Orthobiologics Market Size and Share
Market Overview
| Study Period | 2019 - 2030 |
|---|---|
| Market Size (2025) | USD 6.68 Billion |
| Market Size (2030) | USD 9.06 Billion |
| Growth Rate (2025 - 2030) | 6.28% CAGR |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. |
|
Orthobiologics Market Analysis by Mordor Intelligence
The orthobiologics market size is USD 6.68 billion in 2025 and is forecast to reach USD 9.06 billion by 2030, reflecting a 6.28% CAGR. Growth stems from the steady move away from open surgery toward biologically driven, minimally invasive care that speeds healing and improves long-term function. Pay-for-outcome models, a spike in sports-related injuries, and expanding outpatient surgery networks are channeling demand toward easy-to-handle injectable and synthetic graft products. North America retains leadership on the back of favorable coverage and deep clinical expertise, while Asia-Pacific is accelerating as local device makers scale up production and regulators streamline approvals. Competitive rivalry is sharpening as large device companies widen regenerative portfolios and agile start-ups introduce peptide scaffolds and digital-planning platforms that challenge legacy grafts.
Key Report Takeaways
- By product category, viscosupplementation led with 61.34% of orthobiologics market share in 2024, while stem cell therapies are advancing at a 9.20% CAGR through 2030.
- By surgical site, knee procedures commanded 35.29% share of the orthobiologics market size in 2024, whereas foot and ankle applications are projected to expand at an 8.74% CAGR.
- By delivery method, injectable biologics accounted for 54.18% of the orthobiologics market size in 2024 and topical or surface coatings are set to grow at 9.22% CAGR.
- By application, spinal fusion captured 72.49% of the orthobiologics market share in 2024, while sports soft-tissue injuries are forecast to post an 8.97% CAGR.
- By end-user, hospitals and orthopedic centers held 57.65% share in 2024; ambulatory surgical centers are expected to grow at an 8.30% CAGR.
- By geography, North America dominated with a 43.52% share in 2024, whereas Asia-Pacific is on track for an 8.62% CAGR through 2030.
Global Orthobiologics Market Trends and Insights
Drivers Impact Analysis
| Driver | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Surge in High-Performance Sports Medicine Procedures | +1.2% | North America, Europe, Asia-Pacific | Short term (≤ 2 years) |
| Multi-Injection Hyaluronic Acid Use in Osteoarthritis | +0.9% | Global | Medium term (2-4 years) |
| Orthobiologics Adjuncts in Spinal Fusion | +0.8% | North America, Europe, Asia-Pacific | Medium term (2-4 years) |
| Growing Evidence for PRP And Cell Therapies | +0.7% | Global | Medium term (2-4 years) |
| Shift To Outpatient Centers and Ready-To-Use Grafts | +0.6% | North America, Europe | Short term (≤ 2 years) |
| Pipeline of Synthetic Peptide Bone Grafts | +0.5% | Global | Long term (≥ 4 years) |
| Source: Mordor Intelligence | |||
Surge in High-Performance Sports Medicine Procedures Requiring Rapid Biological Healing
Demand from athletes and active adults is boosting platelet-rich plasma (PRP) and mesenchymal stem cell (MSC) use. Randomized studies[1]Ryan S. D’Souza, “Evidence-Based Clinical Practice Guidelines on Regenerative Medicine Therapy for Chronic Pain: A Consensus Report From a Multispecialty Working Group,” Journal of Pain Research, dovepress.com now show superior symptom relief and faster tissue recovery versus corticosteroids in lateral epicondylitis and knee osteoarthritis. Team physicians are moving these biologics to first-line therapy, shortening rehabilitation and supporting an early return to play across competitive leagues.
Accelerated Adoption of Hyaluronic-Acid Multi-Injection Protocols in Osteoarthritis Management
Novel classification tools such as ViSCNOVAS[2]Fábio Ramos Costa, “ViSCNOVAS: A Novel Classification System for Hyaluronic Acid-Based Gels in Orthobiologic Products and Regenerative Medicine,” Gels, mdpi.com guide clinicians to choose the most effective formulation by viscosity and cross-linking features, improving clinical consistency. Large orthopedic practices in Japan and the United States now favor three-injection regimens that show longer pain relief and joint function gains compared with single-shot products.
Rising Integration of Orthobiologics Adjuncts in Spinal Fusion to Reduce Revision Surgery Rates
Proprietary bone matrices have achieved 100% fusion at 12 months in multilevel procedures, lowering costly re-operations. Hospitals therefore include biologic grafts in value-based purchasing contracts focused on episode-of-care savings.
Expanding Clinical Evidence Supporting PRP and Cell-Based Therapies in Orthopedic Clinics
Meta-analyses covering delayed and non-union fractures reveal faster consolidation when growth factors are added to standard fixation. FDA approval of the allogeneic MSC therapy Ryoncil in December 2024 is encouraging investors to accelerate similar pipelines.
Restraints Impact Analysis
| Restraint | (~) % Impact on CAGR Forecast | Geographic Relevance | Impact Timeline |
|---|---|---|---|
| Absence of reimbursement for autologous cell products | -0.7% | Global | Medium term (2-4 years) |
| Evolving biologics regulatory classification | -0.5% | Global | Medium term (2-4 years) |
| Variability in PRP and stem-cell preparations | -0.4% | Global | Short term (≤ 2 years) |
| Price pressure from commodity allografts | -0.3% | North America, Europe | Short term (≤ 2 years) |
| Source: Mordor Intelligence | |||
Absence of Reimbursement Frameworks for Autologous Cell-Based Orthobiologics Elevating Out-of-Pocket Costs
Major insurers still label many MSC injections as investigational. Patients therefore self-pay, which restricts access to higher socioeconomic groups and slows routine adoption.
Stringent and Evolving Biologics Regulatory Classification Increasing Time-To-Market for Novel Products
The European Union’s new SoHO rules add documentation for human-tissue-derived materials, delaying launches and raising compliance costs.
Segment Analysis
By Product: Viscosupplementation retains scale while stem cells accelerate
Viscosupplementation commanded 61.34% of orthobiologics market share in 2024 and remained a mainstay for knee osteoarthritis thanks to established payer coverage and predictable outcomes. The orthobiologics market size tied to viscosupplementation is set to climb steadily as multi-injection protocols demonstrate durable relief. Parallel research into cross-linked formulations is extending dwell time inside the joint space, creating premium tiers that hospital formularies are adopting.
Stem cell therapies hold only a mid-single-digit revenue base in 2025 yet are posting a 9.20% CAGR, the fastest within the product mix. FDA approval of Ryoncil validated allogeneic platforms, while automated bioreactors like Cocoon promise lower batch-to-batch variation and cost. Demineralized bone matrix, allografts, and bone morphogenetic proteins remain important for surgeons managing complex fusions, with Renovos’ peptide-anchored BMP-2 poised to enter U.S. distribution once pivotal data mature.
Note: Segment shares of all individual segments available upon report purchase
By Surgical Site: Knee dominance widens as foot and ankle emerge
Knee procedures accounted for 35.29% of 2024 revenue, underpinned by the high incidence of osteoarthritis and ligament injuries among aging yet active populations. Clinical guidelines now place PRP ahead of corticosteroids for degenerative knee disease, lifting unit volumes.
The foot and ankle segment holds a smaller base but is on track for an 8.74% CAGR as physicians apply biologics to Achilles and mid-foot reconstruction where traditional grafts underperform. Spine remains core because of fusion necessity, and hip, shoulder, and elbow continue to gain share as sports surgeons broaden rotator cuff and labral repair protocols.
By Delivery Method: Injectables lead and surface coatings gain momentum
Injectables delivered 54.18% of global revenue in 2024, illustrating their versatility across joints and their fit with the outpatient shift. They anchor rapid recovery pathways and support value-based payment bundles by cutting operating time.
Topical and surface coatings are growing at 9.22% CAGR. Advances in nano-porous titanium and antibiotic-eluting ceramics improve implant integration and infection protection in high-risk hips and knees. Hybrid systems merge injectable carriers with 3-D printed scaffolds, letting surgeons coat hardware intraoperatively and boost local biology.
By Application: Spinal fusion still rules while sports injuries surge
Spinal fusion made up 72.49% of 2024 demand, highlighting its reliance on biologics to secure stable arthrodesis in multilevel disease. The orthobiologics market size for spinal fusion is forecast to stay dominant as aging demographics meet rising degenerative disc diagnoses.
Sports soft-tissue injuries will see an 8.97% CAGR. New equine-to-human translational studies showcase faster tendon healing, and professional leagues have started covering PRP injections in collective bargaining agreements. Trauma, fracture, cartilage, and tendon repair together offer additive growth as product lines become site specific.
By End-User: Hospitals anchor adoption yet ambulatory centers expand fast
Hospitals and dedicated orthopedic centers held 57.65% of 2024 sales due to their capacity to manage high-acuity cases that need complex grafts. Many academic centers have set up orthobiologics units that blend clinical care and translational research, standardizing protocols across departments.
