Bone Grafts and Substitutes Market

Market Overview

The global bone grafts and substitutes market size valued at USD 3.02 billion in 2022. It is estimated to reach USD 5.10 billion in 2031, growing at a CAGR of 5.6% over the forecast period (2023–2031). The market for bone substitutes and grafts is driven by the rising prevalence of bone disorders brought on by sports injuries and road accidents. The abovementioned factors are expected to boost the overall bone grafts and substitutes market growth in the coming years.

Bone grafts and substitutes are materials used to replace missing bone or repair fractured bone. The primary purpose of using bone grafts and bone substitutes is to promote the healing of fractures and injuries and replace natural bone. It is widely used for hip, foot, and ankle surgeries, fractures, and musculoskeletal injuries. Bone grafts and bone substitutes are materials or techniques used in medical procedures to repair or replace missing or damaged bone tissue. These procedures are commonly performed in orthopedics, dentistry, and other specialties.

In bone grafting, small pieces of bone, called autografts, are removed from a part of the patient's body (often the iliac crest of the hip) and transplanted to an area where new bone formation is needed. Autografts are considered superior to all other bone grafting methods as a platform for the proliferation of new bone and live bone cells. However, autograft harvesting requires an additional surgical site and can result in pain, infection, and other complications. On the other hand, bone substitutes are synthetic or natural materials that can be used as an alternative to autografts. These substitutes provide a scaffold for bone growth, promote the formation of new bone, and eventually replace the patient's bone.

Market Dynamics

Bone Grafts and Substitutes Market Drivers

Rising Incidence of Bone and Joint Disorders

The increasing incidence of bone disorders due to road accidents and sports injuries drives the market for bone grafts and substitutes. The bone grafts can be used to repair a broken bone, previously injured bone that has not healed, spinal fusion (in the case of an unstable spine), bone regeneration, and to heal the bone around surgical implantation (joint and knee replacement). Spinal fusion surgery is mostly performed on all the bones, as mentioned above in the grafting procedures. According to the Journal of Spine Surgery, as of June 2019, the prevalence of spine deformities affects between 30% and 68% of the elderly population. The common causes of spinal fusion injuries are trauma, falls, collisions, or road traffic accidents.

Furthermore, the increasing incidence of bone fractures increases the rate of bone grafting procedures. According to a CDC analysis, the incidence of hip fractures is expected to increase globally by 240% for women and 310% for men. Osteoporosis is estimated to affect around 200 million women worldwide in 2018. Moreover, the growing target population is increasing the demand for surgical interventions to treat fractures. The spinal fusion procedure is most common in the age group of 45–64. Meanwhile, it is also done on young adults because sports injuries are becoming more common.

Advent of Biocompatible Synthetic Graft

The increasing demand for biocompatible bone grafts to reduce adverse reactions drives the market. Increasing uses of synthetic bone grafts with HAP and TCP, which have shown better biocompatibility than others, fuel the growth. The polymer-based grafts have also shown good biocompatibility. Moreover, industry players continuously try to develop new products with better biocompatibility, bioactivity, and suitable mechanical properties. The different forms of HA have been used for biomedical applications, such as the coating on metallic implants, bone substitutes, scaffolds for tissue engineering, etc.

For instance, in Australia, Brazil, Canada, and the United States, Graftys gained Medical Device Single Audit Programme (MDSAP) approval in October 2020 for their Sterile Calcium Phosphate Resorbable Bone Void Fillers and associated delivery systems. Moreover, it was recertified by CE in Europe. Similarly, the U.S. FDA approved Baxter's Altapore Shape Bioactive Bone Graft in July 2020. This increased the company's selection of Altapore bone transplant alternatives.

