IVD Reagents Market to be Worth $79.76 Billion by 2031 – Exclusive Report by Meticulous Research®

REDDING, Calif., July 8, 2024 /PRNewswire/ — According to a new market research report titled, ‘IVD Reagents Market Size, Share, Forecast, & Trends Analysis by Type (Antibodies, Proteins, Oligonucleotides, Nucleic Acid Probes) Technology (Immunoassay, Biochemistry, Microbiology, Hematology) Use (Clinical, RUO) End User – Global Forecast to 2031,’ published by Meticulous Research®, the IVD reagents market is projected to reach $79.76 billion by 2031, at a CAGR of 5.3% from 2024 to 2031.

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In-vitro diagnostic (IVD) reagents include oligonucleotides, antibodies, nucleic acid probes, purified proteins or peptides, buffers, calibrators, serum, cell medium, and standards & controls used in research activities. These reagents are used to diagnose and prevent diseases or other conditions and manufacture IVD kits & assays for diagnostic purposes.

The growth of this market is driven by the increasing prevalence of infectious diseases, increasing funding for research activities, the rising adoption of advanced diagnostic technologies, the growth in proteomics and genomics research studies, and the growing number of clinical laboratories offering advanced diagnostic testing menus. Additionally, emerging economies and the growing demand for protein therapeutics & personalized medicines are expected to offer significant market growth opportunities.

However, the stringent regulations for antigen-specific reagents restrain the growth of this market. Additionally, the high costs of reagents and the unfavorable reimbursement scenario pose a significant challenge to the market’s growth.

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Increase in Proteomics and Genomics Research Studies to Boost the Growth of the IVD Reagents Market

In recent years, there has been a surge in proteomics and genomics-based research studies, driven by technological advancements and the need to understand the genetic and molecular bases of various diseases. These fields are utilized to identify proteins and genes, along with their structures, functions, and modifications, across multiple research areas, particularly in medical research, drug discovery, and diagnostics. Researchers commonly use various antibodies, including polyclonal, monoclonal, recombinant, and mono-specific antibodies, due to their high target specificity and strong affinity for target molecules.

Traditionally, proteomics and genomics studies relied on conventional Sanger sequencing technology to sequence and analyze single genes, amplicon targets, genomic fragments, and short tandem repeats. However, according to the National Human Genome Research Institute, Sanger sequencing can produce inaccurate results, offer low throughput, and be time-consuming. Consequently, it has recently been largely replaced by Next-Generation Sequencing (NGS).

NGS allows the simultaneous analysis of 100 genes, requires a lower amount of input material, and is cost-effective. Sanger sequencing costs about USD 500 per 1,000 bases, while NGS costs around USD 0.50 per 1,000 bases. This significant cost difference has prompted researchers to adopt more sophisticated and specific techniques. Advanced genomics and proteomics techniques leverage antibody-based research for biomarker identification and drug development. For example, the monoclonal antibody inhibitor trastuzumab (ErbB2, HER-2) has been used as a monotherapy in women with HER-2 overexpressing metastatic breast cancer.

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Proteomics research techniques, such as immunoprecipitation, western blotting, and immunofluorescence, utilize antibody fragments for high-throughput characterization and downstream applications. The latest methods involve antibody chips and intracellular immunization to obtain proteomics data with increased reliability and robustness. Scientists use antibody-based tissue profiling in clinical proteomics to generate data from both normal and diseased tissues. Thus, the growth in proteomics and genomics research studies is supporting the expansion of the IVD reagents market.

The IVD reagents market is segmented based on type [Antibodies (by Type {Monoclonal, Polyclonal}, Target {Cluster Differentiation (CD), T-cell receptor (TCR), Epidermal Growth Factor Receptor (EGFR), Other Targets), Purified Proteins and Peptides, Oligonucleotides, Nucleic Acid Probes, Other Reagents], Technology [Immunoassay/Immunochemistry (Enzyme-linked Immunosorbent Assays (ELISA) and Enzyme-linked Immunospot Assays (ELISpot), Lateral Flow Assays, Western Blotting, Immunofluorescence, Functional Assays, Immunoprecipitation, Other immunoassay Technologies), Biochemistry/Clinical Chemistry, Molecular Diagnostics (Polymerase Chain Reaction (PCR), Hybridization, Isothermal Nucleic Acid Amplification Technology, DNA Sequencing & Next-generation Sequencing, Microarray, Other Molecular Diagnostics Technologies), Microbiology, Hematology, Coagulation/Hemostasis, Urinalysis, Other IVD technologies], Use [Clinical Use, Research Use Only (RUO), Analyte-specific Reagents (ASR)], End User [Reference Laboratories, IVD Manufacturers, Academic Institutes and Research laboratories, Hospital Laboratories].and Geography. The study also evaluates industry competitors and analyzes the market at the regional and country levels.

The report also includes an extensive assessment of the key growth strategies adopted by leading market players in the last three to four years. Some of the key players operating in the IVD reagents market are Thermo Fisher Scientific (U.S.), Becton, Dickinson and Company (U.S.), Merck KGaA (Germany), Bio-Rad Laboratories, Inc. (U.S.), Agilent Technologies, Inc. (U.S.), Abcam plc (U.K.), Hologic Inc. (U.S.), InBios International, Inc. (U.S.), SDIX, LLC (U.S.), Bio Techne Corporation (U.S.), Bio-Synthesis Inc. (U.S.), RayBiotech, Inc. (U.S.), Sino Biological Inc. (China), Oy Medix Biochemica Ab (Finland), QIAGEN N.V. (Netherlands), and Beckman Coulter, Inc. (U.S.).

Among the types, in 2024, the antibodies segment is expected to account for the largest share of 22.1% of the IVD reagents market. The large share of this segment is mainly attributed to the widespread application of antibodies in medicine for research, diagnosis, drug & IVD development, & disease treatment; increasing proteomics & genomics-based research; funding for R&D; and rising need for disease-specific biomarkers.

Among the technologies, in 2024, the immunoassay/immunochemistry segment is expected to account for the largest share of 30.8% of the IVD reagents market. The large share of this segment is mainly attributed to the rising demand for immunoassay-based tests and the significant benefits of these technologies, such as rapid, convenient, and accurate results for the detection and quantitation of targets; continuous development of new biomarkers; cost-benefit; and growing adoption of automated platforms for ELISA.

Among the uses, in 2024, the clinical use segment is expected to account for the largest share of the IVD reagents market. The large market share of this segment can be attributed to the growing need for the early detection of various epidemic and pandemic infections and Initiatives by manufacturers for the development of advanced IVD reagents for clinical applications.

Among the end users, in 2024, the IVD manufacturers segment is expected to account for the largest share of 35% of the IVD reagents market. The large market share of this segment can be attributed to the increasing demand for innovative products and the growing incidence of infectious diseases.

Based on geography, the global IVD reagents market is segmented into North America (U.S., Canada), Europe (Germany, France, U.K., Italy, Spain, Switzerland. Netherlands, Rest of Europe), Asia-Pacific (Japan, China, India, Australia, South Korea, Singapore, Rest of Asia-Pacific), Latin America, and the Middle East & Africa. In 2024, North America is expected to account for the largest share of 37.7% of the global IVD reagents market. North America’s major market share can be attributed to the rising funds and investments for research reagents, increasing adoption of automated instruments, growing automation in clinical & hospital laboratories, and increasing prevalence of infectious diseases.

However, Asia-Pacific is slated to register the highest CAGR during the forecast period. This is attributed to factors such as rapid urbanization, increasing investments by healthcare providers towards infrastructure improvement, the presence of key IVD reagent companies in countries like China, India, Singapore, and South Korea, and government investments in research and development activities. Furthermore, the need to manage the growing burden of infectious diseases, growing accessibility to healthcare services & advanced products, growing income levels of the middle-class population, and increasing number of hospitals and clinics contribute to the growth of this market.

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Scope of the Report: 

IVD Reagents Market Size & Trend Analysis—by Type

AntibodiesAntibodies Market, By TypeMonoclonal AntibodiesPolyclonal AntibodiesAntibodies Market, By TargetCluster of Differentiation (CD)T-cell Receptor (TCR)Epidermal Growth Factor Receptor (EGFR)Other TargetsPurified Proteins and PeptidesOligonucleotidesNucleic Acid ProbesOther Reagents

Notes:      1. Other targets include Nucleic BCMA, DLL/Notch, EpCAM, HER2, PDGFRα, Claudin 18.2, SLAMF7, and DKK1. B-cell maturation antigen (BCMA).
                2. Other reagents include blocking agents, detergents, surfactants, wetting agents, buffers, stabilizers, purified water, dyes, standards and controls, enzymes, cell culture reagents, and anti-coagulants.

IVD Reagents Market Size & Trend Analysis—by Technology

Immunoassay/ImmunochemistryEnzyme-linked Immunosorbent Assays (ELISA) and Enzyme-linked Immunospot Assays (ELISpot)Lateral Flow Assays (LFA)/Rapid TestsWestern Blotting (WB)Immunofluorescence (IF)Functional AssaysImmunoprecipitation (IP)Other Immunoassay TechnologiesBiochemistry/Clinical ChemistryMolecular DiagnosticsPolymerase Chain Reaction (PCR)HybridizationIsothermal Nucleic Acid Amplification TechnologyDNA Sequencing & Next-generation SequencingMicroarrayOther Molecular Diagnostic TechnologiesMicrobiologyHematologyCoagulation/HemostasisUrinalysisOther IVD Technologies

Note:       1. Other technologies include virus neutralization tests, agar gel immunodiffusion, and radioimmunoassay.
                2. Other molecular diagnostic technologies include electrophoresis, ligase chain reaction (LCR), northern blot, and southern blot.
                3. Other IVD technologies include anatomical pathology, histochemistry, and whole blood glucose monitoring.

IVD Reagents Market Size & Trend Analysis—by Use

Clinical UseResearch Use Only (RUO)Analyte-specific Reagents (ASR)

IVD Reagents Market Size & Trend Analysis—by End User

Reference LaboratoriesIVD ManufacturersAcademic Institutes and Research LaboratoriesHospital Laboratories

IVD Reagents Market Size & Trend Analysis—by Geography 

North AmericaU.S.CanadaEuropeGermanyFranceItalyU.K.SpainSwitzerlandNetherlandsRest of EuropeAsia-PacificChinaJapanIndiaSouth KoreaAustraliaSingaporeRest of Asia-PacificLatin AmericaBrazilMexicoRest of Latin AmericaMiddle East & Africa

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