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Cytomegalovirus (CMV) Infections - Market Insights, Epidemiology, and Market Forecast - 2028

  • ID: 4039355
  • Drug Pipelines
  • September 2019
  • Region: Global
  • 275 Pages
  • DelveInsight
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Generic Drugs are Driving the CMV Infection Market, as There is No Patented Drug Available in Any of the Major Market

FEATURED COMPANIES

  • AlloVir: Viralym-M
  • AlphaVax: AVX601
  • CSL Behring: CytoGam
  • Gilead Sciences: Vistide
  • GlaxoSmithKline: Valtrex
  • Helocyte: Triplex
  • MORE
‘Cytomegalovirus (CMV) Infections- Market Insights, Epidemiology, and Market Forecast-2028' report deliver an in-depth understanding of the disease, historical & forecasted epidemiology as well as the market trends of Cytomegalovirus (CMV) Infections in the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

CMV affects young children mainly, but it is estimated that by age 30 in the United States, half of all adults are, or have been, infected. The virus can pass from an infected, pregnant mother to her child through the shared blood supply (umbilical cord).

Among healthy individuals, CMV infection usually causes no symptoms; however, when CMV is transmitted congenitally (congenital CMV or cCMV) it can cause severe sequel. Despite the relatively high prevalence of cCMV infections and potentially serious effects, many women are unfamiliar with the risk of cCMV.

Geography Covered
  • The United States
  • EU5 (Germany, France, Italy, Spain, and the United Kingdom)
  • Japan
Study Period:2017-2028

Cytomegalovirus (CMV) Infections - Disease Understanding and Treatment Algorithm

Cytomegalovirus (CMV) is a commonly acquired infection and a member of the Herpesviridae family. Cytomegalovirus infection (CMV) is a viral infection that rarely causes obvious illness. There are three main types of CMV infections: acquired, recurring, or congenital. When the infection develops for the first time it is called acquired CMV. Recurrent CMV infection is defined as a new CMV infection in a patient with previous evidence of CMV infection in whom the virus has not been detected for at least 4 weeks during active surveillance. If a pregnant woman has an active CMV infection, the virus can be passed to the unborn baby and when it affects a baby in the womb, it's known as congenital CMV.

The primary infection manifests as an asymptomatic or self-limited febrile illness in immuno-competent individuals, after which CMV establishes life-long latency in various cells which serve as reservoirs for reactivation and as carriers of infection to susceptible individuals. There are certain groups at high risk for serious complications from CMV infection which includes: Pregnant Women, Transplant Patients with compromised immune systems, Patients with HIV, and Very low birth weight and premature infants. Cytomegalovirus (CMV) Infections Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology (Total seroprevalence of CMV in 7MM, Total Diagnosed Cases of Cytomegalovirus (CMV) Infection in 7MM, Number of Infants born with Congenital CMV in 7MM, CMV Patients among Hematopoietic Stem Cell Transplants (HSCT) in 7MM, Number of CMV Patients among Solid Organ Transplants (SOT) in 7MM, Number of Refractory CMV Patients after HSCT/SOT in 7MM and CMV Retinitis among HIV Patients in 7MM) scenario of Cytomegalovirus (CMV) Infections in the 7MM covering United States, EU5 countries (Germany, Spain, Italy, France and United Kingdom) and Japan from 2017-2028.

According to this report, the total diagnosed cases of CMV were found out to be approximately 110,540 in the 7MM. The number of CMV cases in the 7MM is expected to increase during the study period of 2017-2028. In 7MM, Hematopoietic Stem Cell Transplants (allogeneic HSCT) patients is increasing throughout the study period (2017-2028). While, HIV patients is decreasing throughout the study period (2017-2018) due to the High Active Antiretroviral Therapy (HAART).

Cytomegalovirus (CMV) Infections Drug Chapters

This segment of the Cytomegalovirus (CMV) Infections report encloses the detailed analysis of marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. Currently, antiviral drugs are used for CMV infection following transplant procedures. The drugs include valganciclovir, ganciclovir, cidofovir, foscarnet, or a combination, etc. Recently, Prevymis (Letermovir) received FDA approval for the prevention of Human Cytomegalovirus (HCMV) infection in transplant patients.

There are two major strategies for CMV disease prevention after liver transplantation that includes preemptive therapy and antiviral prophylaxis. Before ART was widely available, daily use of oral ganciclovir (no longer marketed in the United States) for primary prophylaxis significantly reduced the incidence of CMV disease in a randomized, placebo-controlled trial.