Bone Grafts and Substitutes Market Restraint

Risk of Disease Transmission

The use of autografts is found to be contamination-free and remains the gold standard for bone grafting procedures. However, the limited supply and major drawbacks associated with autografts increase the market for allografts and other synthetic substitutes. The allografts have a risk for disease transmission. The American Association of Tissue Banks has set certain criteria for selecting donors. According to an article titled "Infection in Bone Allografts, Incidence, Nature and Treatment," published in 2012 in the Journal of Bone and Joint Surgery America, the risk of infection is approximately 12%. Therefore, several cases require resection grafts and amputation times to control infection. There is a risk of blood loss or hematomas, infection, or some deformity, resulting in longer procedures, which may hinder the growth of the bone graft and substitutes market.

Moreover, many surgical bone graft procedures demand the adoption of bone grafts to replace bone volume that has been resorbed. In 2015, BMC Med Ethics stated that the patient's preferences and opinions must be obtained and consented to before beginning any surgical treatment for bone graft procedures. A 2015 BMC Med Ethics study predicted that allograft and xenograft operations would have the highest rates of refusal among the patients evaluated for spinal infusion surgery. This ethical consideration is acting as a hindering factor for the market growth.

Bone Grafts and Substitutes Market Opportunities

Growing Demand for Dental Bone Grafts

The increasing use of bone grafts in terms of density propels the market for dental bone grafts and substitutes. With the development of cutting-edge surgical techniques like bone transplants and regeneration, dental implant surgery has become increasingly popular. Further, rising dental implant demand and success rates are driving the market. The American Academy of Implant Dentistry estimated that in 2020, 500,000 more people would receive dental implants annually. The source stated that 95% of implant dental procedures were successful. As of 2017, a 95% to 98% success rate for dental implant surgery was observed, according to a report by the American Dental Association.

The use of synthetic and biocompatible dental bone grafts is contributing to the industry's growth. For instance, TCP is primarily utilized in dentistry as a synthetic scaffold. It provides superior osteoconductivity compared to allografts. The market is also being impacted by industry players' growing endeavors, such as new product launches and mergers and acquisitions. For instance, in May 2018, Dentsply Sirona entered into a distribution agreement with Datum Dental, Ltd. to distribute the OSSIX brand for bone and tissue regeneration in dentistry. In January 2017, Antibe Therapeutics Inc. launched PentOS OI Max for dental and maxillofacial surgery. 

Regional Analysis

North America Dominates the Global Market

Region-wise, the global bone grafts and substitutes market share is segmented into North America, Europe, Asia-Pacific, and LAMEA.

North America is the most significant global bone grafts and substitutes market shareholder and is anticipated to exhibit a CAGR of 5.11% during the forecast period. The growth of the U.S. bone graft and substitute market can be largely attributed to the many orthopedic procedures being performed due to the increased incidence of orthopedic diseases and traumatic injuries. For instance, as per the Wound, Ostomy, and Continence Nurses Society in May 2019, over 83,000 amputation procedures were performed daily in the U.S., primarily due to diabetic foot ulcers. Similarly, in May 2019, as per the CDC, approximately 1 in 4 U.S. adults, i.e., an estimated 54.4 million people, have arthritis, and nearly 27% experience severe joint pain. Hence, the growing incidence of diabetes and arthritis will likely increase the demand for surgery.

Moreover, breakthroughs made by major participants are anticipated to stimulate market expansion with enormous unrealized potential. In October 2019, Medtronic received breakthrough device designation from the U.S. FDA for the Valiant TAAA Stent Graft System. This is expected to help the company enhance its market penetration in the U.S.

Europe is expected to grow at a CAGR of 4.7% during the forecast period. The United Kingdom's aging population and long life expectancy contribute to the market's growth. The need for bone substitutes and grafts has surged due to the growing prevalence of aging-related orthopedic diseases. In the United Kingdom, national healthcare centers provide free healthcare services to the majority of the population as part of a universal healthcare system. As a result, competition in the market is high since the government is the only target customer offering bone grafts and substitutes in the U.K. for market players. Moreover, free healthcare services offered by the government have increased demand for advanced products. Therefore, a large target patient population coupled with favorable healthcare schemes is fueling market growth in the U.K.

