A case study on Smart medical devices market, which will give an answer to these questions.
Industry snapshot – Market Overview
The market size in India
Market share by Product type/Others Classification (anyone)
Industry structure
Domestic Manufacturing & Export-Import scenario
Key Trends
Key growth drivers
Key challenges
Prevailing government policies
Future outlook
Key investments in the sector (Value of investment and key projects etc...)
2. Industry snapshot – Market Overview
What are these devices ?
A smart medical device is an appliance; software, used for variety of therapeutic and diagnostic purposes. It has been used in a wide range of
applications such as monitoring heart rate; glucose monitoring; pain relief; insulin delivery; and so forth. Smartphones play significant role in
operating these smart medical devices in the healthcare sector.
How it is developed ?
Modern medical technology (the application of medical devices) which dates its origins to the first half of the 19th century, only took off in earnest
over the last 50 years.
Current Market
the vast number of different variants brings the figure to about 90 000 with some estimates putting the total as high as 1.5 million.
Rapid Progress in market
Research is making rapid progress within the development of sophisticated medical technologies, such as genetic testing, genetic manipulation of
living tissue, robotic surgery and remote patient management.
4 A’s of medical devices
Availability
Accessibility
Appropriate(ness)
Affordability
3. Market size in India
The medical devices industry in India consists of large multinationals, with extensive service networks, as well as small and medium enterprises (SMEs).
Some statistical point is mentioned below that how the whole market is increasing.
There are several points:
The current market size of the medical devices industry in India is estimated to be $ 5.2 bn.
As per the Department of Pharmaceuticals, the estimated retail market for medical devices is between $ 9.3 bn – $ 10.8 bn.
The market size is expected to reach $ 50 bn by 2025.
Orthopaedic prosthetics and patient aids segments to be the two fastest-growing verticals by 2020 and are projected to grow at a CAGR(compound
annual growth rate) of 9.6% and 8.8%, respectively.
Diagnostic imaging, dental products, and consumables are expected to grow at a CAGR of 7.1%, 7.4% & 7.1%, respectively during 2015-20.
4. Market share by Product type
There are several basic types on the basis of uses
Diagnostic machines
Treatment Equipment
Life support Equipment
Medical monitors
Medical laboratory
Therapeutic
A biomedical equipment technician is a vital component of
the healthcare delivery system.
We must also count those machines which are used for
identification of human UDI(Unique Device identification).
5. Market share by Product type
There are several basic types on the basis of classes
Class I
Class I Medical Devices have the least regulatory control. They present minimal potential harm to the user. Class I devices are typically simple in design.
55% of devices fall under this category.
Examples of Class I devices include tongue depressors, arm slings, and manual stethoscopes.
Class II
Class II devices typically require pre-market notification by submission and FDA review of a 510(k) clearance to market submission. 40% of devices fall
under this category.
Examples of Class II devices include fever thermometer, powered wheelchairs, intravenous tubing, catheters, gas analyzers, and surgical drapes.
Examples of Class IIb devices include blood bags, x-ray units, and dressings for severe wounds.
Class III
Class III Medical Devices have the most stringent regulatory controls. Class III devices usually support or sustain human life, are of substantial
importance in preventing impairment of human health. 5% of devices fall under this category.
6. Industry Structure
Indian market for medical industry is not favorable, because
India came in one of those who only invest 1.3% of its GDP.
A population breakdown statistics shows that Indians between
the age group of 15 and 60 are more than the total population
of several countries.
The government increased the health care budget by 16.67 %
in fiscal year 2019.
Licensing system to medical industry is regulated by Central
Drugs Standard Control Organization(CDSCO).
This kind of structure which is followed by regulatory board is
ambiguous sometime.
7. Domestic Manufacturing &
Export-Import scenario
There are several points to describe the scenario of Domestic Manufacturing.
There are 750–800 domestic medical devices manufacturers in India.
Around 65% of the manufacturers are mostly domestic players operating
in the consumables segment and catering to local consumption with
limited exports.
Key market shares out of the total medical devices industry (2016)
Diagnostic imaging - 36%
Consumables – 19%
Patient aids - 9%
Orthopaedic prosthetics - 8%
Dental products – 4%
8. Domestic Manufacturing & Export-Import scenario
Here is some records of last year of importing-exporting scenario
Import
India has hindered the growth of their export, the data suggests otherwise. From Rs 61.5
billion in 2014-15, import of medical devices from the US was Rs 74.2 bn in 2017-18.
India imports around 80 per cent of its medical devices’ requirement and a fourth of that
comes from the US. The overall medical devices market in India is estimated to be Rs 640
bn.
Export
Since 2013, we have been growing at an average 25-40 per cent year on year, while the
industry growth rate is 17-18 per cent in the country.
The medical devices industry in India is at present valued at $5.2 billion and contributes
4-5 per cent to the $96.7 billion Indian healthcare industry.
9. Key Trends
Cloud-based solutions will
become a lot more significant
Compliance standards will be
more stringent
Medical device
manufacturing is going to get
a lot leaner
10. Key investments in the sector
Recent announcements in medical devices industry in India.
Medical device startup Biosense raises $ 1 mn from Menterra Venture, Artha Venture
Challenge.
Apax Partners acquires Healthium MedTech for $ 350 mn.
Neuberg Diagnostics, an alliance of five leading pathology laboratories from India, South
Africa and the UAE, is planning to invest $ 45.9 mn in India, the Middle East and Africa as
part of its expansion plans.
11. Key growth
Drivers
These are some key growth drivers
of industry
Operational efficiency &
profitability
Unique Product Identifier (UDI)
initiative by the FDA
Cloud-based software solutions
GS1 regulation
Diversified support base
Pharma’s going to try and curb
drug counterfeiting
12. Key challenges
There are 5 key challenges here.
Ensuring Product Quality
Regulatory Compliance and
Government Support
Localization of Medical Devices
I-o-T Integration and Data
Security
Cost of Product Development
13. Prevailing government policies
There are some key elements which every new player in this market needs to be aware of.
One does not require any prior prerequisite for foreign direct investment in
medical device manufacturing.
Additionally, you have an enormous scope of innovation in India’s robust legal system.
India boasts strong patent, trademark, and copyright protection with its Trade-
related conditions of Intellectual Property Rights.
No import duty on some medical equipment.
Individual life-saving medical equipment is exempted from payment of excise duty.
The Indian government has incentivized scientific investigation and development
by catering weight deduction.
14. Future Outlook
The global
implantable medical devices
market is expected to rise to
$49.8 billion by 2024.
Transparency Market Researc
h (TMR) estimates that the
global implantable medical
devices market expand at a
4.9% compound annual
growth rate (CAGR) between
2016 and 2024.
15. Observations
There are some observervations from case-study.
Chinese invasion in this market; market is geeting 72% hike in
manufacturing of medical devices.
But indian market got 65% hike compare to last year growth
rate.
Most of the class III medical devices we imported from US.
Indian lincensing of medical devices manufacturing is still not
an easy process.
The trends of medical devices is not limited to manufacturing,
it is now on cloud, UDI systems and it also reached to
different domain.
Indian markets still need to adapt these changes according to
market trend.
