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Cytomegalovirus (CMV): Opportunity Analysis and Forecasts to 2027

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    Report

  • 162 Pages
  • June 2018
  • Region: Global
  • GlobalData
  • ID: 4621449
Cytomegalovirus (CMV): Opportunity Analysis and Forecasts to 2027

Summary

For nearly two decades, the Cytomegalovirus (CMV) therapeutics landscape has been dominated by ganciclovir and valganciclovir, with modest growth in the form of additional antivirals targeting DNA replication. The 2017 approval of Prevymis in the US marked the first major shift in therapeutic strategy to come to theCytomegalovirus (CMV) market in several years, potentially setting the stage for other experimental therapies for Cytomegalovirus (CMV) currently in clinical development.

Cytomegalovirus (CMV) is a ß 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. Cytomegalovirus (CMV) also has the capacity to establish life-long latent infections, incorporating genomic DNA into host cells without detectable viral gene expression. Although largely asymptomatic in immunocompetent adults, Cytomegalovirus (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.

The Cytomegalovirus (CMV) market is expected to experience moderate growth over the forecast period (2017-2027). The market features several antivirals that are used for both treatment of clinically significant Cytomegalovirus (CMV) infections and prophylaxis in patients considered at high risk for Cytomegalovirus (CMV) infection. The global Cytomegalovirus (CMV) market across the 7MM (US, France, Germany, Italy, Spain, the UK and Japan) was valued over $240M in 2017. Over the 10-year forecast period, the Cytomegalovirus (CMV) market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.5%.

The report "Cytomegalovirus (CMV): Opportunity Analysis and Forecasts to 2027", helps in analyzing the cytomegalovirus (CMV) market and treatment landscape, providing an overview and forecast of the market dynamics from 2017 to 2027.

Key Questions Answered
  • How will the Cytomegalovirus (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 Cytomegalovirus (CMV) treatment management?

  • What drivers and barriers will affect Cytomegalovirus (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.

Table of Contents

1 Table of Contents
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
11.8 Contact Us
11.9 Disclaimer
List of Tables
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
List of 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 Author 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 121

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Atara Bio

  • Biotest AG

  • Helocyte

  • Merck & Co.

  • Novartis

  • Shire

  • ViraCyte