Immunoprotein Diagnostic Testing Market Size, Share & Trends Analysis Report By Test (Immunoglobulin Diagnostic Tests), By Technology, By Application, By Distribution Channel, By End-use, By Region,- Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2025-2034

Immunoprotein Diagnostic Testing Market Size and Growth

The immunoprotein diagnostic testing market size was exhibited at USD 9.75 billion in 2024 and is projected to hit around USD 20.66 billion by 2034, growing at a CAGR of 7.8% during the forecast period 2025 to 2034.

Immunoprotein Diagnostic Testing Market Key Takeaways:

• The immunoglobulin diagnostic tests segment accounted for the largest revenue share of the market of 27.1% in 2024.
• The C-Reactive Protein (CRP) diagnostic tests segment is likely to grow at a CAGR of 8.3% over the forecast period.
• The infectious disease testing segment accounted for the largest revenue share of the market of 24.2% in 2024.
• The oncology testing segment is likely to grow at a CAGR of 8.1% over the forecast period.
• The enzyme-based immunoassay segment accounted for the largest revenue share of the market of 25.0% in 2024.
• The chemiluminescence assay segment is likely to grow at a CAGR of 9.3% over the forecast period.
• The retail sales segment accounted for the largest share of the market of 54.1% in 2024.
• The direct tender segment is likely to grow at a CAGR of 8.1% over the forecast period.
• The hospitals and clinics segment accounted for the largest revenue share of the market of 45.0% in 2024.
• The diagnostic laboratories segment is likely to grow at a CAGR of 8.5% over the forecast period.
• North America immunoprotein diagnostic testing industry dominated and accounted for a 46.0% share in 2024.

U.S. Immunoprotein Diagnostic Testing Market Size and Growth 2025 to 2034

The U.S. immunoprotein diagnostic testing market size is evaluated at USD 3.4 billion in 2024 and is projected to be worth around USD 7.1 billion by 2034, growing at a CAGR of 6.92% from 2025 to 2034.

North America immunoprotein diagnostic testing industry dominated and accounted for a 46.0% share in 2024. The market dominance can be attributed to technological advancements, the high prevalence of chronic diseases, and growing investments in research and development. The region benefits from a well-established healthcare infrastructure, which includes advanced medical facilities, skilled healthcare professionals, and strong regulatory frameworks. These factors ensure easy access to immunoprotein diagnostic testing services for patients, further supporting the growth and dominance of the market.

U.S. Immunoprotein Diagnostic Testing Market Trends

The U.S. immunoprotein diagnostic testing industry is projected to grow significantly during the forecast period. The rising prevalence of chronic diseases, such as cancer, cardiovascular diseases, and autoimmune disorders, in the U.S. is driving the demand for immunoprotein diagnostic testing to support early detection and ongoing monitoring of these conditions. Additionally, the U.S. benefits from stringent regulatory standards enforced by agencies like the U.S. Food and Drug Administration (FDA), which ensures the quality, safety, and reliability of diagnostic tests. These regulations enhance consumer trust and confidence in the market, further promoting the growth of immunoprotein diagnostic testing services in the country.

Europe Immunoprotein Diagnostic Testing Market Trends

The immunoprotein diagnostic testing industry in Europe is likely to emerge as a lucrative region. The regional market growth is driven by the rising prevalence of chronic diseases. Advancements in diagnostic technologies, including enzyme-based immunoassays and chemiluminescence assays, are enhancing the accuracy and speed of test results, contributing to increased adoption in clinical settings. Additionally, the growing focus on personalized medicine, where treatments are tailored based on individual biomarker profiles, is fueling demand for immunoprotein tests.

The UK immunoprotein diagnostic testing market is projected to grow during the forecast period. The UK's strong healthcare infrastructure, including the National Health Service (NHS), provides widespread access to these diagnostic services, further boosting demand. Additionally, the growing emphasis on personalized medicine, where treatments are tailored based on specific biomarkers, is driving the need for more advanced diagnostic tests. The UK’s stringent regulatory standards ensure the quality and safety of these tests, enhancing consumer trust and contributing to the market’s expansion.

The immunoprotein diagnostic testing market in France is expected to show steady growth over the forecast period. The France market is growing on account of rising prevalence of chronic diseases such as breast cancer, prostate cancer, colorectal cancer, rheumatoid arthritis and lupus.

Germany immunoprotein diagnostic testing market is projected to expand during the forecast period. Advances in diagnostic technologies, including enzyme-linked immunosorbent assays (ELISA) and chemiluminescence assays, are improving the accuracy, speed, and sensitivity of tests, enabling early detection and better monitoring of these conditions. Germany's advanced healthcare infrastructure, supported by both public and private healthcare systems, ensures wide access to these diagnostic services, contributing to the market's expansion.

Asia Pacific Immunoprotein Diagnostic Testing Market Trends

The immunoprotein diagnostic testing industry in Asia Pacific is expected to experience the highest growth rate of 8.7% CAGR during the forecast period. The growing demand for personalized medicine, which tailors treatment based on individual biomarker profiles, is further driving the need for these diagnostic tests. APAC's diverse healthcare landscape, with varying levels of healthcare infrastructure across countries, is also a factor in the market growth. While countries like Japan, South Korea, and Australia have advanced healthcare systems, emerging markets such as China and India are witnessing increased access to diagnostic services due to improvements in healthcare infrastructure and rising health awareness.

China immunoprotein diagnostic testing market is projected to expand throughout the forecast period. China’s expanding healthcare infrastructure, along with government initiatives to improve healthcare access and promote early disease detection, is further boosting the market.

The immunoprotein diagnostic testing market in Japan is anticipated to grow during the forecast period. Japan’s investment in research and development, particularly in biotechnology and diagnostics, supports the continuous innovation and growth of the immunoprotein diagnostic testing market.

Latin America Immunoprotein Diagnostic Testing Market Trends

The Latin America immunoprotein diagnostic testing industry is expected to experience significant growth throughout the forecast period. The region's expanding healthcare infrastructure, along with government initiatives aimed at improving access to healthcare services, is contributing to market growth. However, challenges such as economic disparities and varying healthcare standards across countries may impact the accessibility and availability of advanced diagnostic tests in certain areas.

The immunoprotein diagnostic testing market in Brazil is likely to grow over the forecast period. Brazil's expanding healthcare infrastructure, supported by both public and private sectors, is improving access to diagnostic services, especially in urban areas. Technological advancements in diagnostic tools, such as enzyme-linked immunoassays (ELISA) and chemiluminescence assays, are enhancing the accuracy, speed, and efficiency of immunoprotein tests, making them more accessible to patients.

Middle East And Africa Immunoprotein Diagnostic Testing Market Trends

The Middle East and Africa immunoprotein diagnostic testing market is expected to grow due to several driving factors. The rising prevalence of chronic diseases, including cancer, cardiovascular diseases, and autoimmune disorders, is creating a significant demand for diagnostic tests to aid in early detection and monitoring of these conditions. Technological advancements in immunoprotein diagnostic tools, such as enzyme-linked immunoassays (ELISA) and chemiluminescence assays, are improving the accuracy and efficiency of tests, making them more accessible in the region.

The immunoprotein diagnostic testing industry in Saudi Arabia is anticipated to experience lucrative growth during the forecast period. The Saudi government’s Vision 2030 initiative, which aims to diversify the economy and improve healthcare services, is also contributing to the expansion of the healthcare sector, including diagnostic testing services. Increased health awareness, particularly among the growing middle-class population, is encouraging more individuals to seek early detection and preventive healthcare services. Additionally, regulatory bodies in Saudi Arabia, such as the Saudi Food and Drug Authority (SFDA), ensure that diagnostic tests meet high standards of safety and quality, fostering consumer trust and confidence in the market.

Report Scope of Immunoprotein Diagnostic Testing Market

Immunoprotein Diagnostic Testing Market By Test insights

The immunoglobulin diagnostic tests segment accounted for the largest revenue share of the market of 27.1% in 2024. These tests dominate the immunoprotein diagnostic testing market due to their critical role in diagnosing a wide range of conditions, including immune deficiencies, autoimmune disorders, and infectious diseases. These tests measure immunoglobulin levels, such as IgG, IgA, IgM, and IgE, providing valuable insights into immune system function. Their widespread application in monitoring chronic conditions, identifying allergies, and supporting vaccine efficacy studies further drives demand. Additionally, advancements in assay technologies, such as automated and multiplex platforms, enhance test accuracy and efficiency. The growing prevalence of immune-related disorders and the increasing emphasis on personalized medicine solidify their dominance in the market.

The C-Reactive Protein (CRP) diagnostic tests segment is likely to grow at a CAGR of 8.3% over the forecast period. CRP tests are used to assess inflammation in conditions such as infections, autoimmune disorders such as rheumatoid arthritis and lupus along with cardiovascular diseases. With the increasing prevalence of the abovementioned diseases, the demand for CRP tests is anticipated to grow over the forecast period.

Immunoprotein Diagnostic Testing Market By Application Insights

The infectious disease testing segment accounted for the largest revenue share of the market of 24.2% in 2024. Infectious disease testing is in high demand due to the increasing prevalence of infectious diseases, the need for early and accurate diagnosis, and the critical role these tests play in managing public health. The rise of chronic infections such as HIV, tuberculosis, and hepatitis, along with COVID-19 pandemic, has driven the need for reliable diagnostic tools. Early detection is crucial for effective treatment and preventing the spread of these diseases. The COVID-19 pandemic further highlighted the importance of rapid and widespread testing, leading to increased investments in diagnostic technologies.

The oncology testing segment is likely to grow at a CAGR of 8.1% over the forecast period. Oncology testing is in high demand within the immunoprotein diagnostic testing industry due to the increasing incidence of cancer globally and the growing emphasis on early detection, personalized treatment, and monitoring of therapeutic efficacy. According to the World Health Organization, in 2022, there were over 20 million new cancer cases which are likely to cross 35 million by 2050 with an increase of 77% compared to 2022. Immunoproteins, such as tumor markers, play a crucial role in identifying specific proteins associated with different cancer types, enabling early diagnosis and improving patient outcomes.

As cancer remains one of the leading causes of death worldwide, there is a growing need for accurate, reliable, and minimally invasive diagnostic tools. Immunoprotein tests, including those for biomarkers like prostate-specific antigen (PSA) for prostate cancer and CA 125 for ovarian cancer, are essential for identifying cancers at early stages when treatment is more effective. Furthermore, the shift toward personalized medicine in oncology, where treatments are tailored based on individual biomarker profiles, has significantly increased the demand for immunoprotein tests. These tests also aid in monitoring disease progression, assessing treatment response, and detecting potential relapses.

Immunoprotein Diagnostic Testing Market By Technology Insights

The enzyme-based immunoassay segment accounted for the largest revenue share of the market of 25.0% in 2024. These assays, such as ELISA (Enzyme-Linked Immunosorbent Assay), are widely used for detecting and quantifying proteins, antibodies, and other biomarkers, making them essential in diagnosing a range of conditions, including autoimmune diseases, infectious diseases, and cancers. The growing prevalence of these diseases and the need for early, non-invasive diagnostic methods have fueled the demand for enzyme-based immunoassays.

In addition, enzyme-based immunoassays offer several advantages, such as high throughput, ease of automation, and compatibility with various sample types, including blood, serum, and urine. The ability to detect low levels of biomarkers with high specificity makes these assays ideal for monitoring disease progression, treatment efficacy, and detecting relapses, particularly in chronic conditions like cancer and autoimmune disorders.

The chemiluminescence assay segment is likely to grow at a CAGR of 9.3% over the forecast period. These assays utilize light emission resulting from a chemical reaction, providing a much stronger and more detectable signal compared to traditional colorimetric assays. This allows for precise measurements even in small sample volumes, which is crucial for diagnosing conditions that require early detection of biomarkers at low concentrations, such as cancer, autoimmune disorders, and infectious diseases. Furthermore, the non-radioactive nature of CLAs makes them safer and more suitable for routine clinical use compared to older methods that relied on radioactive substances. The ability to automate chemiluminescence assays further boosts their demand, as it enables high-throughput testing, reduces human error, and improves overall efficiency in clinical laboratories.

Immunoprotein Diagnostic Testing Market By Distribution Channel Insights

The retail sales segment accounted for the largest share of the market of 54.1% in 2024. This growth can be attributed to the increased accessibility and convenience for patients. Retail sales make immunoprotein diagnostic tests easily available to individuals, allowing them to access these tests with ease. Furthermore, retail outlets provide patients with the ability to take charge of their health by offering convenient testing options. These sales channels also play a significant role in educating the public about the importance of diagnostic testing, which further contributes to the expansion of the market.

The direct tender segment is likely to grow at a CAGR of 8.1% over the forecast period. Direct tender offers a simplified procurement process for healthcare facilities and institutions that require large volumes of diagnostic tests. This arrangement often leads to cost savings for buyers through bulk purchasing and negotiated pricing, making it a highly attractive option for healthcare providers. In addition, direct tender agreements provide the flexibility to customize products and services to meet the specific needs of healthcare providers, ensuring that they receive the most suitable solutions for their operations.

Immunoprotein Diagnostic Testing Market By End-use Insights

The hospitals and clinics segment accounted for the largest revenue share of the market of 45.0% in 2024. Hospitals and clinics serve a large number of patients daily, driving a high demand for diagnostic testing services. With specialized departments and advanced medical equipment, hospitals are well-equipped to deliver accurate and timely immunoprotein diagnostic testing. The shift from centralized to decentralized testing has further fueled market growth, as it allows for quicker, on-site results and improved patient care. Additionally, advancements in healthcare technology have played a significant role in expanding the market, enabling more efficient, precise, and accessible diagnostic solutions. These factors combined have contributed to the growing demand for immunoprotein diagnostic testing services.

The diagnostic laboratories segment is likely to grow at a CAGR of 8.5% over the forecast period. These laboratories are equipped with state-of-the-art technology and staffed by skilled professionals who ensure high accuracy and reliability in test results. Diagnostic labs offer a wide range of tests, including immunoprotein diagnostics, which are essential for diagnosing various conditions such as autoimmune diseases, infections, and cancer. Additionally, diagnostic laboratories provide centralized testing, allowing for standardized procedures and quality control, which enhances the consistency and trustworthiness of results. They are also able to handle complex and specialized tests that may not be feasible in smaller healthcare settings. The increasing demand for precise and timely diagnostics, coupled with the growing focus on personalized medicine, has further supported the dominance of segment in the market.

Some of the prominent players in the immunoprotein diagnostic testing market include:

• Agilent Technologies, Inc.
• Danaher Corporation
• Thermo Fisher Scientific Inc.
• PerkinElmer Inc.
• Bio-Rad Laboratories, Inc.
• Aurora Biomed Inc.
• Tecan Trading AG
• Promega Corporation
• Charles River Laboratories
• Creative Biolabs.

Immunoprotein Diagnostic Testing Market Recent Developments

• In April 2024, Virax Biolabs introduced ImmuneSelect, a suite of immune profiling solutions within their ViraxImmune T-Cell diagnostic platform. Designed for research purposes, ImmuneSelect evaluates T-Cell-driven immunity to aid in understanding and early characterization of symptoms associated with post-viral syndromes, including Long COVID.
  
  
• In July 2023, Quest Diagnostics, one of the major players in the diagnostic testing market, launched its first diagnostic test in the open market related to Alzheimer's disease. The AD-Detect Test for Alzheimer's Disease test made available through an online platform offers an examination of brain protein and shares an assessment measuring potential risks associated with the disease.
  
  
• In July 2023, Siemens Healthineers, a German organization operating in the healthcare technology and automation industry, launched one of its latest innovations, Atellica CI Analyzer. The new addition to Siemens’ diverse portfolio, dealing with immunoassay and clinical chemistry testing has attained clearance from the U.S. FDA and is distributed among multiple regional markets now.

Segments Covered in the Report

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the immunoprotein diagnostic testing market

By Test

• Complement System Proteins Diagnostic Tests
• Free Light Chain Diagnostic Tests
• Haptoglobin Diagnostic Tests
• Immunoglobulin Diagnostic Tests
• Prealbumin Diagnostic Tests
• C-Reactive Protein (CRP) Diagnostic Tests

By Application

• Infectious Disease Testing
• Oncology Testing
• Endocrine Testing
• Toxicology Testing
• Allergy Testing
• Autoimmune Disease Testing

By Technology

• Radioimmunoassay
• Enzyme Based Immunoassay
• Chemiluminescence Assay
• Immunofluorescence Assay
• Immunoturbidity Assay
• Immunoprotein Electrophoresis

By Distribution Channel

• Direct Tender
• Retail Sales

By End-use

• Hospitals and Clinics
• Diagnostic Laboratories
• Others

By Regional

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa (MEA)