DelveInsight’s ‘Cytomegalovirus (CMV) Infections -Market Insights, Epidemiology, and Market Forecast–2030’ report deliver an in-depth understanding of the CMV Infections, historical and forecasted epidemiology as well as the CMV Infections market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
The CMV Infections market report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM CMV Infections market size from 2018 to 2030. The Report also covers current CMV Infections treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, and market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.
Study Period: 2018–2030
Cytomegalovirus (CMV) Infections Overview
As per the National Organization of Rare Disorders, Cytomegalovirus infection (CMV) is a viral infection that rarely causes obvious illness. The virus that causes CMV is part of the herpes virus family and, like other herpes viruses, may become dormant for a period of time and then be reactivated. 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).
CMV is a member of the herpes virus family which includes the herpes simplex viruses and the viruses that cause chickenpox and mononucleosis. Human cytomegalovirus (HCMV) is a species of the Cytomegalovirus genus of viruses, of the viral family Herpes viridae or herpes viruses, and is the most common of all cytomegaloviruses.
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.
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Cytomegalovirus (CMV) Infections Diagnosis
Most of the CMV infections go undiagnosed because the virus causes little to no symptoms. When a person is infected with CMV, antibodies (proteins) to the virus called IgM and/or IgG anti-CMV antibodies develop and stay in the body for the rest of the person's life. Once a CMV infection is suspected, a doctor conducts tests to detect the virus in body fluids or tissues. In newborns, the diagnosis is usually made by culturing the urine.
A blood test to detect the antibodies will be positive if the person has had a CMV infection. If the antibody test is negative, the person is considered to be uninfected with CMV. Serology tests are useful for determining whether a patient has had CMV infection in the past or not, by the presence or absence of CMV IgG.
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Cytomegalovirus (CMV) Infections Treatment
There are various approaches for the prevention of CMV. Major strategies for prevention are:
1. Antiviral prophylaxis
2. Pre-emptive therapy
Antiviral drugs for CMV prophylaxis are valganciclovir and oral or intravenous ganciclovir. For kidney recipients, valacyclovir is an alternative. In selected patient populations (heart and lung recipients), immunoglobulin preparations are occasionally used as an adjunct in combination with antiviral drugs. Acyclovir should NOT be used for anti-CMV prophylaxis. Infection with ganciclovir-resistant CMV has been associated with increased morbidity and mortality in SOT patients. The incidence is highest among lung transplant recipients.
Genotypic testing should be performed when resistance is suspected. In patients with low-level resistance to ganciclovir conferred by UL97 mutation, an increased dose of IV ganciclovir may be used (up to 10 mg/kg twice daily). Foscarnet is the preferred drug in high-level ganciclovir resistance, though cidofovir has been used occasionally. Reducing immunosuppression or switching from calcineurin to mTOR inhibitors such as sirolimus may be helpful. Experimental antiviral drugs that are being developed or considered for use in CMV resistant to ganciclovir, foscarnet, and cidofovir are letermovir and CMX-001 (orally available lipid prodrug of cidofovir).
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The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Diagnosed Cases of Cytomegalovirus (CMV) Infection, Number of Infants born with Congenital CMV, CMV Patients among Hematopoietic Stem Cell Transplants (HSCT), Number of CMV Patients among SOT, Number of Refractory CMV Patients after HSCT/SOT, CMV Retinitis among HIV Patients scenario in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2018 to 2030.
Key Findings
The epidemiology segment also provides the CMV Infections epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.
Cytomegalovirus (CMV) Infections Emerging Drugs
Triplex: Helocyte
Triplex is a first-in-class, best-in-class, universal (non-HLA-restricted) recombinant modified vaccinia ankara viral vector vaccine engineered to induce a robust and durable virus-specific T cell response to three immuno-dominant proteins linked to CMV complications in the transplant setting: UL83 (pp65), UL123 (IE1) and UL122 (IE2). The drug was developed in partnership with the National Cancer Institute by its lead investigator, Diamond, of the City of Hope. In a phase I study, Triplex was found to be safe, well-tolerated, and highly immunogenic when administered to healthy volunteers.
Currently, phase II clinical trials are being conducted by Helocyte for the study of CMV control in allogeneic HSCT recipients, kidney transplants, and liver transplants.
