Laboratory Developed Test Market

Laboratory Developed Test Market Outlook (2024 to 2034)

The laboratory developed test market size is anticipated to be worth US$ 8,698.6 million in 2024, and is projected to expand at a CAGR of 6.5%, resulting in a valuation of US$ 16,404.2 million by 2034. The market is likely to grow over the decade due to the rise in demand for in-vitro diagnostic tests.

Key Market Growth Drivers

• The increasing incidence of various health disorders is driving the expansion of the lab-developed test market.
• The growing need for individualized medication is another important reason driving demand for laboratory developed tests, making them a more flexible and accessible choice for medical practitioners.
• The rising demand for cost-effective diagnostics is fueling market sales, which helps lower the cost of healthcare for individuals.
• Additionally, the adaptability of tests created in laboratories generates new opportunities for developing diagnostic instruments for a range of medical disorders.
• The LDT sector is witnessing a surge in investment and innovation due to the increasing precision and efficacy of laboratory developed tests in detecting and diagnosing diseases. Businesses are boosting their potential to invest in medical research and enhance patient outcomes.

The laboratory developed test market is anticipated to grow throughout the forecast period, mostly due to a strong product pipeline. As more potent and inventive products are created and made accessible, the industry is expected to expand progressively over the next decade.

Report Attributes	Details
Estimated Market Value (2024E)	US$ 8,698.6 million
Forecasted Market Value (2034F)	US$ 16,404.2 million
Global Market Growth Rate (2024 to 2034)	6.5% CAGR
Clinical Biochemistry Segment Growth Rate (2024 to 2034)	6.0%
Oncology Segment Growth Rate (2024 to 2034)	6.6%
North America Market Share (2024)	38.2%
East Asia Market Share (2024)	10.1%
Key Companies Profiled	Parkview Medical Center United Medical Labs Inc. Desert Regional Medical Center Clinical Lab Med Plus LLC Bristol Bay Area Health Corporation Admera Health Sharp Cornado Hospital & Healthcare Center Ambry Genetics Corp. Adaptive Biotechnologies Corporation 23andMe, Inc. South Texas Clinical Laboratory LLP. Hendry Regional Medical Center Clinical Laboratory Citrano Medical Laboratories Agendia Nv Applied Proteomics, Inc.

Which Factors are Driving the Global Surge in Laboratory Developed Test Industry?

“Personalized Medications Bolstering Demand for Laboratory Developed Tests”

In recent years, healthcare treatments such as cancer treatments have witnessed a significant shift toward personalized medications, as it presents the possibility of more effective and targeted therapy for patients. Such a technique involves analyzing an individual's genetic composition and tailoring treatments accordingly. Several drugs have been specifically developed to target the underlying reasons for the disease, combining the principles of precision medicine and clinical care.

Manufacturers in the laboratory developed test sector have many opportunities to create novel and cutting-edge testing products that can meet the demands of patients and healthcare providers, given the increasing desire for personalized treatment, which can transform the healthcare industry completely by providing patients with a more individualized and efficient treatment plan.

“Growing Research and Development and Lab Dialysis Procedures”

The expansion of healthcare infrastructure and the penetration of new technology are driving growth in the market. The increase in healthcare capital expenditure and the installed base of various types of products in laboratory are stimulating the market demand.

The influence of technology on the market is examined through modifications to healthcare regulatory standards. The growing need for lab dialysis procedures is predicted to propel the laboratory developed test market, pointing to a promising future.

What are the Challenges in the Laboratory Developed Test Market?

“Rising Diagnostic Product Recalls Hindering Market Growth”

Healthcare diagnostic product recalls aim to minimize or eliminate malfunctions in diagnostic tests designed to cure various ailments, including genetic disorders, multiple types of cancers, and infectious diseases. The rise in product recalls acts as a restraining factor in the market.

The central registration and tracking make it difficult to compare LDTs with FDA-approved diagnostics. Due to a lack of oversight, eHealth and insurance coverage must distinguish between laboratory tests and FDA-approved diagnoses. Consultation requires a full database of all lab-developed tests currently in service. These aspects are restricting growth in the market. As the demand for reliable diagnostic tests increases, the need for a comprehensive system for tracking, regulating, and comparing laboratory-developed tests also rises.

Country-wise Insights

The laboratory-developed test market in North America is expected to rise at a 5.1% CAGR through 2034. Laboratory-grade diagnoses are expected to account for 86.5% of the revenue share in the United States in 2024. Meanwhile, the East Asian lab-developed testing business is expected to grow at a 9.7% CAGR through 2034. China is predicted to dominate the East Asian market with a revenue share of 58.1% in 2024.

Why is the United States Dominating the Laboratory Developed Test Market?

