IVD Raw Materials Market

IVD Raw Materials Market Analysis

The IVD Raw Materials Market size is estimated at USD 19.47 billion in 2025, and is expected to reach USD 25.06 billion by 2030, at a CAGR of 5.18% during the forecast period (2025-2030).

The growing prevalence of chronic and infectious diseases, the aging population, and the rising emphasis on early disease detection are driving the demand for diagnostic testing. This increased demand directly impacts the need for high-quality IVD raw materials to support the development of accurate and reliable diagnostic tests.

The significant burden of infectious diseases such as human immunodeficiency virus (HIV) and hepatitis infections is expected to boost the demand for in-vitro diagnostic tests, which in turn fuel the need for raw materials like enzymes, antibodies, and antigens, thus propelling market growth. For instance, the data published by the Joint United Nations Programme on HIV/AIDS (UNAIDS) in 2024 reported that around 39.9 million individuals worldwide were infected with HIV in 2023. Additionally, data published by the World Hepatitis Alliance in 2024 indicated that an estimated 254 million people were living with hepatitis B, while approximately 50 million people were living with hepatitis C globally in 2024. The high incidence of chronic diseases is increasing the demand for substantial diagnostic procedures, which, in turn, is expected to drive the market over the forecast period.

Additionally, the increasing adoption of point-of-care testing solutions for rapid and decentralized diagnostics is driving the demand for portable, user-friendly, and cost-effective diagnostic tests. Raw materials tailored for POCT applications, such as lateral flow assays and biosensors, are in high demand to support this trend. Hence, the launch of new products increases the demand for specialized raw materials tailored for applications. Recently, in April 2024, EFA Technologies introduced RevDx to the Brazilian market. A standout feature of RevDx is its capacity to perform a thorough, complete blood count (CBC) test with just a single drop of blood.

By introducing groundbreaking POCT solutions like RevDx that streamline diagnostic procedures and elevate the standard of patient care, EFA Technologies is likely to stimulate innovation, investment, and growth in the IVD raw materials market. This can lead to increased demand for specialized raw materials tailored for POCT applications, driving advancements in diagnostic technology and contributing to the evolution of decentralized and rapid diagnostic solutions in healthcare. This is likely to drive the market growth.

Certain strategic movements in the market may accelerate segment growth over the forecast period. For instance, in August 2024, Sysmex, a Japanese in-vitro diagnostic (IVD) company, announced that it set up a state-of-the-art reagent manufacturing facility in Himachal Pradesh, India to ensure a stable supply of products to the Indian IVD market. Local manufacturing not only ensures a stable supply chain but also promotes the utilization of domestic raw material sources, potentially boosting the growth of the indigenous raw material market within the IVD industry.

Therefore, owing to the rising prevalence of chronic and infectious diseases, coupled with advanced technologies in in vitro diagnostics products and strategic initiatives by the key players to supply raw materials at affordable prices, the market is anticipated to grow over the forecast period. However, high cost of raw materials may impede the market growth during the projected period.

IVD Raw Materials Market Trends

Antibodies & Antigens Segment is Expected to Register Healthy Growth Over the Forecast Period

The segment growth is driven by the rising prevalence of chronic and infectious diseases, advancements in diagnostic technologies, the growth of point-of-care testing (POCT), and the emergence of novel biomarkers.

The rising global prevalence of diseases like cancer, cardiovascular conditions, and infectious diseases is driving a greater need for diagnostic testing. Immunoassays, which rely significantly on antibodies and antigens, play a crucial role in both detecting and monitoring these illnesses. For instance, according to data published by the International Agency for Research on Cancer in 2024, the number of new cancer cases diagnosed worldwide is projected to increase from 21.3 million in 2025 to 24.1 million by 2030. Thus, the segment is expected to witness significant growth during this period, driven by the increasing demand for diagnostic tools to diagnose antibodies and antigens associated with cancer and to address the rising cancer burden worldwide.

