postmenopausal vaginal atrophy - us drug … filereference code gdhc176cfr | publication date july...

REFERENCE CODE GDHC176CFR | PUBLICATION DATE JULY 2013

POSTMENOPAUSAL VAGINAL ATROPHY - US DRUG FORECAST AND MARKET ANALYSIS

TO 2022

Postmenopausal Vaginal Atrophy – US Drug Forecast And Market Analysis To 2022 2 © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form.

POSTMENOPAUSAL VAGINAL ATROPHY – US DRUG FORECAST AND MARKET ANALYSIS

TO 2022

Executive Summary

Sales for Postmenopausal Vaginal Atrophy (PVA) in US, 2012–2022

The US Postmenopausal Vaginal Atrophy (PVA)

therapeutics market was worth approximately

$975.9 million in 2012, with a projected compound

annual growth rate (CAGR) of 6.90%, to reach a

total of $1.9 billion in 2022.

Major drivers of market growth over this forecast

period are:

Launch of novel, non-estrogen-based drugs

broadening the eligible population and

increasing overall treatment rates

Healthcare reforms which will increase the

number of insured women and drive treatment-

seeking behaviour

Major barriers to the growth of the PVA market are:

Pressures demanding cost-effectiveness

Influx of lower-priced generics through

licensing agreements

Sales for PVA in US by Drug Class, 2012–2022

35%

36%

23%

0% 6%

2012Total: $975.9m

Vaginal Creams

Vaginal Tablets

Oral Therapies

Other Oral

Vaginal Rings

16%

46%

16%

16%

6%

2022Total: $1.9bn

Vaginal Creams

Vaginal Tablets

Oral Therapies

Other Oral

Vaginal Rings

Source: GlobalData



TO 2022

Executive Summary

What Do the Physicians Think?

“If there was a product that could be used, for

example, once a week, with no side effects, that

would be ideal.”

UK KOL, February 2013

“Certainly, the WHI study was a very large factor in

terms of the heightened concerns about hormonal

therapy.”

US KOL, February 2013

“I think we have bottomed out; all the scares

wrapped around the WHI study have now been put

into perspective.”


“The percentage of patients who are treated will

probably increase, based on the fact reassurances

are being released by the North American

Menopause Society and similar organizations.”


“With any drug, the mode of delivery and what the

potential advantage it may have over current

formulations is what matters.”


“There are all sorts of cultural reasons why women

don’t come forward to ask about the possibilities of

relief from this problem. Worldwide, there is a

tremendous variation in terms of how it is

managed.”




TO 2022

Table of Contents

1 Table of Contents

1 Table of Contents ....................................................................................................................... 4

1.1 List of Tables ...................................................................................................................... 7

1.2 List of Figures ..................................................................................................................... 8

2 Introduction ................................................................................................................................. 9

2.1 Catalyst ............................................................................................................................... 9

2.2 Related Reports .................................................................................................................. 9

2.3 Upcoming Related Reports ............................................................................................... 10

3 Disease Overview ..................................................................................................................... 11

3.1 Etiology and Pathophysiology ........................................................................................... 11

3.1.1 Etiology ......................................................................................................................... 11

3.1.2 Pathophysiology ............................................................................................................ 11

3.1.3 Prognosis ...................................................................................................................... 12

3.1.4 Quality of Life ................................................................................................................ 12

3.2 Symptoms ......................................................................................................................... 12

4 Disease Management ............................................................................................................... 14

4.1 Treatment Overview .......................................................................................................... 14

4.2 Treatment Guidelines ........................................................................................................ 14

4.3 Disease Management ....................................................................................................... 15

4.4 United States .................................................................................................................... 18

4.4.1 Diagnosis ...................................................................................................................... 18

4.4.2 Clinical Practice ............................................................................................................. 18

5 Competitive Assessment .......................................................................................................... 19

5.1 Overview ........................................................................................................................... 19

5.2 Strategic Competitor Assessment ..................................................................................... 20

5.3 Product Profiles – Major Brands ........................................................................................ 21

5.3.1 Vagifem (estradiol vaginal tablet) .................................................................................. 21



TO 2022

Table of Contents

5.3.2 Estring (estradiol vaginal ring) ....................................................................................... 25

5.3.3 Premarin (conjugated estrogens cream) ........................................................................ 28

5.3.4 Estrace (17 beta-estradiol cream) ................................................................................. 32

5.3.5 Minor Therapeutic Classes ............................................................................................ 35

6 Opportunity and Unmet Needs .................................................................................................. 37

6.1 Unmet Needs .................................................................................................................... 38

6.1.1 Disease Awareness and Increased Treatment-Seeking Behavior ................................. 39

6.1.2 Alternatives to Estrogen Therapy/Improved Drug Safety Profiles .................................. 39

6.1.3 Convenience and Patient Compliance ........................................................................... 40

6.1.4 Unmet Needs Gap Analysis .......................................................................................... 41

6.1.5 Opportunity 1: Dosing and Administration ..................................................................... 42

6.1.6 Opportunity 2: Compliance and Convenience................................................................ 42

6.1.7 Opportunity 3: Safety ..................................................................................................... 43

7 Pipeline Assessment................................................................................................................. 44

7.1 Overview ........................................................................................................................... 44

7.2 Promising Drugs in Clinical Development .......................................................................... 45

7.2.1 Osphena (ospemifene) .................................................................................................. 48

7.2.2 Vaginorm (prasterone, intravaginal DHEA) .................................................................... 54

7.2.3 BZA/CE (bazedoxifene + conjugated estrogens) ........................................................... 60

7.2.4 Forecast ........................................................................................................................ 65

8 Market Outlook ......................................................................................................................... 66

8.1 United States .................................................................................................................... 66

8.1.1 Forecast ........................................................................................................................ 66

8.1.2 Key Events .................................................................................................................... 68

8.1.3 Drivers and Barriers ...................................................................................................... 68

9 Appendix................................................................................................................................... 71

9.1 Bibliography ...................................................................................................................... 71



TO 2022

Table of Contents

9.2 Abbreviations .................................................................................................................... 77

9.3 Methodology ..................................................................................................................... 79

9.4 Forecasting Methodology .................................................................................................. 79

9.4.1 Diagnosed postmenopausal atrophy patients ................................................................ 79

9.4.2 Percent Drug-Treated Patients ...................................................................................... 80

9.4.3 Launch and Patent Expiry Dates ................................................................................... 80

9.4.4 General Pricing Assumptions ........................................................................................ 81

9.4.5 Individual Drug Assumptions ......................................................................................... 81

9.4.6 Generic Erosion ............................................................................................................ 83

9.4.7 Pricing of Pipeline agents .............................................................................................. 83

9.5 Physicians and Specialists Included in This Study ............................................................ 84

9.6 About the Authors ............................................................................................................. 86

9.6.1 Author ........................................................................................................................... 86

9.6.2 Global Director of Epidemiology and Clinical Trials Analysis ......................................... 86

9.6.3 Director of Oncology, Hematology and Gender Health .................................................. 87

9.6.4 Global Head of Healthcare ............................................................................................ 87

9.7 About GlobalData .............................................................................................................. 88

9.8 Disclaimer ......................................................................................................................... 88



TO 2022

Table of Contents

1.1 List of Tables

Table 1: Symptoms of PVA ............................................................................................................................ 13

Table 2: Treatment Guidelines for PVA .......................................................................................................... 15

Table 3: Most Prescribed Drugs for PVA by Class in the Global Markets, 2012 .............................................. 16

Table 4: Leading Treatments for PVA, 2012................................................................................................... 20

Table 5: Product Profile – Vagifem ................................................................................................................. 22

Table 6: Vagifem SWOT Analysis, 2012 ........................................................................................................ 24

Table 7: Global Sales Forecasts ($m) for Vagifem, 2012–2022 ...................................................................... 24

Table 8: Product Profile – Estring ................................................................................................................... 25

Table 9: Estring SWOT Analysis, 2012 .......................................................................................................... 27

Table 10: Global Sales Forecasts ($m) for Estring, 2012–2022 ...................................................................... 27

Table 11: Product Profile – Premarin ............................................................................................................. 29

Table 12: Premarin Cream SWOT Analysis, 2012 .......................................................................................... 30

Table 13: Global Sales Forecasts ($m) for Premarin Cream, 2012–2022 ....................................................... 31

Table 14: Product Profile – Estrace ................................................................................................................ 32

Table 15: Estrace SWOT Analysis, 2012 ....................................................................................................... 33

Table 16: Global Sales Forecasts ($m) for Estrace, 2012–2022 ..................................................................... 34

Table 17: Summary of Minor Therapeutic Classes, 2012 ............................................................................... 36

Table 18: Overall Unmet Needs – Current Level of Attainment ....................................................................... 38

Table 19: Clinical Unmet Needs – Gap Analysis, 2012 ................................................................................... 41

Table 20: PVA – Phase Pipeline, 2012 .......................................................................................................... 45

Table 21: Comparison of Therapeutic Classes in Development for PVA, 2012 ............................................... 47

Table 22: Product Profile – Osphena ............................................................................................................. 48

Table 23: Osphena SWOT Analysis, 2012 ..................................................................................................... 52



TO 2022

Table of Contents

Table 24: Global Sales Forecasts ($m) for Osphena, 2012–2022 ................................................................... 53

Table 25: Product Profile – Vaginorm ............................................................................................................. 55

Table 26: Vaginorm SWOT Analysis, 2012 .................................................................................................... 58

Table 27: Global Sales Forecasts ($m) for Vaginorm, 2012–2022 .................................................................. 59

Table 28: Product Profile – BZA/CE ............................................................................................................... 61

Table 29: BZA/CE SWOT Analysis, 2012 ....................................................................................................... 64

Table 30: Global Sales Forecasts ($m) for BZA/CE, 2012–2022 .................................................................... 65

Table 31: Sales Forecasts ($m) for PVA in the United States, 2012–2022 ...................................................... 67

Table 32: Key Events Impacting Sales for PVA in the United States, 2012–2022 ........................................... 68

Table 33: PVA Market in the United States – Drivers and Barriers, 2012–2022 .............................................. 68

Table 34: Key Launch Dates .......................................................................................................................... 80

Table 35: Key Patent Expiries ........................................................................................................................ 80

1.2 List of Figures

Figure 1: Competitive Assessment of Late-Stage Pipeline Agents in PVA, 2012–2022 ................................... 46



TO 2022

Introduction

2 Introduction

2.1 Catalyst

Although the postmenopausal vaginal atrophy (PVA) market has experienced anemic growth over

the past decade, it is expected to undergo a considerable change between 2012 and 2022. Several

market-leading therapies, including Pfizer’s Premarin (conjugated estrogens) and Merck’s

Colpotrophine (promestriene), will lose patent protection between 2012 and 2015. In addition, a

number of oral estrogens, vaginal patches, and vaginal creams will lose exclusivity, leading to a

flood of cheaper generic options.

The launches of three novel drugs with improved safety profiles — Osphena (ospemifene),

Vaginorm (prasterone), and BZA/CE (bazedoxifene + conjugated estrogens) — will bolster

treatment-seeking behavior during the forecast period. These non-estrogenic therapies will shift the

PVA treatment paradigm away from systemic estrogen therapies (ETs), such as pills, patches, and

gels. Furthermore, healthcare reform under the Affordable Care Act (ACA) will increase the number

of insured elderly US women, thereby potentially boosting treatment-seeking behavior for

menopausal conditions. These dynamics will be reflected in the moderate growth of the overall

PVA market during the forecast period, which will increase from $1.1bn in 2012 to $2.1bn in 2022

at a Compound Annual Growth Rate (CAGR) of 6.35%.

2.2 Related Reports

GlobalData (2012). GlobalData Healthcare Policy Analysis 2012 – Regulatory, Pricing, and

Reimbursement, July 2012, GDH001HPM

GlobalData (2013). Postmenopausal Vaginal Atrophy – France Drug Forecast and Market

Analysis to 2022, July 2013, GDHC177CFR

GlobalData (2013). Postmenopausal Vaginal Atrophy – Germany Drug Forecast and Market




TO 2022

Introduction

GlobalData (2013). Postmenopausal Vaginal Atrophy – Italy Drug Forecast and Market


GlobalData (2013). Postmenopausal Vaginal Atrophy – Spain Drug Forecast and Market


GlobalData (2013). Postmenopausal Vaginal Atrophy – UK Drug Forecast and Market Analysis

to 2022, July 2013, GDHC181CFR

GlobalData (2013). Postmenopausal Vaginal Atrophy – Japan Drug Forecast and Market


GlobalData (2013). Vagifem (Postmenopausal Vaginal Atrophy) - Forecast and Market

Analysis to 2022, July 2013, GDHC289DFR

GlobalData (2013). Estring (Postmenopausal Vaginal Atrophy) - Forecast and Market Analysis

to 2022, July 2013, GDHC290DFR

GlobalData (2013). Premarin (Postmenopausal Vaginal Atrophy) - Forecast and Market


GlobalData (2013). Estrace (Postmenopausal Vaginal Atrophy) - Forecast and Market Analysis

to 2022, July 2013, GDHC292DFR

GlobalData (2013). Colpotrophine (Postmenopausal Vaginal Atrophy) - Forecast and Market


GlobalData (2013). Postmenopausal Vaginal Atrophy - Current and Future Players.

GDHC1023FPR

2.3 Upcoming Related Reports

GlobalData (2013). Endometriosis – Opportunity Analyzer, September 2013



TO 2022

Appendix

9.7 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, reportsh 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

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.

postmenopausal vaginal atrophy - us drug … filereference code gdhc176cfr | publication date july...

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