NEW
YORK, July 9, 2024 /PRNewswire/ -- The global
antinuclear antibody test market is poised to grow significantly,
with an estimated increase of USD 392
million from 2024 to 2028, at a CAGR of 7.08%. This growth
is driven by rising demand for ANA tests due to increasing
prevalence of autoimmune diseases. However, stringent regulatory
approval processes pose a challenge. Key players such as Abbott
Laboratories, Bio Rad Laboratories Inc., Thermo Fisher Scientific
Inc., and others are pivotal in shaping the market landscape.
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Antinuclear Antibody
Test Market Scope
|
Report
Coverage
|
Details
|
Base year
|
2023
|
Historic
period
|
2018 - 2022
|
Forecast
period
|
2024-2028
|
Growth momentum &
CAGR
|
Accelerate at a CAGR of
7.08%
|
Market growth
2024-2028
|
USD 392
million
|
Market
structure
|
Fragmented
|
YoY growth 2022-2023
(%)
|
6.48
|
Regional
analysis
|
North America, Europe,
Asia, and Rest of World (ROW)
|
Performing market
contribution
|
North America at
31%
|
Key
countries
|
US, Germany, France,
UK, and Japan
|
Key companies
profiled
|
Abbott Laboratories,
Abcam plc, Antibodies Inc., Bio Rad Laboratories Inc., BioVision
Inc., Grifols SA, Immuno Concepts Ltd., Merck KGaA, Orgentec
Diagnostika GmbH, Perkin Elmer Inc., Quidelortho Corp., Seramun
Diagnostica GmbH, Thermo Fisher Scientific Inc., Transasia Bio
Medicals Ltd., Trinity Biotech Plc, Werfenlife SA, and ZEUS
Scientific Inc.
|
Market Driver
The Antinuclear Antibody (ANA) test is a crucial diagnostic tool
for identifying autoimmune disorders, including Systemic Lupus
Erythematosus (SLE) and Psoriasis. A positive ANA test may indicate
the presence of an autoimmune condition, although it can also rule
out various other diseases with similar symptoms. SLE, which
affects approximately 7:1 women to men, is characterized by
debilitating fatigue, fever, and a butterfly rash on the face. The
condition is believed to be linked to the overexpression of
specific genes due to the lack of X Chromosome inactivation during
embryonic development. Psoriasis, another autoimmune disorder, is
marked by the thickening of the stratum corneum layer, leading to
red, salmon, and white-scaly plaques. Prevalent in 11% of Caucasian
and Scandinavian populations, psoriasis affects around 2% of the
global population. Both conditions can cause significant physical,
mental, and emotional stress, necessitating accurate and timely
diagnosis. The ANA test plays a vital role in identifying these
disorders, enabling appropriate treatment and management.
The Antinuclear Antibody (ANA) test market is experiencing
significant growth due to increasing trends in multiplex assays and
autoantibody diagnosis in clinical laboratories and hospitals. New
variants of systemic autoantibodies are being discovered, requiring
the development of new diagnostic assays. The healthcare system is
adapting to these changes, with POLs and medical insurance
companies revising reimbursement policies. Autoimmune diseases such
as motor axonal neuropathy, GBS, and FANA are associated with these
autoantibodies, and the prognostic value of ANA testing is becoming
increasingly recognized. However, lack of awareness in developing
economies and the need for rapid test results pose challenges. The
gold standard for ANA testing remains immunofluorescence, with
different patterns like nucleolar, speckled, and homogenous.
Research institutions like MedRxiv and NCBI are publishing new
findings on autoantibodies associated with diseases like SLE, RA,
and AIHA. The use of disposable cartridges and AI in testing is
also gaining popularity for its convenience and accuracy. Arthritis
Research and MedRxiv are leading the way in advancing our
understanding of ANA testing and its role in autoimmune disease
diagnosis and treatment options.
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Market Challenges
• Regulations
play a crucial role in the approval and marketing of Antinuclear
Antibody (ANA) test kits as medical diagnostic devices. In the US,
the Food and Drug Administration (FDA) and the Center for Medicare
Services of the Department of Health and Human Services oversee
these processes. ANA test kits are classified as Class II devices
with moderate risks, requiring manufacturers to obtain premarket
notification 510(k) before marketing. In Europe, the European Medicines Agency (EMA)
regulates all medical diagnostic devices under EU legislation
2017/745, which involves a conformity assessment and CE mark
certification. In China, the
National Medical Products Administration (NMPA) regulates medical
devices, including ANA test kits. In Japan, the Pharmaceutical and Medical Device
Agency (PMDA) and the Ministry of Health, Labour and Welfare
regulate medical devices. Adherence to these regulations can lead
to delays in product commercialization, potentially impacting sales
and revenues, and therefore, the growth of the global ANA test
market.
