polymers, hydroxyapatite, and other materials are substitutes. In orthopedics, these alternatives treat bone defects, union or non-union surgeries, and spinal fusion. In addition, several advantages of these alternatives, including safety, biocompatibility, and osteoconductiveness to broken bones, have boosted their use over the past ten years.
The growth of the global market for bone grafts and substitutes is attributed to the rising incidence of orthopedic surgeries around the world and bone diseases like tumors and infections of the bone. The market is also anticipated to grow during the forecast period due to the rising demand for synthetic substitutes and various authorities' rising number of product approvals.
|Market Size||USD 4.7 billion by 2030|
|Fastest Growing Market||Europe|
|Largest Market||North America|
|Report Coverage||Revenue Forecast, Competitive Landscape, Growth Factors, Environment & Regulatory Landscape and Trends|
Growing Demand for Biocompatible Synthetic Graft
The market is driven by increased demand for biocompatible bone grafts to lessen adverse reactions. Additionally, polymer-based grafts have demonstrated good biocompatibility. Players in the market are also constantly working to create new products with better bioactivity, biocompatibility, and mechanical properties. The various HAp forms have been employed in biomedical settings for coating metallic implants, bone substitutes, and tissue engineering scaffolds.
The demand for bone grafts and substitutes is rising as Minimally Invasive Surgeries (MIS) become more widely used. Due to numerous benefits like less pain, a shorter post-operative stay, and less tissue damage, surgeons are choosing MIS over open surgery. In addition, minimally invasive techniques are being used to treat various bone disorders, according to Minim Invasive Surg in 2018. With about 400,000 spinal fusion procedures carried out yearly in the U.S., it has become one of the most popular and well-established treatment options for spine trauma, degenerative disorders, tumors, and structural abnormalities. Additionally, the development of synthetic bone grafts through technology is accelerating growth. HAp and tricalcium phosphate-based ceramic-based synthetic bone grafts have been dire efficient than conventional DBM.
Increasing Possibility of Contamination
The gold standard for bone grafting is still autografts because they are proven to be free of contamination. However, allografts and other artificial substitutes are growing in popularity due to the shortage of autografts and their significant disadvantages, but the risk of disease transmission with allografts exists. The American Association of Tissue Banks has established some standards for choosing donors. According to a 2012 Journal of Bone and Joint Surgery America article titled "Infection in Bone Allografts: Incidence, Nature, and Treatment," there is a 12% chance of infection; as a result, some cases call for resection grafts and occasionally amputation to control infection.
Additionally, more lengthy procedures are required due to the possibility of blood loss, hematomas, infection, or deformity, which could impede the market expansion for bone grafts and substitutes. Bone grafts are required in many surgical bone graft procedures to replace lost bone volume. However, the patient's preferences and opinions must be considered before implementing any surgical treatment for a bone graft procedure, according to BMC Med Ethics in 2015.
By region, the global bone grafts and substitutes market share is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America Dominates the Global Market
North America is the most significant shareholder in the global bone grafts and substitutes market and is expected to grow at a CAGR of 5.4% during the forecast period. In 2021, North America dominated the global market for bone grafts and substitutes. Several important factors, including an aging population, increased sports injuries, and fatal accidents, drive the demand for bone grafts and substitutes in North America. In addition, the region's market growth is anticipated to be boosted by a robust healthcare infrastructure. The availability of reimbursement coverage, skilled professionals, and technological advancement are some factors expected to increase demand for bone grafts and substitutes over the forecast period.
Europe is expected to grow at a CAGR of 5%, generating USD 1.349 billion during the forecast period. Germany, the United Kingdom, and France are powerful nations in Europe. The region's relatively lenient approval process for medical devices is primarily driving growth in this market. Additionally, developed economies with high disposable income levels, a well-developed healthcare infrastructure, and qualified professionals are some key drivers of the market's expansion.
