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市场调查报告书
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口腔睡眠呼吸暂停市场——增长、趋势、COVID-19 的影响和预测 (2023-2028)

Oral Sleep Apnea Market - Growth, Trends, And Forecasts (2023 - 2028)
出版日期: | 出版商: Mordor Intelligence | 英文 110 Pages | 商品交期: 2-3个工作天内

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简介目录

在预测期内，口腔睡眠呼吸暂停市场的复合年增长率预计为 14.1%。

最初，COVID-19 大流行对口腔睡眠呼吸暂停市场产生了重大影响。 在 COVID-19 爆发后，口腔睡眠呼吸暂停市场经历了高速增长。 这主要是由于感染 COVID-19 的患者呼吸衰竭的风险增加。 为了管理呼吸问题，已使用口腔睡眠设备（例如下颌前移设备）为 COVID-19 患者提供呼吸支持。 美国牙科睡眠协会建议在大流行期间使用口腔睡眠设备作为患者睡眠呼吸暂停的一线疗法。 根据美国睡眠医学会的说法，口服睡眠呼吸暂停设备可作为侵入性和易感染的气道正压通气 (PAP) 设备的替代疗法。

COVID-19 大流行和封锁使患者很难去看医生、去医院和去睡眠诊所。 然而，在 COVID-19 期间，远程医疗有助于更深入地渗透口服睡眠呼吸暂停药物。 临床医生已迅速将远程医疗纳入他们的实践中，并且可以有效地咨询多个患者。 在 Sleep Medicine 2022 上发表的一项研究中，BlueSleep 中心于 2020 年 3 月在大流行期间远程咨询了 10,171 多名睡眠呼吸暂停患者。

分析表明，在后大流行时代，对口服睡眠呼吸暂停药物的需求预计将稳步增长。 多个市场进入者表示，自 COVID-19 大流行以来，口腔睡眠设备的销量有所增加。 例如，2021 年 12 月，SomnoMed 表示 2022 年上半年的销售额增长了 10%。 我们预计 2022 财年将增长 15%。 此外，Oventus Medical 报告称，从 2020 年到 2021 年，口腔睡眠设备的销量增长了一倍以上。 因此，随着设备和药品销量的增长，预计该市场将进一步稳步增长。

此外，睡眠呼吸暂停综合症患病率的上升和老年人口的迅速增加，与睡眠呼吸暂停综合症相关的基础疾病的发病率不断增加，以及未来设备的技术进步预计将在未来几年继续进行。预计将推动市场的增长

根据 2022 年发表在美国胸科学会杂誌上的一项研究，阻塞性睡眠呼吸暂停 (OSA) 的全球患病率超过 22.6%。 此外，不断增长的老年人口对口服睡眠呼吸暂停药物和设备的需求产生了重大影响，因为老年人患这种疾病的风险更高。 例如，根据国家医学图书馆发表的一项研究，到 2022 年 6 月，全球约有 10 亿人患有阻塞性睡眠呼吸暂停 (OSA)，其中 4.25 亿人年龄在 30-69 岁之间。估计有 10,000 人患有中度至严重的 OSA。 此外，患病率在 50 岁以后随着年龄的增长而增加，并且这种情况在全世界影响着与男性一样多的女性。 此外，世界卫生组织预测，到 2030 年，六分之一的人将超过 60 岁。 因此，易患睡眠呼吸暂停的老年人口增加可能会增加对口服睡眠呼吸暂停设备和药物的需求，从而推动市场增长。

此外，2022 年 6 月的睡眠健康组织指出，肥胖的医学合併症会增加发生睡眠呼吸暂停的风险。 高度肥胖会导致气道阻塞、肺活量降低以及睡眠时喉咙塌陷导致的呼吸困难。

此外，一些市场参与者已获得监管部门的批准，并正在推出先进的口服睡眠呼吸暂停产品，这将推动市场增长。 例如，2022 年 10 月，Airway Management 推出了 flexTAP，这是一种可定制的口腔睡眠设备，专门用于治疗打鼾和轻度至中度阻塞性睡眠呼吸暂停患者。 该设备将获得专利的 Vertex 技术与 flexTAP Mouth Shield 舒适配件相结合，有助于鼻腔呼吸并优化唾液分泌不足或分泌过多。 2021 年 2 月，Oventus Medical 在直接面向消费者的模式和虚拟实验室中推出了 O2Vent Optima 口腔睡眠设备。 该公司提供与口腔睡眠呼吸暂停设备相关的远程医疗服务。

