healthcare-thumbnail.png

Rare Autoimmune Diseases Diagnostics Market Research Report - Segmentation by Disease Type (Eosinophilic granulomatosis with polyangiitis (EGPA), Guillain-Barre syndrome, Kawasaki disease, Mixed connective tissue disease (MCTD), Myasthenia gravis, Others); Test Type (Antinuclear antibody (ANA) tests, Autoantibody tests, Complete blood count (CBC); Comprehensive metabolic panel, C-reactive protein (CRP); Erythrocyte sedimentation rate (ESR), Urinalysis); End User (Academic & Research Institutes, Diagnostic Centers, Hospitals & Clinical Laboratories, Others); and Region - Size, Share, Growth Analysis | Forecast (2023 – 2030)

Rare Autoimmune Diseases Diagnostics Market Size (2023-2030)

Global Rare Autoimmune Diseases Diagnostics Market is estimated to be worth USD 1.21 Billion in 2022 and is projected to reach a value of USD 2.39 Billion by 2030, growing at a CAGR of 8.9% during the forecast period 2023-2030.

rare autoimmune diseases diagnostics market

Autoimmune illnesses happen when the body's immune system tragically misguides its defense and erroneously attacks vital cells, which culminates in an extensive array of health maladies, encompassing rheumatoid arthritis, Crohn's disease, and thyroid disorders. Generally, the immune system guards the body by identifying and targeting foreign cells. However, in autoimmune illnesses, the immune system falters in its ability to discern between foreign and self-cells, giving rise to the creation of autoantibodies that attack vital cells in organs like joints and skin. These diseases can affect specific organs or the entire body, with examples like type 1 diabetes damaging the pancreas and lupus impacting multiple body systems. 

While the exact cause of autoimmune diseases remains elusive, factors like gender, familial lineage, environmental encounters, ethnic background, dietary choices, and concurrent medical conditions can significantly contribute to their emergence and progression. Symptoms vary but may include extreme exhaustion, elevated body temperature, intense muscular discomfort, swelling, impaired cognitive focus, sensory numbness, substantial alopecia, and notable dermatological eruptions. Certain autoimmune diseases exhibit periods of symptom flare-ups and remission, and each ailment presents distinct and individual symptoms depending on the specific bodily systems that are affected.

Global Rare Autoimmune Diseases Diagnostics Market Drivers:

The increasing government and non-profit organizations’ initiatives regarding rare autoimmune diseases are fueling the growth of the global rare autoimmune diseases diagnostics market.

The rare autoimmune disease diagnostics market is anticipated to experience significant growth owing to the efforts of various government and non-profit organizations in distinct regions. These organizations are actively involved in amplifying awareness regarding rare autoimmune diseases. One notable example is the American Autoimmune Related Diseases Association (AARDA), which is dedicated to educating the populace regarding the risk factors, incidence rates, and paucity of awareness surrounding uncommon autoimmune diseases, along with accessible treatment alternatives. By means of their powerful campaigns and initiatives, the AARDA and similar organizations are spreading invaluable information that impels individuals to exhibit unparalleled proactivity in taking care of their health and recognizing the symptoms of autoimmune diseases. These awareness-building activities play a vital role in propelling the growth of the rare autoimmune disease diagnostics market, as they empower people to seek timely diagnosis and treatment.

The growing demand for novel and effective diagnostic techniques is another factor contributing to the growth of the global rare autoimmune diseases diagnostics market.

The rising incidence of uncommon autoimmune disorders among the populace has surged the demand for the development of novel and efficacious diagnostic techniques. This need stems from the necessity to accurately and efficiently diagnose rare autoimmune diseases to facilitate timely treatment and containment measures. As a result, the demand for diagnostic testing services pertaining to rare autoimmune diseases has witnessed a significant surge, fueling the growth of the market. The development of novel diagnostic techniques that can offer enhanced accuracy, sensitivity, and rapid results becomes crucial in addressing the rising population diagnosed with rare autoimmune diseases. Consequently, this increasing need for novel and useful diagnostic techniques acts as a market driver, propelling the growth of the global rare autoimmune diseases diagnostics market during the forecast period.

Rare Autoimmune Diseases Diagnostics

Global Rare Autoimmune Diseases Diagnostics Market Challenges:

The global rare autoimmune diseases diagnostics market is encountering challenges, primarily in terms of the existence of strict regulations. The development of novel rapid diagnostic testing kits has been hindered by stringent regulatory norms, particularly in the United States where diagnostic products undergo a rigorous clearance process by the FDA. These regulatory barriers limit the introduction of novel diagnostic testing products, thus posing a significant constraint on the market's potential for revenue expansion. Moreover, limitations imposed on certain testing kits by regulatory bodies can impede the progress and introduction of advanced and novel diagnostic testing products. These challenges pertaining to regulatory policies and restrictions posit obstacles to the overall revenue growth of the market.