Additionally, the improved sensitivity and specificity of modern diagnostic tests are mainly due to innovations in methods like enzyme-linked immunosorbent assays (ELISA), immunochromatographic assays, and multiplex platforms. These advancements rely on the availability of high-quality antibodies and antigens to guarantee reliable and precise results. For instance, an article published in Journal of International Medical Research in February 2025, highlighted that ELISA assays are highly sensitive techniques used to diagnose various diseases associated with endocrine, metabolic, cardiovascular, and microbiological conditions and quantify substances such as peptides, proteins, and hormones. They can detect minute concentrations, typically in the range of 5-10 pg/ml. This high sensitivity is attributed to the specific interaction between the antibody and its target antigen. Thus, due to the increasing adoption of ELISA assays for accurate disease diagnosis and biomarker quantification, is anticipated to drive the segment growth.

Market players employ various stratgeies such acquisitions to broaden their product portfolio and enhance the availability of offerings for antibodies and antigens. For instance, in September 2024, Leinco Technologies, a reliable supplier of antibodies, recombinant proteins, and other essential IVD raw materials for research and diagnostics, acquired QED Biosciences from Genovis. This acquisition enhanced Leinco's existing antibody development and service offerings, strengthening its position in IVD sector. Thus, this acquisition is expected to contribute to the growth of the antibodies & antigens segment within the IVD raw materials market, driven by increasing demand for high-quality diagnostic components.

Thus, the antibodies & antigens segment is expected to experience robust growth during the forecast period. This growth is driven by the increasing prevalence of chronic and infectious diseases, advancements in diagnostic technologies, and strategic initiatives by market players to enhance product offerings.

North America is Expected to Witness Significant Growth Over the Forecast Period

North America has seen robust growth in the IVD raw materials market, a trend poised to persist. Bolstered by a well-established healthcare sector and a surge in chronic disease prevalence, the region is set to expand its market share. Dominating the North American landscape, the United States benefits from escalating healthcare expenditures and a swift embrace of point-of-care testing and companion diagnostics.

As chronic diseases become more prevalent, the demand for in vitro diagnostic (IVD) testing is surging. IVD testing plays a crucial role in diagnosing and monitoring medical conditions. A study published in January 2023 in Frontiers in Public Health highlighted a concerning trend: by 2050, over 143 million Americans aged 50 and older are projected to grapple with at least one chronic disease. This looming increase in chronic conditions is set to amplify the demand for IVDs. As the appetite for IVDs grows, so too does the market for their raw materials, propelling the overall expansion of the region's market.

Furthermore, the region's battle with chronic and infectious diseases is expected to further fuel the demand for IVD diagnostic tests, bolstering market growth. For example, data from the International Agency for Research on Cancer in 2024 highlighted a troubling trend in Mexico: new cancer cases are projected to hit 255,000 by 2030, marking a 33,000-case increase from 2025. This escalating cancer burden is likely to heighten the demand for IVD testing, further energizing the market.

In addition, strategic moves by companies in the U.S. and Canada, particularly collaborations, are set to amplify the region's market growth. A case in point: in July 2023, Sysmex America, Inc. joined forces with Sysmex Partec, securing the distribution rights for CE-IVD-approved antibodies in Canada. This CE-IVD endorsement not only highlights the superior quality and performance of Sysmex's antibodies, crafted with cutting-edge technology and scientific acumen, but also positions the company to adeptly cater to the burgeoning demands of its Canadian clientele.

In summary, the North American market for IVD raw materials is witnessing robust growth, fueled by the rising prevalence of diseases, technological advancements in diagnostics, and strategic partnerships among industry leaders.

IVD Raw Materials Industry Overview

The IVD raw materials market is fragmented in nature and consists of many regional and local players. However, companies like Creative Diagnostics, Merck KgaA, Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd, and LGC Limited, among others, hold substantial market shares in the IVD raw materials market. New product developments, acquisitions, collaborations, and regional expansions are some of the key strategic initiatives undertaken by major players to maintain stability in the market.

IVD Raw Materials Market Leaders

IVD Raw Materials Market News

• January 2025: Medix Biochemica, a key provider of raw materials for in vitro diagnostics (IVD), acquired Candor Bioscience GmbH. This acquisition expanded Medix Biochemica's portfolio of high-quality IVD raw materials and bolstered its capacity to aid test manufacturers in immunoassay development.
• October 2024: Biosynth, a key supplier of raw materials and services for diagnostics, vaccines, and pharmaceuticals, inaugurated its new Biosynth Biological Technology site in Suzhou, China. The new bio-laboratory facility bolsters the company's internal project development and enhances its material supply capabilities for China's domestic life science market.