Medical Devices Market India

August 2010

Executive Summary
Market
Medical devices market in India is pegged at INR XX bn in 20-- and is expected to grow to INR YY bn at the end of 20-- with diagnostic equipments being the leading segment Growing hospital infrastructure and healthcare spending is fostering the need for high-end devices for accurate and fast treatment Drivers: Challenges:
Increasing hospital infrastructure Increasing healthcare spending Changing demographics and Growing Target consumer group Increasing lifestyle diseases and therapies Increasing Medical tourism in India

Drivers & Challenges

Trends Govt. Bodies, Regulations & Initiatives

Competition

Outsourcing/Relocating of manufacturing facilities Increasing joint ventures and tie-ups Various exhibitions and trade fairs Govt. bodies and associations like A1, A2 and A3 are aiming to provide medical devices in India a regulatory structure in order to promote indigenous production A2 has laid down registration and license regulations to regularize imports of drugs Govt. has provided tax reliefs, import duty relaxations and has implemented major initiatives to boost the sector in India The industry has a huge influx of foreign players who have consolidated their operations in India either through establishing subsidiaries or tying up with Indian distributors Players in India are also increasing their manufacturing capacities and are looking at diversifying their product quality and portfolio
MEDICAL DEVICES MARKET IN INDIA 2010.PPT

LE P M A S

Various summits and seminars Initiatives for consumer awareness Public private partnerships

Introduction Market Overview Drivers & Challenges Trends Government Involvement

Government Bodies Government Regulations Government Initiatives

Competition Key Developments

MEDICAL DEVICES MARKET IN INDIA 2010.PPT

Medical Devices are classified as per the risk level and their intended use
Medical devices under the meaning of Section 3 (b) (iv) of the L refers to:
Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article which is:
intended by the manufacturer to be used alone or in combination for human beings for one or more specific purposes of diagnosis, prevention, monitoring, treatment or alleviation of disease and, which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means Medical Devices in India are classified as per their risk levels and intended use . They are divided into classes and the classification is carried out in accordance with Annex IX of Schedule M-III provided by A1

LE P M A S
Class B

Class A Low Risk Contains devices like P1, P2, P3 and P4 Cannot commence clinical investigations immediately after the date of information and submission to A2

Class C Moderate-high Risk Contains devices like PC1, PC2, PC3 and PC4 Can commence clinical investigations immediately after the date of information and submission to A3

Class D High Risk Contains devices like PD1, PD2, PD3 and PD4 Can commence clinical investigations immediately after the date of information and submission to A4

Low-moderate Risk Contains devices like PB1, PB2, PB3 and PB4 Can commence clinical investigations immediately after the date of information and submission to A2

If a manufacturer desires to reclassify a device to a lower class, it must submit justification to A2 for evaluation that the movement to the lesser stringent class will assure sufficient safety & effectiveness of the device 4

MEDICAL DEVICES MARKET IN INDIA 2010.PPT

India's medical device market is currently the T largest market in Asia and ranks among the worlds top P
Market Overview
Good healthcare infrastructure, population rise and growing economy are fueling growth in the medical equipment market There are some 700 medical devices makers in India
Most of them make low-value products such as needles, syringes, catheters, blood collection tubes, medical electronics and implants High-end specialist products are catered by foreign firms

Market Size and Growth

INR bn

India requires major foreign participation, especially in high-tech devices that account for roughly 45-55% of the entire market
Currently, most of the reputed Indian healthcare institutes use foreign medical equipments for the purpose of surgery, diagnosis of cancer and imaging

LE P M A S

100 80 60 40 20 0

a% XX

YY

2009

2010e

Segmentation of Market
s5% s4% s1% s3% s2%
Segment 1 Segment 2 Segment 3 Segment 4 Segment 5

Currently, according to the new guidance, all medical devices sold in India must carry the ICAC mark (Indian Conformity Assessment Certificate) to indicate their conformity with the provisions of this schedule to enable them to move freely within the country

