The global immunoprotein diagnostic testing market size was valued at USD 5.8 billion in 2016 and is expected to witness lucrative growth over the forecast period. Increase in prevalence of chronic diseases has led to growth of immunoprotein diagnostic testing 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.
U.S. immunoprotein diagnostic testing market, by test type, 2014 - 2025 (USD Million)
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.
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.
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.
Canada immunoprotein diagnostic testing market, by application, 2016 (%)
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 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.
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.
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.
Base year for estimation
Actual estimates/Historical data
2014 - 2015
2017 - 2025
Revenue in USD million and CAGR from 2017 to 2025
North America, Europe, Asia Pacific, Latin America, & MEA
U.S., Canada, UK, Germany, France, Italy, Spain, Japan, India, China, India, Brazil, Mexico, South Africa, Saudi Arabia
Revenue forecast, company share, competitive landscape, growth factors, and trends
15% free customization scope (equivalent to 5 analyst working days)
If you need specific market information, which is not currently within the scope of the report, we will provide it to you as a part of customization
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
Autoimmune Disease Testing
Technology Outlook (Revenue, USD Million; 2014 - 2025)
Enzyme Based Immunoassay
Regional Outlook (Revenue, USD Million; 2014 - 2025)
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