Autoimmune Disease Diagnostics Market Size Will Become USD 10.3 Billion by 2032

According to Market.us, Recent technological advancements have enabled the simultaneous measurement and identification of autoimmune diseases, contributing to the growth of this market.


New York, April 18, 2023 (GLOBE NEWSWIRE) -- The global autoimmune disease diagnostics market size accounted for USD 5.3 billion in 2022 and it is projected to surpass around USD 10.3 billion by 2032, CAGR of 7.1% from 2023 to 2032. Autoimmune diseases are when the immune system attacks itself because of abnormalities. When the immune system fails to recognize immune cells, organs, tissues, or creates autoantibodies against these cells it can cause an immune system malfunction.

Autoimmune Disease Diagnostics Market Value

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Key Takeaway:

  • By product, in 2022, the consumables & assay kits segment has generated a largest revenue share.
  • By Disease Type, the systemic autoimmune disease segment has dominated the market and it is growing at a CAGR of 7.5% over the forecast period 2023 to 2032.
  • In 2022, North America dominated the market with the highest revenue share of 43%.
  • Asia-Pacific will grow at a significant CAGR from 2023-2032.

The rising incidence of autoimmune diseases and the adoption of automation for equipment are driving global market growth.

A variety of initiatives have been launched by organizations to increase awareness about autoimmune disorders. They also seek to increase global use of autoimmune disease diagnostics. Technological advances in diagnostics, improved laboratory automation, and a growing market for autoimmune disease diagnostics is positively driving the growth of this market.

Factors affecting the growth of Autoimmune Disease Diagnostics Market

  • There are several factors that can affect the growth of the autoimmune disease diagnostics industry. Some of these factors include:
  • Increasing incidence of autoimmune diseases: The increased incidence of conditions such as Hashimoto's thyroiditis or rheumatoid arthritis are likely to have a significant impact on the autoimmune disease diagnostics market.
  • Growth strategies by major players: Market size is likely grow due to the product launches and a greater number of growth strategies employed by major players.
  • Advancement in technologies: The most recent technological advancements allow simultaneous measurement and identification of autoimmune diseases which are subjected towards further augmentation of this market.
  • Improvement in testing methods: A wide variety of methods are used to improve analytical sensitivity and reproducibility, including antigen microarrays for antibody profiling and mass spectrometry. This shortens the testing times to use automated testing techniques and thus increasing the demand for autoimmune disease diagnostics products.
  • Large patient pool: The Asia Pacific region's expanding opportunities are due to its enormous potential for development and large patient pool.

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Top Trends in Global Autoimmune Disease Diagnostics Market

Increasing focus on companion diagnostic tests is the key trend boosting the market growth and the increasing demand for diagnostic procedures. Companion diagnostics can be used to identify individuals or groups that might respond better to a therapeutic agent. A companion diagnostic test detects autoimmune disease and monitors the prognosis for patients who are undergoing treatment.

This test provides insight into the therapeutic effect of a treatment regimen on patients suffering from autoimmune diseases. Several companies are now focusing their efforts on companion diagnostics for autoimmune diseases, which is responsible for the amplification of revenue for autoimmune disease diagnostics market.

Over the forecast period, the demand for more accurate and precise diagnostic methods is expected to rise, as well as the rising prevalence of these procedures.

Market Growth

The global autoimmune disease diagnostics market growth is mainly due to the rising disease incidence, an increase in the demand for more accurate diagnostic procedures, increased adoption of rapid recognition technology, and favorable federal regulations. Moreover, the extensive investment on R&D activities, increasing geriatric population, various organizations raising the awareness about autoimmune diseases, and emerging economies offering better diagnostic procedures and treatment for autoimmune diseases are predicted to boost the market growth.

Regional Analysis

The autoimmune disease diagnostics market was dominated by North America, which acquired the most significant revenue share of 43%. Several factors are responsible for the dominant market share, including rising healthcare costs, increasing autoimmune disease burden, new product launches, and the presence of large number of key players in the region. A growing market awareness and positive government initiatives will result in a profitable market expansion. The adoption of automated technology and the establishment of technologically advanced diagnostic centers will provide ample growth opportunities in the years to come. The increased presence of key players and new products launches will fuel the growth of regional market statistics.

