$4550
$2730
The laboratory developed test market is expected to reach US$ 7,269.3 million by 2028 from US$ 4,524.75 million in 2021; it is expected to grow at a CAGR of 7.0% during 2021–2028.
A laboratory developed test (LDT) is a type of in vitro diagnostic test designed and used within a single laboratory. These tests can be used to estimate or distinguish an analytes such as proteins, biomolecules/compounds (glucose, cholesterol, etc.), and DNA extracted from specimens collected from human subjects. The expansion of automated in vitro diagnostics (IVD) methods for laboratories and dispensaries to render precise and error-free analysis is fueling the laboratory developed test market growth.
The growth of the laboratory developed test market is mainly attributed to factors such as the increasing incidents of cancer and genetic disorders, and large number of product launches. However, changing regulatory landscape is hindering the market growth. For example, in Europe, the In-Vitro Device Regulation (IVDR) compliance will be mandatory for all in vitro diagnostic tests from May 2022; the regulation aims to secure the clinical effectiveness and safety of medical tests, thus transforming the diagnostic industry, which is a great concern for the market players.
Lucrative Regions in Laboratory Developed Test Market
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
- Request discounts available for Start-Ups & Universities
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
- Request discounts available for Start-Ups & Universities
Market Insights
Continuous Research on Personalized Medicines Provides Growth Opportunities to Laboratory Developed Test Market Players
LDTs play a vital role in the development of personalized medicines that are likely to prove as promising means of tackling diseases through far eluded effective treatments or cures. As per the Personalized Medicine Coalition, personalized medicines accounted for only 5% of the new FDA-approved molecular entities in 2005; however, in 2016, this number rose to more than 25%. Additionally, 42% of all compounds and 73% of oncology compounds in the pipeline have the potential to serve as personalized medicines. Biopharmaceutical companies have nearly doubled their R&D investments in personalized drugs in the last five years, and they are further expected to increase their investments by 33% in the next five years. Biopharmaceutical researchers also predict a 69% increase in the development of personalized medicines in the next five years. Laboratory tests are used to diagnose illness and predict and monitor drug response as well as to obtain informatics data needed for complex predictive algorithms.
Personalized medicines are becoming the trademark of cancer treatment; it is a constantly evolving approach that is based on the customization of treatments as per the individual genetic makeup. In 2019, the FDA approved 12 personalized medications to investigate and address the root causes of disease, thus combining precision medicine in clinical care. The rising demand for personalized medicine is offering significant growth opportunities for the growth of the players operating in the laboratory developed test market.
Type-Based Insights
The laboratory developed test market, by type, is segmented into clinical biochemistry, critical care, hematology, microbiology, molecular diagnostics, immunology, and others. The molecular diagnostics segment is expected to hold the largest share of the market in 2021. However, the hematology segment is anticipated to register the highest CAGR in the market during the forecast period.
Laboratory Developed Test Market by Type – 2021 and 2028
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
- Request discounts available for Start-Ups & Universities
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
- Request discounts available for Start-Ups & Universities
Application-Based Insights
By application, the laboratory developed test market application into academic institutes, clinical research organizations, hospitals laboratory, specialty diagnostic centers, and others. The hospitals laboratory segment is estimated to account for the largest market share in 2021. However, the specialty diagnostic centers segment is anticipated to register the highest CAGR in the market during the forecast period.
Customize Research To Suit Your Requirement
We can optimize and tailor the analysis and scope which is unmet through our standard offerings. This flexibility will help you gain the exact information needed for your business planning and decision making.
Laboratory Developed Test Market: Strategic Insights
Market Size Value in US$ 4,524.75 Million in 2021 Market Size Value by US$ 7,269.3 Million by 2028 Growth rate CAGR of 7.0% from 2021-2028 Forecast Period 2021-2028 Base Year 2021
Akshay
Have a question?
Akshay will walk you through a 15-minute call to present the report’s content and answer all queries if you have any.
Speak to Analyst
Customize Research To Suit Your Requirement
We can optimize and tailor the analysis and scope which is unmet through our standard offerings. This flexibility will help you gain the exact information needed for your business planning and decision making.
Laboratory Developed Test Market: Strategic Insights
Market Size Value in | US$ 4,524.75 Million in 2021 |
Market Size Value by | US$ 7,269.3 Million by 2028 |
Growth rate | CAGR of 7.0% from 2021-2028 |
Forecast Period | 2021-2028 |
Base Year | 2021 |
Akshay
Have a question?
Akshay will walk you through a 15-minute call to present the report’s content and answer all queries if you have any.
Speak to AnalystProduct launches and approvals are commonly adopted strategies by companies to expand their global footprints and product portfolios. Moreover, the laboratory developed test market players focus on the partnership strategy to enlarge their clientele, which, in turn, permits them to maintain their brand name globally.
The report segments laboratory developed test market as follows
Based on type, the laboratory developed test market is segmented into clinical biochemistry, critical care, hematology, microbiology, molecular diagnostics, immunology, and others. Based on Application, the laboratory developed test market is segmented into academic institutes, clinical research organizations, hospitals laboratory, specialty diagnostic centers, and others. On the basis of geography, the laboratory developed test market is segmented into North America (the US, Canada, and Mexico), Europe (the UK, Germany, France, Italy, Spain, and Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and Rest of Asia Pacific), the Middle East & Africa (the UAE, Saudi Arabia, South Africa, and Rest of the Middle East & Africa), and South and Central America (Brazil, Argentina, and the Rest of South and Central America).
Company Profiles
- Quest Diagnostics Incorporated
- F. HOFFMANN-LA ROCHE LTD.,
- QIAGEN
- Illumina, Inc.,
- Eurofins Scientific
- Biodesix
- Adaptive Biotechnologies
- Biotheranostics
- Rosetta Genomics Ltd.,
- Guardant Health
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Type and Application
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, RoAPAC, RoE, RoMEA, RoSCAM, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed and used within a single laboratory. These tests can be utilized to estimate or distinguish an extensive assortment of analytes materials such as proteins, chemical compounds like glucose or cholesterol, or DNA, from a specimen received from human anatomy. The expansion of automated in vitro diagnostics (IVD) methods for labs and dispensaries to render precise, and error-free analysis is anticipated to fuel the increment.
The growth of the laboratory developed test market is mainly attributed to factors such as the increasing incidents of cancer and genetic disorders, large number of product launches. However, changing regulatory landscape for instance, in Europe, the In-Vitro Device Regulation (IVDR) compliance will be mandatory for all in vitro diagnostic tests from May 2022; the regulation aims to secure the clinical effectiveness and safety of medical tests, thus transforming the diagnostic industry is a great concern to hinder the market growth. In August 2021, eMed, a telehealth company democratizing healthcare through digital-point-of-care solutions, and Quest Diagnostics the world's leading provider of diagnostic information services, are collaborated to bring clinician-guided rapid antigen testing for COVID-19 to employers seeking to foster safer environments by decreasing the risk of COVID-19 exposure in their workplaces which is contributing to the growth of the target market. Such strategic steps are also projected to drive the market growth.
The growth of the region is attributed to factors such as rising public–private partnerships, and increasing funding activities are widely enhancing the performance of medical devices. Moreover, presence of well-developed healthcare infrastructure and government support are some of the prominent factors propelling the market growth in Asia Pacific. In Asia Pacific, India is the largest market for laboratory developed test. The market growth in Asia Pacific is mainly attributed to factors such as the growing usage of laboratory developed test in combating Covid-19, increasing incidents of cancer and genetic disorders, large number of product launches. However concerns high capital investment for setting up advanced labs hinders the market growth in Asia Pacific.
The automation of LDTs can significantly boost productivity and simplify compliance procedures. Clinical laboratories are under huge pressure to manage increasing test volumes and conduct more complex diagnostic assays, which further underlines the need for flexible automation systems. Many MedTech companies are offering automation solutions to help streamline clinical laboratory processes. For instance, Roche Cobas Omni–Utility Channel is beneficial for both IVD assays and high-volume LDTs. It is designed to meet the growing needs of efficient workflows in laboratories, as it can assist in different stages ranging from sample processing to quick data interpretation. It can run up to 96 results in about 3 hours and up to 864 results in 8 hours, thereby boosting the efficiency of laboratories.
The laboratory developed test market is led by type molecular diagnostics segment is growing significantly due to the increasing attention to the development of genetic therapeutics. The growing research in human genomics is playing a vital role in developing laboratory developed tests. The technological advantages of molecular tests make them compelling diagnostic tools, and they have become valuable for detecting a wide range of genetic diseases. For instance, in November 2017, Edico Genome launched the DRAGEN Clinical Genomics Information System (CGIS).
