Immunoprotein Diagnostic Testing Market Size & Share, by Product Type (Instruments, Kits & Reagents), Technology (Chemiluminescence Assay, Enzyme-based Immunoassay, Immunofluorescence Assay, Immunoturbidity Assay, Immunoprotein Electrophoresis), Application (Infectious Disease, Endocrine, Toxicology) - Global Supply & Demand Analysis, Growth Forecasts, Statistics Report 2025-2037

  • Report ID: 5311
  • Published Date: Oct 09, 2024
  • Report Format: PDF, PPT

Global Market Size, Forecast, and Trend Highlights Over 2025-2037

Immunoprotein Diagnostic Testing Market size was over USD 9.38 billion in 2024 and is set to cross USD 24.02 billion by the end of 2037, witnessing more than 7.5% CAGR during the forecast period i.e., between 2025-2037. In the year 2025, the industry size of immunoprotein diagnostic testing is estimated at USD 9.94 billion.

The growth of this market can be attributed to the growing presence of infectious and chronic diseases. Products for immunoprotein diagnostic testing have increased in popularity due to the high frequency of chronic diseases like infectious diseases, cardiovascular diseases, cancer, obesity, and rheumatoid arthritis. Rapid diagnosis is urgently required due to the chronic diseases' rising mortality rates. Nearly half of all fatalities globally are thought to be caused by infectious diseases like AIDS, malaria, and tuberculosis, according to the Centers for Disease Control and Prevention (CDC).

Chemiluminescence assays have been developed as a result of technological developments in immunoprotein diagnostics. This technique uses fully automated devices and high throughput to assist in the quick detection of chronic diseases. Chemiluminescence tests only require a brief processing period, often between 30 and 45 minutes. This technology allows for on-board reagent capacity to speed up turnaround time and reduces any system workflow interruptions. Additionally, the launch of a wide range of goods has been facilitated by the fusion of complementing laboratory technologies with technological advancements related to immunological reagents and kits.


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Immunoprotein Diagnostic Testing Sector: Growth Drivers and Challenges

Growth Drivers

  • Rise in Diagnostics Tests - Numerous diagnostic procedures are assisting in the rise of the immunoprotein diagnostic testing market. Because of the diverse product lines offered by the top market players, C-Reactive Protein (CRP) assays are frequently employed. By calculating the patient's CRP level, these tests assist in identifying inflammation. Additionally, it aids in evaluating the efficacy of cancer and a number of infectious illness treatments. Free light chain diagnostic tests are also anticipated to experience significant growth during the predicted period. This is due to their capacity to support plasma cell diseases' detection, diagnosis, and monitoring. Patients with non-secretory, oligo-secretory, or multiple myeloma with just light chains can benefit from this examination. As a result, the market is growing as a result of all these examinations.
  • Increasing Demand for Chemiluminescence Imaging - Due to its high specificity, sensitivity, and capacity to recognize antigens in human blood and serum samples, the chemiluminescence assay is anticipated to increase at the fastest rate throughout the forecast period. When compared to fluorescence-based detection of tagged probes, chemiluminescence assay is considered to be a more accurate method for making a speedy diagnosis of many diseases.
  • Growing Awareness about Development in Diagnostic Tests Among Patients – The market for immunoprotein diagnostic testing is growing as a result of increasing awareness among patients regarding this diagnostic testing.

Challenges

  • High Cost of Development and Implementation – Immunoprotein diagnostic tests are complex and expensive to develop and implement. This is because they require substantial research and development, as well as validation processes. This can be a barrier to entry for new companies and can also make it difficult for smaller companies to compete with larger, more established players. Therefore, it is predicted to hamper the market expansion of immunoprotein diagnostic testing in the projected time period.
  • Regulatory Hurdles Associated are Expected to Restrict the Market Growth in the Upcoming Time Period.
  • Supply Chain Challenges are Expected to Pose Limitations on the Market Expansion in the Future Times. 

Immunoprotein Diagnostic Testing Market: Key Insights

Base Year

2024

Forecast Year

2024 – 2037

CAGR

7.5%

Base Year Market Size

USD 9.38 billion

Forecast Year Market Size

USD 24.02 billion

Regional Scope

  • North America (U.S., and Canada)
  • Latin America (Mexico, Argentina, Rest of Latin America)
  • Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific)
  • Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)

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Immunoprotein Diagnostic Testing Segmentation

Technology (Chemiluminescence Assay, Enzyme-based Immunoassay, Immunofluorescence Assay, Immunoturbidity Assay, Immunoprotein Electrophoresis)

Immunoprotein diagnostic testing market from the chemiluminescence essay segment is set to hold the largest revenue share of 30% by the end of 2037. The growth may be attributable to a high degree of specificity and sensitivity as well as the ability to identify antigens in human serum or plasma samples. The Chemiluminescence assay is often regarded as an important tool for the rapid identification of a particular disease and it has been shown to be more precise than fluorescently detecting probes, which are labeled.  Furthermore, the enzyme-based immunoassay is estimated to offer lucrative growth opportunities for the market in the upcoming time period. In a large number of companies and laboratories, it can also be used to diagnose disease, as well as for quality control. In addition, a large number of EIA analyzers are at the disposal of most major companies. For example, this technology is used for diagnostic purposes in the Human Complement C3 ELISA Kit by Abcam.