“FDA Monitors Laboratory Developed Test Industry Growth in the United States”

Attribute	Details
CAGR (2024 to 2034)	5.0%

The need for laboratory-created tests is predicted to rise, especially in the United States, with a market value estimated at US$ 2,870 million in 2024. Furthermore, the CAGR for the projection period is expected to be 5.0%. This expansion is expected to result in a market value of US$ 4,691 million by 2034. The US FDA has been actively discussing increased regulation of laboratory developed tests (LDTs) due to their rapid evolution and proliferation and concerns regarding their safety and effectiveness.

The FDA recognizes the need for patients and healthcare providers to have confidence in the accuracy, reliability, and clinical relevance of LDTs. With proper FDA oversight, the in-vitro diagnostic industry, specifically LDTs, can improve. False test results or misleading claims regarding the interpretation of test results can significantly impact patient health outcomes.

As an outcome, the LDT sector in the United States is expected to experience major changes in the following decade.

Which Factor Positions China as a Lucrative Market for Laboratory Developed Tests?

“Regional Endeavours Offer Fertile Ground for the Chinese Laboratory Developed Test Industry”

Attribute	Details
CAGR (2024 to 2034)	9.5%

China's demand for laboratory developed tests is anticipated to rise and reach US$ 510 million in 2024. China's share of the East Asian lab-developed testing industry is expected to be 58.1% in 2024. This industry has seen significant growth in recent years. The market in China is expected to register a CAGR of 9.5% through 2034.

The Chinese medical testing industry has grown significantly in recent years due to continued research and development by academics and pharmaceutical companies, an increase in the prevalence of diabetes, and a growing aging population.

Manufacturers of laboratory diagnostic tests may access a substantial market in China. State-of-the-art technological developments are supporting these rapidly evolving methods. Large corporations are constructing innovation centers and research and development facilities to stimulate market growth in emerging nations such as China.

Category-wise Insights

Based on the type of test, the clinical biochemistry segment is projected to hold a 32.9% market share in 2024. The molecular diagnostics segment is estimated to account for 23.1% of the market.

Based on applications, the oncology segment is expected to hold a 40.8% market share in 2024. The genetics segment is expected to hold a 28.0% market share in 2024.

Which Test Type is Fueling the Market for Laboratory Developed Tests?

“Clinical Biochemistry Dissects the Swelled Laboratory Developed Testing Market”

Attribute	Details
Market Share in 2024	32.9%

In 2024, clinical biochemistry tests are expected to hold a commanding 32.9% market share. Demand for clinical biochemistry is projected to increase at a 6.0% CAGR through 2034. The clinical biochemistry segment is likely to be valued at US$ 2,865.7 million in 2024.

The increasing demand for precise and prompt diagnosis of a wide range of medical disorders has led to an increase in the use of laboratory tests in clinical biochemistry. This has prepared the door for more widespread use of molecular diagnostic procedures, which provide a more precise and focused approach to illness identification and surveillance.

Clinical biochemistry and molecular diagnostics are anticipated to be major drivers of laboratory test demand in the upcoming years as patients and healthcare professionals are adopting practical and efficient methods to diagnose and cure ailments.

Competitive Landscape

Key players in the laboratory developed test market include, Parkview Medical Center, United Medical Labs Inc., Desert Regional Medical Center Clinical Lab, Med Plus LLC, Bristol Bay Area Health Corporation, Admera Health, Sharp Cornado Hospital & Healthcare Center, Ambry Genetics Corp., Adaptive Biotechnologies Corporation, 23andMe, Inc., South Texas Clinical Laboratory LLP., Hendry Regional Medical Center Clinical Laboratory, Citrano Medical Laboratories, Agendia Nv, and Applied Proteomics, Inc.

Key manufacturers are strengthening local and worldwide distribution networks to reach a wider customer base. They are joining forces with tech platforms to expand their online presence, collaborating with medical chains to ensure their products are readily available in physical locations. They are establishing partnerships with pharmacy service providers to address the growing demand for long-lasting and reasonably priced academic research services in the healthcare industry.

Key players of laboratory developed tests are expanding the spectrum of electronic clinical outcome assessments in their product offerings to better meet the needs of a diverse patient population and varying healthcare demands. Market players are also investing in research and development to produce durable, efficient, and alluring digital medical solutions.

Recent Developments

• In December 2023, the Bionano Laboratories published a research paper covering the analytical validation of its laboratory-developed test (LDT), vented as OGM-Dx™ HemeOne.
• In September 2023, the US Food and Drug Administration proposed the petition to oversee the development of the growing category of medical tests that come under laboratory-developed tests.

Segmentation of Laboratory Developed Test Market

• By Test type:

  • Clinical Biochemistry
  • Critical Care
  • Hematology
  • Immunology
  • Microbiology
  • Molecular Diagnostics
  • Others

• By Application:

  • Oncology
  • Genetics
  • Infectious Diseases
  • Auto Immune Disorders
  • Neurology

• By End-User:

  • Hospital Laboratories
  • Specialty Diagnostics Centers
  • Clinical Research Organizations
  • Research Institutes

• By Region:

  • North America
  • Europe
  • East Asia
  • East Asia
  • South Asia & Oceania
  • Middle East & Africa