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Respiratory Devices Market – Insights

Respiratory devices are medical devices that are used to assist a patient suffering from breathing problems. These devices are used in management and treatment of disorders such as fibrosis, asthma, chronic obstructive pulmonary disease (COPD), and acute respiratory distress syndrome (ARDS).

The global respiratory devices market is estimated to account for US$ 16,878.0 Mn in terms of value in 2019 and is expected to reach US$ 34,178.1 Mn by the end of 2027.

Global Respiratory Devices Market: Drivers

High prevalence of COPD and obstructive sleep apnea is expected to propel growth of the global respiratory devices market over the forecast period. For instance, according to a report by Global Initiative for Chronic Obstruction Disease’s 2018 report, COPD is expected to result in 4.5 million global deaths annually by 2030.

Moreover, increasing geriatric population is also expected to aid in growth of the market. For instance, according to the World Health Organization, geriatric population is expected to reach 2 billion by 2050, up from 900 million in 2015.

North America region held dominant position in the global respiratory devices market in 2018, accounting for 41.9% share in terms of value, followed by 2027.

Global Respiratory Devices Market: Restraints

Tempering in respiratory devices is expected to hinder growth of the market. For instance, in July 2019, researchers from CyberMDX reported identifying a susceptibility related to the GE Aestiva and GE Aespire devices, which could lead to unauthorized gas composition input, manipulation of barometric pressure settings and anesthetic agent type selection, remote silencing of alarms, and, alteration of date and time settings.

Moreover, high cost of respiratory devices is also expected to hinder growth of the market. For instance, the cost of a primary portable oxygen concentrator ranges between US$ 2,665 and US$ 3,243.

Global Respiratory Devices Market: Opportunities

R&D of multifunctional polymer composites is expected to offer lucrative growth opportunities for players in the global respiratory devices market. For instance, in February 2020, researchers from National Research Institute, Poland, reported development of a multifunctional polymer composite from polypropylene and poly (ethylene terephthalate) for filtering respiratory protective devices.

Increasing number of pre-term births is also expected to aid in growth of the market. For instance, according to March of Dimes 2019 report card, the preterm birth rate in the U.S. reached 10.02% in 2018 from 9.63% in 2015.

Positive airway pressure devices segment in the global respiratory devices market was valued at US$ 4,551.5 Mn in 2018 and is expected to reach US$ 11,814.6 Mn by 2027 at a CAGR of 11.1% during the forecast period.

Market Trends/Key Takeaways

The market is witnessing development of portable devices for the treatment of ARDS. For instance, in August 2019, researchers from University of Michigan developed a portable device that analyzes a patient’s breath to provide quick and objective results that can help to manage ARDS.

Market players are focused on offering multifunctional devices. For instance, Ventec Life Systems offers VOCSN, an integrated ventilator system that uses one machine to perform mechanical ventilation, oxygen delivery, cough assist, suction, and nebulization.

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, transfilled, 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 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

Value Chain Analysis

Global Respiratory Devices Market: Competitive Landscape

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.

Global Respiratory Devices Market: Key Developments

Major players in the market are focused on adopting M&A strategies to expand their product portfolio. For instance, in January 2020, Masimo Corporation signing of a definitive agreement to acquire the Connected Care assets from NantHealth, Inc.

Similarly, in November 2019, AdaptHealth Corp., a provider of CPAP and BiPAP machines and supplies and respiratory equipment, entered into a definitive agreement to acquire the Patient Care Solutions (PCS) business from McKesson Corporation.