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Immunodiagnostics Market Assessment, By Type, By Product, By Application, By End-user, By Region, Opportunities and Forecast, 2017-2031F

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  • Bio-Rad Laboratories, Inc
  • Johnson & Johnson Services, Inc.
  • Immunodiagnostics Systems Holdings Plc
  • F. Hoffman-La Roche Ltd.
  • Arkray, Inc.
  • Siemens AG
  • bioMerieux SA
  • Danaher Corporation
  • Sysmex Corporation
  • Abbott Laboratories Inc.
  • Diasorin S.P.A.
  • Thermo Fisher Scientific, Inc.

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LSH 24.02.21

Global immunodiagnostics market size was valued at USD 21.21 billion in 2023, expected to reach USD 45.8 billion in 2031, with a CAGR of 10.1% for the forecast period between 2024 and 2031F. Factors propelling the global immunodiagnostics market encompass the upsurge in infectious diseases, advancements in diagnostic technologies, amplified demand for personalized medicine, and heightened awareness regarding early disease detection. Moreover, the growth of the global immunodiagnostics market is fueled by factors such as the aging population, improvement in healthcare infrastructure, and increasing autoimmune conditions.

The global immunodiagnostics market is witnessing an upward trajectory due to various interconnected factors. One of the significant drivers is the increasing prevalence of infectious diseases worldwide. The surge necessitates efficient diagnostic tools, leading to the development and adoption of advanced immunodiagnostic techniques. These technological advancements play a pivotal role in the growth of the global immunodiagnostics market, facilitating more accurate and rapid disease identification. Another contributing factor is the amplified demand for personalized medicine. The recognition of individual variations in immune responses has led to a burgeoning need for tailored diagnostic approaches. Immunodiagnostics, with its ability to assess immune system functions and identify specific biomarkers, aligns perfectly with the requirements of personalized medicine.

Furthermore, heightened awareness regarding early disease detection has become a key focus across healthcare systems globally. Immunodiagnostics offers the advantage of early identification of various conditions, enabling timely intervention and improved patient outcomes. Moreover, demographic shifts, such as aging populations, drive the demand for immunodiagnostic solutions. As age increases, the susceptibility to various diseases rises, elevating the requirement for precise diagnostic tools. Additionally, the escalation of autoimmune conditions further fuels the growth of global immunodiagnostics market, as accurate diagnosis and monitoring become crucial in managing these complex diseases.

Amplified Demand for Personalized Medicine

The increased desire for personalized medicine has stimulated the growth of global immunodiagnostics market. Tailoring treatments to specific individual traits maximize effectiveness while reducing negative impacts. Immunodiagnostics play a crucial role by evaluating the body's immune response to illnesses, aiding in precise treatment choices and diagnoses. The surge in demand arises from various factors. Technological advancements like genomics and proteomics enable a deeper comprehension of individual patient characteristics, facilitating targeted therapies. Also, the growing prevalence of chronic and infectious diseases highlights the necessity for precise and rapid diagnostics, aligning perfectly with the capabilities of immunodiagnostics.

Moreover, the aging global population demands more tailored healthcare solutions, further propelling the market expansion. Continued trends are anticipated to drive the growth of the immunodiagnostics sector. Innovations and investments will lead to the creation of more refined, precise, and personalized diagnostic tools, significantly transforming healthcare delivery systems.

Advancing Technologies

Technological progress stands as a key driving force for the global immunodiagnostics market. Advances in genomics, proteomics, and data analytics enable a deep comprehension of individual biological intricacies, leading to the creation of extremely accurate diagnostic tools. These breakthroughs enable healthcare providers to thoroughly examine immune responses, facilitating quick and precise disease identification. The fusion of these innovative technologies boosts the effectiveness of immunodiagnostics and propels the development of tailored therapies, transforming healthcare by allowing customized treatments for each patient and elevating the expansion of the global immunodiagnostics market.

For instance, to minimize testing gaps for individuals with pre-diabetes and diabetes, healthcare start-up Orange Biomed introduced their reusable, pocket-sized OBM fast A1c test in the United States in April 2023. The OBM fast A1c technology, billed as the world's first glycated hemoglobin analyzer, was in June during the 83rd Scientific Sessions of the American Diabetes Association, which took place in San Diego, California.

Government Initiatives

Governments globally are actively implementing diverse strategies to strengthen the global immunodiagnostics market. These strategies involve financing research and development, cultivating partnerships between academic and industrial sectors and establishing regulatory structures that promote innovation. Through infrastructure investment, grant provisions, and clinical trials, governments strive to expedite the advancement and acceptance of sophisticated immunodiagnostic technologies. These combined endeavors drive market expansion and aspire to improve public health by encouraging early disease identification, enabling customized therapies, and ultimately advancing healthcare outcomes worldwide. For example, the government of Uttar Pradesh dispatched a delegation to visit three government hospitals in Varanasi in October 2023 to evaluate the situation given the rising number of fever patients in the district. The team evaluated the situation considering the rising number of fever patients in the district and ordered Elisa test kits for chikungunya, leptospirosis, scrub typhus, and other illnesses be made available at the Pandit Deendayal Upadhyay District Hospital in Pandeypur and the SSPG Divisional Hospital in Kabir Chaura.

Rising Demand for ELISA

The rising need for ELISA (Enzyme-Linked Immunosorbent Assay) tests significantly propel the expansion of global immunodiagnostics market. ELISA, known for its high sensitivity and specificity, identifies various diseases by measuring antibodies, proteins, or hormones in samples. Its adaptability in diagnosing infectious diseases, autoimmune conditions, and cancers drives its demand. Factors like increased disease prevalence, technological advancements, improving ELISA's precision, and its cost-effectiveness contribute to its prominence. Healthcare experts rely on ELISA for swift and accurate disease identification, making its increasing utilization a substantial factor in shaping the growth and direction of the global immunodiagnostics market. For example, Neogen Corporation stated in November 2023 that it has launched its third assay in its Veratox VIP range of improved quantitative ELISA solutions, the novel Veratox VIP assay for detecting walnut. The new Veratox VIP for Walnut allergy test keeps the straightforward testing process of the Veratox product range while exhibiting strong performance across sample types.

For Diagnosis of Infectious Diseases

The increase in infectious diseases is driving the growth of the global immunodiagnostics market. The rise in contagious illnesses worldwide requires fast and precise diagnostic tools for quick identification and treatment. Immunodiagnostics holds a crucial position by evaluating the body's immune reactions, assisting in accurate disease detection. Emerging pathogens, antimicrobial resistance, and increased global travel contribute to the surge in infectious diseases. Therefore, the growing demand for efficient diagnostic solutions matches the capabilities of immunodiagnostics, leading to its market expansion to address the urgent requirement for swift and accurate disease identification and treatment worldwide. For example, in September 2023, a group of researchers under the direction of Professor Johnjoe McFadden created a brand-new molecular test known as "Electro-chemical LAMP" (eLAMP), which is quick, inexpensive, sensitive, and able to be used in a hospital lab, GP office, or at home. When coupled to a smartphone, eLAMP allows at-home polymerase chain reaction (PCR) testing with the sensitivity of lab-based PCR assays.

Future Market Scenario

Several compelling factors contribute to a promising future for the global immunodiagnostics market. Ongoing technological advancements continually improve diagnostic tools, refining their precision and adaptability. The progress enables healthcare providers to conduct thorough assessments of immune responses, resulting in more precise disease diagnoses. Furthermore, the increasing demand for personalized medicine propels immunodiagnostics' growth by customizing treatments based on individual immune profiles.

Moreover, heightened government initiatives, including funding for research and development and the establishment of favorable regulatory frameworks, further fortifies the market. The global upsurge in chronic and infectious diseases, combined with an aging population, intensifies the need for advanced diagnostic solutions, aligning seamlessly with the capabilities of immunodiagnostics. These combined elements foreshadow a promising path for the global immunodiagnostics market, ensuring ongoing innovation, enhanced precision, and a significant transformative influence on global healthcare delivery.

Key Players Landscape and Outlook

Several prominent corporations are engaged in mergers and acquisitions in the global immunodiagnostics market. These strategic actions target resource consolidation, portfolio expansion, and acquiring innovative technologies. These efforts aid in creating extensive diagnostic solutions and fortifying market standings. Through acquisitions or mergers, firms can combine strengths, expertise, and optimize operations, improving competitiveness. The calculated approach consolidates the market and propels innovations in immunodiagnostic technologies, potentially transforming the industry landscape and enhancing healthcare outcomes more broadly. As an example, in May 2023, the privately held biotech business Freenome announced that it had purchased Oncimmune Ltd., a UK-based global immunodiagnostics developer with a commercialized CE-IVD marked EarlyCDT Lung blood test, an autoantibody platform, and a research and development pipeline of more than seven major cancer detection signatures. By adding more indicators crucial for cancer detection to its autoantibody technology, the acquisition expands Freenome's product offering.

