In-Vitro Diagnostics Market by Component (Data Management Software & Services, Instruments, Reagents & Kits), Technology (Clinical Chemistry, Coagulation & Hemostasis, Hematology), Specimen, Application, End User - Global Forecast 2024-2030

In-Vitro Diagnostics Market by Component (Data Management Software & Services, Instruments, Reagents & Kits), Technology (Clinical Chemistry, Coagulation & Hemostasis, Hematology), Specimen, Application, End User - Global Forecast 2024-2030


The In-Vitro Diagnostics Market size was estimated at USD 109.05 billion in 2023 and expected to reach USD 115.04 billion in 2024, at a CAGR 6.11% to reach USD 165.27 billion by 2030.

In-vitro diagnostics (IVD) is a critical aspect of the healthcare industry that involves the analysis of biological samples outside of the human body in a laboratory setting. These diagnostic tests play a crucial role in disease prevention, early detection, and targeted therapies by providing valuable information on an individual's health status. IVD encompasses various medical devices, assays, reagents, and analytical instruments to facilitate accurate diagnoses and personalized patient treatment plans. IVD testing is performed on multiple biological specimens, such as blood, urine, saliva, tissue biopsies, or other bodily fluids. The test results aid healthcare professionals in making informed decisions regarding diagnosis, prognosis, therapy selection, and disease management. The increasing global aging population and prevalence of chronic diseases are significant factors contributing to market growth. Rising awareness of early disease detection and the adoption of advanced and automated instruments is expected to increase market adoption. Stringent regulations and guidelines imposed by various health authorities and agencies worldwide and complex reimbursement systems may hamper the market growth. Technological innovations within the IVD industry are transforming the landscape by enabling rapid test results with portable devices that reduce turnaround time while maintaining high levels of accuracy.

Regional Insights

The Americas has a significant landscape in the in-vitro diagnostic market owing to the presence of key manufacturers that develop instruments and accessories with strong product lines distinguished by reliable performance and competitive pricing. The region's advanced healthcare infrastructure, high healthcare spending, and favorable reimbursement policies contribute to the widespread adoption of IVD technologies. In Europe, market players are conducting R&D activities to offer more comprehensive solutions, including multiple platforms and formats such as instrumentation, software, and consumables for quality control. Strategies adopted by providers in the EMEA region include partnerships with local distributors and acquisitions of smaller IVD companies to expand their geographical presence. The Asia-Pacific region observed a rapidly growing market for IVD, driven by factors, such as a growing population base, increasing healthcare expenditure, and a rising prevalence of chronic and infectious diseases.

Market Insights

Market Dynamics

The market dynamics represent an ever-changing landscape of the In-Vitro Diagnostics Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

Market Drivers

Increasing prevalence of chronic and infectious diseases
Growing focus on personalized treatment coupled with increased adoption of companion diagnostics
Favourable government initiative for health awareness campaigns and screenings

Market Restraints

Lack of comprehensive reimbursement policies for certain diagnostic tests

Market Opportunities

Expansion of point-of-care testing coupled with growing healthcare infrastructure
Integration of diagnostics with digital health platforms

Market Challenges

Stringent regulations and approval processes associated with in vitro diagnostics

Market Segmentation Analysis

Component: The integral role of instruments, and reagents in in-vitro diagnostics
Application: Revolutionizing application of in-vitro diagnostic in cancer care

Market Disruption Analysis

Porter’s Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis

FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the In-Vitro Diagnostics Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the In-Vitro Diagnostics Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments

Biocare Medical's Advanced Antigen Retrieval Chamber (ARC), Revolutionizing Immunohistochemistry

Biocare Medical is enhancing accuracy in the immunohistochemistry sector with their latest innovation, the Antigen Retrieval Chamber (ARC). This sophisticated device is designed to foster precision in Heat-Induced Epitope Retrieval (HIER), vital for consistent immunohistochemistry (IHC) and in situ hybridization (ISH) staining results. ARC's capability to adjust temperature between 60 - 121°C and accommodate up to 72 standard or 27 double wide slides makes it versatile for clinical, research, and prion studies.

GenWorks Health launches IVD tests for dengue & malaria

GenWorks, has introduced a comprehensive series of in-vitro diagnostic tests. These tests include rapid card test kits for detecting dengue and malaria. These meticulously designed tests play a crucial role in combating seasonal epidemics by facilitating prevention, accurate diagnosis, effective treatment, and eventual cure of these diseases. The iScreen Malaria Card Antigen (Pf/Pv) is a visually intuitive lateral flow immunoassay that accurately identifies P. falciparum and P. Vivax in human whole blood.

Oxford Nanopore and bioMérieux to Enter Into a Strategic Partnership Agreement to Develop Innovative Infectious Disease Diagnostics

Oxford Nanopore and bioMérieux have formed a partnership to explore selected opportunities for introducing nanopore sequencing into the infectious disease diagnostics market. The companies are collaboratively investigating specific opportunities to enhance patient care through the provision of nanopore-based solutions for clinical research and in-vitro diagnostics (IVD). This can enables the company to rapidly and cost-effectively generate specific DNA or RNA sequence data.

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the In-Vitro Diagnostics Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

Key Company Profiles

The report delves into recent significant developments in the In-Vitro Diagnostics Market, highlighting leading vendors and their innovative profiles. These include 10x Genomics, Inc., Abbott Laboratories, Adaptive Biotechnologies Corp, Agilent Technologies Inc., Arkray Inc., Becton, Dickinson and Company, Bio-Rad Laboratories Inc., Biomérieux SA, Danaher Corporation, DiaSorin S.p.A., EKF GmbH, F. Hoffmann-La Roche Ltd., Grifols SA, Hologic, Inc., Illumina, Inc., Menarini Diagnostics, Mindray Medical International Limited, Myriad Genetics, Inc., Ortho-Clinical Diagnostics, Inc., Qiagen GmbH, Randox Laboratories, Siemens AG, Sysmex Corporation, and Thermo Fisher Scientific, Inc..

Market Segmentation & Coverage

This research report categorizes the In-Vitro Diagnostics Market to forecast the revenues and analyze trends in each of the following sub-markets:

Component
Data Management Software & Services
Instruments
Reagents & Kits
Technology
Clinical Chemistry
Basic Metabolic Panel
Electrolyte Panel
Lipid Profile
Liver Panel
Renal Profile
Specialty Chemical Tests
Thyroid Function Panel
Coagulation & Hemostasis
Hematology
Immunochemistry
Enzyme-Linked Immunosorbent Assay
Chemiluminescence Immunoassays
Colorimetric Immunoassays
Fluorescence Immunoassays
Enzyme-Linked Immunospot Assays
Radioimmunoassay
Rapid Test
Western Blotting
Microbiology
Molecular Diagnostics
DNA Sequencing & Next-Generation Sequencing
Hybridization
Isothermal Nucleic Acid Amplification Technology
Microarray
Polymerase Chain Reaction
Urinalysis
Specimen
Blood, Serum & Plasma
Saliva
Urine
Application
Autoimmune Diseases
Cardiology
Diabetes
Drug Testing
HIV/Aids
Infectious Diseases
Nephrology
Oncology
End User
Hospitals & Care Providers
Laboratories
Patient Self-Testing
Region
Americas
Argentina
Brazil
Canada
Mexico
United States
California
Florida
Illinois
New York
Ohio
Pennsylvania
Texas
Asia-Pacific
Australia
China
India
Indonesia
Japan
Malaysia
Philippines
Singapore
South Korea
Taiwan
Thailand
Vietnam
Europe, Middle East & Africa
Denmark
Egypt
Finland
France
Germany
Israel
Italy
Netherlands
Nigeria
Norway
Poland
Qatar
Russia
Saudi Arabia
South Africa
Spain
Sweden
Switzerland
Turkey
United Arab Emirates
United Kingdom

Please Note: PDF & Excel + Online Access - 1 Year


1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Market Dynamics
5.1.1. Drivers
5.1.1.1. Increasing prevalence of chronic and infectious diseases
5.1.1.2. Growing focus on personalized treatment coupled with increased adoption of companion diagnostics
5.1.1.3. Favourable government initiative for health awareness campaigns and screenings
5.1.2. Restraints
5.1.2.1. Lack of comprehensive reimbursement policies for certain diagnostic tests
5.1.3. Opportunities
5.1.3.1. Expansion of point-of-care testing coupled with growing healthcare infrastructure
5.1.3.2. Integration of diagnostics with digital health platforms
5.1.4. Challenges
5.1.4.1. Stringent regulations and approval processes associated with in vitro diagnostics
5.2. Market Segmentation Analysis
5.2.1. Component: The integral role of instruments, and reagents in in-vitro diagnostics
5.2.2. Application: Revolutionizing application of in-vitro diagnostic in cancer care
5.3. Market Disruption Analysis
5.4. Porter’s Five Forces Analysis
5.4.1. Threat of New Entrants
5.4.2. Threat of Substitutes
5.4.3. Bargaining Power of Customers
5.4.4. Bargaining Power of Suppliers
5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Trade Analysis
5.10. Regulatory Framework Analysis
6. In-Vitro Diagnostics Market, by Component
6.1. Introduction
6.2. Data Management Software & Services
6.3. Instruments
6.4. Reagents & Kits
7. In-Vitro Diagnostics Market, by Technology
7.1. Introduction
7.2. Clinical Chemistry
7.3. Coagulation & Hemostasis
7.4. Hematology
7.5. Immunochemistry
7.6. Microbiology
7.7. Molecular Diagnostics
7.8. Urinalysis
8. In-Vitro Diagnostics Market, by Specimen
8.1. Introduction
8.2. Blood, Serum & Plasma
8.3. Saliva
8.4. Urine
9. In-Vitro Diagnostics Market, by Application
9.1. Introduction
9.2. Autoimmune Diseases
9.3. Cardiology
9.4. Diabetes
9.5. Drug Testing
9.6. HIV/Aids
9.7. Infectious Diseases
9.8. Nephrology
9.9. Oncology
10. In-Vitro Diagnostics Market, by End User
10.1. Introduction
10.2. Hospitals & Care Providers
10.3. Laboratories
10.4. Patient Self-Testing
11. Americas In-Vitro Diagnostics Market
11.1. Introduction
11.2. Argentina
11.3. Brazil
11.4. Canada
11.5. Mexico
11.6. United States
12. Asia-Pacific In-Vitro Diagnostics Market
12.1. Introduction
12.2. Australia
12.3. China
12.4. India
12.5. Indonesia
12.6. Japan
12.7. Malaysia
12.8. Philippines
12.9. Singapore
12.10. South Korea
12.11. Taiwan
12.12. Thailand
12.13. Vietnam
13. Europe, Middle East & Africa In-Vitro Diagnostics Market
13.1. Introduction
13.2. Denmark
13.3. Egypt
13.4. Finland
13.5. France
13.6. Germany
13.7. Israel
13.8. Italy
13.9. Netherlands
13.10. Nigeria
13.11. Norway
13.12. Poland
13.13. Qatar
13.14. Russia
13.15. Saudi Arabia
13.16. South Africa
13.17. Spain
13.18. Sweden
13.19. Switzerland
13.20. Turkey
13.21. United Arab Emirates
13.22. United Kingdom
14. Competitive Landscape
14.1. Market Share Analysis, 2023
14.2. FPNV Positioning Matrix, 2023
14.3. Competitive Scenario Analysis
14.3.1. Biocare Medical's Advanced Antigen Retrieval Chamber (ARC), Revolutionizing Immunohistochemistry
14.3.2. GenWorks Health launches IVD tests for dengue & malaria
14.3.3. Oxford Nanopore and bioMérieux to Enter Into a Strategic Partnership Agreement to Develop Innovative Infectious Disease Diagnostics
14.4. Strategy Analysis & Recommendation
15. Competitive Portfolio
15.1. Key Company Profiles
15.2. Key Product Portfolio

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