Feeling the Pressure? How Exits, Entrants and New Products are Reshaping the Ventilator Market

Publication Date: 28/05/2024

Cranfield, UK – 28th May 2024 – Written by Sam Wilson

In the wake of the pandemic, the competitive landscape of the ventilator market has presented a set of formidable challenges, necessitating vendors to exhibit adaptability and strategic foresight. In addition to the slowdown observed in the post-pandemic period, persistent obstacles such as a global economic downturn, ongoing geopolitical conflict, and substantial increases in the costs of the manufacturing process have created a somewhat hostile environment for vendors. These factors have led to significant shifts in market dynamics. Notably, Medtronic has decided to exit the market, and following its recalls, Philips has withdrawn most of its respiratory portfolio in the US. Such substantial changes raise important questions about the future direction of the ventilator market and its key players. How will these exits reshape the competitive landscape, and which companies are poised to capitalise on the emerging opportunities?

The Withdrawal Cycle

Medtronic confirmed the withdrawal of their legacy Puritan Bennett ventilators in February of this year, citing concerns around profitability. This strategic retreat has posed many questions in the market, especially since Medtronic, despite experiencing falling sales, still maintained around a 10% market share in the US. Medtronic’s rich history in the medical devices field has led to a loyal customer base, making its exit particularly impactful. Going forward, we predict that this market opportunity will be seized by the more prominent and trusted players such as Getinge, Hamilton, and Draeger in addition to newer entrants Nihon Kohden and Mindray. These companies are well-positioned to fill the void left by Medtronic, leveraging their strong reputations and extensive experience in the ventilator market to capture a larger market share.

Delving deeper into Medtronic’s decision, it becomes evident that uncertainty often drives firms with more extensive portfolios to prioritise more profitable avenues. Especially in light of recent regulation changes such as the new MDR rules, a decision must be made on whether to supplement the slower segment with higher-performing areas or to neglect the segment altogether. Maintaining a relatively lower-performing segment can be costly, taking hits on profit margins and the ever-increasing cost of innovation. However, this burden is often required only until a level of certainty returns. In Medtronic’s case, they have completely pulled the plug, potentially due to limited innovation within recent years. An official Medtronic publication stated the withdrawal was ‘related to the market preference shift to lower acuity ventilators’. Whilst the market has seen a change as the pandemic increased the exposure to more mid-range devices (capable of similar care), there remains a necessity for high-end ventilation throughout the market, particularly in the US, where Medtronic was most present. However, the non-invasive segment is one area of lower-acuity ventilators experiencing a significant shift.

The Non-Invasive Market Evolution

The benefits of non-invasive ventilation were underscored throughout the pandemic, leading to the rising popularity of combination ventilators that offer the flexibility of both invasive and non-invasive methods. While Signify Research believes non-invasive ventilation will eventually become the standard, there remains little demand for standalone non-invasive ventilators outside the US. In the US, however, the situation is different.

The US has developed a niche market for these ventilators due to differences in care settings, structuring, and product preference. The Philips V60 was explicitly designed for this niche, contributing to its dominance. The recent withdrawal of the V60 from the US market following a series of recalls presents significant opportunities for vendors who can successfully enter this market. Draeger, Getinge, and Nihon Kohden are all vying for market share in the standalone non-invasive segment, introducing the Savina 300 NIV, the Servo-Air NIV (Servo-Air Lite in the US), and the NKV-330, respectively. These devices all use turbines and can provide high-flow O2 therapy. Capturing market share will be a gradual process as customers transition away from the V60, and stockpiles remain high. Draeger and Getinge benefit from strong brand recognition, while Nihon Kohden offers a competitive price and has already made significant progress. We anticipate a slight market downturn as customers adjust to these changes over the coming year.

Mindray also competes in the non-invasive market with the SV70, although it is not yet available in the US. The neonatal market features many standalone non-invasive ventilators, with offerings from Hamilton, Mindray, F. Stephan, and others.