The List of Companies - Laboratory Developed Test Market
- Quest Diagnostics Incorporated
- F. HOFFMANN-LA ROCHE LTD.,
- QIAGEN
- Illumina, Inc.,
- Eurofins Scientific
- Biodesix
- Adaptive Biotechnologies
- Biotheranostics
- Rosetta Genomics Ltd.,
- Guardant Health
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
Trends and growth analysis reports related to Laboratory Developed Test Market
Aug 2021
Colonoscopes Market
Forecast to 2028 - COVID-19 Impact and Global Analysis By Product Type (Fiber Optic Colonoscopy Devices, Video Colonoscopy Devices); Application (Colorectal Cancer, Lynch Syndrome, Ulcerative Colitis, Crohn's Disease, Polyp); End User (Hospitals, Ambulatory Surgery Center, Others), and Geography
Aug 2021
Medical Ultrasound Flow Meter Market
Size and Forecast (2020 - 2030), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Implementation Type (Clamp-On, Inline, and Others), Technology (Doppler, Transit Time, and Hybrid), Application (Heart and Lung Machines, Extracorporeal Membrane Oxygenation, Perfusion, Organ Transportation Systems, and Others), End User (Hospitals and Clinics, Ambulatory Surgical Centers, Research Laboratories, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Aug 2021
Rapid Test Kits Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Type (Rapid Antigen Testing, Rapid Antibody Testing, and Others), Product (Over-the-Counter Rapid Testing Kit and Professional Rapid Testing Kit), Technology (Lateral Flow Assay, Solid Phase, Agglutination, Immunospot Assay, and Cellular Component-Based), Application (Blood Glucose Testing, Infectious Disease Testing, Pregnancy and Fertility, Cardiometabolic Testing, and Others), End User (Hospital and Clinics, Home Care, Diagnostics Centers, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Aug 2021
Osteoarthritis Therapy Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Therapy Type [Transcutaneous Electrical Nerve Stimulation (TENS), Occupational Therapy, Physical Therapy, Platelet-Rich Plasma Therapy and Stromal Vascular Fraction, Prolotherapy, and Others], Disease Indication (Knee Osteoarthritis, Spine Osteoarthritis, Foot and Ankle Osteoarthritis, Shoulder Osteoarthritis, Hand Osteoarthritis, and Others), End User (Hospitals & Clinics, Specialty Clinics, Ambulatory Surgical Centers, Homecare, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Aug 2021
Bariatric Surgeries Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Type [Adjustable Gastric Bands (AGB), Sleeve Gastrectomy, Gastric Bypass, Biliopancreatic Diversion with Duodenal Switch (BPD-DS), and Others], End User (Hospitals and Ambulatory Surgical Centers), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Aug 2021
Post-Acute Care Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Service Type (Skilled Nursing Facilities, Inpatient Rehabilitation Facilities, Long-Term Care Hospitals, Home Health Agency, and Others), Age (Elderly, Adult, and Others), Disease Conditions (Amputations, Wound Management, Brain Injury and Spinal Cord Injury, Neurological Disorders, and Others), and Geography
Aug 2021
Lung Cancer Therapy Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Therapy Type (Noninvasive and Minimally Invasive), Indication (Non-Small Cell Lung Cancer and Small Cell Lung Cancer), End User (Hospitals, Oncology Clinics, Research Centers, and Others), and Geography (North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa)
Aug 2021
Coagulation Market
Size and Forecasts (2020 - 2030), Global and Regional Share, Trends, and Growth Opportunity Analysis Report Coverage: By Disease Indications (Vitamin K Deficiency, Liver Disease, Disseminated Intravascular Coagulation & Pulmonary Embolism, Development of Circulating Anticoagulants, Hemophilia, Von Willebrand's Disease, and Others), Type [Clinical Laboratory Analyzers (Controls & Calibrators, Assays & Reagents, Instruments/Systems, Coagulation Factors, and Others) and Point-of-Care Testing Analyzers], Offering [Diagnosis (Prothrombin Time Testing, Fibrinogen Testing, Activated Clotting Time Testing, Activated Partial Thromboplastin Time Testing, D-Dimmer Testing, Platelets Function Testing, and Others) and Treatment (Anti-Fibrinolytic Drugs, Birth Control Pills, Desmopressin & Immunosuppressive Medicines, Vitamin K Supplements, Blood Thinners, Thrombin Inhibitors or Thrombolytics, Replacement Therapy, Catheter-Assisted Thrombus Removal, and Others)], Technology (Optical Technology, Mechanical Technology, Electrochemical Technology, and Others), End User (Clinical Laboratories, Hospitals, and Others), and Geography (North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa)