Immunoprotein Diagnostic Testing Market Size, Share & Trends Analysis By Type (Complement System Proteins, Free Light Chain, Haptoglobin, Immunoglobulin), By Technology, By Application, And Segment Forecasts, 2018 - 2025

Report Overview

The global immunoprotein diagnostic testing market size to be valued at USD 10.3 billion by 2025 and is expected to grow at a compound annual growth rate (CAGR) of 6.7% during the forecast period. Increase in prevalence of chronic diseases has led to growth of market. High prevalence of chronic disorders, such as infectious diseases, cancer, cardiovascular disease, obesity, type 2 diabetes, and rheumatoid arthritis has led to growth of immunoprotein diagnostic testing products. Increasing mortality due to such chronic diseases has led to an urgent need for rapid diagnosis. According to Centers for Disease Control and Prevention (CDC), infectious diseases like AIDS, malaria, and tuberculosis cause nearly half of the deaths worldwide. Hence, with such high number of deaths due to infectious diseases, the need for rapid diagnosis to reduce the high mortality rate is increasing.

According to National Cancer Institute’s statistics, in the U.S., nearly 1,685,210 new cancer cases were diagnosed in 2016, and it was also expected that 595,690 people would die due to cancer. As a result, fast and accurate diagnosis of such chronic diseases is important to reduce high mortality, and immunoprotein diagnostic devices & reagents have proved to be highly effective in the rapid detection of chronic disorders.

Technological advancements in immunoprotein diagnostics have led to the introduction of chemiluminescence assays. This technology helps in rapid diagnosis of chronic diseases with completely automated instruments and high throughput. Tests conducted using chemiluminescence technology require short processing time, usually just 30 to 45 minutes. This technology minimizes any interruption in workflow of the system and enables on-board reagent capacity to reduce turnaround time.

Moreover, technological advancements associated with immunological reagents and kits are combined with complementary laboratory technologies, which has led to the introduction of a wide variety of products. For instance, VITROS ECiQ Immunodiagnostic System, manufactured by Ortho Clinical Diagnostics, is a versatile system that facilitates verification and documentation of an entire test.

Immunoprotein Diagnostic Testing Market Trends

The rise in the geriatric population and the increasing prevalence of chronic diseases are driving the global market. Factors including increasing awareness of the importance of early diagnosis among people, well-established healthcare systems, and an increase in the number of infectious diseases in developing nations due to unsanitary circumstances are some of the key factors poised to drive the market growth during the forecast period.

The availability of alternative testing methods and a complex regulatory environment limit market growth to a certain extent. Moreover, stringent environmental regulations designed for public interest are also a significant restraint to the industry expansion.

Increasing knowledge about the benefits of immunoprotein diagnostic testing leads to more profitable market opportunities. On the other hand, a number of developments in condition-specific assays and tests, coupled with technological advancements, provide lucrative chances for the market to advance during the forecast period.

Test Type Insights

On the basis of test type, immunoglobulin tests held the largest market share in 2016. This is due to the fact that they are commonly used and enables healthcare professionals to gather information about the functioning of a patient’s immune system in autoimmune or infectious diseases. However, immunoglobulin tests are not effective in some cases, for example, during chemotherapy or radiation therapy and in ongoing blood transfusion or vaccinations.

C-Reactive Protein (CRP) tests also held a significant share in 2016 owing to the wide product portfolio of key players. These tests help detect inflammation by measuring the amount of CRP in a patient’s body. CRP tests also assist in monitoring the effectiveness of treatment for infectious diseases and cancer.

Free light chain diagnostic tests are anticipated to exhibit significant growth over the forecast period. This is due to their ability to help in diagnosis, detection, and monitoring of plasma cell disorders. This type of testing is useful for patients suffering from oligosecretory myeloma, light chain-only multiple myeloma, or nonsecretory myeloma.

Complement system proteins tests are also expected to witness lucrative growth over the forecast period. A complement test facilitates monitoring of patients undergoing treatment for autoimmune disorders, such as rheumatoid arthritis and lupus. This testing method also helps measure how advanced these diseases are by monitoring the activity of complement protein in blood.

Application Insights

On the basis of application, infectious disease testing dominated the market in 2016 owing to the rising prevalence of different types of chronic infectious diseases, such as HIV/AIDS. Rapid diagnosis of infectious diseases in immunoprotein diagnostics has led to growth of this segment. Enzyme-based immunoassays are considered rapid testing techniques for detection of infectious diseases.

Oncology testing also held a significant share in 2016 due to high number of cancer cases throughout the world. Availability of different diagnostic methods, such as Epidermal Growth Factor Receptor (EGFR) testing, help in detection of mutations in EFGR gene, which occurs in patients with non-small cell lung cancer and this helps in treatment planning.

Autoimmune disease testing is another segment expected to exhibit attractive growth in the future due to the growing number of patients suffering from chronic diseases, such as rheumatoid arthritis and lupus. Key players are also engaged in production of immunoprotein tests for patients suffering from chronic autoimmune disorders.

Allergy tests are also anticipated to exhibit high growth over the forecast period due to the rising number of people, including children affected with nasal allergies. Blood tests for allergy search for antibodies in the blood. Symptoms of allergy are often life-threatening; therefore, rapid diagnosis is required to minimize risk.

Technology Insights

On the basis of technology, Enzyme-based Immunoassay (EIA) held the largest market share in 2016. It can be used as a diagnostic tool as well as a quality control tool in numerous companies and laboratories. Moreover, majority of the key companies have an extensive portfolio of analyzers with EIA technology. For instance, Human Complement C3 ELISA Kit by Abcam uses this technology for diagnosis. These are some of the factors that can be attributed for the largest market share of EIA.

Chemiluminescence assay is expected to exhibit the highest growth over the forecast period due to its high specificity and sensitivity as well as ability to detect antigens in human serum & plasma samples. Chemiluminescence assay is frequently characterized as an important tool for instant diagnosis of various diseases and is ascertained to be more accurate than fluorescence-based detection of labeled probes.

Immunoprotein electrophoresis also held a significant share in the market in 2016 due to the fact that this test allows appropriate analysis of protein levels, that is, it analyzes whether protein levels are increasing or decreasing as a result of chronic disorders, such as, autoimmune or cancer-related diseases. It basically helps in the measurement of different types of immunoglobulins present in a patient’s blood.

Regional Insights

In 2016, North America dominated the market due to well-established healthcare infrastructure in the U.S., which has led to an increase in adoption of immunoprotein diagnostic instruments in laboratories and diagnostic centers. Moreover, high incidence of cancer among the U.S. population also led to the growth of this market.

Europe held a significant share in this market in 2016 due to high prevalence of cancer and diabetes among the European population. Increase in number of government initiatives undertaken in Germany to conduct tests for people suffering from multifactorial and chronic diseases, especially to detect cancer, diabetes, lung, and cardiovascular disease, is one of the factors responsible for the growth in this region.

Asia Pacific is expected to witness highest growth over the forecast period owing to extremely rapid economic development coupled with rapid evolvement of the medical healthcare system in countries such as China and India. A collaboration between public health institutions in China, such as Ministry of Health & China CDC, and the U.S. CDC, focused on Chinese healthcare structure pertaining to HIV/AIDS, immunizations, emerging infectious diseases, noncommunicable diseases, and laboratory quality control has also led to the growth of this region.

Key Companies & Market Share Insights

Some of the key companies are Abbott Laboratories; Bio-Rad Laboratories, Inc.; DiaSorin S.p.A; Enzo Biochem, Inc.; F. Hoffmann-La Roche AG; Thermo Fisher Scientific, Inc.; bioMérieux SA; Abcam Plc.; Siemens Healthcare GmbH; Beckman Coulter; and Ortho Clinical Diagnostics

Major strategies undertaken by these key players include new product development, mergers & acquisitions, strategic partnerships, and geographical expansions. For instance, in May 2016, DiaSorin acquired the immunodiagnostic and molecular diagnostic products of Focus Diagnostics from Quest Diagnostics. In June 2016, Ortho Clinical Diagnostics and Beckman Coulter, Inc. entered into a strategic partnership for sales of Ortho’s VITROS 3600 Immunodiagnostic System and portfolio for infectious diseases in the U.S.

Recent Development

• In June 2021, Bio-Rad announced a partnership with Seegene, a key market player in multiplex molecular diagnostics, for the clinical commercialization and development of infectious disease diagnostic solutions

• In July 2021, DiaSorin acquired Luminex corporation. This will help DiaSorin get access to Luminex’s multiplexing technology, and an investment that will reinforce its existing offering, while scaling the group's presence in the United States

• In October 2021, Roche announced its collaboration with PathAI, a world leader in pathology-based AI-powered technology. Under the agreement of development & distribution, the companies aimed to jointly develop an embedded image analysis workflow for pathologists

Immunoprotein Diagnostic Testing Market Report Scope

Global Immunoprotein Diagnostic Testing Market Segmentation

This report forecasts revenue growth at global, regional, & country levels and provides an analysis on the latest trends and opportunities in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the immunoprotein diagnostic testing market on the basis of test type, application, technology, and region.

• Test Type Outlook (Revenue, USD Million; 2014 - 2025)

  • 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

• Application Outlook (Revenue, USD Million; 2014 - 2025)

  • Infectious Disease Testing

  • Oncology Testing

  • Endocrine Testing

  • Toxicology Testing

  • Allergy Testing

  • Autoimmune Disease Testing

• Technology Outlook (Revenue, USD Million; 2014 - 2025)

  • Radioimmunoassay

  • Enzyme Based Immunoassay

  • Chemiluminescence Assay

  • Immunofluorescence Assay

  • Immunoturbidity Assay

  • Immunoprotein Electrophoresis

• Regional Outlook (Revenue, USD Million; 2014 - 2025)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • UK

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • MEA

    • South Africa

    • Saudi Arabia