因此，由于上述因素，预计该市场在分析期内将增长。 然而，口腔睡眠呼吸暂停设备的高成本和严格的法规可能会阻碍市场增长。

口腔睡眠呼吸暂停的市场趋势

下颌前移装置事业部有望实现显着增长

下颌前突装置 (MAD) 是一种口腔睡眠呼吸暂停装置，可调节下巴以扩大气道并在睡眠期间辅助呼吸。 该设备是 PAP 设备的非侵入性替代品，可有效治疗轻度至中度睡眠呼吸暂停。 它是对 PAP 设备感到不适的轻度至中度睡眠呼吸暂停患者的主要治疗方法。 MAD 设备提供定制的灵活性和所需的问题管理。 一些研究出版物表明，从长远来看，MAD 可有效控制睡眠呼吸暂停。 例如，2022 年发表在《颅下颌骨与睡眠实践杂誌》上的一项研究强调了 MAD 治疗轻度至重度睡眠呼吸暂停的功效。 这些设备在减少呼吸暂停低通气指数 (AHI) 和睡眠呼吸暂停相关症状（如打鼾、白天过度疲劳和睡眠不安）方面显示出良好效果。

此外，下颌前突装置的几项重大发展进一步推动了市场增长。 例如，2022 年 7 月，Glidewell 推出了下颌前移装置“Silent Nite Sleep Appliance with Glidewell Hinge”。 该设备是牙医用来治疗打鼾和阻塞性睡眠呼吸暂停的 Silent Nite 品牌的延伸。 此外，2021 年 9 月，Vivos Therapeutics , Inc .获得了 USFDA 510(k) 的市场许可，用于其改良的下颌重新定位夜间矫治器（mmRNA）。

因此，由于功效、产品发布和监管批准等上述因素，预计下颌前移装置部分在预测期内将呈现显着增长。

口腔睡眠呼吸暂停市场-IMG1

北美有望主导口腔睡眠呼吸暂停市场

由于睡眠呼吸暂停的高患病率、庞大的老年人口和先进的医疗基础设施等关键因素，预计北美将主导口腔睡眠呼吸暂停市场。 主要製造商的存在和美国日益流行也是市场扩张的主要原因之一。 根据 AHA 2021，美国超过 17% 的中年女性和 34% 的中年男性符合阻塞性睡眠呼吸暂停的诊断标准。 此外，肥胖的高负担也有望对市场增长产生积极影响。 例如，根据睡眠呼吸暂停组织的数据，到 2021 年，将有超过 3000 万美国人患有睡眠呼吸暂停，而 80% 的中度至重度睡眠呼吸暂停病例未被确诊。 这种情况每年影响超过 20% 的肥胖人群。

此外，主要参与者的战略开发是推动口腔睡眠呼吸暂停综合征市场增长的主要因素之一。 例如，2022 年 5 月，ProSomnus Holdings Inc. 和 Lakeshore Acquisition 根据最终的企业合併协议合併成立了 ProSomnus, Inc.。 该交易有望加速 ProSomnus 口腔矫治器治疗设备的开发和商业化。

2022 年 10 月，Panthera Dental 与 MK1 Dental-Attachment GmbH 签署了独家经销协议，以扩大其在美国和加拿大的口腔睡眠呼吸暂停和牙科产品供应。 2022 年 5 月，Panthera Dental 宣布将与 Medit Corp.合作创建全数字化工作流程，通过集成的数字化工作流程提供世界一流的个性化打鼾和阻塞性睡眠呼吸暂停管理。 此外，该地区的这些持续发展预计将推动市场增长。

因此，由于上述因素，预计北美地区的研究市场将出现增长。

口腔睡眠呼吸暂停市场-IMG2

口腔睡眠呼吸暂停市场竞争对手分析

口服睡眠呼吸暂停药市场因其性质而适度整合，多家公司在全球和区域开展业务。 竞争格局包括 SomnoMed、Whole You、Panthera Dental、ProSomnus Sleep Technologies、Oventus Medical、ResMed、DynaFlex、Airway Management、OravanOSA、Myerson LLC、MPowrx Health & Wellness、Vivos Therapeutics, Inc、Glidewell、Teva Pharmaceutical Industries Ltd、Axsome Therapeutics还有一些在全球和区域公司中占有市场份额的知名分析公司，例如 , Inc.

