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Ventilators: A Paradigm Shift in Patient Care

Thursday, 17 July 2014


Years of research in ventilator designs and close co-operation with leading
clinical researchers has shown the importance of improving flow delivery and
regulation to suit the unique needs of individual patients.

Ventilated patients are among the most vulnerable patients in the hospital facing
an increased risk of infection, ventilator-induced injuries, and higher mortality
rate after failed extubation. Years of research in ventilator designs and close cooperation with leading clinical researchers has shown the importance of
improving flow delivery and regulation to suit the unique needs of individual
patients. The newer ventilation platforms can enhance interaction between the
patient and the ventilator by offering unprecedented levels of speed in sensing
and control as well as a range of ventilation modes and treatment features,
which will help clinicians address the specific needs for a wide array of patient
characteristics. Ventilators have evolved from small, pneumatically powered, and
pneumatically controlled devices to marvels of microprocessor technology
capable of closed-loop control. Mechanical ventilation with an endotracheal tube
or via tracheostomy has become a major component of intensive care. However,
unavoidable drawbacks related to the invasive character of this treatment have
been observed. This has led to wide acceptance of non-invasive ventilation (NIV)
as a long-term treatment for patients with hypercapnic respiratory failure.
Interest in the use of this method appears to be growing for other types of
respiratory failure as well.

Indian Market

{mosimage}In 2013, the Indian ventilator market is estimated at 5830 units,


valued at Rs. 249 crore.

The market for imported equipment is estimated at Rs. 204 crore, with sales at
3400 units. Maquet Medical and Draeger Medical dominate this segment.

The refurbished ventilators, in 2013, had sales of 750 units, valued at Rs. 22.5
crore. These ventilators are preferred by small hospitals and nursing homes in
tier-II and tier-III cities, and semi-urban and rural areas. Major players in this
segment include Zigma, Technomed, and Unitech. This segment is also catered
to by resellers/importers who import the products from the United States, the
United Kingdom, Germany, and Australia.

Transport ventilators are emerging as a niche segment and constitute 19 percent


of this market. Valued at Rs. 11 crore, this segment is steadily gaining
acceptability.

{mosimage}The indigenous market, estimated at 580 units, valued at Rs. 11.5


crore, is dominated by Max Meditech and Medisys. Air Liquide and Schiller also
have some presence in this segment.

The use of mechanical ventilators is not new in India. These are being used for
assisting patients with respiratory problems like respiratory muscle paralysis,
brain injury, and insufficient ventilation due to respiratory blockages and also in
the post-operative room after cardiac or brain surgeries. However, the challenge
lies in increasing their penetration and number per ICU beds.

Global Market

The global mechanical ventilators market is expected to grow at a CAGR of 6.6


percent from 2013 to 2019, to reach an estimated value of Rs. 25,492 crore in
2019.

Mechanical ventilation is the process of artificial ventilation in which a patient is


provided breathing assistance through an external device directly applied to the
airway. The global market for mechanical ventilation has witnessed significant
growth in the past two decades, predominantly characterized by technological
innovation and increase in preference for portable and homecare ventilators.
Technological innovation in design, structure, and usage settings of mechanical
ventilators has altered the nature of disposables used in such devices.

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The global mechanical ventilators market is categorized into critical care


ventilators, neonatal ventilators, and transport and portable ventilators.
Introduction of non-invasive ventilation technology has revolutionized the overall
market, thus triggering phenomenal demand for these devices in homecare and
emergency response settings. Rapid growth in the geriatric population, increase
in incidence of chronic obstructive pulmonary disease, and other respiratory
emergencies, and technological innovation in respiratory care devices are the
major environmental factors that drive growth of the global mechanical
ventilators market. The market for critical care mechanical ventilators accounted
for the largest share of the overall mechanical ventilators market in 2013. The
market is expected to grow at a CAGR of more than five percent from 2013
to2019.

Geographically, the global mechanical ventilators market is dominated by North


America in terms of revenue. It is expected that the same trend will continue
during the forecast period due to availability of better healthcare infrastructure,
advanced reimbursement policy, and rapid adoption of novel technologies. In
case of emerging economies of China, India, Thailand, and Singapore, factors
such as improvement in healthcare technologies, high incidence of neonatal
mortality, unmet medical needs, and economic development will contribute to
market growth in the Asian region. The overall Asia-Pacific market for mechanical
ventilators is expected to record the highest growth at a CAGR of over seven
percent from 2013 to 2019.

Portable ventilators have revolutionized the ventilator market, creating units that
work across the board in hospital and home situations. This evolution of the
portable ventilators means that clinicians have more flexibility of care decisions,
moving people home on the same ventilator used in the hospital even without
weaning. Studies have shown that ventilated patients are not a profit center for
the hospital, creating incentives for hospitals to move ventilated patients into
alternate care delivery settings. As ventilators become smaller, more powerful,
and smarter, portable ventilators have become the treatment modality of choice
in many cases. Emerging markets have a need for state-of-the-art equipment
and value products. A portfolio of value-priced products and services is being
adapted to local needs. Healthcare systems work across several modalities. It
builds units locally and sells globally. The aim is to localize care cycles and care
settings. Emerging markets are set to become the chronic disease centers of the
world. By 2015, China and India will be the largest cardiac markets, and by 2020
three quarters of all cancer deaths will occur in emerging markets. The
fundamental aspect of portable ventilator implementation relates to patient
treatment flexibility. The ability to be responsive to changing patient conditions is
central to the task of controlling hospital costs. The ability of systems to support
flexibility in moving patients to lower cost care delivery sites is anticipated to
spur rapid growth of portable and transport ventilators. Portable and transport
ventilator markets are anticipated to reach Rs. 15,000 crore by 2016.

The global ventilators market is led by a small number of multinational


companies. However, the market also comprises regional and local market
players, which are capable of catering to the local market needs through
customization of their devices.

Predominant Trends in the World Ventilator Market

Intense price competition from local manufacturers in Asia and Latin America

Notable technological advances. Adaptive servo ventilation (ASV), synchronized


intermittent mandatory ventilation (SIMV), proportional assist ventilation (PAV),
and neural control of ventilatory assist (NAVA)
Conventional specialized design and definitions are changing. Many ventilators
are now high and mid-acuity systems; definitions of critical care, neonatal,
depend less on technology and design and more on utilization patterns in a given
facility
Shifting patterns of care. More patients are going home
Manufacturers are offering ventilator models that can be used for any patient in
any location, multimodal, easy weaning features, non-invasive option, advanced
monitors and graphics, and more importantly technology that senses and adapts
to the patient's needs without causing lung damage
Demand continues to surge with rising patient population. Growing rates of COPD
and other respiratory illnesses and ageing populations, which in turn will spur
need for expanding healthcare infrastructure.
Notable Trends in Niche Clinical Markets

Critical care ventilator market - robust growth worldwide. End-users in developed


countries want to replace older systems with the latest technologies and
developing countries have an ever increasing demand due to medical facility
building and expansion
Neonatal ventilator market. Demand for the latest technology is high in North
America and in emerging healthcare markets; the European market is
impacted by low birth rates
Non-invasive ventilator market. This relatively new mode is expanding fast;
already popular in Europe, demand for NIV will increase worldwide
Homecare ventilator market. Fastest expanding market across the world
Transport ventilator market. Highest in Asia and Latin America
Surge in Home Care Ventilation

The home care ventilator segment is forecast with increasing revenue growth.
The ageing population has led to a larger proportion of patients requiring longterm care, further increasing healthcare expenditure. According to the World
Health Organization (WHO), chronic respiratory diseases account for more than 4
million deaths a year. It is suggested that as life expectancy increases,
susceptibility to develop chronic diseases too increases, which in turn fuels the
demand for facilities that can offer assistance in the long-term treatment of
respiratory disease.

Consequently, there is growing pressure on governments to find ways to improve


the health of the population, while reducing the financial burden. With an

increasing number of patients requiring longer term ventilation, there is a trend


for patients to be transferred from the hospital into long-term care facilities.
Clinical use of ventilators is typically invasive, although non-invasive modes are
becoming popular. When a patient needs longer-term ventilator assistance in the
home or alternate care location, non-invasive ventilators are preferred. Coupled
with the rising prevalence of respiratory diseases such as COPD and sleep apnea,
demand for home care ventilation is expanding. Uptake of home care ventilation
has been higher in the developed regions due to the infrastructure and support
required. As the hospital segment establishes in developing regions, more focus
may be paid to the home care market.

What Does the Future Hold?

Manufacturers need to alter their marketing strategies to take advantage of the


existing opportunity.

Continuous medical education programs should be designed to make users


aware of the latest technology, equipment features, advancement in treatment
methods, and test protocols
Design educational and training sessions to increase doctors awareness toward
the need for neonatal ventilators as a tool for all round neonatal care
Design promotional programs like tailor made payment schemes, and credit
facility.
The interfaces of ventilators are being made more user-friendly and offer advice
to the clinicians. Making diagnosis of asynchrony or poor settings start a dialogue
with the user for the benefit of the patient. Modern ventilation needs to be
simplified for the user, and adapted to the moving needs of the patient. At the
same time, the patient might be separated from the ventilator as soon as the
risk of separation and subsequent extubation is not deemed superior to the risk
of keeping the patient under assisted ventilation. All these actions require a high
level of monitoring and frequent reactivity to adapt ventilatory settings.

The goal of next generation is to advance the technology to meet the operational
and clinical needs during an all-hazards event (caused by chemical, biological,
radiological, nuclear exposure, pandemic influenza, and other biological outbreak
or natural disasters) and provide respiratory support for large numbers of
severely ill patients. The advanced ventilator must have increased capability to
meet operational and clinical needs for treatment of respiratory compromised
patients during an all-hazards event in which mass casualties and shortage of
experienced care providers may be expected.

The equipment needs to be able to provide the same standard of performance as


current FDA pre-market cleared portable ventilators but with additional

characteristics that meet the recommended requirements like - ease of use for
an unskilled care provider, increased patient population range from neonate to
adult, portability and usability in a non-clinical environment, standard of care
safety, stockpiling and maintenance ease, and use in all-hazards events. As
ventilation assistance becomes more acceptable, improvement is discerned in
both disease management and patient outcomes, resulting in reduced diagnostic
errors and cut in cost and time.

At this juncture, the importance of interoperability and decision support tools to


optimize workflow in the clinical care area cannot be undermined. As costefficiency becomes an increasingly important factor in purchasing decisions, the
technology offered by manufacturers is being more closely scrutinized.
Traditionally, innovation in the ventilators market has been slow with the focus
on the quality of ventilation provided. However, with increasing pressure on
healthcare providers, manufacturers are witnessing a strong drive for
digitalization in the hospital environment. Consequently manufacturers are
required to consider the total care environment and caregiver in future technical
developments. Interoperability in an ICU ward is becoming more apparent with
ventilators now required to work in conjunction with other devices such as
patient monitors and infusion pumps. Preference has been shown for
manufacturers offering this type of technology.

Digitalization of ventilators is reflective of an increasing trend for medical devices


to be networked to a clinical information system (CIS). With pressure on
physicians and nurses showing no signs of decreasing, automated workflow
within the hospital is becoming more important. Within the ventilators market
there is a need to improve integration with IT systems, allowing data from the
ventilator to be stored digitally. Increased use of electronic patient records (EPR)
stored on the CIS is forecast, allowing more informed decision making and
treatment planning within the hospital.

{mosimage}We are witnessing an increase in market awareness and rapidly


rising brand consciousness in critical care area of hospitals. There is a definite
preference for better presentation of data in cognitive form to reduce data
overload. The availability of superior technological features coupled with good
after-sales service accelerates the growth prospects of Dr?ger in the Indian
market. Distinct markets have distinct behavior. Smaller towns go for value
based offerings while corporate hospitals consider technological superiority and
better after-sales service. An increasingly price driven market presents us with
an opportunity to distinguish the high tech and innovative features of Dr?ger
ventilators. It is not easy to predict but we can expect more ventilator
manufacturers to join an already competitive Indian market.

