The rising prevalence of peripheral artery disease and the increasing incidence of chronic limb ischemia has necessitated innovation in skin perfusion pressure testing devices.
Chronic limb ischemia is the most advanced form of peripheral artery disease, and leads to mortality, morbidity, and high healthcare resource utilization. The assessment for wound healing in limb ischemia requires the skin perfusion pressure method for checking blood flow pressure in the limbs.
In its new study, ESOMAR-certified market research and consulting firm Future Market Insights (FMI) offers insights about key factors driving demand for skin perfusion pressure testing devices.
The report tracks the global sales of skin perfusion pressure testing devices in 20+ high-growth markets, along with analyzing the impact COVID-19 has had on the medical device industry in general, and skin perfusion pressure testing devices in particular.
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Peripheral artery disease (PAD) is a progressive disorder affecting more than 200 million people, worldwide. It has a significant impact on mortality in hemodialysis patients. Approximately 6.5 million people aged 40 years and older in the United States have PAD. The increasing PAD population has propelled the growth of the skin perfusion pressure testing market.
Skin perfusion pressure has become a potential tool for wound healing in patients with chronic limb ischemia. Compared to other non-invasive methods such as toe blood pressure and ankle-brachial index, skin perfusion pressure provides more accurate results, thus, its usage is gaining popularity among physicians.
This technique also remains a clinically relevant and objective tool of local perfusion in the setting of chronic limb ischemia, particularly among higher-risk patients with arterial calicifications and comorbidities that tend to microvascular disease. FMI expects global skin perfusion pressure testing devices market to grow at 4.5% CAGR through 2030.
Non-invasive procedures have continued to grow in popularity as compared to surgeries. The measurement of skin perfusion pressure by a laser doppler is a non-invasive method that is widely used by professionals. Due to high reproducibility, accuracy, specificity, and sensitivity, skin perfusion pressure testing has become one of the soundest methods.
For instance, non-invasive VMS-VASC system (Moor) Instruments), including the laser Doppler monitor moorVMS-LDF, low profile fibre optic probe (VP-SPP), and pressure cuff controller moorVMS-PRES have been specifically designed to aid micro vascular assessments in a variety of clinical applications and physiological research.
Laser dopplers have proven to be effective devices for the measurement of skin perfusion pressure. Laser dopplers are among the regularly utilized gadgets for the appraisal of skin perfusion pressure, they are seen as the ideal instrument for the location of peripheral artery disease as well as diagnosis of wound healing potential in limb ischemia patients.
Furthermore, the accuracy in a laser doppler is much higher than any other traditional method. The high accuracy, simplicity of operability and non-invasiveness feature of the devices are likely to fuel the utilization of laser dopplers by the physicians, boosting the demand of the skin perfusion testing devices.
Due to an increase in the need for assessment of wound healing in peripheral artery disease and limb ischemia, many manufacturers are seeking 510(k) Premarket Notification to FDA which demonstrates the device to be safe and effective as equivalent to a legally-marketed device
For example, Perimed Inc. seeks 510(k) Premarket Notification for PeriFlux System 5000, which is a laser doppler system consisting of main units and functional units
However, according to FDA Modernization Act, devices that fall under class I and II are exempted from premarket approval, thus, the time required for regulatory approval is reduced, which brings down the costs. The increasing FDA approvals attracts the end users, and this expected to boost the demand for skin perfusion pressure testing devices.
Skin pressure perfusion is the most advanced method for the assessment of wound healing in limb ischemia and peripheral artery diseases. This method requires highly trained or skilled professionals to operate the device.
Since it is fully-automated and provides quantitative evaluation of microcirculation, its operability requires skilled people, which as a result may limit the use of skin perfusion pressure testing devices.
Thus, reliability and reproducible measurement is highly dependent on a skilled technician or operator who interprets the results of skin perfusion pressure measurement. Lack of skilled professionals therefore can create significant challenges for the market.
The healthcare system of the USA is well renowned for its advanced infrastructure and expenditure. The care regime of the care centers and hospitals are monitored by various regulatory rules and insurance policies. The massive hospital bills incurred other than the Medicare have been influencing the market in the country.
Government and regulatory bodies of the USA are adopting several cost-containment plans to reduce their healthcare burden. The shift from a volume to a value-based system is majorly driven by the various measures undertaken by providers, governments, biotechnology companies, and insurance payers.
Some of the measures are outcome-based profits, pricing, risk sharing, competitive tendering, and price control.
A value-based healthcare system will not only provide improved outcomes through integrated care pathways, but also levy pricing pressure on medical device companies, and this is likely to impact investments on the R&D of advanced medical treatment technologies.
Furthermore, due to the higher prevalence of critical limb ischemia and peripheral arterial disease in USA, several manufactures are conducting campaigns to raise general awareness among people related to these diseases.
This is likely to support the overall market growth in the country. For example, Amputee Coalition of America (NGO) launched a campaign in April 2018 to raise limb loss awareness among people.
The Federal Statistical Office has reported that healthcare spending in Germany rose by 4% in 2018 from 2017. In 2018, the country’s healthcare spending accounted for 11.7% of the GDP. Furthermore, health expenditure was expected to surge to 407.4 billion Euros by 2019, presenting a lucrative landscape for the expansion of the skin perfusion pressure testing devices.
Also presence of companies such as ELCAT GmbH is supporting the expansion in Germany. The company has been investing significantly in expansion efforts. Growth strategies adopted by these companies are expected to aid the expansion in Germany.
Since 2009, health insurance has been made mandatory for all citizens of the country. According to National Center for Biotechnology Information (NCBI), a total of 70 million people, which roughly covers 85% of the population are covered by statutory health insurance.
Another 11% population of Germany is covered by substitutive private health insurance. Conducive reimbursement policies and regulatory scenario are presenting attractive opportunities for growth.
Increasing disposable income can have significant impact in development of economy in emerging countries which results in affordability of proper healthcare treatment. China’s per capita disposable income reached (about 4,961 USA dollars) in 2020, more than double the level in 2010.
Potential for high healthcare insurance and rising disposable income will contribute to increase in affordability of healthcare services. This will also allow improved accessibility to expensive equipment for treatment of diseases. The market in China is expected to witness significant growth at a CAGR of around 5.4%.
Both chronic limb ischemia and peripheral artery disease impose serious threats to the population. Lack of awareness of diseases and lack of proper treatment leads to high prevalence of these diseases. Due to limited campaigning about the assessment of these diseases, there seems to occur less usage of these devices in hospitals in South Africa.
Moreover, poor healthcare facilities in some countries restrain the growth of the skin perfusion pressure testing market. Despite financial burden, government in South Africa is adopting various initiatives to spread create awareness among population, which is expected to enable steady growth in the market.
The market in South Africa is expected to witness sluggish growth at a CAGR of just around 3.8%.
Laser dopplers are widely used for skin perfusion pressure testing. Due to easy operability and noninvasiveness, most physicians opt for laser dopplers. Since laser dopplers are costly, manufacturers provide reimbursements for such devices.
However, the use of laser dopplers is not only limited to the measurement of skin perfusion pressure. These can be used in a wide range of testing parameters such as toe blood pressure (TBP), post occlusive reactive hyperaemia (PORH), ankle brachial pressure index (ABPI), and others.
For example, Moor Instrument’s new moorVMS-VASC 2.0 monitoring system is designed to test pulse volume recording (PVR) and other parameters apart from skin perfusion pressure.
The portable devices segment will continue to grow and dominate the market during the forecast period. According to FMI, the segment is expected to hold around 73% of the market share, in terms of modality, by the end of 2030. A portable device is a wearable or hand-held device. This is designed for easy usage, to be able to move or carry it from one place to another, thus its ease of operability, makes the device most widely adopted devices in the market.
Hospitals have been dominating the market as key end users because it receives higher footfall of patients. Besides this, hospitals have more advanced infrastructure to support advance equipment. Backed by these factors, FMI forecasts hospitals to continue dominating the market and account for 34.7% of the overall share in 2021.
Most of the medical device companies are currently focusing on designing laser doppler since it has gain much popularity in assessment of wound healing.
For example, Moor Instruments has design moorVMS-VASC 2.0 laser doppler system.
Moreover, the manufactures are focusing on getting stamp of approvals for their product and also entering into partnership and collaboration agreement to expand their product portfolio in different countries globally.
For instance, in April 2016, Perimed AB announced FDA approval for PeriFlux 6000.
Some of the leading companies operating in the market are:
*The list is not exhaustive, and only for representational purposes. Full competitive intelligence with SWOT analysis available in the report.
| Attribute | Details |
|---|---|
| Forecast Period | 2020 to 2030 |
| Historical Data Available for | 2015 to 2019 |
| Market Analysis | USD Million for Value |
| Key Regions Covered | North America; Latin America; Europe; East Asia; South Asia; Oceania Middle East & Africa |
| Key Countries Covered | USA, Canada, Germany, UK, France, Italy, Spain, Poland, Russia, China, Japan, South Korea, India, Thailand, Malaysia, Indonesia, Australia, New Zealand, GCC Countries, Turkey, Northern Africa, South Africa |
| Key Segments Covered | Product Type, Modality, End User, and Region |
| Key Companies Profiled | Vasamed Incorporated; Moor Instruments; Perimed AB; ELCAT GmbH; ATYS Medical; Viasonix; Promed Group |
| Report Coverage | Market Forecast, Competition Intelligence, DROT Analysis, Market Dynamics and Challenges, Strategic Growth Initiatives |
| Customization & Pricing | Available upon Request |
The USA currently leads the global market for skin perfusion pressure testing devices. Sales in the USA will be over 34% of total global demand throughout the forecast period.
Laser doppler comprises the dominant segment as compared to other products such as photoplethysmography due to ease of operability and noninvasiveness.
Some of the leading companies offering skin perfusion pressure testing devices are Vasamed Incorporated, Moor Instruments, Perimed AB, ELCAT GmbH, ATYS Medical, Viasonix, Promed Group, and others.
Hospitals are leading the end user segment of the skin perfusion pressure testing devices market owing to their advanced medical facilities and higher flow of patients for diagnosis and treatment.
Skin Perfusion Pressure Testing Devices Market
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