gbihc248mr women’s health therapeutics market to 2018 … · women’s health therapeutics market...

Women’s Health Therapeutics Market to 2018 Unmet Need for Safe and Effective Treatments due to Unfavorable Risk/Benefit Profile Associated with Hormone Replacement Therapy

GBI Research Report Guidance

GBIHC248MR / Published NOV 2012

© GBI Research. This is a licensed product and is not to be photocopied

GBI Research Report Guidance The objective of updating GBI Research’s coverage is to ensure that it represents the most up-to-date vision of the industry possible. Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources. This report covers menopausal hormone replacement therapy, postmenopausal osteoporosis, endometriosis, infertility and female contraceptives in the seven major geographies, namely the US, the UK, Spain, Germany, Italy, France and Japan.

Chapter three details the market characterization of the global women’s health therapeutics market. Market characterization includes market size (2003-2018), generic share (2011), revenue analysis for the top seven countries (2004-2018), Annual Cost of Treatment (ACT) (2004-2018), and treatment usage patterns (2004-2018).

Chapter four includes the geographical landscape of the women’s health therapeutics market in the major regions: the US, the top five countries of Europe (the UK, Germany, France, Italy and Spain), and Japan.

Chapter five deals with therapeutic landscape for menopausal hormone replacement therapy, postmenopausal osteoporosis, endometriosis, infertility, and female contraceptives. This section provides market forecasts and analysis, annual cost of treatment, treatment usage patterns and treatment flow algorithms for each respective indication. This chapter also includes a section on the profiles and market share of the major marketed drugs, along with market drivers and restraints for the various segments.

Chapter six covers the pipeline analysis of the women’s health therapeutics market (2010-2012). It also contains detailed analysis of key pipeline products and the most promising drugs.

Chapter seven includes profiles of the six major companies operating in the women’s health therapeutics market, detailing the major marketed drugs, sales, and SWOT analysis.

Chapter eight covers strategic consolidations relating to women’s health therapeutics, including mergers and acquisitions (M&A), licensing agreements and co-development deals.

GBIHC248MR / Published NOV 2012


Women’s Health Therapeutics Market to 2018 – Executive Summary

Women’s Health Therapeutics Market to 2018 - Executive Summary The Women’s Health Therapeutics Market is Expected to Grow at a Low Rate due to Patent Expires of Major Blockbuster Drugs

The patent expiries of blockbusters such as Evista, the Premarin family, Forteo, Mirena, Boniva, Actonel, Gonal-F and others during the forecast period are expected to slow down the market growth for the women’s health therapeutics market, while the launch of novel molecules like Elagolix and Odanacatib in the late stage pipeline will drive the market in the forecast period. Female contraceptives account for the largest market share in the women’s health market. The market is expected to grow at a low CAGR (Compound Annual Growth Rate) of XX% between 2011 and 2018.

Women’s Health Therapeutics Market, Global, Revenue Forecasts ($bn), 2003-2018

2003 2011 2018

Rev

enue

s ($

bn)

CAGR (2003-2011): XX%

CAGR (2011-2018): XX%

Source: GBI Research’s Proprietary Epidemiology and Market Size Database [May 29, 2012]; GBI Research’s Proprietary Diseases Database [May 29, 2012]

The Launch of Promising Molecules in the Pipeline will Spur Growth in the Female Sexual Dysfunction Therapeutics Market

The female sexual dysfunction therapeutics market currently does not have any FDA approved drugs that are comparable to Viagra for males. However, there are many promising molecules in the late stage development phase. There are XX drugs in the pipeline. Femprox by Apricus Bio, which is in Phase II stage of trials in the US, has already filed in Europe, Canada and Japan. Libigel by BioSante Pharmaceuticals, currently in the Phase III stage of clinical trials, is another promising molecule. Most of these drugs have demonstrated high safety and efficacy profiles in their clinical trials. There is significant unmet need associated with the current treatment options for female sexual dysfunction. If these new therapies can cater to these unmet needs, they can command a price premium, thus driving the market.

Patent expiries of blockbusters such as Evista, Forteo, Mirena, Boniva, Actonel and Gonal-F during the forecast period are expected to slow down the market growth

GBIHC248MR / Published NOV 2012 Page 5


Table of Contents

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

1.1 List of Tables................................................................................................................8 1.2 List of Figures.............................................................................................................11

2 Women’s Health Therapeutics Market to 2018 - Introduction ..........................................13 2.1 Overview ..................................................................................................................13

3 Women’s Health Therapeutics Market to 2018 - Market Overview ..................................14 3.1 Introduction..............................................................................................................14 3.2 Revenue Forecasts for the Women’s Health Therapeutics Market ........................15

3.2.1 Revenues...........................................................................................................15 3.2.2 Annual Cost of Therapy ....................................................................................16 3.2.3 Branded and Generic Market Share................................................................17

3.3 Treatment Usage Patterns .......................................................................................18 3.4 Drivers and Barriers for the Women’s Health Therapeutics Market ........................20

3.4.1 Drivers for the Women’s Health Therapeutics Market......................................20 3.4.2 Barriers for the Women’s Health Therapeutics Market.....................................20

4 Women’s Health Therapeutics Market to 2018 - Geographical Landscape ...................21 4.1 The US .......................................................................................................................21

4.1.1 Revenue............................................................................................................21 4.1.2 Annual Cost of Therapy ....................................................................................22 4.1.3 Treatment Usage Pattern..................................................................................23

4.2 Top Five Countries of Europe...................................................................................24 4.2.1 Revenue............................................................................................................24 4.2.2 Annual Cost of Therapy ....................................................................................26 4.2.3 Treatment Usage Pattern..................................................................................27

4.3 Japan.......................................................................................................................28 4.3.1 Revenue............................................................................................................28 4.3.2 Annual Cost of Therapy ....................................................................................29 4.3.3 Treatment Usage Pattern..................................................................................30

4.4 Women’s Health Therapeutics Market, Australia - Overview .................................31 4.4.1 Epidemiology ....................................................................................................31 4.4.2 Clinical Trials ......................................................................................................31 4.4.3 Drivers and Restraints ........................................................................................32

4.5 Women’s Health Therapeutics Market, India - Overview .......................................32 4.5.1 Epidemiology ....................................................................................................32 4.5.2 Clinical Trials ......................................................................................................33 4.5.3 Drivers and Restraints ........................................................................................33

4.6 Women’s Health Therapeutics Market, China - Overview .....................................34 4.6.1 Epidemiology ....................................................................................................34 4.6.2 Clinical Trials ......................................................................................................34 4.6.3 Drivers and Restraints ........................................................................................35

5 Women’s Health Therapeutics Market to 2018 - Therapeutic Landscape.......................36 5.1 Menopause..............................................................................................................36

5.1.1 Introduction.......................................................................................................36 5.1.2 Revenues...........................................................................................................37 5.1.3 Branded and Generic Market Share................................................................39 5.1.4 Annual Cost of Therapy ....................................................................................40 5.1.5 Treatment Usage Patterns ................................................................................41 5.1.6 Major Marketed Products in the Menopause Therapeutics Market ...............42 5.1.7 Drivers for the Menopause Therapeutics Market .............................................45 5.1.8 Barriers for the Menopause Therapeutics Market ............................................46



Table of Contents

5.2 Postmenopausal Osteoporosis ................................................................................46 5.2.1 Introduction.......................................................................................................46 5.2.2 Revenues...........................................................................................................47 5.2.3 Branded versus Generic Market Share.............................................................49 5.2.4 Annual Cost of Therapy ....................................................................................50 5.2.5 Treatment Usage Patterns ................................................................................51 5.2.6 Treatment Flow Algorithm.................................................................................53 5.2.7 Major Marketed Drugs in the Postmenopausal Osteoporosis Market .............54 5.2.8 Drivers for the Postmenopausal Osteoporosis Market .....................................61 5.2.9 Barriers for the Postmenopausal Osteoporosis Market.....................................62

5.3 Endometriosis............................................................................................................62 5.3.1 Introduction.......................................................................................................62 5.3.2 Revenues...........................................................................................................63 5.3.3 Branded and Generic Market Share................................................................65 5.3.4 Annual Cost of Therapy ....................................................................................66 5.3.5 Treatment Usage Patterns ................................................................................67 5.3.6 Treatment Flow Algorithm.................................................................................68 5.3.7 Major Marketed Drugs for Endometriosis..........................................................69 5.3.8 Drivers for the Endometriosis Therapeutics Market...........................................72 5.3.9 Barriers for the Endometriosis Therapeutics Market..........................................73

5.4 Infertility ....................................................................................................................73 5.4.1 Introduction.......................................................................................................73 5.4.2 Revenues...........................................................................................................74 5.4.3 Branded and Generic Market Share................................................................76 5.4.4 Annual Cost of Therapy ....................................................................................77 5.4.5 Treatment Usage Patterns ................................................................................78 5.4.6 Treatment Flow Algorithm.................................................................................79 5.4.7 Major Marketed Drugs in the Infertility Therapeutics Market ...........................80 5.4.8 Drivers for the Infertility Therapeutics Market....................................................85 5.4.9 Barriers for the Infertility Therapeutics Market...................................................86

5.5 Female Contraceptives ...........................................................................................86 5.5.1 Introduction.......................................................................................................86 5.5.2 Revenues...........................................................................................................88 5.5.3 Share of Prescription and OTC Contraceptives...............................................91 5.5.4 Annual Cost of Usage.......................................................................................92 5.5.5 Treatment Usage Patterns ................................................................................93 5.5.6 Major Marketed Products in the Female Contraceptives Market...................94 5.5.7 Drivers for the Female Contraceptives Market ................................................96 5.5.8 Barriers for the Female Contraceptives Market ...............................................97

6 Women’s Health Therapeutics Market to 2018 - Pipeline Analysis....................................98 6.1 Overview ..................................................................................................................98 6.2 Research and Development Pipeline - Menopause ............................................100

6.2.1 Overview.........................................................................................................100 6.3 Research and Development Pipeline - Postmenopausal Osteoporosis...............100

6.3.1 Overview.........................................................................................................100 6.4 Research and Development Pipeline - Endometriosis..........................................101

6.4.1 Overview.........................................................................................................101 6.5 Research and Development Pipeline - Infertility...................................................101

6.5.1 Overview.........................................................................................................101 6.6 Research and Development Pipeline - Female Sexual Dysfunction....................102

6.6.1 Overview.........................................................................................................102 6.7 Research and Development Pipeline - Contraceptives.......................................103



Table of Contents

6.7.1 Overview.........................................................................................................103 6.8 Profiles of Promising Drugs in the Women’s Health Therapeutics Market.............104

6.8.1 Menerba .........................................................................................................104 6.8.2 Odanacatib....................................................................................................105 6.8.3 Elagolix ............................................................................................................106 6.8.4 Libigel ..............................................................................................................107 6.8.5 Femprox ..........................................................................................................108 6.8.6 MK 8962 ...........................................................................................................109 6.8.7 Zoely ................................................................................................................110 6.8.8 AMG 785 .........................................................................................................111

7 Women’s Health Therapeutics Market to 2018 - Competitive Landscape ....................112 7.1 Market Share Analysis: Women’s Health Therapeutics Market.............................112 7.2 Competitive Profiling..............................................................................................113

7.2.1 Warner Chilcott...............................................................................................113 7.2.2 Pfizer ................................................................................................................114 7.2.3 Eli-Lilly...............................................................................................................116 7.2.4 Merck ..............................................................................................................117 7.2.5 Roche..............................................................................................................119 7.2.6 Bayer ...............................................................................................................120

8 Women’s Health Therapeutics Market to 2018 - Strategic Consolidations ....................121 8.1 Overview ................................................................................................................121 8.2 Deals by Year .........................................................................................................121 8.3 Deals by Type.........................................................................................................122 8.4 Deals by Value.......................................................................................................122 8.5 Mergers and Acquisitions.......................................................................................123

8.5.1 Major M&A Deals ............................................................................................126 8.6 Licensing Agreements............................................................................................127

8.6.1 Major Licensing Agreements ..........................................................................129 8.7 Partnerships ............................................................................................................130

8.7.1 Major Partnership Deals ..................................................................................131 9 Women’s Health Therapeutics Market to 2018 - Appendix ............................................132

9.1 Abbreviations .........................................................................................................132 9.2 Market Definitions...................................................................................................133 9.3 Bibliography ...........................................................................................................133 9.4 Research Methodology.........................................................................................134

9.4.1 Coverage........................................................................................................135 9.4.2 Secondary Research ......................................................................................135 9.4.3 Primary Research ............................................................................................135 9.4.4 Expert Panel Validation ..................................................................................136 9.4.5 Section-wise Research Methodology.............................................................136

9.5 Therapeutic Landscape ........................................................................................136 9.5.2 Market Size by Geography.............................................................................138

9.6 Geographical Landscape.....................................................................................139 9.7 Pipeline Analysis .....................................................................................................139 9.8 Competitive Landscape........................................................................................139 9.9 Strategic Consolidations ........................................................................................139 9.10 Contact Us .............................................................................................................139 9.11 Disclaimer...............................................................................................................139



Table of Contents

1.1 List of Tables Table 1: Women’s Health Therapeutics Market, Global, Revenue ($bn), 2003-2011..........15 Table 2: Women’s Health Therapeutics Market, Global, Revenue Forecasts ($bn),

2011-2018.................................................................................................................15 Table 3: Women’s Health Therapeutics Market, Global, Annual Cost of Therapy ($),

2003-2011.................................................................................................................16 Table 4: Women’s Health Therapeutics Market, Global, Annual Cost of Therapy ($),

2011-2018.................................................................................................................16 Table 5: Women’s Health Therapeutics Market, Global, Treatment Usage Patterns

(million), 2003-2011 ..................................................................................................18 Table 6: Women’s Health Therapeutics Market, Global, Treatment Usage Patterns

(million), 2011-2018 ..................................................................................................18 Table 7: Women’s Health Therapeutics Market, The US, Revenue ($bn), 2003-2011 ..........21 Table 8: Women’s Health Therapeutics Market, The US, Revenue Forecasts ($bn),

2011-2018.................................................................................................................21 Table 9: Women’s Health Therapeutics Market, The US, Annual Cost of Therapy ($),

2003-2011.................................................................................................................22 Table 10: Women’s Health Therapeutics Market, The US, Annual Cost of Therapy ($),

2011-2018.................................................................................................................22 Table 11: Women’s Health Therapeutics Market, The US, Treatment Usage Patterns (million),

2003-2011.................................................................................................................23 Table 12: Women’s Health Therapeutics Market, The US, Treatment Usage Patterns (million),

2011-2018.................................................................................................................23 Table 13: Women’s Health Therapeutics Market, Top Five Countries of Europe, Revenue

($m), 2003-2011 .......................................................................................................24 Table 14: Women’s Health Therapeutics Market, Top Five Countries of Europe, Revenue

Forecasts ($m), 2011-2018.......................................................................................25 Table 15: Women’s Health Therapeutics Market, Top Five Countries of Europe, Annual Cost

of Therapy ($), 2003-2011........................................................................................26 Table 16: Women’s Health Therapeutics Market, Top Five Countries of Europe, Annual Cost

of Therapy ($), 2011-2018........................................................................................26 Table 17: Women’s Health Therapeutics Market, Top Five Countries of Europe, Treatment

Usage Patterns (million), 2003-2011.........................................................................27 Table 18: Women’s Health Therapeutics Market, Top Five Countries of Europe, Treatment

Usage Patterns (million), 2011-2018.........................................................................27 Table 19: Women’s Health Therapeutics Market, Japan, Revenue ($m), 2003-2011 ...........28 Table 20: Women’s Health Therapeutics Market, Japan, Revenue Forecasts ($m),

2011-2018.................................................................................................................28 Table 21: Women’s Health Therapeutics Market, Japan, Annual Cost of Therapy ($),

2003-2011.................................................................................................................29 Table 22: Women’s Health Therapeutics Market, Japan, Annual Cost of Therapy ($),

2011-2018.................................................................................................................29 Table 23: Women’s Health Therapeutics Market, Japan, Treatment Usage Patterns (million),

2003-2011.................................................................................................................30 Table 24: Women’s Health Therapeutics Market, Japan, Treatment Usage Patterns (million),

2011-2018.................................................................................................................30 Table 25: Women’s Health Therapeutics Market, Pipeline Molecules, Australia, 2012 .........31 Table 26: Women’s Health Therapeutics Market, Pipeline Molecules, India, 2012 ...............33 Table 27: Women’s Health Therapeutics Market, Pipeline Molecules, China, 2012 .............34 Table 28: Menopause Therapeutics Market, Global, Revenue ($m), 2003-2011 ..................37 Table 29: Menopause Therapeutics Market, Global, Revenue Forecasts ($m), 2011-2018..37 Table 30: Menopause Therapeutics Market, Global, Revenue by Geography ($m),

2003-2011.................................................................................................................38 Table 31: Menopause Therapeutics Market, Global, Revenue by Geography ($m),

2011-2018.................................................................................................................39 Table 32: Menopause Therapeutics Market, Global, Annual Cost of Therapy ($), 2003-2011

.................................................................................................................................40



Table of Contents

Table 33: Menopause Therapeutics Market, Global, Annual Cost of Therapy ($), 2011-2018.................................................................................................................................40

Table 34: Menopause Therapeutics Market, Global, Treatment Usage Patterns (million), 2003-2011.................................................................................................................41

Table 35: Menopause Therapeutics Market, Global, Treatment Usage Patterns (million), 2011-2018.................................................................................................................41

Table 36: Postmenopausal Osteoporosis Therapeutics Market, Global, Revenue ($bn), 2003-2011.................................................................................................................47

Table 37: Postmenopausal Osteoporosis Therapeutics Market, Global, Revenue Forecasts ($bn), 2011-2018 ......................................................................................................47

Table 38: Postmenopausal Osteoporosis Therapeutics Market, Global, Revenue by Geographical Segmentation ($m), 2003-2011.......................................................48

Table 39: Postmenopausal Osteoporosis Therapeutics Market, Global, Revenue by Geographical Segmentation ($m), 2011-2018.......................................................49

Table 40: Postmenopausal Osteoporosis Therapeutics Market, Global, Annual Cost of Therapy ($), 2003-2011 ............................................................................................50

Table 41: Postmenopausal Osteoporosis Therapeutics Market, Global, Annual Cost of Therapy ($), 2011-2018 ............................................................................................50

Table 42: Postmenopausal Osteoporosis Therapeutics Market, Global, Treatment Usage Patterns (million), 2003-2011....................................................................................51

Table 43: Postmenopausal Osteoporosis Therapeutics Market, Global, Treatment Usage Patterns (million), 2011-2018....................................................................................51

Table 44: Postmenopausal Osteoporosis Therapeutics Market, Major Marketed Drug Revenues, 2011 .......................................................................................................54

Table 45: Endometriosis Therapeutics Market, Global, Revenue ($m), 2003-2011................63 Table 46: Endometriosis Therapeutics Market, Global, Revenue Forecasts ($m),

2011-2018.................................................................................................................63 Table 47: Endometriosis Therapeutics Market, Global, Revenue by Geography ($m),

2003-2011.................................................................................................................64 Table 48: Endometriosis Therapeutics Market, Global, Revenue by Geography ($m),

2011-2018.................................................................................................................65 Table 49: Endometriosis Therapeutics Market, Global, Annual Cost of Therapy ($),

2003-2011.................................................................................................................66 Table 50: Endometriosis Therapeutics Market, Global, Annual Cost of Therapy ($),

2011-2018.................................................................................................................66 Table 51: Endometriosis Therapeutics Market, Global, Treatment Usage Patterns (million),

2003-2011.................................................................................................................67 Table 52: Endometriosis Therapeutics Market, Global, Treatment Usage Patterns (million),

2011-2018.................................................................................................................67 Table 53: Infertility Therapeutics Market, Global, Revenue ($m), 2003-2011.........................74 Table 54: Infertility Therapeutics Market, Global, Revenue Forecasts ($m), 2011-2018 ........74 Table 55: Infertility Therapeutics Market, Global, Revenue by Geography ($m), 2003-2011

.................................................................................................................................75 Table 56: Infertility Therapeutics Market, Global, Revenue Forecasts by Geography ($m),

2011-2018.................................................................................................................76 Table 57: Infertility Therapeutics Market, Global, Annual Cost of Therapy ($), 2003-2011....77 Table 58: Infertility Therapeutics Market, Global, Annual Cost of Therapy ($), 2011-2018....77 Table 59: Infertility Therapeutics Market, Global, Treatment Usage Patterns (million),

2003-2011.................................................................................................................78 Table 60: Infertility Therapeutics Market, Global, Treatment Usage Patterns (million),

2011-2018.................................................................................................................78 Table 61: Infertility Therapeutics Market, Major Marketed Drug Revenues ($m), 2011.........80 Table 62: Efficacy Outcome by Treatment Groups in Ovulation Induction for Study FPI FSH

99-03 (One Cycle of Treatment).............................................................................84 Table 63: Efficacy Outcome for IVF Study FPI FSH 2001-01 (One Cycle of Treatment) .........85 Table 64: Contraceptives Market, Global, Revenue ($bn), 2003-2011 .................................88 Table 65: Contraceptives Market, Global, Revenue Forecasts ($bn), 2011-2018.................88 Table 66: Contraceptives Market, Global, Revenue by Type ($m), 2003-2011.....................89



Table of Contents

Table 67: Contraceptives Market, Global, Revenue Forecasts by Type ($m), 2011-2018 ....89 Table 68: Contraceptives Market, Global, Revenue by Geographical Segmentation ($m),

2003-2011.................................................................................................................90 Table 69: Contraceptives Market, Global, Revenue Forecasts by Geographical

Segmentation ($m), 2011-2018...............................................................................91 Table 70: Contraceptives Market, Global, Annual Cost of Usage ($), 2003-2011.................92 Table 71: Contraceptives Market, Global, Annual Cost of Usage ($), 2011-2018.................92 Table 72: Contraceptives Market, Global, Treatment Usage Patterns (million), 2003-2011..93 Table 73: Contraceptives Market, Global, Treatment Usage Patterns (million), 2011-2018..93 Table 74: Contraceptives Market, Major Marketed Drug Market Share, 2011 .....................94 Table 75: Women’s Health Therapeutics Market, Global, Pipeline by Phase (%), 2012........98 Table 76: Women’s Health Therapeutics Market, Global, Pipeline by Indication (%), 2012 .99 Table 77: Women’s Health Therapeutics Market, Global, Pipeline Analysis, Most Promising

Molecules, 2012.....................................................................................................104 Table 78: Women’s Health Therapeutics Market, Warner Chilcott, Major Marketed

Products, 2011 .......................................................................................................113 Table 79: Women’s Health Therapeutics Market, Pfizer, Major Marketed Products, 2011..115 Table 80: Women’s Health Therapeutics Market, Eli Lilly, Major Marketed Products, 2011.116 Table 81: Women’s Health Therapeutics Market, Merck, Major Marketed Products, 2011 117 Table 82: Women’s Health Therapeutics Market, Roche, Major Marketed Products, 2011119 Table 83: Women’s Health Therapeutics Market, Bayer, Major Marketed Products, 2011.120 Table 84: Women’s Health Therapeutics Market to 2018, Global, Strategic Consolidations,

Mergers and Acquisitions, 2010-2012....................................................................123 Table 85: Women’s Health Therapeutics Market to 2018, Global, Strategic Consolidations,

Licensing Agreements, 2010-2012.........................................................................127 Table 86: Women’s Health Therapeutics Market to 2018, Global, Strategic Consolidations,

Partnerships, 2010-2012 .........................................................................................130



Table of Contents

1.2 List of Figures Figure 1: Women’s Health Therapeutics Market, Global, Revenue Forecasts ($bn),

2003-2018.................................................................................................................15 Figure 2: Women’s Health Therapeutics Market, Global, Annual Cost of Therapy ($),

2003-2018.................................................................................................................16 Figure 3: Women’s Health Therapeutics Market, Global, Branded and Generic Market

Share (%), 2011 and 2018........................................................................................17 Figure 4: Women’s Health Therapeutics Market, Global, Treatment Usage Patterns

(million), 2003-2018 ..................................................................................................18 Figure 5: Women’s Health Therapeutics Market, Global, Drivers and Barriers .....................20 Figure 6: Women’s Health Therapeutics Market, The US, Revenue Forecasts ($bn),

2003-2018.................................................................................................................21 Figure 7: Women’s Health Therapeutics Market, The US, Annual Cost of Therapy ($),

2003-2018.................................................................................................................22 Figure 8: Women’s Health Therapeutics Market, The US, Treatment Usage Patterns (million),

2003-2018.................................................................................................................23 Figure 9: Women’s Health Therapeutics Market, Top Five Countries of Europe, Revenue

Forecasts ($m), 2003-2018.......................................................................................24 Figure 10: Women’s Health Therapeutics Market, Top Five Countries of Europe, Annual Cost

of Therapy ($), 2003-2018........................................................................................26 Figure 11: Women’s Health Therapeutics Market, Top Five Countries of Europe, Treatment

Usage Patterns (million), 2003-2018.........................................................................27 Figure 12: Women’s Health Therapeutics Market, Japan, Revenue Forecasts ($m),

2003-2018.................................................................................................................28 Figure 13: Women’s Health Therapeutics Market, Japan, Annual Cost of Therapy ($),

2003-2018.................................................................................................................29 Figure 14: Women’s Health Therapeutics Market, Japan, Treatment Usage Patterns (million),

2003-2018.................................................................................................................30 Figure 15: Menopause Therapeutics Market, Global, Revenue Forecasts ($m), 2003-2018.37 Figure 16: Menopause Therapeutics Market, Global, Revenue by Geography ($m),

2003-2018.................................................................................................................38 Figure 17: Menopause Therapeutics Market, Global, Branded and Generic Market Share

(%), 2011 and 2018 ..................................................................................................39 Figure 18: Menopause Therapeutics Market, Global, Annual Cost of Therapy ($), 2003-2018

.................................................................................................................................40 Figure 19: Menopause Therapeutics Market, Global, Treatment Usage Patterns (million),

2003-2018.................................................................................................................41 Figure 20: Menopause Therapeutics Market, Global, Drivers and Barriers.............................45 Figure 21: Postmenopausal Osteoporosis Therapeutics Market, Global, Revenue Forecasts

($bn), 2003-2018 ......................................................................................................47 Figure 22: Postmenopausal Osteoporosis Therapeutics Market, Global, Revenue by

Geographical Segmentation ($m), 2003-2018.......................................................48 Figure 23: Postmenopausal Osteoporosis Therapeutics Market, Global, Branded and

Generic Market Share (%), 2011 and 2018 .............................................................49 Figure 24: Postmenopausal Osteoporosis Therapeutics Market, Global, Annual Cost of

Therapy ($), 2003-2018 ............................................................................................50 Figure 25: Postmenopausal Osteoporosis Therapeutics Market, Global, Treatment Usage

Patterns (million), 2003-2018....................................................................................51 Figure 26: Postmenopausal Osteoporosis Therapeutics Market, Treatment Flow Algorithm .53 Figure 27: Postmenopausal Osteoporosis Therapeutics Market, Major Marketed Drug

Market Share, 2011..................................................................................................54 Figure 28: Postmenopausal Osteoporosis Therapeutics Market, Global, Drivers and Barriers

.................................................................................................................................61 Figure 29: Endometriosis Therapeutics Market, Global, Revenue Forecasts ($m), 2003-2018

.................................................................................................................................63 Figure 30: Endometriosis Therapeutics Market, Global, Revenue by Geography ($m),

2003-2018.................................................................................................................64



Table of Contents

Figure 31: Endometriosis Therapeutics Market, Global, Branded and Generic Market Share (%), 2011 and 2018 ..................................................................................................65

Figure 32: Endometriosis Therapeutics Market, Global, Annual Cost of Therapy ($), 2003-2018.................................................................................................................66

Figure 33: Endometriosis Therapeutics Market, Global, Treatment Usage Patterns (million), 2003-2018.................................................................................................................67

Figure 34: Endometriosis Therapeutics Market, Treatment Flow Algorithm ............................68 Figure 35: Endometriosis Therapeutics Market, Global, Drivers and Barriers ..........................72 Figure 36: Infertility Therapeutics Market, Global, Revenue Forecasts ($m), 2003-2018 ........74 Figure 37: Infertility Therapeutics Market, Global, Revenue by Geography ($m), 2003-2018

.................................................................................................................................75 Figure 38: Infertility Therapeutics Market, Global, Branded and Generic Market Share (%),

2011 and 2018 .........................................................................................................76 Figure 39: Infertility Therapeutics Market, Global, Annual Cost of Therapy ($), 2003-2018....77 Figure 40: Infertility Therapeutics Market, Global, Treatment Usage Patterns (million),

2003-2018.................................................................................................................78 Figure 41: Infertility Therapeutics Market, Treatment Flow Algorithm .....................................79 Figure 42: Infertility Therapeutics Market, Global, Drivers and Barriers ...................................85 Figure 43: Contraceptives Market, Global, Revenue Forecasts ($bn), 2003-2018.................88 Figure 44: Contraceptives Market, Global, Revenue Forecasts by Type ($m), 2003-2018 ....89 Figure 45: Contraceptives Market, Global, Revenue Forecasts by Geographical

Segmentation ($m), 2003-2018...............................................................................90 Figure 46: Contraceptives Market, Global, Share of Prescription and OTC Contraceptives

(%), 2011 ..................................................................................................................91 Figure 47: Contraceptives Market, Global, Annual Cost of Usage ($), 2003-2018.................92 Figure 48: Contraceptives Market, Global, Treatment Usage Patterns (million), 2003-2018.93 Figure 49: Contraceptives Market, Major Marketed Drug Market Share, 2011 .....................94 Figure 50: Contraceptives Market, Global, Drivers and Barriers .............................................96 Figure 51: Women’s Health Therapeutics Market, Global, Pipeline by Phase (%), 2012........98 Figure 52: Women’s Health Therapeutics Market, Global, Pipeline by Indication (%), 2012 .99 Figure 53: Menopause Therapeutics Market, Global, Pipeline by Phase (%), 2012 .............100 Figure 54: Postmenopausal Osteoporosis Therapeutics Market, Global, Pipeline by Phase

(%), 2012 ................................................................................................................100 Figure 55: Endometriosis Therapeutics Market, Global, Pipeline by Indication (%), 2012 ....101 Figure 56: Infertility Therapeutics Market, Global, Pipeline by Indication (%), 2012 .............101 Figure 57: Female Sexual Dysfunction Therapeutics Market, Global, Pipeline by Indication

(%), 2012 ................................................................................................................102 Figure 58: Female Contraceptives Market, Global, Pipeline by Indication (%), 2012..........103 Figure 59: Women’s Health Therapeutics Market, Global, Market Share of Companies (%),

2011 .......................................................................................................................112 Figure 60: Women’s Health Therapeutics Market, Warner Chilcott SWOT Analysis, 2012....114 Figure 61: Women’s Health Therapeutics Market, Pfizer SWOT Analysis, 2012 .....................115 Figure 62: Women’s Health Therapeutics Market, Eli Lilly SWOT Analysis, 2012 ....................116 Figure 63: Women’s Health Therapeutics Market, Merck SWOT Analysis, 2012....................118 Figure 64: Women’s Health Therapeutics Market, Roche SWOT Analysis, 2012 ...................119 Figure 65: Women’s Health Therapeutics Market, Bayer SWOT Analysis, 2012 ....................120 Figure 66: Women’s Health Therapeutics Market to 2018, Global, Strategic Consolidations,

Deals by Year, 2010-2012 ......................................................................................121 Figure 67: Women’s Health Therapeutics Market to 2018, Global, Strategic Consolidations,

Deals by Type, 2010-2012......................................................................................122 Figure 68: Women’s Health Therapeutics Market to 2018, Global, Strategic Consolidations,

Deals by Value, 2010-2012 ....................................................................................122 Figure 69: GBI Research Market Forecasting Model.............................................................138



Women’s Health Therapeutics Market to 2018 – Introduction

2 Women’s Health Therapeutics Market to 2018 - Introduction 2.1 Overview The women’s health therapeutics market is a growing market. The major drugs used in the treatment of women’s health disorders are Yasmin, Mirena, Nuvaring, Premarin (conjugated estrogens), Evista (raloxifene), Forteo (teriparatide), Boniva, Actonel, Lupron (Leuprolide), Gonal-F and Fosamax. Follistim AQ, Evista, Forteo, Boniva and Actonel are prescribed in the treatment of infertility, menopause, endometriosis and postmenopausal osteoporosis, and will expire in the forecast period.

The women’s health therapeutics market will witness an increase in the annual cost of therapy due to the launch of new molecules such as Odanocantib and Aprela in the forecast period. The annual cost of therapy is projected to increase from $XX in 2011 to $XX in 2018, at a CAGR of XX%. The increase can be attributed to the launch of promising molecules such as Odanocantib and Aprela in the forecast period. The launch of new molecules is expected to offset the effect of patent expiries of branded molecules such as Detrol, Evista, Forteo, Boniva and Actonel.

Pipeline analysis for the indications shows promising molecules for the women’s health therapeutics market. There are XX molecules in the R&D pipeline for the women’s health therapeutics market. Contraceptives dominated the pipeline, accounting for XX%, followed by infertility therapeutics.

Launch of new molecules is expected to offset the effect of patent expiries of branded molecules such as Detrol, Evista, Forteo, Boniva and Actonel



Women’s Health Therapeutics Market to 2018 – Market Overview

3.2 Revenue Forecasts for the Women’s Health Therapeutics Market 3.2.1 Revenues

Figure 1: Women’s Health Therapeutics Market, Global, Revenue Forecasts ($bn), 2003-2018

2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018

Rev

enue

s ($

bn)

CAGR (2003-2011): XX%

CAGR (2011-2018): XX%


Table 1: Women’s Health Therapeutics Market, Global, Revenue ($bn), 2003-2011 Year 2003 2004 2005 2006 2007 2008 2009 2010 2011 CAGR (%)

Revenues ($ bn)


Table 2: Women’s Health Therapeutics Market, Global, Revenue Forecasts ($bn), 2011-2018

Year 2011 2012 2013 2014 2015 2016 2017 2018 CAGR (%)

Revenues ($ bn)


In 2011, the women’s health therapeutics market for postmenopausal osteoporosis, hormone replacement therapy, infertility, contraceptives and endometriosis was valued at $XX billion, representing a CAGR of XX% between 2003 and 2011. The contraceptives market accounted for XX% of the total market share, with Bayer dominating this segment. The contraceptives market is dominated by brands such as Yasmin, Mirena and Nuvaring. The postmenopausal osteoporosis segment accounted for XX% of the women’s health therapeutics market share, dominated by brands like Evista, Forteo and Fosamax. Premarin, Prempro (conjugated estrogens and medroxyprogesterone) and Estraderm dominated the menopause therapeutics market. Zoladex (Goserelin acetate) and Lupron are the major selling drugs in the endometriosis therapeutics market. The infertility market contributed XX% of the women’s health therapeutics market, with brands like Follistim AQ and Gonal-F by Merck.



5 Women’s Health Therapeutics Market to 2018 – Therapeutic Landscape

5.2.7 Major Marketed Drugs in the Postmenopausal Osteoporosis Market

Figure 27: Postmenopausal Osteoporosis Therapeutics Market, Major Marketed Drug Market Share, 2011

Evista

Forteo

Reclast/AclastaBoniva

Actonel

Atelvia

Prolia

FosamaxOthers

Source: GBI Research’s Proprietary Epidemiology and Market Size Database [May 20, 2012]

Table 44: Postmenopausal Osteoporosis Therapeutics Market, Major Marketed Drug Revenues, 2011

Drug Company Global Sales ($m)

Evista Eli Lilly

Forteo Eli Lilly

Reclast/Aclasta Novartis

Boniva Roche

Actonel Walner Chilcott

Atelvia Walner Chilcott

Prolia Amgen

Fosamax Merck

Source: GBI Research’s Proprietary Epidemiology and Market Size Database [May 20, 2012] NOTE: *Includes Walner Chilcott and Sanofi Sales

Eli Lilly leads the market for Postmenopausal Osteoporosis (PMO) therapeutics. The combined sales of the two drugs marketed by the company constitute XX% of the total market share. This is followed by Walner Chilcott and Roche, each constituting XX% of the market share. However, Boniva (by Roche) went off patent in March 2012, which will result in a drop in revenues during the forecast period due to the launch of cheaper generics. Both of the drugs from Walner Chilcott are also going off patent, in June 2014. The patent expiries (including Evista) will lead to a drop in the overall PMO market revenue.

In 2010, Amgen launched Prolia, a first-in-class drug for the treatment of postmenopausal osteoporosis. The performance of Prolia since its launch in June 2010 has been below expectations. The low sales of Prolia are primarily because of the reimbursement barriers and Primary Care Physician (PCP) reservations over the “buy and bill” practice. PCPs contribute to about two-thirds of the overall prescription usage, which is a major factor responsible for Prolia’s growth.

In order to create awareness, Amgen is running a Direct-to-Consumer (DTC) campaign for Prolia. In 2010, Prolia was reimbursed in approximately XX% of the total EU potential market, and it is expected that XX% of the opportunity in Europe will ultimately be fulfilled in terms of providing Prolia reimbursement. DTC advertising along with reimbursement will drive Prolia’s growth in the forecast period.



Women’s Health Therapeutics Market to 2018 – Appendix

9 Women’s Health Therapeutics Market to 2018 - Appendix 9.1 Abbreviations ACT - Annual Cost of Therapy

BMD - Bone Mineral Density

CAGR - Compound Annual Growth Rate

CPSSS - Composite Pelvic Sign and Symptoms Score

CE - Conjugated Estrogen

DEXA - Dual Energy X-Ray Absorptiometry

ERA - Estrogen Replacement and Atherosclerosis

EC - European Commission

FDA - Food and Drug Administration

FSH - Follicle Stimulating Hormone

FAS - Full Analysis Set

GnRH - Gonadotropin-Releasing Hormone

HRT - Hormone Replacement Therapy

HT - Hormone Therapy

IUD - Intrauterine Device

LS - Lumbar Spine

NSAIDs - Non-Steroidal Anti-Inflammatory Drugs

OAB - Overactive Bladder

OTC - Over-the-counter

SDs - Standard Deviations

SERM - Selective Estrogen Receptor Modulator

SMART-1 - Selective estrogens Menopause and Response to Therapy

TRPV1 - Transient Receptor Potential V1

TCM - Traditional Chinese medicine

VAS - Visual Analog Scale

VR1 - Vanilloid Receptor 1

WHI - Women’s Health Initiative

WHIMS - WHI Memory Study




9.2 Market Definitions Preclinical Phase: An investigational drug is tested for safety issues to administer in humans during the Preclinical stage.

Phase l: Phase I studies are conducted to verify safety and tolerability of the investigational drug in humans.

Phase ll: Phase II studies are conducted randomly on several hundred patients suffering from a particular disorder.

Phase lll: Phase III studies are designed for further testing of safety and efficacy of an investigational drug.

The global women’s health therapeutics market includes female contraceptives, endometriosis, postmenopausal osteoporosis, infertility and menopausal hormone replacement therapy in the top seven markets (the US, the UK, Germany, France, Spain, Italy and Japan).

Prevalence Population: The diseased population is the estimated number of people at any given point of time in a year who are affected by women’s health disorders.

Diagnosis Rate and Population: The diagnosis rate is the percentage of the prevalence population that is diagnosed with women’s health disorders. The diagnosis population refers to the number of people that are diagnosed with women’s health disorders.

Prescription Population: The prescription rate is the percentage of the diagnosis population that is prescribed medication for women’s health disorders. The prescription population refers to the number of people that are on medication for women’s health disorders.

9.3 Bibliography Australian Bureau of Statistics (2012). Births. Australian Bureau of Statistics. Available

from: http://www.abs.gov.au/ausstats/[email protected]/Lookup/by%20Subject/1301.0~2012~Main%20Features~Births~51 [Accessed September 13, 2012].

Australian Family Physician (2011). Menopause 2000-2010. Available from: https://www.racgp.org.au/afp/201105/201105beach.pdf [Accessed September 13, 2012].

Australian Institute of Health and Welfare (2011). A snapshot of osteoporosis. Available from: http://www.diabetes.mdhs.unimelb.edu.au/news_events/Reports&Media/2011_Aust_Snapshot_Osteoporosis.pdf [Accessed September 13, 2012].

Australian Statistics on Medicine (2009). Australian Statistics on Medicines. Available from: http://www.health.gov.au/internet/main/publishing.nsf/content/913697554D938FFDCA257967007A83EA/$File/ASM%202009.pdf [Accessed September 13, 2012].

Bayer (2012). Annual Report 2011. Available from: http://www.annualreport2011.bayer.com/en/bayer-annual-report-2011.pdfx [Accessed May 2012].

Brown JP, et al. (2002). 2002 Clinical practice guidelines for the diagnosis and management of osteoporosis in Canada. Canadian Medical Association Journal. 167 (10 suppl): S1 - S34.

Eli Lilly (2012). Annual Report 2011. Available from: http://files.shareholder.com/downloads/LLY/1992596331x0x548541/E8FFDA89-5EC1-4D08-AB37-CD85F4C0863D/English.PDF [Accessed May 2012].

Family Practice Notebook (2012). Endometriosis. Family Practice Notebook. Available from: http://www.fpnotebook.com/gyn/Uterus/Endmtrs.htm. [Accessed May 2012].




Hadfield R, et al. (1996). Delay in the diagnosis of endometriosis: a survey of women from the USA and the UK, Human Reproduction; vol.11 no.4: 878-880.

Mazza D, et al. (2012). Current contraceptive management in Australian general practice: an analysis of BEACH data. Med J Aust; 197 (2): 110-114.

Metcalfe L et al. (2001). Postmenopausal Women and Exercise for Prevention of Osteoporosis. ACSM’s Health and Fitness Journal. 5 (3): 6-14.

Merck (2012). Annual Report 2011. Available from: http://www.merck.com/investors/financials/home.html [Accessed May 2012].

Nasir L and Bope ET (2004). Management of Pelvic Pain from Dysmenorrhea or Endometriosis. J Am Board Fam Pract; 17:S43-7.

Novartis (2012). Annual Report 2011. Available from: http://www.novartis.com/investors/financialresults/annual-results-2011.shtml [Accessed May 2012].

Pfizer (2012). Annual Report 2011. Available from http://www.pfizer.com/files/annualreport/2011/financial/financial2011.pdf [Accessed May 2012].

Roche (2012). Annual Report 2011. Available from: http://www.google.co.in/url?sa=t&rct=j&q=roche%20annual%20report%202011&source=web&cd=1&sqi=2&ved=0CE8QFjAA&url=http%3A%2F%2Fwww.roche.com%2Fgb11e.pdf&ei=faoSULb7HcXyrQev5oDQBg&usg=AFQjCNGFw4MGTciiTbEB_bjaDOjYo0zmiQ&cad=rja [Accessed May 2012].

Syamala, T.S. and Sivakami, M (2005). Menopause: An emerging issue in India. Economic and Political Weekly; Vol 40 (47): 4923-4930.

US Department of Health and Human Services (2012). A statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius Available from: http://www.hhs.gov/news/press/2012pres/01/20120120a.html/ [Accessed April 2012].

Wang Y et al. (2009). Osteoporosis in China. Osteoporosis international. 20 (10): 1651-62.

Warner Chilcott (2012). Annual Report 2011. Available from: http://ir.wcrx.com/annuals.cfm [Accessed May 2012].

Xiangyan R (2010). Chinese Menopause Society. Available from: http://210.9.50.4/archive/apmf2010/pdf/countryprogram/Chinese%20Menopause%20Society%20Program.pdf [Accessed September 12, 2012].

9.4 Research Methodology GBI Research’s dedicated research and analysis teams consist of experienced professionals with a pedigree in marketing, market research, consulting backgrounds in the medical devices industry, and advanced statistical expertise.

GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org) .

All GBI Research databases are continuously updated and revised.




9.4.1 Coverage The objective of updating GBI Research’s coverage is to ensure that it represents the most up-to-date vision of the industry possible.

Changes to the industry taxonomy are built on the basis of extensive research of company, association and competitor sources.

Company coverage is based on three key factors: market capitalization, revenues, and media attention/innovation/market potential.

An exhaustive search of 56 member exchanges is conducted, and companies are prioritized on the basis of their market capitalization

The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage• Companies which are making the news, or which are of particular interest due to their innovative approach, are prioritized.

GBI Research aims to cover all major news events and deals in the medical industry, with its databases updated on a regular basis.

The coverage is further streamlined and strengthened with additional inputs from GBI Research’s expert panel (see below).

9.4.2 Secondary Research The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and US Securities and Exchanges Commission (SEC) filings.

Industry trade journals, scientific journals and other technical literature.

Internal and external proprietary databases.

Relevant patent and regulatory databases.

National government documents, statistical databases and market reports.

Procedure registries.

News articles, press releases and webcasts specific to the companies operating in the market.

9.4.3 Primary Research GBI Research conducts hundreds of primary interviews each year with industry participants and commentators, in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on the market size, market trends, growth trends, competitive landscape, future outlook, etc.

Helps in validating and strengthening the secondary research findings; and

Further develops the analysis team’s expertise and market understanding.

Primary research involves email interactions, telephone interviews, and face-to-face interviews for each market, category, segment and sub-segment across geographies.

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers.




Hospital stores, laboratories, pharmacies, distributors and paramedics.

Outside experts: Investment bankers, valuation experts, research analysts specializing in specific medical equipment markets; and

Key Opinion Leaders: Physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment.

9.4.4 Expert Panel Validation GBI Research uses a panel of experts to cross-verify its databases and forecasts.

GBI Research’s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies, academics from research universities, KOLs from hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment and supplies.

Historic data and forecasts are relayed to GBI Research’s Expert Panel for feedback and adjusted in accordance with their feedback.

9.4.5 Section-wise Research Methodology The report consists of five major sections:

Therapeutic Landscape

Geographical Landscape

Pipeline Analysis

Competitive Landscape

Strategic Consolidations

9.5 Therapeutic Landscape Revenues for each indication, geography-wise is arrived at by utilizing the GBI

Research market forecasting model. The global revenue is the sum value of revenues for each indication of all seven regions.

The annual cost of therapy for each indication is arrived at by considering the cost of the drugs, dosage of the drugs and the duration of the therapy.

The generic share of the market for each indication is obtained by calculating the prescription share for generic drugs and the respective cost of treatment.

The treatment usage pattern which includes quantitative data on the diseased population, treatment-seeking population, diagnosed population and treated population for an indication, is arrived at by referring to various sources as mentioned below.

The marketed drugs section contains an overview of the drugs, their mechanism of action, efficacy and safety issues related to the drugs. The drugs profiled in this section are chosen based on estimated revenues and their mechanism of action.

GBI Research uses the epidemiology-based treatment flow model to forecast market size for therapeutic indications.




9.5.1.1 Epidemiology-based Forecasting

The forecasting model used at GBI Research makes use of epidemiology data gathered from research publications and primary interviews with physicians to represent the treatment flow patterns for individual diseases and therapies. The market for any disease segment is directly proportional to the volume of units sold and the price per unit.