The first-line options for therapy of CMV disease, are almost always intravenous ganciclovir or oral valganciclovir. Foscavir (FOS) is considered second-line therapy but is the preferred drug for patients who are failing GCV therapy due to viral resistance, or those who cannot be treated with GCV due to dose-limiting neutropenia or leucopenia. Another second-line therapy for CMV disease, cidofovir (Vistide, Gilead), is - like foscarnet - an inhibitor of the CMV DNA polymerase.

CMV Infection market is flooded with Generic products as the top-selling drugs have gone off-patent. Most recent gone off the patent drug was Valcyte, which lost its patent in 2013 and 2015 in the US and Europe, respectively.

Cytomegalovirus (CMV) Infections Market Outlook

According to this report, the market of Cytomegalovirus (CMV) Infections in 7MM was found to be approximately USD 1195.10 million in 2017. Cytomegalovirus (CMV) Infections market size in the United States accounted for approx. 68.16% of the total market in 2017.

Among the EU5 countries, in 2017, France had the highest market size with approximately USD 84.00 million, while Italy had the lowest market size for CMV Infection with approximately USD 47.00 million.

The market size of prophylactic & therapeutic CMV Infection in seven major markets was approximately USD 771.00 million & 423.00 million in 2017.

Cytomegalovirus (CMV) Infections Drugs Uptake

The dynamics of Cytomegalovirus Infection market is anticipated to change during the forecasted period owing to the expected launch of emerging therapies. There are many pipeline therapies under development for the prevention of Congenital Cytomegalovirus and treatment of Cytomegalovirus infection following transplant (allogeneic hematopoietic stem cell transplantation/Solid-organ transplantation). The therapies which are under development for the prophylaxis or treatment of CMV Infection are Maribavir (Shire), ATA230 (Atara Biotherapeutics), Viralym-M (ViraCyte), V160 (Merck Sharp & Dohme Corp), Cytotect-70 (BioTest, (EU5 only)) and Triplex (Helocyte).

Cytomegalovirus (CMV) Infections Report Insights
  • Patient Population by Total diagnosed cases
  • Infants born with Congenital CMV
  • CMV Patients among Hematopoietic Stem Cell Transplants (HSCT)
  • CMV Patients among Solid Organ Transplants (SOT)
  • Refractory CMV Patients after HSCT/SOT
  • CMV Retinitis among HIV Patients
  • Therapeutic Approaches
  • Pipeline Analysis
  • Market Size and Trends
  • Market Opportunities
  • Impact of upcoming Therapies
Cytomegalovirus (CMV) Infections Report Key Strengths
  • 10 Year Forecast
  • 7MM Coverage
  • Epidemiology Segmentation
  • Drugs Uptake
  • Highly Analyzed Market
  • Key Cross Competition
Cytomegalovirus (CMV) Infections Report Assessment
  • Current Treatment Practices
  • Unmet Needs
  • Detailed Pipeline Product Profiles
  • Market Attractiveness
  • Market Drivers and Barriers
Key Benefits
  • This report will help to develop Business Strategies by understanding the trends shaping and driving Cytomegalovirus (CMV) Infections market
  • Organize sales and marketing efforts by identifying the best opportunities for Cytomegalovirus (CMV) Infections market
  • To understand the future market competition in the Cytomegalovirus (CMV) Infections market.
Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • AlloVir: Viralym-M
  • AlphaVax: AVX601
  • CSL Behring: CytoGam
  • Gilead Sciences: Vistide
  • GlaxoSmithKline: Valtrex
  • Helocyte: Triplex
  • MORE
1. Key Insights

2. Cytomegalovirus (CMV) Infections: Market Overview at a Glance
2.1. Total Market Share (%) Distribution of Cytomegalovirus (CMV) Infections in 2017
2.2. Total Market Share (%) Distribution of Cytomegalovirus (CMV) Infections in 2028

3. Disease Background and Overview: Cytomegalovirus Infections (CMV)
3.1. Introduction
3.2. Classification of Cytomegalovirus Infections (CMV)
3.3. Causes of CMV infections
3.4. Symptoms of CMV infections
3.5. Risk factors of CMV infections
3.6. Pathophysiology of CMV infections
3.7. Diagnosis of CMV infections

4. Epidemiology and Patient Population
4.1. Key Findings
4.2. Forecast Methodology
4.3. Forecasting Assumptions
4.4. Total Sero-Prevalence of CMV in 7MM
4.5. Total Diagnosed CMV Patients in 7MM

5. Country Wise-Epidemiology of CMV Infections
5.1. United States
5.1.1. Assumptions and Rationale
5.1.2. Total Diagnosed Cases of Cytomegalovirus (CMV) Infection in the United States
5.1.3. Number of Infants born with Congenital CMV in the United States
5.1.4. CMV Patients among Hematopoietic Stem Cell Transplants (HSCT) in the United States
5.1.5. Number of CMV Patients among Solid Organ Transplants (SOT) in the United States
5.1.6. Number of Refractory CMV Patients after HSCT/SOT in the United States
5.1.7. CMV Retinitis among HIV Patients in the United States
5.2. EU5 Countries
5.2.1. Assumptions and Rationale
5.3. Germany
5.3.1. Total Diagnosed Cases of Cytomegalovirus (CMV) Infection in Germany
5.3.2. Number of Infants born with Congenital CMV in Germany
5.3.3. CMV Patients among Hematopoietic Stem Cell Transplants (HSCT) in Germany
5.3.4. Number of CMV Patients among Solid Organ Transplants (SOT) in Germany
5.3.5. Number of Refractory CMV Patients after HSCT/SOT in Germany
5.3.6. CMV Retinitis among HIV Patients in Germany
5.4. France
5.4.1. Total Diagnosed Cases of Cytomegalovirus (CMV) Infection in France
5.4.2. Number of Infants born with Congenital CMV in France
5.4.3. CMV Patients among Hematopoietic Stem Cell Transplants (HSCT) in France
5.4.4. Number of CMV Patients among Solid Organ Transplants (SOT) in France
5.4.5. Number of Refractory CMV Patients after HSCT/SOT in France
5.4.6. CMV Retinitis among HIV Patients in France
5.5. Italy
5.5.1. Total Diagnosed Cases of Cytomegalovirus (CMV) Infection in Italy
5.5.2. Number of Infants born with Congenital CMV in Italy
5.5.3. CMV Patients among Hematopoietic Stem Cell Transplants (HSCT) in Italy
5.5.4. Number of CMV Patients among Solid Organ Transplants (SOT) in Italy
5.5.5. Number of Refractory CMV Patients after HSCT/SOT in Italy
5.5.6. CMV Retinitis among HIV Patients in Italy
5.6. Spain
5.6.1. Total Diagnosed Cases of Cytomegalovirus (CMV) Infection in Spain
5.6.2. Number of Infants born with Congenital CMV in Spain
5.6.3. CMV Patients among Hematopoietic Stem Cell Transplants (HSCT) in Spain
5.6.4. Number of CMV Patients among Solid Organ Transplants (SOT) in Spain
5.6.5. Number of Refractory CMV Patients after HSCT/SOT in Spain
5.6.6. CMV Retinitis among HIV Patients in Spain
5.7. United Kingdom
5.7.1. Total Diagnosed Cases of Cytomegalovirus (CMV) Infection in the United Kingdom
5.7.2. Number of Infants born with Congenital CMV in the United Kingdom
5.7.3. CMV Patients among Hematopoietic Stem Cell Transplants (HSCT) in the United Kingdom
5.7.4. Number of CMV Patients among Solid Organ Transplants (SOT) in the United Kingdom
5.7.5. Number of Refractory CMV Patients after HSCT/SOT in the United Kingdom
5.7.6. CMV Retinitis among HIV Patients in the United Kingdom
5.8. Japan
5.8.1. Assumptions and Rationale
5.8.2. Total Diagnosed Cases of Cytomegalovirus (CMV) Infection in Japan
5.8.3. Number of Infants born with Congenital CMV in Japan
5.8.4. CMV Patients among Hematopoietic Stem Cell Transplants (HSCT) in Japan
5.8.5. Number of CMV Patients among Solid Organ Transplants (SOT) in Japan
5.8.6. Number of Refractory CMV Patients after HSCT/SOT in Japan
5.8.7. CMV Retinitis among HIV Patients in Japan

6. Treatment Algorithm
6.1. Canadian society of transplantation consensus workshop on Cytomegalovirus Management in Solid Organ Transplantation Final Report, 2005
6.2. The Third International Consensus Guidelines on the management of Cytomegalovirus in Solid Organ Transplantation
6.3. The Prevention and Management of CMV Disease after Solid Organ Transplantation: British Transplantation Society (2015)
6.4. Guidelines for the management of cytomegalovirus infection in patients with haematological malignancies and after stem cell transplantation from the 2017 European Conference on Infections in Leukaemia (ECIL 7)
6.5. Treatment of Cytomegalovirus(CMV)infection post renal transplantation (The guidelines for CMV infection post renal transplantation in Japanese Society for Clinical Renal Transplantation)
6.6. Congenital Cytomegalovirus A European Expert Consensus Statement on Diagnosis and Management

7. Unmet Needs

8. Marketed Products
8.1. Valcyte: Roche
8.1.1. Product Description
8.1.2. Mechanism of Action
8.1.3. Regulatory Milestones
8.1.4. Safety and Efficacy
8.1.5. Advantages and Disadvantages
8.1.6. Side effects
8.1.7. Product Profile
8.2. Foscavir: Clinigen Group plc
8.2.1. Product Description
8.2.2. Mechanism of Action
8.2.3. Regulatory Milestones
8.2.4. Safety and Efficacy
8.2.5. Advantages and Disadvantages
8.2.6. Side effects
8.2.7. Product Profile
8.3. CytoGam: CSL Behring
8.3.1. Product Description
8.3.2. Mechanism of Action
8.3.3. Regulatory Milestones
8.3.4. Safety and Efficacy
8.3.5. Advantages and Disadvantages
8.3.6. Side effects
8.3.7. Product Profile
8.4. Valtrex: GlaxoSmithKline
8.4.1. Product Description
8.4.2. Mechanism of Action
8.4.3. Regulatory Milestones
8.4.4. Safety and Efficacy
8.4.5. Advantages and Disadvantages
8.4.6. Side effects
8.4.7. Product Profile
8.5. Vistide: Gilead Sciences
8.5.1. Product Description
8.5.2. Mechanism of Action
8.5.3. Regulatory Milestones
8.5.4. Safety and Efficacy
8.5.5. Side effects
8.5.6. Product Profile
8.6. Prevymis: Merck & Co.
8.6.1. Product Description
8.6.2. Mechanism of Action
8.6.3. Regulatory Milestones
8.6.4. Safety and Efficacy
8.6.5. Advantages and Disadvantages
8.6.6. Side effects
8.6.7. Product Profile
8.7. Cytotect CP: Biotest Pharma GmbH
8.7.1. Product Description
8.7.2. Regulatory Milestones
8.7.3. Other development activities
8.7.4. Advantages and Disadvantages
8.7.5. Product Profile

9. Emerging Drugs
9.1. Key cross competition
9.2. CMV-Gyn (Cytotect 70): Biotest AG
9.2.1. Product Description
9.2.2. Other Developmental Activities
9.2.3. Clinical Development
9.2.4. Advantages and Disadvantages
9.2.5. Product Profile
9.3. Maribavir: Shire Pharmaceuticals
9.3.1. Product Description
9.3.2. Other Developmental Activities
9.3.3. Clinical Development
9.3.4. Safety and Efficacy
9.3.5. Advantages and Disadvantages
9.3.6. Product Profile
9.4. ATA230: Atara Biotherapeutics
9.4.1. Product Description
9.4.2. Other Developmental Activities
9.4.3. Clinical Development
9.4.4. Safety and Efficacy
9.4.5. Product Profile
9.5. Triplex: Helocyte
9.5.1. Product Description
9.5.2. Other Developmental Activities
9.5.3. Clinical Development
9.5.4. Safety and Efficacy
9.5.5. Product Profile
9.6. CSJ148: Novartis (Development suspended)
9.6.1. Product Description
9.6.2. Other Developmental Activities
9.6.3. Clinical Development
9.6.4. Product Profile
9.7. Viralym-M: AlloVir
9.7.1. Product Description
9.7.2. Other Developmental Activities
9.7.3. Clinical Development
9.7.4. Safety and Efficacy
9.7.5. Product Profile
9.8. V160: Merck
9.8.1. Product Description
9.8.2. Clinical Development
9.8.3. Safety and Efficacy
9.8.4. Product Profile
9.9. VBI-1501: VBI Vaccines
9.9.1. Product Description
9.9.2. Other Developmental Activities
9.9.3. Clinical Development
9.9.4. Safety and Efficacy
9.9.5. Product Profile
9.10. HB-101 (VaxWave): Hookipa Biotech
9.10.1. Product Description
9.10.2. Other Developmental Activities
9.10.3. Clinical Development
9.10.4. Safety and Efficacy
9.10.5. Product Profile
9.11. AVX601: AlphaVax
9.11.1. Product Description
9.11.2. Other Developmental Activities
9.11.3. Clinical Development
9.11.4. Safety and Efficacy
9.11.5. Product Profile
9.12. CMV glycoprotein B MF59 (gB/MF59): Sanofi
9.12.1. Product Description
9.12.2. Other developmental Activities
9.12.3. Clinical Development
9.12.4. Safety and Efficacy
9.12.5. Product Profile
9.13. ALVAC-CMV (vCP260): Sanofi
9.13.1. Product Description
9.13.2. Clinical Development
9.13.3. Product Profile

10. Failed Therapies
10.1. ASP0113: Astellas Pharma Global Development, Inc.
10.1.1. Product Description
10.1.2. Other Developmental Activities
10.1.3. Clinical Development
10.1.4. Safety and Efficacy
10.1.5. Product Profile
10.2. Brincidofovir: Chimerix Inc.
10.2.1. Product Description
10.2.2. Other Developmental Activities
10.2.3. Clinical Development
10.2.4. Safety and Efficacy
10.2.5. Product Profile

11. Cytomegalovirus Infection: 7 Major Market Analysis
11.1. Key Findings
11.2. Market Size of Cytomegalovirus Infection in 7MM
11.3. Market Size of Prophylactic Cytomegalovirus Infection in 7MM
11.4. Market Size of Prophylactic Cytomegalovirus Infection by therapies in 7MM
11.5. Market Size of Therapeutic Cytomegalovirus Infection in 7MM
11.6. Market Size of Therapeutic Cytomegalovirus Infection by therapies in 7MM

12. The United States Market Outlook
12.1. United States Market Size
12.1.1. Total Market size of Cytomegalovirus Infection
12.1.2. Market Size of Prophylaxis CMV by therapies in the United States
12.1.3. Market Size of Therapeutic CMV by therapies in the United States

13. EU-5 Countries: Market Outlook
13.1. Germany
13.1.1. Total Market size of Cytomegalovirus Infection
13.1.2. Market Size of Prophylaxis CMV by therapies in Germany
13.1.3. Market Size of Therapeutic CMV by therapies in Germany
13.2. France
13.2.1. Total Market size of Cytomegalovirus Infection
13.2.2. Market Size of Prophylaxis CMV by therapies in France
13.2.3. Market Size of Therapeutic CMV by therapies in France
13.3. Italy
13.3.1. Total Market size of Cytomegalovirus Infection
13.3.2. Market Size of Prophylaxis CMV by therapies in Italy
13.3.3. Market Size of Therapeutic CMV by therapies in Italy
13.4. Spain
13.4.1. Total Market size of Cytomegalovirus Infection
13.4.2. Market Size of Prophylaxis CMV by therapies in Spain
13.4.3. Market Size of Therapeutic CMV by therapies in Spain
13.5. United Kingdom
13.5.1. Total Market size of Cytomegalovirus Infection
13.5.2. Market Size of Prophylaxis CMV by therapies in the United Kingdom
13.5.3. Market Size of Therapeutic CMV by therapies in the United Kingdom
13.6. Japan Market Outlook
13.6.1. Total Market size of Cytomegalovirus Infection
13.6.2. Market Size of Prophylaxis CMV by therapies in Japan
13.6.3. Market Size of Therapeutic CMV by therapies in Japan

14. Market Drivers

15. Market Barriers

16. Appendix
16.1. Report Methodology

17. Capabilities

18. Disclaimer

19. About the Publisher
Note: Product cover images may vary from those shown
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  • F. Hoffmann-La Roche AG: Valcyte
  • Clinigen Group Ltd.: Foscavir
  • CSL Behring: CytoGam
  • GlaxoSmithKline: Valtrex
  • Gilead Sciences: Vistide
  • Merck & Co.: Prevymis & V160
  • Biotest Pharma GmbH: Cytotect CP & Cytotect 70
  • Shire Pharmaceuticals: Maribavir
  • Atara Biotherapeutics: ATA230
  • Novartis: CSJ 148
  • Helocyte: Triplex
  • AlloVir: Viralym-M
  • VBI Vaccines: VBI-1501
  • Hookipa Biotech: HB-101
  • AlphaVax: AVX601
  • Sanofi: gB/MF59 & vCP260
  • Astellas Pharma Global Development: ASP0113
  • Chimerix Inc: Brincidofovir
Note: Product cover images may vary from those shown
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