United States RUO Immunoassay Market Size, Share, Opportunities, And Trends By Product Type (Immunoassay Kits, Immunoassay Reagents, Microplate Reader, Microplates, Analyzers (Automated Analyzers, Non-Automated Analyzers), Microplate Washers, Others), By Sample Type (Plasma, Blood Serum, Urine, Saliva, Cell or Tissue Culture Medium, Others), By Application (Oncology, Blood Screening and Toxicology, Infectious Disease, Cardiology, Allergy Diagnostic, Rare and Emerging Condition Diagnostic, Others), By End-User (Research and Academic Laboratories, Pharmaceutical and Biotechnology Companies), And By State - Forecasts From 2025 To 2030

Description

United States RUO Immunoassay Market Size:

The United States RUO immunoassay market is projected to grow at a CAGR of 11.40% from 2025 to 2030.

United States RUO Immunoassay Market Trends:

The USA RUO immunoassay market players are focusing on heading with technological developments and screenings with high-throughput which are pivotal to the market growth. The increasing rates of chronic infections necessitates of the use of efficient diagnostic techniques. The precision medicine approach leverages the use of biomarker-based diagnostics much more. One example of such policy is the law passed in October 2023 in over ten US states, which emphasized inclusive health insurance schemes with big coverage scope for biomarker testing.

The National Institutes of Health (NIH), part of the Department of Health and Human Services (HHS), as the largest public sponsor of research and development (R&D), holds responsibility for the field of scientific studies and the emergence of new technologies. From 2017 -2021, the NIH gave $97 billion to funding basic research, $28 billion to complex clinical trials and their related activities, and $9 billion to biomedical training of the workforce. Given these mounting investments in research in the country, the RUO immunoassay market is anticipated to experience substantial growth in the forthcoming years.

The expanding research activity in academia and corporate settings is further contributing to the market growth. For instance, with a budget of $43 billion in fiscal year 2021, the NIH supports a vast sphere of R&D which, in turn, facilitates medication development. The scientists can use NIH-funded biomedical R&D to ask fundamental biological questions about diseases and to test medication safety and efficacy during preclinical processes as well as conduct clinical trials.

Furthermore, the United States funded $245.1 billion in medical and health research and development (R&D) in 2020, reflecting an 11.1% increase per annum since 2019. The data of January 2020 point out how private-public funding development changes.

Besides that, continuous product developments is address changing research demands and compliances. Regulatory support enhance the quality and dependability of RUO immunoassay products. Overall, these factors continue to drive the United States RUO immunoassay market growth.

In the US, RUO immunoassay players are implementing strategies like novel technologies and innovation to satisfy the researcher's changing needs. Also, investments in R&D and strategic purchases are aimed at improving the competitiveness of the company and giving clients a holistic approach to solving their problems.

For instance, Almac Diagnostic Services has a separate dedicated group for the generation of RUO assays on several platforms. The company has vast expertise in developing and delivering multiplex RNA, DNA, and protein-based Clinical Trials and RUO tests. Almac Diagnostic Services offers its customers the option of platform agility and flexibility, which means in practice that they can do their assays on NGS qPCR or IHC platforms.

Besides, the test offered by Quanterix is aimed at research purposes and detects the presence of the SARS-CoV-2 nucleocapsid protein antigen from the virus in nasopharyngeal swabs. In an infected patient, the active phase of SARS-CoV-2 infection is identified as the presence of the nucleocapsid protein (N protein) in the respiratory fluids in its acute phase. This N protein increase can be employed in an attempt to reveal the SARS-CoV-2 infection in its early stages, before a solid anti-SARS-CoV-2 antibody development, that is the very moment when there is no strong antibody response.

Furthermore, in November 2021, Bio-Rad Laboratories, Inc., a leading global company providing research and clinical diagnostic technologies, developed human IgA and IgM SARS-CoV-2 panels to detect if the antibody exists a SARS-CoV-2 against four SARS-CoV-2 antigens. The panels are designed to be used for the learning research field.

In March 2023, H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio announced the release of the Lumipulse G ApoE4 and Lumipulse G Pan-ApoE tests for the fully automated LUMIPULSE® G Systems. These CLEIA (chemiluminescent enzyme immunoassay) assays allow for the quantitative determination of the E4 isoform of apolipoprotein E (ApoE4), as well as all isoforms of the same protein (Pan-ApoE), in human plasma under 35 minutes. The two new automated blood-based biomarker tests are intended for research purposes only.

