頭蓋顎顔面固定装置の世界市場-2023年～2030年

概要

頭蓋顎顔面固定器具、またはCMF固定器具として知られる医療用インプラントや器具は、頭蓋顔面領域に影響を及ぼす損傷、変形、または疾患を治療するための外科手術で使用されます。この領域には、頭蓋骨、顔面、顎が含まれます。これらの器具は、頭部と顔面の正常な機能と外観を安定させ、回復させるために不可欠です。

頭蓋顎顔面固定器具は、さまざまな手術場面で使用されます。プレートやスクリュー、ワイヤーやピン、外固定装置、再吸収性固定装置、カスタムインプラントなどがあります。プレートとスクリューは骨折した顔面骨を安定させ、骨移植片を固定するもので、ワイヤーとピンは一時的な固定を行うものです。

また、カスタムインプラントは、独特な解剖学的要件を持つ患者のために、3Dプリンターやコンピューター支援技術によって設計されます。各製品タイプは、頭蓋顎顔面の損傷、変形、疾患への対応において特定の役割を果たし、患者の最適な転帰と機能的・審美的な回復を保証します。

市場力学：市場促進要因と市場抑制要因

頭蓋顎顔面固定用再吸収性プレートの採用が増加し、市場成長を牽引する見込み

頭蓋顎顔面固定用の再吸収性プレートは、その強度と時間の経過とともに溶解する能力により、ますます人気が高まっています。従来の金属プレートと比較して、吸収性プレートは除去するための再手術を必要としないです。この目的のための再吸収性プレートの主要な提供者には、ポリ-L-乳酸（PLLA）とポリグリコール酸（PGA）でできたプレートを提供するStryker社、ポリ乳酸（PLA）とポリジオキサノン（PDO）でできたプレートを提供するKLS Martin社、PLLAとPGAでできたプレートを提供するOsteoMed社とZimmer Biomet社があります。

したがって、頭蓋顎顔面固定に再吸収性プレートを使用することは、その堅牢性、再吸収特性、およびプレート抜去のための再手術の回避により、人気が高まっています。さらに、事故や外傷の発生率の上昇、高齢化人口の増加、最小手術の採用増加などが、予測期間中に市場を牽引すると予想される要因です。

阻害要因：

頭蓋顎顔面手術のコスト、合併症、リスク、厳しい規制承認、医療機器に対するコンプライアンス要件が、予測期間中に市場を阻害すると予想される要因です。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 頭蓋顎顔面固定用再吸収性プレートの採用増加
  • 抑制要因
    • 頭蓋顎顔面手術の高コスト
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• 特許分析
• SWOT分析
• DMI見解

第6章 COVID-19分析

第7章 製品タイプ別

• 内部固定具
• 体外固定器具

第8章 材質別

• 金属製
• 生体吸収性
• セラミック

第9章 用途別

• 外傷および骨折
• 顎矯正手術
• 歯科手術
• 頭蓋顔面外科
• その他

第10章 エンドユーザー別

• 病院
• 外来手術センター
• 外傷センター
• 歯科クリニック
• その他

第11章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • スペイン
  • イタリア
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ

第12章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第13章 企業プロファイル

• Stryker
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Zimmer Biomet
• DePuy Synthes
• Medtronic
• Acumed LLC
• Renishaw plc.
• Medartis AG
• Xilloc Medical Int B.V.
• KLS Martin Group
• B. Braun SE

第14章 付録

Overview

Medical implants and instruments known as cranio-maxillofacial fixation devices, or CMF fixation devices, are used in surgical procedures to treat injuries, deformities, or diseases that impact the craniofacial region. This area includes the skull, face, and jaw. These devices are essential in stabilizing and restoring the normal function and appearance of the head and face.

Cranio-maxillofacial fixation devices are used in a variety of surgical scenarios. These devices include plates and screws, wires and pins, external fixators, resorbable fixation devices, and custom implants. Plates and screws stabilize fractured facial bones and secure bone grafts, while wires and pins provide temporary fixation.

External fixators are used for extensive stabilization, resorbable fixation devices dissolve gradually and are used in pediatric cases, and custom implants are designed through 3D printing or computer-assisted techniques for patients with unique anatomical requirements. Each product type serves a specific role in addressing cranio-maxillofacial injuries, deformities, and diseases, ensuring optimal patient outcomes and functional and aesthetic restoration.

Market Dynamics: Drivers and Restraints

Increasing adoption of resorbable plates for craniomaxillofacial fixation is expected to drive the market growth

Resorbable plates for craniomaxillofacial fixation are becoming increasingly popular due to their strength and ability to dissolve over time. Compared to traditional metal plates, resorbable plates do not require a second surgery to remove them. Leading providers of resorbable plates for this purpose include Stryker, which offers plates made of poly-L-lactic acid (PLLA) and polyglycolic acid (PGA), KLS Martin, which offers plates made of polylactide (PLA) and polydioxanone (PDO), as well as OsteoMed and Zimmer Biomet, both of which offer plates made of PLLA and PGA.