Ambulatory surgical centers log the highest growth at 8.30% CAGR. Their business model favors single-use, prefilled, and injection-ready kits. Strategic deals such as SCA Health’s acquisition of OrthoAlliance underline consolidation aimed at scaling outpatient orthopedics.
Geography Analysis
North America accounted for 43.52% of 2024 global revenue. Uptake in the United States is reinforced by a mature reimbursement framework for viscosupplementation and rapid procedure migration to ambulatory centers. The orthobiologics market size in the U.S. is expanding at 5.86% CAGR as breakthrough designations shorten the time to launch for synthetic grafts like RENOVITE BMP-2. Canada mirrors these trends, with provincial plans gradually adding PRP for knee osteoarthritis.
Europe ranks second and is growing at 6.19% CAGR. Adoption is steady in Germany, France, and Italy, where state health systems reimburse established grafts. Compliance work for new SoHO rules is extending approval cycles for tissue-derived therapies, so firms such as Bonesupport[3]BONESUPPORT, “BONESUPPORT Files FDA Submission for Cerament V,” BONESUPPORT Press Release, bonesupport.com are prioritizing synthetic matrices that clear under device codes. Nordic countries lead registry-based evidence generation that bolsters payer confidence.
Asia-Pacific is the fastest riser at 8.62% CAGR. Japan’s multi-injection hyaluronic acid protocols set clinical benchmarks, while China’s “Healthy China 2030” roadmap is spurring domestic innovators to upgrade from commodity allografts to advanced peptide scaffolds. India’s MedTech policy aims to scale the sector to USD 50 billion by 2030, opening local manufacturing incentives for orthobiologics. Smaller yet high-growth markets in South America and the Middle East benefit from rising private insurance coverage and specialist clinic networks that import ready-to-use injectables.
Competitive Landscape
Johnson & Johnson, Medtronic, and Stryker control broad portfolios that span viscosupplementation, demineralized bone matrix, and synthetic grafts. They channel resources into digital planning tools that align implant placement with biologic delivery to enhance accuracy. Zimmer Biomet highlighted[4]Zimmer Biomet, “Zimmer Biomet Highlights Diverse Portfolio of Orthopedic Musculoskeletal Innovations at AAOS 2025 Annual Meeting,” Zimmer Biomet Press Release, investor.zimmerbiomet.com AI-guided knee planning software during AAOS 2025 to complement its subchondroplasty injectable.
Mid-cap specialists, including Bioventus and Bonesupport, focus on evidence-rich platforms. Bioventus backs multicenter registries to support payer dossiers, while Bonesupport pursues antibiotic-eluting bone void fillers to address infection-prone trauma segments. These companies often partner with the distribution networks of larger OEMs to reach community hospitals.
Venture-backed disruptors such as OssDsign and Ventris Medical introduce niche solutions that tackle limitations of allografts. OssDsign Catalyst’s peptide nano-silica matrix achieved 100% fusion in early studies and is now used by 10,000 U.S. patients. Ventris Medical’s Backpack system gained FDA clearance in January 2025 and targets streamlined handling for outpatient spine. Automation technology from Octane Medical promises consistent, lower-cost cell therapy batches that could trigger broader payer adoption. Companies, therefore, race to secure breakthrough labels, intellectual property, and clinical data that translate into pricing power.
Orthobiologics Industry Leaders
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BoneSupport AB
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Johnson & Johnson
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Medtronic PLC
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Stryker Corporation
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Zimmer Biomet Holdings Inc.
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- May 2025: OssDsign reported that 10,000 patients had been treated with OssDsign Catalyst, its synthetic bone graft that enhances natural healing, demonstrating the product’s growing clinical adoption in the United States orthobiologics market.
- January 2025: Ventris Medical received FDA 510(k) clearance for its Backpack bone graft containment system, which includes prefilled osteoinductive and surface-activated versions for optimized bone formation.
- December 2024: The FDA approved Mesoblast’s Ryoncil (remestemcel-L-rknd), an allogeneic bone marrow mesenchymal stromal cell therapy, marking a milestone for MSC products in the United States.
- June 2024: Octane Medical Group acquired B. Braun’s global orthobiologics business, including TETEC AG and Aesculap Biologics, to strengthen its regenerative medicine platform.
Global Orthobiologics Market Report Scope
As per the report's scope, orthobiologics are used by orthopedic surgeons to help injuries heal more quickly. They quicken the healing of broken bones and injured muscles, tendons, and ligaments. These products are made from substances that are naturally found in our bodies. The Orthobiologics Market is Segmented by Product (Viscosupplementation Products, Demineralized Bone Matrices, Synthetic Orthobiologics, Bone Morphogenic Protein, Allografts, and Others (Plasma-rich Protein, and Bone Marrow Aspirate Concentrate)), Application, (Osteoarthritis and Degenerative Arthritis, Spinal Fusion, Soft-tissue Injuries, and Others (Fracture Recovery, and Maxillofacial and Dental Applications)), End User (Hospitals, Orthopedic Clinics, and Ambulatory Care Centers, Academic and Research Institutes, and Dental Clinics and Facilities), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America). The market report also covers the estimated market sizes and trends for 17 countries across major global regions. The report offers the value (USD million) for the above segments.
| Viscosupplementation Products |
| Demineralized Bone Matrix |
| Allografts |
| Synthetic Bone Substitutes |
| Bone Morphogenetic Proteins |
| Platelet-Rich Plasma |
| Stem Cell Therapies |
| Other Orthobiologics |
| Knee |
| Hip |
| Spine |
| Shoulder & Elbow |
| Foot & Ankle |
| Other Joints |
| Injectable Biologics |
| Implantable/Scaffold Grafts |
| Topical & Surface Coatings |
| Spinal Fusion |
| Sports Soft-Tissue Injuries |
| Trauma & Fracture Recovery |
| Other Applications |
| Hospitals & Orthopedic Centers |
| Ambulatory Surgical Centers |
| Sports Medicine & Rehabilitation Clinics |
| Other End-Users |
| North America | United States |
| Canada | |
| Mexico | |
| Europe | Germany |
| United Kingdom | |
| France | |
| Italy | |
| Spain | |
| Rest of Europe | |
| Asia-Pacific | China |
| Japan | |
| India | |
| Australia | |
| South Korea | |
| Rest of Asia-Pacific | |
| Middle East & Africa | GCC |
| South Africa | |
| Rest of Middle East & Africa | |
| South America | Brazil |
| Argentina | |
| Rest of South America |
| By Product | Viscosupplementation Products | |
| Demineralized Bone Matrix | ||
| Allografts | ||
| Synthetic Bone Substitutes | ||
| Bone Morphogenetic Proteins | ||
| Platelet-Rich Plasma | ||
| Stem Cell Therapies | ||
| Other Orthobiologics | ||
| By Surgical Site | Knee | |
| Hip | ||
| Spine | ||
| Shoulder & Elbow | ||
| Foot & Ankle | ||
| Other Joints | ||
| By Delivery Method | Injectable Biologics | |
| Implantable/Scaffold Grafts | ||
| Topical & Surface Coatings | ||
| By Application | Spinal Fusion | |
| Sports Soft-Tissue Injuries | ||
| Trauma & Fracture Recovery | ||
| Other Applications | ||
| By End-User | Hospitals & Orthopedic Centers | |
| Ambulatory Surgical Centers | ||
| Sports Medicine & Rehabilitation Clinics | ||
| Other End-Users | ||
| By Geography (Value) | North America | United States |
| Canada | ||
| Mexico | ||
| Europe | Germany | |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Asia-Pacific | China | |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Middle East & Africa | GCC | |
| South Africa | ||
| Rest of Middle East & Africa | ||
| South America | Brazil | |
| Argentina | ||
| Rest of South America | ||
Key Questions Answered in the Report
Why are multi-injection hyaluronic acid regimens gaining favor over single-shot approaches in osteoarthritis care?
Clinical studies show longer pain relief and improved joint function when multi-injection protocols maintain therapeutic viscosity in the joint space, prompting wider guideline adoption.
What role do synthetic peptide bone grafts play in reducing reliance on autograft harvesting?
Peptide-engineered scaffolds mimic native bone signaling, achieve high fusion rates, and eliminate donor-site morbidity, making them attractive for complex spinal and trauma cases.
How is the shift to outpatient orthopedic centers shaping product design in orthobiologics?
Ambulatory facilities demand ready-to-use, minimally invasive injectables that shorten preparation time and fit same-day discharge workflows, driving innovation in shelf-stable formulations.
Which regulatory pathway is most frequently leveraged by developers of next-generation orthobiologic devices in the United States?
Companies increasingly pursue the FDA’s Breakthrough Devices Program to secure accelerated review for novel biologic-device hybrids offering significant clinical improvement.
How are digital planning tools enhancing the effectiveness of orthobiologic interventions?
AI-driven imaging platforms allow surgeons to map precise graft placement and dosing, improving procedural accuracy and potentially boosting healing outcomes across spine and joint repairs.
Why are outpatient centers important for orthobiologics growth?
Ambulatory surgical centers prefer injectable and ready-to-use grafts that shorten procedure time, which is driving an 8.30% CAGR in this end-user segment.
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