The increasing demand for personalized medicine has created a need for advanced diagnostic tools such as LDTs that can provide personalized and precise information about an individual's health status, enabling tailored treatment approaches and better patient outcomes. Customized medicine tailors medical treatments and diagnostics to individual patients based on their genetic makeup, lifestyle, and other factors.
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LDTs provide customized diagnostic solutions by analyzing specific genetic markers or biomarkers associated with a disease or condition. These tests enable healthcare providers to obtain detailed information about a patient's genetic profile, allowing for more precise diagnosis, prognosis, and treatment selection.
LDTs are developed by clinical laboratories to meet specific testing needs that are not addressed by commercially available tests. They are commonly used in Molecular Diagnostics, genetic testing, pathology, microbiology, and other areas of clinical laboratory medicine. LDTs can encompass various tests, including genetic, oncology, infectious diseases, pharmacogenomic, and others. The development of LDTs involves several stages, including test design, optimization, analytical validation, and clinical validation. Laboratories performing LDTs must comply with regulatory requirements, quality standards, and guidelines to ensure accurate and reliable test results. Regulatory oversight for LDTs varies across different countries and regions, with some jurisdictions imposing stricter regulations.
Data Bridge Market Research analyses that the Global Laboratory-Developed Tests (LDTs) Market is expected to grow with a CAGR of 10.7% in the forecast period from 2023 to 2030 and is expected to reach USD 41,521.83 million by 2030.
Key Findings of the Study
Increasing Demand for Precision Medicine and Targeted Therapy
Precision medicine aims to tailor medical treatment to the individual characteristics of each patient. It involves analyzing a patient's genetic makeup, biomarkers, and other relevant factors to determine the most effective treatment. LDTs play a crucial role in this approach by providing specialized tests that identify specific biomarkers or genetic mutations associated with certain diseases. The growing demand for personalized medicine requires more LDTs to support diagnostic and treatment decisions.
Targeted therapy is a treatment approach that focuses on specific molecular targets involved in developing and progressing diseases, such as cancer. These therapies require accurate and reliable diagnostic tests to identify patients likely to respond to targeted drugs. LDTs can be designed to detect specific genetic mutations or biomarkers that determine patients' suitability for targeted therapies. The increased adoption of targeted therapies fuels the demand for LDTs that enable precise patient stratification.
Recent Development
- In March 2023, Admera Health announced its acquisition of an Illumina NovaSeq X Plus sequencer to bolster its offering. This helped the company to strengthen its product portfolio
- In March 2023, Abbott received FDA clearance for the first commercially available lab-based blood test to help evaluate concussion. This helped the company to establish its global presence
- In February 2023, Bio-Rad Laboratories, Inc. announced that the company's management participated in a fireside chat event during Citi's 2023 Healthcare Services, MedTech, Tools & HCIT Conference on Thursday. This increases the company's global image, among others
- In January 2023, Unilabs and Ambry Genetics (Ambry) announced they entered an exclusive partnership to enhance high-quality genetic testing services for government-sponsored and biopharma companies conducting international clinical trials and research. This helps the organization in developing annual revenue
- In December 2022, BIOMÉRIEUX announced that it would grant CE-marking of VIDAS KUBE, the next-generation system in the VIDAS immunoassay portfolio. This will increase the company's product portfolio
- In January 2022, 23andMe, Inc. received FDA Clearance for a direct-to-consumer genetic test on a hereditary prostate cancer marker. This helped the company to strengthen its product portfolio
Report Scope and Market Segmentation
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Report Metric
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Details
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Forecast Period
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2023 to 2030
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Base Year
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2022
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Historic Years
