Overview
Respiratory devices are surgical gadgets that help patients who are having trouble breathing. Fibrosis, asthma, chronic obstructive pulmonary disease (COPD), and acute respiratory distress syndrome are all managed and treated using these devices (ARDS).
The global respiratory devices market is anticipated to reach US$ 34,178.1 million by 2027, with a market valuation of US$ 16,878.0 million in 2019.
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Drivers
During the forecast period, the global respiratory devices market is predicted to increase due to the increasing incidence of COPD and obstructive sleep apnea. COPD is projected to harm 4.5 million people worldwide each year by 2030, according to the Global Initiative for Chronic Obstruction Disease’s 2018 study.
The growing elderly population is also projected to help the market expand. The geriatric population is predicted to reach 2 billion by 2050, up from 900 million in 2015, according to the World Health Organization.
In terms of value, the North American region dominated the global respiratory devices market in 2018, contributing for 41.9 percent of the market by 2027.
Restraints
The global respiratory devices market’s expansion is projected to be hampered by tempering in respiratory devices. Researchers from CyberMDX discovered a vulnerability in the GE Aestiva and GE Aespire devices in July 2019, which could lead to unauthorized gas composition input, manipulation of barometric pressure settings and anesthetic agent type selection, distant alarm censoring, and date and time manipulation.
Furthermore, the global respiratory devices market is projected to be hampered by the high cost of respiratory equipment. A main portable oxygen concentrator can cost anywhere from $2,665 to $3,243.
Opportunities
For participants in the global respiratory devices market, R&D of multifunctional polymer composites is projected to provide attractive development possibilities. Researchers from Poland’s National Research Institute revealed the creation of a multifunctional polymer composite made of polypropylene for filtering respiratory protection devices in February 2020.
The global respiratory devices market is also projected to increase as the frequency of pre-term babies rises. The premature birth rate in the U.S. increased to 10.02 percent in 2018 from 9.63 percent in 2015, according to the March of Dimes 2019 report card.
Market Trends
Portable devices for the cure of ARDS are being developed in the market. In August 2019, University of Michigan researchers created a portable gadget that analyses a patient’s breath and provides rapid and objective findings that can aid in the management of ARDS. Multifunctional gadgets are the attention of market participants.
Regulations
U.S.
- Medical gases are drugs within the meaning of section 201 (g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321 (g)(1)) and, pursuant to section 503 (b)(1)(A) of the FD&C Act (21 U.S.C. 353 (b)(1)(A)), are required to be dispensed by prescription.
- Medical gases are regulated as finished pharmaceuticals regardless of the stage of processing. Medical gases must be manufactured (e.g., processed, filled, trans-filled, mixed, purified, separated, cascaded, transferred, packaged, and distributed) using CGMP, as set forth in 21 CFR Parts 210 and 211 and in conformance with current industry practice. The FD&C Act requires that a drug, including the finished dosage form and its components, meet CGMPs to assure drug safety, identity, strength, quality, and purity
- Firms manufacturing compressed medical gases are subject to the issuance of Form 483 upon non-conformance with CGMP guidelines
- Common discrepancies noted in manufacturing and supply include
- Inadequate label control
- False or misleading label, label contains an inaccurate statement of the contents, or label contains inadequate directions for use (however, do not cite on FDA 483 as per IOM instructions 5.2.3.3 – Non-Reportable Observations)
- Inadequate cylinder prefill inspections and procedures, particularly failure to perform those intended to remove or detect residual gases or other contaminants in the cylinders
- On November 18, 2016 (81 FR 81685), FDA published a final rule “Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements” that is expected to keep a check on labelling errors and also reduce the likelihood of the wrong gas being connected to a supply system by requiring gas-specific outlet connections
Key Developments
The global respiratory devices market’s major players are focusing on M&A strategies to increase their product offering. Masimo Corporation signed a final deal with NantHealth, Inc. in January 2020 to purchase the Connected Care assets.
In November 2019, AdaptHealth Corp., a provider of CPAP and BiPAP machines, supplies, and breathing devices, signed a formal deal to buy McKesson Corporation’s Patient Care Solutions (PCS) division.
Major Players Are: 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.
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• Current and future of global Respiratory Devices market outlook in the developed and emerging markets
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• The latest developments, market shares, and strategies that are employed by the major market players
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