Immunoprotein Diagnostic Testing Market Size, Share & Trends Analysis Report By Type (C-reactive Protein Diagnostic Test, Complement System Protein Diagnostic Test, Pre-albumin Diagnostic Test, Haptoglobin Diagnostic Test, Immunoglobulin Diagnostic Test, Free Light Chain Diagnostic Test, Others), By Application (Autoimmune Testing, Infectious Disease Testing, Allergy Testing, Endocrine Testing, Oncology Testing, Toxicology Testing, Others), By Technology (Radioimmunoassay, Immunoturbidity Assay, Immunoprotein Electrophoresis, Enzyme-linked immunosorbent assay) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

Immunoprotein Diagnostic Testing Market Size

The global immunoprotein diagnostic testing market size was valued at USD 9.75 billion in 2024 and is projected to grow from USD 10.60 billion in 2025 to reach USD 17.59 billion by 2033, exhibiting a CAGR of 6.54% during the forecast period (2025-2033). 

Immunoprotein Diagnostic Testing (ICI) refers to a specialized diagnostic approach that utilizes immunological methods to detect and analyze specific proteins in the body. These tests play a crucial role in diagnosing various conditions, including infectious and chronic diseases like cancer, by providing personalized results that guide appropriate treatment plans.

The major factors driving the growth of the ICI market include the rising prevalence of infectious and chronic diseases, such as cancer, advancements in screening technologies, a growing geriatric population, and the expansion of healthcare infrastructure. Cancer, being one of the most prevalent chronic diseases, is a major contributor to the market's expansion.

Moreover, the increasing number of cancer cases worldwide underscores the importance of immunoprotein diagnostics, which offer accurate, patient-specific diagnoses to ensure targeted and effective treatments. This has significantly boosted the demand for immunoprotein diagnostic testing, positioning it as a vital component in the global landscape. 

Below Table Represents the Global Cancer Cases in 2022

Source: Global Cancer Observatory and Straits Research

Immunoprotein Diagnostic Testing Market Trends

Adoption of new approaches to discover biomarkers

The increasing focus on discovering novel biomarkers for diagnosing diseases such as cancer and infectious diseases like tuberculosis is driving growth in the global immunoprotein diagnostic testing market. New, innovative approaches are emerging to accelerate the development of these biomarkers.

• For instance, in July 2024, Scipher Medicine launched a new method to identify treatment-response-predicting biomarkers for complex diseases. This approach, called PRoBeNet, aims to fast-track early biomarker development in complex diseases, further contributing to market expansion.

The ongoing adoption of these advanced strategies for biomarker development is significantly driving market growth and unlocking new opportunities in disease diagnosis.

Development of AI-based biosensors

Biosensors, which detect protein biomarkers to diagnose diseases, are becoming more advanced with the integration of artificial intelligence. AI-powered biosensors are making the diagnostic process more accurate, efficient, and detailed.

• For example, researchers from EPFL developed an AI-assisted biosensor capable of detecting neurodegenerative diseases. This technology can assess various treatment options based on the disease’s progression, offering deeper insights into the patient's condition.

The incorporation of AI into biosensor technology is enhancing diagnostic precision and specificity, leading to a higher demand for such innovations and contributing to the market's growth.

Immunoprotein Diagnostic Testing Market Growth Factors

Increasing prevalence of infectious diseases

The rising prevalence of infectious diseases is a significant global market driver. Infectious diseases require person-specific treatment, and immunoprotein diagnostic testing plays a vital role in providing accurate and timely diagnoses. The use of biomarker-based diagnostics ensures precise and targeted treatment.

• For instance, according to the World Health Organization (WHO), the number of tuberculosis (TB) cases increased from 7.5 million in 2022 to 10.8 million in 2023 globally. This surge in infectious diseases, particularly TB, is driving the demand for more diagnostic tests, fueling market growth in immunoprotein diagnostics.

Growing advancement in biomarkers

Advancements in biomarker technologies are further boosting the growth of the global immunoprotein diagnostic testing industry. Cutting-edge developments in diagnostic techniques enable more precise and detailed disease data.

• For example, in July 2022, a researcher from UConn introduced a low-abundance biomarker detection platform designed for early-stage disease diagnosis. This innovation has the potential to detect diseases in their early stages, offering significant benefits in treatment outcomes.

Such technological advancements contribute to the growing demand for accurate, timely, and specific diagnostic results, which are key drivers of the market's expansion.

Market Restraining Factor

Increasing use of alternative technologies

The growing adoption of alternative diagnostic technologies significantly restrains the growth of the global market. These alternatives, including molecular diagnostics, imaging techniques, and biochemical assays, offer competitive options for disease diagnosis, creating a challenging environment for immunoprotein-based methods.

• For example, Next-Generation Sequencing (NGS), a molecular diagnostic technology, is widely used for detecting genetic mutations associated with cancers and inherited diseases. Its capability to provide comprehensive genomic information has made it a preferred choice in oncology over traditional immunoprotein diagnostics.

The widespread availability and adoption of such advanced technologies present strong competition to immunoprotein diagnostic methods, hindering their market growth and posing significant challenges to industry players.

Market Opportunities

Collaborations between market players

Strategic collaborations among market players are fostering innovation and driving market growth by enabling the launch of advanced products that combine individual technological expertise. Such partnerships aim to leverage complementary strengths, enhancing diagnostic capabilities and expanding market opportunities.

• For example, in January 2024, Fujirebio partnered with Agappe Diagnostics to develop CLIA-based immunoassays. This collaboration focuses on integrating Fujirebio's expertise in clinical diagnostic technologies with Agappe’s established market presence, delivering innovative solutions to meet growing diagnostic demands.

These collaborations create an environment ripe for innovation, advancing immunoprotein diagnostic technologies and accelerating the market's growth trajectory.

Regional Insights

North America: Dominant region with 42.36% market share

North America holds the largest revenue share in the global market, driven by advanced healthcare infrastructure, substantial R&D investments, and a high prevalence of cancer and infectious diseases. For instance, the American Cancer Society estimates over 2 million new cancer cases in the U.S. in 2024.

Moreover, the region benefits from the presence of major industry players such as Agilent Technologies, Inc., Thermo Fisher Scientific Inc., PerkinElmer Inc., and Bio-Rad Laboratories, Inc., headquartered in the U.S. and Canada. These companies play a critical role in driving innovation and expanding diagnostic capabilities, further solidifying its dominance.

Asia-Pacific: Rapidly growing region 

Asia-Pacific is poised to witness the fastest CAGR, fueled by rising incidences of cancer and infectious diseases coupled with the rapid development of healthcare infrastructure. Government initiatives to enhance healthcare systems and streamlined regulatory frameworks are accelerating regional growth. s

For example, the World Health Organization (WHO) reported 2.82 million TB cases in India, highlighting the urgent need for advanced diagnostic solutions. Countries like China, Japan, and India are leading this regional expansion, with increasing investments in healthcare technologies and diagnostic tools driving market growth.

Countries Insights

• U.S. –The U.S. leads the global market due to its advanced healthcare system and substantial investment in R&D. The high prevalence of cancer and infectious diseases, including a 5.9% increase in TB cases in 2022, further drives market demand. Strong government support for healthcare innovation and the presence of key industry players continue to solidify its market dominance.
• Canada - Canada’s strong governmental support and initiatives in healthcare fuel the market growth. The Canadian government has implemented policies based on lessons from the COVID-19 pandemic. In March 2023, Ontario and Canada invested in Microbix, a company specializing in antigens for immunoassays, enhancing the country’s diagnostic capabilities.
• Germany– Germany’s robust healthcare system, commitment to innovation, and focus on patient care significantly contribute to the growth of the immunoprotein diagnostic testing industry. With an increasing incidence of cancer and a growing demand for precise diagnoses, Germany is witnessing a rise in demand for advanced diagnostic tools, which drives market expansion.
• UK – In the UK, the rise in autoimmune diseases drives the demand for immunoprotein diagnostic testing. A 2023 study on 22 million people revealed that 10% of the population is affected by autoimmune diseases, further increasing the need for advanced diagnostic solutions in the healthcare sector.
• France - France is experiencing a surge in cancer cases, creating a significant demand for immunoprotein diagnostic testing. With 483,568 new cancer cases in 2022, as reported by the WHO, the need for precise, person-specific diagnostic tests has become a key driver of market growth, prompting a demand for advanced immunoprotein solutions.
• China - China’s rapid rise in tuberculosis (TB) cases, accounting for 7.1% of the global TB cases in 2022, is a major factor driving the growth of the market. As TB remains a leading infectious disease, the need for accurate and efficient immunoprotein diagnostic testing is critical to addressing the growing health challenge.
• India- India’s increasing incidence of cancer and tuberculosis, along with rising awareness of advanced diagnostic options, is propelling the demand for immunoprotein diagnostic testing. Coupled with investments in healthcare infrastructure and government initiatives, these factors are driving significant opportunities for market growth in the country.
• Australia - Australia’s rising cancer cases, with an estimated 162,163 new diagnoses in 2022, have made immunoprotein diagnostic testing an essential tool for timely and precise diagnosis. As cancer prevalence continues to increase, the demand for accurate diagnostic solutions grows, fueling the market for immunoprotein testing in the region.