Triplex is currently the subject of multiple ongoing and planned studies, one involving vaccination of the donor (followed by the recipient) in higher-risk stem cell transplant patients, potentially introducing CMV immunity sooner and positioning Triplex ahead of prophylactic antivirals in the standard of care.
V160: Merck
V160 is human cytomegalovirus (HCMV) with a genome of ~231-kb that includes the ~15- kb deletion present in the parental virus, AD169. Virions consist of a double-stranded linear DNA genome packaged into an icosahedral nucleocapsid that is surrounded by a proteinaceous tegument. This tegument is enveloped by a lipid bilayer containing a variety of viral glycoproteins. Virions have a diameter of ~200 nm. It is being developed by Merck in phase II clinical trial for the treatment of Cytomegalovirus (CMV) Infection, particularly in healthy women. The drug has already completed its phase I trial in healthy adults for the treatment of CMV infection.
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Cytomegalovirus (CMV), is extremely common worldwide. The global burden of Cytomegalovirus Infection has increased over the year (approximately 50% of US adults are infected with CMV). Among the seven major markets, the United States has reported having a maximum number of CMV patients. In most individuals, primary infection with CMV is asymptomatic, with the infected host showing no signs or symptoms of the disease.
Healthy people who are infected with CMV usually do not require medical treatment. Medications are available to treat CMV infection in people who have weakened immune systems and babies with signs of congenital CMV. For babies with signs of congenital CMV infection at birth, antiviral medications may improve hearing and developmental outcomes.
CMV infection or reactivation can lead to serious complications in hosts whose immune systems are either compromised by disease or suppressed, which is a common following stem cell and solid organ transplants.
Prophylactic Management
Transmission of cytomegalovirus is often preventable because it is most often transmitted through infected bodily fluids that come in contact with hands and then are absorbed through the nose or mouth of a susceptible person. There are two major strategies for CMV disease prevention after liver transplantation that includes preemptive therapy and antiviral prophylaxis.
For preemptive therapy, patients are monitored for evidence of CMV replication by sensitive assays, most commonly using quantitative nucleic acid amplification tests by PCR and less commonly by detection of pp65 antigenemia, and upon the detection of asymptomatic CMV replication, antiviral therapy is administered preemptively to prevent progression to symptomatic clinical disease.
CMV end-organ disease is best prevented using ART to maintain the CD4 count >100 cells/mm3. Before ART was widely available, the 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.
Although vaccines for CMV are still in the research and developmental stages, there are some treatment options. One study revealed that hyperimmune globulin, when given to pregnant women with CMV, may help prevent the fetus from contracting the infection. In 2005, a non-randomized study suggested that the administration of CMV-specific hyperimmune globulin (HIG) to pregnant women with primary CMV infection could lead to a significant decrease in the rate of MTCT (decreasing from 40% to 16%) and on the risk of congenital disease (decreasing from 50% to 3%). Subsequently, other non-randomized studies also showed improved outcomes in CMV-infected infants born to mothers who had received HIG in pregnancy, raising optimism around this strategy. However, in 2014 results of the first phase II randomized, placebo-controlled trial on the use of virus-specific HIG for the prevention of congenital CMV infection was published and revealed that the difference in the rate of congenital infection between the group of pregnant women who had received HIG and the placebo group was not statistically significant.
The study by Leruez et al., titled “In utero treatment of congenital cytomegalovirus infection with valacyclovir in a multicenter, open-label, phase II study” evaluated the efficacy of high dose oral valacyclovir (8 g daily) in pregnant women carrying a moderately CMV infected fetus. The drug was well-tolerated in the study population. Using Simon’s optimal two-stage design, valacyclovir was assumed to have a positive effect if at least 31 per 43 neonates were asymptomatic at birth. Study results showed that the number of asymptomatic infants at birth was 34 per 43, implying the benefit of this therapeutic approach. Moreover, compared with a historical cohort, the use of valacyclovir significantly increased the proportion of asymptomatic neonates from 43% without treatment to 82% with treatment.
Therapeutic Management
Currently, antiviral drugs are used for CMV infection following transplant procedures. The drugs include valganciclovir, ganciclovir, cidofovir, foscarnet, or a combination, etc. The several CMV infections caused due to CMV are retinitis, pneumonia, gastrointestinal ulcers, encephalitis, and others (mouth ulcers, pharyngitis, and others).
CMV infections can be controlled by drug therapy but, as yet, cannot be cured. Two drugs that keep the infection from getting worse are ganciclovir and foscarnet. These are delivered intravenously, and treatment must continue over a long period of time.
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Key Findings
“The management of CMV infection is maintained by two approaches i.e. prophylaxis and therapeutic approach. Currently the market is dominated by the use of drugs like valganciclovir, valacyclovir hydrochloride, and others. However the market of these drugs will experience a drop in the market share due to the launch of new emerging therapies. Recently Prevymis got approval in 2017, entered the market in 2018. Prevymis covers a very small targeted population because it is approved only for the prophylaxis (prevention) of cytomegalovirus (CMV) reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Hence, it is alright to say that it will show a positive impact on the market but it will not be responsible for the major increase in the market size. As the patent of prevymis is going to expire in 2029, there is an estimated decline in its market after 2029. Among the prophylactic potential market, two therapies, i.e., V160 and mRNA-1647 are targeting the same patient population, i.e., CMV-seronegative and CMV-seropositive healthy adults (childbearing women). And in therapeutic potential market, it is believed that Maribavir has the potential to be the promising agent in the US to treat Cytomegalovirus Infection.”
The United States Market Outlook
This section provides the total CMV Infections market size and; market size by therapies in the United States.
EU-5 Market Outlook
The total CMV Infections market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.
Japan Market Outlook
The total CMV Infections market size and market size by therapies in Japan are provided.
This section focuses on the rate of uptake of the potential drugs recently launched in the CMV Infections market or expected to get launched in the market during the study period 2018–2030. The analysis covers the CMV Infection market uptake by drugs; patient uptake by therapies; and sales of each drug.
This helps in understanding the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and allows the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.
The report provides insights into different therapeutic candidates in phase II, and phase III stage. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for CMV Infections emerging therapies.
Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.
We perform competitive and market Intelligence analysis of the CMV Infections market by using various competitive intelligence tools that include–SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.
Market Insights:
Epidemiology Insights:
Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:
1. Key Insights
2. Executive Summary of Cytomegalovirus (CMV) Infection
3. Competitive Intelligence Analysis for Cytomegalovirus (CMV) Infection
4. Cytomegalovirus (CMV) Infection: Market Overview at a Glance
4.1. Cytomegalovirus (CMV) Infection Total Market Share (%) Distribution in 2017
4.2. Cytomegalovirus (CMV) Infection Total Market Share (%) Distribution in 2030
5. Cytomegalovirus (CMV) Infection: Disease Background and Overview
5.1. Introduction
5.2. Sign and Symptoms
5.3. Pathophysiology
5.4. Risk Factors
5.5. Diagnosis
6. Patient Journey
7. Cytomegalovirus (CMV) Infection Epidemiology and Patient Population
7.1. Epidemiology Key Findings
7.2. Assumptions and Rationale: 7MM
7.3. Epidemiology Scenario: 7MM
