Market Research Report: Medical Devices Market in India 2010

Medical Devices Market – India

August 2010

2MEDICAL DEVICES MARKET IN INDIA 2010.PPT

SAMPLE

Executive Summary

Market

Trends

Competition

�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

�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

�Outsourcing/Relocating of manufacturing facilities

� Increasing joint ventures and tie-ups

�Various exhibitions and trade fairs

Drivers &

Challenges

Drivers:

� Increasing hospital infrastructure

� Increasing healthcare spending

� Changing demographics and Growing Target

consumer group

� Increasing lifestyle diseases and therapies

� Increasing Medical tourism in India

Govt. Bodies,

Regulations &

Initiatives

�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

Challenges:

� 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


SAMPLE 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

Class A Class B Class C Class D

Low Risk Low-moderate Risk Moderate-high Risk High Risk

• Contains devices like P1,

P2, P3 and P4

• Cannot commence

clinical investigations

immediately after the

date of information and

submission to A2

• Contains devices like

PB1, PB2, PB3 and PB4

• Can commence clinical

investigations



submission to A2


PC1, PC2, PC3 and PC4


investigations



submission to A3


PD1, PD2, PD3 and PD4


investigations



submission to A4

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


SAMPLE

India's medical device market is currently the T largest

market in Asia and ranks among the world’s top P

• 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

• 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

• 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

Market Overview Market Size and Growth

Source:

0

20

40

60

80

100

XX

2009

YY

2010e

a%

INR bn

s1%

Segment 1

s2%

Segment 2

s3%

Segment 3

s4%

Segment 4

s5%

Segment 5

Segmentation of Market


Drivers & Challenges – Summary

Increasing Medical tourism in India

Increasing lifestyle diseases and

therapies

Changing demographics and Growing

Target consumer group

Increasing healthcare spending

Increasing hospital infrastructure

Drivers

Lack of standard regulatory structure

High dependency on exports

Challenges


Trends – Summary

Key

Trends

Outsourcing/Relocating of

manufacturing facilities

Various exhibitions and

trade fairs

Increasing joint ventures

and tie-ups


•Introduction

•Market Overview

•Drivers & Challenges

•Trends

•Government Involvement

�Government Bodies

�Government Regulations

�Government Initiatives

•Competition

•Key Developments


SAMPLE

The efforts of A2 have provided areas of improvement in

medical devices sector of India

Source:

• 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

• 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

A2

Act and Regulatory status of 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

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

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


Segmentation of Players (1/2)

Domestic Players

Electronic treatment

Devices

Surgical Equipment

Imaging Devices

Player 15

Player 14

Player 13

Player 12

Player 11

Player 10

Player 8

Player 7

Player 6

Player 5

Player 3

Player 2

Player 4

Player 9

Player 1

Others Diagnostic Equipment

Players

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Source:

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SAMPLE

Major Domestic Players (1/12)

• 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 Super-

specialty hospitals

Source:

Headquarters XX

Founded 19--

Products Product 1, Product 2 and Product 3

Key People NA

Company Snapshot: Company 1

Business Highlights

Corporate Information Financial Performance

0

200

400

600

0

10

20

30

40

Profit

INR mn

R1

2005-06

R2

2006-07

R3

2007-08

R4

2008-09

Revenue

Profit / LossRevenue

INR mn


Thank you for the attention

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