Immunoprotein Diagnostic Testing Market Segmentation Analysis

By Product Type

Kits & reagents segment dominates the market with the largest market revenue. The kits and reagents segment holds the largest revenue share due to its cost-effectiveness compared to instruments. Kits and reagents offer a more affordable option for diagnostic procedures, lowering the overall cost of testing. This affordability makes them highly accessible and widely adopted in healthcare settings.

• For instance, in July 2024, the Karnataka state government in India capped the price of dengue tests using ELISA kits at $3.0, emphasizing the affordability and accessibility of such diagnostic methods.

By Technology

Enzyme immunoassay segment dominates the market with the largest market revenue. The enzyme immunoassay (EIA) segment dominates the market owing to its high sensitivity, specificity, ease of automation, and affordability. Technological advancements in this segment continue to improve diagnostic accuracy and efficiency.

• For example, a sandwich ELISA was recently developed to detect circulating soluble insulin-regulated aminopeptidase (IRAP), optimizing factors like antibody concentration and reducing conditions to enhance biomarker detection.

This innovation highlights the segment's growth potential through technological advancements.

By Application

Oncology segment dominates the market with the largest market revenue. The oncology segment generates the highest market revenue due to the increasing global prevalence of cancer and its significant mortality rate. Cancer remains the leading cause of death worldwide, driving the demand for precise diagnostic tools.

• For example, the Pan American Health Organization reported approximately 20 million new cancer cases globally in 2023, underscoring the urgent need for advanced diagnostics in oncology.

By End-User

Diagnostic laboratories segment dominates the market with the largest market revenue. The diagnostic laboratories segment leads the market due to its specialization in disease diagnosis. These laboratories focus exclusively on diagnostic services, ensuring high specificity and accuracy in testing. Their role as key providers of healthcare diagnostics solidifies their dominance in the market. With a growing need for reliable diagnostic solutions, this segment continues to expand, providing critical services that support accurate disease management.

Company Market Share

Key players in the market are actively engaging in strategic collaborations and launching innovative technologies to strengthen their product portfolios and expand their market presence. These efforts aim to integrate complementary expertise, leverage advancements in diagnostic technology, and meet the increasing demand for personalized and accurate disease diagnosis.

ACROBiosystems: An emerging provider in the global immunoprotein diagnostic testing market

ACROBiosystems is an emerging and innovative player that is recognized for its cutting-edge ELISA kits. The company’s focus on providing high-quality, reliable solutions has positioned it as a key contributor to the advancement of immunoprotein diagnostics. By leveraging advanced technologies, ACROBiosystems is helping to drive the market forward, enabling more precise and personalized diagnostic testing.

Recent Developments

• July 2024 - ACROBiosystems launched its AAV titration and anti-AAV antibody ELISA kits, providing a crucial step in the quality control of AAV (Adeno-Associated Virus) therapy manufacturing. These innovative kits play a pivotal role in ensuring the accuracy and efficiency of AAV-based gene therapies, which are gaining significant traction in the treatment of various genetic disorders.

Analyst Opinion

As per our analyst, the global market is experiencing significant growth driven by the rising prevalence and mortality rates of cancer, infectious diseases like TB, and continuous technological advancements. The increasing demand for precise and timely diagnoses to address these growing health concerns is contributing to the market's expansion.

Moreover, strategic mergers, acquisitions, and collaborations are playing a pivotal role in accelerating market growth by combining the strengths and technologies of multiple companies. These partnerships not only foster innovation but also enable market players to achieve a global reach, further driving market dynamics.