The foot and ankle allograft market size was USD 120.46 Million in 2021 and is expected to register a revenue CAGR of 6.6% during the forecast period. Increase in geriatric population is a vital factor driving market revenue growth. In addition, rising incidence of chronic wounds and diabetic foot ulcers, increasing prevalence of orthopedic diseases and foot and ankle disorders, continuous product commercialization, and rise in public-private educational and awareness initiatives related to preventive and post-operative care are some major factors driving foot and ankle allograft market revenue growth.
Moreover, emergence of bioresorbable and Three Dimensional (3D)-printed implants and increasing research & development activities are expected to create new growth opportunities for the foot and ankle allograft market during the forecast period. One of the most prevalent trends in the market is strong ongoing Research & Development (R&D) initiatives to develop novel product offerings driven by high demand for efficient allograft substitutes for foot and ankle associated conditions, such as simple or complex fractures and trauma.
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Similarly, increasing number of orthopedic surgical procedures being performed across the globe is expected to generate significant growth opportunities for companies engaged in R&D activities. This can be attributed to increasing number of orthopedic patients demanding better treatment outcomes. In February 2020, for instance, MTF Biologics, a global nonprofit organization engaged in advancement of tissue and organ donation, transplantation, and research, awarded over USD 1.8 million in funding to 12 researchers across the U.S., through its 2019 Extramural Research Grants Program. Such initiatives are expected to lead to product development and launches worldwide.
Moreover, key players are increasingly focusing on development of specialized products for the treatment of various foot and ankle disorders and deformities, as well as to address the unmet market needs. Availability of advanced products and treatment modalities is generating significant interest among end users, owing to better treatment outcomes promised by them.
Driver: Increasing number of arthroscopic surgeries performed
North America is a major region for arthroscopic surgeries followed by Europe, which can be attributed to high prevalence of joint-related disorders and highly integrating cases related to osteoarthritis, sports injuries, joint related disorders, and others. The frequency and proportion of each fracture in the foot and ankle in major trauma hospitals in the United States was analyzed by the National Trauma Data Bank between 2012 and 2017, and a total of 280,933 fractures or dislocations of the foot and/or ankle were identified during this period.
Although the structure of data collection may have resulted in oversampling of more severe damage in younger patients, it was discovered that ankle fractures were the most prevalent foot and ankle fractures. Based on anatomic location, midfoot fractures were the least prevalent of all foot and ankle fractures, while open fractures accounted for about 20% of foot and ankle fractures. Thus, significant increase in the number of fractures and surgeries performed, and sudden increase in innovations by key players in the market are expected to drive revenue growth of the foot and ankle allograft market. In June 2018, for instance, Wright Medical Group N.V. received approval for AUGMENT Injectable Bone Graft for ankle and hindfoot fusion. AUGMENT Injectable has been proven to be a safe and effective alternative to autograft for hindfoot and ankle fusion in a flowable formulation.
Increasing incidence of chronic wounds and diabetic foot ulcers
Increasing incidence of chronic wounds and diabetic foot ulcers is a major factor driving revenue growth of the foot and ankle allograft market. Diabetic foot is defined as an ulcerated foot in a diabetic patient with neuropathy and/or peripheral artery disease of the lower limb, and it is one of the most serious and disabling complications of diabetes and a leading cause of foot ankle allograft surgery. Diabetes foot ulcers impact 4–10% of diabetics, with elderly patients experiencing the condition more commonly. Approximately, 5% individuals with diabetes have a history of foot ulceration, and diabetics have a 15% lifetime risk of developing the condition. Majority of foot ulcers (60–80%) will heal, whereas 10–15% will stay active and 5–24% will eventually lead to limb amputation within 6–18 months of the initial examination, as per the data provided in the NCBI journal.