Asia Pacific is expected to be the fastest-growing market during the forecast period. Janssen Asia Pacific, a division of Johnson & Johnson Private Limited reported that autoimmune, inflammatory, and pulmonary disease such as rheumatoid arthritis and psoriasis were on the rise in Asia Pacific. The region already has the highest levels of chronic obstructive pulmonary disease (COPD), and the highest rate of systemic lupus erythematosus. This will lead to a greater demand for diagnostics in the coming years.

Competitive Landscape

The most prominent players in global market are focused on product launch, strategic partnerships and commercialization to grow their businesses. In order to create innovative products and increase revenue, industry players invest heavily in research. These strategies will likely be a major driver of the global market for autoimmune disease diagnostics.

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Scope of the Report

Report AttributeDetails
Market Value (2022)USD 5.3 Billion
Market Size (2032)USD 10.3 Billion
CAGR (from 2023 to 2032)7.1%
North America Revenue Share43%
Historic Period2016 to 2022
Base Year2022
Forecast Year2032

Market Drivers

The global market is expected to grow due to the rising prevalence of autoimmune diseases. Type 1 diabetes, rheumatoid arthritis, and psoriatic disorders, along with inflammatory bowel diseases, are just some of the many conditions that require autoimmune diagnosis. Type 1 diabetes is a chronic condition in which the immune system attacks insulin-producing cells of pancreas. High blood sugar can cause organ failure including damage to the kidneys, heart, and nerves. These diseases are becoming more common, with significant health consequences and co-morbidities that can increase the mortality rate. The market is likely to see an increase in the use of autoimmune disease diagnostics due to the growing patient population.

Additionally, the market is projected to expand due to the discovery of novel biomarkers that allow for a more accurate diagnosis. It is easier to diagnose autoimmune disorders using novel biomarkers. Multiple symptoms may be present in patients with autoimmune disorders. This makes it more difficult for doctors to diagnose. Laboratory personnel have discovered that the use and reproducibility of single biomarkers is not reliable or useful. Multiple biomarkers are needed to diagnose and evaluate the patient's condition, progress, and response to the treatment. Only a few people are affected by the disease and develop autoantibodies to a specific protein. Research institutes and companies are investing in extensive R&D activities to find biomarkers that can diagnose autoimmune diseases. Multiple biomarkers can be used to screen for autoimmune diseases, this has made diagnosis easier. This has had a significant impact on the global market for autoimmune diseases diagnostics. It is expected to continue to be an advantage for physicians diagnosing these conditions.

Market Restraints

Low equipment costs and competitive pricing are predicted to restrict the market growth of autoimmune disease diagnostics. Low-cost products from local manufacturers are fiercely competing in the market for autoimmune diagnostics. Market growth may be slowed if local manufacturers offer lower-priced products. Due to the continuous technological advances in the market for autoimmune disease diagnosis, manufacturers will be able to offer the best solutions at a low price. Because they must spend more capital to buy technologically advanced products or procedures, customers are reluctant to opt for expensive upgrades. There will be a lot more competition in the market for autoimmune diseases diagnostics, which could result in lower prices and slower growth rates.

Market Opportunities

Emerging economies are anticipated to offer numerous growth opportunities in global market for autoimmune disease diagnostics. Because of their high diagnostic rate, developed countries are more popular than those in developing countries. According to the hygiene hypothesis, children from developed countries are less likely than those from developing nations to be exposed to microbial hazards. This can cause altered immune homeostasis and other immune-mediated disorders. The hygiene hypothesis, based on epidemiological data and migration studies, states that subjects who move from low-incidence to high-incidence areas are more likely to develop immune disorders. Urbanization, obesity, lack of physical activity, stress, and other factors all have contributed to an increase in unhealthy lifestyles in emerging nations. These factors are contributing to the increase in autoimmune disease in developing countries.

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Report Segmentation of the Autoimmune Disease Diagnostics Market

Product Insight

In the global market for autoimmune disease diagnostics, the consumables & assay kits segment held the largest revenue share, with an expected increase in sales over the forecast period. This is due to an increase in autoimmune diseases and product approvals/launches.

Disease Type Insight

In 2022, systemic autoimmune diseases accounted for a substantial market share of 71%. It is expected to grow at 7.5% CAGR over the forecast period. This market share is due to the rapid rise in systemic autoimmune disease, which has been associated with an increasing number of deaths and morbidity. Patients with rheumatoid arthritis have their immune systems attack the synovial tissue in the joints, causing stiffness, redness, warmth, and soreness. This market will continue to grow because of the rising prevalence of systemic autoimmune diseases and advanced technology that can be used to treat them. Due to ongoing clinical research and R&D efforts, the market for autoimmune diseases diagnostics will likely grow in the years to come.

Test Type Insight

The largest revenue share was held by antinuclear antibody tests in 2022. The market is predicted to grow at 7.0% CAGR over the forecast period. This dominant market growth is due to the high prevalence of immune system disorders and chronic conditions like Addison’s disease, type 1 diabetes, myasthenia gravis, and rheumatoid arthritis. Antinuclear antibody tests detect antinuclear antibodies in the blood. Myasthenia gravis is an autoimmune disorder that can be genetically predisposed. According to the NCBI, myasthenia Gravis was present in approximately 20 Americans per 100,000 in 2021. The rising prevalence of genetic autoimmune disorders will likely increase the pace of development of autoimmune disease diagnostics.

By End-User Insight

The majority of market share was held by hospitals, which is 55% in 2022. The market is expected to grow significantly over the forecast period. This is due to hospitals adopting complex interventional surgery-related auto immune disease diagnostics. Modern technology labs in hospitals allow for effective physiotherapy sessions, better patient assistance and counselling, and other services that aids in expansion of the market and increase the demand. Due to increasing incidence of neurological conditions and chronic diseases, the market is anticipated to grow more. Segmental progress can be aided by highly qualified healthcare professionals and advanced facilities. This will result in overall market growth.

Market Segmentation

Based on Product

  • Consumables & Assay Kits
  • Instruments

Based on Disease Type

Based on the Test Type

  • Antinuclear Antibody Test
  • Autoantibody Tests​
  • Complete Blood Count (CBC)​
  • C-reactive Protein (CRP)​
  • Urinalysis​
  • Others Tests

Based on End-User

  • Hospitals
  • Diagnostics Centers
  • Other End-Users

By Geography

  • North America
    • The US
    • Canada
    • Mexico
  • Western Europe
    • Germany
    • France
    • The UK
    • Spain
    • Italy
    • Portugal
    • Ireland
    • Austria
    • Switzerland
    • Benelux
    • Nordic
    • Rest of Western Europe
  • Eastern Europe
    • Russia
    • Poland
    • The Czech Republic
    • Greece
    • Rest of Eastern Europe
  • APAC
    • China
    • Japan
    • South Korea
    • India
    • Australia & New Zealand
    • Indonesia
    • Malaysia
    • Philippines
    • Singapore
    • Thailand
    • Vietnam
    • Rest of APAC
  • Latin America
    • Brazil
    • Colombia
    • Chile
    • Argentina
    • Costa Rica
    • Rest of Latin America
  • Middle East & Africa
    • Algeria
    • Egypt
    • Israel
    • Kuwait
    • Nigeria
    • Saudi Arabia
    • South Africa
    • Turkey
    • United Arab Emirates
    • Rest of MEA

 Market Key Players:

  • Abbott
  • Trinity Biotech
  • BIOMÉRIEUX
  • Bio-Rad Laboratories, Inc.
  • Thermo Fisher Scientific Inc.
  • Hoffmann-La Roche Ltd
  • EUROIMMUN Medizinische Labordiagnostika AG
  • Siemens Healthcare GmbH
  • Danaher Corporation
  • Grifols, S.A.
  • Oncimmune
  • HYCOR Biomedical Corporation
  • Other Key Players

Recent Development of the Autoimmune Disease Diagnostics Market

  • In May 2022, Thermo Fisher Scientific announced that the Phadia2500+ instrument is now available in the United States. This allows for autoimmune testing. This instrument can be used for diagnosing autoimmune conditions such as celiac disease, rheumatoid arthritis, autoimmune liver disease and autoimmune thyroid disease. This strategic launch resulted in increased customer base, business revenue, and increased customer satisfaction.
  • In August 2022, KSL Beutner Laboratories launched a blood test to find an antigen possibly linked to the autoimmune blistering disorder mucous membrane pemphigoid. This condition can cause painful lesions to the oral cavity.

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