Therefore, the utilization of resorbable plates for craniomaxillofacial fixation is gaining popularity due to their robustness, resorption properties, and avoidance of a second surgery to extract the plate. Furthermore, the rising incidence of accidents and traumatic injuries, the growing aging population, and the increasing adoption of minimal surgeries are the factors expected to drive the market over the forecast period.

Restraint:

The cost of craniomaxillofacial surgeries, complications, risks, stringent regulatory approvals, and compliance requirements for medical devices are the factors expected to hamper the market over the forecast period.

Segment Analysis

The global cranio maxillofacial fixation devices market is segmented based on product type, material, application, end-user and region.

The internal fixators from the product type segment accounted for approximately 37.8% of the cranio maxillofacial fixation devices market share

Internal fixators are medical implants and devices that are specialized to stabilize and secure fractures or defects in the bones of the skull, face, and jaw. These fixators are specifically designed for cranio-maxillofacial (CMF) surgeries, promoting proper alignment, facilitating bone healing, and restoring normal function and aesthetics to the craniofacial region.

Internal fixators are used in craniofacial (CMF) surgery to treat various conditions such as facial fractures caused by trauma, congenital craniofacial abnormalities, corrective jaw surgeries, and craniofacial reconstruction. They are essential in preserving the structural integrity of the craniofacial bones.

During cranio-maxillofacial surgery, internal fixators such as plates and screws are frequently utilized. Their primary function is to stabilize fractured bones, secure bone grafts, and promote healing by providing stability. Internal fixators offer a more secure and stable fixation, which reduces the likelihood of soft tissue complications and infections. They are also less visible externally, which is more pleasing to patients from an aesthetic standpoint.

Furthermore, the increasing complexity of CMF surgeries, the rising number of traumatic incidents, such as accidents and sports injuries, and advancements in medical technology for cranio-maxillofacial conditions are the factors expected to drive the segment over the forecast period.

For instance, 3D Systems and Stryker Corporation have partnered to offer personalized surgical planning solutions for craniomaxillofacial surgeries. 3D Systems has provided devices for over 140,000 patient-specific cases and is a leader in personalized healthcare solutions. Stryker specializes in delivering patient-specific options and innovative solutions for surgical suites. The partnership combines Stryker's specialized team and advanced implants with 3D Systems' state-of-the-art 3D printing technologies and expert consulting services, providing superior service to healthcare professionals

Additionally, according to National Center for Biotechnology Information Article, rigid internal fixation with plates and screws is the standard for treating fractures, osteotomies, and craniomaxillofacial reconstruction. Self-drilling, self-tapping screws, and locking mini plates are the latest innovations, offering less instrumentation and faster application. Locking 2.0 mini plates utilize double-threaded screws for a more rigid construct with less interference with bone circulation. They are designed for midface application, with three configurations available for mandibular surgery. They are not meant to replace the heavier 2.4 locking reconstruction plates.

Geographical Analysis

North America accounted for approximately 40.2% of the market share in 2022

North America is expected to hold the largest market share owing to the increasing number of cranio maxillofacial fixation procedures, the latest innovations in cranio maxillofacial fixation devices, the increasing demand for minimally invasive surgeries, and the presence of key market players.

For instance, in 2022, there were a total of 644,818 cranio maxillofacial fixation procedures conducted in the United States. These procedures involve the use of craniomaxillofacial devices, which can be applied in a variety of surgeries such as neurosurgery, orthognathic and dental surgery, plastic surgery, as well as aesthetics and facial reconstruction. The demand for these devices has increased due to the rise in facial abnormalities caused by genetic diseases and trauma, leading to a higher demand for aesthetic surgeries.

Additionally, leading contributors to the cranio-maxillofacial fixation devices market are major companies such as Stryker Corporation, Medtronic Plc, KLS Martin L.P, Medartis AG, and Johnson & Johnson. They are driving market growth by continuously innovating and developing advanced devices for craniomaxillofacial surgeries. Hence, owing to the above factors, the North American region is expected to hold the largest market share over the forecast period.

COVID-19 Impact Analysis:

The cranio-maxillofacial fixation devices market experienced significant impacts due to the COVID-19 pandemic. Many hospitals and healthcare facilities postponed or canceled elective surgeries, including cranio-maxillofacial procedures, in a bid to conserve resources and limit the spread of the virus. This resulted in a temporary reduction in the demand for such devices.

As hospitals and healthcare systems prioritized the treatment of COVID-19 patients, non-emergency surgeries, including cranio-maxillofacial procedures, took a back seat. Patients also became more cautious about undergoing elective surgeries during the pandemic, fearing exposure to the virus in healthcare facilities. Consequently, patient volumes for cranio-maxillofacial procedures decreased.

