Influenza A Market

Key Highlights

• Influenza A viruses are the only influenza viruses known to cause flu pandemics. Influenza A virus has the ability to spread efficiently among people, and against which people have little or no immunity.
• Influenza A viruses have different forms, which are identified by the specific proteins on their surface called hemagglutinin (H) and neuraminidase (N). Current subtypes of influenza A viruses that routinely circulate in people include A(H1N1) and A(H3N2).
• According to the estimates, the highest market size of influenza A was found in the US and the least was in Spain across the 7MM in 2024. The upcoming therapies for influenza A are expected to combat the current unmet needs faced by the patients and add to the overall growth of the influenza A market size.
• Vaccination is the most effective measure for protecting against more severe forms of viral respiratory diseases. Those eligible for vaccination, particularly those at higher risk of severe outcomes, are encouraged to get vaccinated in line with national recommendations.
• Alongside pharmacological interventions, behavioral management strategies, such as encouraging adherence to hygiene practices and promoting vaccination, are vital for protecting high-risk groups from severe disease.
• The key players in the influenza A include Roche, BioCryst Pharmaceuticals, Seqirus, Moderna, Cidara Therapeutics, GlaxoSmithKline, Cocrystal Pharma, and others.
• The influenza A pipeline features promising late- and mid-stage therapies (drugs and vaccines) including mRNA-1010, CD388, Flu Pandemic mRNA (GSK4382276A), CC-42344, and others.
• Emerging pipeline offers effective management options for influenza A. Growing awareness and improved diagnostic techniques are crucial for early detection and better patient outcomes.

DelveInsight’s “Influenza A – Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of influenza A, historical and forecasted epidemiology as well as influenza A market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The influenza A market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM influenza A market size from 2020 to 2034. The report also covers current influenza A treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Influenza A Understanding and Treatment Algorithm

Influenza A Overview

Influenza A viruses are divided into subtypes based on two proteins on the surface of the virus: hemagglutinin (H) and neuraminidase (N). There are 18 different hemagglutinin subtypes and 11 neuraminidase subtypes (H1 through H18 and N1 through N11, respectively). While more than 130 influenza A subtype combinations have been identified in nature, primarily from wild birds, there are potentially many more influenza A subtype combinations. Currently circulating influenza A (H1N1) viruses are related to the pandemic 2009 H1N1 virus that emerged in the spring of 2009 and caused a flu pandemic. These viruses scientifically called the “A (H1N1) pdm09 virus” and more generally called “2009 H1N1,” have continued to circulate seasonally since then and have undergone genetic changes and changes to their antigenic properties. Occasionally with influenza A, an antigenic shift occurs. This is a significant change in the virus surface antigens (HA and NA), which leads to the emergence of a new subtype, often resulting in a global pandemic with increased morbidity and mortality. 

Influenza A symptoms can range from mild to severe. Mild symptoms typically include fever, cough, sore throat, runny nose, body aches, and fatigue. As the illness progresses, symptoms can become more intense, leading to severe fatigue, difficulty breathing, chest pain, and in some cases, pneumonia or sepsis. High-risk individuals, such as the elderly or those with underlying conditions, are more likely to experience these severe complications.

Influenza A Diagnosis

Diagnosis of influenza virus, including Influenza A, is typically based on clinical symptoms and can be confirmed with laboratory tests. Healthcare providers often use Rapid Influenza Diagnostic Tests (RIDTs), which detect viral antigens in respiratory samples and provide results within minutes. More accurate methods, such as Reverse Transcription-Polymerase Chain Reaction (RT-PCR), are used to confirm the virus type and subtype, especially during outbreaks or severe cases. In some situations, viral culture or immunofluorescence tests may also be performed, though these take longer. Early and accurate diagnosis is important for proper treatment and to help prevent the spread of the virus. Rapid molecular assays are a new kind of molecular influenza diagnostic test for upper respiratory tract specimens with high sensitivity and specificity. Two FDA-cleared rapid molecular assays are available in the United States. Rapid molecular assays can provide results in approximately 20 min.

