PUBLISHER: Visiongain | PRODUCT CODE: 1742447
PUBLISHER: Visiongain | PRODUCT CODE: 1742447
The global In Vitro Diagnostics market is projected to grow at a CAGR of 5.1% by 2035.
The In Vitro Diagnostics Market Report 2025-2035 (Including Impact of U.S. Trade Tariffs): This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.
Technological Advancements Propelling Industry Growth
The in-vitro diagnostics (IVD) sector continues to experience significant growth, propelled by advancements in diagnostic technologies that enhance precision, portability, and affordability. A notable milestone was achieved in May 2025 when the U.S. Food and Drug Administration (FDA) approved the first blood test to aid in diagnosing Alzheimer's disease. Developed by Fujirebio Diagnostics, the Lumipulse G pTau217/CE<=-Amyloid 1-42 Plasma Ratio test measures specific biomarkers associated with Alzheimer's, offering a less invasive and more accessible alternative to traditional diagnostic methods like PET scans and spinal taps. This approval is expected to improve early detection and management of Alzheimer's disease, particularly benefiting the aging population .
In parallel, the oncology diagnostics landscape is being transformed by the adoption of blood-based tests for detecting minimal residual disease (MRD). Companies such as Guardant Health, Natera, and Exact Sciences are at the forefront of this revolution, utilising circulating tumour DNA to identify cancer recurrences much earlier than conventional imaging methods. These advancements enable more timely interventions and personalised treatment strategies, marking a significant shift in cancer care .
Segment Analysis
As of 2025, the reagents segment maintains its dominance in the IVD market, accounting for over 60% of the market share. This segment is projected to exhibit the highest compound annual growth rate (CAGR) through 2035, driven by continuous innovation and the development of novel diagnostic reagents and kits. A recent example includes the FDA's clearance of Werfen's Aptiva reagents for enhanced autoimmune diagnostics. These reagents offer improved specificity and efficiency in detecting autoimmune diseases, reflecting the industry's commitment to advancing diagnostic accuracy.
Furthermore, the demand for personalised medicine is fuelling the growth of companion diagnostics. In January 2025, Tempus AI, Inc. announced the national launch of its FDA-approved, next-generation sequencing (NGS)-based in vitro diagnostic device, xT CDx. This comprehensive test provides insights into a wide array of genetic alterations, aiding clinicians in selecting targeted therapies for cancer patients. The integration of such advanced diagnostics into clinical practice underscores the critical role of reagents in enabling precision medicine .
As the IVD industry continues to evolve, investments in research and development of innovative reagents and diagnostic tools remain pivotal. Companies focusing on these areas are well-positioned to lead in the competitive landscape, addressing emerging healthcare needs with cutting-edge solutions.
What would be the Impact of US Trade Tariffs on the Global In Vitro Diagnostics Market?
The influence of U.S. trade tariffs on the global In Vitro Diagnostics (IVD) market can be substantial, affecting cost structures and supply chain dynamics across various regions. A multitude of in vitro diagnostic (IVD) products, encompassing reagents, analysers, and components, are imported into the United States from nations such as China, Germany, and Japan. Tariffs on these imports can increase the cost of goods sold for U.S.-based diagnostics firms, potentially compressing profit margins or resulting in elevated prices for healthcare providers and patients.
The global ripple effect encompasses supply chain realignment, as companies may relocate sourcing or manufacturing to tariff-exempt nations, thereby augmenting operational complexity and expenses. Moreover, uncertainty surrounding tariffs may postpone investments in innovation or international collaborations, especially for small and medium-sized IVD companies dependent on global partnerships. In areas such as the EU and Asia-Pacific, this could create opportunities to enhance domestic production or secure a competitive advantage in exports to non-U.S. markets. In the long term, enduring tariffs may expedite localisation strategies, cultivate regional alliances, and transform the competitive dynamics of the global IVD industry.
What Questions Should You Ask before Buying a Market Research Report?
You need to discover how this will impact the in vitro diagnostics market today, and over the next 10 years:
Segments Covered in the Report
In addition to the revenue predictions for the overall world market and segments, you will also find revenue forecasts for five regional and 20 leading national markets:
The report also includes profiles for some of the leading companies in the In Vitro Diagnostics Market, 2025 to 2035, with a focus on this segment of these companies'operations.
Overall world revenue for In Vitro Diagnostics Market, 2025 to 2035 in terms of value the market will surpass US$95 billion in 2025, our work calculates. We predict strong revenue growth through to 2035. Our work identifies which organisations hold the greatest potential. Discover their capabilities, progress, and commercial prospects, helping you stay ahead.