Orthobiologics Market Size Share Segmentation By Product, By Application (Spinal fusion, Trauma repair, Reconstructive surgery), By End-use, By Region| Global Market Forecast 2024-2032

Orthobiologics Market Report Scope & Overview:

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The Orthobiologics Market was valued USD 7.15 billion in 2023 anticipated to grow USD 11.59 billion by 2032 with compound annual growth rate of 5.55% over the forecast period 2024-2032.

Orthobiologic drugs are advancing to include growth factors as a piece of the market. These biocompatible materials stimulate tissue regeneration and pain relief, setting a new course away from traditional surgical treatment. Primary market drivers include the aging population, who are more prone to osteoarthritis. Other factors, including increasing obesity rates and more accidents as well as a heightened understanding of sophisticated treatments on the orthobiologics market are driving demand higher.

High incidence of bone diseases including tumors and infections (leading to prolonged recovery) is a major factor driving the growth of orthobiologics market. These products helped with treating a variety of traumas, bone lesions and fractures as well. They are favored for the treatment of bone defects due to their efficacy as the preferred treatment option. Furthermore, the increasing application of stem cell-based allografts in orthopedic procedures is also boosting orthobiologics market growth.

A fast-growing area of regenerative medicine, orthobiologics provides non-surgical alternatives for patients with acute orthopedic complaints and chronic degenerative processes. These bioactive products use growth factors to relieve pain, promote the healing process of tissues and restore function. Given varied mechanisms of action and promising results in muscle, joint and soft tissue injuries, orthobiologics have been frequently the focus on much enterprise interest.

The result for patients is further access to its bone regeneration tech, which was marked as a big win in OssDsign's favor. Premier Inc., a leading health care alliance serving approximately 4,350 U.S. hospitals and more than 300,000 other providers has executed a new three-year group purchasing agreement with the company. The agreement, which becomes effective in July 2024, provides Premier members with special pricing and terms for OssDsign's lead offering the OssDsign catalyst.

Bioventus provides an extensive line of surgical biologics for all bone grafting indications. Their products also extend to allografts and include franchise devices in autologous cell extraction bone marrow harvest, ultrasonic surgical tools for tissue specific applications. These solutions span patient conditions, types of surgeries and budgetary requirements.

In early 2024 Kuros Biosciences launched the MagnetOs family of products. The clearance covers the MagnetOs Granules and Easypack Putty for interbody use, plus based on a separate 510(k) filing last year, the MagnesOs granules as a standalone graft for posterolateral spine. In New Zealand, MagnetOs Granules and the recently launched novel putty format were granted regulatory approval by Medsafe in December 2020.

Orthobiologics are a group of advanced biotechnology products, which play in regenerative medicine categories. Novel biomaterials, growth factors and stem cell therapies along with advances in tissue engineering are broadening the field for treatment options leading to a remarkable expansion of orthobiologics market.

Market Dynamics:

Drivers

• Increased Prevalence Of Orthopedic Injuries And Product Launches Drive The Market

The global market for orthobiologics is escalating rapidly due to the increasing population with musculoskeletal diseases. For example, osteoporosis causing more hip and spine fractures are major contributors like 6.8 million orthopedic injury cases annually in the U.S according to American Academy of Orthopedic Surgeons as an example.

key players in the orthobiologics market are introducing novel products which is translating into encouraging growth traction. The spectrum varies from allografts to bone growth factors and synthetic bone substitutes. For example, Royal Biologics gave its DMSO-free viable cellular bone allograft called MAGNUS in January 2020. Moreover, increasing inclination towards antibiotic-eluting bone void fillers in treatment of various bone disorders also favouring the growth of orthobiologics market. This is illustrated through the CE Mark approval of STIMULAN by biocomposites during April 2020 which includes use with certain antibiotic solutions (e.g. vancomycin, gentamicin and tobramycin) in bone void fillers for infected soft tissue and/or bone management applications and with the development of new orthobiologic products is anticipated to increase market growth in future.

For instance, Locate Bio is a new high flyer on the orthobiologics block and has achieved some major milestones in 2023. The company received FDA approval to designation for its LDGraft device in May 2023. This designates medication as "heal or critical" which allows faster approval of new drugs to treat serious diseases and anything generating irreversible suffering. In April 2024, they announced that, hit £9.2 million ($11.6m) in funding to further develop their tests and push towards getting them into clinics, with COVID-19 increasing industrial resonance as it claims the lives not just for elder but also young people across U.S.

Restraints

• High Costs, Regulatory Issues Preventing Growth

Although very promising, the market for orthobiologics is also plagued with several problems. Most importantly, the cost of developing, manufacturing and delivering these products is higher and tends to slow market penetration. Also, because the regulatory processes are so stringent (as they should be to ensure product safety and efficacy) bringing a new product to market can prove time-costly as well - in steps of FDA. All of these together make up an orthobiologics companies complex as well as competitive landscape.

Key Market Segmentation

By Product

• Demineralized Bone Matrix

• Allograft

• Bone morphogenetic protein (BMP)

• Viscosupplementation

• Synthetic bone substitutes

• Stem cell therapy

Viscosupplementation dominated the orthobiologics market in 2023, accounting for over 40% of revenue. This segment is propelled by the surging osteoarthritis patient population, which is expected to increase by 132.2% from 1990 to 2020, reaching 595 million cases globally. Projections indicate further growth in osteoarthritis cases, particularly for knees, hands, and hips, by 74.9%, 48.6%, and 78.6%, respectively, by 2050. Hyaluronic acid injections, the primary method, contributes to orthobiologics market expansion due to their ease of use and good tolerance.

The stem cell therapy segment is poised for the fastest growth during the forecast period. Rising healthcare spending, an emphasis on personalized medicine, and advancements in biotechnology and regenerative medicine are creating a favorable environment for this segment's expansion. Innovative stem cell therapy techniques and products are driving market growth.

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By Application

• Spinal fusion

• Trauma repair

• Reconstructive surgery

Spinal fusion led the orthobiologics market in 2023, with over 50% of share. This is driven by the escalating prevalence of spine disorders, with over 400,000 spinal fusion surgeries performed annually in the U.S. The use of bone morphogenetic proteins, demineralized bone matrices, autografts, and allografts, due to their efficacy in promoting bone stability and healing, is fueling segment growth. For instance, OssDsign AB, now focusing exclusively on orthobiologics, is concentrating on its nanosynthetic bone graft, OssDsign Catalyst, which boasts high-growth margins and is designed for spinal fusion procedures.

The reconstructive surgery segment is projected to experience substantial growth. An aging population, coupled with the rise in musculoskeletal disorders, is driving demand for reconstructive procedures. The surge in both surgical and non-surgical procedures performed by plastic surgeons, increasing by 11.2% in 2022 to reach 18.8 million and 14.9 million, respectively, underscores this factor. Orthobiologics are increasingly utilized in reconstructive surgeries to enhance bone healing, soft tissue repair, and joint function restoration.

By End-use

• Hospitals

• Outpatient Facilities

Hospitals dominated over 60% of the orthobiologics market share in 2023. Their advanced infrastructure and comprehensive services make them well-equipped for utilizing these products.

A key driver for hospitals is the rising demand for minimally invasive procedures, which orthobiologics facilitate. These interventions leverage the body's natural healing processes, minimizing the need for extensive surgeries and long hospital stays. Additionally, hospitals integrate advanced imaging and surgical techniques, allowing for precise administration of orthobiologics, promoting tissue regeneration and swifter recovery.

Outpatient facilities are anticipated to experience significant growth due to the growing trend towards ambulatory care and same-day surgeries. This shift offers patients seeking minor orthopedic procedures or sports injury treatments a convenient and cost-effective option. For example, a Definitive Healthcare report revealed that Specialists One-Day Surgery Centers performed a notable 1.6% of all knee replacement procedures in 2022, highlighting the increasing role of outpatient facilities.

Regional Analysis:

North America held the largest share of the global orthobiologics market in 2023, accounting for 46.2% of revenue. This dominance is attributed to advanced technologies, robust healthcare infrastructure, favorable reimbursement policies, and a supportive regulatory environment. The region's aging population, with a median age increasing to 0.2 years in 2022, further fuels market growth. The U.S. orthobiologics market is the primary growth driver within North America, representing nearly 90% of the regional market. A strong emphasis on research and technological innovation has led to a pipeline of advanced orthobiologic products. For example, Dr. Scott A. Rodeo from Hospital for Special Surgery received a USD 50,000 grant in July 2021 to research an injectable biologic for knee treatment.

The Europe orthobiologics market is the fastest growing region driven by an aging population grappling with an increased incidence of musculoskeletal disorders, demand for innovative treatment solutions like orthobiologics is on the rise. Additionally, the presence of a strong pharmaceutical and medical device industry within Europe fosters research and development in this field, further stimulating market expansion.

Regional coverage

North America

• US

• Canada

• Mexico

Europe

• Eastern Europe

  • Poland

  • Romania

  • Hungary

  • Turkey

  • Rest of Eastern Europe

• Western Europe

  • Germany

  • France

  • UK

  • Italy

  • Spain

  • Netherlands

  • Switzerland

  • Austria

  • Rest of Western Europe

Asia Pacific

• China

• India

• Japan

• South Korea

• Vietnam

• Singapore

• Australia

• Rest of Asia Pacific

Middle East & Africa

• Middle East

  • UAE

  • Egypt

  • Saudi Arabia

  • Qatar

  • Rest of the Middle East

• Africa

  • Nigeria

  • South Africa

  • Rest of Africa

Latin America

• Brazil

• Argentina

• Colombia

• Rest of Latin America

Key Players:

Bone Biologics Corp., Medtronic PLC, Anika Therapeutics, Inc., DePuy Synthes, Arthrex, Inc., Zimmer Biomet, Globus Medical, Stryker Corporation, Orthofix, Inc., Bioventus LLC and others.

Recent Developments

Isto Biologics and Advanced Biologics merged in October 2023 to create a combined force in the orthobiologics market. The merger integrated Advanced Biologics' proprietary products into Isto's Influx allograft portfolio. The companies had previously collaborated since 2020 on Isto's SPARC integrative bone matrix, which leveraged Advanced Biologics' tissue processing technology used in its OsseoGen allograft.