The worldwide infectious disease in-vitro diagnostics (IVD) market is on a strong growth trajectory, with projections indicating it will reach a valuation of approximately US$ 61.2 billion by 2032. This marks an increase from US$ 44.5 billion in 2025, reflecting a compound annual growth rate (CAGR) of 4.7% over the forecast period. Market expansion is being driven by technological innovations, rising disease incidence, and increasing investments in healthcare infrastructure.
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Emerging Market Trends
- The demand for advanced diagnostic technologies is rising, fueled by the growing prevalence of HIV, tuberculosis, and COVID-19.
- The industry is composed of key segments, including diagnostic instruments, reagents, and software & services, each playing a distinct role in market growth.
- Developments in molecular diagnostics, AI-integrated platforms, and point-of-care testing are improving efficiency and accessibility.
- Increased investments in disease surveillance, healthcare advancements, and research & development are accelerating market growth.
- North America is anticipated to maintain a dominant market share due to its sophisticated healthcare system, technological innovations, and government-backed initiatives.
Key Growth Drivers
Increasing Adoption of Home Testing and Telehealth Solutions
- Growing consumer preference for self-diagnostic kits for conditions like HIV, COVID-19, and sexually transmitted infections (STIs).
- Expansion of telemedicine services is propelling demand for at-home diagnostic solutions.
Breakthroughs in Molecular Diagnostics and Precision Medicine
- Advanced diagnostic technologies such as Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), and AI-based diagnostics are revolutionizing disease detection.
- Leading companies continue to innovate and expand their diagnostic capabilities.
- ELITechGroup is expected to launch state-of-the-art molecular diagnostic devices in Europe by 2024.
Opportunities for Business Growth
Biosensors Driving Companion Diagnostics
- The integration of biosensor technology is enhancing precision diagnostics for infectious diseases like HIV, HCV, and COVID-19.
- Products such as OraSure’s OraQuick® rapid test showcase the role of biosensors in personalized treatment approaches.
Multiplex Testing Gaining Popularity
- Multiplex molecular diagnostics enable simultaneous detection of multiple pathogens in a single test.
- Key diagnostic platforms such as BioFire FilmArray® and GenMark ePlex® are optimizing testing procedures for respiratory and gastrointestinal infections.
Regional Insights
North America: A Center for Innovation
- Market dominance of industry leaders such as Abbott, Roche, and Siemens Healthineers.
- Increased government funding for disease prevention and healthcare system improvements.
- Rising adoption of AI-powered diagnostics and molecular testing reinforces the region’s market leadership.
Asia Pacific: Strengthening Healthcare Investments
- The World Health Organization (WHO) reports that 44% of global tuberculosis cases are found in the Asia-Pacific region.
- The incidence of dengue fever has surged by 30% over the last decade, emphasizing the need for improved diagnostic solutions.
- India’s National Tuberculosis Elimination Program (NTEP) screens 100 million individuals annually to control disease spread.
Leading Market Participants
- QIAGEN
- Becton, Dickinson and Company
- bioMérieux SA
- Hoffmann-La Roche Ltd.
- Hologic, Inc. (Gen Probe)
- Abbott
- Quidel Corporation
- Siemens Healthineers AG
- Bio-Rad Laboratories, Inc.
- Danaher
- OraSure Technologies, Inc.
Competitive Landscape Notable market activities and collaborations include:
- BD’s acquisition of Edwards Lifesciences' Critical Care division in September 2024, expanding its patient monitoring portfolio.
- Roche’s acquisition of LumiraDx’s Point-of-Care technology in July 2024, enhancing its diagnostics offerings.
- A strategic partnership between BD and Techcyte in January 2024 to integrate AI-driven digital diagnostics for cervical cancer screening.
Future Market Outlook
- Continuous advancements in AI, molecular diagnostics, and multiplex testing will reshape the industry.
- Enhanced diagnostic tools will facilitate faster and more precise disease detection.
- Emerging markets with rising disease prevalence and increasing healthcare investments present new growth opportunities.
- Government initiatives aimed at expanding healthcare access and promoting technological innovations will support market expansion.
Market Segmentation Overview
- By Product Type: Instruments, Reagents, Software & Services.
- By Technology: Immunoassay, Molecular Diagnostics, Microbiology, Others.
- By Application: MRSA, Clostridium Difficile, Respiratory Virus, Tuberculosis & Drug-resistant TB, HIV, HPV, Hepatitis B & C, COVID-19, and others.
- By End User: Point-of-care, Central Laboratories, Others.
- By Region: North America, Europe, Asia Pacific, Latin America, Middle East & Africa.
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Table of Contents
1. Executive Summary
2. Market Overview
3. Global Growth Factors Market Outlook, 2019 - 2032
4. North America Growth Factors Market Outlook, 2019 - 2032
5. Europe Growth Factors Market Outlook, 2019 - 2032
6. Asia & Pacific Growth Factors Market Outlook, 2019 - 2032
7. Latin America Growth Factors Market Outlook, 2019 - 2032
8. Middle East & Africa Growth Factors Market Outlook, 2019 - 2032
9. Competitive Landscape
10. Appendix
Companies Mentioned
- QIAGEN
- Becton, Dickinson and Company
- bioMérieux SA
- F. Hoffmann-La Roche, Ltd.
- Hologic, Inc. (Gen Probe)
- Abbott
- Quidel Corporation
- Siemens Healthineers AG
- Bio-Rad Laboratories, Inc.
- Danaher
- OraSure Technologies, Inc.
Methodology
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