其他好处

  • Excel 格式的市场预测 (ME) 表
  • 3 个月的分析师支持

内容

第一章介绍

  • 调查假设和市场定义
  • 本次调查的范围

第二章研究方法论

第 3 章执行摘要

第四章市场动态

  • 市场概览
  • 市场驱动力
    • 睡眠呼吸暂停综合征患病率上升，老年人口增加
    • 睡眠呼吸暂停综合征的基础疾病正在增加
    • 未来的技术创新
  • 市场製约因素
    • 口腔内睡眠设备的高成本和严格的监管政策
  • 产业吸引力 - 波特五力分析
    • 新进入者的威胁
    • 买家的议价能力
    • 供应商的议价能力
    • 替代品的威胁
    • 竞争对手之间的竞争强度

第 5 章市场细分（按价值划分的市场规模）

  • 按产品类型
    • 设备
      • 下颌前突装置
      • 舌苔预防装置
      • 快速扩大上颌骨
    • 口腔医学
  • 按购买类型
    • 医生开具的/定制的口腔器具和药物
    • 在线 OTC 口腔器械和药物
  • 最终用户
    • 医院
    • 家庭护理场所/个人
    • 药店
    • 其他最终用户
  • 按地区
    • 北美
      • 美国
      • 加拿大
      • 墨西哥
    • 欧洲
      • 德国
      • 英国
      • 法国
      • 意大利
      • 西班牙
      • 其他欧洲
    • 亚太地区
      • 中国
      • 日本
      • 印度
      • 澳大利亚
      • 韩国
      • 其他亚太地区
    • 中东和非洲
      • 海湾合作委员会
      • 南非
      • 其他中东和非洲地区
    • 南美洲
      • 巴西
      • 阿根廷
      • 其他南美洲

第六章竞争格局

  • 公司简介
    • SomnoMed
    • Whole You
    • Panthera Dental
    • ProSomnus Sleep Technologies
    • Oventus Medical
    • ResMed
    • DynaFlex
    • Airway Management
    • OravanOSA
    • Myerson LLC
    • MPowrx Health & Wellness
    • Glidewell
    • Vivos Therapeutics, Inc.
    • Teva Pharmaceutical Industries Ltd
    • Axsome Therapeutics, Inc.

第7章 市场机会与今后动向

简介目录
Product Code: 93057

The oral sleep apnea market is expected to register a CAGR of 14.1% over the forecast period.

Initially, the COVID-19 pandemic substantially impacted the oral sleep apnea market. With the outbreak of COVID-19, the oral sleep apnea market experienced a hike in growth. It was primarily due to the elevated risk of respiratory failure in the COVID-19-infected patients. For the management of respiratory issues, oral sleep devices, such as mandibular advancement devices, were utilized to provide respiratory support to COVID-19 patients. The American Academy of Dental Sleep Medicine recommended using oral sleep appliances as the first-line therapy for sleep apnea in patients amid the pandemic. According to the American Academy of Sleep Medicine, oral sleep apnea devices work as an alternative therapy to invasive and infection-prone positive airway pressure (PAP) devices.

The massive spread of COVID-19 and the imposition of lockdown made it challenging for patients to visit their physicians, hospitals, or sleep clinics. However, telemedicine helped with the deeper penetration of oral sleep apnea therapies during COVID-19. Clinicians quickly adapted to telemedicine for their clinical practices, which helped them consult with several patients effectively. In a study published in Sleep Medicine 2022, over 10,171 sleep apnea patients were tele-consulted by the BlueSleep Center in March 2020 during the pandemic.

As per the analysis, the demand for oral sleep apnea therapies is expected to grow at a stable pace in the post-pandemic era. Several market participants have stated that sales of oral sleep devices have increased since the COVID-19 pandemic. For instance, in December 2021, SomnoMed stated that its revenue increased by 10% in the first half of the financial year 2022. It forecasted an estimated growth rate of 15% in the financial year 2022. Furthermore, Oventus Medical reported that the sales of oral sleep appliances had more than doubled between 2020 and 2021. Thus, with such an increase in the sales of devices as well as drugs, the market is expected to grow further at a stable pace.

Further, the rising prevalence of sleep apnea and an upsurge in the geriatric population, growing incidences of the underlying conditions associated with sleep apnea, and upcoming technological advancements in devices are likely to boost the market's growth over the coming years.

According to a study published in the Journal of the American Thoracic Society in 2022, obstructive sleep apnea (OSA) has a global prevalence of over 22.6%. Moreover, the enlarging geriatric population has a major impact on the demand for oral sleep apnea drugs and devices, as aged individuals have a high risk of developing this condition. For instance, according to a study published in the National Library of Medicine, in June 2022, nearly 1 billion people worldwide suffer from obstructive sleep apnea (OSA), with 425 million adults aged 30-69 having moderate-to-severe OSA. The study further states that when people reach 50 years or older, the prevalence increases with age, and the condition affects just as many women as men worldwide. Furthermore, the WHO predicts that by 2030, one out of every six people will be 60 years of age or older. Thus, a growing aging population more vulnerable to this condition will likely augment the demand for oral sleep apnea devices and drugs, propelling the market's growth.

In addition, the Sleep Health Organization in June 2022 stated that the medical comorbidity of obesity increases the risk of developing sleep apnea. The high body mass index causes difficulty breathing by obstructing the airway, reducing lung capacity, and causing throat collapse during sleep.

Additionally, several market players have received regulatory approvals and launched advanced oral sleep apnea products, which will propel the market's growth. For instance, in October 2022, Airway Management launched its customizable oral sleep appliance, flexTAP, dedicated to treating patients with snoring conditions and mild to moderate obstructive sleep apnea. The device combines patented Vertex Technology with the flexTAP Mouth Shield comfort accessory, which aids in nasal breathing and optimizes under or over-secretion of saliva. In February 2021, Oventus Medical launched its oral sleep appliance, O2Vent Optima, under its direct-to-consumer model and virtual lab. The company offers telehealth services associated with the oral sleep apnea device.

Therefore, owing to the aforementioned factors, it is anticipated that the studied market will witness growth over the analysis period. However, the high cost of oral sleep appliances and stringent regulatory policies will likely impede the market growth.

Oral Sleep Apnea Market Trends

Mandibular Advancement Devices Segment Expected to Witness Significant Growth

Mandibular advancement devices (MAD) are oral sleep apnea devices that adjust the jaw to expand the airways and assist in breathing during sleep. These devices are a non-invasive alternative to PAP devices and effectively treat mild to moderate sleep apnea. They are the primary treatment for sleep apnea, with mild to moderate severity in patients who feel uneasy with PAP devices. MAD devices offer the flexibility of being custom-made and offer desirable management of the problem. Several research publications have indicated the effectiveness of MADs in managing sleep apnea over the long term. For instance, a study published in the Journal of Craniomandibular & Sleep Practice in 2022 underlined the efficacy of MADs for managing mild to severe sleep apnea. These devices have shown positive results in reducing the apnea-hypopnea index (AHI) and sleep apnea-related symptoms, such as snoring, excessive daytime exhaustion, and unrefreshing sleep.

In addition, some key developments in mandibular advancement devices have further bolstered the market's growth. For instance, in July 2022, Glidewell launched its mandibular advancement device, the Silent Nite Sleep Appliance with Glidewell Hinge. The device is an extension of the Silent Nite brand, which dentists use to treat snoring and obstructive sleep apnea. Further, in September 2021, Vivos Therapeutics, Inc. received the USFDA's 510(k) market clearance for its mmRNA (modified mandibular repositioning nighttime appliance) oral appliance.

Therefore, owing to the abovementioned factors, such as efficacy, product launches, and regulatory approvals, the mandibular advancement devices segment is expected to witness significant growth over the forecast period.

Oral Sleep Apnea Market - IMG1

North America Expected to Dominate the Oral Sleep Apnea Market

North America is expected to dominate the oral sleep apnea market owing to crucial factors, such as the high prevalence of sleep apnea, the vast geriatric population, and the advanced healthcare infrastructure. The presence of key manufacturers in the United States, as well as the increasing prevalence of the condition, are two of the primary reasons for market expansion. According to the AHA 2021, over 17% of middle-aged females and 34% of middle-aged men met the diagnostic criteria for obstructive sleep apnea in the United States. Furthermore, the high burden of obesity is expected to positively impact the market's growth. For instance, according to the Sleep Apnea Organization, in 2021, more than 30 million Americans suffered from sleep apnea, and 80% of moderate-to-severe sleep apnea cases were undiagnosed. The condition affects more than 20% of obese people every year.