• The
Antinuclear Antibody (ANA) testing market is witnessing significant
development activities in the diagnostic assays sector. Two common
ANA patterns, nucleolar and speckled, are widely used for
diagnosing autoimmune diseases such as Systemic Lupus Erythematosus
(SLE), Rheumatoid Arthritis (RA), Scleroderma, Raynaud's Syndrome,
Polymyositis, Mixed Connective Tissue, Drug-induced Lupus, and
Autoimmune Hepatitis. However, challenges persist in developing
economies due to a lack of awareness and limited resources. The
gold standard for ANA testing is immunofluorescence, but rapid test
results are increasingly preferred using systems like Enzyme-linked
Immunosorbent Assay (ELISA) and disposable cartridges. FANA and
AIHA are key players in the ANA testing market, providing assay
kits, reagents, and systems. Diseases associated with
autoantibodies continue to drive market growth, with Arthritis
Research focusing on new treatment options. The prognostic value of
ANA testing is crucial for early diagnosis and effective
treatment.
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challenges - Request a sample report!
Segment Overview
This antinuclear antibody test market report extensively covers
market segmentation by
- End-user
- 1.1 Hospitals
- 1.2 Clinical diagnostic laboratories
- Geography
- 2.1 North America
- 2.2 Europe
- 2.3 Asia
- 2.4 Rest of World (ROW)
1.1 Hospitals- The Antinuclear Antibody (ANA)
test market is significant in the healthcare industry due to the
increasing prevalence of autoimmune diseases. This diagnostic test
identifies the presence of antinuclear antibodies in the blood,
aiding in the diagnosis of various conditions such as systemic
lupus erythematosus and rheumatoid arthritis. Market growth is
driven by rising disease prevalence, increasing awareness, and
technological advancements in testing methods. Companies are
investing in research and development to improve test accuracy and
reduce turnaround time.
For more information on market segmentation with
geographical analysis including forecast (2024-2028) and historic
data (2017-2021) - Download a Sample Report
Research Analysis
The Antibody (ANA) testing market refers to the sale of assay
kits, reagents, and systems used for detecting systemic
autoantibodies in individuals with suspected autoimmune diseases.
ANA testing is essential for diagnosing conditions such as
rheumatoid arthritis, systemic lupus erythematosus, scleroderma,
Raynaud's Syndrome, polymyositis, mixed connective tissue,
drug-induced lupus, autoimmune hepatitis, and other autoimmune
diseases. Enzyme-linked immunosorbent assay (ELISA),
immunofluorescence assay (IFA), and multiplex assay are common
techniques used in ANA testing. Clinical laboratories and hospitals
are significant end-users of ANA testing. Conditions like motor
axonal neuropathy, Guillain-Barré syndrome (GBS), and FANA
(Fibrillar Antinuclear Antibodies) are also diagnosed using ANA
testing. Development activities in diagnostic assays and new
variants of autoantibodies are driving market growth. However, lack
of awareness and reimbursement policies in developing economies
pose challenges. The prognostic value of ANA testing in predicting
disease progression and treatment options is a significant area of
research. The healthcare system's integration of ANA testing into
routine diagnostic procedures is crucial for early and accurate
diagnosis of autoimmune diseases. The National Center for
Biotechnology Information (NCBI) and MedRxiv provide valuable
resources for ANA testing research and updates.
Market Research Overview
The Antibody (ANA) testing market refers to the sale of assay
kits, reagents, and systems used for detecting systemic
autoantibodies in clinical laboratories and hospitals. ANA testing
is essential for diagnosing various autoimmune diseases such as
rheumatoid arthritis (RA), systemic lupus erythematosus (SLE),
scleroderma, Raynaud's Syndrome, polymyositis, mixed connective
tissue, drug-induced lupus, autoimmune hepatitis, and other
conditions. Enzyme-linked immunosorbent assay (ELISA),
immunofluorescence assay (IFA), and multiplex assays are common
techniques used for ANA testing. Autoantibody diagnosis plays a
crucial role in the early detection and treatment of autoimmune
diseases. New variants and developments in ANA testing, including
rapid test results and alternative testing methods like FANA and
AIHA, are under investigation. Autoimmune diseases, including motor
axonal neuropathy, Guillain-Barré syndrome (GBS), and others, can
significantly impact patients' quality of life. The healthcare
system, medical insurance, and reimbursement policies also
influence the ANA testing market. Diseases associated with
autoantibodies, such as arthritis and SLE, continue to be areas of
active research. The lack of awareness and access to ANA testing in
developing economies remains a significant challenge.
Immunofluorescence is considered the gold standard for ANA testing,
with distinct patterns like nucleolar, speckled, and homogenous,
providing valuable diagnostic information.
Table of Contents:
1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation
- End-user
-
- Hospitals
- Clinical Diagnostic Laboratories
- Geography
-
- North America
- Europe
- Asia
- Rest Of World (ROW)
7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix
About Technavio
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Email: media@technavio.com
Website: www.technavio.com/
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