The global monoclonal antibody diagnostic reagent market was valued US$ 7,654.06 million in 2021; it is estimated to grow at a CAGR of 13.5% from 2022 to 2028.
Monoclonal antibodies (mAb) are important diagnostic reagents that are being used in biomedical research; microbiological research; in the diagnosis of Hepatitis, AIDs, influenza, herpes simplex, chlamydia infections; and in the treatment of infections and cancer. The monoclonal antibodies being directed at single epitopes are highly specific, homogeneous, and can be produced in unlimited quantities. The hybridoma-derived or bacterially cloned monoclonal antibody technology has enabled the mass production of highly specific probes for antigenic sites, whether on hormones, enzymes, receptors, or microbial products. Major factors driving the growth of this market include the rising prevalence of cancer and other chronic diseases, presence of strong pipeline of drugs under trial, and extensive R&D efforts to develop novel therapies.
The report offers insights and in-depth analysis of the global monoclonal antibody diagnostic reagent market, emphasizing various parameters, including market trends, technological advancements, market dynamics, and competitive landscape analysis of global leading market players. It also includes the impact of the COVID-19 pandemic on the market across all regions.
The overall impact of the COVID-19 pandemic on the monoclonal antibody diagnostic reagent market was positive; hence, the market continues to gain traction and is expected to grow in the coming years. Celltrion Group has announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved regdanvimab (CT-P59), a monoclonal antibody for the treatment of COVID-19 for the prolonged use in elderly patients aged 50 years and over, or with at least one underlying medical condition such as obesity, cardiovascular disease, chronic lung disease, diabetes, chronic kidney disease, chronic liver disease, and patients with immunosuppressive agents with mild symptoms of COVID-19, and adult patients with moderate symptoms of COVID-19. Further, monoclonal antibody therapy, which has been successfully used in other countries to treat COVID-19 patients with mild or moderate symptoms, has now been approved by the Drugs Controller General of India (DCGI) for use in India.
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Monoclonal Antibody Diagnostic Reagent Market: Strategic Insights
Market Size Value in US$ 7,654.06 Million in 2021 Market Size Value by US$ 18,507.20 Million by 2028 Growth rate CAGR of 13.5% from 2022 to 2028 Forecast Period 2022-2028 Base Year 2021
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Monoclonal Antibody Diagnostic Reagent Market: Strategic Insights
Market Size Value in | US$ 7,654.06 Million in 2021 |
Market Size Value by | US$ 18,507.20 Million by 2028 |
Growth rate | CAGR of 13.5% from 2022 to 2028 |
Forecast Period | 2022-2028 |
Base Year | 2021 |
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By geography, the global monoclonal antibody diagnostic reagent market is segmented into North America (the US, Canada, and Mexico), Europe (France, Germany, the UK, Spain, Russia, Italy, and the Rest of Europe), Asia Pacific (China, India, Japan, Australia, South Korea, Kazakhstan, and the Rest of APAC), the Middle East & Africa (Saudi Arabia, the UAE, South Africa, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).
Lucrative Regions for Monoclonal Antibody Diagnostic Reagent Market
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Market Insights
Extensive R&D Efforts to Develop Novel Therapies
The numerous application of mAbs involves the prevention, diagnosis, and treatment of disease. The application of mAbs in diagnosis is the most advanced, particularly for tests performed on the body fluids such as urine and blood. Additionally, mAbs diagnostic application includes techniques such as ELISA, western blot, immunoblot blot, flow cytometry, immunohistochemistry, radioimmunology assay, and electron microscopy. Also, mAbs intended for diagnostic application can detect antigens and antibodies against viral and fungal diseases of livestock and parasitic diseases.
Further, mAbs are valued reagents intended for abundant applications due to its selectivity, high binding affinity, and immunogenicity/low toxicity; mAbs are best suited for clinical, environmental, and elemental research. The diagnostic applications of mAbs also include medical devices, vitro tests, and medical imaging
Moreover, the utility of mAbs expanded for understanding a range of diseases by contributing to developing new immunotherapy treatments. For example, cancer therapies benefitted from research with mAbs, most probably for the development of RituximAb, proving an effective treatment for many cancers. Also, many mAbs are now recognized by the US Food and Drug Administration (FDA) as safe for utilization in commercial therapeutics. Such factors mentioned above are expected to contribute to the monoclonal antibody diagnostic reagent market growth during the forecast period.
Tests-Based Insights
Based on tests, the global monoclonal antibody diagnostic reagent market is segmented into double antigen sandwich chemiluminescence method, enzyme linked immunosorbent assay, recombinant immunoblot assay, and dot-immunogold filtration assay. In 2021, the enzyme-linked immunosorbent assay segment accounted for the largest market share, and it is anticipated to register the highest CAGR from 2022 to 2028.
Global Monoclonal Antibody Diagnostic Reagent Market, by Tests – 2021 and 2028
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- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
Application-Based Insights
Based on application, the global monoclonal antibody diagnostic reagent market is segmented into hormones diagnosis, tumor monitoring, virus detection, and other application. The tumor monitoring segment held the largest market share in 2021, and it is expected to register the highest CAGR during the forecast period.
The global monoclonal antibody diagnostic reagent market players are adopting organic strategies, including product launch and expansion, to expand their footprint and product portfolio worldwide and meet the growing product demand. A few of the key players operating in the market are BioGenex; Bio-Rad Laboratories, Inc.; Biocare Medical, LLC; Celltrion Healthcare Co., Ltd.; Creative Diagnostics; GenWay Biotech; Thermo Fisher Scientific Inc.; ABclonal, Inc.; Apto-Gen; and Abcam plc.
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Tests and Application
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, UAE, UK, US
Frequently Asked Questions
Monoclonal antibodies (mAb) are important diagnostic reagents that are being used in biomedical research, microbiological research in diagnosis of Hepatitis, AIDs, influenza, herpes simplex, chlamydia infections and in treatment of infections and cancer. The monoclonal antibodies being directed against single epitopes are highly specific, homogeneous and can be produced in unlimited quantities. The hybridoma-derived or bacterially cloned monoclonal antibody technology has enabled the mass production of highly specific probes for antigenic sites, whether on hormones, enzymes, receptors, or microbial products.
Rising prevalence of cancer and other chronic diseases, extensive R&D efforts to develop novel therapies, and presence of strong pipeline of drugs under trial are the major factors contributing to the growth of the monoclonal antibody diagnostic reagent industry.
The monoclonal antibody diagnostic reagent market majorly consists of the players, such as BioGenex; Bio-Rad Laboratories, Inc.; Biocare Medical, LLC; Celltrion Healthcare Co., Ltd.; Creative Diagnostics; GenWay Biotech; Thermo Fisher Scientific Inc.; ABclonal, Inc.; Apto-Gen; and Abcam plc.
The CAGR value of the monoclonal antibody diagnostic reagent market during the forecasted period of 2022-2028 is 13.5%
The monoclonal antibody diagnostic reagent market is estimated to be valued at US$ 8,642.00 million in 2022.
The monoclonal antibody diagnostic reagent market is expected to be valued at US$ 18,507.20 million in 2028.
The enzyme-linked immunosorbent assay segment held the largest share of the market in the global monoclonal antibody diagnostic reagent market contributing a market share of 37.89% in 2021.
The Asia Pacific is expected to be the fastest-growing region in the monoclonal antibody diagnostic reagent market over the forecast period due to growing investments from international players in China and India, increasing disposable income, and chronic diseases in these regions will show promising growth in the monoclonal antibody diagnostic reagent market.
The List of Companies - Monoclonal Antibody Diagnostic Reagent Market
- BioGenex
- Bio-Rad Laboratories, Inc.
- Biocare Medical, LLC
- Celltrion Healthcare Co., Ltd.
- Creative Diagnostics
- GenWay Biotech
- Thermo Fisher Scientific Inc.
- ABclonal, Inc.
- Apto-Gen
- Abcam plc.
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- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
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- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
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Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
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- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
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