As per our report, the global antinuclear antibody test market size was worth USD 1169.4 million in 2019 and expected to reach USD 2109.5 million by 2024 at a CAGR of 12.52%.
The antinuclear antibody test market is showcasing evident potential in the mentioned forecasting period. It is an initial test to check a person’s autoimmune disorders which may affect many tissues and organs in the body. This test is most often used to diagnose the Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis.
When the Individual immune system is failing to differentiate between foreign and self-particles, then it produces a group of antinuclear antibodies. These antibodies attack their cells and cause signs and symptoms such as muscle and joint pain, tissue and organ inflammation and fatigue. Antinuclear antibody tests (ANA) evaluate the patterns and quantity of antibodies in the blood. If the test detects the presence of antinuclear antibody in the individual’s blood, it could mean that the person has an immune disorder. The immune disorders might affect the organs and healthy tissues in the body.
Impact of COVID-19 on ANA Test Market
The situations caused by the coronavirus positively impacted the antinuclear antibody test market. The Antibody screenings will be done to detect the antibodies present in the blood. These are for fighting with an infection like COVID-19. Also, serologic procedures have been developed to respond to the COVID-19 pandemic. The antinuclear antibody test market plays a vital role in COVID-19.
MARKET DRIVERS
Primarily factors such as an increase in the prevalence of autoimmune diseases, such as rheumatoid arthritis and SLE, and growth in the awareness of people about these diseases are driving global antinuclear antibody test market. Autoimmune diseases can also cause type I diabetes. According to WHO, from 1980 to 2014, the diabetes population has increased from 108 million to 422 million. Other factors such as an increase in healthcare expenditure of people due to developing economies, and government healthcare insurance & reimbursement policies are fuelling this market.
Allowance of ANA for SLE test for any autoimmune diseases is boosting the use of antinuclear antibody testing, which is expected to grow more in the future. The demand for ANA is increasing due to factors such as the role of the primary healthcare physician’s delivery system. Rising incidences of autoimmune disorders such as lupus erythematosus and rheumatoid arthritis are elevating the demand of the market. Similarly, the government initiatives for early diagnosis and increasing research & development activities of autoimmune disorders are further expected to fuel the market demand. The ANA tests are accurate. Thus it will help to drive the global antinuclear antibody test market.
MARKET RESTRAINTS
Factors such as diagnostic errors, product approval, and unavailability of skilled labour are hindering the growth of this market. Furthermore, the cost of these tests is less unaffordable for the patients, which can hamper the sale in the global market. Also, the factors like availability of skilled labour, product approval and the diagnostics faults are hampering the antinuclear antibody test market growth.
REPORT COVERAGE
|
REPORT METRIC |
DETAILS |
|
Market Size Available |
2018 to 2024 |
|
Base Year |
2018 |
|
Forecast Period |
2019 to 2024 |
|
Segments Analysed |
By Disease, Technique, Product, End User and Region |
|
Various Analyses Covered |
Global, Regional & Country Level Analysis, Segment-Level Analysis, Drivers, Restraints, Opportunities, Challenges, PESTLE Analysis, Porter’s Five Forces Analysis, Competitive Landscape, Analyst Overview on Investment Opportunities |
|
Regions Analysed |
North America, Europe, Asia Pacific, Latin America, Middle East and Africa |
This research report on the global antinuclear antibody test market has been segmented and sub-segmented based on the disease, technique, product, end-user and region.
Antinuclear Antibody Test Market - By Disease
Based on Diseases, Rheumatoid Arthritis is expected to have the largest share in the market until the end of the forecast period due to the increased incidences of rheumatoid arthritis.
SLE is projected to be the quickest growing segment due to the growing awareness integrated with the initiatives taken by the government and a large number of tests endorsed by the U.S. FDA to identify the disease.
Antinuclear Antibody Test Market - By Technique
Based on the technique, the ELISA is currently leading the market based on the technique used for testing. The segment is likely to experience growth due to the implementations of the antinuclear antibody for testing of autoimmune diseases, and therapeutic level monitoring.
Immunofluorescence segment is likely to have a quick growth rate during the period, and the growth is due to high obtainment in terms of revenue.