Source: MEDICAL DEVICES MARKET IN INDIA 2010.PPT

Drivers & Challenges Summary

Drivers
Increasing hospital infrastructure Increasing healthcare spending Changing demographics and Growing Target consumer group Increasing lifestyle diseases and therapies Increasing Medical tourism in India

Challenges
High dependency on exports Lack of standard regulatory structure

MEDICAL DEVICES MARKET IN INDIA 2010.PPT

Trends Summary

Outsourcing/Relocating of manufacturing facilities

Key Trends
Various exhibitions and trade fairs Increasing joint ventures and tie-ups

MEDICAL DEVICES MARKET IN INDIA 2010.PPT

Introduction Market Overview Drivers & Challenges Trends Government Involvement

Government Bodies Government Regulations Government Initiatives

Competition Key Developments

MEDICAL DEVICES MARKET IN INDIA 2010.PPT

The efforts of A2 have provided areas of improvement in medical devices sector of India
A2
A3 Serves as the main regulatory body for medical devices that will classify medical devices, and any manufacturer seeking a less stringent classification must justify it to the A2

It is the authority regulating medical devices in India under A1

It lays down rules, standards and approves import and manufacturing of T1, T2, T3 and T4 Establishes standards and regulations for R1, R2, R3, R4, R5, R6 and R7

Companies must register all their products with the A2 before its products can be introduced into the Indian market It issued a Gazette Notification S.O. 14-- (20--) that declared L categories of sterile devices to be considered as drugs under Section 3 (b) (iv) of the Q Act In late 20--, A3 (DCGI) prepared an expanded list of medical devices which require registration
The list now includes over X medical devices

LE P M A S

Act and Regulatory status of A2

A4 Regulates the import, manufacture, sale, distribution of X medical devices classified as drugs and also provides licenses which are compulsory for the importers and manufacturers to deal in the said devices

Currently working on a road map to include current status review as well as guiding principles of medical devices and a regulatory process implementation phases to make it an all inclusive process
Source:

A2 has also adopted and recognized BIS YY or its revisions & ISO KK in respect of the specifications to be followed for quality in order for the manufacturer to demonstrate conformity with the relevant regulatory requirements

MEDICAL DEVICES MARKET IN INDIA 2010.PPT

Segmentation of Players (1/2)

Players Diagnostic Equipment Surgical Equipment Imaging Devices Electronic treatment Devices Others

Domestic Players Player 1 Player 2 Player 3 Player 4 Player 5 Player 6 Player 7 Player 8 Player 9 Player 10 Player 11 Player 12 Player 13 Player 14 Player 15
Source: MEDICAL DEVICES MARKET IN INDIA 2010.PPT

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Major Domestic Players (1/12)

Company Snapshot: Company 1
Corporate Information
Headquarters Founded Products Key People XX 19-Product 1, Product 2 and Product 3 NA

Financial Performance
Revenue INR mn
600 400 200 0

Revenue Profit / Loss R1 R2 R3 R4

Profit INR mn
40 30 20 10 0

2005-06

2006-07

2007-08

2008-09

Business Highlights
It provides products and services in information technology and healthcare sectors in India Its healthcare division provides medical equipments to critical care, trauma, and operation theatre areas in the hospitals; develops specialty critical care/trauma care ambulances; manufactures and supplies of mobile medical units for diagnostics; and undertakes turnkey projects for providing customized solutions for construction of modular operation theatres, surgical pendants, and intensive care units Operates as a subsidiary of Company K Its customer base includes major corporates, defense establishments, software technology parks, MNC's and Superspecialty hospitals

E L P M A S

Source: MEDICAL DEVICES MARKET IN INDIA 2010.PPT

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Thank you for the attention

The Medical Devices Market report is part of Research on Indias Healthcare Industry Series. For more detailed information or customized research requirements please contact: Gagan Uppal
Phone: E-Mail: +91 22 4098 7530 gagan.uppal@netscribes.com

Gaurav Kumar
Phone: E-Mail: +91 33 4064 6214 gaurav.kumar@netscribes.com

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