Cytomegalovirus (CMV) Infection Market

• The Cytomegalovirus Infections Market Size is anticipated to grow with a significant CAGR during the study period (2020-2034).
• In 2023, the United States accounts for the largest market size of cytomegalovirus infections, in comparison to EU4 (Germany, France, Italy, and Spain) and the United Kingdom and Japan.
• CMV can affect the brain or the spinal cord. The most common clinical presentations are encephalitis, ventriculoencephalitis, myelitis, polyradiculopathy, and mononeuritis multiplex.
• When the infection threatens life or eyesight, an antiviral drug (valganciclovir, ganciclovir, cidofovir, foscarnet, or a combination) may be given. These drugs may be given by mouth or by vein. When CMV infection retinitis is very severe, the drugs may also be injected directly into the eye. These drugs have serious side effects, which increase the demand and need for more potential therapies.
• Long-term follow-up is needed due to the rarity of the condition, offering a deeper understanding of recurrence and progression-free survival.
• Transplant recipients are at a significantly higher risk for complications and death when dealing with a CMV infection. Takeda's LIVTENCITY is a treatment option specifically available for post-transplant patients with CMV, addressing this critical need.
• In November 2021, the US Food and Drug Administration approved LIVTENCITY as the first drug for treating adults and pediatric patients with post-transplant cytomegalovirus infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for Cytomegalovirus.
• In February 2022, Cheplapharm Arzneimittel GmbH (“Cheplapharm”) signed an agreement with Hoffmann-La Roche to acquire the worldwide rights to VALCYTE (valganciclovir hydrochloride). Under the terms of the agreement, Cheplapharm received product rights for VALCYTE in certain countries worldwide including the US.
• In November 2022, the European Commission approved LIVTENCITY (maribavir) for the treatment of adults with Post-transplant cytomegalovirus infections or diseases that are refractory (with or without resistance) to one or more prior therapies.
• Pharmaceutical cytomegalovirus infections companies continue to invest in research and development efforts aimed at discovering and developing new therapies for CMV infections. This ongoing innovation is likely to drive further market growth.
• Several Cytomegalovirus (CMV) Infection companies are developing innovative therapies to address the unmet medical needs and improve patient outcomes.
• 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 include Triplex (Helocyte), and others.

DelveInsight's “Cytomegalovirus Infections Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth analysis of Cytomegalovirus Infections epidemiology, market, and clinical development in Cytomegalovirus Infections. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the Cytomegalovirus Infections therapeutics market trends in the United States, EU4 (Germany, France, Italy, and Spain ), and the United Kingdom, and Japan.

Cytomegalovirus infections market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted Cytomegalovirus infections market size from 2020 to 2034 in 7MM. The report also covers current cytomegalovirus infection treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s underlying potential.

Cytomegalovirus Infections Treatment Market

Cytomegalovirus Infections Overview and Diagnosis

Cytomegalovirus (CMV) Infections are a type of herpesvirus (herpesvirus type 5) with a wide range of symptoms: from no symptoms to fever and fatigue (resembling infectious mononucleosis) to severe symptoms involving the eyes, brain, or other internal organs. It is a common virus for people of all ages; however, a healthy person’s immune system usually keeps the virus from causing illness. Blood tests show that 60–90% of adults have had Cytomegalovirus Infections at some time. The cytomegalovirus tests market is growing rapidly due to increasing awareness, rising infection rates, and advancements in diagnostic technologies.

In newborns, the diagnosis is usually made by sending a sample of urine to a laboratory to grow (culture) and identify the virus. Blood tests that detect antibodies to Cytomegalovirus can confirm a new infection. However, these tests cannot confirm whether a disease is present. Cytomegalovirus retinitis can be identified by an ophthalmologist, who examines internal eye structures to check for characteristic abnormalities using an ophthalmoscope. Whereas, in people with a weakened immune system, a biopsy of affected tissues is often necessary to confirm Cytomegalovirus disease.

The Cytomegalovirus Infections report provides an overview of Cytomegalovirus Infections pathophysiology, and diagnostic approaches, along with a real-world scenario of a patient’s journey beginning from the first symptom, the time taken for diagnosis to the entire treatment process.

Further details related to country-based variations in diagnosis are provided in the report...