Antinuclear Antibody Test Market - By Product
Based on product, in 2019, Assay Kits & reagents segment accounts for the largest share of the global ANA testing market. It can be because of the growth in several reagent rental agreements. The growth is associated with factors like average increase of autoimmune diseases and high acquisition of reagents & assay kits, better changes in efficiency, worth results and cost-saving.
Antinuclear Antibody Test Market - By End-User
Based on the end-user, the hospital's segment is likely to hold the largest share in the market. The growth is attributed due to the diagnostic assays that are executed at hospitals and laboratories. Easy accessibility of reports to collect and smooth logistics is propelling the demand of the market.
Antinuclear Antibody Test Market - By Region
Regionally, The North America region has the most significant market share in the global market mainly because of growing population and healthcare spending, and growth of people under medical insurances in the U.S. North America is the most influencing and dominating region in the global ANA test market. The growth is associated with factors like well establishes medical management healthcare, the existence of advanced technologies and also increasing awareness among the people. In this region, the U.S. is the leading country due to the growing number of independents which offer medical insurance favouring the market in the U.S.
Europe is the second-largest region in the antinuclear antibody test market, having the highest share followed by North America. Strong support from the countries such as the UK, France, Spain, Germany, and Italy of Europe are boosting the market growth in this region. Western Europe has a particular growth rate which is so high in this region.
Asia-Pacific is growing at the fastest rate in this market in terms of CAGR, and the growth is allocated due to the massive increase of common autoimmune diseases in countries like India and China. The APAC market is likely to grow in terms of CAGR: Japan, South Korea, Australia and the rest of APAC that come under this region. Growth is associated due to the factors like fulfilled requirements for autoimmune diseases and a rising number of clinical trials to develop a drug for novel diseases.
Latin America market size value is set out to reach USD 2.01 billion by 2024 with a CAGR of 3.58% during the period. Countries like Brazil, Mexico and Rest of LATAM are in this region. The growth is due to rising disposable income in urban areas and making betterment changes in healthcare sector accelerating the market growth.
The Middle East & Africa region is expected to have a limited growth rate in the antinuclear antibody test market during the period due to the growth is accredited due to the lack of awareness among the people about the devices and the treatment to be done.
TOP COMPANIES IN THE MARKET
Some of the major companies dominating the global antinuclear antibody test market profiled in the report are Zeus Scientific Inc., Inova Diagnostics, Immuno Concepts, Euroimmun AG, Antibodies Inc., Thermo Fisher Scientific Inc., Trinity Biotech plc, ERBA Diagnostics Inc., Bio-Rad Laboratories Inc. and Alere Inc.
RECENT MARKET DEVELOPMENTS
On August 14, 2018, Inova Diagnostics made a public statement that it received an acceptance for QUANTA Flash HMGCR by the US FDA. This QUANTA Flash HMGCR is assisted in diagnosing idiopathic inflammatory myopathy (IIM). It is a category of circumstances which influence the skeletal muscles which can give outcome in cases that leads to tissue necrosis and disability.
On January 16, 2019, The FDA gave clearance for immune concepts of Histofluor Rodent Tissues Slides. It doesn't require any kind of freezing, including the tissue slides.
On April 22, 2020, Zeus Scientific announced about their submission of emergency use authorization to the US FDA for the in-vitro diagnostic test, which helps to detect SARS COV-2. This flow test uses a patient's serum and plasma which gives out the results within 15minutes.
