Cytomegalovirus (CMV): Opportunity Analysis and Forecasts to 2027

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Cytomegalovirus (CMV) is a β 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.

Atara Bio
Biotest AG
Helocyte
Merck & Co.
Novartis
Shire
ViraCyte

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Cytomegalovirus (CMV): Executive Summary

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

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

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

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

2.5 Diverse Pipeline Therapies Poised to Begin Addressing Unmet Needs

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Etiology

4.1.2 Pathophysiology

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.3.1 CMV Disease in Diagnosed Prevalent HIV Patients

5.3.2 CMV Disease in SOT Patients

5.3.3 CMV Disease in HSCT Patients

5.3.4 Congenital CMV Disease

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for CMV (2017–2027)

5.5.1 Diagnosed Incident Cases of CMV

5.5.2 Age-Specific Diagnosed Incident Cases of CMV

5.5.3 Sex-Specific Diagnosed Incident Cases of CMV

5.5.4 CMV Diagnosed Incident Cases by Population at Risk

5.5.5 HIV-CMV

5.5.6 SOT Patients

5.5.7 SOT-CMV

5.5.8 HSCT Patients

5.5.9 HSCT-CMV

5.5.10 Diagnosed Incident Cases of Congenital CMV

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Treatment Options for Resistant or Refractory CMV Infections

7.2.1 Unmet Need

7.2.2 Gap Analysis and Opportunity

7.3 A Safe and Immunogenic Vaccine for CMV Prevention

7.3.1 Unmet Need

7.3.2 Gap Analysis and Opportunity

7.4 Antiviral Monotherapy or Combination Therapy with Improved Efficacy and Safety

7.4.1 Unmet Need

7.4.2 Gap Analysis and Opportunity

7.5 Prevention and Management of Congenital CMV Infections

7.5.1 Unmet Need

7.5.2 Gap Analysis and Opportunity

7.6 Tools or Biomarkers to Assess Risk of Reactivation

7.6.1 Unmet Need

7.6.2 Gap Analysis and Opportunity

8 R&D Strategies

8.1 Overview

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

8.1.2 Application of cellular immunotherapy

8.1.3 Development of a CMV Vaccine

8.1.4 Immune Globulin and mAb Therapies

8.2 Clinical Trial Design

8.2.1 Antivirals

8.2.2 Cellular Immunotherapy

8.2.3 Vaccines

8.2.4 Immune Globulins

9 Pipeline Assessment

9.1 Overview

9.2 Innovative Early-Stage Approaches

10 Pipeline Valuation Analysis

10.1 Clinical Benchmark of Key Pipeline Products

10.1.1 Therapeutic Agents

10.1.2 Prophylactic Agents

10.2 Commercial Benchmark of Key Pipeline Products

10.2.1 Therapeutic Agents

10.2.2 Prophylactic Agents

10.3 Competitive Assessment

10.3.1 Therapeutic Agents

10.3.2 Prophylactic Agents

10.4 Top-Line 10-Year Forecast

10.4.1 US

10.4.2 5EU

10.4.3 Japan

11 Appendix

11.1 Bibliography

11.2 Abbreviations

11.3 Methodology

11.3.1 Forecasting Methodology

11.3.2 CMV Patient Population Segmentation

11.3.3 Percent Drug-Treated Patients

11.3.4 Drugs Included in Each Therapeutic Class

11.3.5 Launch and Patent Expiry Dates

11.3.6 General Pricing Assumptions

11.3.7 Individual Drug Assumptions

11.3.8 Generic Erosion

11.3.9 Pricing of Pipeline Agents

11.4 Primary Research – KOLs Interviewed for This Report

11.4.1 KOLs

11.5 Primary Research – Prescriber Survey

11.6 About the Authors

11.6.1 Analyst

11.6.2 Therapy Area Director

11.6.3 Epidemiologist

11.6.4 Managing Epidemiologist

11.6.5 Global Director of Therapy Analysis and Epidemiology

11.6.6 Global Head and EVP of Healthcare Operations and Strategy

11.7 About GlobalData

11.8 Contact Us

11.9 Disclaimer

Table

Table 1: CMV: Key Metrics in the 7MM

Table 2: Risk Factors and Comorbidities for CMV

Table 3: Treatment Guidelines for CMV

Table 4: Leading Treatments for CMV, 2018

Table 5: Clinical Trial Designs for CMV Pipeline Antivirals

Table 6: Clinical Trial Designs for CMV Cellular Immunotherapy

Table 7: Clinical Trial Designs for CMV Vaccines

Table 8: Clinical Trial Designs for CMV Immune globulins

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

Table 10: Clinical Benchmark of Key Pipeline Therapeutics – CMV

Table 11: Clinical Benchmark of Key Pipeline Prophylactics – CMV

Table 12: Commercial Benchmark of Key Pipeline Therapeutics – CMV

Table 13: Commercial Benchmark of Key Pipeline Prophylactics – CMV

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

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

Table 16: Key Historical and Projected Launch Dates for CMV

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

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

Figures

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

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

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

Figure 4: Human CMV Virion Structure

Figure 5: CMV Life Cycle in a Human Cell

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

Figure 7: Case Flow Map

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Figure 25: Unmet Needs and Opportunities in CMV

Figure 26: Overview of the Development Pipeline in CMV

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

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

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

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

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

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

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

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

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

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

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

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