Report

The North America Autoimmune Disease Diagnostics Market size is estimated at USD 2.05 billion in 2024, and is expected to reach USD 2.68 billion by 2029, growing at a CAGR of 5.53% during the forecast period (2024-2029).

Key Highlights
-The COVID-19 pandemic significantly impacted market growth, as there were increased complications of COVID-19 associated with various autoimmune diseases such as rheumatoid arthritis and type 1 diabetes, among others. For instance, according to an article published by the Lancet Discovery Science in January 2023, a study was conducted in the United States which showed COVID-19 infected patients had significantly higher risks of autoimmune disorders such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, dermatopolymyositis, and systemic sclerosis among others.
-Thus, the COVID-19 pandemic had a significant impact on the market during the initial phase; however, as the pandemic has subsided, the studied market is expected to have average growth during the forecast period of the study.
-The rising prevalence of autoimmune diseases and growing public awareness of autoimmune disorders is the primary factor driving the market growth. For instance, according to the data updated by the National Psoriasis Foundation of the United States in December 2022, it was estimated that more than 8 million Americans were living with psoriasis in the United States in 2021. An estimated 30% of people living with psoriasis are also expected to develop psoriatic arthritis, and the psoriasis prevalence in African Americans is estimated to be 1.5% compared to 3.6% in Caucasians.
-Thus, the high prevalence of autoimmune diseases such as psoriasis is expected to boost the adoption of autoimmune disease diagnostics. Furthermore, according to data updated by the Canadian Association of Psoriasis Patients in June 2021, psoriasis is considered a common, chronic, and disabling skin disease affecting about 1 million Canadians. Hence, the region's high prevalence of such autoimmune diseases is expected to boost the market growth.
-Moreover, increasing developments by major market players in the region are also expected to boost market growth, enabling patients to have diversified access to various products. For instance, in August 2021, the United States Food and Drug Administration (FDA) approved Thermo Fisher Scientific's blood test for diagnosing systemic lupus erythematosus (SLE) autoimmune disorder. The EliA SmDP-S test reduces the number of false-positive results and provides improved diagnostic guidance for the disease.
-Hence, the factors above, such as the high prevalence of autoimmune disorders such as psoriasis, among others, and the rising developments by major market players, are expected to boost the market growth. However, the slow turnaround time for autoimmune disease diagnostic test results and the high frequency of false positive results are expected to impede the market growth.


North America Autoimmune Disease Diagnostics Market Trends

Immunologic Assays Segment is Expected to Hold a Significant Market Share Over the Forecast Period


- Immunologic reactions are particular, as they can take place only in the presence of proper immunologic agents. Compared to conventional tests, immunologic assays have been proven to provide highly accurate results even with tiny samples. Factors responsible for the segment's growth include cost-effectiveness, the rising prevalence of autoimmune diseases coupled with the increasing geriatric population, growth in the biotechnology and pharmaceutical sectors, and high sensitivity and specificity of immunologic assays.
- For instance, according to an article published by BMC in December 2022, immunologic assays such as indirect immunofluorescence assay using human epithelial type-2 cells (HEp-2 IFA) have high sensitivity and represent a commonly used screening assay for antinuclear antibodies, which are associated with many autoimmune diseases such as systemic lupus erythematosus (SLE), primary Sjogren's syndrome (pSS), and systemic sclerosis (SSc) among others. Thus, the high efficiency of immunologic assays for diagnosing autoimmune diseases is expected to boost segment growth.
- The rising prevalence of autoimmune diseases is the primary factor driving the segment's growth. For instance, according to an article published by BMJ Journals in October 2022, a study was conducted using the last 20 years' data till 2022, which showed that the estimated pooled prevalence of systemic lupus erythematosus (SLE) was 3.66 in Canada in 2022, 6.5 in Mexico, and 12.13 in the United States. Thus, the high prevalence of autoimmune disorders such as SLE is expected to boost the adoption of immunologic assays in the region.
- Moreover, according to the data published by Crohn's and Colitis Canada and Pfizer Canada in November 2022, it was estimated that over 300,000 Canadians were living with inflammatory bowel disease in Canada in 2022, and this number is expected to rise to 403,000 by 2030 which will be equivalent to 1 in 100 people.
- Furthermore, many autoimmune disorders are often linked with old age, so the rising geriatric population is also expected to boost the adoption of immunologic assays. For instance, according to an article published by Science Signaling in April 2021, aging is associated with an increased risk of developing an autoimmune disease because, compared to younger individuals, the elderly has an increased proliferation of naive T-ells in the periphery.
- Hence, the factors above, such as the rising prevalence of autoimmune disorders and the rising geriatric population, are expected to boost segment growth.


United States is Expected to Hold a Significant Market Share Over the Forecast Period

Moreover, increasing developments by major market players in the country are also expected to boost market growth. For instance, in April 2022, Quanterix received a breakthrough device designation by United States FDA for the ultra-sensitive blood test that measures a biomarker of nerve damage in people with multiple sclerosis (MS)-expected to boost the market growth in the country. For instance, according to data updated by the National Institute of Environmental Health Sciences in May 2022, autoimmune diseases are estimated to affect more than 24 million people in the United States. Also, an additional 8 million people are said to have autoantibodies, blood molecules that indicate a person's chance of developing autoimmune disease. Thus, the rising prevalence of autoimmune disorders will boost segment growth.

Furthermore, according to the data published by the International Diabetes Federation in 2022, it was estimated that 32.2 million people were living with diabetes in the United States in 2021, and it is expected to reach 34.8 million by 2030. The same source also stated that around 1.5 million were living with type 1 diabetes in the United States in 2022. Thus, the high prevalence of diabetes in the country is expected to boost segment growth.

Moreover, increasing developments by major market players in the country are also expected to boost market growth. For instance, in April 2022, Quanterix received a breakthrough device designation by United States FDA for the ultra-sensitive blood test that measures a biomarker of nerve damage in people with multiple sclerosis (MS). Hence, the factors above, such as the rising prevalence of autoimmune disorders and the increasing research and development on autoimmune diseases, are expected to boost segment growth.

North America Autoimmune Disease Diagnostics Industry Overview

The North America Autoimmune Disease Diagnostics Market is fragmented in nature. The market comprises several major market players who are focusing on R&D activities and significant growth strategies. Recently, a few diagnostic companies entered into strategic partnerships with hospitals. This trend is expected to continue over the next few years, to meet the high volume of patient needs across different regions. Some of the key players in the North American autoimmune disease diagnostics market are Abbott Laboratories, Biomerieux, Bio-rad Laboratories, Euroimmun AG, and Trinity Biotech, among others.

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- The market estimate (ME) sheet in Excel format
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