人工声帯デバイスの世界市場：2023年～2030年

概要

人工声帯と呼ばれる医療機器は、喉頭摘出手術を受けた人が言葉を取り戻すのをサポートします。喉頭摘出術は、喉頭（声箱）を摘出する外科手術です。喉頭摘出術は、がんやその他の喉頭に関する医学的問題に対して行われることが多いです。喉頭を摘出された患者は自然な声帯を失い、話すことが困難になります。人工声帯のための装置は、発声の代わりを提供する上で非常に重要です。

時が経つにつれて、技術開発は人工声帯デバイスの機能性とデザインを向上させ、喉頭摘出患者の治療成績を向上させてきました。言語聴覚士（SLP）の助けを借りて、人工声帯を効率的に利用する方法を学ぶには言語療法が必要です。人工声帯を使った会話やコミュニケーションの能力を向上させるために、患者はSLPと関わっています。人工声帯に使用されるデバイスは、摩耗や破損による洗浄や交換を含む定期的なケアが必要です。

市場力学：促進要因

音声補綴デバイスへの注目の高まり

重要な腫瘍である喉頭がんの予後には、特に高リスク集団における適切な予防・診断法の開発が不可欠です。発声、嚥下、呼吸、社会的関係、精神的健康はすべて喉頭全摘術によって大きな影響を受け、QOLにも悪影響を及ぼします。食道発声（ES）と気管食道発声（TES）は、喉頭全摘出患者に用いられる2つの主要なリハビリテーション法です。TESは手術によって人工声帯を埋め込み、肺からの空気を人工声帯を通して食道に送り込み、発声させる方法であるが、ESは咽頭食道を使って発声させる方法です。

自動スピーキングバルブ（ASV）を使ってハンズフリーで通常の発声ができるようにすることが、喉頭摘出術後の言語療法の最終目標です。ASVは気管食道発声時に自動的に閉じるため、指や手で気管支腫を閉塞する必要がないです。ASVを使用すると、患者はストーマを指で指し示すことができないため、両手が自由になり、迅速な言語応答が可能になり、障害に集中することが少なくなります。

Inhealth Technologiesは、Blom-Singer Dual Valve Indwelling Voice Prosthesisの2つの弁に、材料の防腐剤として酸化銀を注入しています。二次弁は、一次弁が故障しても機能するように設計されており、流体の漏れを止めるのに役立ちます。ブロム-シンガーデュアル弁式人工声帯には、標準または大型の気管/食道フランジが使用可能です。TEPの二次治療または交換治療に使用するための挿入/洗浄装置および非滅菌人工声帯が含まれています。

限られた認識と利用しやすさ

大きな障壁の一つは、患者や医療従事者が人工声帯デバイスについて無知であることです。最先端の技術や専門家による治療へのアクセスも、地域によっては制限されています。特に、十分な保険が適用されない患者や医療資源が乏しい地域では、人工声帯デバイスや関連医療処置にかかる高額な費用が大きな障壁となります。人工声帯を効率よく使えるようになるには、専門家による音声リハビリテーションが必要で、患者によっては時間がかかり、困難な場合もあります。このような選択肢は、その複雑さゆえに患者に選ばれないこともあります。

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
    • 人工声帯デバイスへの注目の高まり
  • 抑制要因
    • 認知度とアクセシビリティの制限
  • 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
• ロシア・ウクライナ戦争の影響分析
• SWOT分析
• 特許分析
• DMIオピニオン

第6章 COVID-19分析

第7章 製品タイプ別

• 非埋め込み型人工声帯デバイス
• 埋め込み型人工声帯デバイス

第8章 エンドユーザー別

• 病院
• 診療所
• その他

第9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
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋地域
  • 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10章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第11章 企業プロファイル

• Inhealth Technologies
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Andreas Fahl Medizintechnik-Vertrieb GmbH
• Coloplast
• Orbisana Healthcare GmbH（formerly Servona GmbH）
• Teleflex Incorporated
• Innaumation Medical Devices Private Limited
• ICU Medical Inc
• HEIMOMED Heinze
• Atos Medical
• Servona Acclarent Inc.

