Stakeholder Opinions: Sexually Transmitted Diseases - An underestimated threat lacking interventions to prevent transmission

Introduction

Sexually transmitted diseases (STDs) represent a significant health threat given their potentially serious complications and association with increased transmission of human immunodeficiency virus (HIV). High disease burdens, low diagnosis and treatment rates, and a lack of marketed interventions for the prevention of most STDs highlight the clinical and commercial potential in this area.

Scope

*Review of epidemiology and current treatment practice for chlamydia, gonorrhea, HPV, HSV-2 across the US, Japan, France, Italy, Germany, Spain and UK

*Review of current clinical practice and key drugs and vaccines in development for sexually transmitted diseases

*Thorough assessment of key developments, opportunities and threats shaping the sector

*In-depth discussion of future strategies to improve the management of sexually transmitted diseases

Highlights

The potential for prophylactic vaccines against STDs has been demonstrated by the success of marketed prophylactic human papillomavirus vaccines. Due to its wider serotype coverage, Merck & Co's Gardasil continues to outperform GlaxoSmithKline's Cervarix with annual global sales of $1.7 billion versus $292m, respectively.

Challenges for the development of vaccines against chlamydia, gonorrhea or HSV-2 include vaccine design, considering the complexity of pathogen biology and required immune response, as well as reimbursement and uptake. Successful marketing strategies could exploit the link between STDs and infertility as well as increased HIV transmission.

Improvements in rapid point-of-care diagnostic tests and the development of home-testing devices would increase currently low diagnosis and treatment rates for STDs and help to prevent transmission and long-term complications.

Reasons to Purchase

*Review the epidemiological and clinical factors driving new product decisions in STDs as well as unmet needs with current treatment options.

*Understand challenges, unmet needs and future opportunities by learning about the views of key opinion leaders

*Gain competitive advantage by identifying key product characteristics and potential roles for new therapies


Report Highlights

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Overview 1
Catalyst 1
Summary 1
About Datamonitor healthcare 2
About the Vaccines & Infectious Diseases pharmaceutical analysis team 2
Executive Summary 3
Scope of the analysis 3
Datamonitor insight into the sexually transmitted diseases (STDs) market 3
Related reports 5
Upcoming related reports 5
Table of Contents 6
1. Sexually transmitted Diseases - Overview 7
Background 7
STDs are an important global health priority 7
Epidemiological trends 8
The asymptomatic nature of many STDs leads to significant underreporting 8
World Health Organization estimates that 50% of people will have a sexually transmitted disease at some point during their lives 9
Sexually transmitted diseases play a key role as co-factors in HIV acquisition and transmission 10
Key risk factors and high-risk population for sexually transmitted diseases 10
Risk factors 10
High-risk sexual behavior greatly increases the chances of a person acquiring a sexually transmitted disease 10
High-risk population groups 11
Young adolescents and adults 12
Pregnant women 12
Men who have sex with men 13
Injecting drug users 13
Black or African-American race 13
Disease management 13
Underdiagnosis and lack of treatment of sexually transmitted diseases hinder efforts to prevent onward transmission 13
If left untreated, sexually transmitted diseases can develop serious and life-threatening complications 14
Therapeutics 15
Drug therapy plays a major role in the management of chlamydia, gonorrhea, and herpes simplex virus type 2 infection 15
Vaccines 15
Marketed vaccines are only available for human papillomavirus, but not for chlamydia, gonorrhea or HSV 15
Pipeline 16
While the pipeline is sparse for bacterial STDs, R&D interest is growing for viral STDs 16
2. Chlamydia 18
Key findings 18
Disease background 18
Epidemiology 19
Seven major markets 19
US 20
Japan 22
France 22
Germany 23
Spain 24
Italy 24
UK 24
Rest of the world 25
Brazil, India, Russia, China (BRIC countries) 26
Australia 27
Canada 27
Current therapy / market overview 27
Treatment guidelines and available drugs 27
Prevention 30
Screening 30
Surveillance 32
Unmet needs 33
A vaccine would greatly facilitate the prevention of genital chlamydia infections 34
Patient education will improve diagnosis rates and help to limit disease transmission in high-risk populations 35
Growth of expedited partner therapy (EPT) will aid prevention of transmission of chlamydia in the absence of a vaccine 35
Improvements in point-of-care (PoC) testing devices and moving testing out of clinical settings will help to improve treatment rates for chlamydia and prevent serious sequelae 35
Pipeline overview 36
While no new chlamydia drugs are in clinical trials, R&D progress gives hope for future success 36
Research has provided key insight into the human immune response to Chlamydia trachomatis infections 36
Historical problems and a lack of understanding of the human immune response are deterring investment in chlamydia vaccine research 37
Trial failures have led to a cautious approach in chlamydia vaccine research 39
Outlook 40
Improvements in rapid point-of-care diagnostic tests and regulatory clearance of home-testing devices would increase treatment rates 40
With therapeutics largely unaffected by resistance, current 'gold standard' therapies will continue to dominate future treatment of chlamydia 41
Key opinion leaders hope for a chlamydia vaccine, but are doubtful whether this is a realistic prospect 42
Expedited partner therapy will play a growing and important role in restricting transmission of chlamydia infection 43
3. Gonorrhea 45
Key findings 45
Disease background 45
Epidemiology 46
Seven major markets 46
US 47
Japan 49
France 49
Germany 49
Spain 49
Italy 49
UK 50
Rest of the world 50
Brazil, Russia, India, China (BRIC countries) 50
Canada 52
Australia 52
Current therapy/Market overview 52
Treatment guidelines and available drugs 52
Prevention 54
Screening 54
Surveillance 55
Unmet needs 56
Growing antimicrobial resistance threatens the availability of efficacious drugs for gonorrhea infections 56
A gonorrhea vaccine would be advantageous for prevention of transmission but remains many years from the market 57
An increased focus on patient education and disease awareness is needed to improve gonococcal infection control 57
Pipeline 57
Treatment 57
The pipeline for gonorrhea drugs is bare, highlighting the limited commercial opportunity 57
Prevention 58
Historical failures and poor prospects for success deter gonorrhea vaccine R&D 58
Outlook 58
Treatment 58
In the absence of new drugs for gonorrhea, physicians will increasingly rely on combination therapy in a bid to combat antimicrobial resistance 58
Prevention 61
A marketed vaccine would be beneficial for reduction of gonorrhea transmission, although the prospects for commercialization are poor 61
