흉골 폐쇄 시스템 시장 : 시장 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The sternal closure systems market size reached USD 2.64 billion in 2025 and is forecast to touch USD 3.44 billion by 2030, advancing at a 5.45% CAGR during the period.

Growth reflects the steady rhythm of global cardiac surgery volumes, with developed regions moving toward replacement demand and emerging economies adding new procedure capacity. A visible shift from legacy wires to rigid plate-and-screw constructs anchors this expansion because hospitals now link closure performance to lower readmission penalties under value-based reimbursement. Demographic pressure adds momentum as octogenarian patients undergo more complex surgeries that raise sternal stability requirements. Regulatory agencies, especially the FDA, continue to tighten quality-system rules, favoring well-documented devices and slowing low-evidence entrants. Cost containment remains central, but bundled-payment models tilt decisions toward technologies that cut episode-of-care expenses through fewer complications.

Global Sternal Closure Systems Market Trends and Insights

Growing Volume of Open-Heart Procedures & Ageing Demographics

Cardiac units worldwide now treat a much larger cohort of patients aged 80 years and above, whose numbers within surgical case mix have multiplied twenty-fourfold since 2024. Longer life expectancy, advanced anesthesia protocols, and better peri-operative support enable surgeons to accept higher-risk, complex candidates. Elderly chests exhibit brittle bone quality and slower ossification, raising sternal instability hazards that conventional stainless-steel wires cannot fully mitigate. Hospitals increasingly allocate rigid fixation kits to this segment because readmission penalties tied to dehiscence often exceed the premium device cost. In value terms, every avoided wound complication saves up to USD 45,000 across the 90-day episode, making plate systems economically rational even for publicly funded institutions. The demographic driver is therefore structural and sustains long-horizon demand for advanced systems within the sternal closure systems market.

Rising Incidence of Complex, Non-Healing Sternotomy Wounds

Deep sternal wound infection rates vary from 0.5% to 5%, but mortality still climbs above 25% when dehiscence occurs. Diabetes, obesity, and immunosuppression foster poor vascularization at the osteotomy margin, undermining wire-only constructs that permit micro-motion during respiration. Rigid plates distribute load along both cortical tables, maintaining contact to encourage callus formation throughout the 6-to-8-week healing window. Hospitals now stratify patients based on pre-operative HbA1c, BMI, and immune status, reserving titanium plates for the upper-risk quintile. This selective deployment yields demonstrable quality gains: one US multi-center study recorded a 43% drop in deep sternal wound complications after protocol change, trimming average length of stay by 2.6 days. Rising complexity of wound profiles thus elevates rigid fixation from optional to recommended in many guidelines, sustaining expansion of the sternal closure systems market.

Infection & Dehiscence Risks in High-BMI/Diabetic Cohorts

Obese and diabetic patients represent the paradox of need versus risk. Their soft-tissue bulk and impaired microcirculation heighten infection susceptibility, and any foreign body can aggravate inflammatory cascades. Even titanium surfaces occasionally shed nano-scale particles, fueling concern about long-term bioreactivity. Clinicians therefore hesitate to approve novel constructs until safety in these cohorts is documented. A 2024 Polish cohort study flagged elevated metallic ion loads in diabetic implant recipients, prompting calls for extended surveillance protocols. Fear of malpractice litigation fosters a conservative stance and slows new-technology spread within the sternal closure systems market.

Other drivers and restraints analyzed in the detailed report include:

1. Rapid Adoption of Rigid Plate-and-Screw Fixation Systems
2. Hospital Bundled-Payment Programs Favouring Low-Readmission Devices
3. High Device & OR Time Costs vs. Conventional Wires

