Next-Generation IVD (In vitro diagnostics) Market Size & Forecast

Market Research Report

A quick peek into the report

1.1   Product Definition
1.1.1   Inclusion and Exclusion Criteria
1.2   Market Scope
1.2.1   Scope of the Study
1.2.2   Key Questions Answered in the Report
1.3   Research Methodology
1.3.1   Global Next-Generation IVD Market: Research Methodology
1.3.2   Data Sources
1.3.2.1   Primary Data Sources
1.3.2.2   Secondary Data Sources
1.3.3   Market Estimation Model
1.3.4   Criteria for Company Profiling

2.1   Introduction
2.1.1   Global Next-Generation IVD Market Outlook
2.1.1.1   POC-IVD
2.1.1.2   Global Diagnostic Expenditures
2.1.1.3   Pricing Patterns of Next-Generation IVD
2.1.2   Market Size and Growth Potential
2.1.2.1   Short-Term Impact (2020-2025)
2.1.2.2   Long-Term Impact (2026-2033)
2.1.3   Product Benchmarking by Next- Generation In-vitro Diagnostics Market, (by Type)
2.2   COVID-19 Impact on the Next-Generation IVD Market
2.2.1   Impact on Operations
2.2.2   COVID-19 Impact: Current Scenario of the Market
2.2.3   Pre-COVID Assessment
2.2.4   Post-COVID-19 Market Assessment

3.1   Legal Requirements
3.1.1   Legal Requirements and Framework in the U.S.
3.1.2   Legal Requirements and Framework in Europe
3.1.3   Legal Requirements and Framework in Asia-Pacific
3.1.4   Legal Requirement and Framework in Latin America

4.1   Overview
4.2   Impact Analysis
4.3   Market Drivers
4.3.1   Technological Advancements in Next-Generation In-Vitro Diagnostics Transforming Healthcare System
4.3.2   Rising Demand of POC Testing Boosting Next-Generation IVD Market
4.3.3   Growing Incidence of Chronic and Acute Diseases Demanding for Early Treatment
4.3.4   Boost in the Next-Generation IVD Market during COVID-19 Pandemic
4.4   Market Challenges
4.4.1   Regulatory Hurdles Related to Next-Generation IVD Technologies
4.4.2   Poor Reimbursement Scenario
4.5   Market Opportunities
4.5.1   Rising Number of Next-Generation IVD Companies Involved in Business Expansion
4.5.2   Inclination of Emerging Companies toward Next-Generation IVD

5.1   Overview
5.2   Corporate Strategies
5.2.1   Acquisitions
5.2.2   Synergistic Activities
5.3   Business Strategies
5.3.1   Product Launches and Approvals
5.3.2   Business Expansions, Fundings, and Other Activities
5.4   Market Share Analysis
5.4.1   Market Share Analysis (by Company)
5.5   Growth Share Analysis
5.5.1   Growth Share Analysis (by Product)

6.1   Overview
6.2   Consumables
6.3   Instruments
6.4   Software

7.1   Overview
7.2   Core Laboratory Diagnostics
7.2.1   Test Volume
7.2.2   Market Size and Forecast
7.2.2.1   Immunoassay
7.2.2.2   Hematology
7.2.2.3   Clinical Chemistry
7.2.2.4   Other Core Laboratory Diagnostics
7.3   POC Testing
7.3.1   Test Volume
7.3.2   Market Size and Forecast
7.4   Molecular Diagnostics
7.4.1   Test Volume
7.4.2   Market Size and Forecast
7.4.2.1   PCR
7.4.2.2   NGS
7.4.2.3   INAAT
7.4.2.4   Microarray
7.4.2.5   ISH
7.4.2.6   Immunohistochemistry
7.4.2.7   Other Molecular Diagnostics

8.1   Overview
8.2   Diabetes
8.2.1   Type 1
8.2.2   Type 2
8.3   Infectious Diseases
8.3.1   Tuberculosis
8.3.2   Malaria
8.3.3   Hepatitis
8.3.4   Other Infectious Diseases
8.4   Oncology/Cancer
8.4.1   Solid Tumor
8.4.2   Hematological Malignancies
8.5   Cardiology
8.5.1   Cardiac Ischemia
8.5.2   Coronary Artery Diseases
8.6   Other Applications

9.1   Overview
9.1.1   Hospitals and Clinics
9.1.2   Diagnostic Laboratories
9.1.3   Academic and Research Institutions
9.1.4   Other End Users