Cytomegalovirus Infections Treatment 

Cytomegalovirus infection or reactivation can lead to serious complications in hosts whose immune systems are either compromised by disease or suppressed, which is common following stem cell and solid organ transplants. The treatment landscape of Cytomegalovirus infections is divided into Prophylactic Drugs and Therapeutic Drugs. There are two major strategies for Cytomegalovirus disease prevention after liver transplantation which include preemptive therapy and antiviral prophylaxis. The cytomegalovirus infection clinical trials market is expanding rapidly due to rising awareness, novel therapies, and increasing research investments.

Preemptive Therapy: This strategy involves monitoring patients for evidence of Cytomegalovirus replication using sensitive assays like PCR or pp65 antigenemia. Upon detection, antiviral therapy is promptly administered to prevent progression to symptomatic disease.

Antiviral Prophylaxis: Antiviral drugs are administered prophylactically to high-risk individuals, such as transplant recipients, to prevent Cytomegalovirus infection. This approach is particularly crucial in maintaining immunosuppressed patients' health post-transplant.

Currently, antiviral drugs are used for Cytomegalovirus infection following transplant procedures. The drugs include valganciclovir, ganciclovir, cidofovir, foscarnet, or a combination, etc. The several Cytomegalovirus infections caused due to Cytomegalovirus are retinitis, pneumonia, gastrointestinal ulcers, encephalitis, and others (mouth ulcers, pharyngitis, and others).

Cytomegalovirus Infections Epidemiology

The Cytomegalovirus Infections epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as Total diagnosed cases of cytomegalovirus infection, number of infants born with congenital cytomegalovirus, cytomegalovirus patients among hematopoietic stem cell transplants, number of cytomegalovirus patients among solid organ transplantation, number of refractory cytomegalovirus patients after hematopoietic stem cell transplants/solid organ transplant, cytomegalovirus retinitis among human immunodeficiency virus patients in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• In 2023, the United States accounted for the highest number of diagnosed cases of cytomegalovirus infection.
• As per the analysis, Cytomegalovirus Infection affects males and females equally.
• Among EU4 and the UK, France had the highest number of diagnosed cases of cytomegalovirus followed by the UK. On the other hand, Italy had the lowest diagnosed incident population in 2023.
• It was found that 40% of solid organ transplant patients are diagnosed with Cytomegalovirus in the US.  

Cytomegalovirus Infections Drug Chapters

The drug chapter segment of the Cytomegalovirus Infections report encloses a detailed analysis of Cytomegalovirus Infections marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the cytomegalovirus infections' pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Cytomegalovirus Infections Marketed Drugs

LIVTENCITY (maribavir): Takeda Pharmaceuticals

LIVTENCITY is a cytomegalovirus pUL97 kinase inhibitor indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant cytomegalovirus infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. In November 2021, LIVTENCITY got the US FDA approval. The antiviral activity of maribavir is mediated by competitive inhibition of the protein kinase activity of human cytomegalovirus enzyme pUL97, which results in inhibition of the phosphorylation of proteins.

VALCYTE (valganciclovir hydrochloride): Roche/ Cheplapharm

VALCYTE (valganciclovir hydrochloride, film-coated tablets, and powder for oral solution) is indicated for adult patients for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS), the prevention of cytomegalovirus disease in solid organ transplant patients who are at risk. VALCYTE is not a cure for cytomegalovirus retinitis, and immunocompromised patients may continue to experience the progression of retinitis during or following treatment. Patients should be advised to have ophthalmologic follow-up examinations at a minimum of every 4 to 6 weeks while being treated with VALCYTE. Some patients will require more frequent follow-up.

Cytomegalovirus Infections Emerging Drugs

mRNA-1647: Moderna

mRNA-1647 being developed by Moderna comprises six mRNAs encoding two antigens in one vaccine and is designed to protect against Cytomegalovirus infection. Unlike a protein-based vaccine, mRNA-1647 instructs the body’s cells to manufacture the antigens, resulting in functional antigens that mimic those presented to the immune system by Cytomegalovirus during a natural infection. Preclinical data previously published in Vaccine showed that vaccination with mRNA-1647 in animal models elicited potent and durable neutralizing antibody titers. Currently, the mRNA-1647 is in the Phase III investigational stage.

TRIPLEX: Helocyte

TRIPLEX is a first-in-class, best-in-class, universal (non-HLA-restricted) recombinant modified vaccinia ankara viral vector vaccine engineered by Helocyte to induce a robust and durable virus-specific T cell response to three immuno-dominant proteins linked to Cytomegalovirus 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, it is in the Phase II stage.

Note: Detailed emerging therapies assessment will be provided in the final report...

Cytomegalovirus Infections Market Outlook

The cytomegalovirus infections treatment landscape, particularly in immunocompromised patients post-transplant, is multifaceted and evolving. Prophylactic strategies aim to prevent Cytomegalovirus disease through preemptive therapy or antiviral prophylaxis, utilizing sensitive assays for early detection of Cytomegalovirus replication. While vaccines remain in developmental stages, interventions such as hyperimmune globulin offer promise, especially in pregnant women to prevent vertical transmission. Therapeutically, antiviral drugs like ganciclovir, valganciclovir, cidofovir, and foscarnet are pivotal, albeit associated with significant toxicities. Recent approvals like maribavir expand treatment options, offering hope for improved outcomes in both adult and pediatric patients with post-transplant Cytomegalovirus infection/disease. However, challenges persist, highlighting the ongoing need for research and innovation to enhance efficacy while mitigating adverse effects in the management of Cytomegalovirus infections.

• Key players, such as ModernaTX, Helocyte, and others are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products for the treatment of Cytomegalovirus Infections.
• In 2023, the United States accounts for the largest market size of Cytomegalovirus Infections, in comparison to EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan.
• Among the EU4 and the UK, Germany had the highest market size, while Spain had the lowest market size for Cytomegalovirus Infections in 2023.

Cytomegalovirus Infections Drugs Uptake

The mRNA-1647 vaccine candidate, developed by Moderna, has shown promising results by eliciting robust immune responses against cytomegalovirus in Phase II trials. With these encouraging findings, the mRNA vaccine has progressed to Phase III clinical trials, aimed at evaluating its efficacy in protecting against cytomegalovirus infection. This advancement signifies a significant step forward in the quest for an effective vaccine, for a virus that poses substantial health risks, particularly to immunocompromised individuals and pregnant women. The potential of mRNA-1647 to prevent cytomegalovirus infection could have profound implications for public health, offering a much-needed preventive measure against this prevalent viral infection.

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034, which depends on the competitive landscape, safety, and efficacy data along with order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed analysis of emerging therapies drug uptake in the report...

Cytomegalovirus Infections Cancer Activities

The Cytomegalovirus Infections Cancer pipeline report provides insights into different Cytomegalovirus Infections clinical trials within Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Cytomegalovirus Infections Pipeline Development Activities

The Cytomegalovirus Infections Cancer pipeline insight report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Cytomegalovirus Infections emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Professors, and Others.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Vascular Institute of New York, Carolina Vein Institute, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Cytomegalovirus Infections market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Cytomegalovirus Infections Market Report

• The report covers a segment of key events, an executive summary, descriptive overview of cytomegalovirus infections, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the cytomegalovirus infections market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM cytomegalovirus infections market.

Cytomegalovirus Infections Market Report Insights

• Cytomegalovirus Infections Patient Population
• Cytomegalovirus Infections Therapeutic Approaches
• Cytomegalovirus Infections Pipeline Analysis
• Cytomegalovirus Infections Market Size and Trends
• Existing and future Market Opportunity
• Cytomegalovirus Infections Drugs Market

Cytomegalovirus Infections Market Report Key Strengths

• Eleven Years Forecast
• 7MM Coverage
• Cytomegalovirus Infections Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Cytomegalovirus Infections Drugs Uptake
• Key Cytomegalovirus Infections Market Forecast Assumptions

Cytomegalovirus Infections Market Report Assessment

• Current Cytomegalovirus Infections Treatment Practices
• Cytomegalovirus Infections Unmet Needs
• Cytomegalovirus Infections Pipeline Product Profiles
• Cytomegalovirus Infections Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)
• Cytomegalovirus Infections Market Drivers
• Cytomegalovirus Infections Market Barriers

FAQs

• What is the historical and forecasted Cytomegalovirus Infections patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which combination treatment approaches will have a significant impact on cytomegalovirus infections drug treatment market size?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of cytomegalovirus infections?
• How many cytomegalovirus infections Cytomegalovirus Infections companies are developing therapies for the treatment of cytomegalovirus infections?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy Cytomegalovirus Infections Market Forecast Report

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the cytomegalovirus infections market.
• Insights on patient burden/disease Incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.