오소바이오로직스 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the orthobiologics market size is expected to increase from USD 6.68 billion in 2025 to USD 7.06 billion in 2026 and reach USD 9.52 billion by 2031, growing at a CAGR of 6.17% over 2026-2031.

This report is Segmented by Product (Viscosupplementation Products and More), Surgical Site (Knee, Hip, and More), Delivery Method (Injectable Biologics and More), Application (Spinal Fusion and More), End-User (Hospitals & Orthopedic Centers, Ambulatory Surgical Centers, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market Forecasts are Provided in Terms of Value (USD).

Global Orthobiologics Market Trends and Insights

Rising Osteoarthritis Prevalence & Aging Demographics

Global osteoarthritis cases are forecast to top 700 million by 2030 as populations live longer and obesity rates climb. In the United States, clinically diagnosed prevalence reached 32.5 million adults in 2024, a 15% jump from 2015. Confronted with long surgical wait times, nine months for knee replacement in metropolitan Japan, surgeons increasingly deploy viscosupplementation and PRP as bridge therapies. Direct osteoarthritis care costs the United States USD 185 billion in 2024, prompting payers to consider biologics that may delay arthroplasty. As a result, the orthobiologics market is tightly linked to demographic trends that expand the candidate pool for non-operative biologic interventions.

Shift Toward Minimally-Invasive & Outpatient Orthopedic Procedures

Ambulatory surgical centers (ASCs) performed 5.2 million orthopedic cases in the United States during 2024, up 12% year on year after CMS added complex spine and joint reconstructions to its covered list. ASCs value single-use PRP kits and ready-to-use allograft putties that fit fast-throughput workflows, as evidenced by Zimmer Biomet's GPS III PRP system, which delivers a standardized 6 mL concentrate in under 15 minutes. Reimbursement for single-level lumbar fusion averages USD 18,000 in an ASC versus USD 35,000 in hospital outpatient departments, freeing budget for biologics that enhance fusion. Although Europe lags, Germany's insurers still require hospital admission for most spine work; the outpatient shift is expected to broaden across developed regions, redirecting share within the orthobiologics market toward products optimized for ASC use.

High Therapy Cost & Patchy Reimbursement Coverage

Medicare pays for bone graft substitutes but excludes PRP under most CPT codes, a policy mirrored by major commercial insurers, which label autologous blood-derived products as investigational. Consequently, patients often self-fund USD 1,500-2,500 per PRP series, restricting uptake to affluent demographics. Viscosupplementation enjoys broader coverage at about USD 200 per dose, though prior-authorization hurdles tighten annually. A 2024 cost-utility study found that PRP delayed knee arthroplasty by 2.1 years and saved USD 12,000 per patient, yet payers continue to deny coverage due to the absence of 10-year results. The reimbursement stalemate slows diffusion and moderates the growth curve of the orthobiologics market.

Other drivers and restraints analyzed in the detailed report include:

1. Advances in Regenerative Biomaterials
2. Increasing Sports Injuries Demanding Faster Recovery Solutions
3. Stringent, Region-Specific Regulatory Pathways Slowing Approvals

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Viscosupplementation held a commanding 42.92% share in 2025, supported by two decades of uninterrupted Medicare reimbursement. Platelet-rich plasma is forecast to grow at a 7.09% CAGR, benefiting from point-of-care systems that deliver uniform concentrates in minutes, reducing the variability that bedeviled early centrifuge sets. Bone graft substitutes and DBM together account for about 30% of revenue, driven by more than 550,000 spinal fusion procedures performed in the United States in 2024. Stem cell therapies remain confined to trials and cash-pay clinics because of FDA enforcement against non-homologous use under Section 361.

Bone morphogenetic proteins plateaued near 8% share following black-box safety warnings, yet low-dose BMP-2 formulations that cut adverse events 60% could reignite demand. Viscosupplementation faces payer scrutiny; Anthem now requires genetic testing to confirm responders before approving multi-injection series, signaling future volume pressure. The orthobiologics market size for PRP-based products is likely to expand fastest within this category as standardized devices and elite-athlete endorsements mitigate earlier concerns.

Complete Report Scope:

• By Product Type
  • Bone Graft Substitutes
  • Demineralized Bone Matrix
  • Allografts
  • Bone Morphogenetic Proteins
  • Viscosupplementation
  • Stem Cell Therapy
  • Platelet-Rich Plasma
  • Other Product Types
• By Application
  • Spinal Fusion
  • Trauma & Fracture Repair
  • Reconstructive Surgery
  • Osteoarthritis & Joint Degeneration
  • Other Applications
• By End User
  • Hospitals
  • Ambulatory Surgical Centers
  • Orthopedic & Sports Medicine Clinics
  • Research & Academic Institutes
• By Geography
  • 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

Geography Analysis

North America generated 43.17% of global revenue in 2025, buoyed by 550,000 annual spinal fusions and the world's largest network of in-hospital biologics labs. Section 232 tariffs accelerated reshoring, prompting processors to expand to counter 10-25% import duties on orthopedic hardware. Canada's single-payer system restricts PRP and caps viscosupplementation to 3 injections per year, sending some patients cross-border for care. Mexico's orthopedics sector grew 14% in 2024 as medical tourism surged, but reimbursement remains fragmented across public and private insurers.

