세계의 약사 미승인 검사(LDT) 시장 : 검사 유형, 용도, 최종 용도별 예측(2024-2032년)

Global Laboratory Developed Tests Market will reach a 6.4% CAGR from 2024 to 2032, attributed to advancements in diagnostic technologies along with evolving regulatory changes and guidelines. These developments enable labs to create and deploy highly specialized tests swiftly, catering to diverse clinical needs with greater accuracy and efficiency. Regulatory updates ensure rigorous quality assurance, boosting confidence in LDTs' reliability and safety. As healthcare shifts towards personalized medicine, the demand for LDTs tailored to individual patient profiles will grow, driving noteworthy expansion in this pivotal segment of diagnostic innovation.

For instance, in April 2024, the FDA issued a final rule defining laboratory-developed tests (LDTs) as in vitro diagnostics, subjecting them to FDA oversight under the FD&C Act, marking a significant regulatory shift for LDTs in the US. This development implies potential shifts in how LDTs are developed, validated, and marketed, impacting compliance requirements, innovation timelines, and market entry strategies. Globally, this regulatory shift may influence international standards for LDTs, affecting market dynamics, including competitiveness, innovation pace, and patient access to advanced diagnostic technologies.

The laboratory-developed tests industry is classified based on test type, application, end-use, and region.

The clinical biochemistry segment will see a notable surge between 2024 and 2032, owing to its pivotal role in diagnosing metabolic disorders, hormonal imbalances, and other health conditions. As healthcare providers increasingly rely on biochemical assays for precise patient assessment and treatment monitoring, the demand for advanced LDTs grows. This segment's focus on analyzing biomarkers and biochemical parameters crucially supports personalized medicine initiatives, ensuring accurate diagnostics and therapeutic interventions. With ongoing advancements in analytical techniques, clinical biochemistry remains at the forefront, shaping the future of diagnostic testing.

The diagnostic centers segment will amass remarkable gains through 2032, propelled by its specialized capabilities in providing comprehensive diagnostic solutions. These centers offer a wide array of LDTs tailored to individual patient needs, including genetic testing and personalized medicine. With increasing healthcare demands and a focus on early disease detection, diagnostic centers play a critical role in expanding access to advanced diagnostics. Their strategic collaborations with healthcare providers and commitment to quality assurance position them prominently in the laboratory developed tests market outlook.

Asia Pacific will secure a substantial market presence from 2024 to 2032, driven by rapid healthcare infrastructure development and rising demand for personalized medicine. The region's expansive population, increasing healthcare expenditure, and adoption of advanced diagnostic technologies contribute to its dominance. With a growing burden of chronic diseases and infectious ailments, Asia Pacific's contribution to the global laboratory developed tests industry growth is significant, emphasizing its role as a key contributor to advancements in healthcare diagnostics and patient care.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope & definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates & calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Increasing incidence of cancer and genetic disorders
    • 3.2.1.2 Rising prevalence of infectious and chronic diseases
    • 3.2.1.3 Growing awareness and focus on early disease detection
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Availability of alternative testing methods
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Reimbursement scenario
• 3.6 Technological advancements
• 3.7 Porter's analysis
• 3.8 PESTEL analysis
• 3.9 Future market trends

Chapter 4 Competitive Landscape, 2023

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
• 4.4 Competitive positioning matrix
• 4.5 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Test Type, 2021 - 2032 ($ Mn)

• 5.1 Key trends
• 5.2 Clinical biochemistry
• 5.3 Immunology
• 5.4 Haematology
• 5.5 Microbiology
• 5.6 Molecular diagnostics
• 5.7 Flow cytometry
• 5.8 Histology/Cytology
• 5.9 Other test types

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2032 ($ Mn)

• 6.1 Key trends
• 6.2 Oncology
• 6.3 Genetics
• 6.4 Infectious diseases
• 6.5 Autoimmune disorders
• 6.6 Neurology
• 6.7 Mental/behavioral disorder
• 6.8 Nutritional & metabolic diseases
• 6.9 Other applications

Chapter 7 Market Estimates and Forecast, By End-use, 2021 - 2032 ($ Mn)

• 7.1 Key trends
• 7.2 Hospital laboratories
• 7.3 Diagnostic centers
• 7.4 Clinical research organizations
• 7.5 Academic and research institutes
• 7.6 Other end-users

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2032 ($ Mn)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Italy
  • 8.3.5 Spain
  • 8.3.6 Netherlands
  • 8.3.7 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Australia
  • 8.4.5 South Korea
  • 8.4.6 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
  • 8.5.4 Rest of Latin America
• 8.6 Middle East and Africa
  • 8.6.1 Saudi Arabia
  • 8.6.2 South Africa
  • 8.6.3 UAE
  • 8.6.4 Rest of Middle East and Africa

Chapter 9 Company Profiles

• 9.1 23andMe, Inc.
• 9.2 Abbott
• 9.3 Bio-Rad Laboratories, Inc.
• 9.4 Eurofins Scientific
• 9.5 F. Hoffmann-La Roche Ltd.
• 9.6 Illumina, Inc.
• 9.7 NeoGenomics Laboratories
• 9.8 OPKO Health, Inc.
• 9.9 QIAGEN
• 9.10 Quest Diagnostics Incorporated