Latex Agglutination Test Kits Market Size, Share & COVID-19 Impact Analysis, By Test Type (Antibody Detection and Antigen Testing (Streptococcus, Staphylococcus Aureus, Escherichia Coli, and Others)), By Sample Type (Blood, Urine, Cerebrospinal Fluid (Lumbar Puncture), and Others), By End-user (Hospital-based Laboratories and Standalone Clinical Laboratories), and Regional Forecast, 2022-2029

The latex agglutination test kits market size was valued at USD 447.2 million in 2021 and is projected to grow USD 462.4 million in 2022 to USD 620.0 million by 2029, exhibiting a CAGR of 4.3% during 2022-2029. North America dominated the global market with a share of 45.50% in 2021.

Based on our analysis, the global market exhibited a growth of 5.0% in 2020 as compared to 2019. Latex agglutination test kits are widely used to detect antibodies or antigens in body fluids such as cerebrospinal fluid (CSF), blood, urine, and saliva. The test kits comprise coating either antigen or antibody on an artificial carrier particle, latex bead. The rising incidence of infectious and autoimmune diseases coupled with the diversified application areas of these kits strongly contribute to the product adoption. According to an article published by the National Institutes of Health (NIH) in 2021, the global incidence of meningitis is estimated to be 20.0 cases per 100,000 people, representing about 1.2 million cases. It is also reported that most outbreaks occur in Sub-Saharan Africa. The greater presence of such tests in these regions provides an effective measure to combat these diseases as these kits are simple to use and cost-effective. Robust R&D initiatives to evaluate the sensitivity and efficacy of the product and rising infectious disease awareness favor market growth opportunities during the forecast period.

COVID-19 IMPACT

Increased Usage of Latex Agglutination Test Kits among COVID-19 Affected Patients Supported Market Growth

The pandemic exerted a slight positive impact due to surge in certain tests (C-reactive protein (CRP) and D-Dimer) conducted during the COVID-19 pandemic. Meanwhile, decrease in the number of diagnoses of other diseases, such as E.coli, pneumonia, and autoimmune disease, negatively impacted the market due to decline in the number of patient visits to healthcare facilities.

The COVID-19 pandemic represented an unpredictable situation for latex agglutination test kit manufacturers due to disruptions in the supply chain during the period. The decline was observed due to various factors such as drop in the number of autoimmune, E Coli, pneumonia tests conducted, decline in the number of overall patient visits to the hospitals & diagnosis, reduced capacities of hospitals for the diagnosis of other diseases than COVID-19, and others. For instance, according to an article published by the National Institutes of Health (NIH) in 2022, there was 44.0%-53.0% reduction in community-acquired pneumonia admissions in Japan.

In 2021, the diagnosis rate of other diseases increased due to the reopening of healthcare facilities, smoothness in the supply of test kits, and increasing patient visits to clinics for the diagnosis & treatment of various diseases, including pneumonia, rheumatoid arthritis, meningitis, and others. The global market resumed pre-pandemic level growth.

LATEST TRENDS

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Adoption of Point of Care (POC) Techniques/Rapid Diagnostics for Infectious and Autoimmune Diseases to Determine Future Market Growth  

Recently, the global market has witnessed one of the prominent trends, which is the rising adoption of rapid and POC technology. These test kits are included under POC or rapid diagnostics. It requires a small amount of samples for detection. Various types of samples, such as Cerebrospinal Fluid (CSF), blood, urine, and saliva, can be used in this method. These products are easy to standardize and provide quick results. For instance, according to an article published by Medline Plus in 2021, latex agglutination kits provide results in 15 minutes to an hour. Multiple benefits offered by these test kits increase their adoption across the globe.

Furthermore, the rising prevalence of infectious and autoimmune diseases has resulted in increased disease as well as an economic burden. These kits are cost-effective and efficient, thus easily accessible in emerging nations. These factors led to an intense need for these products in the market.

More efficacy of Latex Agglutination Assay (LAA) over other POC technologies is propelling the demand for these test kits. According to an article published by Springer Nature in 2021, in the study, the performance of the Lateral Flow Assay (LFA) with LAA was compared from blood and CSF samples. LFA and LAA had sensitivities of 100% and 93% for the CSF sample. The study shows that the LAA test has suitable efficacy from CSF sample. Such trends are predicted to contribute significantly to the global latex agglutination test kits market growth.

LATEX AGGLUTINATION TEST KITS MARKET GROWTH FACTORS

Diverse Application Areas of Latex Agglutination Test Kits to Favor Market Growth

Latex agglutination test kits are commonly used for hepatitis, meningitis, rheumatoid arthritis, tonsillitis, and other streptococcal infections. Usage of these kits for the diagnosis of various infectious and autoimmune diseases suggests a positive growth trajectory for this market in future. For instance, some commercially available products include the Wellcogen Strep B Rapid Latex Agglutination Test, Wellcogen Strep B 30 Pk for Staphylococcus, Waaler Rose Latex Kits for rheumatoid arthritis, E. coli O157 Latex Test for E.coli, and ASI Rubella test for Rubella Virus.

Also, some studies have been performed to evaluate the efficacy and specificity of these latex agglutination test kits. Such clinical studies provide a scientific basis regarding the efficacy of these test kits, favoring their adoption in the market. According to an article published by the National Institutes of Health (NIH) in 2021, a rapid and accurate agglutination-based testing for SARS-CoV-2 antibodies was developed. It showed excellent sensitivity of the latex agglutination assay and was concluded that it might be used to detect antibody response in the early stages of viral infection and monitor its dynamic changes over time. Hence, the abovementioned factors drive the global market during 2022-2029.   

Rising Prevalence of Infectious and Autoimmune Diseases Augments the Market Expansion

In the current market scenario, latex agglutination kits are available for common infectious diseases such as meningitis, pneumonia, hepatitis, Haemophilus influenzae, typhoid, and tuberculosis. The rising prevalence of these infectious diseases will provide an impetus for the demand for these test kits as they provide rapid diagnosis. According to an article released by the World Health Organization (WHO) in October 2022, on a global level, tuberculosis (TB) is the 13th leading cause of death and the second leading infectious disease after COVID-19 (above HIV/AIDS). In 2021, a total of 10.6 million cases of tuberculosis (TB) were estimated, of which 6.0 million were men, 3.4 million were women, and 1.2 million were children.

Furthermore, rising cases of autoimmune diseases, such as lupus, rheumatoid arthritis, and the availability of these kits in emerging nations favor the rapid adoption of the products. In the market, the SLE Latex Kits for lupus and Waaler Rose latex agglutination test kits for rheumatoid arthritis are available. Therefore, such factors augment the market growth rate.

RESTRAINING FACTORS

Emergence of New and Reliable Alternate Diagnostics to Hinder Market Expansion

Despite several advantages of latex agglutination test kits in diagnostic care, one of the substantial hindrances to market growth is the emergence of new and reliable alternate diagnostics, especially in high-growth regions such as the United States and Europe. These test kits are very simple, rapid, and inexpensive. Standardization is also necessary, or else it will produce false positive reactions. Due to certain limitations of these kits and greater technological advancements in infectious diseases diagnostics, the market is expected to register limited growth prospects. For instance, according to an article published by the International Journal of Microbiology in 2020, Nucleic Acid Amplification Tests (NAATs)-based technologies provide better options for diagnosing infectious gastroenteritis, and it helps in overcoming some of the challenges faced in the traditional microbiological and culture methods. These NAAT-based technologies can diagnose diseases from a small number of specimens and are more specific and sensitive than these test kits.

Furthermore, technological advancements such as point-of-care devices for diagnosing infectious diseases in various settings, including hospitals, also impact market growth. Thus, it could decrease the rate of these test kits usage globally.

