U.S. Influenza Diagnostics Market Size, Share & Trends Analysis Report By Test Type (RIDT, RT-PCR, Cell Culture, Others), By End-use (Hospitals, POCT, Laboratories), And Segment- Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2033

The U.S. influenza diagnostics market size was estimated at USD 199.90 million in 2023 and is expected to surpass around USD 329.04 million by 2033 and poised to grow at a compound annual growth rate (CAGR) of 5.11% during the forecast period 2024 to 2033.

Key Takeaways:

• The RIDT segment dominated the market with the largest revenue share of 37.2% in 2023 and is also expected to expand at the fastest CAGR of 6.6% from 2024 to 2033.
• The RT-PCR segment held a significant share of 21.9% of the market in 2022.
• The hospitals segment dominated the market with the largest revenue share of 42% in 2022
• The POCT segment is expected to advance at the fastest CAGR of 6.4% over the forecast period.

U.S. Influenza Diagnostics Market Overview

The U.S. Influenza Diagnostics market plays a pivotal role in the country's healthcare landscape, providing essential tools for the timely detection and management of influenza infections. This overview aims to delve into the key components of the market, shedding light on its current status, trends, and factors influencing its growth

U.S. Influenza Diagnostics Market Growth

The growth of the U.S. Influenza Diagnostics market is propelled by several key factors. Firstly, the increasing incidence of influenza cases across the nation amplifies the demand for efficient and rapid diagnostic tools. The market's expansion is further driven by the heightened awareness among both healthcare professionals and the general public regarding the significance of early influenza detection. Technological advancements, particularly in molecular diagnostics and point-of-care testing, contribute to enhanced accuracy and speed in diagnosis, fostering market growth. Additionally, strategic collaborations between industry players and regulatory bodies play a crucial role in navigating challenges, ensuring a conducive environment for innovation and market advancement. The dynamic nature of the market, coupled with the continuous evolution of influenza strains, necessitates ongoing research and development efforts, creating opportunities for sustained growth within the U.S. Influenza Diagnostics sector.

U.S. Influenza Diagnostics Market Report Scope

U.S. Influenza Diagnostics Market Dynamics

Drivers

• Increasing Disease Prevalence: The rising incidence of influenza cases in the U.S. serves as a primary driver for the growth of the diagnostics market. As the frequency of influenza outbreaks continues to escalate, there is a heightened demand for accurate and timely diagnostic solutions.
• Emphasis on Early Detection: A growing awareness of the importance of early detection and prompt intervention is a significant driver. The emphasis on early diagnosis not only aids in providing timely and effective medical care but also helps in implementing preventive measures to curb the spread of the virus.

Restraints

• Regulatory Challenges: Stringent regulatory requirements for diagnostic tests pose a significant restraint. Compliance with these regulations is essential for market players, leading to increased costs and potentially hindering the rapid development and commercialization of new diagnostic solutions.
• Reimbursement Issues: Challenges related to reimbursement for diagnostic tests can impede market growth. Inconsistent reimbursement policies and delays in reimbursement approvals may discourage both healthcare providers and patients from adopting advanced influenza diagnostics, affecting market penetration.

Opportunities

• Technological Advancements: Ongoing advancements in diagnostic technologies offer opportunities for the development of more accurate and efficient influenza diagnostic tools. Innovations in molecular diagnostics, artificial intelligence applications, and high-throughput screening can enhance diagnostic capabilities.
• Point-of-Care Testing Expansion: The increasing adoption of point-of-care testing presents a significant opportunity. As healthcare settings move towards decentralized diagnostics, there is a growing market for rapid and portable influenza diagnostic solutions that offer quick and convenient results.

Challenges

• Reimbursement Issues: Inconsistent reimbursement policies for diagnostic tests present a challenge to market stakeholders. Delays in reimbursement approvals and uncertainties in reimbursement rates can hinder the widespread adoption of advanced influenza diagnostics.
• Complexity of Multiplex Testing: While multiplex testing is a growing trend, the complexity and cost associated with these advanced diagnostic methods can be a challenge. Implementation challenges and the need for specialized expertise may limit the widespread adoption of multiplex testing.

Segments Insights:

Test Type Insights

The RIDT segment dominated the market with the largest revenue share of 37.2% in 2023 and is also expected to expand at the fastest CAGR of 6.6% from 2024 to 2033, owing to the easy availability of these tests and user-friendly applications for fast and effective diagnosis. Additionally, the World Health Organization (WHO) has recommended the use of RIDT for influenza diagnosis due to its moderately complex, sensitive, specific, and accurate features.

Based on test type, the U.S. influenza diagnostics market is segmented into RIDT, RT-PCR, cell culture, and others. The RT-PCR segment held a significant share of 21.9% of the market in 2022. It delivers results faster in comparison to cell culture, ranging from 2 minutes to less than 2 hours. This technique also aids in the identification of antiviral resistance. Advancements in these technologies are further expected to boost market growth during the forecast period.

For instance, Thermo Fisher Scientific Inc. offers QuantStudio 3 and 5 RT-PCR systems, which are simple and easy to use and designed for both new and experienced users. QuantStudio 3 and 5 RT-PCR, when combined with the Thermo Fisher Cloud platform, helps individuals to remotely monitor and access results and also enables collaboration with colleagues anytime and anywhere. Therefore, such technological advancements are anticipated to further fuel market growth during the forecast period.

Cell culture is one of the oldest and most reliable methods of diagnosing flu cases and takes 3 to 10 days post-sampling to provide accurate results. This method provides accurate statistics and also enables healthcare professionals to distinguish between various types of influenza viruses. The others segment, which includes immunoassay kits, is expected to expand at a lucrative CAGR over the forecast period. The rise in immunoassay testing offered by market players is expected to fuel industry growth.

For instance, Becton, Dickinson and Company offers the BD Veritor Plus system, a digital immunoassay that is used for the detection of influenza A and B. The product is more efficient than RIDTs in terms of sensitivity and specificity, owing to its integrated software and efficient interpretation of various infectious diseases.

End-use Insights

The hospitals segment dominated the market with the largest revenue share of 42% in 2022, owing to the rising flu prevalence in the U.S. According to the CDC, during the 2021-2022 influenza season in the country, the incidence of symptomatic illnesses caused by the influenza virus ranged from 7.6 to 15.5 million cases. This resulted in a significant number of medical visits, ranging from 3.5 to 7.4 million. Furthermore, the severity of the illness led to hospitalizations ranging from 82,000 to 185,000 cases. Tragically, the impact of the virus resulted in deaths ranging from 3,700 to 20,800.

Based on end-use, the market is segmented into hospitals, laboratories, and POCT. The POCT segment is expected to advance at the fastest CAGR of 6.4% over the forecast period. This growth can be attributed to the advanced technologies developed by market players. For instance, bioMerieux SA offers an easy-to-use, cost-effective, and reliable POCT product, BIONEXIA Influenza A+B, a rapid test for the detection of influenza A & B viruses in humans using nasopharyngeal samples.

New technological advancements in POCT kits facilitating error-free results are expected to boost the U.S. market for influenza diagnostics over the forecast period. Laboratory testing most often involves the usage of real-time PCR techniques. Some advantages of this form of testing include accurate results, sensitivity, cost-effectiveness, and the ability to test multiple samples at once.

Key Companies & Market Share Insights

The rise in the adoption of home testing kits has created a huge demand for influenza diagnostics in recent years. The high demand has created fierce competition in the regional market, thus making space for new companies to venture through advanced products and disruptive technologies, opening up space for innovation in this field. For instance, in October 2017, Alere Inc. obtained 510(k) marketing clearance from the U.S. FDA for their diagnostic test Alere i Influenza A & B 2. This test is designed to effectively detect related infections in both adults and children. The product is a rapid molecular assay that delivers fast and accurate results with high specificity.

In another development, in August 2017, Meridian Bioscience expanded its ImmunoCard STAT! product line with the introduction of ImmunoCard STAT! FLU A&B. This product is used to detect the presence of influenza A & B in nasopharyngeal and nasal swabs within 10-15 minutes. Thus, the rising incidences of product launches by leading market players are further expected to fuel market growth during the forecast period. Some of the major participants in the U.S. influenza diagnostics market include:

Key U.S. Influenza Diagnostics Companies:

• 3M
• Abbott
• BD
• Meridian Bioscience
• Quidel Corporation
• F. Hoffmann-La Roche Ltd
• SA Scientific Ltd.
• SEKISUI Diagnostics
• Thermo Fisher Scientific Inc.

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the U.S. Influenza Diagnostics market.

By Test Type 

• RIDT
• RT-PCR
• Cell Culture
• Others

By End-use 

• Hospitals
• POCT
• Laboratories