Laboratory Developed Test Market Size, Scope, Opportunity and Forecast, 2019 to 2028

Laboratory Developed Test Market Report, By Type (Clinical Biochemistry, Critical Care, Haemotology, Immunology, Microbiology, Molecular Diagnostics), Application (Oncology, Infectious Diseases, Genetics, Auto-Immune Disorders, Neurology), End-User and Geography- Global Market Share, Trend Analysis & Forecast , 2021 - 2031

Report Code : 11380 | Publish Date : July 2022 | Industry : Healthcare | Geography : Global


COVID-19 Impact Analysis on Global Laboratory Developed Test Market

The outbreak of the COVID-19 virus has become a global healthcare emergency that has been spread worldwide, affecting worldwide social and economic development. COVID-19 has been affecting economies and industries in various countries due to lockdowns, travel bans and business shutdowns. The shutdown of various plants and factories has affected the global supply chains and negatively impacted the manufacturing, delivery, and sales of products in the global market. On the other hand, the COVID-19 pandemic has impacted positively on the laboratory developed test market globally as it increased in the number of clinical trials for COVID-19. This situation has provided a great opportunity for the laboratory developed test market. During the pandemic, the LDTs were mainly focusing on development of COVID-19 testing kits, treatment and vaccines. In addition, the LDT’s was focusing on the development of IVD test for COVID-19 testing, which helps in treatment and monitoring.

MARKET OVERVIEW- GLOBAL LABORATORY DEVELOPED TEST MARKET

MARKET DRIVERS

The rising prevalence of disorders, such as cancer, cardiovascular disorders, autoimmune disorders, and health problems, has created the need for advanced and efficient in-vitro diagnostics tests and monitoring of disorders. Growing disposable income rise the affordability in the developing countries driving the demand for in-vitro diagnostic test. Raising the burden of disease has increased the adoption of outsourcing-in drug or device development services as it is time-saving and cost-effective. The growing demand for early precise diagnosis, monitoring and guiding treatment of the patients drives the market growth. The increasing funding for the research and development activities for diagnosis of rare diseases and disorders by the various regulatory authority bodies is also expected to fuel the growth of the global laboratory development test market.

MARKET GROWTH OPPORTUNITIES

An increasing prevalence of disorders, such as cancer and cardiovascular disorders has created a need for advanced and efficient diagnostics which will help in treatment. The growing funding for research and diagnosis of rare diseases and disorders is also expected to boost a lucrative opportunity for the LDTs market.

MARKET RESTRAINTS

The highest cost of laboratory developed tests owing to the high cost of reagents and devices, is hampering the growth of the global laboratory development test market. The rising regulatory guidance on laboratory developed tests may also hamper the growth of the LDT’s market. For instance, in Europe, in-vitro device regulation compliance will be mandatory for all in vitro diagnostic tests, thus transforming the diagnostic industry, which is a great concern for the market players.

MARKET GROWTH CHALLENGES

 The lack of skilled personnel to perform the specialized laboratory developed test, may act as major challenge for the growth of the global laboratory development test market. 

CUMULATIVE GROWTH ANALYSIS

The report provides in-depth analysis of the global laboratory developed test market, market size, and compound annual growth rate (CAGR) for the forecast period of 2022-2028, considering 2021 as the base year. The rising prevalence of infectious diseases increases the demand for diagnostic and clinical trials, which will fuel the growth of the laboratory developed test market. It is expected to witness a growth at a specific CAGR from 2022-2028.

11380-global-laboratory-developed-test-market-report

MARKET SEGMENTAL OVERVIEW

The global laboratory developed test market comprises of different market segment like type, application, end-user and geography. 

LABORATORY DEVELOPED TEST MARKET BY TYPE

By type, the laboratory developed test includes key segment of 

  • Clinical biochemistry 
  • Critical biochemistry
  • Hematology
  • Immunology
  • Microbiology
  • Molecular diagnostics
  • Other test type

The types studied in the global laboratory developed test market are, clinical biochemistry, critical care, hematology, immunology, microbiology, molecular diagnostics & other test types. The molecular diagnostic segment accounted for the largest share in the laboratory developed test market. Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. Molecular diagnostics contribute to improved diagnosis of orthopedic infections. By adopting molecular diagnostics, laboratories are having a greater impact on the treatment and care of patients. These advanced systems are helping physicians treat infectious diseases and with more precision.

LABORATORY DEVELOPED TEST MARKET BY APPLICATION

By application, the laboratory developed test includes key segment of 

  • Oncology 
  • Infectious diseases
  • Genetics
  • Auto-immune disorders
  • Neurology

Laboratory developed tests find its application in oncology, infectious diseases, genetics, auto-immune disorders, neurology. The oncology segment accounted for the largest share in the laboratory developed test market. A test is used to help match a patient to a specific drug or therapy. For instance, a diagnostic test may identify whether a patient’s tumour has a specific gene change that is targeted by the drug. This helps determine if the patient should receive the drug or not. The test offers the opportunity to detect cancer early, for more effective and timely treatment. Adoption of LDTs holds the promise of a healthier future for many people diagnosed with cancer.

LABORATORY DEVELOPED TEST MARKET BY END-USER

By end-user, the laboratory developed test includes key segment of 

  • Hospital laboratory
  • Clinical research organization
  • Specialty diagnostic centers
  • Academic institutes
  • Others

The end-users studied in the global laboratory developed test market are, hospitals laboratory, clinical research organizations, specialty diagnostic centres, academic institutes, & others. The hospital laboratory segment accounted for the largest share in the market. Hospital laboratories are growing owing to the rise in rates of the incidence of diabetes, cancer and other infectious diseases, as the number of patient pool increases. A rising number of developed rapid and widespread testing has helped in demand for market.  Furthermore, these services are cost-effective, cost-effective, and form the least invasive method for clinical decision making. These medical technologies provide flexibility in healthcare management through early diagnosis that improves disease treatment. In addition, the introduction of new technologies that provide faster analysis and are user-friendly contribute towards the market growth of clinical laboratory services.

LABORATORY DEVELOPED TEST MARKET BY GEOGRAPHY

The global laboratory developed test market is studied for the following region 

  • North America
  • Europe
  • Asia-Pacific
  • Rest of the world (RoW)

The global laboratory developed test market is studied for key regions such as North America, Europe, Asia Pacific and the Rest of the World. North America is likely to dominate the global laboratory developed test market. Growing demand for disease diagnosis in countries and growing R&D investment by top market players and due to the developed infrastructure and availability of skilled personnel in the region. Furthermore, an increasing number of road accidents and surgical procedures, by developed key players and the introduction of technologically advanced products. Adding to that, an increasing patient pool and the increasing focus of pharmaceuticals and biotechnology for outsourcing clinical trials for the treatment of various diseases is fueling the North American market size.

COMPETITIVE LANDSCAPE ANALYSIS 

The competitive landscape analysis of the laboratory developed test market is certainly based on the range of market players operating in the market, with an increasing number of chronic disorders such as cancer, and cardiovascular disorders having created the need for advanced and efficient in-vitro diagnostics test. Besides, a number of market players offer a wide range of products for different applications in various geographic locations. The market has major competitive analysis based on new product launches as well as other developments.

The key players studied in market are 

  • Quest Dianostic incorporated
  • HoFFMANN-LA Roche LTD
  • Qiagen, illumine, inc,
  • Eurofins Scientific,
  • Biodesix,
  • Adaptive Biotechnologies,
  • Biotheranostics,
  • Rosetta Genomics Ltd,
  • Gurdant Health,
  • Abbott Laboratories
  • Sonic Helathcare Ltd, 
  • Siemens Healthineers, 
  • Opko Helath inc, 
  • Neo Genomic Laboratories, 
  • Genoptix inc. 

RECENT DEVELOPMENT:

April 2022: NeoGenomics added RaRaR (Residual Disease and Recurrence) to their portfolio of high-quality oncology. RaRaR is a liquid biopsy test assay used to identify MRD (Minimal Residual Disease) in patients with solid tumor.

January 2021: Hologic, Inc. had acquired Biotheranostics, Inc., a privately held, commercial-stage company that provides molecular diagnostic tests for breast and metastatic cancers, for approximately $230 million, subject to working capital and other customary closing adjustments. 

SCOPE OF THE REPORT:

Market Sizing for Year:
2021-2028
Base Year:
2021
Forecast Period:
2022-2028
Value:
USD million
Market Segment studied:

Type

Application

End Users

Geography
Market Players and its Competitors:

Quest Diagnostics Incorporated (US)

F. HOFFMANN-LA ROCHE LTD. (Switzerland)

QIAGEN (Netherlands)

Illumina, Inc. (US)

Eurofins Scientific (France)

Biodesix (US)

Adaptive Biotechnologies (US)

Biotheranostics (US)

Guardant Health (US)

Abbott Laboratories (US)

Sonic Healthcare Ltd. (Netherlands)

Siemens Healthineers (Germany)

OPKO Health Inc. (US)

Neo Genomics Laboratories (US)

Genoptix, Inc. (US)

FREQUENTLY ASKED QUESTIONS

What are challenges faced by the Laboratory Developed Test Market?

The lack of skilled personnel to perform the specialized laboratory developed test, may act as major challenge for the growth of the global laboratory development test market.

Who are the key players in the Laboratory Developed Test market?

The key players studied in market Quest Dianostic incorporated, F. HoFFMANN-LA Roche LTD, Qiagen, illumine, inc, Eurofins Scientific, Biodesix, Adaptive Biotechnologies, Biotheranostics, Rosetta Genomics Ltd, Gurdant Health, Abbott Laboratories, Sonic Helathcare Ltd, Siemens Healthineers, Opko Helath inc, Neo Genomic Laboratories, Genoptix inc. and among others

Which region is the fasted growing in the Laboratory Developed Test market?

The North-America region is accounted largest share in the market due to increasing demand for disease diagnosis in countries and growing R&D investment by top market players and due to the developed infrastructure.