Neuropathic wounds usually heal in 20 weeks or less, whereas neuroischemic ulcers take longer and are more likely to result in limb amputation. Diabetes patients account for 40–70% of all non-traumatic lower limb amputations, and furthermore, many studies have found that foot ulcers precede in roughly 85% of amputations performed in diabetes patients. The risk of foot ulceration and limb amputation increases with age and duration of diabetes. Diabetic foot prevention is critical due to its impact on a patient’s quality of life and the associated financial burden on the healthcare system. Emergence of bioresorbable and 3D-printed implants and rise in research & development activities are paving the way for more novel methods of treatment, which is expected to create new opportunities for foot and ankle allograft market over the forecast period.
Restraint: Clinical limitations associated with the market
Certain clinical limitations, such as adverse reactions resulting from the administration of allograft products, is a major restraining factor for the market. Despite the significant risk of infections and morbidity associated with autogenous and allograft bone transplantations, they are nevertheless considered the gold standard in bone graft in numerous locations. In some circumstances, this may result in the adoption of synthetic products, such as allograft/ Demineralized Bone Matrix (DBM), thereby limiting market revenue growth.
Clinical constraints associated with some bone graft substitutes is another factor to restrict market revenue growth. For example, until recently, synthetic product types solely exhibited osteoconductive capabilities and showed no signs of osteoinductive or osteogenic activity. Although recent product offerings have attempted to disguise the lack of osteoinductive and osteogenic capabilities, these issues are expected to continue to restrain revenue growth of the market during the forecast period.
Product Type Outlook:
Based on product type, the foot and ankle allograft market has been segmented into allograft wedges, allograft tendons, allograft acellular dermal matrix, and cartilage allograft matrix. Allograft tendons segment is expected to account for largest revenue share in the foot and ankle allograft market over the forecast period. Orthopedic surgeons are increasingly using allograft tendons in the treatment of a variety of musculoskeletal conditions, ranging from glenohumeral joint osteochondral abnormalities to meniscal deficit in young athletes. Recent clinical evidence suggests that soft tissue allografts and autografts from the Musculoskeletal Transplant Foundation (MTF) are equivalent for Anterior Cruciate Ligament (ACL) restoration, with no difference in outcome between younger and older patients. This means that by using an MTF allograft, surgeons can get the same results without having to go through the extra time, effort, and invasiveness of harvesting a graft from a patient, and also avoid donor site morbidity and secondary incision sites. Increasing developments in allograft tendons by major manufacturers is one of the key factors to drive revenue growth of this segment.
Based on application, the foot and ankle allograft market has been segmented into arthritis, hammer toe, osteoporosis, and others. Arthritis segment is expected to account for a considerably large revenue share in the foot and ankle allograft market during the forecast period. Rheumatoid arthritis treatment is in high demand due to rising prevalence of arthritis and associated joint issues, owing to a shift towards unhealthy lifestyles, prevalence of metabolic disorders, family history of joint diseases, and rising prevalence of obesity.
In North America and certain European countries, Rheumatoid Arthritis (RA) is very common, and according to a report by the Centers for Disease Control and Prevention (CDC) in 2018, rheumatoid arthritis affected around 54 million people in the United States. Increasing prevalence of RA is creating requirements for effective diagnosis and treatment solutions, which is expected to support revenue growth of this segment.
Surgery Type Outlook:
Based on surgery type, the foot and ankle allograft market has been segmented into orthopedic reconstruction, cartilage restoration, and soft tissue tendon & ligament repair. Orthopedic reconstruction segment is expected to account for a considerably large revenue share in the foot and ankle allograft market. Increasing incidence of osteoarthritis and rheumatoid arthritis around the world, as well as technological advancements in orthopedic joint reconstruction, are the key factors driving revenue growth of this segment. Increase in research & development efforts, as well as increasing geriatric population, are also expected to generate significant growth opportunities during the forecast period.
End User Outlook:
Based on end user, the foot and ankle allograft market has been segmented into hospitals, orthopedic clinics, and ambulatory surgical centers. Hospitals segment is expected to account for a significantly large revenue share over the forecast period. Presence of a large target patient population (especially in developing economies) preferring hospitals, growing procedural volume of arthroscopic surgeries in hospital settings, rising emphasis on effective and early disease diagnosis in hospitals, and high investments by hospitals in various technologically advanced foot and ankle allografts are contributing to revenue growth of the hospitals segment. Furthermore, techniques such as modern tissue-processing and rigorous donor screening are likely to increase the use of allograft tissues in reconstructive procedures in foot and ankle surgeries, thereby driving revenue growth of this segment.
Based on regional analysis, North America is expected to account for largest revenue share in the foot and ankle allograft market, owing to high occurrence of sports-related injuries in the region. According to the Johns Hopkins Medicine, around 30 million children and teenagers in the U.S. participate in organized sports, and sports-related accidents account for more than 3.5 million injuries each year. Furthermore, increasing prevalence of chronic wounds, such as diabetic foot ulcers, is expected to increase demand for allograft products in the region over the forecast period.
According to the National Center for Biotechnology Information (NCBI), diabetic foot ulcers are responsible for causing most hospital admissions than any other complications associated with diabetes. In the U.S., diabetes is the main cause of non-traumatic amputations, and approximately, 5% of people with diabetes mellitus develop foot ulcers, while 1% have their limbs amputated. Thus, increasing prevalence of diabetes and diabetic foot ulcers in North America is expected to play a major role in revenue growth of this regional market.
The market in Europe is expected to register a robust revenue CAGR over the forecast period, owing to increasing geriatric population in the region. According to Eurostat, in 2020, more than one fifth of the EU population (20.6%) was 65 years or older. Between 2020 and 2100, the proportion of people aged 80 years and above in the EU population is expected to increase by two and a half times, from 5.9% to 14.6%. The need for allograft has risen dramatically owing to an increase in the number of revision arthroplasties performed in an ageing population, as well as the trend of novel minimally invasive surgery, notably in the foot and ankle, where the need for allograft is increasing rapidly. In recent years, the amount of allograft available has expanded dramatically, and in Europe, it is the most commonly used bone substitute.
The foot and ankle allograft market is moderately fragmented with a number of key players operating on regional levels. Key players are engaged in product development and strategic alliances to expand their respective product portfolios and gain a robust footing in the market.
Some major players included in the market report are CONMED Corporation, Wright Medical Group N.V., AlloSource, Bone Bank Allografts, RTI Surgical Holdings, Inc., Zimmer Biomet, JRF Ortho, Integra Life Sciences Corporation, Smith & Nephew Plc, and DePuy Synthes, among others.
Initiatives taken by major players are driving revenue growth of the market, for instance:
· In July 2021, Bioventus (U.S.) launched Osteoamp Select Flowable, an allograft bone graft substitute developed for procedures, including lumbar spine fusion, cervical spine fusion, and foot and ankle fusion.
· In June 2019, Metalogix received the Food and Drug Administration (FDA) 510(k) clearance for its Revolution External Plating System, an open ring fixation for long bone fractures, limb lengthening, and correction of bone deformities. It is an all-in-one system intended to be used for the treatment of charcot, foot and ankle, and congenital deformities in adult and pediatric subgroups (except newborns).
Segments Covered in the report
This report offers historical data and forecasts revenue growth at a regional and country level, and provides an analysis of market trends in each sub-segment from 2022 to 2030.For this report, Reports and Data has segmented the foot and ankle allograft market based on product type, application type, surgery type, end user, and region:
Foot and Ankle Allograft Market Report Scope
Segments covered By Product Type Outlook, Application Outlook, Surgery Type Outlook, End User Outlook,Regional Outlook
By Product Type Outlook
Allograft Acellular Dermal Matrix
Cartilage Allograft Matrix
By Application Outlook
By Surgery Type Outlook
Soft Tissue Tendon & Ligament Repair
By End User Outlook
Ambulatory Surgical Centers
Middle East & Africa
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