Global IVD Raw Materials Market - Focused Insights 2024-2029

IVD RAW MATERIALS MARKET SIZE, GROWTH INSIGHTS

The global IVD raw materials market was valued at USD 26.98 billion in 2023 and is expected to reach USD 38.05 billion by 2029, growing at a CAGR of 5.90% during the forecast period. The rising prevalence of chronic conditions and patient populations is driving increased demand for diagnostics and laboratory tests. In vitro diagnostic (IVD) medical devices have become a crucial sector, leading to significant advancements. This increased IVD utilization fuels the demand for raw materials. Furthermore, the growing trends of point-of-care diagnostics and personalized medicine are contributing to the expansion of the IVD raw materials market. IVD products, including devices and reagents, require raw materials. Key raw materials for IVD reagents/kits, such as antigens, antibodies, and enzymes, are critical determinants of product quality and effectiveness. The growing demand for point-of-care diagnostics, and personalized medicine, and the impact of COVID-19 have driven the development of advanced IVD products, further boosting the demand for IVD raw materials.

MARKET TRENDS & DRIVERS

Transforming Healthcare with Microfluidic Technology

Microfluidic technology revolutionizes diagnostic testing by miniaturizing sample analysis within microchannels. This enables high-throughput, rapid, and automated diagnostics, significantly enhancing efficiency and accuracy. Precise fluid control at the microscale allows for complex biochemical assays with minimal sample and reagent use, reducing costs and improving resource efficiency. Rapid fluid manipulation within microchannels facilitates quick analysis and timely results, crucial for time-sensitive diagnoses and prompt treatment decisions. Automation minimizes human error, ensuring consistent and reliable test outcomes. In the IVD raw materials market, microfluidic technology transforms product development and manufacturing. Manufacturers utilize these platforms to create advanced diagnostic reagents and devices that meet the industry's demand for high-performance, cost-effective solutions.

Increased Demand for Advanced Diagnostic Tests

Advanced diagnostic tests are changing the IVD raw materials market. These tests help with early diagnosis, improving patient outcomes and saving healthcare costs. Using new technologies, they find diseases earlier, giving doctors better treatment information. Early diagnosis improves patient lives and treatment success. This rising demand is growing the IVD raw materials market, with companies making more key components. Advanced diagnostics are essential in healthcare today. As healthcare focuses on early detection, the IVD raw materials market will continue to grow with new diagnostic innovations.

INDUSTRY RESTRAINTS

Stringent Regulations in Medical and IVD Devices

Medical and in vitro diagnostic (IVD) devices are subject to stringent global regulations, with the European Union (EU) transitioning to the In Vitro Diagnostic Regulation (IVDR). These regulations align device safety and performance with technological advancements and medical science. The IVDR, replacing existing directives, mandates higher quality and safety standards, compelling manufacturers to adhere to rigorous product development and testing. This shift emphasizes sustainability, environmental responsibility, and enhanced device performance. The point-of-care (POC) diagnostics sector is experiencing rapid growth. While global POC device approvals are increasing, the EU's regulatory approval process is generally faster than the US FDA's. This divergence requires CE mark-approved products to undergo additional scrutiny for FDA approval, highlighting regulatory complexities. The regulatory landscape, shaped by IVDR and REACH, underscores the industry's commitment to safety, sustainability, and innovation. Navigating these regulations requires proactive engagement with compliant suppliers and strategic adaptation by R&D teams to ensure market readiness and product quality in a dynamic global environment.

SEGMENT INSGHTS

• Insights By Product Type: The global IVD raw materials market, segmented by product type, includes antibodies and antigens, enzymes, proteins, biological buffers, and others. The antibody and antigen segment dominates, holding the largest market share. This dominance is driven by the increased demand for antigen and antibody-based tests during the COVID-19 pandemic. Antibodies and antigens are core raw materials for IVD device and reagent manufacturing. Antibodies are vital in various diagnostic assays, with a wide range manufactured for conditions like cancer, autoimmune diseases, infectious diseases, cardiovascular diseases, and hormonal conditions, contributing to segmental growth. Antibody developers also offer custom antibodies, labeling, purification, and other services to OEM manufacturers.
• Insights By Technology: The IVD raw materials market includes antibodies and antigens, enzymes, proteins, and more. Antibodies and antigens lead the market, largely due to increased testing during COVID-19. They are key to making IVD devices. Antibodies are used in many tests, with different types for cancer, infections, and other diseases. Companies also provide custom antibodies and related services to manufacturers.
• Insights By End-User: The IVD raw materials market includes clinical chemistry, immunochemistry, and molecular diagnostics. Molecular diagnostics is growing fastest, driven by PCR and NGS, which analyze genetic information. This segment includes biomarker and genetic tests. For genetic disorders, molecular diagnostics and genetic counseling are key to prevention. Molecular diagnostics is becoming more important in all areas of pathology, growing the market.

GEOGRAPHICAL ANALYSIS

The European region maintains the largest share of the global IVD raw materials market. This market dominance is fueled by a confluence of factors, including the increasing occurrence of infectious and autoimmune diseases, the rising demand for early diagnosis, enhanced availability of IVD devices, the growing adoption of personalized medicine, broader accessibility of IVD raw materials, the increasing utilization of point-of-care diagnostics, and advancements in laboratory automation. The European Commission has enacted a new IVD Regulation designed to establish a well-regulated and efficient market for in vitro diagnostic medical devices within the European Union.

COMPETITIVE LANDSCAPE

The global IVD raw materials market report presents exclusive data on 37 vendors, revealing a landscape of intense competition and rapid technological evolution. Major manufacturers leverage proprietary processing technologies to achieve industry benchmarks and provide customized raw materials with standardized specifications. These strategies are designed to address the increasing demand from the expanding IVD sector, driven by advancements in healthcare technology and escalating global health concerns. Prominent market participants, including Merck KGaA, Fujirebio, Aalto Bio Reagents, Fapon Biotech, F. Hoffmann-La Roche, and Thermo Fisher Scientific, are making substantial investments in research and development to innovate their product portfolios, with a focus on general health management and major infectious disease solutions. Strategic acquisitions are also a key trend, as companies seek to strengthen their capabilities, access novel technologies, and expand their market footprint.