第12章 付録

Overview

Medical devices called voice prosthesis devices assist people who have had laryngectomy surgeries in regaining their speech. A laryngectomy is a surgical surgery in which the larynx (voice box) is removed. This is frequently done in response to cancer or other larynx-related medical issues. Patients who have their larynx removed lose their natural vocal cords, making it hard for them to speak. Devices for voice prostheses are crucial in offering a substitute for vocalization.

Over time, technological developments have enhanced the functionality and design of vocal prosthesis devices, improving the outcomes for laryngectomy patients. With the aid of a speech-language pathologist (SLP), speech therapy is necessary to learn how to utilize a vocal prosthesis efficiently. To improve their speech and communication abilities using their device, patients engage with an SLP. Devices used for voice prostheses need routine care, including cleaning and replacement due to wear and tear.

Market Dynamics: Drivers

The Increasing Focus Towards Voice Prosthesis Devices

The development of adequate preventative and diagnostic methods, particularly in high-risk populations, is crucial for the prognosis of laryngeal cancer, an important oncological entity. Speech, swallowing, breathing, social relations, and emotional health are all significantly impacted by total laryngectomy, which also has an adverse effect on quality of life. Esophageal speech (ES) and tracheoesophageal speech (TES) are the two primary rehabilitation methods used with complete laryngectomy patients. In contrast to TES, which involves surgically implanting a vocal prosthesis that permits air from the lungs to be directed via the prosthesis into the esophagus to make sound, ES uses the pharyngoesophageal segment to produce sound.

Achieving regular hands-free speech with an automated speaking valve (ASV) is the ultimate goal of speech therapy after a laryngectomy. The ASV automatically closes during tracheoesophageal speaking, negating the need to use a finger or hand to occlude the tracheostoma. Because the patient cannot point with his finger at his stoma when using an ASV, it frees up his hands, enables quick verbal response, and lessens the focus on his impairment.

Inhealth Technologies provides silver oxide placed in two valves of the Blom-Singer Dual Valve Indwelling Voice Prosthesis as a material preservative. The secondary speaking valve is designed to function even if the primary valve fails, helping to stop fluid leaking. Standard or large tracheal/esophageal flanges are available for the Blom-Singer Dual Valve Voice Prosthesis. Includes insertion/cleaning equipment and a non-sterile vocal prosthesis for use in secondary or replacement TEP treatments.

Limited Awareness ans Accesibility

One big barrier is patients' and healthcare professionals' ignorance about vocal prosthetic equipment. Accessibility to cutting-edge technology and specialist care also be restricted in some areas. Particularly for patients without adequate insurance coverage or in areas with scarce healthcare resources, high costs connected with vocal prosthesis devices and related medical procedures can be a substantial barrier. It takes specialist speech rehabilitation, which can be time-consuming and difficult for some patients, to learn to utilize voice prosthesis devices efficiently. This option may not be chosen by patients because of its intricacy.

Segment Analysis

The global voice prosthesis devices market is segmented based on product type, end-user, and region.

The in-dwelling voice prosthesis devices segment accounted for approximately 45.4% of the market share

When a person has had their larynx (voice box) removed during a laryngectomy treatment, they will utilize indwelling voice prosthesis devices, also known as indwelling tracheoesophageal voice prostheses (TVP). In order to improve speech and communication for laryngectomy patients, these devices are surgically placed.

Patients with laryngeal malignancies who have had laryngectomy may benefit from voice prosthesis (VPs), which are indwelling silicone valves used for speech therapy. A significant issue is the microbial biofilm buildup on VPs, which need frequent replacement and raises the risk of pneumonia and chest infections.