United States RUO Immunoassay Market Scope:

United States RUO Immunoassay Market Segmentation:

By Product Type

• Immunoassay Kits
  • Enzyme-Linked Immunosorbent Assay (ELISA) Kits
    • Conventional
    • Manual
  • Radioimmunoassay (RIA Kits)
    • Conventional
    • Manual
  • Chemiluminescent Immunoassay (CLIA) Kits
• Immunoassay Reagents
• Microplate Reader
• Microplates
• Analyzers
  • Automated Analyzers
  • Non-Automated Analyzers
• Microplate Washers
• Others

By Sample Type

• Plasma
• Blood Serum
• Urine
• Saliva
• Cell or Tissue Culture Medium
• Others

By Application

• Oncology
• Blood Screening and Toxicology
• Infectious Disease
• Cardiology
• Allergy Diagnostic
• Rare and Emerging Condition Diagnostic
• Others

By End-User

• Research and Academic Laboratories
• Pharmaceutical and Biotechnology Companies

By State

• California
• Texas
• Florida
• New York
• Pennsylvania

Table Of Contents

1. EXECUTIVE SUMMARY 

2. MARKET SNAPSHOT

2.1. Market Overview

2.2. Market Definition

2.3. Scope of the Study

2.4. Market Segmentation

3. BUSINESS LANDSCAPE 

3.1. Market Drivers

3.2. Market Restraints

3.3. Market Opportunities 

3.4. Porter’s Five Forces Analysis

3.5. Industry Value Chain Analysis

3.6. Policies and Regulations 

3.7. Strategic Recommendations 

4. TECHNOLOGICAL OUTLOOK

4.1. Product Pipeline

5. UNITED STATES RUO IMMUNOASSAY MARKET BY PRODUCT TYPE

5.1. Introduction

5.2. Immunoassay Kits

5.2.1. Enzyme-Linked Immunosorbent Assay (ELISA) Kits

5.2.1.1. Conventional 

5.2.1.2. Manual

5.2.2. Radioimmunoassay (RIA Kits)

5.2.2.1. Conventional 

5.2.2.2. Manual

5.2.3. Chemiluminescent Immunoassay (CLIA) Kits

5.3. Immunoassay Reagents

5.4. Microplate Reader

5.5. Microplates

5.6. Analyzers

5.6.1. Automated Analyzers

5.6.2. Non-Automated Analyzers

5.7. Microplate Washers

5.8. Others

6. UNITED STATES RUO IMMUNOASSAY MARKET BY SAMPLE TYPE

6.1. Introduction

6.2. Plasma 

6.3. Blood Serum

6.4. Urine

6.5. Saliva

6.6. Cell or Tissue Culture Medium

6.7. Others

7. UNITED STATES RUO IMMUNOASSAY MARKET BY APPLICATION

7.1. Introduction

7.2. Oncology

7.3. Blood Screening and Toxicology

7.4. Infectious Disease

7.5. Cardiology

7.6. Allergy Diagnostic

7.7. Rare and Emerging Condition Diagnostic

7.8. Others

8. UNITED STATES RUO IMMUNOASSAY MARKET BY END-USER

8.1. Introduction

8.2. Research and Academic Laboratories

8.3. Pharmaceutical and Biotechnology Companies

9. UNITED STATES RUO IMMUNOASSAY MARKET BY STATE

9.1. Introduction

9.2. California

9.2.1. By Product Type

9.2.2. By Sample Type

9.2.3. By Application

9.2.4. By End-User

9.3. Texas

9.3.1. By Product Type

9.3.2. By Sample Type

9.3.3. By Application

9.3.4. By End-User

9.4. Florida

9.4.1. By Product Type

9.4.2. By Sample Type

9.4.3. By Application

9.4.4. By End-User

9.5. New York

9.5.1. By Product Type

9.5.2. By Sample Type

9.5.3. By Application

9.5.4. By End-User

9.6. Pennsylvania

9.6.1. By Product Type

9.6.2. By Sample Type

9.6.3. By Application

9.6.4. By End-User

10. COMPETITIVE ENVIRONMENT AND ANALYSIS

10.1. Major Players and Strategy Analysis

10.2. Market Share Analysis

10.3. Mergers, Acquisitions, Agreements, and Collaborations

10.4. Competitive Dashboard

11. COMPANY PROFILES

11.1. F-Hoffmann-La Roche AG

11.2. Abbott Laboratories

11.3. Siemens Healthineers

11.4. Danaher Corporation (Beckman Coulter, Inc.)

11.5. Thermo Fisher Scientific

11.6. DIAsource

11.7. BioCheck , Inc

11.8. Berthhold Technologies GmbH & Co.

11.9. IBL International

11.10. bioMérieux SA

12. APPENDIX

12.1. Currency 

12.2. Assumptions

12.3. Base and Forecast Years Timeline

12.4. Key benefits for the stakeholders

12.5. Research Methodology 

12.6. Abbreviations 

Companies Profiled

F-Hoffmann-La Roche AG

Abbott Laboratories

Siemens Healthineers

Danaher Corporation (Beckman Coulter, Inc.)

Thermo Fisher Scientific

DIAsource

BioCheck , Inc

Berthhold Technologies GmbH & Co.

IBL International

bioMérieux SA

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