Global Next-Generation IVD Market – Analysis and Forecast (2026-2035)

Industry Overview

Next-Generation In Vitro Diagnostics (IVD) refers to advanced technologies and methodologies that revolutionize diagnostic testing outside the human body. It encompasses cutting-edge approaches like molecular diagnostics, genomics, proteomics, and digital pathology, enabling more precise and personalized healthcare. Next-Generation IVD enhances disease detection, monitoring, and treatment by providing rapid, accurate, and comprehensive insights into an individual's health. These innovations empower healthcare professionals to tailor interventions, predict disease risks, and optimize therapeutic strategies, marking a significant leap forward in the field of diagnostics for improved patient outcomes and healthcare efficiency.

Global next-generation IVD market was worth USD 87.40 billion in 2025 and is expected reach USD 125.00 billion by 2035 with a CAGR of 5.11% during the forecast period, i.e., 2026-2035. The growing demand for next-generation IVD is driven by the advancements in genomics and molecular diagnostics, increasing demand for personalized medicine, a focus on early disease detection, and the rise of digital health technologies for more precise and efficient diagnostic capabilities.

Geographically, the global next-generation IVD market is expanding rapidly in North America, Europe, and the Asia Pacific, as a result of the robust healthcare infrastructure, increasing adoption of advanced diagnostic technologies, rising awareness of personalized medicine, and supportive regulatory frameworks; however, the market confronts constraints such as regulatory complexities, reimbursement issues, and the need for standardization. Overall, the next-generation IVD market offers potential prospects for market participants to develop and fulfill the growing needs of wide range of applications including hospitals and clinics, diagnostic laboratories, academic and research institutions.

Next-Generation IVD Market Segmentation

Insight by Type

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 2023 owing to their essential role in routine clinical testing. These labs offer comprehensive services, integrating advanced technologies for precise and high-throughput analysis. For instance, as of my last knowledge update in January 2023, Roche's cobas 6800/8800 systems, introduced in 2014, exemplify core lab dominance, enabling simultaneous testing of multiple pathogens. Additionally, Siemens Healthineers' Atellica Solution, launched in 2017, integrates various diagnostic disciplines. The scalability, efficiency, and broad testing capabilities of such systems highlight their pivotal role, contributing to the dominance of core laboratory diagnostics in the evolving IVD landscape.

Insight by Product Type

Based on product type, the global next-generation IVD market is segmented into consumables, instruments, and software. Consumable panels dominated the global next-generation IVD market in 2022 as they offer cost-effective and scalable solutions for routine testing. Latest examples include Bio-Rad's ddPCR Multiplex Supermix, launched in 2021, providing precise and multiplexed DNA analysis. Additionally, Illumina's TruSight Oncology 500, introduced in 2020, is a comprehensive panel for cancer profiling. These consumable panels enhance efficiency, reduce turnaround times, and enable targeted analysis. The market dominance of consumable panels is underscored by their adaptability across various diagnostic platforms, facilitating widespread adoption and contributing to the dynamic evolution of the next-generation IVD market.

Insight by Application

Based on application, the global next-generation IVD market is segmented into oncology/cancer, infectious diseases, diabetes, cardiology, and other applications. Oncology/cancer segment dominated the global next-generation IVD market in 2023 due to the increasing demand for precision medicine in cancer treatment. Recent examples include Foundation Medicine's FoundationOne Liquid CDx, approved in 2020, which analyzes circulating tumor DNA for comprehensive genomic profiling. Guardant Health's Guardant360, continually updated, is another example, utilizing liquid biopsy for real-time cancer monitoring. The focus on personalized oncology therapies and the rising incidence of cancer globally drives the prominence of oncology in the next-generation IVD market, reflecting the crucial role these diagnostics play in tailoring treatments and improving patient outcomes.

Insight by End-use

Based on end-use industry, the global next-generation IVD market is segmented into hospitals and clinics, diagnostic laboratories, academic and research institutions, and other end-use industries. Hospitals and clinic dominated the global next-generation IVD market in 2023 as they serve as primary hubs for patient diagnostics and healthcare delivery. The demand for advanced diagnostic capabilities is exemplified by Abbott's Alinity-m molecular diagnostics system, launched in 2020, providing comprehensive infectious disease testing. Additionally, Sysmex Corporation's XN-3100, introduced in 2021, enhances hematology diagnostics in clinical settings. The growing patient influx, coupled with the need for rapid and accurate results, underscores the pivotal role of hospitals and clinics in driving the adoption of next-generation IVD technologies, ensuring effective disease management and improved patient care.

