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Bioabsorbable Stents US Analysis and Market Forecast

GDME1003CFR / Published December 2012

Executive Summary

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Bioabsorbable Stents, Key Metrics in the US Market

Diagnosed Prevalence

Coronary Artery Disease 1.4 million

Peripheral Artery Disease 1.6 million

Pipeline Assessment

Number of stents at preclinical phase 9

Number of stents at early clinical phase 5

Number of stent at late clinical phase 4

Stents for coronary artery disease 67%

Stents for peripheral artery disease 33%

Key events (2011-2018) Level of Impact

Commercial launch of Absorb BVS and DREAMS stent in the US in 2015

↑↑↑

2018 Market Sales ($m)

US $319m

Source: GlobalData

US Bioabsorbable Stent Market Forecast to Witness Signficant Growth Through 2018

Currently, bioabsorbable stents are not available for sale

in the US. As bioabsorbable stents enter the market,

GlobalData estimates the US Bioabsorbable Stent

market in 2013 to be $0.35m and is expected to increase

to $319m by 2018. The coronary bioabsorbable stent

market is expected to have a larger market share than

the peripheral bioabsorbable stent market, with the stent

sales in the coronary market expected to be 10 times that

of the peripheral market.

The key drivers for the market in the forecast period are:

The rising prevalence of coronary and peripheral

artery disease in the major markets covered in this

report.

The need for effective therapies that reduce the risk

of complications such as restenosis and thrombosis

associated with current drug-eluting and bare metal

stents.

The cost-savings for healthcare payers resulting from

reducing the need for repeat revascularization

procedures.

FDA approval and launch of Absorb BVS and

Remedy in the US.

The launch of pipeline fully bioabsorbable stent

products such as the DREAMS stent developed by

Biotronik.

Executive Summary

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Companies Working to Get Their Stents Approved in the Bioabsorbable Stent Market

Bioabsorbable stent technology is in its infancy and has a

long road ahead before it is widely adopted into clinical

practice. This technology has the potential to

revolutionize the stent industry and improve treatment

outcomes for patients with coronary and peripheral artery

disease.

Currently, Germany is leading the way with

bioabsorbable stenting and has the largest market share

in Europe. However, the US will acquire market share

steadily as bioabsorbable stents receive approval.

Companies such as Biotronik and REVA Medical are also

developing fully bioabsorbable stents that will increase

the competition in the market. As these stents enter the

market, they will affect the current selling price and the

market share of Absorb BVS and Remedy.

Unmet Needs Remain a Challenge

Stent technology has evolved over the years to address

the challenges of treating patients with coronary and

peripheral artery disease. Although stents such as drug-

eluting stents improve patient prognosis compared to

invasive cardiac surgeries, there still remain several

unmet needs and limitations with current therapies.

Complications such as restenosis and thrombosis remain

a concern. Effective therapies need to be developed to

reduce the number of stent-in-stent procedures that are

performed, where additional permanent stents are

implanted into patients. Additionally, physicians have

called for other treatment improvements such as

reducing or eliminating the need for dual anti-platelet

therapy that is administered when implanting bare metal

and drug-eluting stents.

A fully degradable and absorbable stent can lower the

risk of restenosis and thrombosis and ensure quality

long-term results for the patient.

Key Players in the Bioabsorbable Stent Market

Currently, the key players in the bioabsorbable stent

market are Abbott Vascular and Kyoto Medical Planning.

Abbott Vascular received CE approval for its Absorb BVS

for coronary artery disease, which is available for sale in

Europe, the Middle East, and parts of Asia-Pacific and

Latin America.

Kyoto Medical Planning received CE approval for its

Remedy stent, which is used to treat peripheral artery

disease and is available for sale in Europe and the

Middle East. These stents have yet to receive FDA

approval for use in the United States.

In the next few years as competitors such as Biotronik

enter the market, GlobalData believes that Abbott

Vascular and Kyoto Medical Planning will see a decrease

in market share of their bioabsorbable stent products.

Bioabsorbable Stents Future Outlook

Bioabsorbable stents provide temporary scaffolding to

the vessel and then disappear over time, leaving behind

a healed artery.

Although bioabsorbable stents offer several advantages,

adoption of this technology will be slow in the US. The

slow adoption can be attributed to the lack of long-term

clinical data and appropriate reimbursement rates and

high selling prices.

Executive Summary

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Although the prevalence of peripheral artery disease is

high in the US, the market share of the peripheral market

is 10 times lower than that of the coronary market. The

low market share can be attributed to lack of data

demonstrating clinical effectiveness of stents such as

drug-eluting stents for different peripheral lesions.

GlobalData believes that the US bioabsorbable stent

market will steadily grow in the future as long-term

clinical data becomes available, appropriate

reimbursement guidelines are implemented and the

selling price decreases.

What do Physicians Think?

Physicians are cautiously optimistic and

acknowledge the benefits of bioabsorbable stents.

“I think bioabsorbable stents are a very exciting

technology. The benefit of having a biodegradable stent

is that if and when it fails, you can go back and do it

again.”

Key Opinion Leader, November 2012

Physicians want to see long-term clinical data to

evaluate the clinical effectiveness of bioabsorbable

stents.

“Adoption of bioabsorbable stents depends on the clinical

data. If it is shown to be cost-effective, then I would

probably use it in 100% of my patients.”

Key Opinion Leader, October 2012

“There will be some adoption. We still need to wait for

strong clinical data. We cannot replace drug-eluting and

bare metal stents that have thousands and thousands of

patients followed over five or 10 years.”

Key Opinion Leader, October 2012

The high selling price of bioabsorbable stents

currently in the market will hinder widespread

adoption.

“If the costs continue to be four times the cost of drug-

eluting stents, I cannot think of a hospital that can afford

that.”

Key Opinion Leader, October 2012

Bioabsorbable stents can potentially change the

treatment paradigm for coronary artery disease.

“It is very possible for bioabsorbable stents to change the

treatment paradigm. However, it is a long way to go for

bioabsorbable stents. They are at the very, very

beginning.”

Key Opinion Leader, October 2012

Table of Contents

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1 Table of Contents

1 Table of Contents ...............................................................................................................5

1.1 List of Tables.............................................................................................................11

1.2 List of Figures ...........................................................................................................14

2 Introduction.......................................................................................................................16

2.1 Catalyst.....................................................................................................................16

2.2 Related Reports ........................................................................................................17

3 Disease Overview.............................................................................................................18

3.1 Coronary Artery Disease ...........................................................................................18

3.2 Peripheral Artery Disease..........................................................................................18

3.3 Anatomy and Physiology ...........................................................................................18

3.4 Pathophysiology........................................................................................................20

3.4.1 Coronary Artery Disease .....................................................................................20

3.4.2 Peripheral Artery Disease ...................................................................................21

3.5 Clinical Presentation..................................................................................................22

3.5.1 Symptoms of Coronary Artery Disease (NHLBI, 2011c).......................................22

3.5.2 Symptoms of Peripheral Artery Disease (Stoppler, 2012) ....................................23

3.5.3 Risk Factors........................................................................................................24

3.5.4 Disease Segments..............................................................................................25

3.5.5 Diagnosis............................................................................................................26

3.6 Clinical Outcomes .....................................................................................................28

3.6.1 Treatment Paradigm ...........................................................................................28

3.6.2 Treatment Modalities...........................................................................................28

3.6.3 Coronary/Peripheral Artery Bypass Grafting ........................................................32

3.6.4 Interventional Cardiology.....................................................................................33

3.7 Epidemiology ............................................................................................................37

3.7.1 Coronary Artery Disease .....................................................................................37

3.7.2 Peripheral Artery Disease ...................................................................................39

Table of Contents

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3.8 Economic Impact.......................................................................................................40

3.8.1 Coronary Artery Disease .....................................................................................40

3.8.2 Peripheral Artery Disease ...................................................................................42

3.8.3 Treatment Costs .................................................................................................43

4 Competitive Assessment...................................................................................................44

4.1 Overview...................................................................................................................44

4.2 Absorb BVS - Abbott Vascular...................................................................................45

4.2.1 Efficacy...............................................................................................................46

4.2.2 SWOT Analysis...................................................................................................47

4.3 Remedy - Kyoto Medical Planning.............................................................................48

4.3.1 Efficacy...............................................................................................................48

4.3.2 SWOT Analysis...................................................................................................49

5 Unmet Needs....................................................................................................................50

5.1 Biodegradable and Bioabsorbable Stents ..................................................................50

5.2 Reduce Risk of Complications...................................................................................51

5.3 Reduce the Need for Stent-in-Stent Procedures ........................................................53

5.4 Long-Term Clinical Data............................................................................................54

5.5 Stent Fracture ...........................................................................................................55

5.6 Dual Anti-Platelet Therapy.........................................................................................55

5.7 Imaging.....................................................................................................................55

6 Pipeline Products..............................................................................................................56

6.1 Overview...................................................................................................................56

6.2 Pipeline by Phases in Development - Coronary Artery Disease..................................56

6.3 Pipeline Product Profiles - Coronary Artery Disease ..................................................58

6.3.1 Igaki-Tamai Stent................................................................................................58

6.3.2 ReZolve Sirolimus Eluting Bioabsorbable Coronary Scaffold ...............................59

6.3.3 Drug-Eluting Absorbable Metal Scaffold ..............................................................60

6.3.4 Absorbable Metal Stents .....................................................................................61

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6.3.5 DESolve Bioabsorbable Coronary Scaffold System .............................................62

6.3.6 ART Stent ...........................................................................................................63

6.3.7 The OrbusNeich Stent.........................................................................................63

6.3.8 TephaFLEX Absorbable Stent .............................................................................63

6.3.9 The Arterius Stent ...............................................................................................63

6.3.10 Zorion Medical Stent ...........................................................................................64

6.3.11 3V Avatar............................................................................................................64

6.3.12 Biosorb ...............................................................................................................64

6.3.13 Summary ............................................................................................................65

6.4 Pipeline by Phases in Development - Peripheral Artery Disease ................................65

6.5 Pipeline Product Profiles- Peripheral Artery Disease..................................................67

6.5.1 Magic Explorer Stent...........................................................................................67

6.5.2 Esprit Bioabsorbable Vascular Scaffold ...............................................................68

6.5.3 ART Stent ...........................................................................................................69

6.5.4 TephaFLEX Absorbable Peripheral Stent ............................................................69

6.5.5 Zorion Medical Stent ...........................................................................................69

6.5.6 Amaranth Medical Stent ......................................................................................70

6.5.7 Summary ............................................................................................................70

6.6 Clinical Trial Analysis ................................................................................................71

6.6.1 Overview.............................................................................................................71

6.6.2 Trials to Watch....................................................................................................71

7 Industry Overview.............................................................................................................74

7.1 Procedure Trends......................................................................................................74

7.1.1 Factors Contributing to Rise of Coronary and Peripheral Interventions.................74

7.1.2 Coronary Artery Disease .....................................................................................75

7.1.3 Peripheral Artery Disease ...................................................................................76

7.2 Market Access...........................................................................................................78

7.2.1 United States ......................................................................................................79

Table of Contents

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7.3 Reimbursement Trends.............................................................................................81

7.3.1 United States ......................................................................................................82

7.4 Regulatory Issues/Recalls .........................................................................................85

8 Current and Future Players...............................................................................................86

8.1 Overview...................................................................................................................86

8.2 Trends in Corporate Strategy.....................................................................................86

8.3 Company Profiles......................................................................................................87

8.3.1 Abbott Vascular...................................................................................................87

8.3.2 Kyoto Medical Planning Co., Ltd..........................................................................89

8.3.3 Biotronik SE & Co. KG ........................................................................................92

8.3.4 REVA Medical, Inc. .............................................................................................94

8.3.5 Elixir Medical Corporation ...................................................................................96

8.3.6 Arterial Remodeling Technologies.......................................................................97

8.3.7 Tepha, Inc...........................................................................................................99

8.3.8 OrbusNeich.......................................................................................................100

8.3.9 Arterius .............................................................................................................102

8.3.10 Zorion Medical ..................................................................................................103

8.3.11 S3V Vascular Technologies ..............................................................................104

8.3.12 ICON Interventional Systems ............................................................................105

8.3.13 Amaranth Medical ............................................................................................. 106

8.3.14 Medlogics Device Corporation...........................................................................107

9 Market Drivers, Opportunities and Barriers......................................................................108

9.1 Market Drivers.........................................................................................................108

9.1.1 Rising Prevalence of Disease............................................................................108

9.1.2 Avoid Stent-in-Stent Procedures .......................................................................109

9.1.3 Reduce/Eliminate Dual Anti-Platelet Therapy ....................................................110

9.1.4 Availability of Long-Term Data...........................................................................110

9.1.5 Treatment Cost Considerations .........................................................................111

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9.1.6 Accurate Stent Placement.................................................................................111

9.1.7 Expected Launch of Bioabsorbable Stents in the US .........................................111

9.2 Opportunities...........................................................................................................112

9.2.1 Bioabsorbable Stent Market Segmentation........................................................ 112

9.2.2 Expand Indications of Bioabsorbable Stenting...................................................113

9.2.3 Target High-Risk Patients .................................................................................114

9.2.4 Improve Deliverability of Bioabsorbable Stents ..................................................114

9.2.5 Emerging Markets............................................................................................. 114

9.3 Market Barriers........................................................................................................115

9.3.1 Slow Adoption...................................................................................................115

9.3.2 Complications with Bioabsorbable Stents .......................................................... 115

9.3.3 High Selling Price.............................................................................................. 116

9.3.4 Reimbursement.................................................................................................116

9.3.5 Substitutes........................................................................................................117

10 Country Outlooks and Forecasts .....................................................................................119

10.1 US Market Overview ............................................................................................... 119

10.2 United States ..........................................................................................................119

10.2.1 Overview...........................................................................................................119

10.2.2 Market Analysis.................................................................................................119

11 Appendix ........................................................................................................................ 122

11.1 Bibliography ............................................................................................................122

11.2 Abbreviations ..........................................................................................................135

11.3 Report Methodology................................................................................................ 137

11.3.1 Overview...........................................................................................................137

11.3.2 Coverage..........................................................................................................137

11.3.3 Secondary Research......................................................................................... 138

11.3.4 Forecasting Methodology..................................................................................138

11.4 Physicians and Specialists Included in this Study ....................................................140

Table of Contents

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11.5 Physician Survey.....................................................................................................141

11.6 About the Authors ...................................................................................................142

11.6.1 Analysts............................................................................................................142

11.6.2 Global Head of Healthcare ................................................................................143

11.7 About MediPoint......................................................................................................143

11.8 About GlobalData....................................................................................................144

11.9 Contact Us ..............................................................................................................144

11.10 Disclaimer.........................................................................................................144

Table of Contents

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1.1 List of Tables

Table 1: Risk Factors Associated with Coronary Artery Disease ...........................................24

Table 2: Risk Factors Associated with Peripheral Artery Disease..........................................24

Table 3: Types of Coronary Artery Bypass Grafting ..............................................................32

Table 4: Drugs Incorporated into Drug-Eluting Stents ...........................................................35

Table 5: Prevalence of CAD in ≥65 population in the US, millions .........................................37

Table 6: Prevalence of PAD Among ≥65 Population in the US, millions.................................39

Table 7: Description of Direct and Indirect Economic Costs ..................................................40

Table 8: Economic Impact ($bn) of CAD in the US................................................................41

Table 9: Economic Impact ($bn) of PAD in the US*...............................................................42

Table 10: US Hospital Charges for Interventional Cardiology Procedures ...............................43

Table 11: Marketed Bioabsorbable Stent Products .................................................................44

Table 12: Absorb BVS Product Portfolio .................................................................................45

Table 13: Absorb BVS SWOT Analysis, 2012.........................................................................47

Table 14: Remedy Stent Product Portfolio ..............................................................................48

Table 15: Remedy SWOT Analysis, 2012...............................................................................49

Table 16: BAS Product Pipeline (Coronary) ............................................................................57

Table 17: Igaki-Tamai Stent SWOT Analysis, 2012.................................................................58

Table 18: ReZolve Stent SWOT Analysis, 2012......................................................................60

Table 19: DREAMS SWOT Analysis, 2012.............................................................................60

Table 20: AMS SWOT Analysis, 2012 ....................................................................................62

Table 21: BAS Product Pipeline (Peripheral) ..........................................................................66

Table 22: Magic Explorer Stent SWOT Analysis, 2012............................................................67

Table 23: Esprit BVS SWOT Analysis, 2012 ...........................................................................69

Table 24: Medicare National Average of Inpatient Hospital Payment for Cardiology Procedures,

2011-2012 ..............................................................................................................82

Table 25: Company Profile - Abbott Vascular..........................................................................87

Table 26: Marketed Bioabsorbable Stent Products by Abbott Vascular ...................................87

Table 27: Pipeline Bioabsorbable Stent Products by Abbott Vascular .....................................88

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Table 28: Abbott Vascular SWOT Analysis, 2012 ...................................................................88

Table 29: Company Profile - Kyoto Medical Planning..............................................................89

Table 30: Marketed Bioabsorbable Stent Products by Kyoto Medical Planning........................91

Table 31: Pipeline Bioabsorbable Stent Products by Kyoto Medical Planning..........................91

Table 32: Kyoto Medical Planning SWOT Analysis, 2012........................................................91

Table 33: Company Profile - Biotronik.....................................................................................92

Table 34: Pipeline Bioabsorbable Stent Products by Biotronik ................................................93

Table 35: Biotronik SWOT Analysis, 2012 ..............................................................................93

Table 36: Company Profile - REVA Medical............................................................................94

Table 37: Pipeline Bioabsorbable Stent Products by REVA Medical........................................95

Table 38: REVA Medical SWOT Analysis, 2012 .....................................................................95

Table 39: Company Profile - Elixir Medical Corporation ..........................................................96

Table 40: Pipeline Bioabsorbable Stent Products by Elixir Medical Corporation ......................96

Table 41: Elixir Medical Corporation SWOT Analysis, 2012 ....................................................97

Table 42: Company Profile - Arterial Remodeling Technologies..............................................97

Table 43: Pipeline Bioabsorbable Stent Products by Arterial Remodeling Technologies..........98

Table 44: Arterial Remodeling Technologies SWOT Analysis, 2012........................................98

Table 45: Company Profile - Tepha ........................................................................................99

Table 46: Pipeline Stent Products by Tepha ...........................................................................99

Table 47: Tepha SWOT Analysis, 2012 ................................................................................100

Table 48: Company Profile - OrbusNeich..............................................................................100

Table 49: Pipeline Bioabsorbable Stent Products by OrbusNeich..........................................101

Table 50: OrbusNeich SWOT Analysis, 2012........................................................................101

Table 51: Company Profile - Arterius ....................................................................................102

Table 52: Arterius SWOT Analysis, 2012..............................................................................102

Table 53: Company Profile - Zorion Medical .........................................................................103

Table 54: Zorion Medical SWOT Analysis, 2012 ...................................................................103

Table 55: Company Profile - S3V Vascular Technologies .....................................................104

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Table 56: S3V Vascular Technologies SWOT Analysis, 2012 ...............................................104

Table 57: Company Profile - ICON Interventional Systems ...................................................105

Table 58: ICON Interventional Systems SWOT Analysis, 2012 .............................................105

Table 59: Company Profile - Amaranth Medical ....................................................................106

Table 60: Amaranth Medical SWOT Analysis, 2012.............................................................. 106

Table 61: Company Profile - Medlogics Device Corporation..................................................107

Table 62: Medlogics Device Corporation SWOT Analysis, 2012............................................107

Table 63: Bioabsorbable Stent Sales ($m) Forecast for the United States, 2011-2018 ..........120

Table 64: Physicians Surveyed, By Country .........................................................................141

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1.2 List of Figures

Figure 1: Anatomy of the Human Heart................................................................................19

Figure 2: Pathophysiology of Coronary Artery Disease ........................................................20

Figure 3: Pathophysiology of Peripheral Artery Disease.......................................................21

Figure 4: Treatment Modalities - Coronary Artery Disease ...................................................29

Figure 5: Interventional Cardiology Procedures for Treating CAD, US and Europe, 2012 .....30

Figure 6: Treatment Modalities - Peripheral Artery Disease..................................................30

Figure 7: Interventional Cardiology for Treating PAD, US and Europe, 2012 ........................31

Figure 8: Types of Stents.....................................................................................................34

Figure 9: Prevalence of CAD in Population ≥65 Years in the US ..........................................37

Figure 10: Percent of Patients (≥65 years) Treated for CAD, US and Europe .........................38

Figure 11: Prevalence of PAD in Population ≥65 Years in the US ..........................................39

Figure 12: Direct and Indirect Costs ($bn) of CAD in the US ..................................................41

Figure 13: Total Costs ($bn) of PAD in the US.......................................................................42

Figure 14: US Hospital Charges for Interventional Procedures, 2011-2018 ............................43

Figure 15: Importance of a Biodegradable and Absorbable Stent to Physicians in the US

(n=20) ..................................................................................................................50

Figure 16: Percent of Patients with CAD Patients Experiencing Complications after Drug-

Eluting Stenting, 2012 (n=10)................................................................................51

Figure 17: Percent of Patients with PAD Patients Experiencing Complications after Drug-

Eluting Stenting, 2012 (n=10)................................................................................52

Figure 18: Percent of Patients (≥ 65 years) with CAD Receiving Stent-in-Stent Procedures,

2012 (n=10)..........................................................................................................53

Figure 19: BAS Coronary Pipeline by Stage in Clinical Development, 2012 ............................56

Figure 20: BAS Peripheral Pipeline by Stage in Clinical Development, 2012...........................65

Figure 21: Population (≥ 65 years) of CAD Patients Receiving Interventional Procedures in the

US........................................................................................................................75

Figure 22: Population (≥ 65 years) of PAD Patients Receiving Interventional Procedures in the

US........................................................................................................................77

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Figure 23: Likelihood of Physicians Adopting Bioabsorbable Stents in the United States, 2012

(n=20) ..................................................................................................................78

Figure 24: Medicare National Average of Outpatient Hospitalization Payment for Interventional

Cardiology Procedures, 2011-2012.......................................................................83

Figure 25: National Medicare Average Payment for Drug-Eluting Stent Procedures for the

Following Years....................................................................................................84

Figure 26: Kyoto Medical Planning Co., Ltd. Sales Volume ($m), May 2002-May 2012 ..........90

Figure 27: US Bioabsorbable Stent Market ($m), 2011-2018 ...............................................120

Introduction

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2 Introduction

Coronary artery disease and peripheral artery disease are global public health and socioeconomic

issues that affect millions of lives each year. Bioabsorbable stents, which provide transient support

to the vessel, are viable alternatives to permanent drug-eluting and bare metal stent implants. In

the report, bioabsorbable stents are defined as fully biodegradable stents that completely

disappear from the vessel overtime. Stents such as BioMatrix Flex by Biosensors International and

Synergy by Boston Scientific are not included in the report because they are drug-eluting stents

with bioabsorbable polymer coatings. Absorption of the bioabsorbable polymer coating still leaves

behind a permanent bare metal stent inside the vessel.

This report focuses on the bioabsorbable stent market in the US. The global stent and

bioabsorbable stent markets are determined for six countries, including the US, France, Germany,

Italy, Spain and the UK. This report identifies the unmet needs in the market, provides an

understanding of physician perception of bioabsorbable stents, and evaluates its adoption in the

future. Through GlobalData’s analysis, it is evident that although there will be early adopters in the

US, widespread adoption of bioabsorbable stents will be slow. Large-scale, long-term studies need

to be conducted to demonstrate clinical efficacy, and new stent technologies need to be integrated

appropriately into the existing reimbursement system in the US. To successfully market

bioabsorbable stents, companies need to design novel stent platforms that address the current

unmet needs of conventional drug-eluting and bare metal stents and show superior clinical

performance to the stents currently in the market.

2.1 Catalyst

Bioabsorbable stents offer a novel treatment solution for patients with coronary artery disease and

peripheral artery disease. They represent the future of stents, as they address the unmet needs of

the current stent market. As more long-term clinical data is available demonstrating its superior

therapeutic benefits, adoption of bioabsorbable stents by the medical community will increase in

the future. As coronary artery disease and peripheral artery disease present enormous global

public health and socioeconomic issues, it is pertinent to find effective treatment modalities that

ensure long-term quality results for patients. This report will evaluate the adoption of bioabsorbable

stents in the US and identify the opportunities for this technology in the future.

Introduction

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2.2 Related Reports

Transcatheter Arotic Valve Replacement - Market Analysis and Forecasts

GDME0165MAR / Published November 2012

Appendix

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11.8 About GlobalData

GlobalData is a leading global provider of business intelligence in the Healthcare industry.

GlobalData provides its clients with up-to-date information and analysis on the latest developments

in drug research, disease analysis, and clinical research and development. Our integrated business

intelligence solutions include a range of interactive online databases, analytical tools, reports and

forecasts. Our analysis is supported by a 24/7 client support and analyst team. GlobalData has

offices in New York, Boston, London, India and Singapore.

11.10 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any

form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior

permission of the publisher, GlobalData.