Autoimmune Disease Diagnostics Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, Canada, UK, Germany, Japan - Size and Forecast 2024-2028

Autoimmune Disease Diagnostics Market 2024-2028

The global autoimmune disease diagnostics market size is estimated to grow by USD 2.99 billion at a CAGR of 9.59% between 2023 and 2028. 

The increasing number of consolidations within the market allows technology exchange, leading to the development of robust immunoassay systems. The autoimmune disease diagnostics market has been witnessing a number of industrial consolidations. The major emphasis for such consolidations can be partly attributed to the manufacturers' intention to expand their portfolio and to incorporate and integrate technology with existing platforms and assays. As a part of such consolidations, manufacturers engage in technology sharing that has led to the introduction of many successful, robust automated immunoassay platforms, which are becoming a trend for manufacturers to attract a wide customer base. Therefore, the increase in the M&A is driving the growth of the global autoimmune disease diagnostics market during the forecast period.

Technavio has segmented the market into  Type, Product and Geography 

• The type segment is classified into localized autoimmune disease diagnostics and systemic autoimmune disease diagnostics
• The product segment is classified into assay kits and analyzer
• The geography segment includes key regions such as North America, Europe, Asia, and Rest of World (ROW)

It also includes an in-depth analysis of drivers, trends, and challenges. Our report examines historic data from 2018 - 2022, besides analyzing the current market scenario.

What will be the size of the Autoimmune Disease Diagnostics Market During the Forecast Period?

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Autoimmune Disease Diagnostics Market Segmentation by Type, Product and Geography Analysis

Type Analysis 

Localized autoimmune disease diagnostics

The market share growth by the localized autoimmune disease diagnostics segment will be significant during the forecast period. The growing incidence of localized autoimmune diseases such as type 1 diabetes, autoimmune thyroiditis, celiac disease, Inflammatory Bowel Diseases(IBD), and primary biliary cirrhosis is expected to propel the market growth. 

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The localized autoimmune disease diagnostics segment was the largest and was valued at USD 2.14 billion in 2018.  Localized autoimmune response against a particular organ leads to organ-specific autoimmune disorders. The auto-antibodies act against their own organs by binding with self-antigens to suppress organ function or cause overstimulation of cells. Further, the growing demand for home care test kits is expected to fuel the growth of the localized autoimmune disease diagnostics market. For example, IBDoc, made by BUHLMANN, helps measure faecal inflammation marker calprotectin at home. This represents continuous advancements in personalized medicine. With such home care test kits, individuals can self-test IBDs such as Crohn's disease and ulcerative colitis. This will drive the adoption rates of localized autoimmune diagnostic tests as it expands the scope into new applications (home care). In addition, collaboration activities between pharmaceutical companies and diagnostic companies are expected to bring novel diagnostic tests into the market.

Product Analysis 

Assay kits

Assay kits are generally used in life science research, environmental monitoring, and drug discovery and development applications. These kits provide reagents that are required to perform analytical tests for the measurement of specific analytes used for different applications in analytical laboratories, biotechnology, and medical research. The increasing adoption of assay kits for autoimmune disease diagnostics drives the demand in the assay kits segment. Factors like the growing need for diagnostics testing for various autoimmune diseases, such as diabetes and others and the increasing demand for point-of-care (PoC) testing will propel the growth of the assay kits segment. Therefore, the assay kits segment of the global autoimmune disease diagnostics market is expected to grow during the forecast period.

Analyzer

An analyzer is a medical laboratory instrument that is designed to measure different chemicals and other analytes in different biological samples with minimal human assistance without taking too much time. Clinical chemistry analyzers run assays on various clinical samples, including blood, serum, plasma, urine, and cerebrospinal fluid, in order to detect the presence of analytes that are associated with specific diseases or drugs. These analyzers add great value in evaluating patients with suspected autoimmune diseases. The results from the analyzer help in confirming a diagnosis of autoimmune disorder, besides estimating disease severity and aiding in assessing the prognosis. Therefore, the increasing prevalence of autoimmune diseases across the world will propel the growth of the analyzer segment of the global autoimmune disease diagnostics market during the forecast period. 

Regional Analysis

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North America is estimated to contribute 42% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period.  The growing incidence of autoimmune disorders, such as RA, SLE, and IBD, is expected to fuel the market growth in the Americas. For instance, according to the American Autoimmune Related Diseases Association (AARDA), autoimmune disease affects more than 50 million US people annually. It is one of the top ten reasons for death in women of age less than 65 years and is the second-leading cause of chronic illness in the US. Also, an autoimmune disease in the US is a poorly understood category of disease comparable to heart disease and cancer. Therefore, researchers are continuously focusing on the development of novel diagnostic products to improve patient outcomes. Such initiatives will lead to an improved understanding of the disease, wherein medications can be administered based on individual needs. This represents a huge step toward the advancement of precision medicine.

In addition, factors such as the increasing prevalence of autoimmune diseases and the prevalence of rheumatoid arthritis among the rising ageing population in the US are attributed to the increasing market size of North America. For instance, according to the CDC, in the US, 24% of all adults, or 58.5 million people, had arthritis in 2021. Therefore, such factors will propel the growth of the autoimmune disease diagnostics market in the region during the forecast period.

COVID Recovery Analysis

The outbreak of the COVID-19 pandemic in 2020 severely impacted the growth of the autoimmune disease diagnostics market in North America. However, with the help of widespread COVID-19 vaccination programs, the number of COVID-19 cases declined to some extent by the first half of 2021, which stabilized the growth of the regional market in focus following the restoration of supply chain activities. Moreover, the rescheduling of patient visits to clinics and hospitals and the increased adoption of autoimmune disease diagnostics are expected to boost the growth of the regional autoimmune disease diagnostics market during the forecast period. 