Application (Infectious Disease, Endocrine, Toxicology)

The endocrine segment in the immunoprotein diagnostic testing market is estimated to hold a substantial revenue share during the forecast period. The growing burden of endocrine diseases, such as diabetes, and the development of products related to immunodiagnostic testing are driving the growth of this segment. According to 2022 statistics, in the United States, type 1 diabetes increased by 2.9% per year, compared to 4.5% for type 2 diabetes. Similarly, according to the US CDC, in 2022, 96 million adults have prediabetes in the U.S., and 8 out of 10 of them don't know if they have the condition. More than 37 million people are living with diabetes and one in five are undiagnosed. Therefore, the significant increase in the prevalence of diabetes is increasing the demand for immunoprotein testing diagnostics, which will have a positive impact on the market.

Our in-depth analysis of the global market includes the following segments:

          Product Type

  • Instruments
  • Kits & Reagents

          Technology

  • Chemiluminescence Assay
  • Enzyme-based Immunoassay
  •  Immunofluorescence Assay
  • Immunoturbidity Assay
  • Immunoprotein Electrophoresis

          Application

  • Infectious Disease
  • Endocrine
  • Toxicology

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Immunoprotein Diagnostic Testing Industry - Regional Synopsis

APAC Market Forecasts

The immunoprotein diagnostic testing market in the Asia Pacific is estimated to hold the highest share of 35% during the forecast period. This can be assumed due to the extremely rapid economic development coupled with the rapid development of medical health systems in countries such as China and India. Collaboration between public health organizations in China, such as the Ministry of Health, China CDC, and the US CDC, focuses on China's healthcare structure related to HIV/AIDS, vaccination, emerging infectious diseases, non-communicable diseases, and laboratory quality control, have also driven the growth of the market in this area.  

North America Market Statistics

The North America immunoprotein diagnostic testing market is expected to grow substantially during the forecast timeframe. Key factors driving market growth in North America include increased healthcare spending and increased awareness of products related to autoimmune disease diagnostics. North America is expected to emerge as a dominant region due to the growing disease burden as well as the development and launch of new products. Furthermore, new product approvals and launches in the region along with collaborations among key market players will drive market growth. For example, in May 2022, OmegaQuant launched an HbA1c test with a sample collection kit for at-home testing. This simple, safe, and practical test measures the amount of sugar (glucose) in the blood. Therefore, it will positively influence the market and witness significant growth in North America during the forecast period due to the above-mentioned factors.

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Companies Dominating the Immunoprotein Diagnostic Testing Landscape

    • Thermofisher Scientific Inc.
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Abbott Laboratories
    • Abcam plc
    • Bio-Rad Laboratories, Inc.
    • Danaher Corporation
    • DiaSorin S.p.A
    • Enzo Biochem
    • Ortho Clinical Diagnostics
    • KSL Diagnostics Inc.
    • KSL Beutner Laboratories

In the News

  • In July 2022, KSL Beutner Laboratories launched the first indirect immunofluorescence (IIF) serum blood test to market in the United States, which positively identified laminin 332, an antigen associated with mucosal pemphigoid (MMP), a chronic and debilitating autoimmune disease.
  • In April 2022, KSL Diagnostics, Inc launched the first antibody test that detects an individual's immune response to COVID-19 and assesses the risk of infection if exposed. The COVID-19 Immunity Index can help monitor protection against the COVID-19 virus with a simple blood test.

Author Credits:  Radhika Pawar


  • Report ID: 5311
  • Published Date: Oct 09, 2024
  • Report Format: PDF, PPT

Frequently Asked Questions (FAQ)

In the year 2025, the industry size of immunoprotein diagnostic testing is estimated at USD 9.94 billion.

The immunoprotein diagnostic testing market size was over USD 9.38 billion in 2024 and is set to cross USD 24.02 billion by the end of 2037, witnessing more than 7.5% CAGR during the forecast period i.e., between 2025-2037. The growing prevalence of chronic disease and rise in diagnostic tests will boost the market growth.

Asia Pacific industry is expected to dominate majority revenue share 35% by 2037, due to rising development of medical health systems in the region.

The major players in the market are of Bio-Rad Laboratories, Inc, Danaher Corporation, DiaSorin S.p.A, Enzo Biochem, Ortho Clinical Diagnostics, KSL Diagnostics Inc., KSL Beutner Laboratories, and others.
Immunoprotein Diagnostic Testing Market Report Scope
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