1.Introduction
1.1 Market Definition
1.2 Study Deliverables
1.3 Base Currency, Base Year and Forecast Periods
1.4 General Study Assumptions
2. Research Methodology
2.1 Introduction
2.2 Research Phases
2.2.1 Secondary Research
2.2.2 Primary Research
2.2.3 Econometric Modelling
2.2.4 Expert Validation
2.3 Analysis Design
2.4 Study Timeline
3. Overview
3.1 Executive Summary
3.2 Key Inferences
3.3 Epidemology
4. Drivers, Restraints, Opportunities, and Challenges Analysis (DROC)
4.1 Market Drivers
4.2 Market Restraints
4.3 Key Challenges
4.4 Current Opportunities in the Market
5. Market Segmentation
5.1 Disease
5.1.1 Introduction
5.1.2 SLE
5.1.3 Rheumatoid Arthritis
5.1.4 Y-o-Y Growth Analysis, By Disease
5.1.5 Market Attractiveness Analysis, By Disease
5.1.6 Market Share Analysis, By Disease
5.2 Technique
5.2.1 Introduction
5.2.2 Immunofluorescence
5.2.3 Multiplex
5.2.4 ELISA
5.2.5 Y-o-Y Growth Analysis, By Technique
5.2.6 Market Attractiveness Analysis, By Technique
5.2.7 Market Share Analysis, By Technique
5.3 Product
5.3.1 Introduction
5.3.2 Software
5.3.3 Systems
5.3.4 Services
5.3.5 Reagents & Assay Kits
5.3.6 Y-o-Y Growth Analysis, By Product
5.3.7 Market Attractiveness Analysis, By Product
5.3.8 Market Share Analysis, By Product
5.4 End-User
5.4.1 Introduction
5.4.2 Hospitals
5.4.3 Clinical Labs
5.4.4 Y-o-Y Growth Analysis, By End-User
5.4.5 Market Attractiveness Analysis, By End-User
5.4.6 Market Share Analysis, By End-User
6. Geographical Analysis
6.1 Introduction
6.1.1 Regional Trends
6.1.2 Impact Analysis
6.1.3 Y-o-Y Growth Analysis
6.1.3.1 By Geographical Area
6.1.3.2 By Disease
6.1.3.3 By Technique
6.1.3.4 By Product
6.1.3.5 By End-User
6.1.4 Market Attractiveness Analysis
6.1.4.1 By Geographical Area
6.1.4.2 By Disease
6.1.4.3 By Technique
6.1.4.4 By Product
6.1.4.5 By End-User
6.1.5 Market Share Analysis
6.1.5.1 By Geographical Area
6.1.5.2 By Disease
6.1.5.3 By Technique
6.1.5.4 By Product
6.1.5.5 By End-User
6.2 North America
6.2.1 Introduction
6.2.2 United States
6.2.3 Canada
6.3 Europe
6.3.1 Introduction
6.3.2 U.K
6.3.3 Spain
6.3.4 Germany
6.3.5 Italy
6.3.6 France
6.4 Asia-Pacific
6.4.1 Introduction
6.4.2 China
6.4.3 India
6.4.4 Japan
6.4.5 Australia
6.4.6 South Korea
6.5 Latin America
6.5.1 Introduction
6.5.2 Brazil
6.5.3 Argentina
6.5.4 Mexico
6.5.5 Rest of Latin America
6.6 Middle East & Africa
6.6.1 Introduction
6.6.2 Middle-East
6.6.3 Africa
7.Strategic Analysis
7.1 PESTLE analysis
7.1.1 Political
7.1.2 Economic
7.1.3 Social
7.1.4 Technological
7.1.5 Legal
7.1.6 Environmental
7.2 Porter’s Five analysis
7.2.1 Bargaining Power of Suppliers
7.2.2 Bargaining Power of Consumers
7.2.3 Threat of New Entrants
7.2.4 Threat of Substitute Products and Services
7.2.5 Competitive Rivalry within the Industry
8.Market Leaders' Analysis
8.1 Zeus Scientific Inc.
8.1.1 Overview
8.1.2 Product Analysis
8.1.3 Financial analysis
8.1.4 Recent Developments
8.1.5 SWOT analysis
8.1.6 Analyst View
8.2 Inova Diagnostics
8.3 Immuno Concepts
8.4 Euroimmun AG
8.5 Antibodies Inc.
8.6 Thermo Fisher Scientific Inc.
8.7 Trinity Biotech plc
8.8 ERBA Diagnostics Inc.
8.9 Bio-Rad Laboratories Inc.
8.10 Alere Inc.
9.Competitive Landscape
9.1 Market share analysis
9.2 Merger and Acquisition Analysis
9.3 Agreements, collaborations and Joint Ventures
9.4 New Product Launches
10.Market Outlook and Investment Opportunities
Appendix
a) List of Tables
b) List of Figures
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