What Is the Size of the IVD Market in 2025?

According to Kalorama Information, the IVD market is $113 billion. As Kalorama releases its 18th edition of the Worldwide Market for In Vitro Diagnostic Tests, the IVD market is experiencing moderate-level growth.

These are the main factors that will shape markets right now in IVD. Some will drive growth and others will limit growth. Some may provide opportunities from companies positioned to take advantage:

Technological Innovation: New tech means new sales. Improvements mean laboratory customers crash plans and new products cut the line. Automation, faster turnaround times, real-time alerts, enhanced quality control, and integrated software systems are improving laboratory efficiency and test reliability.
Syndromic and Multiplex Testing: Take one sample and test for many tests. The concept was initially resisted until COVID-19 necessitated differentiation between the flu and the disease. Now it’s extended to other diseases. These approaches have gained favor with payors in some markets and enjoy increasing adoption by providers for their ability to deliver comprehensive diagnostic insights from single samples.
Artificial Intelligence (AI) and Robotics: AI is already being used in laboratories. At minimum, in billing and often (a recent Kalorama survey suggested as much as 57% of labs) in workflow. There are currently a few test devices that utilize AI features.
Novel Biomarkers and Specialty Analyzers: Better indications of sepsis (blood poisoning), of the onset of Alzheimer’s, and of bacteria vs. virus. These come from new markers. The steady introduction of new biomarkers is enabling more personalized and precise diagnostics.
Healthcare Delivery Expansion: Testing is not just in a hospital or doctor’s office. Retail clinics, urgent care, and the patient’s house now figure in. The latter is a key trend, as the population of the US and other developed nations ages. Increasing focus on smaller clinics and home-based testing presents new opportunities targeted by major IVD vendors.
Reimbursement Landscape: Favorable reimbursement continues for tests that prove clear clinical value, though not all assays benefit equally.
Global Market Expansion: The international IVD market is not the raging engine it once was, but it’s still good for companies to earn some additional growth and impress investors. Emerging markets are experiencing increased private insurance penetration and healthcare access, driving demand for diagnostics.

Other Factors Driving This Market

LOOKING AHEAD over the next five to ten years, moderate and gradual shifts in the IVD product markets are anticipated. Manufacturers can expect growth driven primarily by fundamental demographic and epidemiological trends—an aging global population, rising disease burden, and expanding healthcare infrastructure internationally. However, these positive trends will be partly offset by fiscal challenges, including government funding cuts in the United States, budget constraints in the European Union, and limited hospital spending in China.

Lab companies and healthcare systems are selling labs, consolidating into larger customers. Quest and Labcorp have increased their holdings over the years. This means a smaller customer base and fewer targets, perhaps for IVD.
Cost containment programs by U.S., EU, UK, and Chinese governments, among others. They go by different names and work in different ways in the various countries. One country may see test cost containment as a way to spread more tests (by making each one cheaper); others may just call it cost containment. Either way, these are ways to pay test vendors less in a form.
Yet, no government can contain infectious diseases fully without testing, and so they remain a top priority globally, particularly in developing countries where diagnostic testing is essential and in developed nations facing emerging pathogen threats.
International growth has always been a cornerstone of the IVD market, with all top companies generating revenue in the U.S., EU, and APAC at a minimum. This is more difficult. First, many of even the world’s emerging nations have chosen vendors and found means to limit spending growth. Recently, additional challenges include geopolitical factors such as tariffs and trade policies, which may disrupt supply chains and impact IVD vendors worldwide.
AI will boost the future market if it can break that barrier of crossing over from workflows and lab management assistance to the golden area of healthcare action. That means assisting the doctor in diagnosing. AI holds promise for elevating diagnostic precision and justifying premium pricing, but its broader impact in IVD will depend on demonstrating clear improvements in clinical effectiveness and cost-efficiency.