RUO Immunoassay Market Size, Share, Opportunities, COVID-19 Impact, And Trends By Product (Radioimmunoassay (RIA), Enzyme Immunoassay Or Enzyme-linked Immunosorbent Assays (ELISA), Counting Immunoassay (CIA), Fluoroimmunoassay (FIA), Chemiluminescence Immunoassay (CLIA)), By Application (Infectious Disease, Oncology, Blood Screening And Toxicology, Cardiology, Others), And By Geography - Forecasts From 2022 To 2027

  • Published : Dec 2022
  • Report Code : KSI061614218
  • Pages : 120

Immunoassays designated for research use only (RUO) are called RUO immunoassays and are not meant for use in diagnostic procedures. They are virtually uncontrolled and have a single intended function which is studying. RUO immunoassays use RUO products, and these RUO products may be used in preclinical or nonclinical research settings and with either clinical or nonclinical materials. The evaluation of the possible clinical utility of a product in the early stages of development is the extent of the research for RUO immunoassays. The investigational use of RUO immunoassays (clinical investigations) and research to determine a product's safety and efficacy are prohibited. Results cannot be used to evaluate the patient's condition or for any diagnostic, prognostic, monitoring, or therapeutic reasons. They also cannot be transmitted to the patient's doctor or medical record. The confirmation of the researcher's consent that the product won't be used for clinical reasons is suggested for RUO product manufacturers and distributors.

The demand for effective bioanalytical methods has accelerated in the RUO immunoassays market.

Immunoassays are essential tools for a variety of research fields, including basic science and biopharmaceutical research and development. Applications include determining the pharmacokinetics of biologics as well as evaluating biomarkers, host cell protein contaminants, and release testing quantities. Immunoassays used for research purposes (RUO) are often done retrospectively in batches as the trial advances and do not require the same level of validation. A mix of top-notch reagents, improved methods, and automation is required to accomplish this. For instance, the development of research or retrospective use (RUO) assay design and migration are services are provided by Almac Diagnostic Services on a variety of platforms. Over the past few years, the revenue of such businesses has increased. For instance, Almac experienced a growth of about 8.6%, resulting in total sales of about £735 million in 2021, according to its annual report.

Difficulty to obtain reliable data due to interference that lowers the efficiency of cross-reacting antibody reagents acts as a market restraint.

Interference should be identified early in method development by evaluating a number of parameters, including parallelism/linearity, assay type, sample size, inhibiting agents' effects, therapy and sampling methodology changes, trends, and discrepancies in the study's findings. Drug-target complex dissociation, which can be lessened by optimizing reagent concentrations and incubation/assay periods, can complicate drug-target research.

Key Developments.

  • The fully owned subsidiary of Boai NKY Medical Holdings Ltd., BioVision, Inc., was purchased by Abcam plc, a world leader in the delivery of life science research equipment, for US$340 million in August 2021. In addition to the Acquisition, Abcam and NKY also formed a strategic alliance. As part of this alliance, Abcam created and provided NKY with goods and services to assist its continued product development and marketing efforts in the IVD industry. As a result, Abcam plc had a rise in revenues of over 18% from 2020 to 2021, resulting in total revenue of about £315 million in 2021, as per their annual report.
  • Several RUO immunoassay kits were introduced in the previous two years as a result of the COVID-19 epidemic. For example, Enzo Life Sciences Inc. offers SARS-CoV-2 Spike IgG ELISA Kit with great sensitivity that makes it possible to find human SARS-CoV-2 IgG in serum. In less than two hours, it can deliver qualitative results and has the capacity to measure up to 86 samples per kit.

The majority of the RUO immunoassay market is controlled by North America. In the coming years, it's expected that countries in the Asia-Pacific region would expand in this market at the fastest rate.

In 2021, North America dominated this market attributable to factors, including the convenient accessibility of technologically enhanced diagnostic tools, as well as the increased demand for research brought on by the rise in diseases. The high prevalence of cancer and infectious illnesses including HIV, TB, and influenza and the emergence of new diseases in the area is also driving up the demand for research immunoassays. According to the American Cancer Society, there were about 1.9 million new cases of cancer in 2021 relative to the 16.9 million active cancer cases that were present in America in 2019. Additionally, they predict that by the end of 2022, there may be 2 million additional instances of cancer in the United States.

Due to its huge senior population and high frequency of infectious illnesses, Asia Pacific is anticipated to increase at the quickest rate throughout the projected period. One of the reasons propelling the market in the area is the expanding usage of cutting-edge laboratory methods and processes for quicker examination.

Key Market Segments

  • By Product
    • Radioimmunoassay (RIA)
    • Enzyme Immunoassay or Enzyme-linked Immunosorbent Assays (ELISA)
    • Counting Immunoassay (CIA)
    • Fluoroimmunoassay (FIA)
    • Chemiluminescence Immunoassay (CLIA)
  • By Application
    • Infectious Disease
    • Oncology
    • Blood Screening and Toxicology
    • Cardiology
    • Others
  • By Geography
    • North America
      • United States
      • Canada
      • Mexico
    • South America
    • Europe
      • Germany
      • France
      • United Kingdom
      • Others
    • Middle East and Africa
    • Asia Pacific
      • China
      • Japan
      • South Korea
      • India
      • Others

Frequently Asked Questions (FAQs)

2020 has been taken as the base year in the RUO immunoassay market.
Prominent key market players in the RUO immunoassay market include Roche Diagnostics, Abcam PLC, Quidel Corporation, Merck KGaA, Fujirebio, and BioServUK Ltd., among others.
The global RUO immunoassay market has been segmented by product, application, and geography.
The demand for effective bioanalytical methods has accelerated in the RUO immunoassays market.
The North American region holds a significant share of the RUO immunoassay market.


1.1. Market Definition

1.2. Market Segmentation



2.1. Research Data

2.2. Assumptions



3.1. Research Highlights



4.1. Market Drivers

4.2. Market Restraints

4.3. Porters Five Forces Analysis

4.3.1. Bargaining Power of Suppliers

4.3.2. Bargaining Powers of Buyers

4.3.3. Threat of Substitutes

4.3.4. The Threat of New Entrants

4.3.5. Competitive Rivalry in Industry

4.4. Industry Value Chain Analysis



5.1. Introduction

5.2. Radioimmunoassay (RIA)

5.3. Enzyme Immunoassay or Enzyme-linked Immunosorbent Assays (ELISA)

5.4. Counting Immunoassay (CIA)

5.5. Fluoroimmunoassay (FIA)

5.6. Chemiluminescence Immunoassay (CLIA)



6.1. Introduction

6.2. Infectious Disease

6.3. Oncology

6.4. Blood Screening and Toxicology

6.5. Cardiology

6.6. Others



7.1. Introduction

7.2. North America

7.2.1. United States

7.2.2. Canada

7.2.3. Mexico

7.3. South America

7.4. Europe

7.4.1. Germany

7.4.2. France

7.4.3. United Kingdom

7.4.4. Others

7.5. The Middle East and Africa

7.6. Asia Pacific

7.6.1. China

7.6.2. Japan

7.6.3. South Korea

7.6.4. India

7.7. Others



8.1. Major Players and Strategy Analysis

8.2. Emerging Players and Market Lucrative

8.3. Mergers, Acquisition, Agreements, and Collaborations

8.4. Vendor Competitiveness Matrix



9.1. Roche Diagnostics

9.2. Abcam PLC

9.3. Quidel Corporation

9.4. Merck KGaA

9.5. Fujirebio

9.6. BioServUK Ltd.

9.7. Hyphen Biomed SAS

9.8. Fianostics

Roche Diagnostics

Abcam PLC

Quidel Corporation

Merck KGaA


BioServUK Ltd.

Hyphen Biomed SAS


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