세계의 자가면역질환용 IVD 및 LDT 시장 : 기술별, 용도별 예측(2025-2030년)

The IVD & LDT For Autoimmune Diseases Market was valued at USD 17.27 billion in 2023, expected to reach USD 18.30 billion in 2024, and is projected to grow at a CAGR of 5.22%, to USD 24.68 billion by 2030.

The market scope for In Vitro Diagnostics (IVD) and Laboratory Developed Tests (LDT) for autoimmune diseases involves diagnostic tools and tests designed to detect and monitor autoimmune conditions. The necessity of these tests is underscored by the increasing prevalence of autoimmune disorders, which demand precise and timely diagnosis for effective treatment plans, addressing disorders like rheumatoid arthritis, lupus, and multiple sclerosis. These diagnostics are applied primarily in hospitals, diagnostic laboratories, and research institutions, serving clinicians, researchers, and patients. A key growth driver includes advancements in diagnostic technologies such as molecular diagnostics and the rise in personalized medicine. Additionally, increasing healthcare expenditure, a growing geriatric population susceptible to autoimmune conditions, and rising awareness of early disease detection further fuel market growth. Latest potential opportunities are apparent in next-generation sequencing (NGS) and point-of-care testing advancements, where industry players can leverage strategic collaborations and technological innovations to enhance test accuracy and reliability. However, challenges such as stringent regulatory environments, high costs associated with advanced diagnostic tests, and the complexity of autoimmune diseases can hinder market expansion. To mitigate these challenges, companies should focus on innovation areas such as developing cost-effective, rapid, and highly accurate diagnostic tools, biomarker discovery, and integrating artificial intelligence for predictive diagnostics. The market remains dynamic and competitive, driven by rapid technological advancements, making it crucial for market participants to stay ahead of trends through continuous research and development. By focusing on unmet diagnostic needs, particularly in under-represented autoimmune disorders, and enhancing the accessibility of diagnostics globally, businesses can achieve sustainable growth. The convergence of regulatory approvals, reimbursement policies, and technological integrations shapes the market's nature, highlighting an evolving landscape ripe for innovations that can navigate existing challenges and capitalize on emerging opportunities.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving IVD & LDT For Autoimmune Diseases Market

The IVD & LDT For Autoimmune Diseases Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Rising incidences of autoimmune disorders in economies
  • Increasing awareness regarding diagnostic tests for autoimmune diseases
  • Rising development of healthcare infrastructure and growing healthcare expenditure
• Market Restraints
  • Concerns regarding extra-neuropsychiatric health problems
• Market Opportunities
  • Technological advancements in the field of IVD
  • Rising collaborative growth for the development of in-vitro diagnostic (IVD) test kits
• Market Challenges
  • Stringent regulations of IVDs & LDTs

Porter's Five Forces: A Strategic Tool for Navigating the IVD & LDT For Autoimmune Diseases Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the IVD & LDT For Autoimmune Diseases Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the IVD & LDT For Autoimmune Diseases Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the IVD & LDT For Autoimmune Diseases Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the IVD & LDT For Autoimmune Diseases Market

A detailed market share analysis in the IVD & LDT For Autoimmune Diseases Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the IVD & LDT For Autoimmune Diseases Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the IVD & LDT For Autoimmune Diseases Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the IVD & LDT For Autoimmune Diseases Market

A strategic analysis of the IVD & LDT For Autoimmune Diseases Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

Key Company Profiles

The report delves into recent significant developments in the IVD & LDT For Autoimmune Diseases Market, highlighting leading vendors and their innovative profiles. These include Adaptive Biotechnologies Corporation, Agilent Technologies Inc., Bio-Rad Laboratories, Inc., bioMerieux, Inc., Corgenix, Inc., Creative Biolabs Inc., Diasorin S.P.A., in.vent Diagnostica GmbH, Johnson & Johnson Services, Inc., Microbix Biosystems Inc., PerkinElmer, Inc., Roche Diagnostics Corporation, SQI Diagnostics Inc., and Thermo Fisher Scientific Inc..