Microbial development is encouraged in the esophagus, where they are exposed to food, saliva, liquids, humidity, and temperatures around 37 °C. The inclusion of silver oxide (Blom Singer Advantage) and Teflon-like fluoroplastic (Provox ActiValve) into the VPs material to inhibit microbial colonization are just two strategies that have been suggested to lengthen the lifespan of the VPs.

Geographical Penetration

North America accounted for approximately 41.2% of the market share

North America has been a dominant force in the global voice prosthesis devices market. The most recent projections from the American Cancer Society for the number of new cases of laryngeal cancer in the United States in 2023 are 12,380 (9,900 in men and 2,480 in women). 750 women and 3,820 men will pass away from laryngeal cancer. About 35% of laryngeal malignancies develop above the vocal cords in the supraglottic region, while 60% begin in the glottis (the region containing the vocal cords).

A relatively tiny percentage of those who are diagnosed with laryngeal cancer are under the age of 55. Laryngeal cancer diagnoses typically occur in adults 66 and older.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global voice prosthesis devices market. The pandemic affected the manufacturing and distribution of medical goods, especially voice prosthesis, by upsetting worldwide supply networks. This might have caused brief shortages and delays in the availability of devices.

Numerous healthcare resources were diverted to deal with the pandemic's immediate crisis, which can have an impact on elective procedures and rehabilitation plans, particularly those using vocal prosthetic devices. During the pandemic, patients had reluctant to have elective surgery, which might have decreased the number of laryngectomy procedures and consequently the demand for voice prosthetic devices.

By Product Type

• Non-dwelling Voice Prosthesis Devices
• In-dwelling Voice Prosthesis Devices

By End-user

• Hospitals
• Clinics
• Others

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

major global players in the market include: F. Hoffmann-La Roche Ltd., Sanofi, Novartis AG, Regeneron Pharmaceuticals, ICU Medical Inc., HEIMOMED Heinze, Atos Medical, and Servona Acclarent Inc.

Why Purchase the Report?

• To visualize the global voice prosthesis devices market segmentation based on product type, 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 voice prosthesis 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 voice prosthesis devices market report would provide approximately 46 tables, 53 figures, and 186 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 End-user
• 3.3. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. The Increasing Focus Towards Voice Prosthesis Devices
  • 4.1.2. Restraints
    • 4.1.2.1. Limited Awareness and Accessibility
  • 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. Russia-Ukraine War Impact Analysis
• 5.6. SWOT Analysis
• 5.7. Patent Analysis
• 5.8. 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 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. Non-dwelling Voice Prosthesis Devices*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. In-dwelling Voice Prosthesis Devices

8. By End-user

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 8.1.2. Market Attractiveness Index, By End-user
• 8.2. Hospitals*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Clinics
• 8.4. Others

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.5.1. U.S.
    • 9.2.5.2. Canada
    • 9.2.5.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.5.1. Germany
    • 9.3.5.2. UK
    • 9.3.5.3. France
    • 9.3.5.4. Italy
    • 9.3.5.5. Spain
    • 9.3.5.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.5.1. Brazil
    • 9.4.5.2. Argentina
    • 9.4.5.3. Rest of South America
• 9.5. Asia-Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.5.1. China
    • 9.5.5.2. India
    • 9.5.5.3. Japan
    • 9.5.5.4. Australia
    • 9.5.5.5. Rest of Asia-Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product Type
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By End-user

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Inhealth Technologies*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. Andreas Fahl Medizintechnik-Vertrieb GmbH
• 11.3. Coloplast
• 11.4. Orbisana Healthcare GmbH (formerly Servona GmbH)
• 11.5. Teleflex Incorporated
• 11.6. Innaumation Medical Devices Private Limited
• 11.7. ICU Medical Inc
• 11.8. HEIMOMED Heinze
• 11.9. Atos Medical
• 11.10. Servona Acclarent Inc.

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us