Laboratory-Developed Testing Market Forecasts to 2028 – Global Analysis By Test Type (Microbiology, Immunology, Haematology, Molecular Diagnostics), Product (R&D, Mass Spectrometry, Microarrays, PCR, NGS), Application (Genetics, Oncology, Infectious Disea

Laboratory-Developed Testing Market Forecasts to 2028 – Global Analysis By Test Type (Microbiology, Immunology, Haematology, Molecular Diagnostics), Product (R&D, Mass Spectrometry, Microarrays, PCR, NGS), Application (Genetics, Oncology, Infectious Diseases, Neurology), End User (Specialty Diagnostics Centers, Academic Institutes, Hospital Laboratories), and By Geography

According to Stratistics MRC, the Global Laboratory-Developed Testing Market is accounted for $4.88 billion in 2022 and is expected to reach $8.45 billion by 2028 growing at a CAGR of 9.6% during the forecast period. Laboratory developed test is a type of in vitro diagnostic test that is planned and utilized within a single laboratory. These tests can be used to gauge or discriminate a wide variety of analytes materials such as proteins, chemical compounds like cholesterol or glucose, or DNA, from a specimen received from human anatomy. The development of automated in vitro diagnostics (IVD) techniques for labs and dispensaries to deliver exact and error-free analysis is expected to fuel the increment. Laboratory developed tests are beneficial for the detection and monitoring of oncology, genetics, infections, and autoimmune diseases. These tests are the best option for the population curious about their genetic makeup concerning the presence of any disease-related markers. This testing offers numerous advantages such as improved quality of life, monitoring pre-existing conditions, and maintaining one’s lifestyle accordingly, which makes them preferable over hospitalization for daily checkups or the treatment of disease occurrence.

According to the American Heart Association, in 2017, 868,662 people died due to various forms of cardiovascular diseases in the U.S. Moreover, in 2018, coronary heart disease (42.1%) was one of the leading causes of death along with high blood pressure (11%), stroke (17%), arteries diseases (2.9%), and heart failure (9.6%). Therefore, for detection and treatment of these cardiovascular diseases, in-vitro diagnostics methods are highly preferred by the doctors. In addition, As per American Cancer Society, in 2020, about 1.8 million new cancer cases were diagnosed, and approximately 606,520 cancer deaths occurred in the United States. Moreover, people with chronic conditions are the most frequent users of healthcare facilities in the United States.

Market Dynamics:

Driver:
Increasing product offerings related to genetic health risks
Manufacturers of laboratory-developed tests across the world will have ample of lucrative prospects in the future. They have begun to recognize the value of R&D spending to provide a diversified product line. For instance, 23andMe and Virgin Group's VG Acquisition Corp. merged to become a publicly-traded company that will transform personalized healthcare and therapeutic advancement using human genetics. Many companies are taking extensive measures to make their product offerings more versatile through innovations, such as providing data related to genetic health risks, ancestry, and traits.

Restraint:

Stringent regulations

The in vitro diagnostic medical devices regulation (IVDR) will produce results in May 2022. This rule has a large impact on both the clinical laboratories and manufacturers of in vitro diagnostic medical devices. For clinical laboratories, the IVDR poses limitations on the exploit of laboratory developed tests (LDTs). To give a uniform interpretation of the IVDR for contemporaries in clinical practice, the IVDR task force was created by the scientific societies of laboratory specialties. A guidance document with explanations and interpretations of pertinent passages of the IVDR was drafted to assist laboratories prepare for the impact of this new legislation. With new regulations, a massive amount of work will be required to transition from the IVDD to the IVDR. IVDR is more intricate and detailed and will need more resources to uphold and implement for IVD manufacturers.

Opportunity:

Continuous research on personalized medicines provides growth opportunities to laboratory developed test market players

LDTs play a crucial function in the expansion of personalized medicines that are probable to show as hopeful means of handling diseases during distant eluded effectual treatments or cures. According to the Personalized Medicine Coalition, personalized medicines accounted for only 5% of the new FDA-approved molecular entities in 2005; though, in 2016, this numeral rose to more than 25%. Moreover, 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 additionally anticipated to augment their investments by 33% in the next five years. Biopharmaceutical researchers also forecast a 69% increase in the expansion of personalized medicines in the next five years. Laboratory tests are used to diagnose disease and foresee and monitor drug response as well as to get informatics data required for complex predictive algorithms. Personalized medicines are becoming the trademark of cancer treatment; it is a continually 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.

Threat:

Operational barriers faced in conducting diagnostic tests

Clinical laboratories across significant markets are still developing; technicians face operational challenges in guaranteeing effectual storage, sample procurement, and transportation, particularly while adopting new technologies such as NGS and lab-on-a-chip PCR devices. Laboratory space also wants to be reconfigured to meet the necessities of conducting precise diagnostic tests used for pathogen detection as a means of avoiding cross-contamination and ensuring efficient time management. This results in substantial cost escalation to uphold and operate advanced molecular diagnostic instruments, particularly those capable of handling a single sample type. In addition, owing to the rapid mutation of microbes and the growing outbreak of epidemics, clinical laboratories require to adopt innovative technologies capable of rapid sample diagnosis. Though, the shortage of skilled laboratory technicians to operate advanced diagnostic products has hindered their overall adoption, particularly in emerging markets. Numerous providers find it difficult to transition to IT-based approaches from manual or traditional approaches or may not prefer to make the shift at all.

Covid-19 Impact

As part of the response to COVID 19, virtually all OECD countries affected by the virus have introduced strict restrictions to social and economic life, including social distancing and even full lockdowns. Gaining intelligence on the evolution of the epidemic, including on when a threshold for herd immunity has been reached. In the case of COVID 19, it has been estimated that 50% to 60% of the population needs to be immune to the virus to halt its spread. During the early phase of the coronavirus disease 2019 (COVID-19) pandemic, design, development, validation, verification and implementation of diagnostic tests were actively addressed by a large number of diagnostic test manufacturers. Hundreds of molecular tests and immunoassays were rapidly developed, albeit many still await clinical validation and formal approval.

The molecular diagnostics segment is expected to be the largest during the forecast period

The molecular diagnostics segment is estimated to have a lucrative growth, due to the increasing attention toward the development of genetic therapeutics and growing research in human genomics. Technological advantages in molecular tests make them valuable diagnostic tools for detecting a wide range of genetic diseases. For instance, in November 2017, Edico Genome launched the DRAGEN Clinical Genomics Information System (CGIS). It is designed to enable clinical laboratories to develop sequencing-based laboratory developed tests in a quick, simple, and efficient manner.

The clinical research organizations segment is expected to have the highest CAGR during the forecast period

The clinical research organizations segment is anticipated to witness the fastest CAGR growth during the forecast period, as these organizations can develop LDTs based on any diagnostic test technology used in the clinical lab. For some technologies, such as chemistry tests or immunoassays, automated platforms with large test menus are commercially available. As a result, in some labs, there may be less development and use of LDTs based on these technologies than LDTs based on newer technologies such as next-generation sequencing. Clinical research organizations may also perform tests on types of specimens that are not included in the approved labeling for a test or may have other reasons why they decide to develop an LDT.

Region with highest share:

North America is projected to hold the largest market share during the forecast period, due to the developed laboratory infrastructure, availability of skilled personnel in the region, technological advancements, and trends like personalized medicine, and growing elderly population. The elderly population in countries like the United States are covered with social reimbursement schemes like MediCaid, which provides all healthcare benefits to people over 65. The growth of the elderly population, the cost-effective nature of lab-based testing, and available social support will drive tremendous growth for players in the market.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR over the forecast period due to the presence of well-developed healthcare infrastructure, government support, increasing research and development activities along with the growing medical tourism in the region, growing usage of laboratory developed test in combating Covid-19, increasing incidents of cancer and genetic disorders, and large number of product launches. In Asia Pacific, India is the largest market for laboratory developed test.

Key players in the market

Some of the key players profiled in the Laboratory-Developed Testing Market include Qiagen, Epic Sciences, Inc., F. Hoffmann-La Roche Ltd, Bruker Corporation, Illumina, Inc., Bio-Rad Laboratories, Inc., Eurofins Scientific, Thermo Fisher Scientific Inc., Quest Diagnostics, Siemens Healthcare Private Limited, Sonic Healthcare Ltd., Abbott Laboratories, Adaptive Biotechnologies, OPKO Health Inc., Rosetta Genomics Ltd., Guardant Health, Genoptix, Inc., and Quidel Corporation.

Key Developments:

In May 2022, Epic Sciences, Inc. announced the launch of DefineMBC™, a novel comprehensive blood-based test for distinguishing metastatic breast cancer. This test will provide both cell-based and cell-free analysis from a single blood draw to provide comprehensive profiling in the absence of a tissue biopsy result.

In March, 2022, Illumina, Inc. announced the release of TruSightTM Oncology (TSO), a single test that examines numerous tumor genes and biomarkers to determine a patient's cancer molecular profile.

In December 2021, Roche launched the AVENIO Edge System, which simplifies and automates sample preparation for next-generation sequencing, reducing human error and advancing precision medicine.

In September 2021, QIAGEN N.V. received a contract from the United States government to grow its production capacity for consumables for its NeuMoDx 96 and 288 integrated PCR testing systems.

In January 2021, Eurofins launched the NovaType test for detecting and monitoring new variants of SARS-CoV-2. This RT-PCR assay is clinically validated for identifying B.1.1.7 and B.1.351 variants with a short time. NovaType is already available as an LDT in Germany, and it will be made available in over 50 Eurofins laboratories worldwide for testing patients for COVID-19.

Test Types Covered:
• Critical Care
• Microbiology
• Clinical Biochemistry
• Immunology
• Haematology
• Molecular Diagnostics

Products Covered:
• Research and Development (R&D)
• Commercial Service
• Mass Spectrometry
• Microarrays
• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)

Applications Covered:
• Genetics
• Autoimmune Disorders
• Oncology
• Infectious Diseases
• Neurology

End Users Covered
• Specialty Diagnostics Centers
• Academic Institutes
• Hospital Laboratories
• Clinical Research Organizations

Regions Covered:
• North America
US
Canada
Mexico
• Europe
Germany
UK
Italy
France
Spain
Rest of Europe
• Asia Pacific
Japan
China
India
Australia
New Zealand
South Korea
Rest of Asia Pacific
• South America
Argentina
Brazil
Chile
Rest of South America
• Middle East & Africa
Saudi Arabia
UAE
Qatar
South Africa
Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2020, 2021, 2022, 2025, and 2028
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements