Flu Anxiety Trapping 300 Million People Fuels a Booming Diagnostic Market
As we are currently in the peak season for influenza, many people cannot help but feel anxious.
People are paying more attention than ever to abnormal reactions in their respiratory tracts, eager to identify the underlying causes and initiate treatment within the golden therapeutic window to shorten the course of the disease as much as possible. This overwhelming anxiety,The demand for drugs and tests is often extraordinarily high.
In2023the winter-spring transition of the year, plagued by3The flu anxiety of hundreds of millions once ignited the market for multiplex respiratory pathogen testing.2023By year-end, Meituan and JD.com successively launched home-based rapid testing services for respiratory pathogens within their internet healthcare divisions. Through these online platforms, consumers can place orders from home, have samples collected by delivery riders at their doorstep, and then receive prescriptions or medication recommendations from platform physicians based on the test results. This closed-loop model—spanning testing, consultation, and medication outside hospital settings—gained immediate popularity upon launch, particularly during peak flu seasons when hospitals are overwhelmed with patients.
According to Meituan Medicine,2024Data presented at the World Influenza Conference, from2023Year8Month to2024Year5MonthInterval, the number of at-home multi-pathogen respiratory tests exceeded5010,000 person-visits, nearly equivalent to the annual volume of influenza-like illness samples submitted for testing by sentinel hospitals across China.This also ignited2024The development boom in multiplex respiratory pathogen testing.
According to statistics from VCBeat,2024In [year], a total of in China13A record-high number of multiplex respiratory diagnostic kits have been approved for market launch, prompting more testing companies to join the fierce competition triggered by flu-related anxiety through outsourced sample testing. The last time such intensive development of diagnostic products occurred was inHPVAlthough testing was in its early stages of popularity, the speed of this product’s launch and the frequency of its technological iterations have far exceeded previous norms.
Respiratory Infections Surge Once Again
Self2023Since the beginning of this year, the wave of respiratory infections seems to have never subsided.
According to statistics from the Beijing Center for Disease Control and Prevention,2023Throughout the year, various pathogens erupted in alternating waves.2Month to3During the month, influenza viruses raged across China. Entering4A month later, respiratory syncytial virus began to spread, and in5Month to6emerged as the predominant pathogen causing respiratory tract infections in China during the month. By7In [Month], Mycoplasma pneumoniae and parainfluenza virus began to prevail, dominating the subsequent4Respiratory tract infections with high incidence over the course of months.11In May, although Mycoplasma pneumoniae infections remained at high levels, respiratory syncytial virus and influenza virus have made a resurgence.
Such a trend, in2024The year was nearly replicated. Based on current surveillance data, the turmoil of alternating outbreaks of respiratory pathogens,2025will continue for the year, with severity potentially exceeding2023peak level of the year. According to the weekly influenza surveillance report from the National Center for Disease Control and Prevention,2024Year12Month23DayTo2024Year12Month29DayDuring the period, the proportion of influenza-like illness (ILI) cases reported by sentinel hospitals in southern provinces among total outpatient visitsFor 5.7%, higher than the previous week and2021the level of the same period in the previous year.Meanwhile, the data reported by sentinel hospitals in northern provincesFor7.2%，Also higher than the previous week's level, even exceeding it2021Aged2023Yearthe same period.
Certainly, in most cases, respiratory tract infections do not lead to severe consequences. However, the timely and correct management of these conditions remains a significant challenge for both hospitals and patients.
On the one hand, respiratory tract infections are characterized by a high number of cases, wide distribution, short disease course, and contagiousness.As early as2019In [year], the number of patients seeking medical attention for respiratory infections reached3.08100 million people. If patient samples are tested in traditional laboratories, it takes a long time to obtain results, thereby prolonging the waiting time for outpatient and emergency patients at healthcare facilities and increasing the risk of nosocomial transmission of respiratory infectious diseases.
On the other hand, and more importantly, mixed infections account for a high proportion of respiratory diseases.According to data from the China National Center for Disease Control and Prevention,23.3%Acute respiratory patients with co-infections of more than two viruses or bacteria are prone to missed or misdiagnosis if only a single pathogen is tested, which can affect treatment outcomes.
In this sense, rapid and easily deployable diagnostic tools have become an urgent unmet clinical need for respiratory tract infections.2024 Year2 month, the National Health Commission of China in2024The annual quality control improvement objectives for various specialties explicitly state the goals of increasing the positive rate of etiological diagnosis of influenza prior to the use of anti-influenza antiviral drugs, and raising the rate of pathogen testing submission before initiating antimicrobial therapy in hospitalized patients. The following month, the National Center for Quality Control in Infectious Diseases issued the Guidelines for Patient Visits to Fever Clinics, requiring medical institutions to configure antigen detection and multiplex antigen testing panels for multiple pathogens in accordance with the epidemiological characteristics of infectious diseases. It also recommends that medical institutions with the necessary capabilities implement point-of-care testing and multiplex testing for common pathogens in fever clinics to further enhance testing efficiency.
Driven by the dual forces of clinical demand and regulatory guidance, China’s market for multiplex respiratory diagnostics has entered a period of rapid growth.
Cross-Industry Players Elevate Product Competition to New Heights
For years, empirical medication for respiratory infections has been widely criticized, yet the process of changing this status quo has been slow and tortuous.This is not unrelated to the fact that the pathogens causing respiratory infections are complex and diverse, while the corresponding toolkit systems remain relatively outdated.
Typically, at different stages of respiratory tract infections, methods such as pathogen culture, antigen detection, inflammatory marker testing, nucleic acid testing, and antibody testing can be employed to achieve etiological diagnosis, evaluate the type of infection, or monitor treatment efficacy. Clinically, traditional complete blood count (CBC) and inflammatory marker testing remain the mainstream tools for detecting respiratory diseases. However, these approaches can only determine whether a bacterial or viral infection is present, without identifying the specific pathogen, and asRespiratory Pathogen Testing“Gold Standard”Pathogen culture, due to its complex procedures and time-consuming nature, is no longer common in primary clinical practice.
2023In [year], the National Health Commission issued the "National Goals for Improving Medical Quality and Safety," which explicitly required increasing the coverage rate of nucleic acid testing for respiratory pathogens and the percentage of nucleic acid testing for respiratory infectious diseases, as well as improving the rate of etiological specimen submission before antimicrobial therapy in hospitalized patients. This provided policy support for medical institutions to conduct non-COVID-19 respiratory molecular testing and report new test items.
In recent years, molecular testing has been introduced in hospital inpatient departments and high-tier outpatient clinics, while more user-friendly colloidal gold assays have begun to be deployed in primary care outpatient settings. Among these, molecular testing offers high accuracy and covers a prolonged disease course. With continuous optimization of technical factors such as automation and detection speed, it has demonstrated the potential to conduct large-scale screening for respiratory pathogens in hospital inpatient, emergency, and outpatient settings.
also from2023Since [year], the development of diagnostic reagents for respiratory pathogens, which had been dormant for a long time, has entered a peak period.Arrived.2024In [year], the number of approved domestic multiplex respiratory diagnostic reagents hit a record high., for the entire year13approval of the relevant reagent for market launch is virtually equivalent to2015The total number of approvals for similar reagents in each year since [year].
Notably,2024Several companies that have had respiratory pathogen detection reagents approved for market launch this year had previously made few inroads in this field.For example, Getein Biotech and Snibe Diagnostics had previously focused primarily on the development of chemiluminescence reagents for traditional in-hospital in vitro diagnostic tests. They2024Approved for Market Launch in the Year/Influenza B Virus and Respiratory Syncytial Virus Nucleic Acid Combined Detection Kit, Respiratory Syncytial VirusIgMAntibody detection kits, all of which are the first approved products in this field. For another example, due to securing over10Baochuang Biotech and Chuanglan Biotech, which have garnered significant attention for their respiratory pathogen detection products, do not possess substantial accumulated expertise in this field. This indicates that the influence of the surging demand for multiplex respiratory testing has extended beyond established players such as Innotest Biotechnology and Sansure Biotech, which have long specialized in this area, thereby creating opportunities for a broader range of in vitro diagnostic manufacturers to establish new growth trajectories.
2024Another notable feature of the development of domestic respiratory pathogen detection reagents in China is the significantly increased number of respiratory pathogens that can be detected by a single product.Previously, whether based on antibodies, antigens, or nucleic acids, respiratory pathogen testing primarily targeted a single pathogen. In2023Herschel Gene's13For a long period before the approval and market launch of the multiplex detection kit for respiratory pathogens, Innotest Biotech covered9Antibodies Against Respiratory PathogensIgMThis test kit is the assay on the market capable of simultaneously detecting the largest number of respiratory pathogens.
And in2024approved in the year13Of the reagent types, nearly half have been included in5two or more types of respiratory pathogens, especially when it comes to2024Year-end,10Respiratory pathogen detection reagents for moderate-to-severe and above cases have become mainstream. It is reported that some companies have already attempted to develop products covering nearly30Diagnostic reagents for respiratory pathogens. Interestingly, most of the companies developing multiplex and ultra-multiplex respiratory pathogen detection kits are newcomers to the field. For instance, Baochuang Biotech, Chuanglan Biotech, and Aikeruite, as mentioned earlier, are all leveraging more powerful products to carve out markets where they lack first-mover advantage.
Moreover, at the pricing level, respiratory multiplex testing reagents, whose performance continues to break through ceilings, are becoming increasingly cost-effective.A search of public information by VCBeat revealed that the end-user sales prices for various multiplex respiratory pathogen testing products, including the assay with the largest current panel of respiratory pathogens, are all within1000within yuan. Furthermore, as the number of respiratory pathogens increases, the cost per individual pathogen test shows a downward trend. For example,6The average price for testing major respiratory pathogens is approximately300yuan, and9The price of reagents for detecting severe pathogens is approximately420yuan, corresponding to a cost of approximately per pathogen test50Yuanhe46Yuan.
Enhanced detection capabilities and lower product pricing have undoubtedly laid a solid foundation for the widespread clinical adoption of multiplex respiratory diagnostic reagents.
How Much Longer Will It Stay Hot?
Behind the Clustered Launch of Multiplex Respiratory Diagnostic Kits Lies a Sales-Driven Performance Surge That Spanned Nearly the Entire Respiratory Infection Epidemic Cycle
First to take action was Sansure Biotech.In the field of respiratory diseases, Sansure Biotech offers single-target tests and multiplex panels, Multiple Combined Solutions, Including Immunoantigens, Drug Resistance Gene Screening, and Next-Generation Sequencing of Pathogens, Have Been Launched Successively60A variety of products. Among them,2021Six nucleic acid detection kits for respiratory pathogens approved for market launch this year, covering Influenza A virus, Influenza B virus, Respiratory Syncytial Virus, Adenovirus, Human Rhinovirus, Mycoplasma pneumoniae, and others.6high-incidence respiratory pathogens, and has even become2023star product of the year. According to Sansure Biotech's financial report,2023year, respiratory product revenue exceeded4hundred million yuan, a year-on-year increase of680%。
Notably, Sansure Biotech has also taken the lead in piloting digital home-based monitoring, directlyCpropelling point-of-care respiratory pathogen testing to a peak.2023In 2023, Sansure Biotech partnered with third-party e-commerce platforms such as Meituan and JD.com to launch its “At-Home Rapid Testing” service. According to information available on the JD.com platform,CTerminal operations have been launched in cities including Beijing, Shanghai, Guangzhou, Shenzhen, Suzhou, Chengdu, Chongqing, Tianjin, Wuhan, and Hangzhou. As mentioned at the beginning of this article,50Tens of thousands of at-home multi-pathogen respiratory tests were conducted following the launch of this collaboration.According to the latest financial report,2024In the first half of the year, Sansure Biotech's operating revenue and net profit increased by respectively.67.6%、49.1%, the revenue growth driven by multiplex respiratory panel testing continues.
Furthermore,Focus onPOCTInnovent Biologics’ products also struck gold amid the major outbreak of respiratory infections.. According to the latest financial report,2024first half of the year,achieved operating revenue4.21RMB 100 million, a year-on-year increase of88.3%, among which net profit2.06hundred million yuan, a year-on-year increase of166.4%, becoming the fastest-growing in China during the same periodIVDone of the companies.And in2024In the first half of the year, revenue from respiratory infection testing accounted for a proportion of Innovent Biologics' operating income reaching98%。
As early as2019In [year], InnoTest Biology became the leading manufacturer in China's market for rapid diagnostic tests for respiratory pathogens.2023Second Half of the Year, as peaks in Mycoplasma pneumoniae infections emerged in multiple regions across China, Innotest Biotechnology leveraged pediatric emergency outpatient services as an entry point to rapidly introduce its multiplex respiratory pathogen testing products into hospitals. According to reports, top-tier children’s hospitals in China, including the Children’s Hospital Affiliated to the Capital Institute of Pediatrics, Beijing Children’s Hospital Affiliated to Capital Medical University, Shanghai Children’s Medical Center, and Children’s Hospital of Fudan University, have adopted Innotest Biotechnology’s relevant products.Among them, Innotest Biotech2021Antibodies against Respiratory Tract Infection Pathogens Approved for Marketing This YearIgMThe detection kit, which covers major seasonal respiratory pathogens including Mycoplasma pneumoniae, Chlamydia pneumoniae, influenza A virus, influenza B virus, parainfluenza virus, respiratory syncytial virus, adenovirus, Coxsackievirus, and Legionella pneumophila, has become a flagship product.
However, in the respiratory multiplex testing market, which has already become a fiercely competitive "red ocean," it seems no easy feat for specific products and companies to replicate such a surge in performance.
On one hand, Sansure Biotech and InnoCare Pharma’s ability to align with the alternating outbreak cycles of respiratory pathogen infections was partly serendipitous.
At the onset of a respiratory infection outbreak2023In that year, the market offered limited reagent options for sweat virus detection, with most targeting respiratory syncytial virus (RSV), thereby creating favorable conditions for Sansure Biotech’s six-item respiratory pathogen nucleic acid detection kit to stand out. Meanwhile, Innotest Biotechnology not only capitalized on the demand for Mycoplasma pneumoniae testing but also strategically focused in advance on pediatric settings with high testing demands, thereby driving sales growth of its corresponding reagents.
On the other hand, the in-hospital application of multiplex respiratory pathogen detection assays is still in its early exploratory stage, with many urgent issues to be addressed regarding clinical implementation and scale-up.
For instance, regarding pricing and medical insurance reimbursement, currently, most multiplex respiratory pathogen detection reagents do not have independent billing codes within hospitals and can only be billed under the general category of "pathogens."DNA、RNAThis approach to bundled pricing may lead to issues such as unbundling and duplicate billing in medical insurance reimbursements. Furthermore, the clinical value of multiplex respiratory pathogen testing remains controversial. At present, aside from specific therapeutics already available for certain influenza and respiratory syncytial virus (RSV) infections, the majority of respiratory infections can only be managed with symptomatic treatment. There is no consensus on whether it is necessary to employ increasingly extensive panels of targets to differentiate pathogens. If the clinical utility of multiplex or ultra-multiplex respiratory pathogen diagnostic assays is negated, companies will be unable to ensure the inclusion of future emerging pathogens by expanding their target ranges, thereby introducing significant uncertainty into the commercial viability of these products.
Of course, the precise detection of respiratory pathogens, accelerated by influenza-related anxiety, has significantly improved the efficiency of diagnosis and treatment for this disease. However, as a profit-driven business, this sector still requires time to mature.