Global Next-Generation IVD Market Report Coverage

Industry Dynamics

Next-Generation IVD Market Growth Drivers

Increasing Emphasis on Early Disease Detection and Preventive Healthcare

A significant driver for the growth of the global next-generation in vitro diagnostics (IVD) market is the increasing emphasis on early disease detection and preventive healthcare. Illumina's introduction of the Grail Galleri test exemplifies this trend. Galleri is a multi-cancer early detection blood test designed to identify more than 50 types of cancers at an early, potentially curable stage. This reflects a paradigm shift toward proactive healthcare strategies, aligning with the global push for precision medicine and personalized treatment approaches. The ability of such tests to detect multiple cancer types simultaneously and at early stages enhances the prospects for successful intervention, fostering a broader adoption of Next-Generation IVD in routine clinical practice.

Furthermore, the integration of CRISPR technology in diagnostics, demonstrated by Sherlock Biosciences' Sherlock CRISPR SARS-CoV-2 kit, authorized for Emergency Use showcases the market's response to emerging infectious threats. The demand for rapid, accurate, and multiplexed diagnostics, particularly in the context of infectious diseases, propels the growth of Next-Generation IVD, emphasizing its crucial role in global health preparedness and response.

Integration of Artificial Intelligence (AI) and Machine Learning (ML) in Diagnostics

The integration of Artificial Intelligence (AI) and Machine Learning (ML) in diagnostics is a key driver for the growth of the global Next-Generation In Vitro Diagnostics (IVD) market. These technologies enhance the accuracy, efficiency, and personalization of diagnostic processes. For instance, Paige Prostate employs AI for pathology interpretation, aiding in prostate cancer diagnosis. Tempus' Tempus ONE utilizes ML to streamline clinical workflows and improve cancer care. These platforms leverage large datasets to identify patterns and correlations that may be imperceptible to human analysis, enabling more precise diagnostics and treatment decisions. 

The continual evolution of AI and ML applications in diagnostics is catalyzing innovation, driving the adoption of Next-Generation IVD technologies, and revolutionizing the landscape of medical diagnostics for improved patient outcomes and healthcare efficiency. For instance, PathAI, in collaboration with Bristol Myers Squibb, employs AI-powered pathology solutions to improve diagnostic accuracy and efficiency. This amalgamation of cutting-edge technologies not only enhances diagnostic precision but also underscores the transformative potential of next-generation IVD in reshaping healthcare by enabling more proactive and personalized approaches to disease management.

Next-Generation IVD Market Challenge

End-of-Life Management of Next-Generation IVD

One significant challenge for the next-generation IVD industry is the need for standardization and regulatory harmonization. Differing regulations across regions create complexities in product development, approval processes, and market access. Achieving global standardization is critical for ensuring the seamless integration of advanced diagnostic technologies, fostering innovation, and addressing regulatory uncertainties. Overcoming these challenges is essential to facilitate the widespread adoption of next-generation IVD solutions and unlock their full potential in enhancing healthcare outcomes on a global scale.

Next-Generation IVD Market Geographic Overview

The global next-generation IVD market is segmented into North America, Europe, the Asia-Pacific, South America, and the Middle East and Africa region. The global next-generation IVD market is dominated by North America due to its robust healthcare infrastructure, technological advancements, and strategic investments. The region is at the forefront of adopting innovative diagnostic solutions. For instance, Exact Sciences' Cologuard, FDA-approved, revolutionizes colorectal cancer screening through non-invasive methods. Additionally, Illumina's NovaSeq 6000, exemplifies cutting-edge genomic sequencing. The region's proactive approach in integrating these technologies into clinical practice, coupled with favorable regulatory frameworks, positions North America as a leader in driving the growth and adoption of next-generation IVD technologies.

Next-Generation IVD Market Competitive Insight

Roche holds a prominent position in the next-generation in vitro diagnostics (IVD) market, continually innovating to advance diagnostic capabilities. Roche's leadership extends to personalized medicine with Foundation Medicine, a subsidiary, offering comprehensive genomic profiling services. Through these initiatives, Roche remains a key player driving advancements in the next-generation IVD landscape and contributing significantly to the evolution of diagnostic technologies.

Abbott Laboratories is another major player in the Next-Generation In Vitro Diagnostics (IVD) market, known for its innovative solutions. The approval of the Abbott RealTime SARS-CoV-2 assay showcased the company's rapid response to the pandemic, providing reliable diagnostic tools. Abbott's Alinity m molecular diagnostics system, exemplifies its commitment to high-throughput and comprehensive infectious disease testing. The system offered versatility and efficiency in clinical settings. Abbott's strategic focus on cutting-edge diagnostics positions it as a key contributor to advancements in the Next-Generation IVD market, addressing critical healthcare challenges with innovative solutions.

Recent Development by Key Players

Helix which is a leader in precision health, has partnered with leading cancer diagnostics company Veracyte that will make it easier for urologists to add comprehensive germline testing for patients with high-risk localized and metastatic prostate cancer. With this partnership, Helix's whole-exome based hereditary cancer test will be available alongside Veracyte's Decipher Prostate test, that shall enable a more complete view of each patient's cancer biology and inherited risk.

Waters Corporation has unveiled the Waters Xevo Charge Detection Mass Spectrometer (CDMS), that delivers unmatched measurement and characterization for the broadest range of mega-mass biomolecules central to next-generation therapeutics and structural biology. 

The Next-generation IVD market report offers a comprehensive market segmentation analysis along with an estimation for the forecast period 2026–2035.

Primary Research Interviews Breakdown

1.    Research Overview

        1.1.    The Report Offers
        1.2.    Market Coverage
                  1.2.1.    By Type 
                  1.2.2.    By Product Type 
                  1.2.3.    By Application 
                  1.2.4.    By End-use 
        1.3.    Research Phases
        1.4.    Limitations
        1.5.    Market Methodology
                  1.5.1.  Data Sources
                             1.5.1.1. Primary Research
                             1.5.1.2. Secondary Research
                  1.5.2.  Methodology
                             1.5.2.1. Data Exploration
                             1.5.2.2. Forecast Parameters
                             1.5.2.3. Data Validation
                             1.5.2.4. Assumptions
                  1.5.3.  Study Period & Data Reporting Unit

2.    Executive Summary

3.    Industry Overview

       3.1.    Industry Dynamics
                 3.1.1.    Market Growth Drivers
                 3.1.2.    Market Restraints
                 3.1.3.    Key Market Trends
                 3.1.4.    Major Opportunities
       3.2.    Industry Ecosystem
                 3.2.1.    Porter’s Five Forces Analysis
                 3.2.2.    Recent Development Analysis
                 3.2.3.    Value Chain Analysis
       3.3.    Competitive Insight
                 3.3.1.    Competitive Position of Industry Players
                 3.3.2.    Market Attractive Analysis
                 3.3.3.    Market Share Analysis

4.    Global Market Estimate and Forecast

       4.1.    Global Market Overview
       4.2.    Global Market Estimate and Forecast to 2035

5.    Market Segmentation Estimate and Forecast

       5.1.    By Type 
                 5.1.1. core laboratory diagnostics
                           5.1.1.1. Market Definition
                           5.1.1.2. Market Estimation and Forecast to 2035
                 5.1.2. POC testing
                           5.1.2.1. Market Definition
                           5.1.2.2. Market Estimation and Forecast to 2035
                 5.1.3. molecular diagnostics
                           5.1.3.1. Market Definition
                           5.1.3.2. Market Estimation and Forecast to 2035

       5.2.    By Product Type 
                 5.2.1. consumables
                           5.2.1.1. Market Definition
                           5.2.1.2. Market Estimation and Forecast to 2035
                 5.2.2. instruments
                           5.2.2.1. Market Definition
                           5.2.2.2. Market Estimation and Forecast to 2035
                 5.2.3. software
                           5.2.3.1. Market Definition
                           5.2.3.2. Market Estimation and Forecast to 2035

       5.3.    By Application 
                 5.3.1. oncology/cancer
                           5.3.1.1. Market Definition
                           5.3.1.2. Market Estimation and Forecast to 2035
                 5.3.2. infectious diseases
                           5.3.2.1. Market Definition
                           5.3.2.2. Market Estimation and Forecast to 2035
                 5.3.3. diabetes
                           5.3.3.1. Market Definition
                           5.3.3.2. Market Estimation and Forecast to 2035
                 5.3.4. cardiology
                           5.3.4.1. Market Definition
                           5.3.4.2. Market Estimation and Forecast to 2035
                 5.3.5. other applications
                           5.3.5.1. Market Definition
                           5.3.5.2. Market Estimation and Forecast to 2035

       5.4.    By End-use 
                 5.4.1. hospitals and clinics
                           5.4.1.1. Market Definition
                           5.4.1.2. Market Estimation and Forecast to 2035
                 5.4.2. diagnostic laboratories
                           5.4.2.1. Market Definition
                           5.4.2.2. Market Estimation and Forecast to 2035
                 5.4.3. academic and research institutions
                           5.4.3.1. Market Definition
                           5.4.3.2. Market Estimation and Forecast to 2035
                 5.4.4. other end-use industries
                           5.4.4.1. Market Definition
                           5.4.4.2. Market Estimation and Forecast to 2035

6.   North America Market Estimate and Forecast

      6.1.    By Type   
      6.2.    By Product Type   
      6.3.    By Application   
      6.4.    By End-use   
                6.4.1.    U.S. Market Estimate and Forecast
                6.4.2.    Canada Market Estimate and Forecast
                6.4.3.    Mexico Market Estimate and Forecast

7.   Europe Market Estimate and Forecast

      7.1.    By Type   
      7.2.    By Product Type   
      7.3.    By Application   
      7.4.    By End-use   
                7.4.1.    Germany Market Estimate and Forecast
                7.4.2.    U.K. Market Estimate and Forecast
                7.4.3.    France Market Estimate and Forecast
                7.4.4.    Italy Market Estimate and Forecast
                7.4.5.    Spain Market Estimate and Forecast
                7.4.6.    Russia Market Estimate and Forecast
                7.4.7.    Rest of Europe Market Estimate and Forecast

8.   Asia-Pacific (APAC) Market Estimate and Forecast

      8.1.    By Type   
      8.2.    By Product Type   
      8.3.    By Application   
      8.4.    By End-use   
                8.4.1.    China Market Estimate and Forecast
                8.4.2.    Japan Market Estimate and Forecast
                8.4.3.    India Market Estimate and Forecast
                8.4.4.    South Korea Market Estimate and Forecast
                8.4.5.    Vietnam Market Estimate and Forecast
                8.4.6.    Thailand Market Estimate and Forecast
                8.4.7.    Malaysia Market Estimate and Forecast
                8.4.8.    Rest of Asia-Pacific Market Estimate and Forecast

9.   Rest of the World (RoW) Market Estimate and Forecast

      9.1.    By Type   
      9.2.    By Product Type   
      9.3.    By Application   
      9.4.    By End-use   
                9.4.1.    Brazil Market Estimate and Forecast
                9.4.2.    Saudi Arabia Market Estimate and Forecast
                9.4.3.    South Africa Market Estimate and Forecast
                9.4.4.    U.A.E. Market Estimate and Forecast
                9.4.5.    Other Countries Market Estimate and Forecast

10.  Company Profiles

       10.1.   Abbott Laboratories
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Becton
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Dickinson and Company
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   BioMérieux SA
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Bio-Rad Laboratories Inc.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Danaher Corporation
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   F. Hoffmann-La Roche Ltd.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Illumina Inc.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   QIAGEN N.V.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Shenzhen Mindray Bio-Medical Electronics Co. Ltd
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Siemens Healthineers AG
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Thermo Fisher Scientific Inc.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Wama Diagnostica
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Wiener Laboratorios SAIC
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   QuidelOrtho Corporation
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   Agilent Technologies Inc.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments
       10.1.   DiaSorin S.p.A.
                  10.1.1.    Snapshot
                  10.1.2.    Overview
                  10.1.3.    Offerings
                  10.1.4.    Financial Insight
                  10.1.5.    Recent Developments

11.    Appendix

         11.1.    Exchange Rates
         11.2.    Abbreviations

Note: Financial insight and recent developments of different companies are subject to the availability of information in the secondary domain.