In general, the most widely used respiratory devices comprise inhalers, nebulizers, oxygen concentrators, positive airway pressure (PAP) devices, mechanical ventilators, pulse oximeters, polysomnography devices, and spirometer devices.
Global Respiratory Devices Market Analysis:
The global respiratory devices market accounted for US$ 16,878.0 million, in terms of value, in 2019 and is expected to reach US$ 34,178.1 million by the end of 2027.
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Increasing air pollution is one of the most prominent factors bolstering the growth of the global respiratory devices market. According to the 2019 report by the State of Global Air, air pollution (PM2.5, ozone, and household air pollution) ranks fifth among the top risk factors leading to mortality across the globe. Increasing investment in R&D pertaining to respiratory diseases further predicted to be offering lucrative growth opportunities for the key market players in the global respiratory devices market. For instance, in February 2020, Peter Weiss AO, an Australian businessman and arts philanthropist, announced a funding worth US$ 4 million for critical research in lung diseases.
Respiratory devices are highly susceptible to critical errors in inhalation tests, which however, hinders the growth of the global respiratory devices market. These errors are therefore likely to adversely impact drug delivery and reduce the treatment benefits. Moreover, the lack of adherence to medication is a restraining factor for the global market growth.
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The positive airway pressure (PAP) devices segment, which was valued at US$ 4,551.5 million in 2018, is expected to reach US$ 11,814.6 million by 2027, at a CAGR of 11.1%. Increasing product launches is expected to support growth of the segment in the near future. For instance, in April 2019, ResMed Inc. launched a product, AirFit P30i, an interface device for continuous positive airway pressure (CPAP).
The portable oxygen concentrator sub-segment, under the oxygen concentrators segment, dominated the global respiratory devices market in 2018, accounting for an incredible 66.6% share, in terms of value. New product launches is expected to drive growth of this segment. For instance, in 2018, ResMed a healthcare company has launched Mobi, its first ResMed-branded portable oxygen concentrator (POC).
The pulse oximeters segment accounted for a magnificent 12.7% market share, in terms of value, in the global market. Increasing regulatory approvals for pulse oximeters are expected to propel the growth of this segment. For instance, in June 2019, Masimo received the U.S. FDA clearance for the neonatal indication of its O3 Regional Oximetry product.
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Key Market Trends
The major players operating in the global respiratory devices market include Masimo Corporation, Teleflex Incorporated, Fisher & Paykel Healthcare Limited, ResMed Inc., Hamilton Medical AG, Medtronic PLC, Koninklijke Philips N.V., Smiths Medical, General Electric Healthcare Limited, Drägerwerk AG & Co. KGaA, and Inogen Inc.
These companies are focused on the development and launch of new devices. For instance, in October 2019, HCmed Innovations Co., Inc., a drug-device combination company, presented Pulmogine, a mesh nebulizer, at the 2019 ERS International Congress.
However, the recall of products is expected to limit growth of the market. For instance, in February 2020, Teleflex Incorporated announced a worldwide voluntary recall of the COMFORT FLO Humidification System due to the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
Furthermore, in February 2020, Medtronic plc announced that the company and the Medtronic Foundation are committing around US$ 1.2 million to coronavirus relief efforts worldwide. In June 2019, rapid Oxygen partnered with the Connecticut Alliance of Boys & Girls Clubs to donate its R15, a portable oxygen cylinder.
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Stringent Regulations Enforced in Europe:
- Medical gas systems need to be CE Certified and Labelled in accordance with Council Directive 93/42 EEC Concerning Medical Devices (Class IIB); 2006/42 EC Machinery Directive; 97/23/EEC Pressure Equipment Directive (PED) and 2006/95/EC, Low Voltage Electrical Equipment Directive (LVD)
- In Europe the MOS systems are treated as medical devices and classified as IIB
- They require a CE mark for legal marketing. However, the CE Marking process will change as Europe’s new Medical Device Regulation (MDR) comes into force in May 2020
- Implementation, modification, and maintenance of a quality system (usually ISO 13485) that will meet European and other international requirements are further specifications.
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