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Antibodies are common and essential research tools for various applications, including enzyme-linked immunosorbant assay (ELISA), flow cytometric analysis, immunoprecipitation, immunocytochemistry, immunohistochemistry, and western blotting. Monoclonal antibodies (MAbs) are important diagnostic reagents used in biomedical research, microbiological research, in diagnosis of chlamydia, hepatitis, herpes simplex, HIV, and influenza infections, and also for the treatment of diseases such as cancer.

Diagnostic tests based on the use of MAbs as reagents are routinely used in enzyme-linked immunosorbent assays and radioimmunoassay in laboratories. These tests measure the circulating concentrations of hormones (gastrin, growth hormone, human chorionic gonadotropin, insulin, progesterone, thyroid stimulating hormone, thyroxine, triiodothyronine, and renin) and cell products (blood clotting factors, blood group antigens, histocompatibility antigens, interferon, interleukins, and tumor markers).

Monoclonal antibodies play a valuable role in diagnostic medicine during tests to determine the concentration of specific proteins in blood or urine. For instance, high blood level of a prostate-specific antigen, measured by its interaction with a monoclonal antibody, provides an early warning for prostate cancer. Antibodies to target biomarkers are widely used for detecting carcinogenic-embryonic antigen (colorectal cancer), prostate specific antigen (expressed in prostate cancer), CA125 (ovarian cancer), CA19-9 (gastrointestinal cancer), CA15-3 antigen, and HER-2/neu proteins (breast cancer).

Monoclonal Antibody Diagnostic Reagents Market Dynamics

Increasing use of monoclonal antibodies in various R&D applications, cancer therapies, and immunological disorders is expected to drive growth of the global monoclonal antibody diagnostic reagents market size. Monoclonal  antibody  diagnostic  kits  are  increasingly  used  to  detect  communicable  diseases  including  transfusion  transmissible  infections (TTI). According to World Health Organization (WHO) data of 2017, each year about 15 million people die due to infectious diseases in emerging economies. Tropical parasitic infections such as schitosomiasi and sexually transmitted infections such as syphilis also cause morbidity. There is an urgent need for development of accurate, simple, and stable diagnostic tools.

Non-infectious diseases are the leading cause of mortality and morbidity worldwide. As per the WHO 2017 data, around 40 million individuals suffering from cardiovascular diseases, cancer, chronic respiratory diseases, diabetes, and stroke die every year across the globe. Prevailing cancer incidence rate are expected to fuel demand for disease diagnosis. According to International Agency for Research on Cancer (IARC), the incidence of cancer is expected to reach to 26.8 million new cases and 17.1 million deaths annually by the year 2030.

Monoclonal antibodies are effective biological reagents in immunodiagnostic assays due to their binding accuracy to many pathogens, thereby, making it an important research tool. Despite many advantages and applications offered by monoclonal antibodies, it is difficult to get the right antibodies and attach a compound to it. Monoclonal antibodies need considerable amount of time, money, and manpower to produce them which can hinder the market size to some extent.

Monoclonal Antibody Diagnostic Reagents Market Regional Insights

Regional segmentation of monoclonal antibody diagnostic reagents market by Coherent Market Insights includes North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to be dominant in the global monoclonal antibody diagnostic reagents market in 2026 in terms of revenue share, owing to the presence of well-established healthcare infrastructure and increasing government funding for cancer research and technology for development of new diagnostics procedures. In 2016, National Cancer Institute (NCI) received a total funding of $4.952.6 billion, reflecting an increase of five percent, or $262.1 million from 2015. The number of monoclonal antibody products approved for commercial sale in the U.S. and Europe has grown steadily for the last several years.

Asia Pacific monoclonal antibody diagnostic reagents market is expected to exhibit the highest growth rate, due to rising incidence of lifestyle-induced diseases coupled with rising population base demanding disease diagnosis. According to WHO data, non-communicable diseases deaths are projected to increase by 15% between 2010 and 2020, with the highest numbers predicted in the Western Pacific (12.3 million deaths) and South-East Asia (10.4 million deaths) regions.

Monoclonal Antibody Diagnostic Reagents Market Competitive Landscape

Key players operating in the monoclonal antibody diagnostic reagents market include AnaSpec, BioGenex, Bio-Rad, Biocare Medical, BioVision, Celltrion, Creative Diagnostics, GenWay Biotech, Innovent Biologics, Medix Biochemica, Qiagen, and Teva Pharmaceutical Ltd.

Monoclonal Antibody Diagnostic Reagents Market Taxonomy

On the basis of diagnostic tests, the global monoclonal antibody diagnostic reagents market is segmented into:

  • Dot-immunogold Filtration Assay
  • Double Antigen Sandwich Chemiluminescence Method
  • Enzyme Linked Immunosorbent Assay
  • Recombinant Immunoblot Assay

On the basis of application, the global monoclonal antibody diagnostic reagents market is segmented into:

  • Hormones Diagnosis
  • Tumor Monitoring
  • Virus Detection
  • Other Applications

On the basis of region, the global monoclonal antibody diagnostic reagents market is segmented into:

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.

Data Triangulation Methodology | Coherent Market Insights

Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

Market Analysis | Coherent Market Insights

Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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