Industry Insight Indian Medical Devices & Equipments

INDUSTRY INSIGHT
MEDICAL DEVICES & EQUIPMENT
IN INDIA

June 2009

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Cygnus Business Consulting & Research Pvt. Ltd. 2009

Industry Insight Indian Medical Devices & Equipments

SYNOPSIS
Growing per capita income and adoption of new lifestyles has made healthcare services in India
to undergo rapid change to meet the increasing demand for quality healthcare services. Urban
areas have seen the construction of new, state-of-the-art hospitals and associated satellite
facilities, while others in semi-urban and rural areas are yet to avail the same healthcare
infrastructure. This has fueled the demand for healthcare equipment and devices across
segments and according to Cygnus Research estimates Indian medical equipment and devices
market in 2008 was US$2.75 billion in 2008. The medical instruments & appliances segment,
which has been estimated at US$690 million in 2008, is further projected to reach US$1,236.5
million in 2012. The medical devices and equipments market is poised for phenomenal growth
due to focused investment in healthcare infrastructure and foreign manufacturers of medical
devices and equipments eyeing for India for creating global hub for manufacturing medical
devices and equipments. According to Cygnus Research estimates the market is expected to
reach US$5 billion by 2012 with an annual growth rate of nearly 15%.

In the backdrop of this encouraging scenario, Cygnus Research has come up with an industry
analysis of medical devices and equipments in India. The report comprises eleven chapters. It
discusses general overview of the global medical devices industry with brief discussion about
some major global markets, Indias market and key market trend in the recent past, growth
drivers of the industry, issues and challenges, major players, major associations leading the
industry, critical success factors and future outlook.

The report would be useful to medical devices manufacturers, importers of medical equipments,
industry researchers, analysts, financial institutes offering credit services to the sector,
healthcare-related professionals and individual foreign investors tracking this segment of
healthcare in India.

No of Pages -113

No of Annexure -3

No of Figures 23

Cygnus Business Consulting & Research Pvt. Ltd. 2009

No of Tables -10

Industry Insight Indian Medical Devices & Equipments

CONTENTS
1. EXECUTIVE SUMMARY .................................................................................. 8
2. HIGHLIGHTS ............................................................................................... 10
3. MARKET OVERVIEW ................................................................................... 12
3.1 Global market scenario........................................................................................... 14
3.1.1 Market size ................................................................................................. 14
3.1.2 Segmentation by geography ....................................................................... 14
3.1.3 Segmentation by application ...................................................................... 15
3.2 Major markets ......................................................................................................... 15
3.2.1 The US........................................................................................................ 15
3.2.2 Japan ........................................................................................................... 17
3.2.3 Germany ..................................................................................................... 18
3.3 Indian market scenario............................................................................................ 19
3.3.1 Indian Market for Medical Equipment and Devices ................................... 20
3.3.2 Segmentation by application ...................................................................... 21
3.3.3 Market Trends............................................................................................ 22
3.3.4 Imports and exports .................................................................................. 22
3.3.4 Peculiarities of India Value Chain Vs Other Regions ................................. 25
3.3.5 Indian Medical Equipment/Devices Supply Chain ...................................... 26
3.4 SWOT Analysis ....................................................................................................... 27
4. MARKET TRENDS ........................................................................................ 28
4.1 Developments in 2009 (until May) ......................................................................... 28
4.1.1 Market Developments ............................................................................... 28
4.1.2 New Products ............................................................................................ 30
4.1.3 Company Developments ........................................................................... 30
4.2 Developments in 2008 ............................................................................................ 32
4.2.1 Market developments ................................................................................ 32
4.2.2 Company Developments ........................................................................... 33
4.2.3 New products ............................................................................................ 35
5. GROWTH DRIVERS ..................................................................................... 37
5.1 Booming Economy .................................................................................................. 37

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Industry Insight Indian Medical Devices & Equipments

5.2 Increasing Healthcare Expenditure ......................................................................... 37

5.3 Changing Demographic Profile ............................................................................... 39
5.4 Increasing Incidence of Lifestyle Diseases .............................................................. 39
5.5 Increasing Number of Medical Tourists ................................................................. 40
5.6 Proliferation of Hospitals ........................................................................................ 42
5.7 Government Programmes and Support ................................................................. 43
5.8 Outsourcing/Relocating of Medical Devices Manufacturing by Western Companies44
5.9 User Friendly and Handy Devices .......................................................................... 45
5.10 Telemedicine ......................................................................................................... 45
5.11 Rising Demand for Quality healthcare.................................................................. 46
6. ISSUES AND CHALLANGES ......................................................................... 47
6.1 Dependency on Imports ......................................................................................... 47
6.2 Low Levels of Health Insurance Coverage ............................................................. 48
6.3 Recent Stringent Regulatory Amendment .............................................................. 49
6.4 High Import Duties to Escalate the Cost of Medical Devices ............................... 51
6.5 Poor Medical Infrastructure Facilities and Low Level of Awareness in Rural India52
7. REGULATORY ENVIRONMENT .................................................................... 53
7.1 Guidelines for Manufacturing of Medical Devices .................................................. 54
7.1.1 Manufacture of Medical Devices in the Country ....................................... 54
7.1.1.1 Manufacturing Details ............................................................................... 54
7.1.1.2 Product Details ........................................................................................ 55

7.2 Guidelines for Import of Medical Devices .............................................................. 56

7.2.1 Registration of Medical Devices for Import .............................................. 57
7.2.1.1 Applicant Details ...................................................................................... 57
7.2.1.2 Product Information ................................................................................. 57
7.2.1.3 Regulatory Status ..................................................................................... 58
7.2.1.4 Master File (Details of Good Manufacturing Practices employed by the
manufacturer to ensure quality of the device) .................................................... 58
7.2.1.5 Devices containing medicinal product ..................................................... 59
7.2.1.6 Post Market Surveillance .......................................................................... 59
7.2.1.7 Undertaking of Conformity with Respect to Product Standards, Safety and
Effectiveness Requirements and Quality Systems in the Country of Origin ....... 59

7.3 Sale of Medical Devices in the Country ................................................................. 60

7.4 New Quality Guidelines for Medical Device .......................................................... 60

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Industry Insight Indian Medical Devices & Equipments

8. MAJOR PLAYERS ........................................................................................ 61

8.1 B. Braun Medical (I) Pvt. Ltd. .................................................................................. 62
8.2 BL Life sciences Ltd................................................................................................. 63
8.3 Becton, Dickinson and Company ........................................................................... 65
8.4 Johnson & Johnson Medical India (JJMI) Ltd ........................................................... 67
8.5 Nicholas Piramal India Ltd. ..................................................................................... 69
8.6 Opto Circuits (I) Limited ........................................................................................ 71
8.7 Philips Electronics India Ltd (Medical Systems Division) ........................................ 74
8.8 Roche Diagnostics India .......................................................................................... 78
8.9 Siemens India Ltd .................................................................................................... 80
8.10 Span Diagnostics Ltd. ............................................................................................ 82
8.11 Trivitron Medical Systems .................................................................................... 85
8.12 Wipro GE Medical Systems .................................................................................. 88
8.13 BPL Healthcare ..................................................................................................... 90
8.14 Medtronics ............................................................................................................ 92
8.15 Boston Scientific .................................................................................................... 94
9. INDUSTRY ASSOCIATIONS ......................................................................... 98
9.1 Association of Medical Devices and Suppliers of India........................................... 98
9.2 All India Syringes & Needles Manufacturers Association ...................................... 99
9.3 Association of Indian Medical Device Industry (AIMED) ..................................... 100
10. CRITICAL SUCCESS FACTORS .................................................................. 101
10.1 Striking Alliances with Overseas Companies ..................................................... 101
10.2 Investments in R&D ............................................................................................ 102
10.3 Low Cost Devices............................................................................................... 104
11. FUTURE OUTLOOK ................................................................................. 105
Annexure 1 Major Industry Events ................................................................ 108
Annexure 2 List of Abbreviation ................................................................... 111
Annexure 3 - Bibliography ............................................................................. 113

Cygnus Business Consulting & Research Pvt. Ltd. 2009