An outline of India's Medical Devices market, along with practical tips on Market Entry for Startups and SME's on navigating the complexities. For more details connect at https://ontogenix.com

1. 2021.10
For: Start-ups & SME’s
India Med-Tech Opportunity

2. Authors Bio
linkedin.com/in/mbala5
Balasubramaniam M
A healthcare leader with deep domain knowledge
and understanding of the APAC Healthcare
Industry, backed by more than 2 decades of
managing large & medium organizations with
complete P&L responsibility. Served in senior
management roles in India and Singapore.
Shikharesh Das
Senior executive specialized in execution of
commercialization & market entry strategy, in a mix of
MNC & SME experience in regional and global roles.
Strong track record in business development, sales,
and marketing. Highly connected in start-up
ecosystem.
linkedin.com/in/shikharesh/
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3. Agenda
1. Indian Healthcare Landscape
2. MedTech Opportunity
3. Healthcare Delivery
4. Distribution Models
5. Start-up : Tips for Market Entry
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Image copyright attributes:
https://commons.wikimedia.org/wiki/File:Taj-
Mahal.jpg
https://en.wikipedia.org/wiki/File:Wockhardt_Hospi
tal_Bangalore.jpeg

4. Country Overview
Growing Population : India’s population is set to
touch 1.45 billion by 2028.
Life Expectancy : Life expectancy in India is
expected to increase to 70 years by 2025
Changing Preferences: Increasing lifestyle
diseases driving towards preventive healthcare,
Growing Middle Class: A rapidly growing
middle class has contributed to the growth of
private players
Policy Support & Incentives : 100% FDI
allowed in Greenfield & Brownfield projects,
India Healthcare Landscape Overview
Medtech Indices
Shifting Disease Burden: Non-Communicable
Diseases account for 60% of all deaths in India
Health Insurance: Approx. 40% of Indians
have health insurance cover
Rise in Medical Tourism: experiencing a 22-
25% growth. It contributes over $2 BN to the
healthcare market in India.
Nascent MedTech industry: Imports more
than 90% of sophisticated devices, domestic
industry has a huge scope for R&D capacity
Infrastructural Development: Four medical
devices parks active in India
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5. Macro Health Economic Data* – India
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Govt Healthcare Spend
US$170 BN, CAGR ~ 30%
Hospital Spend
US$120 BN
Med Tech Spend
US$11 BN
* Est in 2019
• Reach : Disruptive models emerging to scale & meet the unmet demand
• Manufacturing: Value products, D & D through Frugal Innovation & leverage sourcing efficiency
• Technology: Center of Excellence on core technology. X-ray Tubes, Flat Panel Detectors, Sensors
• Equipment as Service: Combine efficiency in Sourcing, extending Life cycle & Asset management,

6. Is Med-Tech the next wave?
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• Estd. lead in early 2000’s
• US$ 6.0 BN in ‘05 to US$
55 BN in ‘20
• FDI US$ 11B
• Import < 15%
• FDI US$ 3.0 BN
• Growth in smaller cities
• NHPS – 500 MN new
patients
• Currently 85% imported
• Cost Vs Quality balance
• Frugal innovation is key
• Opportunity to replace
imports
Pharma
Set early pace
Hospitals
Following pharma’s pace
Med. Tech
Next growth Engine?
FDI = Foreign Direct Investment NHPS = National Health Protection Scheme

7. ▪ Med Devices in Govt. Strategic focus
▪ Increasing demand > supported by
Govt. investments
▪ Focus on import substitute & export
to emerging markets
▪ Medical Devices Bill : Quality &
Regulatory focus
▪ Destination India : Manufacturing
base to attract companies currently
sourcing from other parts of Asia
Med Tech Innovation : Next Big wave &
Disruption opportunity
India Med-Tech Opportunity : Favourable factors
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8. 6th Largest Global Market
Expected to rank in the top 3 by 2025
India Med-Tech Opportunity – Market Size
Segment Total Sales USD
MN (Est 2020)
Imports %
Disposables &
Consumables
3,200 35%
Equipment's 6,000 85%
Implants 750 80%
In Vitro Reagents 880 75%
Total 10,830 75%
Key Summary
• Market is expected to grow to $20B by 2025
with CAGR @15%
• MedTech imports constitute about 85%.
“Make in India” initiative to improve self-
sufficiency in Med-Tech
• Innovation ecosystem is fast evolving and
vibrant > local startups co-creating products
• Government,Academic Research, Incubators,
VC firms providing funding support.
• Vendor ecosystem developed by MNC’s
provide good starting point
• Type of product determines optimum target
segment and sector (Govt or Private)
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0% 20% 40% 60% 80% 100%
Spend
Beds
Govt Private
https://www.statista.com/statistics/1128673/india-number-of-public-and-private-hospital-beds-estimated/

