세계의 상처 치료용 생물제제 시장 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The wound care biologics market reached USD 2.34 billion in 2025 and is set to rise to USD 3.51 billion by 2030, reflecting an 8.45% CAGR.

Momentum stems from expanding clinical evidence that biologic matrices, xenografts, and growth-factor dressings shorten healing time and reduce infection risk compared with conventional dressings. Mandatory Local Coverage Determinations (LCDs) issued by the Centers for Medicare & Medicaid Services (CMS) in April 2025 require proof of 50% wound-area reduction within four weeks before reimbursements are approved, which weeds out marginal products and redirects budgets toward options with published outcomes. Product innovation is intensifying, guided by FDA plans to reclassify antimicrobial dressings into stricter device classes, prompting manufacturers to prioritize resistance-mitigation features. Meanwhile, the U.S. Department of Defense's USD 1.66 billion Chemical and Biological Defense Program budget accelerates battlefield-to-bedside translation of trauma-oriented biologics.

Global Wound Care Biologics Market Trends and Insights

Growing Prevalence of Diabetic Foot Ulcers

Escalating diabetes incidence keeps chronic ulcers front-of-mind for payers and providers. CMS now requires a documented 50% area reduction after four weeks of standard care before covering biologic dressings, anchoring biologics in step-therapy protocols, and rewarding formulations with randomized-trial data. Platelet-derived growth-factor gels show 48% complete-healing rates versus 25% with conventional dressings, a difference that resonates in value-based purchasing. Japan's early adoption of basic fibroblast growth factor reinforces the commercial payoff when regulation and reimbursement converge. Asia-Pacific's population is aging, and surging diabetes prevalence intensifies demand curves. Parallel growth of outpatient wound centers channels purchasing toward biologics with quick-healing properties, ensuring formulary placement in ambulatory settings.

Increasing Incidence of Burns & Road-Traffic Injuries

Rising industrial accidents and climate-related disasters have pushed burns to the fastest-growing wound type at a 9.75% CAGR to 2030. Emergency departments are moving toward biologic matrices that lower infection risk and accelerate granulation. FDA clearance of plant-based Traumagel for battlefield trauma underscores civilian adoption of defense-driven biotech. Copper-impregnated matrices outpace traditional silver dressings in wound-closure speed and have earned approvals in more than 25 countries. Emerging-market trauma units favor cost-efficient xenografts that require minimal cold-chain logistics yet deliver high epithelialization rates.

High Procedure & Product Cost

The United States spends USD 96.8 billion each year treating chronic wounds, yet reimbursement caps force clinicians to ration biologics across patients. LCDs restrict usage to eight applications within 12-to-16-week episodes, compelling product selection based on probability of full closure within that window. ConvaTec's 6.7% wound-care revenue growth in the first half of 2024 shows that competitively priced biologics can still win share amid budget pressure. In emerging markets, tiered-pricing models that align with local purchasing power are becoming critical for market entry.

Other drivers and restraints analyzed in the detailed report include:

1. Government Reimbursement Expansions for Advanced Wound Care
2. Surge in Battlefield & Disaster-Response Procurement of Biologics
3. Stringent Tissue-Bank Regulations

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

Segment Analysis

Acellular dermal matrices retained a 37.78% wound care biologics market share in 2024, buoyed by widespread surgeon familiarity and payer coverage for reconstructive needs. Xenografts-propelled by fish-skin pioneers such as Kerecis-are expanding at a 10.82% CAGR, outpacing all other categories. Placental and amniotic membranes face episodic shortages as tissue-bank scrutiny intensifies, steering formulary committees toward synthetic scaffolds that promise consistent supply. FDA clearance of only one growth-factor product (Regranex) leaves a white space for next-generation carriers able to stabilize sensitive proteins while meeting new antimicrobial standards.

Growth-factor sprays are being reformulated with polymer micro-capsules to prolong bioactivity in exudative wounds. Hybrid biosynthetic dressings combine silicone backings with fish-skin grafts, enabling rapid drainage without sacrificing moisture balance. Within hospital value-analysis committees, total cost-of-care calculators highlight shorter length-of-stay when biologic matrices are deployed early, helping justify higher acquisition prices. Xenograft suppliers emphasize disease-specific protocols-diabetic foot ulcers, pressure injuries, and oncology excisions-providing targeted clinical pathways that resonate with evidence-based purchasing. As payer audits intensify, products capable of delivering documented 50% area reduction within four weeks will secure coding priority, reinforcing the segment hierarchy inside the wound care biologics market.

Ulcers represented 62.94% of the wound care biologics market size in 2024, confirming their primacy in the wound care biologics market. Within that group, diabetic foot ulcers account for the largest patient pool owing to global diabetes escalation. CMS's LCD requires proof of prior standard-care failure, effectively channeling biologic spend toward refractory ulcer cohorts. In contrast, burns are on a 9.75% CAGR trajectory-the swiftest within the wound care biologics industry-driven by rising factory incidents in Asia and heat-related disasters elsewhere.

The wound care biologics market size for burn indications is expected to double by 2030 as trauma centers integrate biologics into first-line protocols. Copper-infused matrices deliver shorter epithelialization times against silver dressings, a finding now replicated across 25 regulatory jurisdictions. Military-origin hydrogels suitable for austere settings have migrated to community ERs, reinforcing the burn segment's momentum. Conversely, pressure ulcers in long-term care settings require cost-attenuated biologics, pushing suppliers toward volume-based contracts with nursing-home networks.

The Wound Care Biologics Market is Segmented by Product (Biological Skin Substitutes and Topical Agents), Wound Type (Ulcers, Surgical and Traumatic Wounds and Burns), End User (Hospitals/Clinics, Ambulatory Surgical Centers and Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East & Africa, and South America).

Geography Analysis

North America's 44.92% of the wound care biologics market size in 2024 rested on mature payer frameworks and broad clinical familiarity with biologics. Yet forecast growth moderates to an 8.15% CAGR as penetration approaches ceiling levels. The VA's USD 340 million contract with KCI USA underscores government muscle in shaping formularies. Canada leverages Health Canada-FDA reciprocity to accelerate approvals, while Mexico's private hospitals import U.S.-cleared fish-skin grafts to serve self-pay patients.

Europe is tracking an 8.46% CAGR, supported by CE-mark harmonization that lets manufacturers sell across 27 states using a unified dossier. Germany and the United Kingdom remain volume anchors, but Southern Europe shows quicker percentage growth as austerity budgets loosen. Value-based procurement consortia compare total cost of closure rather than unit price, favoring biologics with trial-backed healing rates. Scandinavian health systems spearhead real-world registries that feed reimbursement recalibration every two years.

Asia-Pacific leads on growth at 10.29% CAGR. China upgrades hundreds of county hospitals with burn units equipped for xenograft application as part of its Healthy China 2030 plan. Japan's long history with basic fibroblast growth factor eases acceptance of new biologics, while India's multi-tier price corridors encourage domestic production of collagen matrices. Australia's Medicare Benefits Schedule newly covers outpatient biologic dressing reviews, expanding rural uptake. Collectively, these forces shift future revenue weight toward Asia, diversifying the wound care biologics market's geographic footprint.

1. Avita Medical
2. B. Braun
3. Bioventus Inc.
4. Coloplast
5. Convatec Group plc
6. Essity
7. Grifols
8. Integra LifeSciences
9. Kerecis Ehf
10. Lynch Biologics
11. Marine Polymer Technologies
12. Medline Industries
13. MiMedx Group Inc.
14. Molnlycke AB
15. MTF Biologics
16. Organogenesis Holdings
17. Skye Biologics Holdings
18. Smiths Group
19. Solventum Corporation
20. Stryker

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 Growing Prevalence of Diabetic Foot Ulcers
  • 4.2.2 Government Reimbursement Expansions for Advanced Wound Care
  • 4.2.3 Increasing Incidence of Burns & Road-Traffic Injuries
  • 4.2.4 Rising Adoption of Fish-Skin Xenografts
  • 4.2.5 Surge in Battlefield & Disaster-Response Procurement of Biologics
  • 4.2.6 Shift from Inpatient to Outpatient Wound Centers Driving Biologic Formulary Inclusion
• 4.3 Market Restraints
  • 4.3.1 High Procedure & Product Cost
  • 4.3.2 Stringent Tissue-Bank Regulations
  • 4.3.3 Supply-Chain Fragility For Placental / Amniotic Raw Material
  • 4.3.4 Growing Antimicrobial-Resistance Scrutiny on Biologic Dressings
• 4.4 Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value)

• 5.1 By Product
  • 5.1.1 Acellular Dermal Matrices
  • 5.1.2 Amniotic & Placental Membranes
  • 5.1.3 Xenografts
  • 5.1.4 Synthetic & Biosynthetic Scaffolds
  • 5.1.5 Growth-Factor & Cell-based Topical Agents
  • 5.1.6 Other Products
• 5.2 By Wound Type
  • 5.2.1 Ulcers
    • 5.2.1.1 Diabetic Foot Ulcers
    • 5.2.1.2 Venous Ulcers
    • 5.2.1.3 Pressure Ulcers
    • 5.2.1.4 Other Ulcers
  • 5.2.2 Surgical & Traumatic Wounds
  • 5.2.3 Burns
• 5.3 By Distribution Channel
  • 5.3.1 Online
  • 5.3.2 Offline
• 5.4 By End-User
  • 5.4.1 Hospitals & Clinics
  • 5.4.2 Ambulatory Surgical Centers
  • 5.4.3 Home-Care Settings
  • 5.4.4 Other End-Users
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Competitive Benchmarking
• 6.3 Market Share Analysis
• 6.4 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)
  • 6.4.1 Avita Medical
  • 6.4.2 B. Braun Melsungen AG
  • 6.4.3 Bioventus Inc.
  • 6.4.4 Coloplast A/S
  • 6.4.5 Convatec Group plc
  • 6.4.6 Essity AB
  • 6.4.7 Grifols S.A.
  • 6.4.8 Integra LifeSciences
  • 6.4.9 Kerecis Ehf
  • 6.4.10 Lynch Biologics
  • 6.4.11 Marine Polymer Technologies
  • 6.4.12 Medline Industries
  • 6.4.13 MiMedx Group Inc.
  • 6.4.14 Molnlycke AB
  • 6.4.15 MTF Biologics
  • 6.4.16 Organogenesis Holdings
  • 6.4.17 Skye Biologics Holdings
  • 6.4.18 Smith & Nephew plc
  • 6.4.19 Solventum Corporation
  • 6.4.20 Stryker Corporation

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment