IVD Raw Materials Market Size, Share & Trends Analysis Report By Product Type (Antibody, Antigens, Proteins, Enzymes, Biological Buffers, Substrates, Others), By Technology (Molecular Diagnostics, Clinical Chemistry, Immunochemistry, Others), By End User (Diagnostic Laboratories, Pharmaceutical & Biotechnological Companies, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

IVD Raw Materials Market Size and Trends

The global IVD raw materials market size was valued at USD 17.08 billion in 2024 and is projected to reach from USD 19.35 billion in 2025 to USD 52.56 billion by 2033, growing at a CAGR of 13.30% during the forecast period (2025–2033).

This strong growth is driven by a combination of factors, primarily the global increase in chronic and infectious diseases, which necessitates precise and timely diagnostic solutions. The essential role that IVD products play in the early detection, treatment planning, and monitoring of diseases underscores their importance amidst rising disease burdens.

Technological advancements in diagnostic techniques, such as molecular diagnostics and immunoassays, are also boosting the demand for high-quality raw materials. The market encompasses essential components like antibodies, antigens, enzymes, and nucleic acids, which are critical for the development and manufacturing of diagnostic tests. Additionally, the increasing prevalence of chronic diseases, heightened health awareness, and favorable regulatory frameworks are driving market growth. Significant investments in healthcare infrastructure, particularly in developing countries, further support the expansion of the market.

Top 4 Key Highlights

• Antibody dominates the product type
• The immunochemistry dominates the technology
• Pharmaceutical and biotechnological companies dominates the end user
• North America is the highest shareholder in the global market

IVD Raw Materials Market Growth Factors

Continuous Advancements in Diagnostic Technologies

In vitro diagnostic (IVD) raw material suppliers are at the center of an exciting revolution in the diagnostics industry. A leading company is adopting organic and inorganic growth methods to ensure its place in this fast-growing field with the emergence of cutting-edge technologies, e.g., molecular diagnostics, laboratory chemistry, or immunochemistry. A continuous flow of high-quality raw materials for IVD is ensured by this double approach (organic and inorganic strategies). 

Strategic acquisitions and partnerships (inorganic growth) allow them to bolster their offerings and expertise, ensuring they have a finger on the pulse of the latest advancements. For instance, the successful completion of the acquisition of IBEX Technologies Inc., a leading developer and manufacturer of high-precision enzymes and diagnostic solutions located in Montreal, Quebec, was announced by BBI Solutions OEM Limited, an independent global manufacturer of immunodiagnostic reagents, in April 2024.

This acquisition strategically enhanced BBI's ability to support in vitro diagnostic IVD manufacturers, given the growing global demand for IVD hemostasis testing, driven by an aging population, increasing prevalence of chronic diseases, and increased reliance on point-of-care tests in surgical and trauma settings. By incorporating IBEX’s innovative enzyme technologies into its extensive portfolio of recombinant proteins, BBI is also responding to the notable industry shift towards recombinantly produced reagents for IVD tests, reflecting a growing preference for more standardized and reliable testing methodologies.

Restraining Factors

Shortage and Variable Cost of Raw Materials

One of the critical challenge in the market for IVD raw materials is stress of innovation and volatile supply routes. The profitability of an IVD kit is significantly influenced by the price comparison between these raw materials. A large obstacle may arise from any significant change, such as shortages or price increases. As manufacturers may be forced to raise prices, which could have an impact on the availability of products, a rise in material costs might lead to reduced profit margins. 

In addition, the shortage may lead to a reduction in production schedules, a lack of adequate laboratory equipment, and delays in placing new products on the market. Unstable dependence on raw materials, which requires creative solutions to ensure affordability and a reliable supply chain, severely limits the IVD market.

Market Opportunities

Diagnostics on the Rise: Partnerships and Innovation Fuel Progress

The market for in vitro diagnostics raw materials is a major beneficiary of this development in the diagnostics sector, which thrives on a powerful combination of collaboration and innovation. A major opportunity for suppliers of IVD raw materials is the rapid development of new-generation diagnostic tools. For example, ultrapure enzymes are required for high-throughput genetic testing or specialized critical nanoparticles in rapid diagnostic tests.

The demand for high-quality and Innovative IVD Raw Materials is growing as the diagnostic industry uses modern technology. This creates a lucrative opportunity for companies that are able to meet the needs of this rapidly evolving environment. IVD raw material suppliers can play a key role in shaping the future of healthcare by staying at the forefront of materials science and establishing strong partnerships with diagnostic providers.

• For instance, in October 2023, Fapon, a leading life-science organization, signed a strategic cooperation agreement with Halodoc, the largest telehealth platform in Indonesia. Together with Halodoc's strong sales channels and local service provisions, this partnership brought together Fapon's expertise in in vitro diagnostics technology and integrated solutions.

Moreover, an increase in the use of point-of-care (POC) diagnostics is expected to provide significant growth opportunities for the players in the global IVD raw materials market. Increased demand for quick diagnostic tests drives the market, and industry players respond by providing point-of-sale solutions.

Regional Insights

North America Dominates the Global Market

North America holds a dominant position in the IVD raw materials market, primarily driven by the number of diagnostic tests performed each year, which constitutes approximately 3.3 billion, and a demographic shift towards an aging population. Over the past 20 years, the older population in the US has grown at twice the rate of the general population.

The United States IVD raw materials market is leading as healthcare system of the country is known for early adoption of new technologies. This includes advanced IVD tests that rely on sophisticated raw materials. Moreover, significant numbers of leading manufacturers and research institutions in the IVD field are housed in the U.S. These strong base fuels innovation and technological advancements in raw materials for IVD tests.

The Canadian IVD raw materials market is poised to grow as the Canadian government is currently increasing investments in healthcare infrastructure, which includes funding for IVD technologies along with the raw materials these tests require. Furthermore, the government has in place favourable policies for the domestic manufacture of IVD products, and this fosters a strong market for IVD raw materials in the country.

Asia-Pacific: Rapid Growth in China and India

Asia-Pacific is the fastest-growing region during the forecast period. The in vitro diagnostics (IVD) raw materials market is expanding at the most rapid pace in the Asia-Pacific region as a result of a confluence of factors including rising healthcare demands, demographic shifts, and economic expansion.

Moreover, in Asia-Pacific, China's IVD raw materials market has a major role in shaping the dynamics of the Asia-Pacific IVD raw materials market. China is focusing on the development of the domestic healthcare industry to reduce its dependence on imports. This will spur the production of IVD raw materials locally. In addition, the Chinese government is putting much effort into the improvement of country healthcare infrastructure.

Also, Indian IVD raw materials market is increasing as India has a vast population with a significant unmet medical need. This presents a massive opportunity for the IVD market, and consequently, for IVD raw material suppliers. Moreover, the prevalence of chronic diseases such as diabetes and cancer are increasing in India.

IVD Raw Materials Market Segmentation Analysis

By Product Type

Antibody dominates the product type segment. Antibodies accounted for the highest market share, primarily due to their pivotal role in enabling highly specific detection and targeting of analytes in diagnostic assays, essential for accurate disease diagnosis and patient management.

Antibodies are essential components of various diagnostic assays, playing a critical role in detecting and identifying a wide range of diseases. There are two main types of antibodies used in diagnostics, i.e., monoclonal and polyclonal. These antibodies are utilized as raw materials in the development and manufacture of diagnostic assays, such as enzyme-linked immunosorbent assays (ELISAs), lateral flow assays, immunohistochemistry (IHC), and others.

By Technology

The immunochemistry dominates the technology segment. Immunochemistry accounted for the highest market share, primarily due to its versatility in detecting a wide range of analytes with high specificity and sensitivity, making it a cornerstone technology in diagnostic assays for various diseases and conditions. Immunochemistry is used in the detection and quantification of antigens, antibodies, and other molecules in biological samples. This field utilizes the specific binding properties of antibodies and antigens to enable the accurate diagnosis and monitoring of various diseases.

Immunochemistry plays a crucial role in diagnosing infectious diseases, autoimmune disorders, cancer, and hormonal imbalances. It is also used in therapeutic drug monitoring and allergy testing, among other applications. Immunoassays, such as enzyme-linked immunosorbent assays (ELISA) and chemiluminescent immunoassays (CLIA), are common techniques employed in immunochemistry.

By End User

The pharmaceutical and biotechnological companies dominates the end user segment. The pharmaceutical and biotechnological companies accounted for the highest market share as they heavily rely on these materials for research, development, and manufacturing processes, ensuring quality control and efficacy of their pharmaceutical and diagnostic products. Pharmaceutical and biotechnological companies are major consumers of IVD raw materials. These companies utilize IVD technologies for drug discovery, development, and clinical trials. Raw materials are integral to the development of companion diagnostics used to identify suitable patient populations for targeted therapies. With the growing emphasis on precision medicine and the rise of biologics and biomarker-based therapies, pharmaceutical and biotech firms are investing heavily in IVD technologies, thereby bolstering the demand for raw materials.

• For instance, Certest Biotec, S.L. is an independent biotechnology company devoted to the development and manufacturing of IVD diagnostic products in the human clinical field. The company offers a comprehensive range of raw materials essential for immunodiagnostic applications.

Recent Developments

• In May 2023, Sysmex Corporation, a manufacturer of medical equipment and devices, signed agreement for joint development and investment with biotechnology startup ThinkCyte for the production and sale of a new artificial intelligence-enabled cell analysis technology for in-vitro diagnostics.
• In August 2022, Biosynth, a supplier of critical materials to the life science industry, announced that it had signed an agreement to acquire EUCODIS Bioscience, experts in engineering and developing enzymes for pharma, biotech and applied markets. The two companies have worked together on innovation projects in enzyme development for a number of years, with Biosynth already stocking EUCODIS’ catalogue enzymes as part of its broad research product offering.

Analyst’s Perspective

As per our research analysts, the global market for in vitro diagnostics (IVD) raw materials is becoming highly opportunistic due to the rapid developments in biotechnology, the high incidence of chronic diseases, and an escalating demand for personalized medicine. Companies are coming up with improved products to support the high levels of innovation happening in the market. In this regard, companies are heavily investing in R&D to develop high-grade reagents, antibodies, and enzymes that promote the enhancement of diagnostic accuracy and efficiency. Moreover, expansion of healthcare infrastructure in developing countries and the growing aging population are further expected to contribute to market expansion, making it a highly lucrative sector for investment and strategic partnerships.