9. India Healthcare delivery
Private has larger share of market
Tertiary Care
Intermediate care
Villages
Primary Care
Govt 40%
Core hospitals in
key cities
Distributed clinics
Limited Presence
Private 60%
70% of
population
MedTech net value: 30% in
Tertiary Hospital investments.
Premium /High performance
market
MedTech net value: 50% in
Intermediate care
investments. Opportunity for
Value / affordable solutions
Driver
Shortage of skilled manpower.
<20% of resources deployed.
Increase access, remote solutions
using innovative technology / AI
Tier 1
Cities
Tier 2 & 3
Cities
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Tier definition: https://aspiringyouths.com/general-knowledge/tier-1-tier-2-indian-cities/

10. Tertiary Care
Drivers
• Patient Care / Outcomes
• Clinical efficacy / Staying ahead
• High throughput / Productivity
• Seamless Connectivity within
Group Hospitals
• Lifetime ownership costs
important
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AIIMS New Delhi
Care Hospital Hyderabad
Apollo Hospital, Delhi

11. Primary Healthcare
Key considerations:
• Access
• Affordability
• Quality of care
• Remote solutions
• Wearable / AI
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Image credit: https://pixnio.com/science/medical-science/doctor-inspects-a-child

12. Distribution Overview
N
W
S
E
• Strong Regional distributors exist with
local relationships. Few National
distributors exist
• Hybrid distribution models are popular
• Medtech devices / Consumables leverage
‘stockist’ models
• Digital channels / e-commerce platforms
are now growing
• Govt purchases are higher in Capital
region in the North
• Net prices are generally higher in the
South & West
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The geographicaldivisionsare shown just to illustratehow companiesusuallysplittheir regions
https://commons.wikimedia.org/wiki/File:India-map-en.svg

13. Distribution Models
Hybrid model
• Most popular
• Local distributor provides customer facing activity. Company bills & pay
dealer commission.
• Parent company undertakes certain financials and logistics risks
Direct Distribution
model
• Upcoming model for certain products
• Large Distributors operate on Stock & Sell model with min. annual commitment
• Auto replenishment of stock on reaching inventory threshold
• Distributors focus on last mile delivery, payments & relationships
Electronic
Marketplace
• Gaining popularity
• Disruption in Consumables / low value equipment
• Replaces consignment model for inventory. Manages customer inventory
• Payment solutions need to evolve for better adoption
1
3
2
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14. Government support for MedTech Industry
https://www.investind
ia.gov.in/setting-up-
business-in-india
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Key Observations on Govt. Support :
1. Startups can choose any of the entry options depending on the long term strategic plan.
2. Govt. Support like Production linked incentive, Preferential market access, Price preference in
public tenders are available for manufacturing companies n India
3. Access to MedTech parks and incentives given to manufacturers are available to Foreign
companies

15. India Medical Device Registration Pathway
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Online application
Click on link
Received by Nodal
Officer
Forwarded to reviewing
officer
Forwarded to Dy
Director Admin
Approval granted online
Forwarded to
Licensing Authority
Queries on
deficiency
Learn about CDSCO
Download CDSCO Manual
See Classification of Devices
CDSCO = India’s FDA
https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/GCT_PDFs/Approval_process_flowchart_GCT_Online.pdf
Note: timeline for approval varies
based on novelty of device

16. Challenges for Healthcare Start-ups & Mitigation plan
Sl no Description Solution
1 Revamped Regulatory
Framework: MDR 2017 : Backed by
government and other industry-
regulatory apex bodies
Obtain CE mark or FDA First.
Then apply for India CDSCO
registration.
2 Infrastructure support required for
adoption
Understand local workflow and
legacy system
3 ‘Me too’ products offerings Will not take off – avoid market entry
4 Absence of National Distributors Go by region, focus on one region
for entry & expand
5 Many local players Identify and focus on niche
segment. Leverage local partners
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17. Key takeaways
• Look for niche underserved sector with
a need
• Navigate regulatory: Get CE or FDA
first > then apply for local license
• Collaborate with strong local partner
• Be ready for volume game
• Access to 6th largest market
• Outstanding clinical data source
• Inexpensive market access
• Strong local IP protection
• Easy legal access by Arbitration route
Recommended steps for entry
Benefits for Entrant
• Large growing patient population
• Increased spending power
• Easy adoption to private sector
• Lower operational costs
• Innovative business models: Revenue
share, Equipment as a service
• Bring products tailored to India needs.
• Leverage India’s clinical spread
• Deliver quality at moderate prices.
Upfront cost differentiation is critical.
• Provide prompt & efficient service
What India offers Key considerations
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18. Strategy &
GTM models
Distributor Search
& management
Market Research
& pricing
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Web: https://www.ontogenix.com
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