Milind Deshpande
Vice President - Marketing,

Drger India Private Limited

Industry Speak
Patent-Ventilator Synchrony

{mosimage}Indian healthcare sector is expected to grow at 12-15 percent per


annum and currently represents five percent of GDP and is estimated to be worth
USD 50 billion. Indian respiratory devices market is growing at a CAGR of 12
percent and is estimated at USD 70 million in 2013. The mid-segment ventilator
market is growing rapidly at the rate of 15-18 percent, whereas the high-end
ventilator market is growing at the rate of 11 percent.

The respiratory devices market is expected to grow steadily on the back of


increasing life expectancy, unhealthy lifestyles, and therefore more surgical
procedures, medical tourism, and increased healthcare spending by the
government and their PPP initiatives. In India, due to pollution neonates and
geriatric population are suffering from asthma and COPD (chronic obstructive
pulmonary disease). Today, the healthcare has been revolutionized by the
emergence of newer technologies - high-end ventilators offering CLIO an
advance ventilation feature that automatically adjusts the fraction of inspired
oxygen (FiO2) to maintain a target oxygen saturation level (SpO2) in neonates.

PFLEX is another tool for generating a static pressure-volume curve, which can
help clinicians identify the appropriate PEEP level for difficult-to-ventilate
patients. Using this tool, trans-pulmonary pressure can be determined for proper
PEEP setting.

Patients with stiff lungs complications require high frequency oscillatory


ventilation (HFOV) by delivering small tidal volumes. HFOV keeps lungs/alveoli
open at constant, less variable, airway pressure. This prevents the lung inflatedeflate cycle, which can damage alveoli and further complicate lung disease. The
delivery of tidal volume to dead spaces at a very high frequency enables the
maintenance of minute volume. Hence, lungs are kept open at a constant airway
pressure via a mean pressure adjust system. HFOV is used for the treatment of
acute respiratory failure in adults and children weighing more than 35 kg.

In a nutshell, better technological advancement along with features like PatentVentilator Synchrony will act as a driver despite price game.

Industry Speak

Cost and Services Will Play an Important Role


{mosimage}The ventilators market in India has been on the growth path for the
last couple of years. The main drivers for this business have been increased
awareness on usage of ventilators in home and hospital environments and
increased incidence of respiratory-based diseases mainly due to lifestyle trends
of current generation and increased air pollution.

The ventilator to ICU bed ratio continues to be lopsided in mist hospitals. Many
mid-sized and smaller hospitals have a ratio as poor as one ventilator for every
four to five ICU beds. This also gives an opportunity for growth in this segment.
Ventilators market in India has been dominated by refurbished ventilators sales,
which is almost 40-45 percent of the market. Though ventilators are cheap and
hence affordable, they have a major downside for the buyers. The sellers in this
segment belong to the unorganized sector leading to lack of commitment for
after-sales services. The market is fast expected to be replaced by new costefficient ventilators manufactured and sold through the organized sector where
long-term commitments make them attractive for prospective buyers. Buyers
can relax paying marginally higher costs to such companies and be assured of
after-sales services, which include all important spares.

Technological advances in ventilators include sensitive triggers that can


accurately sense and respond to patient's efforts. Better synchronization
between man and machine now leads to the ultimate goal of ventilation - faster
and effective weaning. Most design teams worldwide now focus on these
advances.

Indian manufacturers are now beginning to assert themselves in this largely


import-dependent market adding a new third dimension to the prevalent twodimensional market that consisted of advanced ventilators and refurbished
ventilators. Skanray Technologies who has recently acquired Pricol's Medical
Business arm is one of the leaders in this segment. The challenges in future are
going to be thrown by the Chinese players who were largely missing in this life
saving equipment market earlier. Cost considerations coupled with long-term
service assurance will play an important role in the coming years in the decision
making process of the buyers.