10.1   Overview
10.2   North America
10.2.1   Market Dynamics
10.2.2   Market Size and Forecast
10.2.2.1   North America Next-Generation IVD Market (by End User)
10.2.2.2   North America Next-Generation IVD Market (by Type)
10.2.2.2.1   North America Next-Generation Core Laboratory IVD Market, (by Type)
10.2.2.3   North America Next-Generation IVD Market (by Country)
10.2.2.3.1   U.S.
10.2.2.3.1.1   Market Size and Forecast
10.2.2.3.1.1.1   U.S. Next-Generation IVD Market (by End User)
10.2.2.3.1.1.2   U.S. Next-Generation IVD Market (by Type)
10.2.2.3.2   Canada
10.2.2.3.2.1   Market Size and Forecast
10.2.2.3.2.1.1   Canada Next-Generation IVD Market (by End User)
10.2.2.3.2.1.2   Canada Next-Generation IVD Market (by Type)
10.3   Europe
10.3.1   Market Dynamics
10.3.2   Market Size and Forecast
10.3.2.1   Europe Next-Generation IVD Market (by End User)
10.3.2.2   Europe Next-Generation IVD Market (by Type)
10.3.2.2.1   Europe Next-Generation Core Laboratory IVD Market, (by Type)
10.3.2.3   Europe Next-Generation IVD Market (by Country)
10.3.2.3.1   Germany
10.3.2.3.1.1   Market Size and Forecast
10.3.2.3.1.1.1   Germany Next-Generation IVD Market (by End User)
10.3.2.3.1.1.2   Germany Next-Generation IVD Market (by Type)
10.3.2.3.2   France
10.3.2.3.2.1   Market Size and Forecast
10.3.2.3.2.1.1   France Next-Generation IVD Market (by End User)
10.3.2.3.2.1.2   France Next-Generation IVD Market (by Type)
10.3.2.3.3   U.K.
10.3.2.3.3.1   Market Size and Forecast
10.3.2.3.3.1.1   U.K. Next-Generation IVD Market (by End User)
10.3.2.3.3.1.2   U.K. Next-Generation IVD Market (by Type)
10.3.2.3.4   Italy
10.3.2.3.4.1   Market Size and Forecast
10.3.2.3.4.1.1   Italy Next-Generation IVD Market (by End User)
10.3.2.3.4.1.2   Italy Next-Generation IVD Market (by Type)
10.3.2.3.5   Spain
10.3.2.3.5.1   Market Size and Forecast
10.3.2.3.5.1.1   Spain Next-Generation IVD Market (by End User)
10.3.2.3.5.1.2   Spain Next-Generation IVD Market (by Type)
10.3.2.3.6   Rest-of-Europe
10.3.2.3.6.1   Market Size and Forecast
10.3.2.3.6.1.1   Rest-of-Europe Next-Generation IVD Market (by End User)
10.3.2.3.6.1.2   Rest-of-Europe Next-Generation IVD Market (by Type)
10.4   Asia-Pacific
10.4.1   Market Dynamics
10.4.2   Market Size and Forecast
10.4.2.1   Asia-Pacific Next-Generation IVD Market (by End User)
10.4.2.2   Asia-Pacific Next-Generation IVD Market (by Type)
10.4.2.2.1   Asia-Pacific Next-Generation Core Laboratory IVD Market, (by Type)
10.4.2.3   Asia-Pacific Next-Generation IVD Market (by Country)
10.4.2.3.1   China
10.4.2.3.1.1   Market Size and Forecast
10.4.2.3.1.1.1   China Next-Generation IVD Market (by End User)
10.4.2.3.1.1.2   China Next-Generation IVD Market (by Type)
10.4.2.3.2   Japan
10.4.2.3.2.1   Market Size and Forecast
10.4.2.3.2.1.1   Japan Next-Generation IVD Market (by End User)
10.4.2.3.2.1.2   Japan Next-Generation IVD Market (by Type)
10.4.2.3.3   India
10.4.2.3.3.1   Market Size and Forecast
10.4.2.3.3.1.1   India Next-Generation IVD Market (by End User)
10.4.2.3.3.1.2   India Next-Generation IVD Market (by Type)
10.4.2.3.4   Australia
10.4.2.3.4.1   Market Size and Forecast
10.4.2.3.4.1.1   Australia Next-Generation IVD Market (by End User)
10.4.2.3.4.1.2   Australia Next-Generation IVD Market (by Type)
10.4.2.3.5   South Korea
10.4.2.3.5.1   Market Size and Forecast
10.4.2.3.5.1.1   South Korea Next-Generation IVD Market (by End User)
10.4.2.3.5.1.2   South Korea Next-Generation IVD Market (by Type)
10.4.2.3.6   Rest-of-Asia-Pacific
10.4.2.3.6.1   Market Size and Forecast
10.4.2.3.6.1.1   Rest-of-Asia-Pacific Next-Generation IVD Market (by End User)
10.4.2.3.6.1.2   Rest-of-Asia-Pacific Next-Generation IVD Market (by Type)
10.5   Latin America
10.5.1   Market Dynamics
10.5.2   Market Size and Forecast
10.5.2.1   Latin America Next-Generation IVD Market (by End User)
10.5.2.2   Latin America Next-Generation IVD Market (by Type)
10.5.2.2.1   Latin America Next-Generation Core Laboratory IVD Market, (by Type)
10.5.2.3   Latin America Next-Generation IVD Market (by Country)
10.5.2.3.1   Brazil
10.5.2.3.1.1   Market Size and Forecast
10.5.2.3.1.1.1   Brazil Next-Generation IVD Market (by End User)
10.5.2.3.1.1.2   Brazil Next-Generation IVD Market (by Type)
10.5.2.3.2   Mexico
10.5.2.3.2.1   Market Size and Forecast
10.5.2.3.2.1.1   Mexico Next-Generation IVD Market (by End User)
10.5.2.3.2.1.2   Mexico Next-Generation IVD Market (by Type)
10.5.2.3.3   Rest-of-Latin America
10.5.2.3.3.1   Market Size and Forecast
10.5.2.3.3.1.1   Rest-of-Latin America Next-Generation IVD Market (by End User)
10.5.2.3.3.1.2   Rest-of-Latin America Next-Generation IVD Market (by Type)
10.6   Middle East and Africa
10.6.1   Market Dynamics
10.6.2   Market Size and Forecast
10.6.2.1   Middle East and Africa Next-Generation IVD Market (by End User)
10.6.2.2   Middle East and Africa Next-Generation IVD Market (by Type)
10.6.2.2.1   Middle East and Africa Next-Generation Core Laboratory IVD Market, (by Type)

11.1   Overview
11.2   Global Next-Generation IVD Market Ecosystem Active Players
11.3   Abbott Laboratories
11.3.1   Company Overview
11.3.2   Role of Abbott Laboratories in the Global Next-Generation IVD Market
11.3.3   Financials
11.3.4   Recent Developments
11.3.4.1   Business Strategies
11.3.5   Analyst Perspective
11.4   Agilent Technologies, Inc.
11.4.1   Company Overview
11.4.2   Role of Agilent Technologies, Inc. in the Global Next-Generation IVD Market
11.4.3   Financials
11.4.4   Recent Developments
11.4.4.1   Corporate Strategies
11.4.4.2   Business Strategies
11.4.5   Analyst Perspective
11.5   Becton, Dickinson and Company
11.5.1   Company Overview
11.5.2   Role of Becton, Dickinson and Company in the Global Next-Generation IVD Market
11.5.3   Financials
11.5.4   Recent Developments
11.5.4.1   Corporate Strategies
11.5.4.2   Business Strategies
11.5.5   Analyst Perspective
11.6   bioMérieux SA (BioFire Diagnostics)
11.6.1   Company Overview
11.6.2   Role of bioMérieux SA (BioFire Diagnostics) in the Global Next-Generation IVD Market
11.6.3   Financials
11.6.4   Recent Developments
11.6.4.1   Corporate Strategies
11.6.4.2   Business Strategies
11.6.5   Analyst Perspective
11.7   Bio-Rad Laboratories, Inc.
11.7.1   Company Overview
11.7.2   Role of Bio-Rad Laboratories, Inc. in the Global Next-Generation IVD Market
11.7.3   Financials
11.7.4   Recent Developments
1.1.1.1   Business Strategies
11.7.5   Analyst Perspective
11.8   Danaher Corporation
11.8.1   Company Overview
11.8.2   Role of Danaher Corporation in the Global Next-Generation IVD Market
11.8.3   Financials
11.8.4   Recent Developments
1.1.1.2   Corporate Strategies
1.1.1.3   Business Strategies
11.8.5   Analyst Perspective
11.9   F. Hoffmann-La Roche Ltd. (Roche Molecular Systems, Inc.)
11.9.1   Company Overview
11.9.2   Role of F. Hoffmann-La Roche Ltd. in the Global Next-Generation IVD Market
11.9.3   Financials
11.9.4   Recent Developments
11.9.4.1   Business Strategies
11.9.5   Analyst Perspective
11.10 Guardant Health
11.10.1   Company Overview
11.10.2   Role of Guardant Health in the Global Next-Generation IVD Market
11.10.3   Financials
11.10.4   Analyst Perspective
11.11   Illumina, Inc.
11.11.1   Company Overview
11.11.2   Role of Illumina, Inc. in the Global Next-Generation IVD Market
11.11.3   Financials
11.11.4   Recent Developments
11.11.4.1   Corporate Strategies
11.11.4.2   Business Strategies
11.11.5   Analyst Perspective
11.12   Invivoscribe, Inc.
11.12.1   Company Overview
11.12.2   Role of Invivoscribe, Inc. in the Global Next-Generation IVD Market
11.12.3   Recent Developments
11.12.3.1   Corporate Strategies
11.12.4   Analyst Perspective
11.13   PerkinElmer Inc.
11.13.1   Company Overview
11.13.2   Role of PerkinElmer Inc. in the Global Next-Generation IVD Market
11.13.3   Financials
11.13.4   Recent Developments
11.13.4.1   Corporate Strategies
11.13.4.2   Business Strategies
11.13.5   Analyst Perspective
11.14   QIAGEN N.V.
11.14.1   Company Overview
11.14.2   Role of QIAGEN N.V. in the Global Next-Generation IVD Market
11.14.3   Financials
11.14.4   Recent Developments
11.14.4.1   Corporate Strategies
11.14.4.2   Business Strategies
11.14.5   Analyst Perspective
11.15   Quest Diagnostics Incorporated
11.15.1   Company Overview
11.15.2   Role of Quest Diagnostics Incorporated in the Global Next-Generation IVD Market
11.15.3   Financials
11.15.4   Analyst Perspective
11.16   Sysmex Corporation
11.16.1   Company Overview
11.16.2   Role of Sysmex Corporation in the Global Next-Generation IVD Market
11.16.3   Financials
11.16.4   Recent Developments
11.16.4.1   Business Strategies
11.16.5   Analyst Perspective
11.17   Laboratory Corporation of America Holdings.
11.17.1   Company Overview
11.17.2   Role of Laboratory Corporation of America Holdings. in Global Next-Generation IVD Market
11.17.3   Financials
11.17.4   Recent Developments
11.17.4.1   Business Strategies
11.17.5   Analyst’s Perspective
11.18   Myriad Genetics, Inc.
11.18.1   Company Overview
11.18.2   Role of Myriad Genetics, Inc. in the Global Next-Generation IVD Market
11.18.3   Financials
11.18.4   Analyst Perspective
11.19   Siemens Healthineers AG
11.19.1   Company Overview
11.19.2   Role of Siemens Healthineers AG in the Global Next-Generation IVD Market
11.19.3   Financials
11.19.4   Recent Developments
11.19.4.1   Corporate Strategies
11.19.4.2   Business Strategies
11.19.5   Analyst Perspective
11.20 Tempus
11.20.1   Company Overview
11.20.2   Role of Tempus in the Global Next-Generation IVD Market
11.20.3   Recent Developments
11.20.3.1   Business Strategies
11.20.4   Analyst Perspective
11.21   Thermo Fisher Scientific Inc.
11.21.1   Company Overview
11.21.2   Role of Thermo Fisher Scientific Inc. in the Global Next-Generation IVD Market
11.21.3   Financials
11.21.4   Recent Developments
11.21.4.1   Corporate Strategies
11.21.4.2   Business Strategies
11.21.5   Analyst Perspective
11.22   Emerging Companies
11.22.1   Geneseeq Technology Inc.
11.22.2   Genes2Me
11.22.3   Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
11.22.4   Spindiag GmbH

Table 1:   Impact Analysis of Market Drivers, and Restraints on the Global Next-Generation IVD Market
Table 2:   Impact of COVID-19 on Different Countries
Table 3:   Likert Scale
Table 4:   Impact Analysis of Market Drivers
Table 5:   Impact Analysis of Market Restraints
Table 6:   Impact Analysis of Market Opportunities
Table 7:   Technology Offered by Next-Generation IVD Ecosystem
Table 8:   Examples of Expansion Strategy by Global Next-Generation IVD Market Players
Table 9:   Companies Offering Next-Generation-IVD Kits
Table 10:   Companies Offering Next-Generation IVD Instruments
Table 11:   Companies Offering Next-Generation IVD Software
Table 12:   Companies Offering POC Test
Table 13:   North America: Market Dynamics
Table 14:   Europe: Market Dynamics
Table 15:   Asia-Pacific: Market Dynamics
Table 16:   Latin America: Market Dynamics
Table 17:   Middle East and Africa: Market Dynamics
Table 18:   Global Next-Generation IVD Market, Active Players

Figure 1:   Facts about Global Next-Generation IVD Market
Figure 2:   Equipment’s used for Next-Generation In-Vitro Diagnostics
Figure 3:   Global Next-Generation IVD Market, $Billion, 2022 and 2033
Figure 4:   Trend Analysis of Next-Generation In-vitro Diagnostics Ecosystem
Figure 5:   Common Chronic Conditions for Population Above 65 years
Figure 6:   Key Challenges in the Global Next-Generation IVD Market based on Primary Respondents
Figure 7:   New In-Vitro Diagnostics Regulations (IVDR) and Medical Device Regulation (MDR)
Figure 8:   Major Highlights Witnessed in the Next-Generation IVD Market During COVID-19 Impact
Figure 9:   Role of POC Diagnostics in Next-Generation IVD Market During Pandemic
Figure 10:   Leading and Emerging Companies in the Next-Generation IVD Ecosystem
Figure 11:   Leading Companies in the Next-Generation IVD Ecosystem and Their Market Share (%)
Figure 12:   Key Developments Undertaken by Companies in the Next-Generation IVD Market, July 2019-June 2023
Figure 13:   Product Benchmarking of Next-Generation In-Vitro Diagnostics Ecosystem (by Test)
Figure 14:   Global Next-Generation IVD Market (by Type), Share (%), 2022 and 2033
Figure 15:   Global Next-Generation IVD Market (by Product), Share (%), 2022 and 2033
Figure 16:   Global Next-Generation IVD Market (by Application), Share (%), 2022 and 2033
Figure 17:   Global Next-Generation IVD Market (by End User), Share (%), 2022 and 2033
Figure 18:   Global Next-Generation In-Vitro Diagnostics Market (by Region), $Billion, 2022 and 2033
Figure 19:   Europe Next-Generation IVD Market, Market Snapshot
Figure 20:   Global Next-Generation IVD Market Segmentation
Figure 21:   Global Next-Generation IVD Market: Research Methodology
Figure 22:   Primary Research Methodology
Figure 23:   Bottom-Up Approach (Segment-Wise Analysis)
Figure 24:   Top-Down Approach (Segment-Wise Analysis)
Figure 25:   Global Next-Generation IVD Market, $Billion, 2022-2033
Figure 26:   Product Benchmarking of Next-Generation In-vitro Diagnostics Market (by Type)
Figure 27:   In-Vitro Diagnostic Trends during the COVID-19 Pandemic
Figure 28:   Timeline of IVDR 2017/746
Figure 29:   Global Next-Generation IVD Market Dynamics
Figure 30:   Factors Contributing to Growing Demand of POC Testing
Figure 31:   Current Trend in In-Vitro Diagnostics: From Centralized Laboratory to Point-of-Care Testing
Figure 32:   Annual Global Mortality by Chronic Illness in 1990, 2002, and 2020
Figure 33:   Trend in COVID-19 Diagnostic Test Development and the Used Technology
Figure 34:   Top Challenges in the IVDR Compliance
Figure 35:   Key Area of Focus by Next-Generation IVD Companies
Figure 36:   Share of Key Developments, July 2019-June 2023
Figure 37:   Share of Acquisitions (by Company), July 2019-June 2023
Figure 38:   Share of Synergistic Activities (by Company), July 2019-June 2023
Figure 39:   Share of Product Launches and Approvals (by Company), July 2019-June 2023
Figure 40:   Share of Business Expansions, Fundings, and Other Activities (by Company), July 2019-June 2023
Figure 41:   Market Share Analysis of Global Next-Generation IVD Market (by Company), 2022
Figure 42:   Growth Share Analysis for Global Next-Generation IVD Market (by Product), 2022
Figure 43:   Global Next-Generation IVD Market (by Product)
Figure 44:   Global Next-Generation IVD Market (by Product), $Billion, 2022 and 2033
Figure 45:   Global Next-Generation IVD Market (Consumables), $Billion, 2022-2033
Figure 46:   Global Next-Generation IVD Market (Instruments), $Billion, 2022-2033
Figure 47:   Global Next-Generation IVD Market (Software), $Billion, 2022-2033
Figure 48:   Global Next-Generation IVD Market (by Type)
Figure 49:   Global Next-Generation IVD Market (by Type), $Billion, 2022 and 2033
Figure 50:   Global Next-Generation IVD Market (Core Laboratory Diagnostics), Thousand Units, 2022-2033
Figure 51:   Global Next-Generation IVD Market (Core Laboratory Diagnostics), $Billion, 2022-2033
Figure 52:   Global Next-Generation IVD Market (Immunoassay), $Billion, 2022-2033
Figure 53:   Global Next-Generation IVD Market (Hematology), $Billion, 2022-2033
Figure 54:   Global Next-Generation IVD Market (Clinical Chemistry), $Billion, 2022-2033
Figure 55:   Global Next-Generation IVD Market (Other Core Laboratory Diagnostics), $Billion, 2022-2033
Figure 56:   Global Next-Generation IVD Market (POC Testing), Thousand Units, 2022-2033
Figure 57:   Global Next-Generation IVD Market (POC Testing), $Billion, 2022-2033
Figure 58:   Global Next-Generation IVD Market (Molecular Diagnostics), Thousand Units, 2022-2033
Figure 59:   Global Next-Generation IVD Market (Molecular Diagnostics), $Billion, 2022-2033
Figure 60:   Global Next-Generation IVD Market (PCR), $Billion, 2022-2033
Figure 61:   Global Next-Generation IVD Market (NGS), $Billion, 2022-2033
Figure 62:   Global Next-Generation IVD Market (INAAT), $Billion, 2022-2033
Figure 63:   Global Next-Generation IVD Market (Microarray), $Billion, 2022-2033
Figure 64:   Global Next-Generation IVD Market (ISH), $Billion, 2022-2033
Figure 65:   Global Next-Generation IVD Market (Immunohistochemistry), $Billion, 2022-2033
Figure 66:   Global Next-Generation IVD Market (Other Molecular Diagnostics), $Billion, 2022-2033
Figure 67:   Global Next-Generation IVD Market (by Application)
Figure 68:   Global Next-Generation IVD Market (by Application), Share (%), 2022 and 2033
Figure 69:   Global Next-Generation IVD Market (Diabetes), $Billion, 2022-2033
Figure 70:   Global Next-Generation IVD Market (Type 1), $Billion, 2022-2033
Figure 71:   Global Next-Generation IVD Market (Type 2), $Billion, 2022-2033
Figure 72:   Global Next-Generation IVD Market (Infectious Diseases), $Billion, 2022-2033
Figure 73:   Global Next-Generation IVD Market (Tuberculosis), $Billion, 2022-2033
Figure 74:   Global Next-Generation IVD Market (Malaria), $Billion, 2022-2033
Figure 75:   Global Next-Generation IVD Market (Hepatitis), $Billion, 2022-2033
Figure 76:   Global Next-Generation IVD Market (Other Infectious Diseases), $Billion, 2022-2033
Figure 77:   Global Next-Generation IVD Market (Oncology/Cancer), $Billion, 2022-2033
Figure 78:   Global Next-Generation IVD Market (Solid Tumor), $Billion, 2022-2033
Figure 79:   Global Next-Generation IVD Market (Hematological Malignancies), $Billion, 2022-2033
Figure 80:   Global Next-Generation IVD Market (Cardiology), $Billion, 2022-2033
Figure 81:   Global Next-Generation IVD Market (Cardiac Ischemia), $Billion, 2022-2033
Figure 82:   Global Next-Generation IVD Market (Coronary Artery Diseases), $Billion, 2022-2033
Figure 83:   Global Next-Generation IVD Market (Other Applications), $Billion, 2022-2033
Figure 84:   Global Next-Generation IVD Market (by End User)
Figure 85:   Global Next-Generation IVD Market (by End User), Share (%), 2022 and 2033
Figure 86:   Global Next-Generation IVD Market (Hospitals and Clinics), $Billion, 2022-2033
Figure 87:   Global Next-Generation IVD Market (Diagnostic Laboratories), $Billion, 2022-2033
Figure 88:   Global Next-Generation IVD Market (Academic and Research Institutes), $Billion, 2022-2033
Figure 89:   Global Next-Generation IVD Market (Other End Users), $Billion, 2022-2033
Figure 90:   Global Next-Generation IVD Market (by Region), Share (%), 2022
Figure 91:   Global Next-Generation IVD Market (by Region), $Billion, 2022-2033
Figure 92:   North America Next-Generation IVD Market, $Billion, 2022-2033
Figure 93:   North America Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 94:   North America Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 95:   North America Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 96:   North America Next-Generation IVD Market (by Country), $Billion, 2022-2033
Figure 97:   Factors Accelerating U.S. Next-Generation IVD Market
Figure 98:   U.S. Next-Generation IVD Market, $Billion, 2022-2033
Figure 99:   U.S. Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 100:   U.S. Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 101:   U.S. Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 102:   Canada Next-Generation IVD Market, $Billion, 2022-2033
Figure 103:   Canada Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 104:   Canada Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 105:   Canada Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 106:   Europe Next-Generation IVD Market, $Billion, 2022-2033
Figure 107:   Europe Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 108:   Europe Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 109:   Europe Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 110:   Europe Next-Generation IVD Market (by Country), $Billion, 2022-2033
Figure 111:   Germany Next-Generation IVD Market, $Billion, 2022-2033
Figure 112:   Germany Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 113:   Germany Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 114:   Germany Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 115:   France Next-Generation IVD Market, $Billion, 2022-2033
Figure 116:   France Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 117:   France Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 118:   France Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 119:   U.K. Next-Generation IVD Market, $Billion, 2022-2033
Figure 120:   U.K. Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 121:   U.K. Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 122:   U.K. Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 123:   Italy Next-Generation IVD Market, $Billion, 2022-2033
Figure 124:   Italy Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 125:   Italy Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 126:   Italy Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 127:   Spain Next-Generation IVD Market, $Billion, 2022-2033
Figure 128:   Spain Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 129:   Spain Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 130:   Spain Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 131:   Rest-of-Europe Next-Generation IVD Market, $Billion, 2022-2033
Figure 132:   Rest-of-Europe Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 133:   Rest-of-Europe Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 134:   Rest-of-Europe Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 135:   Asia-Pacific Next-Generation IVD Market, $Billion, 2022-2033
Figure 136:   Asia-Pacific Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 137:   Asia-Pacific Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 138:   Asia-Pacific Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 139:   Asia-Pacific Next-Generation IVD Market (by Country), $Billion, 2022-2033
Figure 140:   China Next-Generation IVD Market, $Billion, 2022-2033
Figure 141:   China Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 142:   China Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 143:   China Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 144:   Japan Next-Generation IVD Market, $Billion, 2022-2033
Figure 145:   Japan Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 146:   Japan Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 147:   Japan Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 148:   India Next-Generation IVD Market, $Billion, 2022-2033
Figure 149:   India Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 150:   India Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 151:   India Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 152:   Australia Next-Generation IVD Market, $Billion, 2022-2033
Figure 153:   Australia Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 154:   Australia Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 155:   Australia Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 156:   South Korea Next-Generation IVD Market, $Billion, 2022-2033
Figure 157:   South Korea Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 158:   South Korea Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 159:   South Korea Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 160:   Rest-of-Asia-Pacific Next-Generation IVD Market, $Billion, 2022-2033
Figure 161:   Rest-of-Asia-Pacific Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 162:   Rest-of-Asia-Pacific Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 163:   Rest-of-Asia-Pacific Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 164:   Latin America Next-Generation IVD Market, $Billion, 2022-2033
Figure 165:   Latin America Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 166:   Latin America Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 167:   Latin America Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 168:   Latin America Next-Generation IVD Market (by Country), $Billion, 2022-2033
Figure 169:   Brazil Next-Generation IVD Market, $Billion, 2022-2033
Figure 170:   Brazil Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 171:   Brazil Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 172:   Brazil Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 173:   Mexico Next-Generation IVD Market, $Billion, 2022-2033
