Asia Pacific Laboratory Developed Test Market

Market Introduction

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.

Market Overview and Dynamics

The Asia Pacific laboratory developed test market is projected to reach US$ 4,028.17 million by 2028 from US$ 2,372.68 million in 2021; it is estimated to grow at a CAGR of 7.9% from 2021 to 2028. The key factors attributing to the market’s growth are the increasing incidence of cancer and genetic disorders and the rising automation of laboratory processes across the globe. However, the changing regulatory landscape is hampering the growth of the Asia Pacific laboratory development test market.

Automation is emerging as an approach to minimize human involvement in laboratory processes. The automation of routine laboratory procedures with the help of dedicated workstations and system software helps increase efficiency and reduce human errors. Laboratories are increasingly adopting laboratory information management systems (LIMS) and other automation tools to maintain stringent regulatory compliance, increase efficiency and productivity, and enhance data security and integrity. As per the study published in the Journal of Lab Automation, the error frequencies in fully automated, semiautomated, and manual operations are 1–5%, 1–10%, and 10–30%, respectively. Moreover, high volumes of data generated by laboratory systems are triggering the demand for effective data processing, analysis, and sharing methods, thereby highlighting the need for efficient and cost-effective solutions such as the LIMS. The automation of LDTs can significantly boost productivity and simplify compliance procedures. Clinical laboratories are under enormous pressure to manage increasing test volumes and conduct more complex diagnostic assays, further underlining 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 need for 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 3 hours and up to 864 results in 8 hours, thereby enhancing the efficiency of laboratories. Also, the rising incidence of cancer and growing awareness regarding the importance of early diagnostics are boosting the adoption of LDTs.

The COVID-19 outbreak has pushed diagnostics to the forefront of healthcare and increased awareness about quality testing worldwide. Many countries in Asia Pacific have taken extraordinary measures to contain the infection by ramping up the testing capacity. For instance, the new “Regulation for Medical Device Administration and Supervision,” Order 739 LDT, that allows the development of laboratory developed tests (LDT) was released in China in March 2021. This new regulation relaxes the restrictions on LDTs in China—allowing China medical institutions to develop their IVD reagents under certain conditions. Also, relaxation in government regulations regarding LDTs is further driving the market growth in the region. In addition, increasing product launches by market players are further driving the growth of the market. Hence, such developments will boost the Asia Pacific laboratory developed test market.

Key Market Segments

The Asia Pacific laboratory developed test market, by type, is segmented into clinical biochemistry, critical care, haematology, microbiology, molecular diagnostics, immunology, and other test types. The haematology segment was sub-segmented into coagulation and hemostasis, hemoglobin testing, blood count testing, and others. The molecular diagnostics segment is expected to hold the largest market share in 2021. However, the haematology segment is anticipated to register the highest CAGR during the forecast period.

The Asia Pacific laboratory developed test market, by application, is segmented into academic institutes, clinical research organizations, hospitals laboratory, specialty diagnostic centers, and others. The hospitals laboratory segment is expected to hold the largest market share in 2021. However, the specialty diagnostic centers segment is anticipated to register the highest CAGR during the forecast period.

Major Sources and Companies Listed

A few of the primary and secondary sources referred to while preparing the Asia Pacific laboratory developed test market report are the China Food and Drug Administration (CFDA), Ministry of Health, Labor, and Welfare (MHLW), and National Cancer Institute (NCI).

Reasons to buy the report

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ASIA PACIFIC LABORATORY DEVELOPED TEST MARKET SEGMENTATION

By Type

• Clinical Biochemistry
• Critical Care
• Haematology

• • Coagulation and Hemostasis,
  • Hemoglobin Testing
  • Blood Count Testing
  • Others

• Immunology
• Microbiology
• Molecular Diagnostics
• Other Test Types

By Application

• Academic Institutes
• Clinical Research organizations
• Hospitals laboratory
• Specialty Diagnostic Centers
• Others

By Country

• India
• Japan
• China
• South Korea
• Australia
• Rest of Asia Pacific

Company Profiles

• Quest Diagnostics Incorporated
• F. HOFFMANN-LA ROCHE LTD.
• QIAGEN
• Illumina, Inc.
• Eurofins Scientific

Asia Pacific Laboratory Developed Test Market Strategic Insights

Asia Pacific Laboratory Developed Test Market Segmentation Analysis

Asia Pacific Laboratory Developed Test Market Report Highlights

Asia Pacific Laboratory Developed Test Report Scope

Asia Pacific Laboratory Developed Test Market Country and Regional Insights