Global In Vitro Diagnostics Market Share Grows at a Staggering CAGR of 6.35%

Introduction

Straits Research released its highly anticipated report, “Global In Vitro Diagnostics Market Size & Outlook, 2026-2034.”. According to the study, the global market size is valued at USD 84.99 billion in 2025 and is projected to expand to USD 138.98 billion by 2034, registering a compound annual growth rate (CAGR) of 6.35%.

Market Dynamics

The market growth is primarily attributed to the high burden of influenza cases, which continues to drive the demand for in vitro diagnostic (IVD) products for early detection and disease monitoring. For example, in May 2025, according to data from the Centers for Disease Control and Prevention (CDC), the 2024–2025 flu season recorded at least 47 million flu-related illnesses. Such a factor signifies the critical need for rapid and accurate diagnostic solutions. However, stringent product registration requirements limit the market access to companies, as in France. For a non-European manufacturer, there is a requirement for an authorized representative to be appointed for registration of IVD devices. This specific requirement hinders the availability of multiple products and, hence, market growth. Despite these challenges, the market presents significant opportunities, such as the growing network of domestic distribution of in vitro diagnostic kits, which presents as a significant market opportunity, with an increase in the availability of IVD kits. For instance, in June 2024, Cupid, a Nashik-based company, has expanded its distribution network for in vitro diagnostic kits across several Indian states, including Maharashtra, Goa, Gujarat, Rajasthan, Jammu & Kashmir, and Madhya Pradesh. Such regional expansion highlights a rising demand for reliable diagnostic solutions, driven by increasing healthcare awareness, public health initiatives, and the need for early disease detection.

Market Highlights

• Products and Services: The Reagents and Kits segment dominated the market in 2025 with a revenue share of 81%.
• Technology: The immunodiagnostics segment dominated the market in 2025 with a revenue share of 29%.
• Application: The Oncology segment is expected to witness the highest CAGR (7.82%) during the forecast period, fuelled by the rising prevalence of cancer and advancements in molecular and genetic testing for oncology. 
• End-User: The Stand-alone Laboratories segment dominated the market in 2025, with a revenue share of 37.26%.
• Regional Insights: North America dominates with over 37.76% share, due to well well-established healthcare infrastructure and advanced diagnostic equipment. 

Competitive Players

1. Hoffmann-La Roche Ltd
2. Abbott
3. Biomérieux
4. Bio-Rad Laboratories, Inc.
5. Danaher Corporation
6. QIAGEN
7. Quest Diagnostics
8. Siemens Healthineers AG
9. Sysmex Corporation
10. Thermo Fisher Scientific Inc.
11. Agilent Technologies, Inc.
12. Exact Sciences Corporation
13. Illumina, Inc.
14. BD
15. Beijing Strong Biotechnologies, Inc
16. Genome Diagnostics Pvt. Ltd.
17. Biofootprints Healthcare Pvt Ltd.
18. Trivitron Healthcare
19. Angstrom Biotech Pvt. Ltd.
20. Creative Diagnostics
21. Others

Recent Developments

Segmentation

1. By Product and Services (2026-2034)
   1. Reagents and Kits
   2. Instruments
   3. Data Management Software and Services
2. By Technology (2026-2034)
   1. Molecular Diagnostics
   2. Clinical Chemistry
   3. Immunodiagnostics
   4. Hematology
   5. Microbiology
   6. Others
3. By Application (2026-2034)
   1. Infectious Diseases
   2. Oncology
   3. Cardiac Diseases
   4. Autoimmune Diseases
   5. Nephrological Diseases
   6. Diabetes
   7. Others
4. By End User (2026-2034)
   1. Hospitals & Clinics
   2. Standalone Laboratories
   3. Home Care Settings
   4. Others