U.S. IVD and LDT for Autoimmune Diseases Market Size Study, By Type (IVD, LDT), By Technology (Immunoassays, Clinical Chemistry, Molecular Diagnostics), By Application (Psoriasis, Crohn's Disease), and Regional Forecasts 2022-2032

Description

The U.S. IVD and LDT for Autoimmune Diseases Market is poised to achieve substantial growth in the forecast period, driven by the rising prevalence of autoimmune disorders and advancements in diagnostic technologies. In 2023, the market was valued at USD 2.51 billion and is expected to grow at a robust CAGR of 6.6% through 2032. With over 50 million Americans grappling with autoimmune diseases annually, the demand for innovative diagnostic solutions is rapidly increasing. Laboratory-developed tests (LDTs) and in vitro diagnostics (IVD) are pivotal in meeting this demand, offering enhanced accuracy, speed, and reliability in disease detection.

Recent advancements in the field underscore the market's dynamism. For example, the FDA's updated regulatory framework, finalized in April 2024, classifies all IVDs, including LDTs, as medical devices. This shift in oversight is aimed at ensuring safety, reliability, and efficacy in diagnostic testing, which aligns with the broader trend of prioritizing patient outcomes in healthcare. Additionally, significant technological progress, such as next-generation sequencing (NGS), is revolutionizing the landscape by enabling comprehensive genomic analysis for diseases like rheumatoid arthritis and other autoimmune disorders.

The increasing penetration of LDTs in clinical settings has led to innovative breakthroughs, such as Mayo Clinic's biomarker discoveries in 2022, which have significantly enhanced diagnostic precision. However, challenges persist, including stringent regulatory hurdles and ongoing legal debates, which could potentially restrict market entry for some LDT solutions.

Regionally, North America is a dominant player, underpinned by cutting-edge research and well-established healthcare infrastructure. Meanwhile, applications such as psoriasis diagnostics continue to hold the largest market share due to heightened awareness and targeted initiatives, while Crohn's disease diagnostics exhibit the fastest growth rate, reflecting the urgent need for effective solutions in managing inflammatory bowel diseases.

Major market players included in this report are:

Abbott Laboratories
Agilent Technologies, Inc.
Adaptive Biotechnologies Corporation
Bio-Rad Laboratories, Inc.
Thermo Fisher Scientific, Inc.
F. Hoffmann-La Roche Ltd.
Quest Diagnostics, Inc.
Siemens Healthcare GmbH
PerkinElmer, Inc.
bioMerieux, Inc.
Beckman Coulter, Inc.
Mayo Foundation for Medical Education and Research
Moleculera Labs
Omega Diagnostics Group PLC
SQI Diagnostics

The detailed segments and sub-segments of the market are explained below:

By Type:

By Technology:

Immunoassays
Clinical Chemistry
Hematology
Coagulation
Microbiology
Molecular Diagnostics
Others

By Application:

Psoriasis
Crohn's Disease
Rheumatoid Arthritis
Systemic Lupus Erythematosus
Multiple Sclerosis
Diabetes Type 1
Uveitis
Antiphospholipid Antibody Syndrome
Ankylosing Spondylitis
Addison's Disease
Alopecia Areata
Systemic Sclerosis
Ulcerative Colitis
Narcolepsy
Others

By Region:

North America
- U.S.
Europe
- UK
- Germany
- France
- Spain
- Italy
- Rest of Europe
Asia Pacific
- China
- India
- Japan
- Australia
- South Korea
- Rest of Asia Pacific
Latin America
- Brazil
- Mexico
- Rest of Latin America
Middle East & Africa
- Saudi Arabia
- South Africa
- Rest of Middle East & Africa

Years considered for the study are as follows:

Historical year - 2022
Base year - 2023
Forecast period - 2024 to 2032

Key Takeaways:

Market Estimates & Forecasts for 10 years from 2022 to 2032.
Annualized revenues and regional level analysis for each market segment.
Detailed analysis of geographical landscape with country-level analysis of major regions.
Competitive landscape with information on major players in the market.
Analysis of key business strategies and recommendations on future market approaches.
Analysis of competitive structure of the market.
Demand-side and supply-side analysis of the market.

