Sinus Dilation Devices Market

Market Overview

The global sinus dilation devices market size was valued at USD 2,573 million in 2022. It is estimated to reach USD 5,217 million by 2031, growing at a CAGR of 10.79% during the forecast period (2023–2031).

Sinusitis is an infection of the sinus lining brought on by bacteria, fungi, or viruses. It may also be caused by structural issues, such as a blocked sinus opening (ostium). Closed ostium results in difficulty in normal mucus drainage, further leading to inflammation and infection of the sinuses. Sinus is also known as rhinosinusitis, resulting in symptoms such as facial pain, runny or stuffy nose, and occasional fever.

Sinus dilation, also called balloon sinuplasty, is a minimally invasive procedure that allows adequate airflow and restores natural drainage by opening obstructed sinus passages. It uses a variety of implantable devices to lessen postoperative inflammation, gives local medicine, and increase the patency of sinus apertures. These devices are replacing traditional sinus devices as the preferred method of treating chronic rhinosinusitis (CRS), proving to be refractory. Patients with severe ethmoid or other sinus irritations can also utilize them with other treatments. Several manufacturers release instruments that use microsensors to pinpoint device placement during operations.

Key Highlights

• Balloon sinus dilation devices dominate the product segment
• Adult dominates the application segment
• Hospitals dominate the end-user segment
• North America is the highest shareholder in the global market

Market Dynamics

Market Drivers

Favorable Reimbursement Scenario

An increase in medical reimbursements across major markets will likely fuel market growth. Growing per capita expenditure coupled with the rising adoption of health insurance in developed and developing countries is anticipated to influence the market positively. The U.S. has a combination of private and public health insurance systems, whereas countries like Japan, Canada, and several European countries have universal insurance systems. In the U.S., the federal government governs Medicare's health insurance program, which covers senior citizens and disabled people.

In contrast, Medicaid is a government plan covering low-income people. Moreover, the Children's Health Insurance Program (CHIP) provides healthcare to pediatric patients. In the U.S., around 84% of the population is covered by public (26%) or private (70%) health insurance. Administered by the federal government, Medicare is the largest health insurer in the U.S., covering around 13% of the population. Therefore, the growing adoption of health insurance coupled with favorable reimbursement policies for procedures such as nasal/sinus endoscopy surgery, Functional Endoscopic Sinus Surgery (FESS), tube balloon dilation procedure, computer-assisted navigation, and related devices are anticipated to boost the market growth further.

Rising Preference for Minimally Invasive Surgical Procedures

Minimally invasive surgeries offer several benefits compared to open surgery techniques, augmenting the growth of sinus dilation devices. Minimally invasive surgeries offer several advantages, such as faster recovery time, smaller incisions, reduced scarring and pain, increased accuracy, and shorter hospital stay. Moreover, major market players operating in the sinus dilation market are focusing on continuous research and developmental activities to introduce minimally invasive procedures creating a positive impact on adopting MIS procedures.

Some of the inventions in the market related to endoscopic approaches include nasal endoscopes, rhinoscopes, and balloon sinus dilation devices. Balloon sinuplasty is among the popular minimally invasive sinus procedures as it does not need any tissue removal and is often combined with surgery. This procedure causes minimal pain, less bleeding, and no visible cuts. Hence, rising demand for minimally invasive surgical procedures is predicted to boost the market of sinus dilation devices.

Market Restraint

High Adoption Rate of Alternative Treatment

There are two main categories of sinusitis, i.e., acute and chronic. The common cold mostly causes acute sinusitis, and medications are the widely preferred treatment. Saline nasal sprays; decongestants; nasal corticosteroids such as Rhinocort, Flonase, Nasonex, Veramyst, Qnasl, and Beconase AQ; OTC pain relievers such as Motrin IB, Advil, Tylenol, etc. are prescribed as first treatment line for acute sinusitis by doctors. Instead, doctors advise aspirin desensitization therapy, nasal sprays or solutions, oral or injectable corticosteroids, nasal corticosteroids, and other non-surgical treatments for chronic sinusitis (when swelling and inflammation persist for over 12 weeks despite treatment attempts). Therefore, positive outcomes delivered by medications and the vast availability of drugs in the market are factors predicted to limit the market growth.

Market Opportunities

Technological Advancements and New Product Launch

Medtronic, Smith & Nephew, and Acclarent, Inc. are key players operating in the market, focusing on investments in research and developmental activities to receive product approval and technological advancements. For instance, Smith & Nephew invested USD 222 million during FY 2015 and USD 223 million in 2017. Furthermore, technological advancements such as surgical laser technologies in sinus surgery improve the patient's life and have fewer side effects. This technology uses a laser to remove unwanted sinus tissue and offers relief from chronic sinusitis with minimal pain and bleeding.

Furthermore, an increase in mergers and acquisitions is anticipated to positively impact the market due to the increasing reach of products at the global level. For instance, in December 2017, Stryker Corporation acquired Entellus Medical, a U.S.-based company delivering minimally invasive ENT solutions in the market. Similarly, recent product launches are further expected to boost the market. For instance, in July 2016, SinuSys Corporation announced the U.S. FDA approval for its Vent-Os device. The system is used in the treatment of sphenoid and frontal sinuses. Such factors create opportunities for market growth.

Regional Analysis

The global sinus dilation devices market is bifurcated based on region into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

North America is the most significant global sinus dilation devices market shareholder and is anticipated to grow at a CAGR of 10.89% during the forecast period. North America held the most prominent market share in sinus dilation devices because of the highly regulated and developed healthcare infrastructure. Increase in collective efforts by key players to improve their product portfolio and ensure high-quality products are projected to boost the demand for sinus dilation devices across this region. For instance, in February 2018, Stryker entered a definitive agreement to acquire Entellus Medical, Inc. Some of the leading players in the North American sinus dilation device market who place a high priority on R&D spending to develop a technically cutting-edge product portfolio include Medtronic, Smith & Nephew, Entellus Medical, Inc., Acclarent, Inc., Olympus Corporation, and Intersect ENT, Inc. In addition, the increasing prevalence of chronic sinusitis in the U.S. and Canada is further expected to fuel market growth. According to the Centers for Disease Control and Prevention, in 2017, the number of adults diagnosed with sinusitis was 26.9 million, around 11% of the adult American population. Favorable reimbursement policies are also expected to fuel market growth further.

Europe is estimated to exhibit a CAGR of 10.4% over the forecast period. Europe is among the most developed regions in the world. Increasing public and private investments in increasing prevalence of Chronic Rhinosinusitis (CRS) is anticipated to drive the demand for sinus dilation devices in Europe. For instance, according to Global Allergy and Asthma European Network, the prevalence of CRS has been increasing in the European population, reaching around 11% in 2018. In addition, sophisticated healthcare infrastructure and favorable reimbursement policies have augmented the implementation of sinus dilation devices in the European region. For instance, according to European External Action Service (EEAS), USD 4.7 million were invested by the European government to boost healthcare infrastructure during FY 2016. Technological advancements in devices by key players are also projected to drive the sinus dilation devices market over the forecast period.

The Asia-Pacific market for sinus dilation devices is expected to exhibit a significant rate over the projection period because of the increase in disposable income and patient awareness about sinus surgical procedures. Olympus Corporation, Jilin Coronado Medical Ltd., Meril Life Sciences Pvt. Ltd., and InnAccel Technologies are some of the significant players operating in the Asia-Pacific sinus dilation devices market focusing on mergers and acquisitions to expand product portfolio and deliver high-quality products in the emerging markets at an affordable price. For instance, in April 2017, Olympus Corporation entered into a definitive agreement to acquire Image Stream Medical, Inc. for USD 87 million to enhance medical solution assistance for healthcare facilities.

In addition, the increasing prevalence of CRS coupled with the growing penetration of healthcare insurance policies is anticipated to boost the demand for sinus dilation devices in Asia. For instance, in March 2015, according to a paper published on NCBI, 107 million people were affected by chronic sinusitis in China. Increasing medical tourism is also expected to boost regional market growth further.

Brazil and Mexico are major countries contributing to the growth of the Latin American sinus dilation devices market. The Latin American sinus dilation devices market is growing due to CRS's increasing prevalence. According to a report published by NCBI in 2015, 16.55% population was affected by CRS in the Latin America region, and the number is growing each year. Furthermore, a large population coupled with the growing adoption of healthcare insurance services in this region is another important factor contributing to the sinus dilation devices market growth.

The Middle East and Africa (MEA) regional market for sinus dilation devices is projected to develop considerably owing to the increasing prevalence of CRS. According to the International Journal of Advanced Research (IJAR), in 2016, the prevalence of CRS among women was around 61.6%, which was higher than that among men accounting for around 55.6%. The most affected age group in Saudi Arabia was 21-30 years. Furthermore, there is a growth in the number of nonprofit organizations, such as the ENT Society of South Africa, Saudi Otorhinolaryngology-Head and Neck Society, Saudi Cancer Society, The South African Society of Otorhinolaryngology-Head and Neck Surgery, and Cancer Association of South Africa (CANSA). These organizations are making efforts to raise awareness about the causes of CRS, which is expected to boost market growth to a certain extent.

Segmental Analysis

The global market for sinus dilation devices is segmented by product, procedure, application, and end-user.

Based on the product, the global market is bifurcated into balloon sinus dilation devices, endoscopes, sinus stents/implants, functional endoscopic sinus instrument sets, and others. 

The balloon sinus dilation devices segment is the most significant contributor to the market and is anticipated to exhibit a CAGR of 11.41% over the forecast period. Balloon sinus dilation devices are safe, small, flexible, and effective in improving symptoms of sinusitis. As the sinus dilation procedure does not remove any tissue or bone, it reduces bleeding compared to regular sinus surgery, likely favoring the market growth. These devices offer improved and faster recovery time. It also offers a reduced risk of postoperative infection. Such devices provide a reduced risk of scarring and continued inflammation and have a reduced risk of structural damage or unintentional tissue.

Based on procedure, the global market is divided into standalone and hybrid. 

The standalone segment dominates the global market and is projected to exhibit a CAGR of 10.3% over the forecast period. The standalone procedure is predicted to dominate the market owing to the high success rate of revision surgeries. Balloon sinus ostial dilation is performed as a standalone procedure. In addition, balloon dilation alone is just as effective as functional endoscopic sinus surgery in treating chronic rhinosinusitis. Similarly, a lower rate of post-surgery sinus infections and reduced episodes of sinusitis will further boost segment growth. Rising preferences for minimally invasive surgical procedures due to increased health insurance adoption will fuel segment growth. According to the International Forum of Allergy & Rhinology (2017), in the U.S., balloon sinuplasty standalone procedures have increased from 5% in 2011 to 22.5% in 2014.

Based on application, the sinus dilation devices market is bifurcated into pediatric and adult. 

The adult segment is the most significant contributor to the market share and is anticipated to exhibit a CAGR of 10.5% over the forecast period. The adult patient segment is predicted to witness considerable expansion during the forecast period, owing to an increase in the prevalence of sinusitis in adults. In September 2017, as per the CDC, sinusitis was more prevalent in adults than in children; nine out of ten cases of viral sinusitis in adults were observed in the United States.

Based on end-user, the market is segmented into hospitals, ambulatory surgical centers, and ENT clinics/in-offices. 

The hospital segment owns the highest market share and is projected to exhibit a CAGR of 10.2% during the forecast period. The hospital segment is expected to grow considerably over the projection period because of the high volume of hospital surgical procedures. The segment is projected to develop due to the rising prevalence of chronic sinusitis and attractive reimbursement standards. The availability of technologically advanced infrastructure, medical equipment, and the ability to perform complex sinus surgeries will boost market growth.

Recent Developments

• May 2022- Medtronic plc (NYSE: MDT), a world leader in healthcare technology, announced that it had completed the acquisition of Intersect ENT, widening the company's extensive ear, nose, and throat (ENT) portfolio with innovative sinus products used to improve postoperative outcomes and treat nasal polyps.
• February 2022- Olympus, a global leader in developing and supplying innovative solutions for surgical and medical procedures, announced that its CELERISTM single-use sinus debrider system had received FDA certification and will soon be available on the market.