In-Vitro Diagnostics Market by Component, Technology, Specimen, Application, End User

Description

List of Tables

[190 Pages Report] 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.

KEY MARKET STATISTICS
Base Year [2023]	USD 109.05 billion
Estimated Year [2024]	USD 115.04 billion
Forecast Year [2030]	USD 165.27 billion
CAGR (%)	6.11%

Component: The integral role of instruments, and reagents in in-vitro diagnostics

Data management software in in-vitro diagnostics is designed to handle and analyze the vast amount of data generated by diagnostic tests. This software helps manage patient information, test results, and laboratory workflow efficiently. Diagnostic instruments are used to conduct tests and analyses on collected biological samples. These instruments include simple manual devices, such as pipettes and centrifuge and complex automated systems that simultaneously perform multiple tests with minimal human intervention. Reagents & kits are crucial consumables used in conjunction with in-vitro diagnostics instruments to perform diagnostic tests. Reagents are chemical substances that react with specific sample components to produce measurable signals or detect analytes of interest. In addition to software and consumables, services include maintenance and support for diagnostic equipment, training programs for laboratory personnel, consulting on regulatory compliance, quality management systems, and assistance with test method validation.

Application: Revolutionizing application of in-vitro diagnostic in cancer care

In-vitro diagnostics (IVD) plays a critical role in diagnosing autoimmune diseases to enable effective treatment strategies. In-vitro diagnostics technologies such as enzyme-linked immunosorbent assays (ELISA) and immunofluorescence tests are increasingly used for identifying autoantibodies specific to these conditions. Cardiology IVD tests aid in the diagnosis and risk assessment of cardiovascular diseases (CVD), including heart attacks, heart failure, and hypertension, that help in measuring cardiac biomarkers, including troponins, creatine kinase-MB (CK-MB), and B-type natriuretic peptide (BNP) to identify cardiac injury and monitor heart health. IVD plays a vital role in diabetes management by providing accurate and rapid glucose testing solutions. Blood glucose meters, continuous glucose monitoring (CGM) devices, and HbA1c tests are essential IVD tools in diabetes care. In nephrology, IVD tests are employed for detecting and monitoring kidney diseases, electrolyte imbalances, and kidney function, which includes Common tests such as serum creatinine, blood urea nitrogen (BUN), and urine protein measurements. Advancements in IVD technologies, including liquid biopsies and next-generation sequencing (NGS), are transforming cancer diagnostics by offering minimally invasive testing options that support early detection, personalized therapies, and monitoring treatment response.

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.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the In-Vitro Diagnostics Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis 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: 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 examination of the current state of vendors in the In-Vitro Diagnostics Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. 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 this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

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., Biomerieux 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

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the In-Vitro Diagnostics Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the In-Vitro Diagnostics Market?

3. What are the technology trends and regulatory frameworks in the In-Vitro Diagnostics Market?

4. What is the market share of the leading vendors in the In-Vitro Diagnostics Market?

5. Which modes and strategic moves are suitable for entering the In-Vitro Diagnostics Market?

Product Code: MRR-434CCDA04D33

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 bioMerieux 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