However, as healthcare systems adapted to the pandemic and vaccination efforts progressed, the market for cranio-maxillofacial surgery devices began to recover, with increased demand for essential and urgent procedures.

Competitive Landscape

The major global players in the cranio maxillofacial fixation devices market include: Stryker, Zimmer Biomet, DePuy Synthes, Medtronic, Acumed LLC, Renishaw plc., Medartis AG, Xilloc Medical Int B.V., KLS Martin Group, and B. Braun SE among others.

Key Development

• On July 11, 2023, Stryker, one of the world's leading medical technology companies, commercially launched its Q Guidance System with Cranial Guidance Software to provide surgeons with an image-based planning and intraoperative guidance system that assists in positioning instruments and identifying patient anatomy during cranial surgery. The software can be used for craniotomies, skull base and transsphenoidal procedures, shunt placements, and biopsies.
• On June 15, 2022, Ricoh USA, Inc. RICOH 3D for healthcare received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its craniomaxillofacial (CMF) and orthopedic patient-specific anatomic modeling.

Why Purchase the Report?

• To visualize the global cranio maxillofacial fixation devices market segmentation based on product type, material, application, end-user and region, as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of cranio maxillofacial fixation devices market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global cranio maxillofacial fixation devices market report would provide approximately 69 tables, 70 figures, and 189 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Product Type
• 3.2. Snippet by Material
• 3.3. Snippet by Application
• 3.4. Snippet by End-User
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing adoption of resorbable plates for craniomaxillofacial fixation
  • 4.1.2. Restraints
    • 4.1.2.1. High cost of craniomaxillofacial surgeries
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Patent Analysis
• 5.6. SWOT Analysis
• 5.7. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During the Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Product Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 7.1.2. Market Attractiveness Index, By Product Type
• 7.2. Internal Fixators*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. External Fixators

8. By Material

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
  • 8.1.2. Market Attractiveness Index, By Material
• 8.2. Metallic*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Bioabsorbable
• 8.4. Ceramic

9. By Application

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.1.2. Market Attractiveness Index, By Application
• 9.2. Trauma and Fractures*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Orthognathic Surgery
• 9.4. Dental Surgery
• 9.5. Craniofacial Surgery
• 9.6. Others

10. By End-User

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 10.1.2. Market Attractiveness Index, By End-User
• 10.2. Hospitals*
  • 10.2.1. Introduction
  • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 10.3. Ambulatory Surgical Centers
• 10.4. Trauma Centers
• 10.5. Dental Clinics
• 10.6. Others

11. By Region

• 11.1. Introduction
  • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 11.1.2. Market Attractiveness Index, By Region
• 11.2. North America
  • 11.2.1. Introduction
  • 11.2.2. Key Region-Specific Dynamics
  • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
  • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.2.7.1. U.S.
    • 11.2.7.2. Canada
    • 11.2.7.3. Mexico
• 11.3. Europe
  • 11.3.1. Introduction
  • 11.3.2. Key Region-Specific Dynamics
  • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
  • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.3.7.1. Germany
    • 11.3.7.2. UK
    • 11.3.7.3. France
    • 11.3.7.4. Spain
    • 11.3.7.5. Italy
    • 11.3.7.6. Rest of Europe
• 11.4. South America
  • 11.4.1. Introduction
  • 11.4.2. Key Region-Specific Dynamics
  • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
  • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.4.7.1. Brazil
    • 11.4.7.2. Argentina
    • 11.4.7.3. Rest of South America
• 11.5. Asia-Pacific
  • 11.5.1. Introduction
  • 11.5.2. Key Region-Specific Dynamics
  • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
  • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User
  • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.5.7.1. China
    • 11.5.7.2. India
    • 11.5.7.3. Japan
    • 11.5.7.4. Australia
    • 11.5.7.5. Rest of Asia-Pacific
• 11.6. Middle East and Africa
  • 11.6.1. Introduction
  • 11.6.2. Key Region-Specific Dynamics
  • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material
  • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-User

12. Competitive Landscape

• 12.1. Competitive Scenario
• 12.2. Market Positioning/Share Analysis
• 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

• 13.1. Stryker*
  • 13.1.1. Company Overview
  • 13.1.2. Product Portfolio and Description
  • 13.1.3. Financial Overview
  • 13.1.4. Key Developments
• 13.2. Zimmer Biomet
• 13.3. DePuy Synthes
• 13.4. Medtronic
• 13.5. Acumed LLC
• 13.6. Renishaw plc.
• 13.7. Medartis AG
• 13.8. Xilloc Medical Int B.V.
• 13.9. KLS Martin Group
• 13.10. B. Braun SE

LIST NOT EXHAUSTIVE

14. Appendix

• 14.1. About Us and Services
• 14.2. Contact Us