Table of Contents

1. Research Methodology

2. Project Scope & Definitions

3. Executive Summary

4. Global Immunodiagnostics Market Outlook, 2017-2031F

  • 4.1. Market Size & Forecast
    • 4.1.1. Value
    • 4.1.2. Volume
  • 4.2. By Type
    • 4.2.1. Radioimmunoassay (RIA)
    • 4.2.2. ELISA
    • 4.2.3. Chemiluminescent immunoassay (CLIA)
    • 4.2.4. Fluorescent immunoassay (FIA)
    • 4.2.5. Lateral flow assay (LFA)
    • 4.2.6. Rapid Test
    • 4.2.7. Others
  • 4.3. By Product
    • 4.3.1. Reagents
    • 4.3.2. Instruments
    • 4.3.3. Software & Services
  • 4.4. By Application
    • 4.4.1. Oncology
    • 4.4.2. Endocrinology
    • 4.4.3. Infectious diseases, Allergy & Autoimmune Diseases
    • 4.4.4. Environmental Pollution
    • 4.4.5. Food Technology
    • 4.4.6. Proteomics
    • 4.4.7. Cardiac Biomarker
    • 4.4.8. Drug Monitoring
    • 4.4.9. Others
  • 4.5. By End-user
    • 4.5.1. Hospitals
    • 4.5.2. Clinical Laboratories
    • 4.5.3. Academics & Research Centers
    • 4.5.4. Pharma & Biotech Industry
    • 4.5.5. Others
  • 4.6. By Region
    • 4.6.1. North America
    • 4.6.2. Europe
    • 4.6.3. South America
    • 4.6.4. Asia-Pacific
    • 4.6.5. Middle East and Africa
  • 4.7. By Company Market Share (%), 2023

5. Global Immunodiagnostics Market Outlook, By Region, 2017-2031F

  • 5.1. North America*
    • 5.1.1. Market Size & Forecast
      • 5.1.1.1. Value
      • 5.1.1.2. Volume
    • 5.1.2. By Type
      • 5.1.2.1. Radioimmunoassay (RIA)
      • 5.1.2.2. ELISA
      • 5.1.2.3. Chemiluminescent immunoassay (CLIA)
      • 5.1.2.4. Fluorescent immunoassay (FIA)
      • 5.1.2.5. Lateral flow assay (LFA)
      • 5.1.2.6. Rapid Test
      • 5.1.2.7. Others
    • 5.1.3. By Product
      • 5.1.3.1. Reagents
      • 5.1.3.2. Instruments
      • 5.1.3.3. Software & Services
    • 5.1.4. By Application
      • 5.1.4.1. Oncology
      • 5.1.4.2. Endocrinology
      • 5.1.4.3. Infectious diseases, Allergy & Autoimmune Diseases
      • 5.1.4.4. Environmental Pollution
      • 5.1.4.5. Food Technology
      • 5.1.4.6. Proteomics
      • 5.1.4.7. Cardiac Biomarker
      • 5.1.4.8. Drug Monitoring
      • 5.1.4.9. Others
    • 5.1.5. By End-user
      • 5.1.5.1. Hospitals
      • 5.1.5.2. Clinical Laboratories
      • 5.1.5.3. Academics & Research Centers
      • 5.1.5.4. Pharma & Biotech Industry
      • 5.1.5.5. Others
    • 5.1.6. United States*
      • 5.1.6.1. Market Size & Forecast
      • 5.1.6.1.1. Value
      • 5.1.6.1.2. Volume
      • 5.1.6.2. By Type
      • 5.1.6.2.1. Radioimmunoassay (RIA)
      • 5.1.6.2.2. ELISA
      • 5.1.6.2.3. Chemiluminescent immunoassay (CLIA)
      • 5.1.6.2.4. Fluorescent immunoassay (FIA)
      • 5.1.6.2.5. Lateral flow assay (LFA)
      • 5.1.6.2.6. Rapid Test
      • 5.1.6.2.7. Others
      • 5.1.6.3. By Product
      • 5.1.6.3.1. Reagents
      • 5.1.6.3.2. Instruments
      • 5.1.6.3.3. Software & Services
      • 5.1.6.4. By Application
      • 5.1.6.4.1. Oncology
      • 5.1.6.4.2. Endocrinology
      • 5.1.6.4.3. Infectious diseases, Allergy & Autoimmune Diseases
      • 5.1.6.4.4. Environmental Pollution
      • 5.1.6.4.5. Food Technology
      • 5.1.6.4.6. Proteomics
      • 5.1.6.4.7. Cardiac Biomarker
      • 5.1.6.4.8. Drug Monitoring
      • 5.1.6.4.9. Others
      • 5.1.6.5. By End-user
      • 5.1.6.5.1. Hospitals
      • 5.1.6.5.2. Clinical Laboratories
      • 5.1.6.5.3. Academics & Research Centers
      • 5.1.6.5.4. Pharma & Biotech Industry
      • 5.1.6.5.5. Others
    • 5.1.7. Canada
    • 5.1.8. Mexico

