Global Oral Appliances Market

The Oral Appliances Market was valued at USD 905.54 million in 2023, and the total revenue is expected to grow at a CAGR of 5.79% from 2024 to 2030, reaching nearly USD 1342.65 million by 2030.

Oral Appliances Market Overview

Oral appliances are custom made devices shown in the mouth to address many medical and dental conditions, mainly for sleep apnea, bruxism, and TMJ disorders. For OSA (obstructive sleep apnea), an oral appliance repositions the tongue and jaw to keep the airway open, reduction snoring and apnea episodes as a replacement to CPAP therapy.

The growing prevalence of sleep disorders, like obstructive sleep apnea (OSA), is substantially driving the growth of the Oral Appliances Market. In Oct 2023, National Council on Aging data signifies that OSA, illustrated by irregular breathing and reduced oxygen supply to the brain, influences about 39 million adults in the United State and a projected 936 million adults worldwide. The high popularity of sleep apnea in an older population often goes undiagnosed owing to factors such as lack of awareness and non-specific symptoms. With the international population aged 60 and above predicted to reach 2 billion by 2050 and the elderly population expected to double from 12% to 22%, the numbers of sleep disorders, specifically OSA, is on the increase. OSA influences 13% to 32% of people aged 65 and above. The growth geriatric population's liability to sleep apnea is expected to initiative the adoption of oral appliances.

Market Insights: Aging Population and the Rise of Sleep Disorders

The report for oral appliances market offers a comprehensive analysis of the global market for oral appliances products. The MMR report includes crucial statistics concerning the status of leading players in the oral appliances market, highlighting potential opportunities and key trends within the oral appliances market by region.

The MMR report provides an analysis of the driving and restraining factors affecting oral appliances market growth. This includes factors for instance technological advancements, and regulatory policies affecting the oral appliances market. The MMR report presents a aspect summary of the industry, integrating both qualitative and quantitative data. Furthermore, the global report studies factors impacting the oral appliances market from both the supply and demand sides. The MMR report contains the detailed company profiles in the oral appliances market. This section includes information on company profiles, product portfolios, mergers and acquisitions, oral appliances market strategies, and their position in the oral appliances market globally. The overall goal of oral appliances market report is to require stakeholders, businesses, and investors, with a comprehensive understanding of oral appliances market globally.

Oral Appliances Market Dynamics:

Obstructive Sleep Apnea: Increasing Health Concern and the Growing Need for Oral Appliances

Oral Appliances Market is gaining pace aggressively, mainly due to the increasing incidence of Obstructive Sleep Apnea (OSA). OSA is increasingly seen in the population because people are aging, obesity rates are gradually emerging, and lifestyle is changing. The disease is more common with the aged because muscular weakening around the airway allows its prospect.

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The higher rates of obesity increase the chances of accumulative fats around the neck and obstruct the airway. Moreover, sedentary behaviour, poor diet, and alcoholism have generally dominated lifestyle in this modern age, increasing the propensity for the condition. Untreated OSA can lead to serious health outcomes such as hypertension, heart disease, and stroke, making it imperative to be diagnosed and treated in a timely manner. With millions afflicted globally, the need for effective, non-invasive treatments has surged and an oral appliance is also emerging as one of the popular treatments. Growing awareness about the health conditions caused by OSA coupled with the increasing number of patients strongly drives the demand for growth in the oral appliances market.

• In October 2023, National Council on Aging data signifies that OSA, illustrated by irregular breathing and decreased oxygen supply to the brain, affects nearly 39 million adults in the U.S. and an expected 936 million adults internationally.

The Growing Demand of Oral Appliances Over PAP Therapy:

In the oral appliances market, a significant change is taking place where patients are shifting their PAP (Positive Airway Pressure) devices for oral appliances owing to their lesser bulky nature, positive clinical outcomes, improved ease of use, and a drastic rise in patient satisfaction. Reports from ex-PAP users show that oral appliances are more comfortable and deliver better sleep, hence their increasing popularity. Many people who previously studied PAP machines bulky, uncomfortable, or hard to bear, are now switching to oral appliances which indicates a steady preference towards these devices and their further acceptance. It was reported in the Journal of Clinical Sleep Medicine that more than 60% of ex-PAP users who did not currently use the device said that oral appliances were easier to use and more comfortable, especially those who struggled with the respiratory machine’s masks. This change is due not only to the discomfort patients feel, but also to the growing recognition of oral appliances as a viable alternative to standard PAP therapy. Furthermore, the oral appliances market growth is enhanced owing to the increased availability encouraged by the technological innovation in dental medicine and the rising number of dental practitioners that provide these types of treatments.

• For instance, a survey by the American Academy of Dental Sleep Medicine exposed a 35% rise in the number of dental practices offering oral appliance therapy over the past 5 years, making it easier for patients to access these solutions and further driving the shift away from PAP devices.

Challenges Facing the Oral Appliances Market: Cost and Regulatory Barriers

The stringent regulatory policies and high cost of oral sleep appliances are significant factors affecting the Oral Appliances Market. These devices are mainly used for the treatment of sleep apnea and snoring, which are expensive compared to other alternative treatments like CPAP machines, thus restraining a wider patient population. The high cost of production, especially for custom-fitted appliances, adds up to the total price. The cost expected to rise with advanced materials, custom designs, and the mandatory dental consultation for adjustment or fitting. Therefore, the patients are less likely to prefer oral appliances because of other viable low-cost alternatives.

The regulatory policies are challenging, which makes the matter even more difficult in the oral appliances market. Oral appliances are often required to meet precise health and safety standards as set by regional regulatory authority bodies such as the U.S. This means food and drug administration (FDA) or the European Medicines Agency (EMA). More importantly, regulatory requirements of this nature ensure that devices are safe and effective but add costs and resource usage in getting these products on the oral appliances market. Device cost paired with the problems of regulations presents a key challenge to oral appliances market growth, especially in emerging markets where healthcare affordability may be a concern. However, these factors work to improve the quality and efficiency of oral appliances as a high-end, long-term sleep apnea and related disorders remedy. Considering these expected developments, cost reduction and increased accessibility will be expected with innovation in manufacturing processes, and possible update of regulatory policies.

Recent Developments in Oral Appliances Market:

Oral Appliances Market Segmentation:

By Product Type, Mandibular Advancement Devices (MADs) segment held the largest oral share of over 72% for the oral appliances market in 2023. Mandibular Advancement Devices are widely conceded and suggested by healthcare professionals for their efficiency in treating mild to moderate obstructive sleep apnea. These devices work by repositioning the lower jaw forward, accordingly, maintaining an open airway during sleep. Their user-friendly design, comfort, and ease of use have led to higher patient acceptance and compliance. As per the National Library of Medicine insights from March 2022, current changes in German healthcare regulations have increased the availability of Mandibular Advancement Devices (MADs) as a treatment option for OSA, manufacture them more available to general dentists and their patients. Additionally, increasing FDA regulations are also driving oral appliances market growth.

For example, in January 2024, SnoreLessNow published that the FDA granted 510(k) clearance for its OTC mandibular development device, known as SomniFit-S in Europe. The Anti-Snore Mouth Guard+ reduces snuffling by gently advancing the jaw, thereby removing airway obstruction and increasing airflow without the need for hoses, masks, or electronics.

The Tongue-Retaining Devices (TRDs) segment is expected to grow significantly over the 2024-2030. Growing awareness of sleep-related disorders, specifically obstructive sleep apnea (OSA), has led to imposing demand for non-invasive treatment options. TRDs are favoured for their effectiveness in avoiding airway obstruction during sleep by preserving the tongue's position. Technological development in these devices improved the comfort and efficacy of TRDs, increasing patient compliance.

Hybrid devices are a newer innovation in the oral appliances market, combining the benefits of both MADs and TRDs. They are growing in popularity as a versatile option for patients who require a more comprehensive solution, although their oral appliances market share remains relatively smaller compared to MADs and TRDs.

Based on End Use, Homecare segment is dominate the oral appliances market, with the market share of nearly 64.56% by 2030. The developing preference for home-based treatments and the convenience of using oral appliances in the comfort of one's own home have substantially contributed to the segment's prominence. Home care settings offer patients with the flexibility to manage their sleep apnea without the need for hospital visits, reducing healthcare costs and increasing patient compliance.

Oral Appliances Market Regional Analysis:

North America is expected to dominate the oral appliances market owing to crucial factors, like 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 key reasons for oral appliances market growth. Furthermore, the rising number of FDA approvals for sleep apnea conditions would likely drive oral appliances market growth in the region. Such as, in November 2023, Vivos expected FDA 510(k) clearance for its CARE oral appliances, considered to treat severe obstructive sleep apnea (OSA). Vivos' CARE oral appliances provide a non-invasive alternative to CPAP for severe OSA patients by increasingly shifting the airway's hard and soft tissues, thereby increasing airway function and flow. The FDA-cleared suite involves the DNA, mRNA, and mmRNA oral appliances. Data accepted to the FDA directed superior treatment outcomes in patients with severe OSA associated to those with mild-to-moderate OSA, with a standard treatment period of 9.7 months.

Asia-Pacific oral appliances market is expected to grow highest CAGR of 6.12% during the forecast period owing to various factors. Such as, in April 2024, IDEM Singapore 2024, a prominent dental event in the APAC region, showcased the recent developments in dentistry, innovators, drawing industry leaders, and practitioners. Smartee's participation emphasised mandibular repositioning technology, showcasing its promise to advancing orthodontic services over advanced technologies and innovative clear aligner solutions, driving growth in the Asia Pacific oral appliances market.

Oral Appliances Market Country-Wise Analysis:

In 2023, The Oral Appliances Market observed strong performance across key economies. The U.S. led the oral appliances market, driven by innovation like ProSomnus's FDA-cleared EVO [PH] device, designed to provides adapted and compact sleep solutions. In the UK, increasing awareness of sleep disorders such as OSA, combined with non-invasive treatment preferences, boosted oral appliances market growth.

Germany’s oral appliances market was supported by protective care awareness, reimbursement options, and developments in customizable devices. Australia gained ground in the Asia-Pacific region through regulatory clearances, for instance Vivos Therapeutics' authorization for OSA treatments. India is set for rapid growth, fuelled by higher healthcare spending, increased awareness of sleep health, and improved access to dental care services.

Oral Appliances Market Scope: Inquire Before Buying

Oral Appliances Market, by Region

North America (United States, Canada, and Mexico)
Europe (UK, France, Germany, Italy, Spain, Sweden, Austria, and the Rest of Europe)
Asia Pacific (China, South Korea, Japan, India, Australia, ASEAN, and the Rest of APAC)
Middle East & Africa (South Africa, GCC, Nigeria, Rest of ME&A)
South America (Brazil, Argentina Rest of South America)

Oral Appliances Market, Key Players

North America:
• ResMed Inc. (USA)
• SomnoMed (USA)
• ProSomnus (USA)
• Vivos (USA)
• Glidewell (USA)
• Airway Management (TAP) (USA)
• Apnea Sciences (USA)
• Achaemenid, LLC (USA)
• VitalSleep (USA)
• Zyppah (USA)
• Signifier Medical Technologies (USA)
• SleepTight Mouthpiece (USA)
• The Dr. Oxy (USA)
Europe:
• SleepWell (UK)
Asia Pacific:
• Mitsui Chemicals, Inc. (Japan)
• Others

Frequently Asked Questions:

1. Which region has the largest share in Global Oral Appliances Market?
Ans: North America region held the highest share in 2023.

2. What is the growth rate of Global Oral Appliances Market?
Ans: The Global Oral Appliances Market is growing at a CAGR of 5.79% during forecasting period 2023-2030.

3. What is scope of the Global Oral Appliances Market report?
Ans: Global Oral Appliances Market report helps with the PESTEL, PORTER, COVID-19 Impact analysis, Recommendations for Investors & Leaders, and market estimation of the forecast period.

4. Who are the Major players in Global Oral Appliances Market?
Ans: The important major players in the Global Oral Appliances Market are – ResMed Inc. (USA), SomnoMed (USA), ProSomnus (USA), Vivos (USA), Glidewell (USA) and others.

5. What is the study period of this Market?
Ans: The Global Oral Appliances Market is studied from 2023 to 2030.