ORTHOBIOLOGICS MARKET ANALYSIS

Market Size and Trends

The global orthobiologics market is estimated to be valued at USD 7.21 Bn in 2024 and is expected to reach USD 10.96 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 6.2% from 2024 to 2031.

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The orthobiologics market is expected to witness high growth over the forecast period. The market is driven by factors such as rising geriatric population, increasing incidence of chronic conditions, and sports injuries. Additionally, advantages of orthobiologics over traditional therapies such as lesser risk of disease transmission and reduced procedural invasiveness are boosting their demand. Furthermore, the ongoing development of advanced products with improved therapeutic efficacy is expected to provide opportunities for market growth. However, higher costs compared to alternative treatments and stringent regulatory frameworks are some challenges hampering the market growth.

Increasing prevalence of orthopedic diseases

The Increasing prevalence of diseases and conditions has been on the rise over the past few decades. As lifestyle patterns changed with increased sedentary jobs and less physical activity, obesity rates surged dramatically impacting musculoskeletal health. According to studies, obesity significantly increases the risk of developing osteoarthritis, one of the most common orthopedic ailments affecting mobility and quality of life especially in the geriatric population. Similarly, the risks of bone fractures, joint replacements, and spinal disorders are heightened due to excess weight. With overall improvement in life expectancy worldwide. Old age itself is a risk factor for osteoarthritis and osteoporosis as the regenerative abilities of the body slows down with time. Moreover, weight-bearing and repetitive physical activities performed throughout lifetime often manifest their effects on the bones and joints only later in life. Seniors are also prone to fall-related injuries like hip fractures.

Market Concentration and Competitive Landscape

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The adoption of inorganic growth strategies such as product launches by key market players is expected to drive the global orthobiologics market growth over the forecast period. For instance, in July 2022, Ossifix Orthopedics, a subsidiary of Umbra Applied Technologies Group, Inc., a medical technology company, announced that it had launched crunch, a demineralized bone matrix that contains cancellous bone fragments to provide the osteoconductive scaffolding to promote new bone growth. This product launch will expand its suite of orthopedic products.

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Increasing number of product recalls by regulatory authorities such as the U.S. Food and Drug Administration is expected to hinder the market growth over the forecast period. For instance, in June 2021, the U.S. Food and Drug Administration recalled a FiberCel Fiber Viable Bone Matrix, a bone repair product made from human tissue that is used in various orthopedic and spinal procedures. The product was manufactured by Aziyo, a biotechnology company. The device was recalled due to the post-surgical infections in patients treated with FiberCel.

Market Opportunities – Increasing Adoption of Inorganic Growth Strategies  

Increasing agreements among key market players are expected to offers lucrative opportunities in the market over the forecast period. For instance, in August 2022, Orthofix Medical Inc., a medical device company with a focus on spine and orthopedics, announced a strategic partnership agreement with CGBio, a developer of innovative, synthetic bone grafts currently used clinically in Asia Pacific for spine, orthopedic, trauma, and dental applications. The two companies will work together for the clinical development and commercialization of Novosis recombinant human bone morphogenetic protein-2 (rhBMP-2) bone growth materials and other future tissue regenerative solutions for the U.S. and Canadian markets.

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The product type segment includes bone allograft, machined bones, demineralized bone matrix, synthetic bone substitutes, bone morphogenetic protein (bmp), and others. The bone allograft sub-segment is estimated to hold 33.4% of the market share in 2024 owing to its advantages over synthetic substitutes. Bone allografts are the most preferred option for orthopedic procedures like spinal fusion due to their osteoinductive properties that aid in new bone formation. Compared to synthetic substitutes, bone allografts provide a more physiological healing environment and help achieve long term fusion through remodeling. Advancements in allograft processing have also addressed safety concerns related to disease transmission, making them safer and readily available. Moreover, bone allografts elicit a more natural healing response from the body as compared to synthetic bone graft substitutes. This factor has been a major driver for the growth of the bone allograft segment. Developments in bone processing technologies that efficiently maintain the biological properties and microstructures of donated bones further support the increasing demand for bone allografts in orthopedic surgical procedures.

Insights, By Application: Rising Incidence of Spinal Disorders

The application segment includes spinal fusion, trauma fixation, reconstructive joint surgery, and others. The spinal fusion sub-segment is estimated to hold 37.4% of the market share in 2024 owing to the rising prevalence of spinal disorders globally. Conditions like degenerative disc disease, spondylolisthesis, spinal stenosis, and spinal deformities lead to severe back pain and neurological compromise. Spinal fusion surgery offers clinical benefits like reduced pain, restored stability, and improved neurological function in patients with unstable spinal conditions. It is gradually becoming the standard of care for spine pathologies warranting surgical intervention. The availability of advanced interbody fusion devices, bone graft substitutes, and fixation systems has further boosted the adoption of spinal fusion as a preferred technique for correcting spinal deformities.

Insights, End User: Expanding Healthcare Infrastructure

The end user segment includes hospitals, orthopedic clinics, ambulatory surgical centers, and others. The hospitals sub-segment is estimated to hold 39.9% of the market share in 2024 owing to their advanced infrastructure and concentration of specialty orthopedic surgeons. Well-equipped operation theatres, intensive care facilities, and in-house rehabilitation services enable complex orthobiologics procedures like spinal fusions to be performed safely under hospital settings. Expanding healthcare infrastructure in developing nations, favorable government initiatives towards boosting healthcare access, and rising medical tourism are fueling the demand for orthopedic services within hospitals. Preference for hospitals also stems from the fact that most orthobiologics procedures require care beyond stand-alone clinics during the early postoperative period. Moreover, large patient volumes allow for cost-saving through bulk procurement of orthobiologics products in hospitals. These factors have established hospitals as the key end-users for orthobiologics.

Regional Insights

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North America remains the dominant region in the global orthobiologics market and is estimated to hold 37.6% of the market share in 2024. This can be attributed to factors such as the strong presence of international players in countries like the U.S. These companies have been investing heavily in R&D to develop advanced orthobiological solutions. Moreover, favorable reimbursement policies for orthopedic procedures have ensured higher adoption of orthobiologics in medical practices. The U.S. market in particular benefits from a well-established healthcare infrastructure and presence of major research universities that contribute to ongoing innovation.  Another notable trend has been the emergence of strong domestic players in North America. As they improve their product portfolios through innovations, they have been able to grab a significant market share locally. This has further intensified competition and accelerated new product launches. The region also serves as an export hub with North American companies looking to establish their global footprints.

The Asia Pacific region has emerged as the fastest growing market owing to rapid economic development and growing medical expenditures that have raised healthcare standards across multiple countries such as China and India. This has boosted the number of orthopedic surgeries performed annually. Coupled with rising awareness about advanced treatments, the demand for orthobiologics is surging rapidly in Asia Pacific. Countries like China and India with their huge patient pools present immense opportunities for market players. Local manufacturers have strengthened their presence with production facilities catering to significant domestic needs as well as overseas markets through exports. This has made the region less dependent on imports. Governments are also implementing new regulations to encourage clinical research and product innovation. Various new specialized hospitals and bone banks have come up to support the market growth. Overall, Asia Pacific's promising economic outlook and healthcare reforms are likely to cement its position as the fastest growing market for orthobiologics.

Market Report Scope

Key Developments

• On February 13, 2024, Tetrous, Inc., a regenerative medicine company, announced the launch of EnFix TAC to its family of EnFix demineralized bone allograft implants for use in rotator cuff surgery
• In October 2023, Orthofix US LLC., a global spine and orthopedics company, announced the launch of OsteoCove, an advanced bioactive synthetic graft for use in spine and orthopedic procedures
• In April 2023, ZimVie Inc., a global life science company, announced the launch of RegenerOss CC Allograft Particulate, a natural blend of cortical and cancellous bone particles that can be used to fill bony voids in a variety of dental applications, and the RegenerOss Bone Graft Plug, an easy-to-use grafting solution for filling extraction sockets and periodontal defects
• In June 2022, AlloSource, allograft providers in the U.S., announced the addition of AlloFuse Micro Fibers Demineralized Bone allograft for use in spinal, foot, and ankle or other orthopedic procedures. AlloFuse Micro Fibers are made of 100 percent demineralized cortical bone and does not contain any form of carrier.
• In March 2022, Molecular Matrix, Inc., a regenerative medicine polymer technology company, announced that it had launched Osteo-P Synthetic Bone Graft Substitute (BGS) for use in the musculoskeletal system. Osteo-P BGS is made using Molecular Matrix, Inc.’s hyper-crosslinked carbohydrate polymer (HCCP) technology platform which has been engineered to optimize the microenvironment for bone repair and regeneration.
• In March 2022, SeaSpine, a medical technology company, launched the NorthStar cervical facet fusion and Flash navigation lumbar facet fusion orthobiologic systems to streamline reproducible procedural workflow while maximizing the area for fusion with OsteoStrand DBM fibers contained within the facet joint

*Definition: Orthobiologics use body’s own cells and healing factors to reverse the effects of orthoarthritis and accelerate the healing of tendon and ligament injuries (rotator cuff tendonitis, ankle sprain, etc.). Orthobiologics involve substances that help the body to heal more quickly. They can improve the healing of injured muscles, tendons, and ligaments and help to repair damage from osteoarthritis. These products are made from substances that are naturally found in body. Stem cells are special cells in body that can turn into other types of cells. During the healing process, stem cells are called to the area of body that needs to repair.

Market Segmentation

• Product Type Insights (Revenue, USD Bn, 2019 - 2031)
  • Bone Allograft
  • Machined Bones
  • Demineralized Bone Matrix
  • Synthetic Bone Substitutes
  • Bone Morphogenetic Protein (BMP)
  • Others
•  Application Insights (Revenue, USD Bn, 2019 - 2031)
  • Spinal Fusion
  • Trauma Fixation
  • Reconstructive Joint Surgery
  • Others
•  End User Insights (Revenue, USD Bn, 2019 - 2031)
  • Hospitals
  • Orthopedic Clinics
  • Ambulatory Surgical Centers
  • Others
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Zimmer Biomet
  • Bone Biologics Corp.
  • Globus Medical
  • Stryker
  • ATEC Spine, Inc.
  • XTANT MEDICAL
  • Johnson & Johnson Services, Inc.
  • Exactech, Inc.
  • NuVasive, Inc.
  • Orthofix US LLC.
  • SeaSpine
  • Spine Wave, Inc.
  • Locate Bio Limited
  • Cerapedics
  • Ossifix Orthopedics
  • Arthrex Inc.
  • AlloSource