All segments will be provided for all regions and countries covered

  • 5.2. Europe
    • 5.2.1. Germany
    • 5.2.2. France
    • 5.2.3. Italy
    • 5.2.4. United Kingdom
    • 5.2.5. Russia
    • 5.2.6. Netherlands
    • 5.2.7. Spain
    • 5.2.8. Turkey
    • 5.2.9. Poland
  • 5.3. South America
    • 5.3.1. Brazil
    • 5.3.2. Argentina
  • 5.4. Asia-Pacific
    • 5.4.1. India
    • 5.4.2. China
    • 5.4.3. Japan
    • 5.4.4. Australia
    • 5.4.5. Vietnam
    • 5.4.6. South Korea
    • 5.4.7. Indonesia
    • 5.4.8. Philippines
  • 5.5. Middle East & Africa
    • 5.5.1. Saudi Arabia
    • 5.5.2. UAE
    • 5.5.3. South Africa

6. Market Mapping, 2023

  • 6.1. By Type
  • 6.2. By Product
  • 6.3. By Application
  • 6.4. By End-user
  • 6.5. By Region

7. Macro Environment and Industry Structure

  • 7.1. Supply Demand Analysis
  • 7.2. Import Export Analysis
  • 7.3. Value Chain Analysis
  • 7.4. PESTEL Analysis
    • 7.4.1. Political Factors
    • 7.4.2. Economic System
    • 7.4.3. Social Implications
    • 7.4.4. Technological Advancements
    • 7.4.5. Environmental Impacts
    • 7.4.6. Legal Compliances and Regulatory Policies (Statutory Bodies Included)
  • 7.5. Porter's Five Forces Analysis
    • 7.5.1. Supplier Power
    • 7.5.2. Buyer Power
    • 7.5.3. Substitution Threat
    • 7.5.4. Threat from New Entrant
    • 7.5.5. Competitive Rivalry

8. Market Dynamics

  • 8.1. Growth Drivers
  • 8.2. Growth Inhibitors (Challenges and Restraints)

9. Regulatory Framework and Innovation

  • 9.1. Clinical Trials
  • 9.2. Patent Landscape
  • 9.3. Regulatory Approvals
  • 9.4. Innovations/Emerging Technologies

10. Key Players Landscape

  • 10.1. Competition Matrix of Top Five Market Leaders
  • 10.2. Market Revenue Analysis of Top Five Market Leaders (in %, 2023)
  • 10.3. Mergers and Acquisitions/Joint Ventures (If Applicable)
  • 10.4. SWOT Analysis (For Five Market Players)
  • 10.5. Patent Analysis (If Applicable)

11. Pricing Analysis

12. Case Studies

13. Key Players Outlook

  • 13.1. Bio-Rad Laboratories, Inc.
    • 13.1.1. Company Details
    • 13.1.2. Key Management Personnel
    • 13.1.3. Products & Services
    • 13.1.4. Financials (As reported)
    • 13.1.5. Key Market Focus & Geographical Presence
    • 13.1.6. Recent Developments
  • 13.2. Johnson & Johnson Services, Inc.
  • 13.3. Immunodiagnostics Systems Holdings Plc
  • 13.4. F. Hoffman-La Roche Ltd.
  • 13.5. Arkray, Inc.
  • 13.6. Siemens AG
  • 13.7. bioMerieux SA
  • 13.8. Danaher Corporation
  • 13.9. Sysmex Corporation
  • 13.10. Abbott Laboratories Inc.
  • 13.11. Diasorin S.P.A.
  • 13.12. Thermo Fisher Scientific, Inc.

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work

14. Strategic Recommendations

15. About Us & Disclaimer

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