Asia-Pacific is projected to grow at an 11.27% CAGR through 2031, propelled by China's 12 regenerative-medicine fast-track approvals in 2025 and India's 22% jump in orthopedic-device imports. China's Tier 1 cities now reimburse stem cell therapies, while rural provinces lag, creating a two-speed market. India's clinical endorsement of PRP in early 2025 legitimized private-sector offerings in a predominantly cash-pay environment. Japan's aging population is putting pressure on capacity, extending wait times for knee replacements, and prompting the use of biologic bridge therapies. Australia harmonized its biologics rules with the FDA in 2024, slashing approval timelines to 10 months. South Korea's National Health Insurance now covers DBM in spinal fusion, expected to lift utilization 30% over two years.

Europe represented significant revenue but faces MDR-related delays that extend product approvals beyond 18 months. Germany's mandatory hospital admission for most spine surgery limits ASC penetration to under 8%, though pilots in Munich and Frankfurt test outpatient models. The United Kingdom's NICE backed PRP for lateral epicondylitis in 2024, opening prospects for wider NHS adoption. France's delisting of viscosupplementation cut its utilization 60%, spurring a shift toward PRP in private practice. GCC countries and Brazil account for the bulk of revenue in the Middle East & Africa and South America, driven by private payers and selective reimbursement for bone graft substitutes.

1. AlloSource
2. Arthrex
3. Baxter
4. Bioventus
5. BoneSupport AB
6. Johnson & Johnson
7. Exactech
8. Globus Medical
9. Kuros Biosciences
10. Medtronic
11. MTF Biologics
12. NuVasive
13. Organogenesis
14. Orthofix
15. Sanofi
16. Seaspine
17. Smiths Group
18. Stryker
19. Terumo
20. Zimmer Biomet

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Osteoarthritis Prevalence & Aging Demographics
  • 4.2.2 Shift Toward Minimally-Invasive & Outpatient Orthopedic Procedures
  • 4.2.3 Advances in Regenerative Biomaterials
  • 4.2.4 Increasing Sports Injuries Demanding Faster Recovery Solutions
  • 4.2.5 Proliferation of In-Hospital Biologics Labs Enabling Point-of-Care Therapies
  • 4.2.6 Tariff-Driven Reshoring Accelerating Localized Orthobiologic Manufacturing
• 4.3 Market Restraints
  • 4.3.1 High Therapy Cost & Patchy Reimbursement Coverage
  • 4.3.2 Stringent, Region-Specific Regulatory Pathways Slowing Approvals
  • 4.3.3 Lack of Standardized Preparation Protocols Causing Outcome Variability
  • 4.3.4 Physician Skepticism Due to Limited Long-Term Efficacy Data
• 4.4 Regulatory Landscape
• 4.5 Technological Outlook
• 4.6 Porter's Five Forces Analysis
  • 4.6.1 Threat of New Entrants
  • 4.6.2 Bargaining Power of Buyers
  • 4.6.3 Bargaining Power of Suppliers
  • 4.6.4 Threat of Substitute Products
  • 4.6.5 Intensity of Competitive Rivalry

5 Market Size & Growth Forecasts

• 5.1 By Product Type
  • 5.1.1 Bone Graft Substitutes
  • 5.1.2 Demineralized Bone Matrix
  • 5.1.3 Allografts
  • 5.1.4 Bone Morphogenetic Proteins
  • 5.1.5 Viscosupplementation
  • 5.1.6 Stem Cell Therapy
  • 5.1.7 Platelet-Rich Plasma
  • 5.1.8 Other Product Types
• 5.2 By Application
  • 5.2.1 Spinal Fusion
  • 5.2.2 Trauma & Fracture Repair
  • 5.2.3 Reconstructive Surgery
  • 5.2.4 Osteoarthritis & Joint Degeneration
  • 5.2.5 Other Applications
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Ambulatory Surgical Centers
  • 5.3.3 Orthopedic & Sports Medicine Clinics
  • 5.3.4 Research & Academic Institutes
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as Available, Strategic Information, Market Rank/Share for Key Companies, Products & Services, and Recent Developments)
  • 6.3.1 AlloSource
  • 6.3.2 Arthrex
  • 6.3.3 Baxter International
  • 6.3.4 Bioventus
  • 6.3.5 BoneSupport AB
  • 6.3.6 DePuy Synthes (Johnson & Johnson)
  • 6.3.7 Exactech
  • 6.3.8 Globus Medical
  • 6.3.9 Kuros Biosciences
  • 6.3.10 Medtronic
  • 6.3.11 MTF Biologics
  • 6.3.12 NuVasive
  • 6.3.13 Organogenesis
  • 6.3.14 Orthofix Medical
  • 6.3.15 Sanofi
  • 6.3.16 SeaSpine
  • 6.3.17 Smith & Nephew
  • 6.3.18 Stryker Corporation
  • 6.3.19 Terumo BCT
  • 6.3.20 Zimmer Biomet Holdings Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment