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市场调查报告书
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1679249
睡眠呼吸中止症口腔器具市场预测至 2030 年:按产品类型、性别、年龄层、最终用户和地区进行的全球分析Sleep Apnea Oral Appliances Market Forecasts to 2030 - Global Analysis By Product, Type, Gender, Age Group, End User and By Geography |
根据 Stratistics MRC 的数据,全球睡眠呼吸中止口腔器具市场预计在 2024 年达到 8.5495 亿美元,到 2030 年将达到 23.4341 亿美元,预测期内的复合年增长率为 18.3%。
睡眠呼吸中止症口腔器具是自订的牙科设备,透过重新定位下颚和舌头来保持睡眠期间气道畅通,从而治疗阻塞型睡眠呼吸中止症(OSA)。这些装置有时被称为舌固定装置(TRD)或下颚前移装置(MAD),它们可以改善整体呼吸模式、减少打鼾并减少气道崩坏。患有轻度至中度 OSA 或难以接受 CPAP 治疗的患者通常选择 TRD 作为 CPAP 治疗的非侵入性治疗方法。
根据《临床睡眠医学杂誌》发表的一项研究,口腔器械治疗(OAT)显着降低了呼吸中止低通气指数(AHI),平均每小时降低了12次,改善了阻塞型睡眠呼吸中止症(OSA)患者的睡眠品质。
睡眠呼吸中止症盛行率不断上升
睡眠呼吸中止症口腔器具市场的成长很大程度上受到睡眠呼吸暂停,尤其是阻塞型睡眠呼吸中止症(OSA)盛行率不断上升的推动。 OSA 是由肥胖率上升、久坐的生活方式、吸烟、饮酒和人口老化等因素造成的。此外,研究表明,大量睡眠呼吸中止症病例未被诊断出来,这可能导致严重的健康併发症,如糖尿病、心血管疾病和认知障碍。随着世界各地的医疗保健系统越来越重视睡眠障碍的早期发现和治疗,作为治疗轻度至中度 OSA 的实用有效方法,口腔器具的需求预计会增加。
对严重睡眠呼吸中止症的疗效有限
口腔器具在治疗严重阻塞型睡眠呼吸中止症(OSA)的限制是限制此类设备市场的主要因素之一。对于轻度至中度病例,通常建议使用口腔器具,但在严重病例中,其有效性会急剧下降,而持续性阳压呼吸器(CPAP) 治疗仍是黄金标准。此外,口腔器具可能不足以维持严重 OSA 患者的气道压力,通常需要更高程度的支撑。在这种情况下,医生可能会提案联合治疗或替代疗法,如 CPAP、BiPAP 甚至手术,从而限制独立口腔器械的市场成长。
未确诊的睡眠呼吸中止症病例增加
随着阻塞型睡眠呼吸中止症(OSA)的盛行率在全球范围内不断上升,治疗睡眠呼吸中止症的口腔器具市场可能会成长。研究表明,数百万人未被诊断出来,许多患有睡眠呼吸中止症的人甚至不知道自己患有这种疾病。由于政府、私人医疗机构和卫生组织的宣传活动不断加强,诊断率逐渐上升,治疗需求也逐渐增加。此外,由于睡眠呼吸中止症通常与肥胖、糖尿病、心血管疾病和高血压等疾病有关,这些合併症的盛行率不断上升,预计将推动对口腔器具和其他有效的 OSA 管理解决方案的需求。
来自手术和 CPAP 介入的激烈竞争
CPAP(持续性呼吸道正压通气)设备是治疗中度至重度阻塞型睡眠呼吸中止症(OSA)的黄金标准,在睡眠呼吸中止口腔器械市场上竞争激烈。 CPAP 设备之所以经常被推荐,是因为它们具有即使在患者不遵医嘱的情况下也能保持气道畅通的能力。下颚前移术 (MMA)、舌下神经刺激术、腭咽成形术 (UPPP) 等外科手术也越来越受欢迎,尤其是在寻求长期治疗方法的患者中。此外,随着技术进步提高了 CPAP 的舒适度、手术成功率并限制了口腔器械成长的潜力,患者可能更有可能选择这些方案。
COVID-19 疫情以多种方式影响了睡眠呼吸中止症口腔器械市场,既带来机会,也带来挑战。新口腔器械配件最初的下降是由于供应链中断、製造业放缓以及患者到牙科诊所和睡眠中心的就诊次数减少。市场限制、医疗机构关闭和封锁导致许多睡眠呼吸中止症患者推迟治疗,阻碍了市场扩张。但这场大流行也提高了人们对呼吸健康和睡眠问题的认识,导致远端医疗咨询和在家睡眠测试的增加。此外,我们也向一些患者提出了考虑口腔器械治疗作为 CPAP替代的想法,特别是考虑到人们担心 CPAP 机器可能会将呼吸道飞沫雾化。