Moreover, strategic developments by the leading players are one of the major factors driving the growth of the oral sleep apnea market. For instance, in May 2022, ProSomnus Holdings Inc. and Lakeshore Acquisition merged under the definitive business combination agreement to become ProSomnus, Inc. The deal is expected to accelerate the development and commercialization of ProSomnus' oral appliance therapy devices.

In October 2022, Panthera Dental signed an exclusive distribution agreement with MK1 Dental-Attachment GmbH to expand the oral sleep apnea and dental products offering in the United States and Canada. In May 2022, Panthera Dental, in collaboration with Medit Corp., announced the creation of a completely digital workflow to provide world-class custom-made snoring and obstructive sleep apnea management through an integrated digital workflow. Further, these continuous developments in the region are anticipated to drive the growth of the market.

Therefore, owing to the aforesaid factors, the growth of the studied market is anticipated in the North American region.

Oral Sleep Apnea Market - IMG2

Oral Sleep Apnea Market Competitor Analysis

The oral sleep apnea market is moderately consolidated in nature due to the presence of a few companies operating globally as well as regionally. The competitive landscape includes an analysis of some international and local companies that hold market shares and are well known, including SomnoMed, Whole You, Panthera Dental, ProSomnus Sleep Technologies, Oventus Medical, ResMed, DynaFlex, Airway Management, OravanOSA, Myerson LLC, MPowrx Health & Wellness, Vivos Therapeutics, Inc., Glidewell, Teva Pharmaceutical Industries Ltd, and Axsome Therapeutics, Inc.

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 DYNAMICS

  • 4.1 Market Overview
  • 4.2 Market Drivers
    • 4.2.1 Rising Prevalence of Sleep Apnea and Upsurge in Geriatric Population
    • 4.2.2 Growing Incidences of the Underlying Conditions Associated with Sleep Apnea
    • 4.2.3 Upcoming Technological Advancements
  • 4.3 Market Restraints
    • 4.3.1 High Cost of the Oral Sleep Appliances and Stringent Regulatory Policies
  • 4.4 Industry Attractiveness - Porter's Five Forces Analysis
    • 4.4.1 Threat of New Entrants
    • 4.4.2 Bargaining Power of Buyers
    • 4.4.3 Bargaining Power of Suppliers
    • 4.4.4 Threat of Substitute Products
    • 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION (Market Size by Value - USD million)

  • 5.1 By Product Type
    • 5.1.1 Devices
      • 5.1.1.1 Mandibular Advancement Devices
      • 5.1.1.2 Tongue-retaining Devices
      • 5.1.1.3 Rapid Maxillary Expansion
    • 5.1.2 Oral Drugs
  • 5.2 By Purchase Type
    • 5.2.1 Physician-prescribed/Customized Oral Appliances and Drugs
    • 5.2.2 Online OTC Oral Appliances and Drugs
  • 5.3 By End-user
    • 5.3.1 Hospital
    • 5.3.2 Home Care Settings/Individual
    • 5.3.3 Pharmacies
    • 5.3.4 Other End-users
  • 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 and Africa
      • 5.4.4.1 GCC
      • 5.4.4.2 South Africa
      • 5.4.4.3 Rest of Middle East and 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 Company Profiles
    • 6.1.1 SomnoMed
    • 6.1.2 Whole You
    • 6.1.3 Panthera Dental
    • 6.1.4 ProSomnus Sleep Technologies
    • 6.1.5 Oventus Medical
    • 6.1.6 ResMed
    • 6.1.7 DynaFlex
    • 6.1.8 Airway Management
    • 6.1.9 OravanOSA
    • 6.1.10 Myerson LLC
    • 6.1.11 MPowrx Health & Wellness
    • 6.1.12 Glidewell
    • 6.1.13 Vivos Therapeutics, Inc.
    • 6.1.14 Teva Pharmaceutical Industries Ltd
    • 6.1.15 Axsome Therapeutics, Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS