Infectious Diseases In-Vitro Diagnostics Market by Product, Technology, Indication, End-user

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[189 Pages Report] The Infectious Diseases In-Vitro Diagnostics Market size was estimated at USD 49.06 billion in 2023 and expected to reach USD 52.51 billion in 2024, at a CAGR 7.22% to reach USD 79.95 billion by 2030.

The infectious diseases in-vitro diagnostics market comprises devices, consumables, and services used to detect and identify infectious diseases in human samples, such as blood, urine, throat swabs, and others. The applications of these diagnostics encompass a wide range of diseases, such as Human Immunodeficiency Virus (HIV), Hepatitis, Tuberculosis (TB), Sexually Transmitted Infections (STIs), Respiratory Infections, and others. These tests are crucial for early detection, disease surveillance, epidemiology, and management of infections. The growth of the infectious diseases IVD market is influenced by factors such as the increased prevalence of infectious diseases globally, growing awareness and education about the importance of early detection and prevention, and rising healthcare expenditures and investments in healthcare infrastructure. However, stringent regulatory environments, lack of infrastructure and trained personnel, and high cost of advanced technologies are significant barriers to the market growth. Furthermore, developing point-of-care testing kits for rapid and on-site diagnosis and integrating artificial intelligence and machine learning algorithms to improve diagnostic accuracy and predictive analytics offer significant growth opportunities for infectious diseases in-vitro diagnostics.

KEY MARKET STATISTICS
Base Year [2023]	USD 49.06 billion
Estimated Year [2024]	USD 52.51 billion
Forecast Year [2030]	USD 79.95 billion
CAGR (%)	7.22%

Product: Rising demand for advanced reagents for testing infectious pathogens

Infectious disease diagnostics require sophisticated and specialized instruments designed to detect the presence of pathogens in clinical samples. These instruments vary from simple point-of-care testing kits to complex laboratory equipment, including PCR machines, immunoassay analyzers, and next-generation sequencers. The need for instruments can vary by healthcare setting; high-throughput systems are preferred in reference laboratories for their efficiency and automation, while point-of-care settings demand portable and user-friendly instruments. Reagents are essential consumables in infectious disease diagnostics, consisting of the chemicals and biological materials used in tests to detect the presence of pathogen-specific markers. These include primers, probes, antibodies, and enzymes necessary for assays. The need for reagents is sustained by the volume of tests performed and the diversity of pathogens that can be tested. Hence, laboratories often prefer vendors who can provide various reagents compatible with multiple instrument platforms. The software segment in infectious disease diagnostics includes data analysis, interpretation software, and information management systems that are critical for the operational efficiency of diagnostics. Preferences in software are based on user-friendly interfaces, robust data management capabilities, interoperability with other hospital systems, and compliance with regulatory standards such as HIPAA.

Technology: Expanding adoption of molecular diagnostics technology to quickly detect and quantify viral load, such as in HIV or hepatitis infections

Immunochemistry, or immunoassay, is a key technology in infectious disease diagnostics, using the immune response (antibodies, antigens) to detect and quantify specific biomarkers in a sample. It includes tests such as ELISA (enzyme-linked immunosorbent assay), lateral flow assays, and Western blotting. Microbiology remains a foundational method for identifying infectious diseases, often involving collecting samples to isolate and identify pathogens using biochemical and phenotypic analysis. Microbiology is essential for drug resistance testing and understanding the epidemiology of infections. It's preferred when information about the antibiotic susceptibility of pathogens is required, guiding targeted treatment. Molecular diagnostics involves analyzing nucleic acids to identify infectious agents with high sensitivity and specificity. Common technologies include polymerase chain reaction, reverse-transcription PCR, and next-generation sequencing.

Regional Insights

The Americas represents a significant portion of the infectious diseases in-vitro diagnostics market due to its advanced healthcare infrastructure, high prevalence of infectious diseases, and strong presence of leading market players. Recent trends include the adoption of Molecular Diagnostics (MDx), Point-of-Care (PoC) testing, and increased investment in personalized medicine. EU countries exhibit diverse healthcare systems and regulations but collectively show a strong demand for high-quality in-vitro diagnostics. EU customers value the precision and reliability of tests, combined with the need for compliance with stringent EU regulations. The Middle East and Africa region encompass various markets with varying degrees of development. In Middle Eastern countries, there is a significant demand for state-of-the-art healthcare solutions, including the latest in-vitro diagnostics. Investments in healthcare infrastructure are notable in the Gulf Cooperation Council (GCC) countries. Meanwhile, the African market needs cost-effective and robust testing due to challenges like infectious disease prevalence and limited access to healthcare. International initiatives often drive investment and innovation, focusing on expanding access and building local expertise in diagnostics.

The Asia Pacific region is rapidly growing in the infectious diseases in-vitro diagnostics market. China's vast population and increasing healthcare expenditures drive market growth, with strong government support for improving healthcare infrastructure. Japan, with its advanced technology, focuses on high-end, automated diagnostic solutions and is an innovation hub with significant patents in diagnostics technology. India's market is burgeoning due to rising awareness and affordability. Preventive screenings and accessibility to diagnostics have become pivotal in customer purchasing behavior across the Asia Pacific region.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Infectious Diseases 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 Infectious Diseases 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 Infectious Diseases In-Vitro Diagnostics Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., bioMerieux SA, Danaher Corporation, DiaSorin S.p.A, DX Lab Inc., Epitope Diagnostics, Inc., F. Hoffmann La-Roche Ltd., Genspeed Biotech GmbH, Grifols, S.A., Hologic, Inc., Illumina, Inc., InBios International, Inc., Koninklijke Philips N.V., Laboratory Corporation Of America Holdings, Merck KGaA, Meril Life Sciences Pvt. Ltd., OraSure Technologies, Inc., PerkinElmer, Inc., Qiagen N.V., Quest Diagnostics, Quidel Corporation, Siemens Healthineers AG, Sysmex Corporation, Thermo Fisher Scientific Inc., Trinity Biotech PLC, Uniogen Oy, and Vela Diagnostics.

