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Cytomegalovirus (CMV): Opportunity Analysis and Forecasts to 2027

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Cytomegalovirus (CMV): Opportunity Analysis and Forecasts to 2027

Summary

Cytomegalovirus (CMV) is a ? human herpesvirus (HHV-5) of the herpesviridae family. Exposure to the virus can result in lytic infection, producing symptoms that range from those of a common cold to more serious morbidities, including hepatitis and pneumonitis. CMV also has the capacity to establish life-long latent infections, incorporating genomic DNA into host cells without detectable viral gene expression. CMV is a globally ubiquitous pathogen that affects 1/3 of children by the age of 5 and over half of adults by the age of 40. Although largely asymptomatic in immunocompetent adults, CMV infection is a clinically significant disease in patients with compromised immune systems or those receiving immunosuppressive therapy. Particularly vulnerable patients include solid organ transplant (SOT), bone marrow transplant (BMT), hematopoietic stem cell transplant (HSCT), and human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) patients, as well as newborns that acquire the infection by transmission from the mother through the placenta.

Currently available therapies for CMV can be divided into two general classes: antiviral drugs for treatment of clinically significant CMV infections and antiviral drugs for CMV prophylaxis. The majority of antivirals are administered in a clinical setting as both therapy and prophylaxis, with variations in dosing parameters depending on the treated patient population. However, major shifts are expected to occur in the CMV market during the forecast period with the projected launch of first-in-class products for CMV therapy and prophylaxis, including cellular immunotherapy and a CMV vaccine.

Key Questions Answered

- How will the CMV therapeutic market landscape in the 7MM (US, France, Germany, Italy, Spain, UK, Japan) change from 2017-2027?

- What are the most promising late-stage pipeline drugs for CMV?

- How do the clinical and commercial attributes of late-stage pipeline therapies compare with one another, and against existing treatment options?

- What are the remaining unmet needs in CMV treatment management?

- What drivers and barriers will affect CMV therapeutics sales in the 7MM over the forecast period?

Scope

- Overview of CMV, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and current management strategies.

- Topline CMV market revenue from 2017-2027. Annual cost of therapy (ACOT) and major pipeline product sales in this forecast period are included.

- Key topics covered include current treatment and prophylactic options, unmet needs and opportunities, and the drivers and barriers affecting CMV therapeutics sales in the 7MM.

- Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, synopses of innovative early-stage projects, and detailed analysis of late-stage pipeline products.

- Analysis of the current and future market competition in the global CMV therapeutics and prophylactics market. Insightful review of the key industry drivers, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

The report will enable you to-

- Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

- Develop business strategies by understanding the trends shaping and driving the global CMV therapeutics market.

- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the CMV therapeutics market in the future.

- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

- Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

READ MORE

Table Of Content

Scope

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 7

2 Cytomegalovirus (CMV): Executive Summary 8

2.1 Moderate Growth Is Projected for the CMV Market from 2017 to 2027 9

2.2 Manufacturers Are Focusing on Novel CMV Prophylactic Strategies with Less Toxicity 10

2.3 Significant Unmet Need Remains for Products to Prevent Congenital CMV Infections 11

2.4 Opportunities Exist for Long-Term and Cost-Effective Prophylaxis Therapies 11

2.5 Diverse Pipeline Therapies Poised to Begin Addressing Unmet Needs 12

2.6 What Do Physicians Think? 14

3 Introduction 17

3.1 Catalyst 17

3.2 Related Reports 18

3.3 Upcoming Related Reports 18

4 Disease Overview 19

4.1 Etiology and Pathophysiology 19

4.1.1 Etiology 19

4.1.2 Pathophysiology 23

5 Epidemiology 25

5.1 Disease Background 25

5.2 Risk Factors and Comorbidities 25

5.3 Global and Historical Trends 27

5.3.1 CMV Disease in Diagnosed Prevalent HIV Patients 28

5.3.2 CMV Disease in SOT Patients 29

5.3.3 CMV Disease in HSCT Patients 29

5.3.4 Congenital CMV Disease 30

5.4 Forecast Methodology 30

5.4.1 Sources 31

5.4.2 Forecast Assumptions and Methods 35

5.5 Epidemiological Forecast for CMV (2017-2027) 49

5.5.1 Diagnosed Incident Cases of CMV 49

5.5.2 Age-Specific Diagnosed Incident Cases of CMV 50

5.5.3 Sex-Specific Diagnosed Incident Cases of CMV 51

5.5.4 CMV Diagnosed Incident Cases by Population at Risk 52

5.5.5 HIV-CMV 53

5.5.6 SOT Patients 55

5.5.7 SOT-CMV 56

5.5.8 HSCT Patients 57

5.5.9 HSCT-CMV 58

5.5.10 Diagnosed Incident Cases of Congenital CMV 59

5.6 Discussion 61

5.6.1 Epidemiological Forecast Insight 61

5.6.2 Limitations of Analysis 62

5.6.3 Strengths of Analysis 63

6 Current Treatment Options 64

6.1 Overview 64

7 Unmet Needs and Opportunity Assessment 67

7.1 Overview 67

7.2 Treatment Options for Resistant or Refractory CMV Infections 69

7.2.1 Unmet Need 69

7.2.2 Gap Analysis and Opportunity 70

7.3 A Safe and Immunogenic Vaccine for CMV Prevention 71

7.3.1 Unmet Need 71

7.3.2 Gap Analysis and Opportunity 73

7.4 Antiviral Monotherapy or Combination Therapy with Improved Efficacy and Safety 74

7.4.1 Unmet Need 74

7.4.2 Gap Analysis and Opportunity 75

7.5 Prevention and Management of Congenital CMV Infections 76

7.5.1 Unmet Need 76

7.5.2 Gap Analysis and Opportunity 77

7.6 Tools or Biomarkers to Assess Risk of Reactivation 78

7.6.1 Unmet Need 78

7.6.2 Gap Analysis and Opportunity 79

8 R&D Strategies 81

8.1 Overview 81

8.1.1 Development of Antivirals with Novel MOAs to target refractory or resistant CMV 81

8.1.2 Application of cellular immunotherapy 83

8.1.3 Development of a CMV Vaccine 85

8.1.4 Immune Globulin and mAb Therapies 87

8.2 Clinical Trial Design 90

8.2.1 Antivirals 90

8.2.2 Cellular Immunotherapy 92

8.2.3 Vaccines 94

8.2.4 Immune Globulins 96

9 Pipeline Assessment 98

9.1 Overview 98

9.2 Innovative Early-Stage Approaches 100

10 Pipeline Valuation Analysis 103

10.1 Clinical Benchmark of Key Pipeline Products 103

10.1.1 Therapeutic Agents 103

10.1.2 Prophylactic Agents 104

10.2 Commercial Benchmark of Key Pipeline Products 105

10.2.1 Therapeutic Agents 105

10.2.2 Prophylactic Agents 106

10.3 Competitive Assessment 107

10.3.1 Therapeutic Agents 107

10.3.2 Prophylactic Agents 109

10.4 Top-Line 10-Year Forecast 110

10.4.1 US 115

10.4.2 5EU 117

10.4.3 Japan 119

11 Appendix 122

11.1 Bibliography 122

11.2 Abbreviations 140

11.3 Methodology 143

11.3.1 Forecasting Methodology 143

11.3.2 CMV Patient Population Segmentation 143

11.3.3 Percent Drug-Treated Patients 144

11.3.4 Drugs Included in Each Therapeutic Class 144

11.3.5 Launch and Patent Expiry Dates 145

11.3.6 General Pricing Assumptions 146

11.3.7 Individual Drug Assumptions 147

11.3.8 Generic Erosion 151

11.3.9 Pricing of Pipeline Agents 151

11.4 Primary Research-KOLs Interviewed for This Report 154

11.4.1 KOLs 154

11.5 Primary Research-Prescriber Survey 157

11.6 About the Authors 158

11.6.1 Analyst 158

11.6.2 Therapy Area Director 158

11.6.3 Epidemiologist 158

11.6.4 Managing Epidemiologist 159

11.6.5 Global Director of Therapy Analysis and Epidemiology 159

11.6.6 Global Head and EVP of Healthcare Operations and Strategy 160

11.7 About GlobalData 161

11.8 Contact Us 161

11.9 Disclaimer 162


List Of Figure

1.2 List of Figures

Figure 1: Global Sales Forecast by Country for CMV in 2017 and 2027 10

Figure 2: Competitive Assessment of the Marketed and Pipeline Therapeutics Benchmarked Against the SOC, Ganciclovir and Valganciclovir. 13

Figure 3: Competitive Assessment of the Marketed and Pipeline Prophylactics Benchmarked Against the Standard of Care (SOC), Ganciclovir and Valganciclovir. 14

Figure 4: Human CMV Virion Structure 20

Figure 5: CMV Life Cycle in a Human Cell 22

Figure 6: Age-Standardized Diagnosed Incidence of CMV Disease, All Ages, 2017 28

Figure 7: Case Flow Map 30

Figure 8: Sources Used and Not Used for Calculations of Diagnosed Incident Cases of HIV-CMV 31

Figure 9: Sources Used and Not Used for Calculations of SOT Patients 32

Figure 10: Sources Used and Not Used for Calculations of Diagnosed Incident Cases of SOT-CMV 33

Figure 11: Sources Used and Not Used for Calculations of HSCT Patients and Diagnosed Incident Cases of HSCT-CMV 34

Figure 12: Sources Used and Not Used for Calculations of Live Births and cCMV Cases 35

Figure 13: Diagnosed Incident Cases of CMV, 7MM, Men and Women, All Ages, 2017 50

Figure 14: 7MM, Age-Specific Diagnosed Incident Cases of CMV Disease, Men and Women, 2017 51

Figure 15: 7MM, Sex-Specific Diagnosed Incident Cases of CMV Disease, All Ages, 2017 52

Figure 16: 7MM, Diagnosed Incident Cases of CMV Disease by Population at Risk, Men and Women, All Ages, 2017 53

Figure 17: 5EU and Japan, Diagnosed Incident Cases of HIV-CMV, Men and Women, All Ages, 2017-2027 54

Figure 18: US, Diagnosed Incident Cases of HIV-CMV, Men and Women, All Ages, 2017-2027 55

Figure 19: 7MM, SOT Patients, Men and Women, All Ages, 2017-2027 56

Figure 20: 7MM, Diagnosed Incident Cases of SOT-CMV, Men and Women, All Ages, 2017-2027 57

Figure 21: 7MM, HSCT Patients, Men and Women, All Ages, 2017-2027 58

Figure 22: 7MM, Diagnosed Incident Cases of HSCT-CMV, Men and Women, All Ages, 2017-2027 59

Figure 23: 5EU and Japan, Diagnosed Incident Cases of cCMV, Men and Women, All Ages, 2017-2027 60

Figure 24: US, Diagnosed Incident Cases of cCMV, Men and Women, All Ages, 2017-2027 61

Figure 25: Unmet Needs and Opportunities in CMV 68

Figure 26: Overview of the Development Pipeline in CMV 99

Figure 27: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for CMV in the 7MM During the Forecast Period 100

Figure 28: Competitive Assessment of the Marketed and Pipeline Therapeutics Benchmarked Against the SOC, Ganciclovir and Valganciclovir. 108

Figure 29: Competitive Assessment of the Marketed and Pipeline Prophylactics Benchmarked Against the SOC, Ganciclovir and Valganciclovir. 110

Figure 30: Global (7MM) Sales Forecast by Country for CMV in 2017 and 2027 112

Figure 31: Global Sales Forecast by Product for CMV in 2017 and 2027 113

Figure 32: Therapeutic Sales Forecast for CMV in the US in 2017 and 2027 116

Figure 33: Prophylactic Sales Forecast for CMV in the US in 2017 and 2027 117

Figure 34: Therapeutic Sales Forecast for CMV in the 5EU in 2017 and 2027 118

Figure 35: Prophylactic Sales Forecast for CMV in the 5EU in 2017 and 2027 119

Figure 36: Therapeutic Sales Forecast for CMV in Japan in 2017 and 2027 120

Figure 37: Prophylactic Sales Forecast for CMV in Japan in 2017 and 2027 121


List Of Table

1.1 List of Tables

Table 1: CMV: Key Metrics in the 7MM 8

Table 2: Risk Factors and Comorbidities for CMV 26

Table 3: Treatment Guidelines for CMV 66

Table 4: Leading Treatments for CMV, 2018 66

Table 5: Clinical Trial Designs for CMV Pipeline Antivirals 90

Table 6: Clinical Trial Designs for CMV Cellular Immunotherapy 92

Table 7: Clinical Trial Designs for CMV Vaccines 94

Table 8: Clinical Trial Designs for CMV Immune globulins 96

Table 9: Innovative Early-Stage Approaches for CMV, 2018 102

Table 10: Clinical Benchmark of Key Pipeline Therapeutics-CMV 104

Table 11: Clinical Benchmark of Key Pipeline Prophylactics-CMV 105

Table 12: Commercial Benchmark of Key Pipeline Therapeutics-CMV 106

Table 13: Commercial Benchmark of Key Pipeline Prophylactics-CMV 107

Table 14: Key Events Impacting Sales for CMV, 2017-2027 114

Table 15: CMV Market-Global Drivers and Barriers, 2017-2027 115

Table 16: Key Historical and Projected Launch Dates for CMV 145

Table 17: Key Historical and Projected Patent Expiry Dates for CMV 145

Table 18: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 157

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Products and Companies


Companies

Atara Bio

Biotest AG

Helocyte

Merck & Co.

Novartis

Shire

ViraCyte