Further details related to diagnosis are provided in the report…

Influenza A Treatment

The treatment depends on the severity of diseases. For patients with uncomplicated seasonal influenza, symptomatic treatment is recommended, with advice to stay home to prevent spreading the virus. Treatment focuses on relieving symptoms of influenza, such as fever. Patients should monitor themselves to detect if their condition deteriorates and seek medical attention. High-risk patients should receive antiviral medications, such as oseltamivir, within 48 hours of symptom onset. Severe cases, including pneumonia or sepsis, require immediate antiviral treatment. Neuraminidase inhibitors should be prescribed for at least 5 days, and corticosteroids should only be used if necessary. Vaccination remains the most effective prevention method, with annual doses recommended to maintain immunity.

Further details related to treatment are provided in the report…

Influenza A Epidemiology

The influenza A epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total vaccinated pool of influenza A, total influenza vaccine failure cases, total influenza A positive cases, and strain-specific cases of influenza A in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034. 

• The total vaccinated pool of influenza A is categorized into age groups, including children aged 0–4, 5–12; adolescents aged 13–17; adults aged 18–49, 50–64, ≥65, and pregnant women. Most vaccinations in the total vaccinated pool were reported in adults aged 18–49 in the US, while the least number of vaccinations reported in the pregnant women category in 2024.
• In 2024, the vaccine failure rate in the US was estimated to be around 70%.
• According to the Ministry of Health, Labor, and Welfare of Japan, the average number of influenza A cases in 2024 was 64.39 per institution, significantly higher than the previous peak of 57.09 in January 2019.
• As per European Respiratory Virus Surveillance Summary (ERVISS) (2025), influenza A (H1N1) pdm09 was the main subtype among all studies, ranging between 57% and 93% of influenza A subtypes in Europe in 2024.
• The total influenza A positive cases in the US are projected to rise from during the study period 2020–2034. 

Influenza A Drug Chapters

The drug chapter segment of the influenza A report encloses a detailed analysis of the marketed and the late, mid, and early stage (Phase III, Phase II, and Phase I/II) pipeline drugs. The marketed drugs segment encloses drugs such as FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT, and FLUCELVAX QUADRIVALENT (Seqirus), FLUMIST (AstraZeneca), XOFLUZA (baloxavir marboxil) (Roche and Shionogi), RAPIVAB (peramivir) (BioCryst Pharmaceuticals), and others. The drug chapter also helps understand the influenza A clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.

Marketed Drugs

XOFLUZA (baloxavir marboxil): Roche and Shionogi

XOFLUZA is a first-in-class, single-dose oral medicine with an innovative proposed mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies. XOFLUZA is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.  In October 2018, Roche announced that the US FDA had approved XOFLUZA for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. In August 2022, Genentech announced that the US FDA approved a supplemental New Drug Application for XOFLUZA to treat acute, uncomplicated influenza in healthy children aged 5 to under 12, showing symptoms for no more than 48 hours. The FDA also approved its use for preventing influenza in the same age group after exposure to an infected person. XOFLUZA is approved in the EU for the treatment of uncomplicated influenza and for post-exposure prophylaxis of influenza in children aged one year and above, and in adolescents and adults.

• According to a January 2025 presentation, a regulatory submission was filed in Europe in June 2024 to seek approval for XOFLUZA for the treatment of influenza in pediatric patients aged 0 to 1 year.
• According to a January 2025 presentation, a regulatory submission was filed in the US for XOFLUZA targeting influenza transmitted through direct contact, with FDA acceptance of the submission currently pending.
• In September 2024, Roche announced the positive topline results of the Phase III CENTERSTONE study of XOFLUZA showing a reduction in the transmission of influenza viruses.

RAPIVAB (peramivir): BioCryst Pharmaceuticals

RAPIVAB (peramivir) is an antiviral drug with activity against influenza virus. It is an inhibitor of influenza virus neuraminidase. RAPIVAB is approved in the United States for the treatment of acute uncomplicated influenza in patients six months and older who have been symptomatic for no more than two days. Efficacy of RAPIVAB is based on clinical trials of naturally occurring influenza in which the predominant influenza infections were influenza A virus and a limited number of patients infected with influenza B virus. It is approved in Japan with the brand name RAPIACTA for the treatment of adults, children, and infants with uncomplicated seasonal influenza and those patients at high-risk for complications associated with influenza. RAPIVAB received its initial FDA approval for the treatment of influenza infection in December 2014. This was followed by approval for a pediatric indication in September 2017, and a further expansion in February 2021, allowing use in children six months of age and older.

In September 2024, the HHS awarded us up to a USD 69 million contract for the procurement of up to 95,625 doses over a five-year period of RAPIVAB for the treatment of influenza under the HHS Contract.

IV: intravenous; IM: intramuscular

Note: Detailed list will be provided in the final report.

Emerging Drugs

CC-42344: Cocrystal Pharma

CC-42344, a novel PB2 inhibitor, was selected as a preclinical lead as an oral or inhaled treatment of pandemic and seasonal influenza A. This candidate binds to a highly conserved PB2 site of influenza polymerase complex (PB1: PB2: PA) and exhibits a novel mechanism of action. CC-42344 showed excellent in vitro antiviral activity against influenza A strains, including avian pandemic strains and TAMIFLU and XOFLUZA resistant strains, and has favorable pharmacokinetic and drug resistance profiles. In addition to the oral candidate of CC-42344, the inhaled CC-42344 is being developed for the potential prophylactic treatment of pandemic and seasonal influenza infections. Dry powder inhalation development and toxicology studies have been evaluated. The company had received authorization from the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) to conduct a Phase IIa human challenge study with CC-42344. 

• In December 2024, Cocrystal Pharma announced the plan to extend enrollment in the Phase IIa human challenge study with its investigational product CDI-42344.
• In May 2024, Cocrystal Pharma announced the completion of enrollment of 78 subjects who were infected with influenza A in a randomized, double-blind, placebo-controlled Phase IIa human challenge clinical study.

CD388: Cidara Therapeutics

Cidara aims to develop CD388, its lead flu DFC, to achieve universal prevention of seasonal and pandemic influenza with a single dose. Drug-Fc conjugates are not vaccines or monoclonal antibodies. Their targeting domains are small molecule antivirals that bind to a highly conserved target on the influenza cell surface, which is essential for viral proliferation and enables universal influenza coverage. These long-acting, bispecific DFCs are designed to directly inhibit viral proliferation while directing immune-mediated clearance of the virus. The two distinct and complementary mechanisms are designed to maximize the antiviral activity of DFCs. CD388 is being developed for universal, season-long flu protection in all patient populations. The company had completed two Phase I studies and one Phase IIa study of CD388, our influenza DFC candidate. These include a randomized, double-blind, dose-escalation Phase I trial (NCT05285137), a Japanese bridging study (NCT05619536), and a Phase IIa trial (NCT05523089) evaluating CD388’s pre-exposure prophylactic activity against influenza. In June 2023, the FDA, granted Fast Track designation to CD388 for the prevention of influenza A and B infection in adults who are at high risk of influenza complications due to underlying immunodeficiency and may not mount an adequate response to influenza vaccine or are at high risk of severe influenza despite influenza vaccination, including those for whom vaccines are contraindicated

• In March 2025, Cidara Therapeutics announced two upcoming presentations on CD388 in Influenza at the 38th International Conference on Antiviral Research (ICAR).
• In September 2024, the company initiated the CD388 Phase IIb NAVIGATE study to further evaluate its efficacy and safety in preventing influenza.
• In April 2024, the Company and Janssen entered into a license and technology transfer agreement, or the Janssen License Agreement, under which the Company reacquired all rights for CD388 from Janssen to develop and commercialize CD388.

SC: subcutaneous

Note: Detailed list will be provided in the final report.

Drug Class Insights

PB2 inhibitor

Inhibitors targeting the PB2 subunit of the influenza A virus RNA-dependent RNA polymerase have been developed to disrupt the viral replication cycle. The PB2 protein plays an essential role in the cap-snatching mechanism, wherein the virus cleaves 5′-capped primers from host pre-mRNA to initiate the synthesis of viral mRNA. PB2 inhibitors function by binding to the cap-binding domain of the subunit, thereby preventing the acquisition of host-derived RNA primers and effectively halting viral transcription.

Note: Detailed insights will be provided in the final report.

Influenza A Market Outlook

Influenza A vaccines are essential in protecting against the most prevalent strains of the virus, with annual updates based on global surveillance data. Vaccines like FLUZONE (inactivated influenza vaccine) and FluMist (live attenuated influenza vaccine) stimulate the immune system to produce antibodies that can prevent infection or reduce the severity of illness. These vaccines are crucial in mitigating seasonal flu outbreaks and safeguarding vulnerable populations, such as the elderly and those with chronic health conditions.

Antiviral medications play a vital role in managing influenza by both treating the infection and reducing the risk of serious complications, such as bacterial pneumonia. When administered promptly, these drugs can lessen the severity of symptoms and typically shorten the duration of illness by about one day. Early treatment is particularly crucial for individuals at high risk of flu-related complications, including the elderly and those with weakened immune systems. At present, four antiviral drugs are recommended for influenza treatment: TAMIFLU, RELENZA, RAPIVAB, and XOFLUZA. TAMIFLU and RELENZA received FDA approval in 1999, followed by newer options introduced after a gap of nearly 15 years.

Over the past few years, improvements in the field of influenza A have been observed though there is still a necessity to have a profound understanding of the disease and its unmet needs. The best way to prevent influenza is to get a flu vaccine yearly. However, the flu viruses constantly change through antigenic drift or antigenic shift, increasing the odds of failure.

Companies like Cocrystal Pharma (CC-42344), Moderna (mRNA-1010), and others are developing promising therapies for the management of Influenza A, the investigational candidates and are likely to launch during the study period.

• The US accounted for the largest market size of influenza A, in comparison to EU4 and the UK (Germany, France, Italy, the UK, and Spain) and Japan in 2024.
• Among the EU4 and the UK, Germany had the highest market size, while Spain had the lowest market size for influenza A in 2024.
• The emerging landscape for influenza A is having many management options that are being evaluated in the pipeline. The expected launch of these therapies is expected to increase the market size of influenza A in the coming years.

Influenza A Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020–2034. The landscape of influenza A treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, professionals, and the entire healthcare community in their tireless pursuit of advancing disease care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience. 

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

Influenza A Pipeline Development Activities

The report provides insights into therapeutic candidates in Phase III, Phase II, and Phase I/II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for influenza A emerging therapy.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on influenza A evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including infectious disease specialists, and others.

Delveinsight’s analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as - Medicine at Harvard Medical School in the US, Oxford University in the UK, University of California, San Francisco, and University of Heidelberg in Germany. Their opinion helps understand and validate current and emerging therapy treatment patterns or influenza A market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

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 disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

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, some of the primary outcome measures include time to alleviation of influenza symptoms, time to clinical resolution, among others.

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

Globally, influenza A patient families spend an essential proportion of their household income on influenza A care. Influenza A patients have to face economic burden alone without any healthcare coverage or proper reimbursement policies.

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.

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

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of influenza A, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the influenza A 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 shape and drive the 7MM influenza A market.

Influenza A Report Insights

• Patient Population
• Therapeutic Approaches
• Influenza A Pipeline Analysis
• Influenza A Market Size and Trends
• Existing and Future Market Opportunity 

Influenza A Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage 
• Influenza A Epidemiology Segmentation
• Key Cross Competition 
• Drugs Uptake and Key Market Forecast Assumptions

Influenza A Report Assessment

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

FAQs

• What was the influenza A market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like by 2034? What are the contributing factors for this growth?
• What are the pricing variations among different geographies for approved therapies?
• What can be the future treatment paradigm of influenza A?
• What are the disease risks, burdens, and unmet needs of influenza A? What will be the growth opportunities across the 7MM concerning the patient population with influenza A?
• Who is the major competitor of statins in the market and how the competitors will affect their market share?
• What are the current options for the treatment of influenza A? What are the current guidelines for treating influenza A in the US, Europe, and Japan?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies? 

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the influenza A market.
• Insights on patient burden/disease prevalence, 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 Analyst view section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of current 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.