SEGMENTATION

By Test Type Analysis

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Increased Infectious Disease Outbreaks Aided Dominance of Antigen Testing Segment in 2021

Based on test type, the market is segmented into antibody detection and antigen testing. The antigen testing segment is further sub-segmented into streptococcus, staphylococcus aureus, escherichia coli, and others. The antigen testing segment held a dominant global latex agglutination test kits market share owing to a large number of patient population being impacted by various bacterial, viral, and fungal diseases. In most of these cases of infectious diseases, antigen testing is recommended for disease diagnosis. According to an article published by the Journal of Clinical Laboratory Analysis in 2020, a study was conducted in the Children's Hospital of Zhejiang University, School of Medicine (Hangzhou, China). It was found that this test showed positive results and was efficient in detecting rotavirus and adenovirus antigens. The sensitivity and specificity of this test for detecting rotavirus A were 81.0% and 97.4%, respectively.

The antibody detection segment is projected to witness growth prospects in the market. Increasing adoption of antibody testing by these test kits and the rising prevalence of diseases such as rheumatoid arthritis in which rheumatoid factor (RF) is calculated through these test kits are likely to augment the segment's growth.

By Sample Type Analysis

Strong Utilization of Blood as Sample for Disease Detection to Enable the Segment to Occupy Significant Market Share in 2021

Based on sample type, the market is segmented into blood, urine, cerebrospinal fluid (lumbar puncture), and others. The blood segment dominates the market share as it is widely used in antigen and antibody latex agglutination test kits. Various bacterial and fungal detections require blood or serum samples. Such factors contributed to the segment’s expansion. For instance, according to an article published by the National Institutes of Health (NIH) in 2020, a retrospective review of patients with cryptococcosis from 2002 to 2019 at Barnes-Jewish Hospital found that sensitivity for serum CrAg latex agglutination was estimated to be 94.7%.

The urine segment held a substantial market share in 2021 as urine samples are commonly taken to detect human chorionic gonadotropin (hCG) hormones and fibrin. It is also utilized for parasitic diseases such as kala-azar.

The cerebrospinal fluid (lumbar puncture) segment accounted for the lowest market share in 2021. Generally, E. coli meningitis and some fungal infections, such as C. neoformans, might require CSF samples for latex tests. The others segment comprises saliva and fecal.

By End-user Analysis

Robust Patient Admissions at Hospital-based Laboratories Led to Segment Dominance in 2021

Based on end-user, the market is segmented into hospital-based laboratories and standalone clinical laboratories. The hospital-based laboratories segment dominated the market in 2021 due to favorable health reimbursement policies for infectious diseases diagnostics and rising awareness regarding the early diagnosis of infectious diseases. For instance, according to an article published by the National Institutes of Health (NIH) in 2020, hospital-based laboratories conduct more tests than all other laboratories and provide easy access to diagnosing infectious diseases. Such benefits of hospital-based laboratories are a contributing factor to the segment’s growth.

The standalone clinical laboratories segment occupied the second-largest market share in 2021. The increase in the number of standalone clinical laboratories conducting infectious disease diagnostics, including latex agglutination tests, is anticipated to contribute to the expansion of the standalone clinical laboratories segment.

REGIONAL INSIGHTS

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Region-wise, the global market is segmented into North America, Europe, Asia Pacific, and the Rest of the World.

The North America market size stood at USD 203.5 million in 2021 and is anticipated to dominate the global market. Diverse application areas of these kits in various diseases and the presence of major operating players in North America enabled it to hold a dominant position in the global market. The robust usage of these test kits and the increasing number of Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories are expected to drive the market's growth in the region. As per estimates published by the Centers for Disease Control and Prevention (CDC) in 2022, there are approximately 330,000 CLIA-certified laboratory entities across the U.S.