The Asia-Pacific region is anticipated to have profitable growth over the forecast period. The region's aging population growth increases the danger of joint and bone ailments. Government initiatives and an increase in medical tourism are responsible for the growth. Moreover, strict regulatory requirements in several nations constrain, particularly, the expansion of this region. The Korean Food and Drug Administration (KFDA) should approve the product in South Korea. In Australia, the products are regulated by the Therapeutic Goods Administration (TGA). The stringent regulatory scenario in Japan may restrain growth in the coming years. Geistlich is one of the major companies for dental xenograft products in this region. Medical tourism in India for grafting surgery is another growth-propelling factor for the market.

The Latin American market for bone grafts and substitutes is predicted to expand significantly. The existence of nations such as Brazil and Mexico mostly drives market expansion in Latin America, which has quickly growing economies. The availability of advanced healthcare treatments in the region at cheaper costs compared to North America and Europe is responsible for the growing medical tourism industry. Moreover, the governments of the respective countries focus on improving Latin America's healthcare infrastructure. Therefore, patients from developed countries such as Canada, the U.S., and Germany consider Latin America a viable option for treating orthopedic diseases.

Segmental Analysis

The global bone grafts and substitutes market is segmented based on product and type.

By product, the global bone grafts and substitutes market is categorized into allografts (demineralized bone matrix and others), synthetics (ceramics, HAP, β-TCP, α-TCP, bi-phasic calcium phosphates (BCP), and others), composites, and polymers. 

The allografts segment dominates the global market and is expected to exhibit a CAGR of 4.7% during the forecast period. Allografts are increasingly used instead of autografts due to their qualities, including instant structural support and osteoconductivity. Moreover, allografts save surgical time and hasten wound healing as no additional surgery is required to collect bone. Therefore, allografts are most commonly used in areas such as the spine, hip, and knee. A tissue that has been transplanted from one individual to another is known as an allograft. The Greek root of the prefix allo means "other." (The process of transferring tissue from one body area to another is known as an autograft.) Annually, over one million allografts are used for transplantation. Therefore, the market is expected to grow significantly during the forecast period.

Based on application, the global bone grafts and substitutes market is categorized into spinal fusion, dental, joint reconstruction, craniomaxillofacial, foot and ankle, and long bone. 

The spinal fusion segment owns the highest market share and is estimated to grow at a CAGR of 5.3% during the forecast period. A spinal fusion treatment is performed to fix problems with the spine's tiny bones or vertebrae. It is mostly employed to immobilize the spinal column. According to the CDC, 195,235 spinal fusion surgeries were carried out in the age range of 45 to 65 in 2012. The aging population, prone to spondylolisthesis and disc degeneration, as well as the increased incidence of trauma from auto accidents and sports injuries, are some of the factors contributing to the growth of the spinal fusion market. Moreover, major market players in the spinal fusion segment include Medtronic, Johnson & Johnson Private Limited, and Stryker. Some of the other players operating in the market are NuVasive and Globus Medical, Inc.

The dental segment is the second largest. Bone grafts are essential for maximizing the outcome of dental implant surgeries. They are fillers or scaffolds to augment bone formation and promote wound healing. Bovine bone (cow bone) is a graft material in most dental surgery centers for tissue regeneration. Growing awareness about dental health and advancements in dental implant placement techniques are expected to boost the number of dental surgeries, thereby promoting the adoption of bone grafts.

Recent Developments

• June 2023: Baxter International Inc., a global MedTech leader, published its 2022 Corporate Responsibility Report. The annual report features performance updates on the company's 2030 Corporate Responsibility Commitment and Goals. It demonstrates Baxter's steadfast commitment to operating as a responsible corporate citizen and providing transparent information to its stakeholders on the most important environmental, social, and governance topics.
• May 2023: Locate Bio's bone graft technology for patients with degenerative disc disease (DDD) was designated as a breakthrough device by the US Food and Drug Administration (FDA).