The Worldwide Market for IVD Tests, 19th Edition

The global in vitro diagnostics (IVD) market is entering a period of measured but positive growth, shaped less by disruptive platform launches and more by strategic portfolio realignment, digital integration, and selective innovation. Kalorama Information’s 19th Edition of The Worldwide Market for In Vitro Diagnostic (IVD) Tests examines how industry participants are navigating competitive pressures, cost constraints, and evolving healthcare needs while positioning for sustainable growth through 2030.

Shifting Areas of Strategic Focus

Since publication of the 18th Edition, Kalorama Information has identified three dominant areas of concentration across the IVD industry:

• Portfolio expansion
• Customization
• Digital health

Research conducted for the 19th Edition indicates that companies are prioritizing portfolio and menu expansion over investment in entirely new platforms or disruptive instrumentation. This evolution reflects a strategic shift rather than a retreat from innovation.

Portfolio Expansion as a Core Growth Strategy

Portfolio expansion has emerged as the primary mechanism for growth, driven by several factors:

• Expansion of test menus on existing platforms
• Entry into adjacent disease areas
• Increased reliance on acquisitions and restructuring to strengthen portfolio breadth

Examples include acquisitions aimed at expanding cancer diagnostics portfolios and corporate restructuring efforts designed to refocus on high value strengths within existing portfolios.

New products continue to enter the market, particularly in select growth areas such as proteins. However, the overall pace of new platform introductions remains limited.

Innovation Pathways and Partnership Models

While disruptive platform innovation is currently constrained, meaningful innovation continues across several key technology areas:

• Molecular diagnostics
• Companion diagnostics
• Point of care (POC) molecular diagnostics
• Digital pathology
• AI driven diagnostics

Notably, companies are increasingly acquiring or partnering to access innovation rather than relying solely on internal development.

The Expanding Role of Digital Health

Digital health is becoming a central element of competitive differentiation, advancing through:

• Connectivity
• Data management
• Artificial intelligence

These capabilities are enabling companies to move toward integrated solution models that support recurring revenue streams, strengthen customer relationships, and enhance differentiation in a crowded marketplace.

Market Growth Outlook and Segment Performance

Kalorama Information’s analysis points to incremental annual growth across the forecast period, though performance will vary widely by segment.

Segment Dynamics

• Routine testing areas may see flat or modest growth
• Higher growth segments are expected to outperform the market average

Epidemiological Drivers of Demand

At the foundation of sustained IVD demand is the growing global burden of chronic disease, particularly the prevalence of multiple chronic conditions within individual patients.

Key indicators include:

• Approximately 40% of Americans and 33% of the global population live with at least one chronic condition
• Nearly 20% of U.S. adults live with two or more chronic conditions

The co occurrence of conditions such as hypertension, chronic lung disease, asthma, heart disease, and cancer drives:

• Increased healthcare utilization
• Longer care cycles or extended treatment plans
• Rising demand for home based diagnostics

These trends continue to fuel IVD test volume growth across care settings.

Over the next five to ten years, Kalorama Information anticipates moderate, gradual shifts in IVD product markets. Growth will be driven primarily by:

• An aging global population
• Rising disease burden
• Expansion of international healthcare infrastructure

These forces are expected to offset, though not eliminate, fiscal and policy related headwinds.

Report Scope and Methodology

• Global IVD market coverage with forecasts for 2025–2030, presented in U.S. dollars
• Market size based on manufacturer revenues, not retail or reimbursement pricing
• Segment analysis by test category and, where possible, analyte
• Emphasis on corporate developments, financial performance, and vendor activity
• Recognition that all market values and forecasts are estimates, subject to evolving market conditions, trade policies, and reported company revenues

Long term trends including artificial intelligence, next generation sequencing, gene editing, and microbiome research are examined in dedicated sections of the report.

Value to Industry Stakeholders

This 19th Edition provides senior executives, marketers, and strategic decision makers with:

• A clear view of how investment priorities are reshaping the IVD industry
• Insight into which segments and technologies are positioned to outperform
• Context for evaluating growth opportunities amid fiscal, regulatory, and policy uncertainty

By combining industry expertise, extensive secondary research, and interviews with market participants, the report delivers a grounded, transparent assessment of where the IVD market is headed and how companies can position themselves to compete effectively.

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