Global Autoimmune Disease Diagnostics Market By Product (Consumables & Assay Kits ), By Disease Type (Systemic Autoimmune Disease and Localized Autoimmune Disease), By Test Type, By End-User, By Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends, and Forecast 2024-2032

Report Overview

Global Autoimmune Disease Diagnostics Market size is expected to be worth around USD 10.3 Billion by 2032 from USD 5.7 Billion in 2023, growing at a CAGR of 7.1% during the forecast period from 2024 to 2032.

The global market’s growth is driven by the rising incidence of autoimmune diseases and the adoption of automation for equipment. Autoimmune diseases can develop when the immune system attacks itself due to abnormalities. The immune system malfunctions when it fails to recognize immune cells, tissues, and organs or produces autoantibodies that target these cells.

Organizations have launched a variety of initiatives to raise awareness about autoimmune diseases. They also aim to increase the global usage of autoimmune disease diagnostics. The market for autoimmune disease diagnostics is growing due to technological advances in diagnostics and improved laboratory automation.

Key Takeaways

• Market Size: Autoimmune Disease Diagnostics Market size is expected to be worth around USD 10.3 Billion by 2032 from USD 5.7 Billion in 2023
• Market Growth: The market growing at a CAGR of 7.1% during the forecast period from 2024 to 2032.
• Product Analysis: Consumables & assay kits segment dominate Autoimmune Disease Diagnostics Market in 2022.
• Disease Type Analysis: The systemic autoimmune disease segment accounted for a substantial market share of 71% in 2022.
• End-Use Analysis: Hospitals accounted for the majority of the market share, which is 55% in 2022.
• Regional Analysis: North America dominated the Autoimmune Disease Diagnostics Market By 43% in 2022.
• Technological Advancements: Advances in diagnostic technologies, such as the development of novel biomarkers and advanced imaging techniques, are enhancing the accuracy and efficiency of autoimmune disease diagnostics. These innovations are crucial in early disease detection and personalized treatment approaches.
• Rising Healthcare Expenditure: Increasing healthcare expenditure in developed and developing regions is supporting the growth of the market. Governments and private organizations are investing heavily in healthcare infrastructure, leading to improved diagnostic facilities and accessibility.
• Challenges: Despite the growth, the market faces challenges such as high costs associated with advanced diagnostic tests and the lack of standardized procedures. Addressing these issues is crucial for the sustained growth of the autoimmune disease diagnostics market.

Product Analysis

In 2022, the consumables & assay kits segment dominated the global market

Based on product, the global autoimmune disease diagnostics market is segmented into consumables  & assay kits and instruments. Among these products, the consumables & assay kits segment held the largest revenue share in 2022 and is expected to grow more during the forecast period. This can be attributed to an increased incidence of autoimmune diseases and increased product approvals/launches.

Disease Type Analysis

Systemic autoimmune disease accounted for holding a significant market share

Based on disease type, the market for autoimmune disease diagnostics is divided into systemic and localized autoimmune diseases. Systemic autoimmune disease is further subdivided into rheumatoid arthritis, psoriasis, systemic lupus erythematosus (SLE), multiple sclerosis, and other systemic autoimmune diseases. On the other hand, localized autoimmune disease is further subdivided into inflammatory bowel disease, type 1 diabetes, thyroid, and other localized autoimmune diseases.

The systemic autoimmune disease segment accounted for a substantial market share of 71% in 2022 and is expected to register over 7.5% CAGR during the forecast period. This significant market share concerns the rapid increase of systemic autoimmune diseases associated with increased morbidity and mortality. Among patients who have rheumatoid arthritis, the immune systems of these patients attack the synovial tissues in joints leading to redness, warmth, soreness, and stiffness in the joints.

The market will grow due to the rising prevalence of systemic autoimmune diseases and advanced automation technology that can be used to treat them. The market for autoimmune disease diagnostics will continue to grow due to the continued clinical studies and R&D efforts to evaluate and promote efficacy.

By Test Type

In 2022, the antinuclear antibodies segment dominated the market with the largest revenue share

Based on test type, the global autoimmune diagnostics market is classified into antinuclear antibody test, autoantibody test, complete blood count (CBC)​, C-reactive protein (CRP)​, urinalysis​, and other tests. Antinuclear antibody tests held the largest revenue share in 2022. It is expected to grow at 7.0% CAGR during the forecast period. Significant contributors to this dominant market growth are the high prevalence of immune system diseases and chronic conditions such as Addison’s disease, type 1 diabetes, rheumatoid arthritis, and myasthenia gravis.

Antinuclear antibody testing detects antinuclear antibodies within the blood. Myasthenia Gravis is an autoimmune disease that can be genetically predisposed. The NCBI reports that myasthenia gravis prevalence in the United States was approximately 20 per 100,000 people in 2021. This rate is growing at an increasing pace, according to NCBI. The high prevalence of genetic autoimmune diseases will likely accelerate the development of autoimmune disease diagnostics.

By End-User

The hospital’s segment held the maximum market share of 55% in 2022

Based on end-user, the autoimmune disease diagnostics market is divided into Hospitals, Diagnostics Centers, and Other End-Users. Hospitals accounted for the majority of the market share, which is 55% in 2022. This segment is expected to continue the market growth over the analysis period. This is due to the increased adoption of complex interventional surgery-related autoimmune disease diagnostics in hospitals.

Hospitals have sophisticated technology labs that provide practical physiotherapy sessions, better patient aid and counseling, and other services that help expand the market and increase demand. In addition, the market will expand due to the rising incidence of many chronic diseases and neurological conditions that can lead to autoimmune diseases. Segmental progress is aided by the availability of highly qualified medical and healthcare professionals and advanced facilities. This will lead to overall growth of the market.

Key Market Segments

Based on Product

• Consumables & Assay Kits
• Instruments

Based on Disease Type

• Systemic Autoimmune Disease
  • Rheumatoid Arthritis
  • Psoriasis
  • Systemic Lupus Erythematosus (SLE)
  • Multiple Sclerosis
  • Other Systemic Autoimmune Diseases
• Localized Autoimmune Disease
  • Inflammatory Bowel Disease
  • Type 1 Diabetes
  • Thyroid
  • Other Localized Autoimmune Diseases 

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

Drivers

Rising prevalence of autoimmune diseases

The market is expected to grow due to an increase in autoimmune diseases. Type 1 diabetes, rheumatoid arthritis, psoriatic diseases, and inflammatory bowel disease are just a few of the many conditions that need autoimmune diagnosis and treatment. For example, type 1 diabetes is a chronic condition when the immune system attacks the pancreas’s insulin-producing cells. As a result, high blood sugar levels can lead to organ failure, including the heart, kidneys, and nerves.

The rising prevalence of these diseases has significant health implications and co-morbidities, which can lead to substantial mortality. With the increasing patient population, the market is expected to see a significant increase in the use of autoimmune disease diagnostics.

Discovery of novel biomarkers that allow for a more accurate diagnosis

Novel biomarkers have made it easier to diagnose autoimmune diseases. Multiple symptoms can occur in people with autoimmune disorders, making diagnosing difficult for doctors. Laboratory personnel has found that using single conventional biomarkers has limited utility and reproducibility. There is a greater demand for multiple biomarkers to help diagnose and assess the patient’s condition, disease type, progression, and response to treatment for autoimmune diseases.

The development of autoantibodies against a particular protein is only seen in a few individuals with the disease. Vendors and research institutes are pursuing extensive R&D and posting promising results with multiple biomarkers to diagnose autoimmune diseases. It is possible to screen individuals with multiple biomarkers associated with autoimmune diseases. This has helped improve the diagnosis. It has also significantly influenced the global market for autoimmune disease diagnostics and will continue to be an advantage to physicians in diagnosing such conditions.

Restraints

Low equipment costs and competitive pricing restrict the market growth

Local manufacturers offering low-cost products fiercely compete in the autoimmune disease diagnostics market. As a result, the market growth could be slowed by increased competition from local manufacturers offering low prices. Manufacturers are expected to offer the most up-to-date solutions due to continuous technological advancements in the autoimmune disease diagnosis market.

Customers hesitate to choose expensive upgrade procedures because they have to spend more capital to purchase technologically advanced products and procedures. As a result, the market for autoimmune disease diagnostics will see much competition, which could lead to lower prices and a slower growth rate.

