Asia Pacific Laboratory Developed Tests Market Size, Share & Trends Analysis Report By Technology (Immunoassays, Molecular Diagnostics, Flow Cytometry), By Application, By Country, And Segment Forecasts, 2025 - 2030

Market Size & Trends

The Asia Pacific laboratory developed tests market size was estimated at USD 2.72 billion in 2024 and is projected to grow at a CAGR of 6.4% from 2025 to 2030. A PubMed study estimated approximately 3,246,625 new cancer cases in China in 2024, reflecting a continued trend in rising cancer incidence. In Japan, cancer remains a leading cause of death, with around 1 million new cases annually as of 2023. In India, the number of cancer cases is projected to increase to 1.5 million by 2025, while in Australia, approximately 150,000 new cancer cases are diagnosed each year. These rising numbers have created a significant demand for specialized diagnostic tests, prompting the development of laboratory developed tests (LDTs) tailored to specific patient needs and conditions.

Recent regulatory changes have also contributed to the growth of the LDT market in the Asia Pacific region. China’s implementation of Order 739 in 2021 has allowed for increased development of LDTs, with regulatory clearances expected to support growth in 2023 and beyond. In Japan, regulatory support for innovative diagnostics continues to evolve, enhancing the approval process for LDTs. Similarly, in India and Australia, ongoing regulatory reforms aim to streamline the approval process for diagnostics, including LDTs. These changes have created a more favorable environment for companies to develop and commercialize LDTs in the region.

The growing trend towards automation in laboratories has also enhanced efficiency and accuracy in testing procedures, making LDTs more appealing to healthcare providers. In China and Japan, significant investments in laboratory automation technologies have been reported, with automation adoption rates increasing by approximately 15% annually in major hospitals. In India and South Korea, automation trends are growing, with many laboratories adopting automated systems to improve efficiency and accuracy, further driving the adoption of LDTs in the region.

In the Asia Pacific region, the COVID-19 pandemic significantly advanced the landscape for LDTs, emphasizing their essential role in public health. Markets such as Australia and Singapore established clear definitions for LDTs, leading to better regulatory frameworks, while others still lack formal definitions, resulting in inconsistent perceptions and management. Regulatory oversight often involves multiple bodies, complicating compliance for laboratories. However, robust market authorization processes and post-market surveillance practices are emerging, particularly in jurisdictions with defined regulations. Collaborative initiatives among academic institutions, research centers, and healthcare organizations in countries such as Japan and South Korea are driving innovation, enhancing the quality of diagnostic tests, and supporting market growth.

Technology Insights

Molecular diagnostics dominated the market and accounted for a revenue share of 24.3% in 2024. Molecular diagnostics is crucial for rapid pathogen detection and timely treatment decisions. Technological advancements, including Polymerase Chain Reaction (PCR), Next Generation Sequencing (NGS), and microarray techniques, improved diagnostic speed and accuracy. The region’s focus on personalized medicine, rising healthcare expenditure in China, India, and Japan, and regulatory support, such as China’s Order 739, have fostered innovation. The growing preference for point-of-care testing also contributed to the robust demand for these essential diagnostic solutions.

Immunoassays are expected to grow at the fastest CAGR of 7.6% over the forecast period. Immunoassays play a crucial role in early diagnosis and management, particularly in China and India, where healthcare needs are evolving. Recent advancements in technologies such as ELISA and Chemiluminescent Immunoassays have improved test sensitivity and specificity, enhancing patient care. Expanded healthcare infrastructure and regulatory support have facilitated access to these vital diagnostic tools, while the shift towards personalized medicine has further fueled demand for immunoassays tailored to individual biomarkers, especially in Japan.

Application Insights

The oncology segment dominated the market and accounted for a revenue share of 23.8% in 2024. The region has experienced a significant surge in cancer cases, underscoring the need for advanced diagnostics such as LDTs. Innovations such as NGS and PCR have enhanced cancer diagnostics. Governments have invested heavily in healthcare infrastructure and cancer control initiatives, while growing awareness of early diagnosis has spurred screening rates. The shift towards personalized medicine and collaborative efforts further drives the demand for oncology LDTs across the region.

