Global IVD Raw Materials Market - Focused Insights 2024-2029

MARKET 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. With the rise in chronic conditions and patient population, the demand for diagnostics and laboratory tests is increasing. IVD medical devices have become a major sector in the field of diagnosis, leading to major advancements. Such factors are increasing the utilization of IVDs, and there is a simultaneous demand for its raw materials. Furthermore, growing trends for point-of-care diagnostics and personalized medicine are contributing to the growth of the IVD raw materials market.

IVD products, such as devices and reagents, require raw materials. The core raw materials of in vitro diagnostic (IVD) reagents/kits are antigens, antibodies, enzymes, etc., which are important determinants of the quality and effectiveness of the products. With growing demand for point-of-care diagnostics, personalized medicine, and the advent of COVID-19, the development of advanced IVD products has contributed to the demand for IVD raw materials.

MARKET TRENDS & DRIVERS

Advancing Healthcare Through Microfluid Technology

Microfluidic technology significantly advances diagnostic testing by miniaturizing sample analysis processes into tiny flow channels. This innovation enables high-throughput, rapid, and automated diagnostic testing, offering substantial benefits in efficiency and accuracy. By precisely controlling fluid flow at a microscale, microfluidic devices can perform complex biochemical assays with minimal sample volumes and reduced reagent consumption, thereby lowering costs and enhancing resource efficiency. Microfluidic devices facilitate quick analysis and rapid results due to their ability to manipulate fluids precisely within microchannels. This capability is crucial for time-sensitive diagnoses and enables healthcare providers to deliver prompt treatment decisions. Moreover, automation features in microfluidic platforms reduce human error, ensuring consistent and reliable test outcomes across different settings. Adopting microfluidic technology in the IVD raw materials market reshapes product development and manufacturing processes. Manufacturers are leveraging microfluidic platforms to design and produce advanced diagnostic reagents and devices that align with the industry's demand for high-performance, cost-effective solutions.

Growing Demand for Advanced Diagnostic Tests

The increasing demand for advanced diagnostic tests fundamentally reshapes the in vitro diagnostic (IVD) raw materials sales market landscape. These sophisticated tests are pivotal in enabling early diagnosis and treatment across a spectrum of diseases, thereby enhancing patient outcomes and reducing healthcare costs. Advanced diagnostic tests leverage cutting-edge technologies to detect diseases at earlier and more treatable stages. These tests provide clinicians with crucial insights into disease presence, progression, and optimal treatment strategies by identifying specific biomarkers, genetic mutations, or other indicators. Timely diagnosis facilitated by advanced tests enables healthcare providers to initiate interventions promptly, improving patient prognosis and quality of life. Early detection can significantly enhance treatment efficacy and survival rates for diseases like cancer, cardiovascular conditions, infectious diseases, and genetic disorders. The escalating demand for advanced diagnostic tests drives substantial growth in the IVD raw materials market. Manufacturers are innovating and scaling production to meet this demand, particularly for critical components such as reagents, assays, and diagnostic kits. The surge in demand for advanced diagnostic tests underscores their indispensable role in modern healthcare. As healthcare systems worldwide prioritize early detection and personalized medicine, the IVD raw materials market stands poised for robust growth, driven by innovations that continue to redefine diagnostic capabilities and patient care standards.

INDUSTRY RESTRAINTS

Navigating Regulatory Landscapes in Medical and IVD Devices

Medical and in vitro diagnostic (IVD) devices are subject to stringent regulations globally, with the European Union (EU) implementing specific directives and now transitioning to the new In Vitro Diagnostic Regulation (IVDR). These regulations align device safety and performance standards with technological advancements and evolving medical science. The IVDR replaces existing directives to incorporate advancements in technology and regulatory practices. It mandates higher quality and safety standards for IVD devices, compelling manufacturers to comply with rigorous product development and testing requirements. This shift emphasizes sustainability, environmental responsibility, and improved device performance and safety. The point-of-care (POC) diagnostics sector is experiencing rapid growth compared to traditional IVD industries. Despite increasing approvals of POC devices globally, the regulatory approval process, particularly in the EU, tends to be quicker than in other regions like the US FDA. This divergence necessitates CE mark-approved products to undergo additional scrutiny for FDA approval, highlighting the complexity of global regulatory pathways. The regulatory landscape for medical and IVD devices, 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 continued market readiness and product quality in a dynamic global environment.

SEGMENT INSGHTS

INSIGHTS BY PRODUCT TYPE

The global IVD raw materials market by product type is segmented into antibody & antigen, enzymes, proteins, biological buffers, and others. The antibody & antigen segment dominates with the largest market share. The growing demand for antigen and antibody-based tests that increased during COVID-19 led to its major market share. Antigens and antibodies are the core raw materials for manufacturing IVD devices and reagents. Antibodies are regarded as a vital element in various diagnostic assays. The wide and well-characterized range of antibodies is manufactured for various conditions such as cancer, autoimmune diseases, infectious diseases, cardiovascular diseases, and hormonal conditions, thus helping segmental growth. Antibody developers also provide custom antibodies, antibody labeling, purification, and other services to OEM manufacturers.

INSIGHTS BY TECHNOLOGY

The global IVD raw materials market by technology is categorized into clinical chemistry, immunochemistry, molecular diagnostics, and others. Molecular diagnostics shows significant growth, with the fastest-growing CAGR during the forecast period. The segment growth is fueled by real-time-polymerase chain reaction (PCR) and next-generation sequencing (NGS), which allow amplification and decoding of genetic and epigenetic information. Several types of molecular diagnostics include biomarker tests, genetic tests, and companion diagnostics. Without specific treatment, molecular diagnosis, carrier detection, and prenatal diagnosis or pre-implantation, genetic diagnosis for these disorders with appropriate genetic counseling is the best approach to prevent their recurrence/transmission to future generations. Molecular diagnostic methods and platforms are performing a larger and more critical role in all areas of clinical and anatomic pathology, thus helping the market to grow.

INSIGHTS BY END-USER

Based on the end-user, the pharma & biotech companies segment holds the largest share of the global IVD raw materials market. In vitro diagnostic (IVD) companies manufacture instruments and reagents to screen, diagnose, and monitor diseases. IVD manufacturers are challenged to produce innovative assays and keep pace with rapidly changing clinical trends while continuing to focus on developing novel solutions that optimize testing efficiency and patient results. Pharmaceutical biotech & medtech companies need R&D for production and outsource the manufacture of various in vitro diagnostic devices by procuring raw materials from other suppliers. Outsource manufacturing is being considered due to its advantages of cost effectivity, flexibility, commercial effectiveness, specialization, and innovative technologies, thus helping the segment's growth.

GEOGRAPHICAL ANALYSIS

The European region dominates the global IVD raw materials market share. Major factors contributing to the growth of the market in the region are the rise in various infectious and autoimmune diseases, growing demand for early diagnosis, rising availability of IVD devices, increasing awareness of personalized medicine, widening availability of various IVD raw materials, growing demand for point of care diagnostics, and advancements in lab automation. The European Commission has recently passed a new regulation for the manufacturing of IVD devices. This IVD regulation aims to establish a well-regulated and smoothly functioning market for in vitro diagnostic medical devices within the European Union.

COMPETITIVE LANDSCAPE

The global IVD raw materials market report contains exclusive data on 37 vendors. The market is characterized by intense competition and rapid technological advancements. Major manufacturers use proprietary processing techniques to meet industry standards and offer customized raw materials with off-the-shelf specifications. These efforts aim to satisfy the increasing demand from the IVD sector, which is expanding due to advancements in healthcare technology and rising global health concerns. Leading key players are Merck KGaA, Fujirebio, Aalto Bio Reagents, Fapon Biotech, F. Hoffmann-La Roche, and Thermo Fisher Scientific, and they are heavily investing in research and development to innovate their product portfolios, particularly in areas relevant to general health management and major infectious diseases. Strategic acquisitions are also prevalent as companies seek to enhance their capabilities, access new technologies, and broaden their market presence.