Respiratory Disposables Market:
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The respiratory disposables market consists of sales of respiratory disposables and related services. Respiratory disposobles include disposable resuscitators, disposable masks, disposible tubes, and other consumables and accessories.
The global respiratory disposables market is expected to grow from $1.5 billion in 2019 to $4.5 billion in 2020 at a compound annual growth rate (CAGR) of 199.5%. The fact that Covid-19 is essentially a respiratory ailment has boosted the market growth. There is an increased demand for respiratory devices such ventilators, nebulizers, pulse oximeters and spirometers since oxygen therapy is a major intervention for patients with severe Covid-19 infection, and this factor is contributing to the market growth. In order to compensate for lack of ventilators due to the huge demand and short supply, hospitals have started to convert anesthesia machines into breathing machines. The market is then expected to grow at a CAGR of 6.6% from 2021 and reach $3.2 billion in 2023.
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High prevalence rate of respiratory diseases globally is driving the respiratory disposables market. Excessive smoking, exposure to toxic materials, adverse climate conditions and air pollution are some of the main causes which are leading to rise in respiratory diseases such as asthma, lung cancer, Chronic Obstructive Pulmonary Disease (COPD) and obstructive sleep apnea (OSA). According to a study, around 65 million people suffer from chronic obstructive pulmonary disease (COPD) and around 3 million people die every year because of this disease. It was also reported that around 334 million people suffer from asthma diseases caused by air pollution as well as tobacco smoke, toxic disposable devices. These factors are increasing the demand for treatment of respiratory ailments, thus driving the respiratory diseases market.
Respiratory disposables market is being restrained due to stringent regulatory policies. Regulatory agencies and governments across various countries are imposing stringent restrictions on product approval and launch, this is limiting the market growth. For instance, in 2005, FDA banned Amphastar Pharmaceutical’s Primatene product, an albuterol CFC inhalers for asthma because of ozone-depleting chlorofluorocarbon (CFC) propellants have depleted the ozone layer. In 2014, the FDA rejected Amphastar’s first attempt to bring a reformulated version of Primatene mist to market. Again in 2016, the FDA rejected another application for Primatene Mist. In November 2018, FDA approved new formulation of Primatene Mist. Stringent regulations result in rise in development costs and potential sales loss due to delays in product launch, thus restraining the Respiratory disposables market.
Rapid advances in technology are driving innovation in respiratory disposable manufacturing. Areas of particular development are likely to be AIR gel technology, wearable technologies, and 3D printing technology. These technologies are being used in the manufacturing of respiratory disposables, resulting in higher productivity, lower costs and higher margins. Companies in this market are increasingly focusing on AIR gel technology, in which gel is incorporated into the bag on the edges of the mask which helps to the protection of the skin and creates a bridge to minimize the irritation of the skin and for effective sealing. For example, Vyair medical prepared Veraseal 2 disposable mask, used for acute care with AIR gel technology and advantage of vented and non-vented versions. Similarly, Sleepnet prepared Mojo ventilation masks with Airgel technology.
In the USA, occupational safety and health administration (OSHA) regulates all respiratory medical equipment, guidelines for which are specified in 29 CFR 1910. 134. Under OSHA, national institute for occupational safety and health/national personal protective technology laboratory (NIOSH/ NPPTL) provides market approval certificate and FDA approves the product for marketing. Before market approval, all the medical devices should be analyzed appropriately by performing compatibility test within a hospital environment,. They are tested on Electrical bench and Non clinical performance testing is also required. Moreover, proper software verification, validation, and hazard analysis must be performed. Labels on the devices are required to include the purpose of the device.
In April 2018, Vyaire Medical acquired Acutronic Medical for an undisclosed amount. The acquisition is expected to enhance Vyaire’s product portfolio, technological capabilities and expand their intellectual capital. Acutronic Medical develops and sells ventilation solutions for NICU’s/PICU’s, ICU’s and Intensive Care Transportation. The company was founded in 1981 and is headquartered in Switzerland.
Major players in the market are Fisher & Paykel, Becton Dickinson Company, Ambu A/S, Smiths Medical, Armstrong Medical
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