Osteoporosis India Drug Forecast and Market Analysis to 2022

Reference Code: GDHC1054CFR

Publication Date: February 2013

Executive Summary

Sales for Osteoporosis in India The figure below illustrates the osteoporosis sales by drug class in India during the forecast period. The Indian osteoporosis drug market was valued at

approximately $437m in 2012, and is forecast to recede Sales for Osteoporosis Drugs in India by Drug Class, 2012–2022 to $433m at a negative CAGR of 0.1% by 2022 .

2% 2012 Major drivers of market growth over this forecast period Total: $437m 20% will include:

Bisphosphonates  Increased investment in healthcare and facility 43% SERMs accessibility nationwide (rural and urban) PTH Strontium Calcitonin Major barriers to the growth of the osteoporosis market will include: 31% 4%  Loose IP laws and guidelines 2022 3% Total: $433m  Price-cutting practices 17%

Bisphosphonates 42% SERMs PTH Strontium Calcitonin

35% 3%

Source: GlobalData

Executive Summary

What Do the Physicians Think? “The NOG guidelines that are in place in the UK and that are being implemented for harmonization throughout “[The] [b]iggest need right now is that patients just don’t Europe gives you a differing percentage based upon the want to take our drugs. And we live in this environment age of the individual, so that younger people get treated that’s just becoming increasingly poisonous as far as at lower 10-year risk and older people get treated at patient perception [is concerned]. I think the WHO has higher 10-year risk.” done a fairly nice job with the FRAX calculator. Is it perfect? No. You still need clinical judgment, but that’s Key opinion leader, September 2012 what doctors are doing. We need some way to convey “The parathyroid hormone will only be used, or it should risk as well.” be used, in the population once the patent has expired, Key opinion leader, September 2012 and demosumab will have an important part of the market over the next five years, unless [reimbursement] “We are in dire need of new medications, and more limitations are put in some countries.” anabolic therapies have just immense potential. If you have a bone anabolic agent that doesn’t carry the black Key opinion leader, September 2012 box warning of osteosarcoma, that would be a really

good thing.”

Key opinion leader, September 2012

Table of Contents

1 Table of Contents

1 Table of Contents ...... 4

1.1 List of Tables ...... 7

1.2 List of Figures ...... 9

2 Introduction ...... 10

2.1 Catalyst ...... 10

2.2 Related Reports ...... 10

2.3 Upcoming Related Reports ...... 12

3 Disease Overview ...... 13

3.1 Etiology and Pathophysiology ...... 13

3.1.1 Etiology ...... 13

3.1.2 Pathophysiology...... 16

3.1.3 Risk Factors ...... 17

3.1.4 Quality of Life ...... 17

3.2 Symptoms ...... 18

4 Disease Management ...... 19

4.1 Treatment Overview ...... 19

4.1.1 Diagnosis and Referral ...... 19

4.1.2 Treatment Guidelines ...... 20

4.1.3 Disease Management ...... 21

4.2 India ...... 25

4.2.1 Diagnosis ...... 25

4.2.2 Clinical Practice ...... 25

5 Competitive Assessment ...... 26

5.1 Overview ...... 26

5.2 Strategic Competitor Assessment ...... 26

5.3 Product Profiles – Major Brands ...... 30

5.3.1 Actonel (risedronate sodium) ...... 30

Table of Contents

5.3.2 Evista (raloxifene hydrochloride) ...... 33

5.3.3 Reclast (zolendronic acid) ...... 36

5.3.4 Forteo (teriparatide) ...... 40

5.3.5 Prolia (denosumab) ...... 44

5.3.6 Protelos (strontium ranelate) ...... 47

5.3.7 Miacalcin and Fortical (calcitonin-salmon) ...... 50

5.3.8 Viviant/Conbriza (bazedoxifene) ...... 54

5.3.9 Recalbon/Bonoteo (minodronic acid hydrate) ...... 56

5.3.10 Alendronate sodium ...... 59

5.3.11 Ibandronate...... 60

6 Opportunity and Unmet Need ...... 62

6.1 Overview ...... 62

6.2 Unmet Needs ...... 62

6.2.1 Disease Awareness and Early Diagnosis...... 63

6.2.2 Patient Compliance ...... 63

6.2.3 Efficacy ...... 64

6.2.4 Safety ...... 65

6.2.5 Treatment Cost ...... 66

6.2.6 Earlier Intervention ...... 66

6.3 Unmet Needs Gap Analysis ...... 67

6.4 Opportunity 1: Dual-Action Therapies ...... 69

6.5 Opportunity 2: Osteoporosis Prevention Therapies ...... 70

6.6 Opportunity 3: Dosing and Administration ...... 71

7 Pipeline Assessment...... 72

7.1 Overview ...... 72

7.2 Promising Drugs in Clinical Development ...... 73

7.2.1 Aprela (bazedoxifene and conjugated estrogens) ...... 74

7.2.2 Romosozumab (AMG-785)...... 81

Table of Contents

7.2.3 Odanacatib ...... 87

7.2.4 BA-058 ...... 92

7.2.5 PTH(1-31)NH2...... 96

7.2.6 Ostora (recombinant salmon calcitonin) ...... 100

8 Market Outlook ...... 106

8.1 India ...... 106

8.1.1 Forecast...... 106

8.1.2 Key Events ...... 108

8.1.3 Divers and Barriers ...... 109

9 Appendix ...... 111

9.1 Bibliography ...... 111

9.2 Abbreviations ...... 118

9.3 Methodology ...... 120

9.4 Forecasting Methodology ...... 121

9.4.1 Diagnosed Osteoporosis Patients...... 121

9.4.2 Percent Drug-Treated Patients ...... 121

9.4.3 Drugs Included in Each Therapeutic Class ...... 122

9.4.4 General Pricing Assumptions ...... 122

9.4.5 Individual Drug Assumptions ...... 122

9.4.6 Generic Erosion ...... 126

9.4.7 Pricing of Pipeline Agents ...... 127

9.5 Physicians and Specialists Included in this Study ...... 128

9.5.1 About the Authors ...... 129

9.5.2 Global Head of Healthcare ...... 130

9.6 About GlobalData ...... 131

9.7 Contact Us ...... 131

9.8 Disclaimer ...... 131

Table of Contents

1.1 List of Tables

Table 1: Etiology of Primary Osteoporosis ...... 13

Table 2: Etiology of Secondary Osteoporosis ...... 15

Table 3: Symptoms of Osteoporosis ...... 18

Table 4: Diagnostic Tests for Osteoporosis ...... 19

Table 5: T-Score Ranges for Determination of BMD ...... 20

Table 6: Treatment Guidelines for Osteoporosis ...... 21

Table 7: Most Prescribed Drugs for Osteoporosis by Therapeutic Class in the Global Markets, 2012 ...... 23

Table 8: Leading Treatments for Osteoporosis, 2012 ...... 29

Table 9: Product Profile – Actonel...... 31

Table 10: Actonel SWOT Analysis, 2012 ...... 32

Table 11: Product Profile – Evista ...... 34

Table 12: Evista SWOT Analysis, 2012 ...... 35

Table 13: Product Profile – Reclast ...... 38

Table 14: Reclast SWOT Analysis, 2012 ...... 39

Table 15: Product Profile – Forteo ...... 41

Table 16: Mean Percent Change from Baseline in BMD with Forteo vs. Placebo in Postmenopausal Women with Osteoporosis ...... 42

Table 17: Forteo SWOT Analysis, 2012 ...... 43

Table 18: Product Profile – Prolia ...... 44

Table 19: Prolia SWOT Analysis, 2012...... 46

Table 20: Product Profile – Protelos ...... 47

Table 21: Protelos SWOT Analysis, 2012 ...... 48

Table 22: Product Profile – Miacalcin and Fortical Nasal Spray ...... 51

Table 23: Adverse Events with Miacalcin Nasal Spray ...... 52

Table 24: Miacalcin and Fortical Nasal Spray SWOT Analysis, 2012 ...... 53

Table 25: Product Profile – Viviant/Conbriza ...... 54

Table 26: Viviant/Conbriza SWOT Analysis, 2012 ...... 55

Table of Contents

Table 27: Product Profile – Recalbon/Bonoteo ...... 57

Table 28: Recalbon/Bonoteo SWOT Analysis, 2012 ...... 58

Table 29: Overall Unmet Needs – Current Level of Attainment ...... 62

Table 30: Clinical Unmet Needs – Gap Analysis, 2012 ...... 68

Table 31: Osteoporosis – Pipeline, 2012 ...... 73

Table 32: Comparison of Therapeutic Classes in Development for Osteoporosis, 2012 ...... 73

Table 33: Product Profile – Aprela ...... 76

Table 34: Aprela SWOT Analysis, 2012 ...... 80

Table 35: Product Profile – Romosozumab ...... 82

Table 36: Romosozumab SWOT Analysis, 2012 ...... 86

Table 37: Product Profile – Odanacatib ...... 87

Table 38: Odanacatib SWOT Analysis, 2012 ...... 91

Table 39: Product Profile – BA-058 ...... 92

Table 40: BA-058 SWOT Analysis, 2012 ...... 95

Table 41: Product Profile – PTH(1-31)NH2 ...... 97

Table 42: PTH(1-31)NH2 SWOT Analysis, 2012 ...... 99

Table 43: Product Profile – Ostora ...... 102

Table 44: Ostora SWOT Analysis, 2012 ...... 104

Table 45: India Sales Forecasts ($m) for Osteoporosis, 2012-2022 ...... 107

Table 46: Key Events Impacting Sales for Osteoporosis in India, 2012–2022 ...... 108

Table 47: Osteoporosis Market – Drivers and Barriers in India, 2012–2022 ...... 109

Table 48: Number of High-Prescribing Physicians Surveyed ...... 128

Table of Contents

1.2 List of Figures

Figure 1: Company Portfolio Gap Analysis in Osteoporosis, 2012–2022 ...... 74

Figure 2: Sales for Osteoporosis Drugs in India by Drug Class, 2012–2022 ...... 108

Introduction

2 Introduction

2.1 Catalyst

Despite its maturity, the osteoporosis market is expected to undergo substantial change between 2012 and 2022. Most importantly, the “gold-standard” bisphosphonates will lose patent protection by the end of 2013, which will result in flooding of the marketplace with less expensive generic versions of these physician- preferred medications. In addition, Eli Lilly’s blockbuster Evista (raloxifene), the only available selective estrogen receptor modulator (SERM) in the US, will lose patent protection in 2014, which will result in flooding of the market with yet more affordable generic options. Also, during the forecast period covered by this report, osteoporosis drug development research will lead to the launches of a wave of novel anabolic drugs with greater efficacy and safety, causing a major market shift away from antiresorptive drugs. The number of companies vying for patient share will shrink by as much as 50%, as established players exit the market or acquire smaller players. Lastly, the aging of the population in developed markets will result in a larger patient pool.

These changes in the osteoporosis market will be reflected in the slow market growth during the forecast period, increasing from $6 billion to $8 billion in 2012 at a Compound Annual Growth Rate (CAGR) of 3%.

2.2 Related Reports

 GlobalData Healthcare Policy Analysis 2012 – Regulatory, Pricing, and Reimbursement, July 2012, GDH001HPM.

 GlobalData (2013). Osteoporosis – United States Drug Forecast and Market Analysis to 2022. GDHC1047CFR.

 GlobalData (2013). Osteoporosis – United Kingdom Drug Forecast and Market Analysis to 2022. GDHC1052CFR.

 GlobalData (2013). Osteoporosis – France Drug Forecast and Market Analysis to 2022. GDHC1048CFR.

 GlobalData (2013). Osteoporosis – Germany Drug Forecast and Market Analysis to 2022. GDHC1049CFR.

Introduction

 GlobalData (2013). Osteoporosis – Italy Drug Forecast and Market Analysis to 2022. GDHC1050CFR.

 GlobalData (2013). Osteoporosis – Spain Drug Forecast and Market Analysis to 2022. GDHC1051CFR.

 GlobalData (2013). Osteoporosis – Japan Drug Forecast and Market Analysis to 2022. GDHC1053CFR.

 GlobalData (2013). Osteoporosis – China Drug Forecast and Market Analysis to 2022. GDHC1055CFR.

 GlobalData (2013). Actonel (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1073DFR.

 GlobalData (2013). Evista (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1074DFR.

 GlobalData (2013). Reclast (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1075DFR.

 GlobalData (2013). Forteo (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1076DFR.

 GlobalData (2013). Prolia (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1077DFR.

 GlobalData (2013). Protelos (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1078DFR.

 GlobalData (2013). Viviant/Conbriza (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1079DFR.

 GlobalData (2013). Recalbon/Bonoteo (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1080DFR.

 GlobalData (2013). Aprela (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1081DFR.

 GlobalData (2013). Romosozumab (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1082DFR.

 GlobalData (2013). Odanacatib (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1083DFR.

 GlobalData (2013). BA-058 (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1084DFR.

Introduction

 GlobalData (2013). PTH(1-31)N2 (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1085DFR.

 GlobalData (2013). Ostora (Osteoporosis) – Forecast and Market Analysis to 2022. GDHC1086DFR.

 GlobalData (2013). Osteoporosis – Current and Future Players. GDHC1006FPR.

Appendix

9.6 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.

9.8 Disclaimer

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.