Medical Devices Market in India 2010 Sample 100810083708 Phpapp01

8/3/2019 Medical Devices Market in India 2010 Sample 100810083708 Phpapp01

1/12

Medical Devices Market IndiaAugust 2010


2/12

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 YYbn 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 diversifyingtheir 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


3/12


Introduction

Market Overview

Drivers & ChallengesTrends

Government Involvement

Government Bodies

Government Regulations

Government Initiatives

Competition

Key Developments


4/12


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 themovement to the lesser stringent class will assure sufficient safety & effectiveness of the device


5/12


SAM

PLE

India's medical device market is currently the T largest

market in Asia and ranks among the worlds 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 ICACmark (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


6/126MEDICAL DEVICES MARKET IN INDIA 2010.PPT

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

KeyTrends

Outsourcing/Relocating of

manufacturing facilities

Various exhibitions and

trade fairs

Increasing joint ventures

and tie-ups



Introduction

Market Overview

Drivers & ChallengesTrends

Government Involvement

Government Bodies

Government Regulations

Government Initiatives

Competition

Key Developments



SA

MPLE

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

ElectronictreatmentDevices

SurgicalEquipment

ImagingDevices

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

OthersDiagnosticEquipment

Players

Source:


11/1211MEDICAL DEVICES MARKET IN INDIA 2010.PPTS

AMPLE

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

About Netscribes

Netscribes is a knowledge-consulting and solutions firm with clientele across the globe. The companys expertise spans areas of investment &business research, business & corporate intelligence, content-management services, and knowledge-software services. At its core lies a true

value proposition that draws upon a vast knowledge base. Netscribes is a one-stop shop designed to fulfil clients profitability and growth

objectives.

The Medical Devices Market report is part of Research on Indias Healthcare Industry Series.

For more detailed information or customized research requirements please contact:

Disclaimer: This report is published for general information only. Although high standards have been used the preparation, Research on India,

Netscribes (India) Pvt. Ltd. or Netscribes is not responsible for any loss or damage arising from use of this document. This document is thesole property of Netscribes (India) Pvt. Ltd. and prior permission is required for guidelines on reproduction.

Research on India is a product of Netscribes (India) Pvt. Ltd. Research on India is dedicated to disseminating information and providing quick

insights on hot industries in India and other emerging markets. Track our new releases and major updates in these industries on

Gaurav KumarPhone: +91 33 4064 6214

E-Mail: [email protected]

Gagan UppalPhone: +91 22 4098 7530

E-Mail: [email protected]

Documents

Medical Devices Market in India 2010 Sample 100810083708 Phpapp01