Market Segmentation & Coverage

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

Product
- Instruments
- Reagents
- Software

Technology
- Immunochemistry
- Microbiology
- Molecular Diagnostics

Indication
- Candidiasis
- Chlamydia
- Clostridium difficile
- CRE
- Gastroenteritis
- Gonorrhea
- Hepatitis
- HIV
- HPV
- MRSA
- Respiratory Virus
- Streptococcus
- TB and Drug-resistant TB
- VRE

End-user
- Academic Research Institutes
- Diagnostic Laboratories
- Hospitals & Clinics

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 Infectious Diseases In-Vitro Diagnostics Market?

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

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

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

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

Product Code: MRR-A339DAEFAD44

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 and Periodic Outbreak of Infectious Diseases
  - 5.1.1.2. Rising Adoption of Rapid Test Kits for Diagnosis of Infectious Diseases
  - 5.1.1.3. Implementation of Government Initiatives to Curb Viral Diseases
- 5.1.2. Restraints
  - 5.1.2.1. Product Recalls of Infectious Disease In-vitro Diagnostics
- 5.1.3. Opportunities
  - 5.1.3.1. Advancements in Genomics and Proteomics
  - 5.1.3.2. Increasing Investments in R&D to Launch New IVD Products
- 5.1.4. Challenges
  - 5.1.4.1. Limited Accessibility of Infectious Diseases In-vitro Diagnostics Kits
5.2. Market Segmentation Analysis
- 5.2.1. Product: Rising demand for advanced reagents for testing infectious pathogens
- 5.2.2. Technology: Expanding adoption of molecular diagnostics technology to quickly detect and quantify viral load, such as in HIV or hepatitis infections
5.3. Market Trend Analysis
5.4. Cumulative Impact of Russia-Ukraine Conflict
5.5. Cumulative Impact of High Inflation
5.6. Porter's Five Forces Analysis
- 5.6.1. Threat of New Entrants
- 5.6.2. Threat of Substitutes
- 5.6.3. Bargaining Power of Customers
- 5.6.4. Bargaining Power of Suppliers
- 5.6.5. Industry Rivalry
5.7. Value Chain & Critical Path Analysis
5.8. Regulatory Framework Analysis
5.9. Client Customization

6. Infectious Diseases In-Vitro Diagnostics Market, by Product

6.1. Introduction
6.2. Instruments
6.3. Reagents
6.4. Software

7. Infectious Diseases In-Vitro Diagnostics Market, by Technology

7.1. Introduction
7.2. Immunochemistry
7.3. Microbiology
7.4. Molecular Diagnostics

8. Infectious Diseases In-Vitro Diagnostics Market, by Indication

8.1. Introduction
8.2. Candidiasis
8.3. Chlamydia
8.4. Clostridium difficile
8.5. CRE
8.6. Gastroenteritis
8.7. Gonorrhea
8.8. Hepatitis
8.9. HIV
8.10. HPV
8.11. MRSA
8.12. Respiratory Virus
8.13. Streptococcus
8.14. TB and Drug-resistant TB
8.15. VRE

9. Infectious Diseases In-Vitro Diagnostics Market, by End-user

9.1. Introduction
9.2. Academic Research Institutes
9.3. Diagnostic Laboratories
9.4. Hospitals & Clinics

10. Americas Infectious Diseases In-Vitro Diagnostics Market

10.1. Introduction
10.2. Argentina
10.3. Brazil
10.4. Canada
10.5. Mexico
10.6. United States

11. Asia-Pacific Infectious Diseases In-Vitro Diagnostics Market

11.1. Introduction
11.2. Australia
11.3. China
11.4. India
11.5. Indonesia
11.6. Japan
11.7. Malaysia
11.8. Philippines
11.9. Singapore
11.10. South Korea
11.11. Taiwan
11.12. Thailand
11.13. Vietnam

12. Europe, Middle East & Africa Infectious Diseases In-Vitro Diagnostics Market

12.1. Introduction
12.2. Denmark
12.3. Egypt
12.4. Finland
12.5. France
12.6. Germany
12.7. Israel
12.8. Italy
12.9. Netherlands
12.10. Nigeria
12.11. Norway
12.12. Poland
12.13. Qatar
12.14. Russia
12.15. Saudi Arabia
12.16. South Africa
12.17. Spain
12.18. Sweden
12.19. Switzerland
12.20. Turkey
12.21. United Arab Emirates
12.22. United Kingdom

13. Competitive Landscape

13.1. Market Share Analysis, 2023
13.2. FPNV Positioning Matrix, 2023
13.3. Competitive Scenario Analysis
- 13.3.1. Roche Launches Next-Generation Qpcr System to Advance Clinical Needs In Molecular Diagnostics and Address Public Health Challenges
- 13.3.2. Biocare Medical Announces the Launch of ARC: The New IVD Antigen Retrieval Chamber for Reliable, Precise and Consistent Heat Induced Epitope Retrieval (HIER)
- 13.3.3. Launch of Optimer-Fc as a New Reagent Solution for Immunohistochemistry
- 13.3.4. DxLab Delivers Lab-Quality Detection of Infectious Diseases and Harmful Pathogens in a Toaster-Size Box

14. Competitive Portfolio

14.1. Key Company Profiles
14.2. Key Product Portfolio