Opportunity

Emerging economies offer numerous growth opportunities in the market

Due to their high diagnosis rate, developed countries have a higher market penetration than developing countries. Therefore, the hygiene hypothesis states that children in developed countries are less likely to be exposed to microbial threats than children from developing nations. This results in altered immune homeostasis, leading to several immune-mediated disorders.

Based on epidemiological data, especially migration studies, the hygiene hypothesis states that immune disorders are common in subjects who migrate from low-incidence areas to high-incidence ones. In addition, in developing countries, unhealthy lifestyles have increased due to urbanization, obesity, lack of physical activity, stress, and other factors. These factors contribute to the rise in autoimmune diseases in developing countries.

Trends

Increasing focus on companion diagnostic tests

Companion diagnostics screen individuals and groups that may respond better to a therapeutic agent. A companion diagnostic test is a test that detects autoimmune diseases and monitors the prognosis of patients undergoing treatment.

This test provides insight into the therapeutic regimen’s positive effect on patients with autoimmune diseases. Numerous vendors are now focusing on companion diagnostic tests for autoimmune disorders, which is subjected to the growth of the autoimmune disease diagnostic market.

Regional Analysis

North America dominated the market with the largest market share of 43% in 2022

Based on regions, the market for autoimmune disease diagnostics includes North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The dominant market share can be attributed to several factors, including the increasing autoimmune disease burden, rising healthcare expenditure, product launches, and the presence of prominent players throughout the country.

The growing awareness and positive government initiatives will lead to profitable market growth. In addition, there will be ample opportunities for growth due to the adoption of automation technology and technologically advanced diagnostic centers. The growth of the region’s market statistics is expected to be fueled by the presence of prominent players and the launch of new products.

Asia Pacific is predicted as the fastest-growing market over the forecast period

Janssen Asia Pacific, a Johnson & Johnson Private Limit division, reported that autoimmune, inflammatory, and pulmonary diseases such as rheumatoid arthritis and psoriasis were increasing in Asia Pacific. Already, the region has the highest level of chronic obstructive lung disease (COPD) and the highest incidence of systemic lupus erythematosus. This will increase the demand for diagnostics over the next few years.

Key Regions

• 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

Key Players Analysis

Most prominent players focus on strategic partnerships, product launches, and commercialization to expand their businesses. These strategies will likely fuel the growth in the global market for autoimmune disease diagnostics.

Below are some of the most prominent autoimmune disease diagnostics market players.

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 Developments

• Acquisition (February 2023): Abbott acquired Rejuvenix Technologies, specializing in advanced autoimmune disease diagnostics. This acquisition enhances Abbott’s diagnostic portfolio and strengthens its market position in autoimmune disease detection, as reported in the company’s press release.
• Trinity Biotech (March 2023): Trinity Biotech launched a new diagnostic assay, the Autoimmune Panel Plus. This product offers enhanced accuracy and speed in detecting various autoimmune diseases, significantly improving diagnostic workflows in clinical laboratories.
• BIOMÉRIEUX (April 2023): BIOMÉRIEUX merged with AutoImmunTech to expand its autoimmune disease diagnostics capabilities. This merger aims to integrate AutoImmunTech’s innovative technologies into BIOMÉRIEUX’s existing diagnostic solutions, enhancing overall efficiency and accuracy.
• Bio-Rad Laboratories, Inc.(January 2023): Bio-Rad Laboratories acquired AutoDx Solutions, a company known for its cutting-edge autoimmune diagnostic products. This acquisition aims to bolster Bio-Rad’s market presence and diversify its diagnostic offerings in the autoimmune sector.
• Thermo Fisher Scientific Inc.(May 2023): Thermo Fisher Scientific introduced the Autoimmune Assay Kit, designed to provide rapid and accurate results for autoimmune disease detection. This new product is expected to improve diagnostic capabilities and patient management.
• Hoffmann-La Roche Ltd (June 2023): Hoffmann-La Roche acquired ImmunoDiagnostics, a leader in autoimmune disease diagnostics. This acquisition is set to enhance Roche’s diagnostic portfolio and strengthen its position in the autoimmune diagnostics market, providing more comprehensive testing solutions.

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