4. Human papillomavirus 63
Key findings 63
Disease background 64
Epidemiology 65
Seven major markets 65
US 67
Japan 67
France 67
Germany 67
Italy 68
Spain 68
UK 68
Rest of the World 69
Brazil, Russia, India, China (the BRIC countries) 69
Australia 70
Canada 70
Current therapy / Market overview 70
Treatment 70
Prevention is the key strategy in HPV management 70
Prevention 71
Two prophylactic vaccines against HPV are available and widely recommended across the seven major markets 71
Due to its first-to-market advantage and wider serotype coverage, Gardasil outperforms Cervarix in terms of sales 74
Screening 75
Screening for high-risk HPV types is crucial to securing an early diagnosis of cervical cancer 75
Surveillance 76
The availability of HPV vaccines has highlighted the need for improved disease reporting and surveillance across the seven major markets 76
Unmet needs 77
Ethical and social issues remain an obstacle to establishing HPV vaccination among young females 78
Prophylactic HPV vaccines with a wider serotype coverage could further increase protection against infection with high-risk types 79
Patient education and increasing disease awareness remain important for promoting screening and reducing the prevalence of serious sequelae of HPV infection 80
Pipeline 80
R&D activity for human papillomavirus is growing 80
V503 (Merck & Co) 82
Drug profile 82
Outlook 84
Extent of cross-protection for Gardasil and Cervarix will determine the market opportunity for pipeline vaccines with wider high-risk HPV serotype coverage 84
Increased efforts for parental and patient education will help to allay HPV vaccination fears and ensure that vaccines are reaching the target groups that most need them 87
Vaccine coverage of genital warts is attractive for patients and physicians and adds commercial value 89
Recommendation for vaccination of boys in the US will expand patient populations for HPV vaccines, although a similar recommendation in the five major EU markets remains uncertain 90
Regulatory delays and doubts regarding cost/benefit are obstacles for a recommendation of HPV vaccination in older women 91
Although there is significant potential for HPV therapeutics, success will depend on the level of prophylactic vaccine coverage across the seven major markets 92
5. Herpes simplex virus type 2 94
Key findings 94
Disease background 95
Epidemiology 95
Seven major markets 95
US 96
Japan 97
France 98
Germany 98
Spain 98
Italy 99
UK 99
Rest of the World 100
Brazil, Russia, India, China (BRIC countries) 100
Australia 101
Canada 101
Current therapy / Market overview 101
Treatment 101
Cheap, efficacious antivirals relatively unaffected by resistance are available to treat initial and recurrent genital herpes infections and to reduce transmission 101
Guidelines for the treatment of HSV-2 infection are available in the US and Europe, although adherence is weak 105
Prevention 106
First HSV-2 vaccine candidates have reached late-stage clinical development 106
Screening 107
Surveillance 107
Reporting and surveillance of genital herpes infections is inconsistent across the seven major markets 107
Unmet needs 108
Key opinion leaders remain skeptical about the feasibility of a vaccination approach 109
Patient education is vital to reducing initial episodes, transmission, and the recurrence of HSV-2 infections 109
A rapid point-of-care (PoC) test based on serology for HSV-2 infection would enable physicians to treat early and restrict transmission in sexual networks 110
Pipeline 110
R&D activity is diverse for HSV-2 as drug developers see lucrative future markets for prophylactic and therapeutic vaccines in addition to antiviral drugs and topical products 110
Simplirix (GSK208141, GlaxoSmithKline) 112
Drug profile 112
Outlook 114
A vaccine for HSV-2 may be marketed in the medium term, with benefits for reducing transmission of both HSV-2 and HIV infection 114
Therapeutic vaccines would provide an efficacious and convenient alternative to long-term antiviral therapy for recurrent HSV-2 infections 117
A genericized market and lack of significant resistance restrict market opportunity for new HSV-2 antiviral drugs 118
Bibliography 119
Journals 119
Websites 128
Datamonitor reports 135
Appendix A 136
Data definitions, limitations and assumptions 136
Standard units 136
Country group definitions 136
Rest of European Union 136
Middle East and North Africa (MENA) 136
Rest of World 136
Appendix B 137
Contributing experts 137
Conferences attended 137
Report methodology 137
About Datamonitor 138
About Datamonitor Healthcare 138
About the Infectious Diseases analysis team 139
Disclaimer 141
List of Tables
Table 1: Common sexually transmitted diseases (STDs) of viral, bacterial, and parasitic etiology 7
Table 2: Sexually transmitted diseases (STDs) covered in this report 8
Table 3: Risk factors for acquiring sexually transmitted diseases (STDs) 11
Table 4: Chlamydia incidence and prevalence rates across the seven major markets 20
Table 5: Leading treatments for chlamydia infection, 2010 29
Table 6: Chlamydia screening recommendations in the seven major markets, 2010 31
Table 7: Chlamydia reporting and surveillance methodologies across the seven major markets, 2010 33
Table 8: Selected products in development for Chlamydia trachomatis infection, 2010 38
Table 9: Gonorrhea incidence and prevalence rates across the seven major markets 47
Table 10: Gonorrhea screening policy in the seven major markets, 2010 54
Table 11: Gonorrhea - overview of surveillance programs in the seven major markets, 2010 55
Table 12: Human papillomavirus (HPV) incidence and prevalence rates across the seven major markets, 2010 66
Table 13: Vaccines for the prevention of human papillomavirus (HPV) infection, 2010 72
Table 14: Human papillomavirus (HPV) vaccination recommendations in the seven major markets, 2010 73
Table 15: Human papillomavirus (HPV) screening recommendations in the seven major markets, 2010 76
Table 16: Human papillomavirus (HPV) - overview of surveillance programs in the seven major markets, 2010 77
Table 17: Products in clinical development for human papillomavirus (HPV) infection, 2010 81
Table 18: Ongoing Phase III clinical trials for Merck's V503 83
Table 19: V503 - drug profile, 2010 84
Table 20: Cervarix vaccine efficacy against individual non-vaccine high risk human papillomavirus (HPV) types against 6- and 12-month persistent infection 85
Table 21: Efficacy of Cervarix and Gardasil against cervical intraepithelial neoplasia grade II (CIN2+) non-vaccine human papillomavirus (HPV) types 86
Table 22: Herpes simplex virus type 2 (HSV-2) seroprevalence rates across the seven major markets 96
Table 23: Seroprevalence of herpes simplex virus type 2 (HSV-2) in various target groups in the US 97
Table 24: Seroprevalence of herpes simplex virus type 2 (HSV-2) in various target groups in Frankfurt, Germany 98
Table 25: Leading treatments for herpes simplex virus (HSV) infection, 2010 103
Table 26: Centers for Disease Control and Prevention (CDC) recommendations for the treatment of genital herpes infections 106
Table 27: The International Union against Sexually Transmitted Infections (IUSTI) and the World Health Organization (WHO) draft European guideline (2010) for the management of genital herpes 106
Table 28: Herpes simplex virus type 2 (HSV-2) screening policy in the seven major markets, 2010 107
Table 29: Genital herpes - overview of surveillance programs in the seven major markets 2010 108
Table 30: Products in clinical development for herpes simplex type 2 (HSV-2) infection, 2010 111
Table 31: Simplirix (GSK208141) - drug profile, 2010 114
List of Figures
Figure 1: Chlamydia and gonorrhea incidence rates per 100,000 persons in the US and UK, 1999-2008 10
Figure 2: Population groups at high risk of acquiring sexually transmitted diseases (STDs) 12
Figure 3: Factors contributing to underdiagnosis and lack of treatment of sexually transmitted diseases (STDs) 14
Figure 4: Chlamydia incidence rate per 100,000 persons in the US, 1988-2008 21
Figure 5: Age and sex-specific chlamydia incidence rates per 100,000 persons in the US, 2008 22
Figure 6: Confirmed STDs per 1,000 people attending sentinel chlamydia screening in the period January 2003-June 2005 23
Figure 7: Number of chlamydia cases by sex and age in the UK, 2008 25
Figure 8: Chlamydia incidence and prevalence rates in Brazil, Russia, India, China, Canada, and Australia, 2007-2010 26
Figure 9: Key unmet needs for chlamydia infection, 2010 33
Figure 10: Gonorrhea incidence rate per 100,000 persons in the US, 1988-2008 48
Figure 11: Age and sex-specific gonorrhea incidence rates per 100,000 persons in the US, 2008 48
Figure 12: New cases of gonorrhea infection in the UK, 1999-2008 50
Figure 13: Gonorrhea incidence and prevalence rates in Brazil, Russia, India, China, Canada, and Australia 51
Figure 14: Key unmet needs for gonorrhea, 2010 56
Figure 15: Human papillomavirus (HPV) prevalence and incidence rates in Brazil, Russia, India, China, Australia, and Canada 69
Figure 16: Sales of Gardasil versus Cervarix in human papillomavirus (HPV) vaccination, 2006-09 74
Figure 17: Key unmet needs for human papillomavirus (HPV), 2010 78
Figure 18: Human papillomavirus (HPV) pipeline, 2010 82
Figure 19: Age- and sex-specific seroprevalence of herpes simplex virus type 2 (HSV-2) in the US, 2008 97
Figure 20: New genital herpes infections (both new first episodes and recurrent infections) in the UK, 1999-2008 99
Figure 21: Herpes simplex virus type 2 (HSV-2) seroprevalence rates in Brazil, Russia, India, China, Australia, and Canada 100
Figure 22: Key unmet needs for herpes simplex virus type 2 (HSV-2), 2010 108
Figure 23: Herpes simplex virus type 2 (HSV-2) pipeline, 2010 112

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