预计下颚前移器具市场在预测期内将占据最大份额
预计下颚前牵引装置将在预测期内占据最大的市场占有率,因为它们应用广泛、效果显着,并且相对于其他牙科器械更受患者青睐。轻度至中度阻塞型睡眠呼吸中止症(OSA) 可以透过 MAD 有效治疗,MAD 透过将下颚略微向前移动来防止睡眠期间气道崩坏。与舌头稳定装置 (TSD) 等替代品相比,这些装置更舒适,并且保证按照牙医或牙齿矫正医师的规定使用。此外,其非侵入性、易于使用以及作为 CPAP 疗法替代品的日益普及使其在市场上占据优势。
预计预测期内家庭护理环境部分将实现最高的复合年增长率。
由于人们对睡眠呼吸中止症管理认识的不断提高、对家庭治疗选择的偏好增加以及远端医疗的进步,预计家庭治疗环境部分将在预测期内见证最高的增长率。为了避免频繁就医,患者越来越多地寻求舒适、实惠且可在家中使用的非侵入性解决方案。居家睡眠测试(HST)的使用增加正推动需求,因为它有助于快速诊断和更早开始口腔器械治疗。此外,为了进一步促进这个市场,保险公司也在扩大家庭睡眠呼吸中止症治疗的覆盖范围。
预计预测期内北美地区将占据最大的市场占有率。这是由强大的医疗保健体系、高度的认识和不断上升的睡眠呼吸中止症盛行率所推动的。美国占据市场主导地位,随着筛检、人口老化和肥胖率上升,美国的肥胖病例诊断数量不断增加。最先进的牙科设备、主要市场参与企业的强大影响力以及优惠的报销政策进一步加速了其应用。此外,美国睡眠医学学会 (AASM) 和其他监管机构积极推广口腔器械疗法作为治疗方法的可行替代方案,从而提高了患者和医疗保健专业人员对该治疗的接受度。
预计预测期内亚太地区将呈现最高的复合年增长率。这现象的发生正值肥胖相关睡眠呼吸中止症盛行率不断上升、医疗成本不断上升以及人们对睡眠障碍的认识不断提高。生活方式的改变、都市化和压力水平的增加导致中国、印度和日本等国家的睡眠呼吸中止症诊断数量增加。这导致对非侵入性和有效治疗方案的需求增加。此外,家庭睡眠测试 (HST) 的采用、保险覆盖范围的扩大和医疗保健基础设施的改善正在推动市场成长。国际牙科和睡眠护理品牌在该地区越来越普及,3D 列印和自订口腔器具的发展也有助于降低治疗费用。
According to Stratistics MRC, the Global Sleep Apnea Oral Appliances Market is accounted for $854.95 million in 2024 and is expected to reach $2343.41 million by 2030 growing at a CAGR of 18.3% during the forecast period. Sleep apnea oral appliances are custom-fitted dental devices designed to treat obstructive sleep apnea (OSA) by repositioning the lower jaw and tongue to keep the airway open during sleep. These devices, sometimes referred to as tongue-retaining devices (TRDs) or mandibular advancement devices (MADs), facilitate better breathing patterns overall, lessen snoring, and lessen airway collapse. Patients with mild to moderate OSA or those who have trouble adhering to CPAP therapy often choose them because they are a non-invasive substitute for CPAP therapy.
According to a study published in the Journal of Clinical Sleep Medicine, oral appliance therapy (OAT) significantly reduced the apnea-hypopnea index (AHI) by an average of 12 events per hour, improving sleep quality for patients with obstructive sleep apnea (OSA).
Increased sleep apnea prevalence
The market for sleep apnea oral appliances is driven in large part by the rising prevalence of sleep apnea, especially obstructive sleep apnea (OSA), which is caused by factors like rising obesity rates, sedentary lifestyles, smoking, alcohol consumption, and an aging population. Additionally, research shows that a significant number of sleep apnea cases go undiagnosed, which can result in serious health complications like diabetes, cardiovascular diseases, and cognitive impairment. As healthcare systems around the world emphasize early detection and treatment of sleep disorders, the demand for oral appliances are expected to increase as a practical and efficient way to manage mild to moderate OSA.
Limited effectiveness in cases of severe sleep apnea
Oral appliances limited ability to treat severe obstructive sleep apnea (OSA) is one of the main factors limiting the market for these devices. In mild to moderate cases, oral appliances are commonly advised; however, in severe cases, where continuous positive airway pressure (CPAP) therapy is still the gold standard, their effectiveness drastically decreases. Furthermore, oral appliances may not be sufficient to support severe OSA patients' airway pressure, which frequently calls for higher levels of support. In these situations, medical practitioners are more likely to suggest combination therapies, alternative treatments like CPAP, BiPAP, or even surgery, which limits the market expansion for standalone oral appliances.
Growing number of sleep apnea cases without a diagnosis
The market for sleep apnea oral appliances has a great chance to grow due to the rising incidence of obstructive sleep apnea (OSA) worldwide. According to studies, millions of people go undiagnosed, and many people with sleep apnea are unaware that they have the condition. Growing awareness campaigns by governments, private healthcare facilities, and health organizations are progressively raising diagnosis rates, which raises the need for treatment. Moreover, because sleep apnea is frequently associated with diseases like obesity, diabetes, cardiovascular disorders, and hypertension, the growing prevalence of these comorbidities is anticipated to increase demand for oral appliances and other efficient OSA management solutions.
Tough competition from surgical and CPAP interventions
Continuous Positive Airway Pressure (CPAP) devices, the gold standard for treating moderate to severe obstructive sleep apnea (OSA), are a fierce competitor in the sleep apnea oral appliances market. CPAP machines are frequently prescribed because of their demonstrated ability to keep the airway open, even in the face of patient noncompliance. Surgical procedures like maxillomandibular advancement (MMA), hypoglossal nerve stimulation, and uvulopalatopharyngoplasty (UPPP) are also becoming more and more common, especially among patients looking for a long-term cure for their ailment. Additionally, patients may choose these alternatives as technology advances increase CPAP comfort and surgical success rates, which would restrict the potential for oral appliance growth.
The COVID-19 pandemic shaped the sleep apnea oral appliances market in a number of ways, including opportunities and challenges. The initial decline in new oral appliance fittings was caused by supply chain disruptions, manufacturing slowdowns, and fewer patients visiting dental clinics and sleep centers. Financial restraints, healthcare facility closures, and lockdowns caused many sleep apnea patients to put off their treatments, which hindered market expansion. But the pandemic also raised awareness of respiratory health and sleep issues, which resulted in more telemedicine consultations and home-based sleep tests. Furthermore, this gave some patients the idea to look into oral appliance therapy as a substitute for CPAP, particularly in light of worries that CPAP devices might aerosolize respiratory droplets.
The Mandibular Advancement Devices segment is expected to be the largest during the forecast period
The Mandibular Advancement Devices segment is expected to account for the largest market share during the forecast period because it is widely used, very effective, and preferred by patients over other dental appliances. Mild to moderate obstructive sleep apnea (OSA) can be effectively treated with MADs because they prevent airway collapse during sleep by moving the mandible, or lower jaw, slightly forward. Compared to alternatives such as Tongue Stabilizing Devices (TSDs), these devices are more comfortable and guaranteed to be used as prescribed by dentists or orthodontists. Moreover, they have established their dominance in the market owing to their non-invasiveness, simplicity of use, and increasing popularity as a substitute for CPAP therapy.
The Home Care Settings segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the Home Care Settings segment is predicted to witness the highest growth rate because of the growing awareness of managing sleep apnea, the growing preference for at-home treatment options, and the advancements in telemedicine. In order to avoid frequent clinical visits, patients are increasingly looking for comfortable, affordable, and non-invasive solutions that they can use at home. The increasing use of home sleep testing (HST) has increased demand by facilitating speedier diagnosis and early oral appliance therapy initiation. Furthermore, to further boost this market, insurance companies are also increasing coverage for treatments for sleep apnea that can be done at home.
During the forecast period, the North America region is expected to hold the largest market share, fuelled by a strong healthcare system, a high level of awareness, and the rising incidence of sleep apnea. The market is dominated by the United States, where more cases are being diagnosed as a result of improved screening techniques, aging populations, and rising obesity rates. Adoption has been further accelerated by the availability of cutting-edge dental appliances, the robust presence of important market participants, and advantageous reimbursement policies. Moreover, oral appliance therapy is also actively promoted by the American Academy of Sleep Medicine (AASM) and other regulatory organizations as a viable substitute for CPAP, which increases patient and healthcare provider acceptance of the treatment.
Over the forecast period, the Asia-Pacific region is anticipated to exhibit the highest CAGR, driven by a growing prevalence of obesity-related sleep apnea, rising healthcare costs, and growing awareness of sleep disorders. Due to shifting lifestyles, urbanization, and increased stress levels, sleep apnea diagnoses are on the rise in nations like China, India, and Japan. This has increased demand for non-invasive and efficient treatment options. Additionally, the market is also growing faster due to the adoption of home sleep testing (HST), increased insurance coverage, and better healthcare infrastructure. International dental and sleep therapy brands are becoming more widely available in the area, and developments in 3D-printed and custom-fitted oral appliances are also helping to make treatment more affordable.
Key players in the market
Some of the key players in Sleep Apnea Oral Appliances market include Thermo Fisher Scientific Inc., Zephyr Sleep Technologies, Dentsply Sirona Inc, Fisher & Paykel Healthcare Limited, Airway Management, Inc., Koninklijke Philips N.V, BMC Medical Co., Ltd., DynaFlex Inc, ProSomnus, Inc., Straumann Group, SICAT GmbH and Co. KG, Myerson Solicitors LLP, Apnea Sciences Inc, SomnoMed Inc and ResMed Inc.
In February 2025, Thermo Fisher Scientific Inc. announced that the company has entered into a definitive agreement with Solventum to acquire Solventum's Purification & Filtration business for approximately $4.1 billion in cash. Solventum's Purification & Filtration business is a leading provider of purification and filtration technologies used in the production of biologics as well as in medical technologies and industrial applications.
In July 2023, ResMed announced the acquisition of privately held Somnoware, a U.S. leader in sleep and respiratory care diagnostics software. Somnoware software streamlines the processes of physicians as well as sleep and pulmonary function testing labs for diagnosing and evaluating a patient's sleep and respiratory care test results, ordering PAP treatment equipment, setting up appointments, tracking PAP compliance, and electronically providing this information directly into a patient's electronic health record - all from within the Somnoware platform.
In July 2022, Straumann Group Acquires a Strategic Minority Stake and is Partnering with CareStack to Offer United States Dental Practices an Integrated, All-in-One Practice Management Solution. As a result of this partnership, CareStack will expand its service offering and presence in the United States market and beyond. Working closely with practitioners around the world, CareStack has developed a streamlined digital practice solution for the modern, growth-ready dental practice.