What is IgM/IgG Rapid Test Kits?
The Rapid COVID-19 IgM / IgG Combo Test Kit is a lateral flow immunoassay for the purpose of qualitative detection as well as differentiation of immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies that work against SARS-CoV-2 in human serum and acid citrate dextrose (ACD) )) Plasma. The global market for corona test kits is growing rapidly due to the global outbreak of the coronavirus. The number of patients in hospitals is growing rapidly and these countries are trying to get access to the test kit to screen every suspect and slow the spread of the virus. BioMedomics' combined IgM-IgG rapid test for COVID-19 is a lateral flow immunoassay that can be used to qualitatively detect IgG and IgM antibodies of the new coronavirus in human serum, plasma, or whole blood in vitro. The test should not be used with heat-inactivated or any other inactivated human specimens such as blood, serum, plasma, etc. Fresh samples should be collected and tested immediately. The combo test kit is usually used for identifying individuals with an adaptive immune response to SARS-CoV-2 who indicate a recent or previous infection. At this point, it is unknown how long antibodies persist after infection and whether the presence of antibodies confers protective immunity. The IgM / IgG Combo Test Kit is not be used for diagnosing acute SARS-CoV-2 infection. The tests are limited to laboratories that are certified according to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42, USA, 263a, and meet the requirements for performing tests of medium or high complexity. The fast COVID-19 IgM / IgG combination test kit is based on the principle of immunochromatography. Mouse anti-human IgM and human IgG antibodies are immobilized on the nitrocellulose membrane as two individual test lines (IgM line and IgG line) in the test window of the test device. The IgM line in the test window is closer to the sample well, followed by the IgG line. While the test sample flows through the membrane.
Attributes | Details |
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Study Period | 2018-2030 |
Base Year | 2023 |
Unit | Value (USD Million) |
Key Companies Profiled | Cellex (Germany), RayBiotech (United States), Biopanda (United Kingdom), BioMedomics (United States), GenBody(South Korea), SD Biosensor(South Korea), Advaite (United States), Premier Biotech (United States), Epitope Diagnostics (United States), CTK Biotech (United States), Creative Diagnostics (United States), Eagle Biosciences (United States), Sure Biotech (United States), SugenTech Inc. (South Korea), Sensing Self, PTE. Ltd (Singapore), Euroimmun AG (Germany), Liming Bio (China), Beijing Wantai Biological (China) and Livzon Diagnostics (China) |
CAGR | 20.3% |
The study covers a detailed analysis segmented by key business segments i.e. by type (RDT(Rapid Diagnostic Test), ELISA(Enzyme-linked Immunosorbent Assay) and Neutralization Assay) , by application (Hospital, Special Clinic and Research Institution) and major geographies. Research Analyst at AMA predicts that United States Players will contribute to the maximum growth of Global IgM/IgG Rapid Test Kits market throughout the predicted period.
The competition is expected to become even more intense in the years to come due to the entry of several new players in the market. To help clients improve their revenue shares in the market, this research study provides an in-depth analysis of the markets competitive landscape and offers information on the products offered by various leading companies. Additionally, this IgM/IgG Rapid Test Kits market report suggests strategies that Players can follow and highlights key areas they should focus on, in order to take maximum benefits of growth opportunities.
The report offers several leading Players, some of them are Cellex (Germany), RayBiotech (United States), Biopanda (United Kingdom), BioMedomics (United States), GenBody(South Korea), SD Biosensor(South Korea), Advaite (United States), Premier Biotech (United States), Epitope Diagnostics (United States), CTK Biotech (United States), Creative Diagnostics (United States), Eagle Biosciences (United States), Sure Biotech (United States), SugenTech Inc. (South Korea), Sensing Self, PTE. Ltd (Singapore), Euroimmun AG (Germany), Liming Bio (China), Beijing Wantai Biological (China) and Livzon Diagnostics (China).
Market Overview:
In August 2020, SSI Diagnostica acquires the American company CTK Biotech, which developed one of the worlds most precise Covid-19 antibody tests. The purchase expands our product portfolio and strengthens our global production and distribution network including access to new markets worldwide.
“Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised) - Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff.” “This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act).”
The companies are now exploring the market by adopting mergers & acquisitions, expansions, investments, new developments in existing products, and collaborations as their preferred strategies. The players are also exploring new geographies and industries through expansions and acquisitions so as to avail a competitive advantage through combined synergies.
Influencing Trend:
Increasing Number of Investments for Research & Development of IgM/IgG Rapid Test Kits, Increasing Government and Industry Players Initiatives and Increasing Number of Laboratory to Check Diseases
Market Growth Drivers:
Increasing Demand for Corona Test Kits in Hospitals to Diagnose the Patients with Symptoms, Increasing Prevalence of Chronic Diseases and The Opening of Coronavirus Test Centers at Different Parts of Countries Across the World
Challenges:
Shortage of Corona Test Kits
Restraints:
Lack of WorkForce for Manufacturing of Test Kits and Stringent Government Policies about the Kits
Opportunities:
The number of patients in the hospitals is increasing rapidly, and the countries are trying to get access to the test kit to inspect each and every suspected person to slow the spread of the virus.
Key highlights of the Global IgM/IgG Rapid Test Kits market Study:
CAGR of the market during the forecast period 2023-2030
In-depth information on growth factors that will accelerate the IgM/IgG Rapid Test Kits market in next few years.
Detailed Insights on futuristic trends and changing consumer behavior
Forecast of the Global IgM/IgG Rapid Test Kits market size and its contribution to the parent market by type, application and by country.
A broad view of customer demand
Uncover markets competitive landscape and in-depth information on various Players
Comprehensive information about factors that will challenge the growth of IgM/IgG Rapid Test Kits Players
Transformation and Important Triggers:
Business transformation has taken hold across the broad corporate landscape due to the confluence of several important triggers, including:
A tipping point in globalization
A major slowdown in Western economies
Significant shifts in technology and cost structure
The challenges of regulatory compliance
New forms of competition developing
Research Methodology:
The top-down and bottom-up approaches are used to estimate and validate the size of the Global IgM/IgG Rapid Test Kits market.
In order to reach an exhaustive list of functional and relevant players, various industry classification standards are closely followed such as NAICS, ICB, and SIC to penetrate deep into important geographies by players, and a thorough validation test is conducted to reach the most relevant players for survey in IgM/IgG Rapid Test Kits market.
In order to make a priority list sorting is done based on revenue generated based on the latest reporting, using paid databases such as Factiva, Bloomberg, etc.
Finally the questionnaire is set and specifically designed to address all the necessities for primary data collection after getting prior appointment> by targeting key target audience that includes New Entrants/Investors, Analysts and Strategic Business Planners, and Manufacturer, Raw Material Suppliers, Dealers, Suppliers, Traders, and Distributors, Venture Capitalists and Private Equity Firms, Government Regulatory and Research Organizations and End-Use Industry.
This helps us to gather the data for the players revenue, operating cycle and expense, profit along with product or service growth, etc.
Almost 70-80% of data is collected through primary medium and further validation is done through various secondary sources that include Regulators, World Bank, Association, Company Website, SEC filings, OTC BB, Annual reports, press releases, etc.