LDT 시장 : 기회, 성장 요인, 업계 동향 분석, 예측(2025-2034년)

The Global Laboratory Developed Tests Market was valued at USD 17.8 billion in 2024 and is estimated to grow at a CAGR of 10.5% to reach USD 48.5 billion by 2034.

The rapid growth is largely driven by increasing awareness around early disease detection, the rising prevalence of infectious and chronic illnesses, and a growing number of cancer and genetic disorder cases. LDTs, which are diagnostic tests created, manufactured, and used within a single laboratory, revolutionize personalized medicine, improving disease management and aiding clinical decision-making. Their ability to rapidly innovate and tailor tests to specific patient needs is transforming healthcare, especially in the context of complex conditions that require precise and individualized diagnostics. Companies offer an extensive range of tests, from advanced next-generation sequencing (NGS) panels to sophisticated molecular diagnostics and biomarker assays. These tests utilize state-of-the-art technologies, including high-throughput genomics, AI-driven algorithms, bioinformatics platforms, and cloud-enabled data integration. As cancer rates continue to climb, the demand for early, accurate, and personalized diagnostics intensifies. LDTs play a crucial role by enabling the swift detection of genetic mutations, biomarkers, and disease subtypes, which are vital for tailoring targeted treatments and enhancing patient outcomes.

The immunohistochemistry (IHC) segment is anticipated to grow at a CAGR of 9.9% through 2034, due to the increasing global burden of cancer. IHC is essential for identifying tumor markers, assisting treatment choices, and supporting personalized medicine strategies, solidifying its place in oncology diagnostics.

The infectious diseases segment is expected to grow at a 11% CAGR through 2034, driven by the rising global incidence of viral and bacterial infections. The flexibility and rapid turnaround offered by LDTs make them indispensable for managing outbreaks and everyday infectious disease diagnosis.

U.S. Laboratory Developed Tests Market generated USD 6.8 billion in 2024, benefiting from a robust network of hospitals and reference labs capable of developing and validating complex tests, particularly in oncology, infectious diseases, and genetic conditions. The regulatory environment in North America, especially the U.S., has traditionally encouraged innovation in LDTs, allowing labs to respond to emerging health challenges. The integration of AI, automation, and next-generation sequencing technologies continues to fuel growth, establishing the region as a leader in advanced diagnostic development.

Leading companies in the Global Laboratory Developed Tests Market include IgX, Freenome, GUARDANT, HealthBio, veracyte, BioReference, MicroGenDX, prognomiQ, MAYO CLINIC LABORATORIES, SONIC HEALTHCARE USA, and GeneDx. Companies in the Laboratory Developed Tests Market focus on continuous innovation by integrating cutting-edge technologies such as AI, machine learning, and next-generation sequencing to enhance test accuracy and turnaround time. Strategic collaborations and partnerships with hospitals, research institutes, and biotech firms enable expanded test portfolios and faster market entry. Investments in bioinformatics and cloud computing facilitate advanced data analytics and seamless integration of patient information, improving diagnostic precision. Additionally, companies prioritize regulatory compliance and agile adaptation to changing health landscapes to maintain a competitive advantage.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definition
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
  • 1.3.1 Global
  • 1.3.2 Regional/Country
• 1.4 Base estimates and calculations
  • 1.4.1 Base year calculation
  • 1.4.2 Key trends for market estimation
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
• 1.6 Forecast model
• 1.7 Research assumptions and limitations

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis
• 2.2 Key market trends
  • 2.2.1 Regional trends
  • 2.2.2 Technology trends
  • 2.2.3 Application trends
  • 2.2.4 End use trends
• 2.3 CXO perspectives: Strategic imperatives
  • 2.3.1 Key decision points for industry executives
  • 2.3.2 Critical success factors for market players
• 2.4 Future outlook and strategic recommendations

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
    • 3.2.1.4 Technological advancements
  • 3.2.2 Industry pitfalls & challenges
    • 3.2.2.1 Availability of alternative testing methods
  • 3.2.3 Market opportunities
    • 3.2.3.1 Integration of automation & digital pathology
• 3.3 Growth potential analysis
• 3.4 Reimbursement scenario
  • 3.4.1 LDT pricing models & strategies
  • 3.4.2 Clinical laboratory fee schedule (CLFS) impact analysis
  • 3.4.3 Medicare Part B coverage & reimbursement rates
• 3.5 Regulatory landscape
• 3.6 Technological landscape
  • 3.6.1 Current technologies
  • 3.6.2 Emerging technologies
• 3.7 Future market trends
• 3.8 Value chain analysis
• 3.9 Consumer behavior analysis
• 3.10 Investment landscape
• 3.11 Pricing analysis, 2024
• 3.12 Porter's analysis
• 3.13 PESTEL analysis
• 3.14 Gap analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company matrix analysis
• 4.3 Company market share analysis
  • 4.3.1 North America
  • 4.3.2 Europe
  • 4.3.3 Asia Pacific
  • 4.3.4 LAMEA
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Key developments
  • 4.6.1 Mergers & acquisitions
  • 4.6.2 Partnerships & collaborations
  • 4.6.3 New product launches
  • 4.6.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Technology, 2021 - 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Polymerase chain reaction (PCR)
• 5.3 Next-generation sequencing (NGS)
• 5.4 Immunohistochemistry (IHC)
• 5.5 Other technologies

Chapter 6 Market Estimates and Forecast, By Application, 2021 - 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Oncology
• 6.3 Infectious diseases
• 6.4 Genetic & rare disorders
• 6.5 Cardiology
• 6.6 Autoimmune & inflammatory conditions
• 6.7 Other applications

Chapter 7 Market Estimates and Forecast, By End Use, 2021 - 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Hospital laboratories
• 7.3 Private reference labs
• 7.4 Specialty diagnostic labs
• 7.5 Other End use

Chapter 8 Market Estimates and Forecast, By Region, 2021 - 2034 ($ 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 Spain
  • 8.3.5 Italy
  • 8.3.6 Netherlands
• 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
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
• 8.6 Middle East and Africa
  • 8.6.1 South Africa
  • 8.6.2 Saudi Arabia
  • 8.6.3 UAE

Chapter 9 Company Profiles

• 9.1 ARUP Laboratories
• 9.2 BioReference
• 9.3 EXACT SCIENCES
• 9.4 Freenome
• 9.5 GeneDx
• 9.6 GUARDANT
• 9.7 HealthBio
• 9.8 IgX
• 9.9 Labcorp
• 9.10 MAYO CLINIC LABORATORIES
• 9.11 MicroGenDX
• 9.12 prognomiQ
• 9.13 Quest Diagnostics
• 9.14 SONIC HEALTHCARE USA
• 9.15 Veracyte