The CMV market targets patients with immunodeficiencies, particularly patients receiving solid organ or hematopoietic stem cell transplants. Current therapies have strong antiviral activity but notable side effects, in particular myelotoxicity. These safety issues and a lack of alternative therapies contribute to the substantial unmet need for additional therapeutic options. Several companies are developing novel antivirals, adoptive cell therapies, and therapeutic and prophylactic vaccines to address various aspects of CMV. The anticipated launch of these agents is expected to transform the CMV space and give patients with high unmet need much-needed treatment options.

Table of contents

  • Cytomegalovirus (CMV) - Landscape & Forecast - Disease Landscape & Forecast
    • Executive Summary
      • Introduction
        • Key Findings
        • CMV Market Parameters and Forecast
        • SWOT Analysis
        • Actionable Recommendations in the CMV Market
    • Commercial Outlook
      • Market Outlook
        • Key Findings
        • Market Overview
        • CMV Market Landscape
      • Drivers and Constraints
        • What Factors Are Driving the Market for Cytomegalovirus?
        • What Factors Are Constraining the Market for Cytomegalovirus?
        • Antivirals
    • Forecast
      • Forecast Sales of Key Therapies in CMV
    • Etiology and Pathophysiology
      • Etiology
        • CMV in SOT and HSCT Patients
        • Congenital CMV Infection
        • Risk Factors
      • Pathophysiology
        • Evasion of Host Immune Responses
        • Host Immune Responses Against CMV
        • CMV Immune Evasion Mechanisms
      • Clinical Presentation and Symptomology
        • Clinical Presentation and Key Symptoms
      • Key Pathways and Drug Targets
        • CMV Viral Structure
    • Epidemiology Overview
      • Introduction
        • Key Findings
        • Expert Insights
        • Prevalence of CMV Seropositive Pregnant Women per 1,000 Among Women Aged 15-44 in 2015 and 2025
        • Prevalence of CMV Seropositive Pregnant Women per 1,000 Among Women Aged 15-44 in 2015 and 2025
        • Distribution of High-Risk HSCT Events in 2015 and 2025
        • Autologous HSCT Events at Increased Risk of CMV Disease per 100,000 Among People of All Ages in 2015 and 2025
        • Allogeneic HSCT Events at Increased Risk of CMV Disease per 100,000 Among People of All Ages in 2015 and 2025
        • Distribution of High-Risk SOT Events in 2015 and 2025
        • Relative Sizes of the Contributing Factors to the Trend in High-Risk SOT Events over the Next Ten Years
        • Relative Sizes of the Contributing Factors to the Trend in Kidney Transplant Events at Increased Risk of CMV Disease over the Next Ten Years
        • Relative Sizes of the Contributing Factors to the Trend in Lung Transplant Events at Increased Risk of CMV Disease over the Next Ten Years
        • Proportion of High-Risk HSCT and SOT Events that are Diagnosed and Drug-Treated in 2015
        • Analysis of HSCT Events at Increased Risk of CMV Disease in 2015 by Diagnosis and Drug-Treated Status
        • Analysis of Solid-Organ Transplant Events at Increased Risk of CMV Disease in 2015 by Diagnosis and Drug-Treated Status
      • Epidemiology Populations
        • Disease Definition for High-Risk HSCT Events
        • Methods
        • Sources Used for HSCT Events at Increased Risk of CMV Syndrome or Disease
        • Total Autologous Transplant Events at Increased Risk of CMV Disease or Syndrome in the Major Pharmaceutical Markets, 2015-2025
        • Total Allogeneic Transplant Events at Increased Risk of CMV Disease or Syndrome in the Major Pharmaceutical Markets, 2015-2025
        • Disease Definition for High-Risk Solid Organ Transplant Events
        • Methods
        • Sources Used for Solid Organ Transplant Events with Increased Risk of CMV Syndrome or Disease
        • Total High-Risk Kidney Transplant Events in the Major Pharmaceutical Markets, 2015-2025
        • Total High-Risk Liver Transplant Events in the Major Pharmaceutical Markets, 2015-2025
        • Total High-Risk Lung Transplant Events in the Major Pharmaceutical Markets, 2015-2025
        • Total High-Risk Heart Transplant Events in the Major Pharmaceutical Markets, 2015-2025
        • Disease Definition for CMV Seropositive Pregnant Women
        • Methods
        • Sources Used for CMV Seropositive Pregnant Women
        • Total Prevalent Cases of CMV Seropositive Pregnant Women in the Major Pharmaceutical Markets, 2015-2025 (thousands)
    • Current Treatment Overview
      • Introduction
        • Key Findings
        • Expert Insight
        • Treatment Overview
      • Diagnosis
        • Diagnostics For Various Patient Groups
        • Treatment Providers and Referral Patterns
        • Expert Insight on Diagnosis of CMV
      • Treatment Goals
        • Key End Points Used in Clinical Trials for CMV
        • Key Physician Insights on Clinical End Points
        • Expert Insight on Clinical End Points
      • Key Current Therapies
        • Overview
        • Mechanism of Action of Key Current Drugs or Drug Classes Used for CMV
        • Current Treatments Used for CMV Indications
        • Approved vs. Recommended Therapies for CMV
        • Market Events Impacting the Use of Key Current Therapies in CMV
        • Ganciclovir (Cytovene)
        • Clinical Trial Outcomes for Ganciclovir
        • Select Clinical Analysis of Ganciclovir for the Treatment of CMV
        • Advantages and Disadvantages of Ganciclovir
        • Expert Insight on Ganciclovir
        • Valganciclovir (Valcyte)
        • Clinical Trial Outcomes for Valganciclovir
        • Clinical Analysis of Valganciclovir for the Treatment of CMV
        • Advantages and Disadvantages of Valganciclovir
        • Expert Insight on Valganciclovir
      • Medical Practice
        • Overview
        • Preemptive vs. Prophylactic Therapy for CMV
        • CMV Treatment Guidelines, by Market
        • CMV Drug Target Populations and Treatment Approaches
        • Generalized Treatment Decision Tree for CMV in Solid Organ Transplant Recipients
        • Generalized Treatment Decision Tree for CMV in Hematopoietic Stem Cell Transplant Recipients
        • Generalized Treatment Decision Tree for CMV in AIDS Patients
        • Generalized Treatment Decision Tree for Patients with Congenital CMV infection
    • Unmet Need Overview
      • Introduction
        • Key Findings
        • Expert Insight
      • Attainment of Unmet Needs
        • Current Attainment of Unmet Needs in CMV
        • Future Attainment of Unmet Needs in CMV
        • Top Unmet Needs in CMV—Current and Future Attainment
        • Expert Insight on CMV Unmet Needs
    • Emerging Therapies Overview
      • Introduction
        • Key Findings
        • Expert Insight
        • Pipeline Overview
        • Pipeline Trends for CMV
      • Late-Phase Pipeline Analysis
        • Notable Developments in the Late-Phase Pipeline for CMV
        • Therapies in Late-Phase Development for CMV
        • Estimated Launch Dates of Key Emerging Therapies for the Treatment of CMV
      • Orphan Drug Designation
        • Expanded Market Exclusivity
        • Tax Credits
        • Support During the Drug Approval Process
        • Grants
        • Market Exclusivity
        • Fee Reductions
      • Patient Registries
        • Patient Registries for CMV Infection
      • Key Emerging Therapies
        • Letermovir Profile
        • Select Clinical Trial Results for Letermovir for the Prevention of CMV in Allogeneic Stem Cell Transplant Recipients
        • Letermovir Clinical Development
        • Key Ongoing Clinical Trials for Letermovir for the Prevention of CMV in CMV-Seropositive Allogeneic Hematopoietic Stem Transplant Recipients
        • Expert Insight
        • Expert Insight on Letermovir
        • Expectations for Launch and Sales Opportunity of Letermovir
        • Brincidofovir
        • Select Clinical Trial Results for Brincidofovir to Prevention of CMV Infection in CMV-seropositive HSCT Recipients
        • Brincidofovir Clinical Development
        • Expert Insight
        • Expert Insight on Brincidofovir
        • Expectations for Launch and Sales Opportunity of Brincidofovir
        • Maribavir Profile
        • Select Clinical Trial Results for Maribavir for the Prevention of CMV Disease in Transplant Patients
        • Maribavir Clinical Development
        • Expert Insight
        • Expert Insight on Maribavir
        • Expectations for Launch and Sales Opportunity of Maribavir
        • ASP-0113
        • Select Clinical Trial Results for ASP-0113 for the Prevention CMV disease in HSCT Patients
        • ASP-0113 Clinical Development
        • Expert Insight
        • Expert Insight on ASP-0113
        • Expectations for Launch and Sales Opportunity of ASP-0113
        • Cytovir-CMV Profile
        • Select Clinical Trial Results for Cytovir-CMV for the Prevention of CMV Reactivation in Allogeneic Stem Cell Transplant Recipients
        • Cytovir-CMV Clinical Development
        • Expert Insight
        • Expert Insight on Cytovir-CMV
        • Expectations for Launch and Sales Opportunity of Cytovir-CMV
      • Early-Phase Pipeline Analysis
        • Notable Developments in the Early-Phase Pipeline for CMV
        • Select Early-Phase Compounds in Development for CMV
    • Access and Reimbursement Overview
      • Region-Specific Reimbursement Practices
      • Methodology
        • Appendix
          • Key Abbreviations Related to CMV
          • Brands, Marketers, and Generic Availability of Key Therapies for CMV, by Market
          • Experts Interviewed
          • CMV Bibliography

      Author(s): Michael Breen, PhD

      Michael is a business insights analyst on the Infectious, Niche, and Rare Diseases team. He has authored reports on cystic fibrosis, nonalcoholic steatohepatitis, vaccines, and  respiratory syncytial virus, and will author a report on cytomegalovirus. He also provides coverage for Decision Resources’ Company & Drug Insights covering anti-infectives, vaccines, and transplant therapy areas.

      Michael received his Bachelor’s degree from Hunter College with a dual major in biology and biochemistry. He received his Ph.D. in biochemistry from Boston University School of Medicine. His postdoctoral research was carried out at Brigham and Women’s Hospital/Harvard Medical School, with a focus on identifying novel pathways regulating thermogenesis in search of a therapeutic for obesity and diabetes.