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The global next-generation IVD market was worth USD 87.40 billion in 2022 and is expected reach USD 125.00 billion by 2030 with a CAGR of 5.11% during the forecast period, i.e., 2023-2030. Next-Generation In Vitro Diagnostics (IVD) refers to advanced technologies transforming diagnostic testing outside the body, including molecular diagnostics, genomics, proteomics, and digital pathology. The market is driven by the demand for precise, personalized healthcare, leveraging innovations like CRISPR, AI, and high-throughput sequencing. Key players like Roche, Abbott, and Illumina contribute to market dominance with platforms like Cobas systems, Alinity-m, and NextSeq 550Dx. Challenges include regulatory complexities, reimbursement issues, and the need for global standardization, hindering seamless integration of advanced diagnostics. Harmonizing policies and addressing reimbursement concerns are critical to sustaining growth and achieving the full potential of Next-Generation IVD in revolutionizing disease detection, monitoring, and treatment.

In November 2023, Dutch company CleanNA launched its first CE-IVD marked product, the 'Clean Cell Free DNA Kit,' for isolating cell-free DNA from human plasma. This magnetic bead-based nucleic acid extraction kit is designed for automation, offering a three-step process – bind, wash, and elute. With applications in prenatal screening, oncology, transplant medicine, and cardiovascular diseases, the kit's minimal invasiveness, requiring only a blood sample, enhances its utility. The CE-IVD mark ensures compliance with EU regulations, reflecting the product's safety, effectiveness, and reliability in diagnostic procedures.

Browse 75 market data Tables and 45 Figures spread through 226 Pages and in-depth TOC on "Next-Generation IVD Market, by Type (Core Laboratory Diagnostics, POC Testing, and Molecular Diagnostics), by Product Type (Consumables, Instruments, and Software), by Application (Oncology/Cancer, Infectious Diseases, Diabetes, Cardiology, and Other Applications), by End-Use Industry (Hospitals and Clinics, Diagnostic Laboratories, Academic and Research Institutions, and Other End-Use Industries), and by Region (North America, Europe, Asia-Pacific, Middle East and Africa, and South America) - Global Forecast to 2030

By type, core laboratory diagnostics dominate the global next-generation IVD market.

Based on type, the global next-generation IVD market is segmented into core laboratory diagnostics, POC testing, and molecular diagnostics. Core laboratory diagnostics dominated the next-generation IVD market in 2022 owing to their pivotal role in routine clinical testing. Advancements like the introduction of Beckman Coulter's Access SARS-CoV-2 IgG II assay in 2020 showcase core labs' significance, allowing high-throughput serology testing for COVID-19 antibodies. These labs provide comprehensive services, incorporating advanced technologies for precise analysis, exemplified by Sysmex Corporation's XN-3100, enhancing hematology diagnostics. Their scalability and broad testing capabilities position core labs as key drivers in the adoption of next-generation IVD technologies, ensuring efficient and accurate clinical assessments for improved patient care.

“The Asia-Pacific (APAC) is expected to register the fastest CAGR during the forecast period in the global next-generation IVD market.”

The Asia-Pacific is expected to registered the highest CAGR during 2023-2030 in the global next-generation IVD market owing to increasing healthcare infrastructure, rising disease prevalence, and technological advancements. In 2021, Seegene, a South Korean company, launched the Allplex™ SARS-CoV-2 Variants I Assay, demonstrating the region's commitment to cutting-edge diagnostics. As the demand for personalized medicine and advanced diagnostic technologies grows, coupled with supportive government initiatives, the Asia-Pacific region is expected to emerge as a significant contributor, fostering the adoption and innovation of Next-Generation IVD solutions for improved healthcare outcomes.

Some of the major players in the global next-generation IVD market include Abbott Laboratories, Becton, Dickinson and Company, bioMérieux SA, Bio-Rad Laboratories, Inc., Danaher Corporation, F. Hoffmann-La Roche Ltd., Illumina, Inc., QIAGEN N.V., Shenzhen Mindray Bio-Medical Electronics Co., Ltd, Siemens Healthineers AG, Thermo Fisher Scientific Inc., Wama Diagnostica, Wiener Laboratorios SAIC, QuidelOrtho Corporation, Agilent Technologies Inc., and DiaSorin S.p.A.

Global Next-Generation IVD Market Coverage (By Value)

• Type Insight and Forecast 2018-2030

• Laboratory Diagnostics

• POC Testing

• Molecular Diagnostics

• Product Type Insight and Forecast 2018-2030

• Consumables

• Instruments

• Software

• Application Process Insight and Forecast 2018-2030

• Oncology/Cancer

• Infectious Diseases

• Diabetes

• Cardiology 

• Other Applications

• End-use Industry Process Insight and Forecast 2018-2030

• Hospitals and Clinics

• Diagnostic Laboratories

• Academic and Research Institutions

• Other end-use industry

Geographical Segmentation

Global Next-Generation IVD Market by Region

• North America

• By Type

• By Product Type

• By Application

• By End-use Industry

• By Country – U.S., Canada, and Mexico

• Europe

• By Type

• By Product Type

• By Application

• By End-use Industry

• By Country – Germany, U.K., France, Italy, Spain, Russia, and Rest of Europe

• Asia-Pacific (APAC)

• By Type

• By Product Type

• By Application

• By End-use Industry

• By Country – China, Japan, India, South Korea, and Rest of Asia-Pacific

• South America

• By Type

• By Product Type

• By Application

• By End-use Industry

• By Country – Argentina, Brazil, Chile, and Rest of South America

• Middle East and Africa

• By Type

• By Product Type

• By Application

• By End-use Industry

• By Country – Saudi Arabia, U.A.E, South Africa, and Rest of Middle East and Africa