The Asia-Pacific region is anticipated to experience profitable growth over the forecast period. Increased medical tourism, government initiatives, and the region's aging population are raising the risk of bone diseases, and joint issues are responsible for the growth. Contrarily, the development of this region is constrained by strict regulatory standards in some nations. For instance, the Korean Food and Drug Administration (KFDA) in Japan and the Therapeutic Goods Administration (TGA) in Australia oversee the products for approval in the coming years. The friendly regulatory environment in Japan could limit growth in the upcoming years. Also, one of the leading manufacturers of dental xenograft products in this region is Geistlich. Medical tourism to India for procedures such as grafting surgery is another factor driving market expansion.
The market for bone grafts and substitutes in Latin America is expected to expand significantly over the forecast period. The market expansion in Latin America is primarily driven by rapidly developing economies like Brazil and Mexico. The region's ability to provide cutting-edge medical care at lower costs than North America and Europe drives the region's medical tourism industry forward. Additionally, each nation's government is working on upgrading Latin America's healthcare system. As a result, patients from developed nations like Canada, the United States, and Germany view Latin America as a viable option for treating orthopedic diseases.
The Middle East and Africa market is anticipated to experience significant growth over the forecast period. The market for bone grafts and substitutes has experienced rapid growth in Middle Eastern nations due to rising disease burden and increased access to health insurance. Some factors impeding the growth of the Middle East and Africa market include a lack of a clearly defined regulatory framework and a shortage of qualified professionals to carry out complex orthopedic surgical procedures.
However, several government initiatives are creating new growth opportunities in the Middle East and African bone grafts and substitutes market to improve healthcare infrastructure in South Africa, the United Arab Emirates, and Saudi Arabia. For instance, through developing a professional network in orthopedic technology, physiotherapy, and rehabilitation, the African Federation of Orthopedic Technicians (FATO) promotes access to the right to functional rehabilitation for people with disabilities in Africa.
The global bone grafts and substitutes market is segmented by product and application.
Based on product, the global bone grafts and substitutes market is bifurcated into allografts and synthetic.
The allografts segment is the highest contributor to the market and is expected to grow at a CAGR of 5% during the forecast period. Allografts are increasingly used instead of autografts due to qualities like immediate structural support and osteoconductive. Additionally, allografts reduce surgery time and hasten wound healing because no additional surgery is needed to harvest bone. Allografts are thus most frequently used in the spine, hip, and knee. As a result, the market is anticipated to expand significantly over the forecast period. However, among the key elements anticipated to impede the segment's growth are risks like disease transmission and unfavorable immune reactions linked to allografts. Allografts have disadvantages like accelerated resorption, delayed or incomplete graft incorporation, slow bone formation, and delayed vascular penetration.
The synthetic segment is anticipated to grow the fastest over the forecast period. Bone morphogenic proteins, composites, polymers, and ceramics have been categorized as synthetic material markets. Chemically created compounds are sintered and heated to create synthetic bone void fillers, which are then used as bone graft material.
Based on the application, the global bone grafts and substitutes market is bifurcated into spinal fusion, dental, joint reconstruction, craniomaxillofacial, foot and ankle, and long bone.
The spinal fusion segment owns the highest market share and is expected to grow at a CAGR of 5.6% during the forecast period. Spinal fusion treats problems with the spine's small bones or vertebrae and is mainly employed to immobilize the spinal column. According to the CDC, 195,235 spinal fusion procedures were conducted in the age range of 45 to 65 in 2012. One of the factors driving the growth of the spinal fusion segment is the aging population, which is more prone to spondylolisthesis and disc degeneration, as well as the rising incidence of trauma from car accidents and sports injuries.
Bone grafts are crucial to ensure the best possible results from dental implant surgeries. They are scaffolds or fillers to enhance bone formation and accelerate wound healing. Bovine bone (cow bone) is typically used as a graft material for tissue regeneration in dental surgery facilities. Increased dental procedures are anticipated, which will encourage the use of bone grafts. This is due to rising dental health awareness and improvements in dental implant placement techniques. High costs incurred during and after treatment and a shortage of qualified orthodontic surgeons in developing regions limit market growth.
The key players are