Global Rare Autoimmune Diseases Diagnostics Market Opportunities:

Market expansion strategies present lucrative opportunities in the global rare autoimmune diseases diagnostics market. The prominent players in the global rare autoimmune diseases diagnostics market possess tremendous growth potential in emerging economies including India, South Korea, Brazil, and Mexico. These countries provide opportunities owing to their high disease rates, large populations in need of healthcare, improving medical facilities, rising disposable incomes, and a growing trend of medical tourism. Furthermore, the region of Asia-Pacific, including these countries, is becoming an attractive destination for business owing to its adaptable environment and fewer strict regulations and data requirements. This combination of factors makes these economies exceedingly promising markets for enterprises operating in the diagnostics sector.

COVID-19 Impact on the Global Rare Autoimmune Diseases Diagnostics Market:

The outbreak of the COVID-19 pandemic substantially impacted the global rare autoimmune diseases diagnostics market. The pandemic caused disruptions in supply chains and distribution of goods and services, which highly affected the supply of essential materials like reagents and testing equipment for diagnostic testing for rare autoimmune diseases. Moreover, the shifted focus of healthcare infrastructure resources and personnel to COVID-19 testing and treatment further declined the demand for rare autoimmune diseases diagnostic testing. These factors negatively impacted the growth of the global rare autoimmune diseases diagnostics market. Despite these challenges, the global rare autoimmune diseases diagnostics market is projected to recover and grow in the coming years.

Global Rare Autoimmune Diseases Diagnostics Market Recent Developments:

  • In September 2022, Avesthagen Limited launched AVGEN Diagnostics, an all-inclusive personalized genetic testing service using NGS sequencing and AI-driven analytics. Catering to both individual consumers and corporate entities, it forms partnerships with healthcare providers and insurers, forging alliances to serve a wide range of clientele. The extensive portfolio encompasses diverse realms such as cancer, cardiac care, neurodegenerative disorders, autoimmune conditions, rare diseases, pharmacogenomics, ancestry analysis, and women's health. Powered by Congenica's AI platform, AVGEN enables precise medical interventions through cutting-edge analytics for enhanced precision medicine.
  • In July 2022, KSL Beutner Laboratories, a widely acclaimed international provider of immunologic testing for diverse skin disorders, unveiled a pioneering indirect immunofluorescence (IIF) serum blood test in the United States. This test specifically detects the presence of laminin 332, an antigen intricately linked to the persistent and incapacitating autoimmune condition known as mucous membrane pemphigoid (MMP). This milestone represents a remarkable leap forward in diagnostic capabilities for the precise identification of MMP.
  • In June 2022, Thermo Fisher Scientific, Inc. unveiled that the company has received clearance from the FDA for two blood tests, namely EliA RNA Polymerase III and EliA Rib-P, which are ingeniously designed to accurately pinpoint and diagnose 2 specific autoimmune disorders, systemic sclerosis (SSc) and systemic lupus erythematosus (SLE). The approval of these tests enhances the EliA portfolio, providing a comprehensive range of automated connective tissue disease tests. This expansion allows for a stronger clinical offering, catering to a wider range of diagnostic needs in the field of connective tissue diseases.

RARE AUTOIMMUNE DISEASES DIAGNOSTICS MARKET REPORT COVERAGE:

REPORT METRIC

DETAILS

Market Size Available

2022 - 2030

Base Year

2022

Forecast Period

2023 - 2030

CAGR

8.9%

Segments Covered

By Disease Type, Test Type, End User, and Region

Various Analyses Covered

Global, Regional & Country Level Analysis, Segment-Level Analysis, DROC, PESTLE Analysis, Porter’s Five Forces Analysis, Competitive Landscape, Analyst Overview on Investment Opportunities

Regional Scope

North America, Europe, APAC, Latin America, Middle East & Africa

Key Companies Profiled

Thermo Fisher Scientific Inc. (United States), Danaher Corporation (United States), Abbott Laboratories (United States), F. Hoffmann-La Roche AG (Switzerland), Siemens Healthineers (Germany), bioMérieux SA (France), Bio-Rad Laboratories, Inc. (United States), Trinity Biotech plc (Ireland), Seramun Diagnostica GmbH (Germany), Quest Diagnostics (United States)

Global Rare Autoimmune Diseases Diagnostics Market Segmentation:

Global Rare Autoimmune Diseases Diagnostics Market Segmentation: By Disease Type

  • Eosinophilic granulomatosis with polyangiitis (EGPA)
  • Guillain-Barre syndrome
  • Kawasaki disease
  • Mixed connective tissue disease (MCTD)
  • Myasthenia gravis
  • Others

In 2022, the eosinophilic granulomatosis with polyangiitis (EGPA) segment held the highest market share. The growth can be ascribed to the higher prevalence of EGPA disease in contrast to other rare autoimmune diseases. This autoimmune illness, formerly referred to as Churg Strauss syndrome, is marked by amplified levels of a certain type of white blood cells called eosinophils. This elevation frequently initiates inflammation within the blood vessels, potentially leading to detrimental effects on numerous organs encompassing the lungs, kidneys, heart, and other bodily systems. Generally, individuals with this condition initially experience symptoms related to asthma and allergies.

Global Rare Autoimmune Diseases Diagnostics Market Segmentation: By Test Type

  • Antinuclear antibody (ANA) tests
  • Autoantibody tests
  • Complete blood count (CBC) 
  • Comprehensive metabolic panel
  • C-reactive protein (CRP)
  • Erythrocyte sedimentation rate (ESR)
  • Urinalysis

In 2022, the antinuclear antibody (ANA) tests segment held the highest market share. The growth can be ascribed to the rising incidence of rare autoimmune diseases and the presence of favorable medical insurance and reimbursement policies. Guillain-Barré Syndrome (GBS), an exceedingly uncommon and exceedingly swift-developing disorder distinguished by nerve inflammation, resulting in muscular debility and, in severe instances, total immobilization, afflicts approximately 1 to 2 individuals per 100,000 people each year, as per the data provided by the Rare Disease Organization. Antinuclear antibody tests, encompassing immunofluorescence assay and Enzyme-Linked Immunosorbent Assay (ELISA), are extensively employed to attain remarkably precise diagnostic outcomes. Furthermore, the introduction of novel diagnostic testing equipment is significantly augmenting the revenue expansion of this segment.

Global Rare Autoimmune Diseases Diagnostics Market Segmentation: By End User

  • Academic & Research Institutions
  • Diagnostic Centers
  • Hospitals & Clinical Laboratories
  • Others

In 2022, the hospitals and clinical laboratories segment held the highest market share. The growth can be ascribed to the elevated patient footfall in these healthcare settings. Hospitals and clinical laboratories provide comprehensive healthcare amenities, incorporating specialized laboratory infrastructures and experienced healthcare professionals to guarantee prompt and proficient diagnostic examinations. In hospitals, there exist intensive care units (ICUs) and emergency departments, which stand readily prepared for urgent intervention and care of individuals diagnosed with rare autoimmune diseases. Individuals diagnosed with rare autoimmune diseases often necessitate hospital admittance, and hospitals provide a suitable environment for continuous monitoring and intervention. Access to resources, including advanced diagnostic equipment and seasoned professionals, further empowers hospitals and clinical laboratories to execute diverse diagnostic examinations with utmost efficiency.

Global Rare Autoimmune Diseases Diagnostics Market Segmentation: By Region

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East & Africa

The region of North America held the largest share of the global rare autoimmune diseases diagnostics market in the year 2022. The rising incidence of uncommon autoimmune illnesses, including Eosinophilic granulomatosis with polyangiitis (EGPA), Kawasaki disease, POEMS syndrome, Scleroderma, and Retroperitoneal fibrosis, the presence of well-established healthcare infrastructure in nations, such as the United States and Canada, rapid advancements in clinical diagnostics, and the introduction of novel technologies that aid in the accurate and efficient detection of rare autoimmune diseases are some of the factors propelling the region's growth. Furthermore, the region of North America houses a multitude of renowned market giants, encompassing Thermo Fisher Scientific Inc., Danaher Corporation, Abbott Laboratories, Bio-Rad Laboratories, Inc., and Quest Diagnostics, among others.

The region of Asia-Pacific is anticipated to expand at the quickest rate over the forecast period owing to the ascending development of the medical diagnostics industry in nations, such as China, India, and Japan, and the growing awareness and emphasis on preventive healthcare, such as rare autoimmune diseases screening and treatment.