Figure 174:   Mexico Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 175:   Mexico Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 176:   Mexico Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 177:   Rest-of-Latin America Next-Generation IVD Market, $Billion, 2022-2033
Figure 178:   Rest-of-Latin America Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 179:   Rest-of-Latin America Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 180:   Rest-of-Latin America Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 181:   Middle East and Africa Next-Generation IVD Market, $Billion, 2022-2033
Figure 182:   Middle East and Africa Next-Generation IVD Market (by End User), $Billion, 2022-2033
Figure 183:   Middle East and Africa Next-Generation IVD Market (by Type), $Billion, 2022-2033
Figure 184:   Middle East and Africa Next-Generation Core Laboratory IVD Market (by Type), $Billion, 2022-2033
Figure 185:   Total Number of Companies Profiled
Figure 186:   Abbott Laboratories: Product Portfolio
Figure 187:   Abbott Laboratories: Overall Financials, $Million, 2020-2022
Figure 188:   Abbott Laboratories: Revenue (by Segment), $Million, 2020-2022
Figure 189:   Abbott Laboratories: Revenue (by Region), $Million, 2020-2022
Figure 190:   Abbott Laboratories: R&D Expenditure, $Million, 2020-2022
Figure 191:   Agilent Technologies, Inc.: Product Portfolio
Figure 192:   Agilent Technologies, Inc.: Overall Financials, $Million, 2020-2022
Figure 193:   Agilent Technologies, Inc.: Net Revenue (by Segment), $Million, 2020-2022
Figure 194:   Agilent Technologies, Inc.: Net Revenue (by Region), $Million, 2020-2022
Figure 195:   Agilent Technologies, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 196:   Becton, Dickinson and Company: Product Portfolio
Figure 197:   Becton, Dickinson and Company: Overall Financials, $Million, 2020-2022
Figure 198:   Becton, Dickinson and Company: Revenue (by Segment), $Million, 2020-2022
Figure 199:   Becton, Dickinson and Company: Revenue (by Region), $Million, 2020-2022
Figure 200:   Becton, Dickinson and Company: R&D Expenditure, $Million, 2020-2022
Figure 201:   bioMérieux SA (BioFire Diagnostics): Product Portfolio
Figure 202:   bioMérieux SA (BioFire Diagnostics): Overall Financials, $Million, 2020-2022
Figure 203:   bioMérieux SA (BioFire Diagnostics): Revenue (by Segment), $Million, 2020-2022
Figure 204:   bioMérieux SA (BioFire Diagnostics): Revenue (by Region), $Million, 2020-2022
Figure 205:   bioMérieux SA (BioFire Diagnostics): R&D Expenditure, $Million, 2020-2022
Figure 206:   Bio-Rad Laboratories, Inc.: Product Portfolio
Figure 207:   Bio-Rad Laboratories, Inc.: Overall Financials, $Million, 2020-2022
Figure 208:   Bio-Rad Laboratories, Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 209:   Bio-Rad Laboratories, Inc.: Revenue (by Region), $Million, 2020-2022
Figure 210:   Bio-Rad Laboratories, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 211:   Danaher Corporation: Product Portfolio
Figure 212:   Danaher Corporation: Overall Financials, $Million, 2020-2022
Figure 213:   Danaher Corporation: Revenue (by Segment), $Million, 2020-2022
Figure 214:   Danaher Corporation: Revenue (by Region), $Million, 2020-2022
Figure 215:   Danaher Corporation: R&D Expenditure, $Million, 2020-2022
Figure 216:   F. Hoffmann-La Roche Ltd.: Product Portfolio
Figure 217:   F. Hoffmann-La Roche Ltd.: Overall Financials, $Million, 2020-2022
Figure 218:   F. Hoffmann-La Roche Ltd.: Revenue (by Segment), $Million, 2020-2022
Figure 219:   F. Hoffmann-La Roche Ltd.: Revenue (by Region), $Million, 2020-2022
Figure 220:   F. Hoffmann-La Roche Ltd.: R&D Expenditure, $Million, 2020-2022
Figure 221:   Guardant Health: Product Portfolio
Figure 222:   Guardant Health: Overall Financials, $Million, 2020-2022
Figure 223:   Guardant Health: Revenue (by Segment), $Million, 2020-2022
Figure 224:   Guardant Health: Revenue (by Region), $Million, 2020-2022
Figure 225:   Guardant Health: R&D Expenditure, $Million, 2020-2022
Figure 226:   Illumina, Inc.: Product Portfolio
Figure 227:   Illumina, Inc.: Overall Financials, $Million, 2020-2022
Figure 228:   Illumina, Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 229:   Illumina, Inc.: Revenue (by Region), $Million, 2020-2022
Figure 230:   Illumina, Inc.: R&D Expenditure, $Million, 2020-2022
Figure 231:   Invivoscribe, Inc.: Product Portfolio
Figure 232:   PerkinElmer Inc.: Product Portfolio
Figure 233:   PerkinElmer Inc.: Overall Financials, $Million, 2020-2022
Figure 234:   PerkinElmer Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 235:   PerkinElmer Inc.: Revenue (by Region), $Million, 2020-2022
Figure 236:   PerkinElmer Inc.: R&D Expenditure, $Million, 2020-2022
Figure 237:   QIAGEN N.V.: Product Portfolio
Figure 238:   QIAGEN N.V.: Overall Financials, $Million, 2020-2022
Figure 239:   QIAGEN N.V.: Revenue (by Segment), $Million, 2020-2022
Figure 240:   QIAGEN N.V.: Revenue (by Region), $Million, 2020-2022
Figure 241:   QIAGEN N.V.: R&D Expenditure, $Million, 2020-2022
Figure 242:   Quest Diagnostics Incorporated: Product Portfolio
Figure 243:   Quest Diagnostics Incorporated: Overall Financials, $Million, 2020-2022
Figure 244:   Quest Diagnostics Incorporated: Revenue (by Segment), $Million, 2020-2022
Figure 245:   Sysmex Corporation: Product Portfolio
Figure 246:   Sysmex Corporation: Overall Financials, $Million, 2020-2022
Figure 247:   Sysmex Corporation: Revenue (by Segment), $Million, 2020-2022
Figure 248:   Sysmex Corporation: Revenue (by Region), $Million, 2020-2022
Figure 249:   Sysmex Corporation: R&D Expenditure, $Million, 2020-2022
Figure 250:   Laboratory Corporation of America Holdings.: Product Portfolio
Figure 251:   Laboratory Corporation of America Holdings.: Overall Financials, $Million, 2020-2022
Figure 252:   Laboratory Corporation of America Holdings.: Revenue (by Segment), $Million, 2020-2022
Figure 253:   Laboratory Corporation of America Holdings.: Revenue (by Region), $Million, 2020-2022
Figure 254:   Myriad Genetics, Inc.: Product Portfolio
Figure 255:   Myriad Genetics, Inc.: Overall Financials, ($Million), 2020-2022
Figure 256:   Myriad Genetics, Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 257:   Myriad Genetics, Inc.: R&D Expenditure, ($Million), 2020-2022
Figure 258:   Siemens Healthineers AG: Product Portfolio
Figure 259:   Siemens Healthineers AG: Overall Financials, $Million, 2020-2022
Figure 260:   Siemens Healthineers AG: Revenue (by Region), $Million, 2020-2022
Figure 261:   Siemens Healthineers AG: R&D Expenditure, $Million, 2020-2022
Figure 262:   Tempus: Product Portfolio
Figure 263:   Thermo Fisher Scientific Inc.: Product Portfolio
Figure 264:   Thermo Fisher Scientific Inc.: Overall Financials, $Million, 2020-2022
Figure 265:   Thermo Fisher Scientific Inc.: Revenue (by Segment), $Million, 2020-2022
Figure 266:   Thermo Fisher Scientific Inc.: Revenue (by Region), $Million, 2020-2022
Figure 267:   Thermo Fisher Scientific Inc.: R&D Expenditure, $Million, 2020-2022

Market Report Coverage

Key Market Players and Competition Synopsis

The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.

The top next-generation IVD market type segment players who are leading capture around 69.90% of the presence in the market. Players in other industries, such as POC testing, and molecular diagnostics, account for approximately 12.24% and 17.86% of the presence in the market.

Key Companies Profiled:

•   Abbott Laboratories
•   Agilent Technologies, Inc.
•   Becton, Dickinson and Company
•   bioMérieux SA (BioFire Diagnostics)
•   Bio-Rad Laboratories, Inc.
•   Danaher Corporation
•   F. Hoffmann-La Roche Ltd. (Roche Molecular Systems, Inc.)
•   Guardant Health
•   Illumina, Inc.
•   Invivoscribe, Inc.
•   PerkinElmer Inc.
•   QIAGEN N.V.
•   Quest Diagnostics Incorporated
•   Sysmex Corporation
•   Laboratory Corporation of America Holdings.
•   Myriad Genetics, Inc.
•   Siemens Healthineers AG
•   Tempus
•   Thermo Fisher Scientific Inc.

How Can This Report Add Value to an Organization?

Product/Innovation Strategy: The global next-generation IVD market has been extensively segmented on the basis of various categories, such as product, type, application, end user, and region. This can help readers get a clear overview of which segments account for the largest share and which ones are well-positioned to grow in the coming years.

Growth/Marketing Strategy: Synergistic activities, product launches, and approvals accounted for the maximum number of key developments, i.e., nearly 80% of the total developments in the global next-generation IVD market were between January 2021 to June 2023.

Competitive Strategy: The global next-generation IVD market has numerous startups paving their way into manufacturing kits, panels, assays, and instruments and entering the market. Key players in the global next-generation IVD market analyzed and profiled in the study involve established players that offer various kinds of disease-specific panels and multiplex instruments.

Introduction of Next-Generation IVD

The next-generation IVD market was valued at $86.21 billion in 2022 and is expected to reach $152.62 billion by 2033, growing at a CAGR of 5.41% between 2023 and 2033. Next-generation in-vitro diagnostics (IVDs) refer to advanced and innovative technologies that are utilized for diagnostic testing outside the human body. These cutting-edge diagnostic tools represent a significant advancement in the field, offering enhanced accuracy, efficiency, and reliability in detecting and monitoring various diseases and conditions. Moreover, the next-generation IVD industry also faces challenges such as stringent regulations, industry consolidation, new healthcare reforms, and ever-changing demographics. However, despite these challenges, the advent of new technologies being used for diagnosis and innovations has the potential to invigorate the growth of the next-generation IVD market. Molecular diagnostics, genomics, and NGS are expected to be primary facilitators of this growth by providing new avenues for improved disease diagnosis, hence, redefining patient outcomes.

Market Introduction

The market for next-generation in-vitro diagnostics (IVD) holds considerable growth potential, driven by multiple factors. These include advancements in technology used for IVD, rising ageing population, a growing prevalence of chronic diseases, increasing demand for personalized medicine, and the need for more efficient diagnostic solutions. Further, global IVD market has exhibited consistent growth, and the introduction of next-generation IVD technologies is expected to further fuel market expansion. Market is projected to maintain a robust growth trajectory in the years ahead.

Industrial Impact

The industrial impact for growth in emerging countries, including developing nations, is substantial for next-generation in-vitro diagnostics (IVDs) market. These regions is experiencing a growing need for enhanced healthcare infrastructure, improved access to high-quality diagnostics, and the adoption of advanced technologies to address diseases effectively. This factor holds an opportunity for market to develop more in these countries. Further, the regulatory environment and reimbursement policies plays a crucial role in shaping the adoption and expansion of next-generation IVDs globally. Favourable regulations and reimbursement frameworks that facilitate the seamless integration of these technologies into routine healthcare practices can significantly boost market growth.

Market Segmentation:

Segmentation 1: by Type
•   Core Laboratory Diagnostics
•   POC Testing
•   Molecular Diagnostics

Core Laboratories Segment to Continue its Dominance as the Leading Type

The next-generation IVD market based on type is led by the core laboratories, with a 69.90% share in 2022. Core laboratory technologies in IVD encompass a range of analytical instruments and platforms used for centralized testing in laboratory settings. These technologies play a crucial role in clinical diagnostics and patient care. Core laboratory diagnostics include technologies such as immunoassay, hematology, and clinical chemistry, among others.

Segmentation 2: by Product
•   Consumables
•   Instruments
•   Software

Consumables Expected to Continue to Dominate the Product Segment

The next-generation IVD market based on product is led by consumables panels based on product, with a 69.94% share in 2022. Next-generation in-vitro diagnostics (NG-IVD) uses a various range of consumables that are instrumental in conducting sample testing and analysis for any experiment undertaken in the laboratories. These consumables are essential for ensuring the precise and effective implementation of IVD technologies. Consumables such as assay kits used for in-vitro diagnostics comprise of essential consumables that include reagents, chemicals, and materials necessary for specific diagnostic tests. These assay kits are designed to provide standardized components and protocols, ensuring consistent and reliable results.

Segmentation 3: by Application
•   Oncology/Cancer
•   Infectious Diseases
•   Diabetes
•   Cardiology
•   Other Applications

Oncology/Cancer Dominates the Next-Generation IVD Market in Application

As of 2022, the global next-generation IVD market (by application) was dominated by the oncology/cancer segment, holding a 34.95% market share, and is growing with a CAGR of 5.10%. Increasing prevalence of cancer cases across the globe and efforts by the diagnostics companies for carrying out treatment regimen for treating cancer is driving the market growth of this segment.

Segmentation 4: by End User
•   Hospitals and Clinics
•   Diagnostic Laboratories
•   Academic and Research Institutions
•   Other End Users

Hospital and Clinics Dominates the Next-Generation IVD Market by End User

The next-generation IVD market by end user is led by hospitals and clinics, with a 44.14% share in 2022. Hospitals and clinics are the major end users for the next-generation IVD market. Apart from the central laboratory testing at hospitals, IVD is being increasingly adopted for the rapid and bed side analysis for various parameters. These are usually performed by the non-laboratory trained individuals such as nurses, paramedics, and physicians, among others. Hospitals and clinics rely extensively on next-generation in-vitro diagnostics (IVD) as an integral part of their daily functioning. These diagnostic tests play a vital role in ensuring accurate disease diagnosis, monitoring patient well-being, and informing treatment strategies. IVD is essential in various healthcare settings.

Segmentation 5: by Region
•   North America - U.S., Canada
•   Europe - Germany, U.K., France, Italy, Spain, and Rest-of-Europe
•   Asia-Pacific - Japan, India, China, South Korea, Australia, and Rest-of-Asia-Pacific
•   Latin America - Brazil, Mexico, and Rest-of-Latin America
•   Middle East and Africa

In 2022, the North America next-generation IVD market dominated the global market with a market value of $35.97 million in 2022, and it is expected to hold its dominance throughout the forecast period 2023-2033. However, the Asia-Pacific (APAC) region, constituting several emerging economies, is expected to register the highest CAGR of 7.05% during the forecast period 2023-2033.

Recent Developments in the Global Next-Generation IVD Market

•   In June 2023, BD launched a new automated instrument i.e. BD-FACSLyric-Duet that prepares samples for clinical diagnostics using flow cytometry. The system leverages liquid-handling robotics to automate the entire sample preparation process, for both in-vitro diagnostics (IVD) and user-defined test.
•   In April 2023, Thermo Fisher Scientific launched its 37 CE-IVD-marked broad PCR Test menu.
•   In January 2023, Tempus company received the FDA approval for Premarket Approval (PMA) application for its xT CDx which is a companion diagnostic test. xT CDx is a 648-gene NGS test for solid tumor profiling, which includes companion diagnostic and microsatellite instability status claims for colorectal cancer patients.
•   In January 2023, QIAGEN N.V. launched the EZ2 Connect MDx IVD platform for automated sampling in diagnostic laboratories. The company provides this platform. The platform holds a high degree of automation and enables laboratories to DNA and RNA purification from up to 24 samples in 30 minutes.
•   In June 2023, BD commercially launched a new automated instrument that prepares samples for clinical diagnostics using flow cytometry. The company enables a workflow solution designed to improve reproducibility and standardization in cellular diagnostics.
•   In May 2023, Beckman Coulter unveiled the DxI 9000 Access Immunoassay Analyzer, a next-generation analyzer for the most productive immunoassay analyzer per footprint. The DxI 9000 Analyzer can run up to 215 tests per hour per square meter (tests/hr/m2).
•   In June 2023, Invivoscribe, Inc. partnered with Complete Genomics to commercialize and develop biomarker tests for oncology research. The partnership uses NGS platforms from Complete Genomics to develop new tests.
•   In June 2023, QIAGEN N.V. and Sysmex formed an alliance to foster collaborations with pharmaceutical companies for the drug treatments for cancer and also promote ultra-sensitive liquid biopsy companion diagnostics adoption.
•   In April 2023, bioMérieux SA and Oxford Nanopore entered into a partnership to develop diagnostic solutions. The partnership was focused on providing access to nanopore-based clinical research and IVD solutions.
•   In April 2023, ALPCO-GeneProof and Thermo Fisher Scientific, Inc. partnered to bring TaqPath Menu GeneProof PCR kits into the market. The partnership helped to bring ALPCO-GeneProof’s expertise in molecular diagnostics with Thermo Fisher’s supply chain and support systems.

Demand – Drivers, Challenges, and Opportunities

Market Demand Drivers:

Technological Advancements in Next-Generation In-Vitro Diagnostics Transforming Healthcare System: The field of in vitro diagnostics (IVD) has been transformed by ongoing technological advancements, including genomics, proteomics, and molecular diagnostics. These advancements, such as Next Generation Sequencing (NGS), digital PCR, and other pioneering techniques, have significantly enhanced the precision, sensitivity, and efficiency of diagnostic testing. Consequently, these improvements have played a vital role in stimulating the expansion of the Next-Generation IVD market.

Furthermore, IVD and advancements in the technology being used are having a profound impact on the healthcare system, revolutionizing medical diagnoses and the delivery of healthcare. Technological progress in IVD, including molecular diagnostics, genomics, and proteomics, has significantly boosted the precision and accuracy of diagnostic tests. This empowers healthcare professionals to make more dependable diagnoses, leading to targeted and appropriate treatment plans. IVD technologies generate vast amounts of data, which, when effectively analyzed and interpreted, can provide valuable insights for healthcare providers. Advanced analytics and machine learning algorithms can extract meaningful information from this data, supporting clinical decision-making, treatment selection, and population health management.

Technological advancements in next-generation IVD have given rise to portable and handheld devices that enable testing to be conducted remotely and at the point of care. This is particularly advantageous in resource-limited settings and remote areas where access to centralized laboratories is limited. Point-of-care testing delivers rapid results, enabling immediate clinical decision-making and timely interventions.

IVD technologies, such as wearable devices and home testing kits, enable remote monitoring of patients' health conditions. This permits continuous monitoring of chronic diseases and facilitates remote disease management. Patients can track their health parameters and transmit data to healthcare providers for timely interventions and adjustments to treatment plans. In conclusion, the ongoing technological advancements in in-vitro diagnostics are transforming the healthcare system by improving precision and accuracy, enabling early disease detection, supporting personalized medicine, facilitating remote and point-of-care testing, driving data-driven healthcare, enhancing workflow efficiency, and enabling remote monitoring and disease management. These advancements have the potential to enhance patient outcomes, optimize resource utilization, and reshape the delivery of healthcare services.

Rising Demand of POC testing Boosting Next-Generation In-Vitro Diagnostics Market: The healthcare industry is witnessing an increasing need for quick and convenient diagnostic testing directly at the point of care. Next-Generation in vitro diagnostics (IVD) technologies, including portable and handheld devices, have emerged to fulfill this demand. These advanced devices enable real-time testing at the site of care, leading to reduced turnaround times for results and facilitating immediate clinical decision-making. The demand for point-of-care (POC) testing in in vitro diagnostics (IVD) is on the rise, with an increasing number of healthcare providers adopting this approach.

POC testing refers to diagnostic tests performed at or near the patient's location, providing immediate results that can guide clinical decision-making. Several factors contribute to the growing demand for POC testing in next-generation IVD. The rising demand and increasing utilization of POC testing in in-vitro diagnostics are driven by the need for rapid diagnoses, improved patient management, convenience, accessibility, effectiveness in remote settings, infectious disease control, and the availability of advanced POC testing devices. This trend is expected to continue as technology continues to advance, enabling more efficient and accurate testing at the point of care.

Growing Incidence of Chronic and Acute Diseases Demanding for Early Treatment: Next-Generation IVD technologies enable the early identification of diseases, even before symptoms become apparent. This early detection allows for timely interventions, resulting in improved patient outcomes and potentially reduced treatment costs. Screening tests for conditions like cancer, infectious diseases, and genetic disorders are increasingly sensitive and specific, facilitating early intervention and preventive measures. Next-Generation In-vitro Diagnostics (IVDs) are highly beneficial in monitoring the efficacy of treatments and making necessary adjustments to therapies. They enable the evaluation of treatment response, drug levels, and the development of drug resistance, enabling personalized and precise therapeutic interventions. According to the published article in PubMed in American College of Rheumatology in 2020, approximately half of the population in the United States is affected by chronic diseases, which has led to an epidemic. Moreover, a significant 86% of healthcare expenses can be attributed to these chronic conditions. Unfortunately, the medical profession and its leaders have not adequately acknowledged or addressed the increasing prevalence of chronic diseases.

Boost in the Next-Generation IVD Market during COVID-19 Pandemic: The COVID-19 pandemic had a substantial impact on the field of in vitro diagnostics (IVD), leading to the accelerated development and adoption of next-generation IVD technologies. Heightened demand for diagnostic testing during the pandemic created an urgent requirement for precise and rapid diagnostic tests for COVID-19. This demand has driven the innovation of advanced next-generation IVD technologies, such as nucleic acid-based tests such as PCR and RT-PCR, which have played a crucial role in detecting the SARS-CoV-2 virus.

Furthermore, the need for quick testing in diverse settings, including hospitals, clinics, and non-medical facilities, has spurred the development of next-generation point-of-care testing devices. These devices enable swift and accurate testing at the location where patients are receiving care, reducing the time taken to obtain test results and facilitating prompt decision-making. Pandemic has underscored the significance of molecular diagnostics in the detection and monitoring of infectious diseases. Next-generation molecular diagnostic technologies, such as high-throughput sequencing, digital PCR, and CRISPR-based diagnostics, have witnessed substantial advancements and found applications in COVID-19 testing. These technologies offer enhanced sensitivity, specificity, and the ability to detect multiple targets simultaneously.

Market Challenges:

Regulatory Hurdles Related to Next-Generation IVD Technologies: The development, adoption, and implementation of next-generation in vitro diagnostics (IVD) encounter various challenges. Securing regulatory approvals and adhering to rigorous regulations present significant hurdles for these advanced IVD technologies. The intricate nature of these technologies, particularly those incorporating novel platforms or innovative biomarkers, often necessitates additional validation studies and regulatory procedures to ensure their efficacy and safety are thoroughly established.

Under the In Vitro Diagnostic Regulation (IVDR), manufacturers will face increased requirements and stricter oversight from notified bodies, resulting in additional costs to successfully market IVD products in compliance with the new regulations. Manufacturers have to carefully assess and streamline their IVD portfolios, which may lead to limitations on the availability of certain assays or product types for a temporary period.

Poor Reimbursement Scenario: The manufacturers of in-vitro diagnostics tests face specific challenges to boost payers to cover in-vitro diagnostics tests and to set payment rates that comply with the cost required to perform such tests. In-vitro diagnostics tests and kits have been recognized as an integral part of medical care and are currently reimbursed by a number of federal and private sector health care insurers. However, the reimbursement rates are non-specific for any particular IVD test. They vary significantly with different reimbursing agencies. While the policies for coding, billing, and payment for IVD tests/kits remain similar to pharmaceutical drugs and medical devices, these policies are indistinct in nature and vary from payer to payer.

Market Opportunities:

Rising Number of Next-Generation IVD Companies involved in Business Expansion: The expanding business of next-generation vitro diagnostics (IVD) market can be attributed to the escalating prevalence of chronic diseases and infectious conditions. In the present economic situation, there has been a noticeable increase in chronic ailments like diabetes, cancer, heart disease, and tuberculosis. The utilization of next-generation in vitro diagnostics (IVD) technologies holds promise for the early identification of diseases, facilitating timely interventions and preventive actions. Next-generation IVD technologies are instrumental in the early detection, monitoring, and management of these ailments which is helping companies to expand their IVD business.

Inclination of Emerging Companies Towards Next-Generation In-vitro Diagnostics: Emerging companies within the in vitro diagnostics (IVD) sector are placing their focus on several key areas to drive innovation and advancements in the field. emerging companies in the IVD sector are dedicated to technological innovation, personalized medicine, digital health integration, point-of-care testing, novel biomarker development, and harnessing the potential of data analytics and artificial intelligence (AI). Their collective efforts are directed towards advancing next-generation IVD technologies to transform disease diagnosis, monitoring, and management.

Analyst’s Thoughts

According to Prateeksha Singh, Lead Analyst – BIS Research, “The next-generation IVD industry is heading, but technological advancements and regulatory considerations may shape the industry's landscape and boost the overall market in the near future. The Asia-Pacific next-generation IVD market, particularly, is expected to register significant growth during the forecast period 2023-2033.”

Next-Generation IVD (In vitro diagnostics) Market - A Global and Regional Analysis

Focus on Products, Type, Application, End User, and Regional Analysis - Analysis and Forecast, 2023-2033

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Frequently Asked Questions

Next-generation in-vitro diagnostics (IVDs) is defined as the adoption of advanced and innovative technologies that are used for diagnostic testing outside the human body. As per BIS research, the next-generation IVD market includes test, kits, assay & reagents and instruments used to perform next-generation in-vitro diagnostics tests.

Synergistic activities and product launches/approvals accounted for the maximum number of key developments, i.e., nearly 87% of the total developments in the global next-generation IVD market, between January 2019 and June 2023. Key players such as QIAGEN N.V., Seegene, Inc., and Thermo Fisher Scientific, Inc. are involved in launching new kits and panels and more advanced instruments and engaging in synergistic partnerships to gain further market share.

The following are the USPs of this report:

•   Vast segmentation of the report, especially the test type, application, product of IVD is considered
•   Product specifications, product benchmarking, and comparative analysis
•   Market dynamic analysis of the opportunities, trends, and challenges in the market
•   Competitive benchmarking of key players for each product type
•   Growth share analysis for key segments

This report will be useful for firms planning to enter the next-generation IVD market and investors who want to invest in the product. Additionally, established market players in this market can also benefit from this report. This is because the report discusses the benefits of using next-generation IVD and the latest advancements in the market right now.

Global In Vitro Diagnostic Market: Focus on Product, Test Type, Application, End User, Region and Co

The global market for IVD is predicted to grow at a CAGR of 5.06% over the forecast period of...

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Table of Contents

Market Report Coverage

How Can This Report Add Value to an Organization?

Introduction of Next-Generation IVD

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Next-Generation IVD (In vitro diagnostics) Market - A Global and Regional Analysis

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Global In Vitro Diagnostic Market: Focus on Product, Test Type, Application, End User, Region and Co

Next-Generation IVD (In vitro diagnostics) Market - A Global and Regional Analysis

A quick peek into the report

Table of Contents

1 Markets

2 Market Overview

3 Industry Analysis

4 Market Dynamics

5 Competitive Landscape

6 Global Next-Generation IVD Market (By Product), ($Billion), 2022-2033

7 Global Next-Generation IVD Market (By Type), ($Billion), 2022-2033

8 Global Next-Generation IVD Markets (by Application), $Billion, 2022-2033

9 Global Next-Generation IVD Market (By End User), ($Billion), 2022-2033

10 Global Next-Generation IVD Market, by Region, $Million, 2022-2033

11 Company Profiles

List of Tables

List of Figures

Market Report Coverage

How Can This Report Add Value to an Organization?

Introduction of Next-Generation IVD

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Next-Generation IVD (In vitro diagnostics) Market - A Global and Regional Analysis

Frequently Asked Questions

Q: What is next-generation IVD?

Q: What kinds of new strategies are being adopted by the existing market players to strengthen their market position in the industry?

Q: What is the USP of this report?

Q: Who should buy this report?

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Global In Vitro Diagnostic Market: Focus on Product, Test Type, Application, End User, Region and Co