The U.S. IVD and LDT for autoimmune diseases market size is expected to reach USD 3.88 billion by 2030, growing at a CAGR of 6.6% from 2025 to 2030. The high prevalence of autoimmune disorders, growing awareness about these ailments, growing demand for technologically developed & high performance products, and high investments in research are the driving factors for the expanding growth of the market.
These health problems are second leading cause of chronic illness in the U.S. and are amongst the leading causes of deaths in the U.S. women. They have an adverse impact on the work productivity and the quality of life of patients and form an economic burden greatly affecting the healthcare spending in the U.S. The National Institute of Health estimates the direct healthcare costs associated with these disorders accounted for around USD 100 billion, whereas the cancer costs accounted for USD 57 billion.
A large number of people suffering from these disorders and rising prevalence at an alarming rate resulting in an increase of healthcare spending in the U.S. are all priority concerns, and is thus are expected to drive growth. Furthermore, the complications resulting from such health hazards like damage to internal organs, loss of mobility, and risk of death make it crucial for early diagnosis and intervention of such conditions. The rising awareness about these conditions is expected to lead market growth.
It is believed by number of researchers that the increase in the number of autoimmune diseases globally is due to the genetic predisposition and environmental factors. But there is very little knowledge about what exactly in the environment triggers the occurrence of autoimmune diseases. and mainly focused on commercial kits that are widely used by laboratories.
The FDA regulates IVD as medical devices however in the past it did not use its authority to regulate LDT. The FDA later announced that it would enforce its medical device regulatory authority to regulate the LDTs. Some researchers believe that the FDA regulation on LDTs would lead to an increase in the time and cost required to develop the tests.
These health problems are second leading cause of chronic illness in the U.S. and are amongst the leading causes of deaths in the U.S. women. They have an adverse impact on the work productivity and the quality of life of patients and form an economic burden greatly affecting the healthcare spending in the U.S. The National Institute of Health estimates the direct healthcare costs associated with these disorders accounted for around USD 100 billion, whereas the cancer costs accounted for USD 57 billion.
A large number of people suffering from these disorders and rising prevalence at an alarming rate resulting in an increase of healthcare spending in the U.S. are all priority concerns, and is thus are expected to drive growth. Furthermore, the complications resulting from such health hazards like damage to internal organs, loss of mobility, and risk of death make it crucial for early diagnosis and intervention of such conditions. The rising awareness about these conditions is expected to lead market growth.
It is believed by number of researchers that the increase in the number of autoimmune diseases globally is due to the genetic predisposition and environmental factors. But there is very little knowledge about what exactly in the environment triggers the occurrence of autoimmune diseases. and mainly focused on commercial kits that are widely used by laboratories.
The FDA regulates IVD as medical devices however in the past it did not use its authority to regulate LDT. The FDA later announced that it would enforce its medical device regulatory authority to regulate the LDTs. Some researchers believe that the FDA regulation on LDTs would lead to an increase in the time and cost required to develop the tests.
U.S. IVD And LDT For Autoimmune Diseases Market Report Highlights
- The IVD segment gained a major market share in 2024 and is expected to grow at a CAGR of 6.26% over the forecast period, attributed to its efficient testing for both systemic & organ-specific autoimmune pathologies and better reimbursement policies.
- Psoriasis held the largest share of 15.21% in 2024 and is expected to maintain a dominant share throughout the forecast period. The rise in psoriasis prevalence and the strategic initiatives undertaken by the NPF to improve diagnostic accuracy are key factors contributing to the segment's growth.
- The clinical chemistry segment held the largest revenue share of 30.32% in 2024. Clinical chemistry tests play a central role in testing and diagnosing various diseases in patients.
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players worldwide.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the global market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listing for you to stay ahead of the curve
- COVID-19's impact and how to sustain in these fast-evolving markets
Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. Market Variables, Trends, & Scope
Chapter 4. Type Business Analysis
Chapter 5. Technology Business Analysis
Chapter 6. Application Business Analysis
Chapter 7. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- Adaptive Biotechnologies Corporation
- Agilent Technologies, Inc
- Bio-Rad Laboratories, Inc.
- bioMerieux, Inc.
- Corgenix, Inc. (Sebia)
- F. Hoffmann-La Roche Ltd.
- Quest Diagnostics, Inc.
- PerkinElmer, Inc
- Abbott Laboratories
- Thermo Fisher Scientific, Inc.
Methodology
LOADING...
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 110 |
| Published | November 2024 |
| Forecast Period | 2024 - 2030 |
| Estimated Market Value ( USD | $ 2.66 Billion |
| Forecasted Market Value ( USD | $ 3.88 Billion |
| Compound Annual Growth Rate | 6.6% |
| Regions Covered | United States |
| No. of Companies Mentioned | 10 |