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2021 (Customizable to 2015-2020)
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Quantitative Units
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Revenue in Million, Pricing in USD
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Segments Covered
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Test Type (Clinical Chemistry and Immunology, Critical Care, Hematology, Molecular Diagnostics, Microbiology, and Other Test), By Product Type (Consumables, Analyzers and Instruments, and Accessories), By Sample Type (Blood, Urine, Tissue, Cerebrospinal Fluid (CSF), and Others), By Therapeutic Area (Infections, Genetic Disorders, Oncology/Cancer, Autoimmune Disease, Urology, Gynecology, and Others), By Gender (Male, and Female), By Age Group (Geriatrics, Adult, and Pediatric), By End Users (Hospital-Based Labs, Stand-Alone Labs, Diagnostic Chains, Academic Institutes, Clinical Research Organizations, Specialty Diagnostic Centers, and Others), By Distribution Channel (Direct Tender, Retail Sales, Third Party Distributors, and Others)
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Countries Covered
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U.S., Canada, Mexico, Germany, France , U.K., Italy, Russia, Spain, Turkey, Netherlands, Switzerland, Belgium, Poland, Sweden, Denmark, Finland, Norway, Rest of Europe, China, Japan , South Korea , India , Australia , Singapore, Thailand , Indonesia , Philippines , Malaysia , New Zealand , Vietnam , Taiwan, Rest Of Asia-Pacific, Brazil, Argentina, Rest of South America, South Africa , Saudi Arabia , UAE , Egypt, Israel , Oman , Bahrain , Kuwait , Qatar , Rest of Middle East and Africa
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Market Players Covered
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F. Hoffmann-La Roche Ltd (Switzerland), bioMérieux, Inc. (France), Sysmex Corporation (Japan), Biomerica, Inc. (U.S.), Bio-Rad Laboratories, Inc. (U.S.), BD (U.S.), Quest Diagnostics Incorporated (U.S.), Hologic, Inc.(U.S.), Siemens Medical Solutions USA, Inc. (Germany), Abbott (U.S.), Eurofins Scientific (Belgium), Beckman Coulter, Inc. (U.S.), 23andMe, Inc. (U.S.), OPKO Health, Inc. (U.S.), Seegene Inc. (Republic of Korea), QIAGEN (Germany), Guardant Health (U.S.), NeoGenomics Laboratories. (U.S.), Ambry Genetics (U.S.), BGI (China), Agendia (U.S.), Biodesix. (U.S.), Milab Scientific (UAE), Admera Health (U.S.) among others.
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Data Points Covered in the Report
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In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.
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Segment Analysis
The global laboratory-developed tests (LDTs) market is segmented into eight notable segments based on test type, product type, sample type, therapeutic area, gender, age group, end user, and distribution channel.
- Based on test type, the global laboratory-developed tests (LDTs) market is segmented into clinical chemistry and immunology, critical care, haematology, molecular diagnostics, microbiology, and other test.
In 2023, the clinical chemistry and immunology segment of test type segment is anticipated to dominate the global laboratory-developed tests (LDTs) market
In 2023, the clinical chemistry and immunology segment of this market is expected to dominate the laboratory-developed tests (LDTs) market with a market share of 33.54% and are estimated to reach USD 14,326.37 million by 2030, growing at a CAGR of 11.2% in the forecast period of 2023 to 2030.
- Based on product type, the global laboratory-developed tests (LDTs) market is segmented into consumables, analyzers & instruments, and accessories. In 2023, consumables segment is expected to dominate the global laboratory-developed tests (LDTs) market with a market share of 53.65% and is estimated to reach USD 22,794.28 million by 2030, growing at a CAGR of 11.1% in the forecast period of 2023 to 2030
- Based on sample type, the global laboratory-developed tests (LDTs) market is segmented into blood, urine, tissue, Cerebrospinal Fluid (CSF), and others. In 2023, blood segment is expected to dominate the global laboratory-developed tests (LDTs) market with a market share of 34.02% and is estimated to reach USD 15,259.21 million by 2030, growing at a CAGR of 11.9% in the forecast period of 2023 to 2030
In 2023, the blood segment of test type segment is anticipated to dominate the global laboratory-developed tests (LDTs) market
In 2023, the blood segment of this market will dominate the laboratory-developed tests (LDTs) market is expected to dominate with a market share of 34.02% and is estimated to reach USD 15,259.21 million by 2030, growing at a CAGR of 11.9% in the forecast period of 2023 to 2030.
- Based on therapeutic area, the global laboratory-developed tests (LDTs) market is segmented into infections, Genetic Disorders, oncology/cancer, autoimmune disease, urology, gynecology, and others. In 2023, infections segment is expected to dominate the global laboratory-developed tests (LDTs) market with a market share of 24.57% and is estimated to reach USD 12,106.00 million by 2030, growing at a CAGR of 13.5% in the forecast period of 2023 to 2030
- Based on gender, the global laboratory-developed tests (LDTs) market is segmented into male, and female. In 2023, male segment is expected to dominate the global laboratory-developed tests (LDTs) market with a market share of 73.98% and is estimated to reach USD 30,792.05 million by 2030, growing at a CAGR of 10.8% in the forecast period of 2023 to 2030
- Based on age group, the global laboratory-developed tests (LDTs) market is segmented into geriatrics, adult, and pediatric. In 2023, geriatrics segment is expected to dominate the Global laboratory-developed tests (LDTs) market with a market share of 53.08% and are estimated to reach USD 22,473.23 million by 2030, growing at a CAGR of 11.0% in the forecast period of 2023 to 2030
- Based on end users, the global laboratory-developed tests (LDTs) market is segmented into hospital-based labs, stand-alone labs, diagnostic chains, academic institutes, clinical research organizations, specialty diagnostic centres, and others. In 2023, hospital-based labs segment is expected to dominate the global laboratory-developed tests (LDTs) market with a market share of 25.76% and are estimated to reach USD 11,422.87 million by 2030, growing at a CAGR of 11.8% in the forecast period of 2023 to 2030
- Based on distribution channel, the global laboratory-developed tests (LDTs) market is segmented into direct tender, retail sales, third party distributors, and others. in 2023, direct tender segment is expected to dominate the global laboratory-developed tests (LDTs) market with a market share of 39.98% and is estimated to reach USD 17,277.01million by 2030, growing at a CAGR of 11.4% in the forecast period of 2023 to 2030
Major Players
Data Bridge Market Research recognizes the following companies as the market players in global laboratory-developed tests (LDTs) market are F. Hoffmann-La Roche Ltd (Switzerland), bioMérieux, Inc. (France), Sysmex Corporation (Japan), Biomerica, Inc. (U.S.), Bio-Rad Laboratories, Inc. (U.S.), BD (U.S.), Quest Diagnostics Incorporated (U.S.), Hologic, Inc.(U.S.), Siemens Medical Solutions USA, Inc. (Germany), Abbott (U.S.) among others.
Regional Analysis
Geographically, the countries covered in the global laboratory-developed tests (LDTs) market report are U.S., Canada, Mexico, Germany, France , U.K., Italy, Russia, Spain, Turkey, Netherlands, Switzerland, Belgium, Poland, Sweden, Denmark, Finland, Norway, Rest of Europe, China, Japan , South Korea , India , Australia , Singapore, Thailand , Indonesia , Philippines , Malaysia , New Zealand , Vietnam , Taiwan, Rest Of Asia-Pacific, Brazil, Argentina, Rest of South America, South Africa , Saudi Arabia , UAE , Egypt, Israel , Oman , Bahrain , Kuwait , Qatar , Rest of Middle East and Africa.
As per Data Bridge Market Research analysis: The global laboratory-developed tests (LDTs) market is expected to grow at a CAGR of 10.7% due to the growing prevenance of chronic diseases.
North America is the dominant region in the global laboratory-developed tests (LDTs) market during the forecast period 2023 -2030
In 2023, North America dominated the global laboratory-developed tests (LDTs) market because of the higher level of investments by various manufacturers and increasing and technological advancements in the region. North America will continue to dominate the global laboratory-developed tests (LDTs) market in terms of market share and market revenue and will continue to flourish its dominance during the forecast period.
North America is estimated to be the fastest growing region in laboratory-developed tests (LDTs) market the forecast period 2023 -2030. This is due to the growing adoption of advanced technology and launch of new products in this region.
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