7.3.1. Cytomegalovirus (CMV) Infection Epidemiology Scenario in the 7MM (2017-2030)
7.4. United States Epidemiology
7.4.1. Cytomegalovirus (CMV) Infection Epidemiology Scenario in the United States (2017-2030)
7.5. EU-5 Country-wise Epidemiology
7.5.1. Germany Epidemiology
7.5.1.1. Cytomegalovirus (CMV) Infection Epidemiology Scenario in Germany (2017-2030)
7.5.2. France Epidemiology
7.5.2.1. Cytomegalovirus (CMV) Infection Epidemiology Scenario in France (2017-2030)
7.5.3. Italy Epidemiology
7.5.3.1. Cytomegalovirus (CMV) Infection Epidemiology Scenario in Italy (2017-2030)
7.5.4. Spain Epidemiology
7.5.4.1. Cytomegalovirus (CMV) Infection Epidemiology Scenario in Spain (2017-2030)
7.5.5. United Kingdom Epidemiology
7.5.5.1. Cytomegalovirus (CMV) Infection Epidemiology Scenario in the United Kingdom (2017-2030)
7.5.6. Japan Epidemiology
7.5.6.1. Cytomegalovirus (CMV) Infection Epidemiology Scenario in Japan (2017-2030)
8. Treatment Algorithm, Current Treatment, and Medical Practices
8.1. Cytomegalovirus (CMV) Infection Treatment and Management
8.2. Cytomegalovirus (CMV) Infection Treatment Algorithm
9. Unmet Needs
10. Key Endpoints of Cytomegalovirus (CMV) Infection Treatment
11. Marketed Products
11.1. List of Marketed Products in the 7MM
11.2. Drug Name: Company Name
11.2.1. Product Description
11.2.2. Regulatory Milestones
11.2.3. Other Developmental Activities
11.2.4. Pivotal Clinical Trials
11.2.5. Summary of Pivotal Clinical Trial
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12. Emerging Therapies
12.1. Key Cross
12.2. Drug Name: Company Name
12.2.1. Product Description
12.2.2. Other Developmental Activities
12.2.3. Clinical Development
12.2.4. Safety and Efficacy
12.2.5. Product Profile
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13. Cytomegalovirus (CMV) Infection: Seven Major Market Analysis
13.1. Key Findings
13.2. Cytomegalovirus (CMV) Infection Market Size in 7MM
13.3. Cytomegalovirus (CMV) Infection Market Size by Therapies in the 7MM
14. Attribute analysis
15. 7MM: Market Outlook
15.1. United States: Market Size
15.1.1. Cytomegalovirus (CMV) Infection Total Market Size in the United States
15.1.2. Cytomegalovirus (CMV) Infection Market Size by Therapies in the United States
15.2. EU-5 countries: Market Size and Outlook
15.3. Germany Market Size
15.3.1. Cytomegalovirus (CMV) Infection Total Market Size in Germany
15.3.2. Cytomegalovirus (CMV) Infection Market Size by Therapies in Germany
15.4. France Market Size
15.4.1. Cytomegalovirus (CMV) Infection Total Market Size in France
15.4.2. Cytomegalovirus (CMV) Infection Market Size by Therapies in France
15.5. Italy Market Size
15.5.1. Cytomegalovirus (CMV) Infection Total Market Size in Italy
15.5.2. Cytomegalovirus (CMV) Infection Market Size by Therapies in Italy
15.6. Spain Market Size
15.6.1. Cytomegalovirus (CMV) Infection Total Market Size in Spain
15.6.2. Cytomegalovirus (CMV) Infection Market Size by Therapies in Spain
15.7. United Kingdom Market Size
15.7.1. Cytomegalovirus (CMV) Infection Total Market Size in the United Kingdom
15.7.2. Cytomegalovirus (CMV) Infection Market Size by Therapies in the United Kingdom
15.8. Japan Market Outlook
15.8.1. Japan Market Size
15.8.2. Cytomegalovirus (CMV) Infection Total Market Size in Japan
15.8.3. Cytomegalovirus (CMV) Infection Market Size by Therapies in Japan
16. Access and Reimbursement Overview of Cytomegalovirus (CMV) Infection
17. KOL Views
18. Market Drivers
19. Market Barriers
20. Appendix
20.1. Bibliography
20.2. Report Methodology
21. DelveInsight Capabilities
22. Disclaimer
23. About DelveInsight
*The table of contents is not exhaustive; the final content may vary.
Table 1 : 7MM Cytomegalovirus (CMV) Infection Epidemiology (2017-2030)
Table 2 : 7MM Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases (2017-2030)
Table 3 : Disease% Epidemiology in the United States (2017-2030)
Table 4 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in the United States (2017-2030)
Table 5 : Cytomegalovirus (CMV) Infection Epidemiology in Germany (2017-2030)
Table 6 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in Germany (2017-2030)
Table 7 : Cytomegalovirus (CMV) Infection Epidemiology in France (2017-2030)
Table 8 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in France (2017-2030)
Table 9 : Cytomegalovirus (CMV) Infection Epidemiology in Italy (2017-2030)
Table 10 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in Italy (2017-2030)
Table 11 : Cytomegalovirus (CMV) Infection Epidemiology in Spain (2017-2030)
Table 12 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in Spain (2017-2030)
Table 13 : Cytomegalovirus (CMV) Infection Epidemiology in the UK (2017-2030)
Table 14 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in the UK (2017-2030)
Table 15 : Cytomegalovirus (CMV) Infection Epidemiology in Japan (2017-2030)
Table 16 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in Japan (2017-2030)
Table 17 : Drug Name, Clinical Trials by Recruitment status
Table 18 : Drug Name, Clinical Trials by Zone
Table 19 : Total Seven Major Market Size in USD, Million (2017-2030)
Table 20 : Region-wise Market Size in USD, Million (2017-2030)
Table 21 : 7MM-Market Size by Therapy in USD, Million (2017-2030)
Table 22 : United States Market Size in USD, Million (2017-2030)
Table 23 : United States Market Size by Therapy in USD, Million (2017-2030)
Table 24 : Germany Market Size in USD, Million (2017-2030)
Table 25 : Germany Market Size by Therapy in USD, Million (2017-2030)
Table 26 : France Market Size in USD, Million (2017-2030)
Table 27 : France Market Size by Therapy in USD, Million (2017-2030)
Table 28 : Italy Market Size in USD, Million (2017-2030)
Table 29 : Italy Market Size by Therapy in USD, Million (2017-2030)
Table 30 : Spain Market Size in USD, Million (2017-2030)
Table 31 : Spain Market Size by Therapy in USD, Million (2017-2030)
Table 32 : United Kingdom Market Size in USD, Million (2017-2030)
Table 33 : United Kingdom Market Size by Therapy in USD, Million (2017-2030)
Table 34 : Japan Market Size in USD, Million (2017-2030)
Table 35 : Japan Market Size by Therapy in USD, Million (2017-2030)
*The list of tables is not exhaustive; the final content may vary
Figure 1 : 7MM Cytomegalovirus (CMV) Infection Epidemiology (2017-2030)
Figure 2 : 7MM Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases (2017-2030)
Figure 3 : Cytomegalovirus (CMV) Infection Epidemiology in the United States (2017-2030)
Figure 4 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in the United States (2017-2030)
Figure 5 : Cytomegalovirus (CMV) Infection Epidemiology in Germany (2017-2030)
Figure 6 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in Germany (2017-2030)
Figure 7 : Cytomegalovirus (CMV) Infection Epidemiology in France (2017-2030)
Figure 8 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in France (2017-2030)
Figure 9 : Cytomegalovirus (CMV) Infection Epidemiology in Italy (2017-2030)
Figure 10 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in Italy (2017-2030)
Figure 11 : Cytomegalovirus (CMV) Infection Epidemiology in Spain (2017-2030)
Figure 12 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in Spain (2017-2030)
Figure 13 : Cytomegalovirus (CMV) Infection Epidemiology in the UK (2017-2030)
Figure 14 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in the UK (2017-2030)
Figure 15 : Cytomegalovirus (CMV) Infection Epidemiology in Japan (2017-2030)
Figure 16 : Cytomegalovirus (CMV) Infection Diagnosed and Treatable Cases in Japan (2017-2030)
Figure 17 : Drug Name, Clinical Trials by Recruitment status
Figure 18 : Drug Name, Clinical Trials by Zone
Figure 19 : Total Seven Major Market Size in USD, Million (2017-2030)
Figure 20 : Region-wise Market Size in USD, Million (2017-2030)
Figure 21 : 7MM-Market Size by Therapy in USD, Million (2017-2030)
Figure 22 : United States Market Size in USD, Million (2017-2030)
Figure 23 : United States Market Size by Therapy in USD, Million (2017-2030)
Figure 24 : Germany Market Size in USD, Million (2017-2030)
Figure 25 : Germany Market Size by Therapy in USD, Million (2017-2030)
Figure 26 : France Market Size in USD, Million (2017-2030)
Figure 27 : France Market Size by Therapy in USD, Million (2017-2030)
Figure 28 : Italy Market Size in USD, Million (2017-2030)
Figure 29 : Italy Market Size by Therapy in USD, Million (2017-2030)
Figure 30 : Spain Market Size in USD, Million (2017-2030)
Figure 31 : Spain Market Size by Therapy in USD, Million (2017-2030)
Figure 32 : United Kingdom Market Size in USD, Million (2017-2030)
Figure 33 : United Kingdom Market Size by Therapy in USD, Million (2017-2030)
Figure 34 : Japan Market Size in USD, Million (2017-2030)
Figure 35 : Japan Market Size by Therapy in USD, Million (2017-2030)
*The list of figures is not exhaustive; the final content may vary.