Figure 1 – Overview of the market size for Non-Invasive ventilators

The Newer Entrants

Mindray, while not new to the market, has begun to establish itself within the ventilator market. Over the years, it has accumulated a substantial installed base of patient monitors, leveraging this to promote their comprehensive portfolio of other clinical devices and establish the necessary service infrastructure. In June last year, Mindray received 510(k) clearance for their high-end solutions, the SV800 and SV600. Despite this development, US purchasing restrictions and perception remain the biggest obstacles in the country. However, Mindray has significantly increased its market share in other regions, dominating Indian and Chinese markets.

Towards the end of 2023, Comen received MDR approval for its ventilator portfolio, marking significant progress for Asian vendors in establishing themselves in other regions. However, Comen appears to be in the early stages of building brand awareness and acceptance through patient monitors, similar to Mindray’s strategy, with minimal progress in the European ventilator market to date. The court ruling between Mindray and Comen is noteworthy, as Comen was ultimately found to have infringed on a Mindray patent related to a valve used in the V3 and V6 ventilators following a series of legal reversals. At the beginning of the year, our 2024 Clinical Care Predictions highlighted the trend of emerging companies attaining MDR regulation; Signify Research expects other companies to follow in Comen’s footsteps.

The Importance of Software Solutions

Over the past year, aside from the introduction of new non-invasive ventilation (NIV) products, hardware developments in the ventilator market have been limited. The primary innovations have centred on updated software solutions, significantly enhancing ventilators’ safety, reliability, and effectiveness, thereby improving patient outcomes. These software advancements also enhance the functionality and user experience of the devices, making them more intuitive and efficient for healthcare professionals to use. Additionally, these improvements facilitate better integration with other hospital systems, ensuring seamless data sharing and improving overall workflow efficiency. As discussions around interoperability and the potential of the Service-oriented Device Connectivity (SDC) for bi-directional data and information transfer continue, these benefits are expected to increase even further. This focus on software-driven innovation highlights the industry’s shift towards creating more connected and intelligent healthcare environments, ultimately aiming to provide better care for patients.

Future Outlook

Stringent regulations and high barriers to entry have long characterised the ventilator market, creating a challenging environment for both new entrants and established companies. While these regulations are crucial for ensuring patient safety and product efficacy, they significantly hinder the pace of innovation within the industry. Navigating complex regulatory frameworks requires substantial resources and expertise, which can be a formidable barrier, especially for smaller companies or those new to the market. Additionally, managing profitability amidst rising costs and stringent regulations further complicates the landscape. Ventilator manufacturers must balance these regulatory demands while investing in research and development to drive technological advancements. Those manufacturers that can achieve a delicate balance between meeting regulatory requirements, controlling costs, and pushing the boundaries of innovation are poised to make significant progress within the market.

Related Research

Signify Research has recently published its ‘Ventilators—World—2024’ report. This iteration expands on last year’s offering, now including additional country breakouts, further segmentation of the Transport & Emergency segment, and market share analysis for Non-Invasive ventilators.

About The Author

Sam Wilson joined Signify Research in 2023 as a Market Analyst within the Clinical Care team. He brings experience working as an Economist for the Intellectual Property Office, creating strategy reviews and impact evaluations, used to aid government trade negotiations. Sam holds a first-class bachelor’s degree in economics from Loughborough University, where modules included topical issues such as healthcare. Away from the office Sam enjoys staying active with dog walks, football and cricket, and his interest in volunteering took him on a charity visit to Ethiopia.

About the Clinical Care Team

The clinical care team provides market intelligence and detailed insights on the clinical care equipment and IT markets. Our areas of coverage include patient monitoring, diagnostic cardiology, infusion pumps, ventilators, anaesthesia devices, and high-acuity IT. Our reports provide a data-centric and global outlook of each market with granular country-level insights. Our research process blends primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.

About Signify Research

Signify Research provides healthtech market intelligence powered by data that you can trust. We blend insights collected from in-depth interviews with technology vendors and healthcare professionals with sales data reported to us by leading vendors to provide a complete and balanced view of the market trends. Our coverage areas are Medical Imaging, Clinical Care, Digital Health, Diagnostic and Lifesciences and Healthcare IT.

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