Global Rare Autoimmune Diseases Diagnostics Market Key Players:

  1. Thermo Fisher Scientific Inc. (United States)
  2. Danaher Corporation (United States)
  3. Abbott Laboratories (United States)
  4. F. Hoffmann-La Roche AG (Switzerland)
  5. Siemens Healthineers (Germany)
  6. bioMérieux SA (France)
  7. Bio-Rad Laboratories, Inc. (United States)
  8. Trinity Biotech plc (Ireland)
  9. Seramun Diagnostica GmbH (Germany)
  10. Quest Diagnostics (United States)

 

Chapter 1. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET – Scope & Methodology

1.1. Market Segmentation

1.2. Assumptions

1.3. Research Methodology

1.4. Primary Sources

1.5. Secondary Sources

Chapter 2. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET – Executive Summary

2.1. Market Size & Forecast – (2023 – 2030) ($M/$Bn)

2.2. Key Trends & Insights

2.3. COVID-19 Impact Analysis

      2.3.1. Impact during 2023 – 2030

      2.3.2. Impact on Supply – Demand

Chapter 3. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET – Competition Scenario

3.1. Market Share Analysis

3.2. Product Benchmarking

3.3. Competitive Strategy & Development Scenario

3.4. Competitive Pricing Analysis

3.5. Supplier - Distributor Analysis

Chapter 4. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET - Entry Scenario

4.1. Case Studies – Start-up/Thriving Companies

4.2. Regulatory Scenario - By Region

4.3 Customer Analysis

4.4. Porter's Five Force Model

       4.4.1. Bargaining Power of Suppliers

       4.4.2. Bargaining Powers of Customers

       4.4.3. Threat of New Entrants

       4.4.4. Rivalry among Existing Players

       4.4.5. Threat of Substitutes

Chapter 5. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET - Landscape

5.1. Value Chain Analysis – Key Stakeholders Impact Analysis

5.2. Market Drivers

5.3. Market Restraints/Challenges

5.4. Market Opportunities

Chapter 6. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET - By Disease Type

6.1. Eosinophilic granulomatosis with polyangiitis (EGPA)

6.2. Guillain-Barre syndrome

6.3. Kawasaki disease

6.4. Mixed connective tissue disease (MCTD)

6.5. Myasthenia gravis

6.6. Others

Chapter 7. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET - By Test Type

7.1. Antinuclear antibody (ANA) tests

7.2. Autoantibody tests

7.3. Complete blood count (CBC) 

7.4. Comprehensive metabolic panel

7.5. C-reactive protein (CRP)

7.6. Erythrocyte sedimentation rate (ESR)

7.7. Urinalysis

Chapter 8. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET - By End User

8.1. Academic & Research Institutions

8.2.Diagnostic Centers

8.3. Hospitals & Clinical Laboratories

8.4. Others

Chapter 9. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET – By Region

9.1. North America

9.2. Europe

9.3.The Asia Pacific

9.4.Latin America

9.5. Middle-East and Africa

Chapter 10. RARE AUTOIMMUNE DISEASES DIAGNOSTICS   MARKET– Company Profiles – (Overview, Product Portfolio, Financials, Developments)

10.1. Thermo Fisher Scientific Inc. (United States)

10.2. Danaher Corporation (United States)

10.3. Abbott Laboratories (United States)

10.4. F. Hoffmann-La Roche AG (Switzerland)

10.5. Siemens Healthineers (Germany)

10.6. bioMérieux SA (France)

10.7. Bio-Rad Laboratories, Inc. (United States)

10.8. Trinity Biotech plc (Ireland)

10.9. Seramun Diagnostica GmbH (Germany)

10.10. Quest Diagnostics (United States)

Download Sample

The field with (*) is required.

Choose License Type

$

2500

$

4250

$

5250

$

6900

Frequently Asked Questions

Global Rare Autoimmune Diseases Diagnostics Market is estimated to be worth USD 1.21 Billion in 2022 and is projected to reach a value of USD 2.39 Billion by 2030, growing at a CAGR of 8.9% during the forecast period 2023-2030.

 

The Global Rare Autoimmune Diseases Diagnostics Market Drivers are the increasing government and non-profit organization initiatives regarding rare autoimmune diseases and the growing demand for novel and effective diagnostic techniques. 

Based on the Disease Type, the Global Rare Autoimmune Diseases Diagnostics Market is segmented into Eosinophilic granulomatosis with polyangiitis (EGPA), Guillain-Barre syndrome, Kawasaki disease, Mixed connective tissue disease (MCTD), Myasthenia gravis, and Others.

The United States is the most dominating country in the region of North America for the Global Rare Autoimmune Diseases Diagnostics Market.

 

Thermo Fisher Scientific Inc., Danaher Corporation, and Abbott Laboratories are the leading players in the Global Rare Autoimmune Diseases Diagnostics Market.

 

Analyst Support

Every order comes with Analyst Support.

Customization

We offer customization to cater your needs to fullest.

Verified Analysis

We value integrity, quality and authenticity the most.