Market Segmentation & Coverage

This research report categorizes the IVD & LDT For Autoimmune Diseases Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Technology, market is studied across Clinical Chemistry, Coagulation, Hematology, Immunoassays, Microbiology, and Molecular Diagnostics.
• Based on Application, market is studied across Addison's Disease, Alopecia Areata, Ankylosing Spondylitis, Antiphospholipid Antibody Syndrome, Crohn's Disease, Diabetes Type 1, Multiple Sclerosis, Narcolepsy, Psoriasis, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Ulcerative Colitis, and Uveitis.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Rising incidences of autoimmune disorders in economies
    • 5.1.1.2. Increasing awareness regarding diagnostic tests for autoimmune diseases
    • 5.1.1.3. Rising development of healthcare infrastructure and growing healthcare expenditure
  • 5.1.2. Restraints
    • 5.1.2.1. Concerns regarding extra-neuropsychiatric health problems
  • 5.1.3. Opportunities
    • 5.1.3.1. Technological advancements in the field of IVD
    • 5.1.3.2. Rising collaborative growth for the development of in-vitro diagnostic (IVD) test kits
  • 5.1.4. Challenges
    • 5.1.4.1. Stringent regulations of IVDs & LDTs
• 5.2. Market Segmentation Analysis
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. IVD & LDT For Autoimmune Diseases Market, by Technology

• 6.1. Introduction
• 6.2. Clinical Chemistry
• 6.3. Coagulation
• 6.4. Hematology
• 6.5. Immunoassays
• 6.6. Microbiology
• 6.7. Molecular Diagnostics

7. IVD & LDT For Autoimmune Diseases Market, by Application

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

8. Americas IVD & LDT For Autoimmune Diseases Market

• 8.1. Introduction
• 8.2. Argentina
• 8.3. Brazil
• 8.4. Canada
• 8.5. Mexico
• 8.6. United States

9. Asia-Pacific IVD & LDT For Autoimmune Diseases Market

• 9.1. Introduction
• 9.2. Australia
• 9.3. China
• 9.4. India
• 9.5. Indonesia
• 9.6. Japan
• 9.7. Malaysia
• 9.8. Philippines
• 9.9. Singapore
• 9.10. South Korea
• 9.11. Taiwan
• 9.12. Thailand
• 9.13. Vietnam

10. Europe, Middle East & Africa IVD & LDT For Autoimmune Diseases Market

• 10.1. Introduction
• 10.2. Denmark
• 10.3. Egypt
• 10.4. Finland
• 10.5. France
• 10.6. Germany
• 10.7. Israel
• 10.8. Italy
• 10.9. Netherlands
• 10.10. Nigeria
• 10.11. Norway
• 10.12. Poland
• 10.13. Qatar
• 10.14. Russia
• 10.15. Saudi Arabia
• 10.16. South Africa
• 10.17. Spain
• 10.18. Sweden
• 10.19. Switzerland
• 10.20. Turkey
• 10.21. United Arab Emirates
• 10.22. United Kingdom

11. Competitive Landscape

• 11.1. Market Share Analysis, 2023
• 11.2. FPNV Positioning Matrix, 2023
• 11.3. Competitive Scenario Analysis
• 11.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Adaptive Biotechnologies Corporation
• 2. Agilent Technologies Inc.
• 3. Bio-Rad Laboratories, Inc.
• 4. bioMerieux, Inc.
• 5. Corgenix, Inc.
• 6. Creative Biolabs Inc.
• 7. Diasorin S.P.A.
• 8. in.vent Diagnostica GmbH
• 9. Johnson & Johnson Services, Inc.
• 10. Microbix Biosystems Inc.
• 11. PerkinElmer, Inc.
• 12. Roche Diagnostics Corporation
• 13. SQI Diagnostics Inc.
• 14. Thermo Fisher Scientific Inc.