The Europe market was anticipated to be the second-leading region in 2021. Rising R&D initiatives to detect the efficacy of these kits and increasing government expenditure to provide diagnostic care for patients are factors attributable to the market growth in Europe. According to a research article published by Austin Journal of Clinical Case Reports in 2021, a pilot study was conducted in the emergency department of the Hospital Puerta de HierroMajadahonda in Madrid (Spain). It was a rapid test for the detection of COVID-19 disease by using latex agglutination. It showed positive results and could be considered as a complementary method to the techniques used for the detection of SARS CoV-2. This is poised to surge the market growth.

Asia Pacific is projected to grow with the highest CAGR during the forecast period. The region possesses a significant proportion of the global burden of infectious diseases. According to an article published by NIH in 2021, the national population-based study (2010 to 2018) states that a total of 119,644 hospitalizations and 58 deaths were identified due to pediatric meningitis in South Korea. The rising number of hospital based laboratories and standalone laboratories will boost the promotion of latex agglutination testing.

Furthermore, the rest of the world, which includes Latin America and the Middle East & Africa, is expected to witness growth prospects due to the rising adoption of these test kits, which are easy to use and cost-effective.

KEY INDUSTRY PLAYERS

Strong Product Portfolio and Market Presence of Thermo Fisher Scientific Inc. and Hardy Diagnostics Enabled them to Gain Leading Positions 

The global market is highly fragmented, with various global and domestic players. Regarding the competitive landscape, the global market is highly fragmented, with various global and domestic players. Some of the market leaders include Thermo Fisher Scientific Inc. and Hardy Diagnostics, which account for a significant proportion of the market share, owing to a large customer base and a robust presence of healthcare professionals in their network. For instance, Thermo Fisher Scientific Inc. holds one of the largest product types of these test kits across the globe.

Atlas Medical GmbH, HiMedia Laboratories, and Liofilchem S.r.l. are some other prominent players operating due to their increasing strategic initiatives in the market. The other players such as Bio-Rad Laboratories, Inc., Pro Lab Diagnostics Inc., Arlington Scientific, Inc., and Biotec (Novacyt) hold slightly lower share in the global market. Increasing market presence through advanced launches and strategic initiatives is anticipated to fortify the market position of the above-mentioned companies.

LIST OF KEY COMPANIES IN LATEX AGGLUTINATION TEST KITS MARKET:

• Atlas Medical GmbH (Germany)


• Thermo Fisher Scientific Inc. (U.S.)


• Bio-Rad Laboratories, Inc. (U.S.)


• HiMedia Laboratories (India)


• Pro Lab Diagnostics Inc. (Canada)


• Arlington Scientific, Inc. (U.S.)


• Hardy Diagnostics (U.S.)


• Liofilchem S.r.l. (Italy)


• Biotec (Novacyt) (U.K.)

KEY INDUSTRY DEVELOPMENTS:

• July 2022: Bio-Rad Laboratories, Inc. launched two products, the Synthetic Negative Run Control for tick-borne, meningitis/encephalitis, and sexually-transmitted infections products, and HAI Negative Run Control for hospital-associated infections products.


• April 2022: Bio-Rad Laboratories, Inc. participated in the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022. The company showcased its complete range of infectious disease testing systems, reagents, and quality controls for optimizing testing workflows.


• June 2022: Thermo Fisher Scientific partnered with Diagnostic BioSystems (DBS) to offer a wide spectrum of primary antibodies in the U.S.


• October 2021: Hardy Diagnostics launched the HardyCHROM Candida + Auris. It is a chromogenic media for the selective isolation and differential identification of Candida species.


• August 2021: Hardy Diagnostics launched the HardyCHROM Group A Strep agar. It is a chromogenic medium for the selective cultivation and differentiation of Group A Streptococcus (S. pyogenes) from clinical specimens.

REPORT COVERAGE

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The report comprises an exhaustive global market analysis. It focuses on major aspects such as test type, sample type, end-user, and geography. The report depicts insights into market dynamics, key industry developments, disease incidences, economic burdens, key players, and COVID-19 impact on the market. Furthermore, the report covers numerous factors that have favored the growth of the global market.

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