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Key Autoimmune Disease Diagnostics Market Players 

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:

Bio Rad Laboratories Inc. - The company offers autoimmune diagnostics solutions such as BioPlex 2200 Autoimmune Panels.

• Autoimmune Technologies LLC
• bioMerieux SA
• Danaher Corp.
• DiaSorin SpA
• Exagen Inc.
• F. Hoffmann La Roche Ltd.
• Gold Standard Diagnostics Corp.
• Grifols SA
• Hemagen Diagnostics Inc.
• HUMAN Gesellschaft fur Biochemica und Diagnostica mbH
• Immco Diagnostics Inc.,
• Laboratory Corp. of America Holdings
• PerkinElmer Inc.
• Quest Diagnostics Inc
• R Biopharm AG
• Siemens AG
• Svar Life Science AB
• Thermo Fisher Scientific Inc.
• Werfenlife SA

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Autoimmune Disease Diagnostics Market: Key Drivers, Trends, Challenges, and Customer Landscape

There are multiple factors influencing market growth. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. 

Key Autoimmune Disease Diagnostics Market Drivers

Advancements in laboratory automation platforms are notably driving market growth.  The incidence of autoimmune diseases is rising worldwide, which is increasing the volume of samples being collected for analysis. This has led to the demand for automation in autoimmune disease diagnostics for rapid analysis and interpretation of results. Automation involves a series of integrated steps that include pre-analytical and post-analytical stages to help minimize the need for manual intervention and thus avoid errors. Most central laboratories resort to the use of automation as they conduct large-scale analyses of samples. Companies are offering automated systems to central and medium-sized laboratories for sample analysis.

However, decentralized testing for autoimmune disease diagnosis is gaining popularity among medical facilities. This procedure reduces the time required for sending the sample for analysis from the central laboratories. However, the limited understanding of autoimmune diseases and the need for confirmatory results for effective therapy are resulting in the need for centralized testing of samples for disease diagnosis. Therefore, such factors drive the growth of the global autoimmune disease diagnostics market during the forecast period.

Significant Autoimmune Disease Diagnostics Market Trends

Focus on companion diagnostic tests is an emerging trend shaping the market growth. Companion diagnostics allow the screening of individuals or groups who are likely to respond better to a therapeutic agent. The advances in companion diagnostic test for an autoimmune disease involves the use of a diagnostic test and monitoring of disease prognosis in individuals undergoing therapy.

In addition, the test offers insights into the therapeutic regimen's positive impact on these people by reducing the intensity of autoimmune diseases. Therefore, the growing focus on companion diagnostic tests will drive the growth of the global autoimmune disease diagnostics market during the forecast period.

Major Autoimmune Disease Diagnostics Market Challenges

Significant concerns over the lack of standardization in the quality of immunoassay kits is a significant challenge hindering the market growth. Accuracy and consistency are the major factors that influence the quality of diagnostic tests. From a laboratory technician's perspective, there are marked variations in the quality of results obtained from many commercialized immunoassay kits. This is evident primarily in the diagnosis of systemic vasculitis using ANCA testing. For instance, granulomatosis with polyangiitis can be life-threatening when the disease is not diagnosed quickly and accurately.

However, there is a large range of varied performance characteristics for immunoassay tests across various laboratories in the world, particularly in Europe. Such inconsistencies pose a serious challenge to diagnosis and treatment and will affect the brand equity of the manufacturers. Therefore, such factors will adversely impact the growth of the global autoimmune disease diagnostics market during the forecast period.

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Key Autoimmune Disease Diagnostics Market Customer Landscape

The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

Global Autoimmune Disease Diagnostics Market Customer Landscape

Segment Overview

The autoimmune disease diagnostics market report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2018 to 2028. 

• Type Outlook
  • Localized autoimmune disease diagnostics
  • Systemic autoimmune disease diagnostics

• Product Outlook
  • Assay kits
  • Analyzer
• Region Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest Of World
    • Brazil
    • Australia
    • Argentina 

Autoimmune Disease Diagnostics Market Scope
Report Coverage	Details
Page number	162
Base year	2023
Historic period	2018-2022
Forecast period	2024-2028
Growth momentum & CAGR	Accelerate at a CAGR of 9.59%
Market Growth 2024-2028	USD 2.99 billion
Market structure	Fragmented
YoY growth 2023-2024(%)	8.85
Regional analysis	North America, Europe, Asia, and Rest of World (ROW)
Performing market contribution	North America at 42%
Key countries	US, Canada, UK, Germany, and Japan
Competitive landscape	Leading Vendors, Market Positioning of Vendors, Competitive Strategies, and Industry Risks
Key companies profiled	Autoimmune Technologies LLC, Bio Rad Laboratories Inc., bioMerieux SA, Danaher Corp., DiaSorin SpA, Exagen Inc., F. Hoffmann La Roche Ltd., Gold Standard Diagnostics Corp., Grifols SA, Hemagen Diagnostics Inc., HUMAN Gesellschaft fur Biochemica und Diagnostica mbH, Immco Diagnostics Inc., Laboratory Corp. of America Holdings, PerkinElmer Inc., Quest Diagnostics Inc., R Biopharm AG, Siemens AG, Svar Life Science AB, Thermo Fisher Scientific Inc., and Werfenlife SA
Market dynamics	Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the forecast period
Customization purview	If our report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Autoimmune Disease Diagnostics Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the growth of the autoimmune disease diagnostics market between 2024 and 2028
• Precise estimation of the autoimmune disease diagnostics market size and its contribution of the market in focus to the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria 
• Companies landscape comparing criticality of inputs and factors of differentiation
• Exclusive Matrix on companies position and classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• A thorough analysis of the market’s competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of autoimmune disease diagnostics market companies

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