Sales = Volume of units sold Price per unit

The volume of units sold is calculated based on the average dosage regimen for that disease, the duration of treatment, and the number of patients who are prescribed drug treatment (the prescription population). The prescription population is calculated as a percentage of the population diagnosed with a disease (the diagnosis population). The diagnosis population is the population diagnosed with a disease expressed as a percentage of the population that is seeking treatment (the treatment seeking population). The prevalence of a disease (diseased population) is the percentage of the total population who suffer from a disease/condition.

Data on treatment seeking rate, diagnosis rate and prescription rate, if unavailable from research publications, are gathered from interviews with physicians and are used to estimate the patient volumes for the disease under consideration. Therapy uptake and compliance data are fitted in the forecasting model to account for patient switching and compliance behavior.

To account for differences in patient affordability of drugs across various geographies, macroeconomic data such as inflation and GDP, and healthcare indicators such as healthcare spending, insurance coverage and average income per individual, are used.

Annual cost of treatment is calculated using product purchase frequency and the average price of the therapy. Product purchase frequency is calculated from the dosage data available for the therapies, and drug prices are gathered from public sources.

The epidemiology-based forecasting model uses a bottom-up methodology, and makes use of estimations in the absence of data from research publications. Such estimations may result in a final market value that is different from the actual value. To correct this ‘gap’, the forecasting model uses triangulation, with the help of base year sales data (from company annual reports, internal and external databases) and sales estimations.

Analogous Forecasting Methodology

Analogous forecasting methodology is used to account for the introduction of new products, patent expiries of branded products and subsequent introduction of generics. Historic data for new product launches and generics penetration are used to arrive at robust forecasts. Increase or decrease of prevalence rates, treatment seeking rate, diagnosis rate and prescription rate are fitted into the forecasting model to estimate market growth rate.

The proprietary model enables GBI Research to account for the impact of individual drivers and restraints in the growth of the market. The year of impact and the extent of impact are quantified in the forecasting model to provide close-to-accurate data sets.

Diseased Population

The diseased population for any indication is the prevalence. The prevalence rates are usually obtained from various journals, online publications, sources such as the World Health Organization (WHO) or associations and foundation websites for that particular disease.

Diagnosed Population

Out of the patients who undergo diagnostic tests to confirm a disease, only a few people get diagnosed with the disease. This number as a percentage of the diseased population is the diagnosis rate. The diagnosis population is primarily driven by the sensitivity of the diagnostic tests, state-of-the-art technology, patient access to these diagnostic tests, and cost of the diagnostic tests.




Treatment Seeking Population

For any disease, multiple treatment options exist. For example, in cancer treatment various treatment options such as surgery, radiation therapy and drug therapy are available. The prescription population is defined as the number of patients who are prescribed drug therapy. This is calculated as a percentage of the diagnosis population. The prescription population is primarily driven by the age at which the disease is diagnosed, the disease stage, patient health and the cost of drug treatment.

9.5.2 Market Size by Geography The treatment usage pattern and annual cost of treatment in each country has been factored in while deriving the individual country market size.

Forecasting Model for Therapeutic Areas

Figure 69: GBI Research Market Forecasting Model

D is ea se P opu la ti onGe ner a l Po pu lation 7 43,535 ,04 8

Q ualifyin g c ond ition 1 (Ag e/S ex/O c c upa tion etc )Q ualifyin g c ond ition 2 (Ag e/S ex/O c c upa tion etc )

Prev al e nce t issu e v alve dise ase 0 .2% 1,784 ,48 4 Q ualifyin g c ond ition (c om plic at ion, s everi ty)DIS EA SE D P OPULAT IO N 1,784 ,48 4

T r eatm e nt Flow P attern sT rea tm ent S eek i ng R ate (Sy m ptom s/ Dis Awa reness ) 89 % 1,588 ,19 1 Diagn osis Rat e (C lin ical a nd D ia gn ostic Test s) 75 % 1,191 ,14 3

Pres cr iption R ate ( Ph ys ician P e rcep t io n, Tr e atm ent E ffec tiv e n es s)Tis s ue V alve 70 % 833 ,80 0 O the r T reatm en ts for Valve (Sur g/M ed/N one) -

F ulfi llm en tA vailab i lit y NAW ill ingn ess to Us e (Patient Pe rc eptions) NARe ady to U se (S urg ery e l ig ib i lity , R e us e e tc ) NA

Affo rd a bil it y at Pric eHE as % of G D P s pen dA vera ge Inc om e (p er ind ividu al)P atient O ut-of -poc ket Bud get (A nn ual)

Budg et a lloc ation to one-t im e s urgeryBudg et a lloc ation to othe r h ealth needs

A vera ge Pay or C overag eP atient L iab il ityTa rg et Pr ic e (@ 20 % p at liab)A SP for Cos t o f T herap y

T O TA L P AT IEN T V OLU M E SPro du c t P urcha se Fr equen c y 1

T OT AL UN IT VO LU M ES

Pr icin g per Un it 18 ,00 0$ In f lat ionP rice D ec re as e du e to c om pet ition

M ar ket Valu e

G B I R ese ar ch M ar ket Siz in g M o de l

Source: GBI Research

The above figure represents a typical forecasting model constructed by GBI Research. As discussed previously, the model is built on the treatment flow patterns. The model starts with the general population, then diseased population as a percentage of general population, and then follows the treatment seeking population as a percentage of the diseased population, and the diagnosed population as a percentage of the treatment




seeking population. Finally, the total volume of units sold is calculated by multiplying the treated population by the average dosage per year per patient.

The marketed drugs section is taken from company websites and internal databases.

9.6 Geographical Landscape GBI Research analyzes seven major geographies, namely, the US, the top five countries in Europe (the UK, Germany, France, Spain and Italy), and Japan. The total market size for each country is provided, which is the summarized value of the market sizes of all the indications for that particular country.

9.7 Pipeline Analysis This section provides a list of molecules at different stages in the pipeline for various indications. The list is sourced from internal databases and validated for the accuracy of phase and mechanism of action at clinicaltrials.gov and company websites. The section also includes a list of promising molecules, which is narrowed down based on the results of the clinical trials at various stages and the novelty of the mechanism of action.

9.8 Competitive Landscape Profiles of leading players are provided, along with an overview of key products marketed by the companies for various indications. An analysis of strengths, weaknesses, opportunities and threats of each company with respect to various indications is also listed.

GBI Research aims to cover all major M&A, licensing deals and co-development deals related to the market. This section is sourced from the companies’ websites and internal databases.

9.9 Strategic Consolidations This section provides the strategic consolidations that took place for various indications. The list is sourced from internal databases and validated for the accuracy of year, companies and deal value at company websites. The section also includes description of some major deals which is narrowed down based on the deal value and the deal motive and the companies involved in the deals.

9.11 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, GBI Research.

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