Infectious Disease In-vitro Diagnostics Market Predicted to Transform Healthcare Testing - Persistence Market Research

The global infectious disease in-vitro diagnostics (IVD) market is on a trajectory of steady growth, with Persistence Market Research estimating it to reach US$ 46.6 Bn in 2025 and expand at a CAGR of 4.7% through 2032, ultimately achieving US$ 64.1 Bn in value. This growth is driven by the rising prevalence of bacterial, viral, fungal, and parasitic infections, which is accelerating the demand for rapid and accurate diagnostic tools. Over 60% of clinical decisions are influenced by IVD tests, yet they account for only 2% of healthcare costs-indicating vast potential for market expansion through affordable diagnostic innovations.

Key drivers include advancements in molecular diagnostics, growing government healthcare investments, and the integration of AI and machine learning to enhance diagnostic accuracy and speed. The reagents segment leads the product category with a projected 64.7% share in 2025, while Europe, led by the U.K., dominates geographically due to its strong R&D ecosystem and robust regulatory framework.

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Key Highlights from the Report

➤ The market is projected to grow from US$ 46.6 Bn in 2025 to US$ 64.1 Bn by 2032, at a CAGR of 4.7%.
➤ Reagents remain the leading product segment, with a 64.7% market share in 2025.
➤ Immunoassays lead technology adoption with a 36.3% share in 2025 due to cost-effectiveness and versatility.
➤ The U.K. market benefits from world-class research institutions and high healthcare investments.
➤ India's growth is supported by government-led healthcare initiatives and rising infectious disease cases.
➤ Rising antimicrobial resistance (AMR) is fueling demand for precise diagnostic solutions globally.

Market Segmentation

By Product Type:
The market is primarily segmented into instruments, reagents, and software/services. Reagents dominate due to their recurring use in diagnostic testing and their essential role in both central laboratory and point-of-care (POC) applications. The increase in POC testing and genetic/molecular diagnostics further boosts reagent demand, with a CAGR of 5.1% projected through 2032.

By Technology:
Immunoassays represent the largest technology segment, holding a 36.3% market share in 2025. Their affordability, speed, and suitability for low-resource settings make them indispensable in disease outbreak situations. Molecular diagnostics, however, are gaining momentum due to their unmatched precision in detecting pathogens at the genetic level, especially for emerging diseases.

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Regional Insights

Europe:
Europe, particularly the U.K., is a leader in the infectious disease IVD market, thanks to robust research and development investments, a supportive regulatory environment, and collaborations between academic institutions and industry players.

Asia-Pacific:
Countries such as India are emerging as high-growth markets, driven by increasing infectious disease prevalence, government healthcare initiatives, and the adoption of advanced diagnostic technologies like PCR, immunoassays, and NGS.

Market Drivers

Rise in Home Testing and Telemedicine:
Home-based testing kits for infectious diseases such as HIV, COVID-19, and STIs are in high demand. The parallel rise of telemedicine supports the adoption of remote diagnostics, allowing patients to test and consult healthcare providers without visiting clinics.

Advancements in Molecular Diagnostics:
Technologies like PCR, next-generation sequencing (NGS), and multiplex testing enable precise and rapid pathogen detection. These innovations improve clinical decision-making, reduce treatment delays, and allow for personalized medicine approaches.

Government-led Screening Initiatives:
Routine screening programs for diseases like tuberculosis, hepatitis, and HIV-supported by public health organizations-are increasing test volumes and expanding market penetration.

Market Restraints

Uncertain Reimbursement Policies:
Lack of consistent reimbursement across countries discourages healthcare providers from adopting advanced diagnostic technologies, especially in low- and middle-income regions.

Pricing Pressures:
Diagnostic manufacturers face pressure to keep costs low, impacting profit margins and potentially slowing innovation in new test development.

Regulatory Complexity:
Stringent regulatory requirements in certain markets can delay product launches, particularly for novel diagnostic technologies.

Market Opportunities

Addressing Antimicrobial Resistance (AMR):
AMR detection tests are becoming essential for guiding appropriate antibiotic use. Companies developing rapid resistance profile tests are positioned for strong growth.

NGS for Personalized Medicine:
The falling cost of sequencing and its ability to detect rare pathogens make NGS a high-potential technology for both clinical diagnostics and research applications.

Expansion in Emerging Markets:
Improving healthcare infrastructure in regions like Southeast Asia, Africa, and Latin America presents vast untapped potential for diagnostic manufacturers.

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Reasons to Buy the Report

✔ Gain in-depth insights into the global infectious disease IVD market trends and projections through 2032.
✔ Identify the fastest-growing segments and regions to focus investment strategies effectively.
✔ Understand the competitive landscape and key innovation areas shaping the market's future.
✔ Access detailed analysis on technological advancements driving diagnostic efficiency.
✔ Leverage actionable intelligence to strengthen market positioning and operational decision-making.

Frequently Asked Questions (FAQs)

How Big is the Infectious Disease In-vitro Diagnostics Market in 2025?
Who are the Key Players in the Global Infectious Disease IVD Market?
What is the Projected Growth Rate of the Market through 2032?
What is the Market Forecast Value for 2032?
Which Region is Estimated to Dominate the Industry during the Forecast Period?

Company Insights

✦ 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.

Recent Developments

March 2025: QIAGEN received U.S. regulatory clearance for its second QIAstat-Dx mini gastrointestinal panel, enhancing its syndromic testing portfolio.

March 2025: Bio-Rad Laboratories obtained the IVDR quality certificate for 40 infectious disease molecular QC products, marking compliance with EU regulations.

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