Chapter 1. U.S. IVD and LDT for Autoimmune Diseases Market Executive Summary

1.1. U.S. IVD and LDT for Autoimmune Diseases Market Size & Forecast (2022-2032)
1.2. Regional Summary
1.3. Segmental Summary
- 1.3.1. By Type
- 1.3.2. By Technology
- 1.3.3. By Application
1.4. Key Market Trends
1.5. Recession Impact
1.6. Analyst Recommendation & Conclusion

Chapter 2. U.S. IVD and LDT for Autoimmune Diseases Market Definition and Research Assumptions

2.1. Research Objective
2.2. Market Definition
2.3. Research Assumptions
- 2.3.1. Inclusion & Exclusion
- 2.3.2. Limitations
- 2.3.3. Supply Side Analysis
  - 2.3.3.1. Availability
  - 2.3.3.2. Infrastructure
  - 2.3.3.3. Regulatory Environment
  - 2.3.3.4. Market Competition
  - 2.3.3.5. Economic Viability (Consumer's Perspective)
- 2.3.4. Demand Side Analysis
  - 2.3.4.1. Technological Advancements
  - 2.3.4.2. Consumer Awareness & Acceptance
2.4. Estimation Methodology
2.5. Years Considered for the Study
2.6. Currency Conversion Rates

Chapter 3. U.S. IVD and LDT for Autoimmune Diseases Market Dynamics

3.1. Market Drivers
- 3.1.1. Rising Prevalence of Autoimmune Diseases
- 3.1.2. Advancements in Diagnostic Technologies
- 3.1.3. Regulatory Reforms Enhancing Oversight
3.2. Market Challenges
- 3.2.1. Stringent Regulatory Frameworks
- 3.2.2. High Costs of Development and Implementation
3.3. Market Opportunities
- 3.3.1. Expansion of Next-Generation Sequencing Technologies
- 3.3.2. Increasing Demand for Personalized Healthcare Solutions

Chapter 4. U.S. IVD and LDT for Autoimmune Diseases Industry Analysis

4.1. Porter's 5 Force Model
- 4.1.1. Bargaining Power of Suppliers
- 4.1.2. Bargaining Power of Buyers
- 4.1.3. Threat of New Entrants
- 4.1.4. Threat of Substitutes
- 4.1.5. Competitive Rivalry
- 4.1.6. Futuristic Approach to Porter's 5 Force Model
- 4.1.7. Porter's 5 Force Impact Analysis
4.2. PESTEL Analysis
- 4.2.1. Political
- 4.2.2. Economical
- 4.2.3. Social
- 4.2.4. Technological
- 4.2.5. Environmental
- 4.2.6. Legal
4.3. Top Investment Opportunities
4.4. Top Winning Strategies
4.5. Disruptive Trends
4.6. Industry Expert Perspective
4.7. Analyst Recommendations

Chapter 5. U.S. IVD and LDT for Autoimmune Diseases Market Size & Forecast by Type (2022-2032)

5.1. Segment Dashboard
5.2. IVD
5.3. LDT

Chapter 6. U.S. IVD and LDT for Autoimmune Diseases Market Size & Forecast by Technology (2024-2030)

6.1. Segment Dashboard
6.2. Immunoassays
6.3. Clinical Chemistry
6.4. Hematology
6.5. Coagulation
6.6. Microbiology
6.7. Molecular Diagnostics
6.8. Others

Chapter 7. U.S. IVD and LDT for Autoimmune Diseases Market Size & Forecast by Application (2022-2032)

7.1. Addison's Disease
7.2. Ankylosing Spondylitis
7.3. Alopecia Areata
7.4. Rheumatoid Arthritis
7.5. Systemic Lupus Erythematosus
7.6. Systemic Sclerosis
7.7. Psoriasis
7.8. Antiphospholipid Antibody Syndrome
7.9. Diabetes Type 1
7.10. Crohn's Disease
7.11. Ulcerative Colitis
7.12. Narcolepsy
7.13. Multiple Sclerosis
7.14. Uveitis
7.15. Others

Chapter 8. Competitive Intelligence

8.1. Key Company SWOT Analysis
- 8.1.1. Abbott Laboratories
- 8.1.2. Adaptive Biotechnologies Corporation
- 8.1.3. Bio-Rad Laboratories, Inc.
8.2. Top Market Strategies
8.3. Company Profiles
- 8.3.1. Abbott Laboratories
  - 8.3.1.1. Key Information
  - 8.3.1.2. Overview
  - 8.3.1.3. Financial (Subject to Data Availability)
  - 8.3.1.4. Product Summary
  - 8.3.1.5. Market Strategies
- 8.3.2. Adaptive Biotechnologies Corporation
- 8.3.3. Bio-Rad Laboratories, Inc.
- 8.3.4. bioMerieux, Inc.
- 8.3.5. Thermo Fisher Scientific, Inc.

Chapter 9. Research Process

9.1. Research Process
- 9.1.1. Data Mining
- 9.1.2. Analysis
- 9.1.3. Market Estimation
- 9.1.4. Validation
- 9.1.5. Publishing
9.2. Research Attributes