Nutritional and metabolic diseases are projected to grow at the fastest CAGR of 9.2% over the forecast period. Asia Pacific has seen a marked rise in nutritional deficiencies and metabolic disorders. Aging populations in countries such as Japan and China are more vulnerable to these conditions, increasing the demand for specialized assessments. Enhanced awareness of preventive healthcare, alongside government initiatives in nations such as Thailand to combat malnutrition and obesity, drives the need for advanced diagnostic tests. Furthermore, technological innovations and the trend toward personalized nutrition are essential for effective management of these health issues.

Country Insights

China Laboratory Developed Tests Market Trends

China laboratory developed tests market dominated the Asia Pacific market with a revenue share of 27.2% in 2024. Government initiatives, such as free cervical cancer screening campaigns, has improved access to diagnostic services. Advancements in molecular diagnostics and increased healthcare investments foster LDT growth. As the aging population is projected to reach 487 million by 2050, there is a pressing demand for personalized and innovative diagnostic solutions to tackle the evolving health challenges in China’s healthcare landscape.

Australia Laboratory Developed Tests Market Trends

The laboratory developed tests market in Australia is projected to grow lucratively over the forecast period, propelled by the high prevalence of chronic diseases, with approximately 1.4 million Australians living with diabetes, expected to rise to 1.6 million by 2030, as reported by Diabetes Australia. Increasing government initiatives aimed at improving healthcare access and advancements in diagnostic technologies further drive demand for LDTs. The aging population in Australia highlights the urgent need for effective diagnostic solutions for managing age-related health issues.

Key Asia Pacific Laboratory Developed Tests Company Insights

Some key companies operating in the market include Quest Diagnostics Incorporated; Abbott; Guardant Health; among others. Growing collaborations among academic institutions and healthcare organizations, alongside regulatory reforms, are driving technological advancements and strategic product launches in LDTs.

• Quest Diagnostics is a provider of diagnostic testing services in the Asia Pacific region, offering a comprehensive array of LDTs for various health conditions, including molecular diagnostics and genetic testing to facilitate disease management and personalized medicine.

• Guardant Health focuses on precision oncology with its advanced liquid biopsy tests in the industry. The company provides LDTs for detecting circulating tumor DNA (ctDNA), supporting informed treatment decisions and non-invasive monitoring of cancer progression.

Recent Developments

• In September 2024, QIAGEN secured CE-marking for its QIAstat-Dx syndromic testing systems in Europe, affirming compliance with the EU’s IVDR. This approval potentially fostered innovations in colorectal cancer screening, aligning with the region’s objective to enhance diagnostic capabilities and screening rates.

• In May 2024, Guardant Health secured EU IVDR certification for Guardant360 CDx in Europe, facilitating expanded genomic profiling of solid tumors and potentially prompting similar regulatory developments in Asia Pacific countries.

Asia Pacific Laboratory Developed Tests Market Report Scope

Asia Pacific Laboratory Developed Tests Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the Asia Pacific laboratory developed tests market report based on technology, application, and region:

• Technology Outlook (Revenue, USD Million, 2018 - 2030)

  • Immunoassays

  • Hematology & Coagulation

  • Molecular Diagnostics

  • Microbiology

  • Clinical Chemistry

  • Histology/Cytology

  • Flow Cytometry

  • Mass Spectroscopy

  • Others

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

    • Companion Diagnostics

    • Genomics Sequencing and Others

  • Genetic Disorders/Inherited Disease

  • Infectious & Parasitic Diseases

  • Immunology

  • Endocrine

  • Nutritional & Metabolic Disease

  • Cardiology

  • Mental/Behavioral Disorder

  • Pediatrics-Specific Testing

  • Hematology/General Blood Testing

  • Bodily Fluid Analysis

  • Toxicology

  • Others

• Country Outlook (Revenue, USD Million, 2018 - 2030)

  • Japan

  • China

  • India

  • Australia

  • South Korea

  • Thailand