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

Segment Analysis

Traditional stainless-steel wires controlled 45.51% of the sternal closure systems market share in 2024. Unit volume dominance persists because surgeons in low-risk coronary bypass cases prefer a familiar, inexpensive technique. Plates and screws, however, recorded a vigorous 9.65% CAGR, capturing share in geriatric valve replacements and redo sternotomies where shear loads are higher. Legacy cement and adhesive lines remain niche, primarily for complex reconstructions involving bone loss. Bio-absorbable plates, fabricated from polylactide and reinforced PEEK fibers, appeal in pediatric repairs but face adult uptake barriers due to particulate scrutiny. Economic modeling shows that rigid plates become cost-neutral when infection incidence drops by 0.4 percentage points; tertiary centers already exceed that threshold, explaining their early conversion. Device manufacturers support the transition with surgeon workshops and intramedullary load calculators, enabling evidence-based selection rather than brand influence. Over the forecast horizon, plates are projected to reach 35% unit mix, leaving wires to retreat yet remain essential for low-budget facilities, ensuring plural technology coexistence within the sternal closure systems market.

Advanced plate systems like Johnson & Johnson's MatrixSTERNUM introduced modular designs that help customize span, screw vector, and load sharing with minimal bend adjustments, reducing intra-operative guesswork. This engineering flexibility dovetails with hospital inventory preferences because a single tray can cover body mass index extremes. Meanwhile, mini-screw technology trims profile height, allowing easier soft-tissue closure and lowering postoperative discomfort. Collectively, these refinements push rigid fixation deeper into everyday practice and lift premium ASPs, which in turn uplifts total revenue even if overall case volumes plateau. Although wires will not vanish, their relative revenue impact will shrink compared with plate-centric growth inside the sternal closure systems market.

Median sternotomy continued as the workhorse, securing 78.53% of the sternal closure systems market size in 2024. Complete exposure to the heart is indispensable for multivessel bypasses and complex valve reconstructions. Closure across the entire sternum demands robust fixation that counters respiratory torsion, historically the domain of full-length wire cerclage. Bilateral thoracosternotomy created a high-growth pocket, adding a 9.85% CAGR because hybrid valve-plus-CABG protocols and robotic harvesting techniques favor lateral access. Surgeons adopting bilateral windows need shorter plates with offset screw geometry to avoid internal mammary pedicles, spurring niche product lines.

Hemi-sternotomy, often used for isolated aortic valve replacement, balances exposure and tissue preservation, providing a middle ground on fixation complexity. It fosters demand for contourable fixation strips that accept either wires or screws, letting teams tailor closure to anatomy. Regulatory bodies now require procedure-specific bench testing. Plate vendors respond with finite-element models that prove load dispersion under asymmetric breathing cycles. As the mix migrates toward limited-access surgery, versatile closure kits capable of segmental stability across variable cut lengths will command pricing power, reinforcing growth of premium tiers in the sternal closure systems market.

The Sternal Closure Systems Market Report is Segmented by Product (Wires, Plates and Screws, Bone Cement, and More), Procedure (Median Sternotomy, Hemi-Sternotomy, and Bilateral Thoracosternotomy), Material (Stainless Steel, Titanium, and More), End User (Tertiary Care Hospitals, Ambulatory Surgery Centers, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America captured 42.32% of 2024 revenue due to extensive cardiac surgery infrastructure and early embrace of rigid fixation reimbursement pathways. Hospitals in the United States already integrate closure choices into 30-day readmission metrics tracked under Hospital Value-Based Purchasing, a practice that sets the technological tone for Canada and Mexico. FDA oversight raises documentation hurdles but also signals long-term stability once approvals are secured. Growth remains steady rather than explosive, tied more to replacement demand and technology refresh cycles than to procedure expansion.

Europe contributes a balanced growth profile underpinned by centralized purchasing but evidence-driven device evaluation. The Medical Device Regulation compels continuous post-market surveillance, pushing manufacturers to maintain clinical databases that prove benefit in real-world registries. Germany and the United Kingdom lead plate adoption because academic networks publish outcome data rapidly, swaying clinician sentiment continent-wide. Southern and Eastern Europe focus on cost-optimized titanium kits, importing from regional producers that meet MDR yet undercut multinational prices. Currency volatility and healthcare budget negotiations influence unit flow, but ageing populations promise demand resilience inside the European slice of the sternal closure systems market.

Asia-Pacific posts the fastest 11.61% CAGR. China's public-private hospital modernization programs increased open-heart capacity by 14% year on year, while India's private tertiary chains invest in high-acuity cardiac floors that attract medical tourism. Japan retains strict Shonin device clearance, extending time to market but rewarding durable safety records once obtained. Lower-income ASEAN members favor hybrid procurement, often equipping flagship state hospitals with titanium plates while community centers still rely on wires. Cultural emphasis on scar minimization spurs minimally invasive procedure uptake, indirectly supporting plate adoption. Vendors successful in this region run dual portfolios: imported titanium for tier-1 cities and stainless assembled locally for price-sensitive provinces, achieving breadth in the sternal closure systems market.

1. Johnson & Johnson (DePuy Synthes & Ethicon)
2. Zimmer Biomet
3. Stryker
4. KLS Martin Group
5. B. Braun
6. Acumed
7. Medtronic
8. Orthofix
9. Abyrx
10. Kinamed Inc
11. Jace Medical
12. Praesidia
13. IDEAR SRL
14. RTI Surgical
15. Arthrex
16. Jeil Medical Corp
17. Neos Surgery SL
18. MedXpert GmbH

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 Volume of Open-Heart Procedures & Ageing Demographics
  • 4.2.2 Rising Incidence of Complex, Non-Healing Sternotomy Wounds
  • 4.2.3 Rapid Adoption of Rigid Plate-And-Screw Fixation Systems
  • 4.2.4 Hospital Bundled-Payment Programs Favouring Low-Readmission Devices
  • 4.2.5 Emergence of Bio-Absorbable Polymer/PEEK Sternum Implants
  • 4.2.6 AI-Guided Intra-Operative Imaging Improving Closure Accuracy
• 4.3 Market Restraints
  • 4.3.1 Infection & Dehiscence Risks In High-BMI/Diabetic Cohorts
  • 4.3.2 High Device & OR Time Costs Vs. Conventional Wires
  • 4.3.3 Shortage Of Surgeons Trained On Rigid Fixation Systems
  • 4.3.4 Heightened Regulatory Scrutiny On Implant Particulates (Micro-Plastics)
• 4.4 Technological Outlook
• 4.5 Porter's Five Forces
  • 4.5.1 Threat of New Entrants
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Bargaining Power of Suppliers
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Product
  • 5.1.1 Wires
  • 5.1.2 Plates & Screws
  • 5.1.3 Bone Cement & Adhesives
  • 5.1.4 Bio-absorbable Systems
  • 5.1.5 Others
• 5.2 By Procedure
  • 5.2.1 Median Sternotomy
  • 5.2.2 Hemi-sternotomy
  • 5.2.3 Bilateral Thoracosternotomy
• 5.3 By Material
  • 5.3.1 Stainless Steel
  • 5.3.2 Titanium
  • 5.3.3 Polyether-ether-ketone (PEEK)
  • 5.3.4 Composite/Bio-absorbable Polymers
• 5.4 By End User
  • 5.4.1 Tertiary Care Hospitals
  • 5.4.2 Cardio-Thoracic Specialty Clinics
  • 5.4.3 Ambulatory Surgery Centers
• 5.5 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 South Korea
    • 5.5.3.5 Australia
    • 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 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 Johnson & Johnson (DePuy Synthes & Ethicon)
  • 6.3.2 Zimmer Biomet Holdings
  • 6.3.3 Stryker Corporation
  • 6.3.4 KLS Martin Group
  • 6.3.5 B Braun SE
  • 6.3.6 Acumed LLC
  • 6.3.7 Medtronic plc
  • 6.3.8 Orthofix Holdings Inc
  • 6.3.9 Abyrx Inc
  • 6.3.10 Kinamed Inc
  • 6.3.11 Jace Medical
  • 6.3.12 Praesidia SRL
  • 6.3.13 IDEAR SRL
  • 6.3.14 RTI Surgical
  • 6.3.15 Arthrex Inc
  • 6.3.16 Jeil Medical Corp
  • 6.3.17 Neos Surgery SL
  • 6.3.18 MedXpert GmbH

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment