Top 10 Companies In In Vitro Diagnostic (IVD) Reagents Market

The In Vitro Diagnostic (IVD) Reagents Market is expected to register a CAGR of 5.4% during the forecast period to reach $75.67 billion by 2030, says Meticulous Research^®.  In-vitro diagnostic (IVD) reagents include oligonucleotides, antibodies, nucleic acid probes, purified proteins or peptides, buffers, calibrators, serum, cell medium, and standards & controls used in research activities. These reagents are used to diagnose and prevent diseases or other conditions and manufacture IVD kits & assays for diagnostic purposes.

The growth of this market is driven by the increasing prevalence of infectious diseases, increasing funding for research activities, the rising adoption of advanced diagnostic technologies, the growth in proteomics and genomics research studies, and the growing number of clinical laboratories offering advanced diagnostic testing menus. Additionally, emerging economies and the growing demand for protein therapeutics and personalized medicines are expected to offer significant market growth opportunities.

However, the stringent regulations for antigen-specific reagents restrain the growth of this market. Additionally, the high costs of reagents and the unfavorable reimbursement scenario pose a significant challenge to the market’s growth.

Here are the top 10 companies operating in the In Vitro Diagnostic (IVD) Reagents Market

Thermo Fisher Scientific (U.S.)

Founded in 1956 and headquartered in Massachusetts, U.S., Thermo Fisher Scientific Inc. is a biotechnology company engaged in life sciences research, improving patient diagnostics, and increasing laboratory productivity. The company operates through four reportable segments: Life Sciences Solutions, Analytical Instruments, Specialty Diagnostics, and Laboratory Products & Biopharma Services.

The Specialty Diagnostics segment has five businesses: Clinical Diagnostics, Immunodiagnostics, Microbiology, Transplant Diagnostics, and Healthcare Market Channel. The company operates in the IVD reagents market through its Clinical Diagnostics business by providing liquid, ready-to-use, and lyophilized immunodiagnostic reagents. Thermo Fisher offers IVD reagents for customers in healthcare, clinical, pharmaceutical, industrial, and food safety laboratories.

Some major brands of Thermo Fisher are Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. In June 2019, Thermo Fisher Scientific sold its Anatomical Pathology business to PHC Holdings Corporation (Japan), which primarily offered products for cancer diagnosis & medical research in histology, cytology, and hematology applications.

The company has a direct presence through its regional offices and production sites in the U.S., Mexico, Brazil, Germany, Belgium, Austria, the U.K., Italy, the Netherlands, South Africa, the UAE, India, China, Japan, Australia, and the Republic of Korea. Some of its subsidiaries operating in the IVD reagent market are Thermo Fisher Scientific Operating Company LLC (Delaware), Fisher Clinical Services Japan K.K. (Japan), Fisher Clinical Services (Korea) Co., Ltd (Korea), Thermo Electron A/S (Denmark), Thermo Fisher Scientific C.V. (Netherlands), Thermo Fisher Scientific Middle East Holdings Inc. (South Africa), Thermo CRS Holdings Ltd. (Canada), Thermo Ramsey Italia S.r.l. (Italy), and Thermo Fisher Scientific SL (Spain).

Becton, Dickinson and Company (U.S.)

Founded in 1897 and headquartered in New Jersey, U.S., Becton, Dickinson and Company (BD) is a medical technology company that manufactures and sells a wide range of medical devices, laboratory equipment, and diagnostic products used by healthcare institutions, clinical laboratories, pharmaceutical companies, and research centers. The company operates in three business segments: BD Medical, BD Life Sciences, and BD Interventional.

The BD Life Sciences business segment offers products through two major categories: Integrated Diagnostic Solutions and Biosciences. The company provides IVD reagents through its Biosciences category of BD Life Sciences business segment. The primary customers served by the BD Life Sciences segment are hospitals, laboratories, clinics, blood banks, healthcare workers, public health agencies, physicians’ office practices, retail pharmacies, academic and government institutions, and pharmaceutical and biotechnology companies.

Through its manufacturing and sales operations, BD has a direct presence in the U.S., Brazil, Canada, China, France, Spain, the U.K., Germany, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Singapore, and the Netherlands. The R&D facilities of the company are in China, France, India, Ireland, the U.S., and Singapore. BD has a wide global distribution network and markets its products through independent distribution channels and directly to hospitals, healthcare institutions, and independent sales representatives.

Some of its subsidiaries operating in the IVD reagent market are BD Holding S. de R.L. de C.V. (Mexico), Becton Dickinson Canada Inc. (Canada), Becton Dickinson Biosciences, Systems and Reagents Inc. (U.K.), BD Rapid Diagnostic (Suzhou) Co., Ltd. (China), Becton Dickinson Infusion Therapy B.V. (Netherlands), Becton Dickinson Hungary Kft. (Hungary), Becton Dickinson India Private Limited (India) and BDIT Singapore Pte. Ltd. (Singapore).

Merck KGaA (Germany)

Founded in 1668 and headquartered in Darmstadt, Germany. Merck KGaA is a science and technology company aimed to improve the health and well-being of people and advance their lives through science and technology. The company operates in three reportable segments: Healthcare, Life Science, and Electronics. The company operates in the IVD reagents market through the Life Science business segment and offers more than 300,000 products through its brand—Merck Millipore.

The Life Science business segment of the company has 59 manufacturing sites across the globe and more than 100 distribution centers. The sector has corporate offices, manufacturing units, and distributors across Argentina, Germany, France, Romania, Colombia, Japan, Brazil, Belgium, Croatia, the U.S., and Iraq. Some of its subsidiaries operating in the IVD reagent market are Sigma-Aldrich Biochemie GmbH (Germany), Merck Life Science Germany GmbH (Germany), Merck Millipore Ltd. (Ireland), Merck Life Science S.r.l. (Italy), Merck Life Science AS (Norway), Sigma-Aldrich International GmbH (Switzerland), and Merck Ltd. (China).

 Bio-Rad Laboratories, Inc. (U.S.)

Founded in 1952 and headquartered in California, U.S., Bio-Rad Laboratories, Inc. is a distributor and manufacturer of clinical diagnostic products and life science research. The company manufactures and supplies a wide array of products and systems to separate complex chemical and biological materials and to identify, analyze, and purify their components. The company’s products are used by various end users engaged in life science research, healthcare, and analytical chemistry markets.

Bio-Rad Laboratories operates through two reportable segments: Clinical Diagnostics and Life Sciences. The company provides IVD reagents through its Clinical Diagnostics segment. The company provides over 3,000 products through the Clinical Diagnostics segment, comprising over 300 clinical reagents, including IVD reagents. The company’s offerings cater to physician offices, diagnostic reference laboratories, hospital laboratories, and transfusion laboratories. This segment designs, manufactures, sells, and supports test systems, informatics systems, test kits, and specialized quality controls that serve clinical laboratories globally.

The company has a direct presence through its manufacturing, research, and distribution facilities in the U.S., France, Switzerland, Germany, Belgium, Switzerland, and Singapore. The company has a direct distribution source in over 35 countries outside the U.S., including Afghanistan, France, Hong Kong, Japan, Korea, Iceland, Germany, Australia, Spain, the Netherlands, and South Africa. The company’s principal manufacturing and research facilities for the Clinical Diagnostics segment are located in the U.S., Singapore, France, Switzerland, Germany, and Belgium.

Some of its subsidiaries operating in the IVD reagent market are Bio-Rad Laboratories Pty. Limited (Australia), Bio-Rad Pacific Limited (U.S.), Bio-Rad Laboratories SAS (France), Bio-Rad Laboratories G.m.b.H. (Germany), Bio-Rad Laboratories K.K. (Japan), Bio-Rad Korea Limited (Korea), and Bio-Rad China Ltd. (Hong Kong).

Agilent Technologies, Inc. (U.S.)

Founded in 1999 and headquartered in California, U.S., Agilent Technologies, Inc. provides application-focused solutions for the life sciences, diagnostics, and applied chemical markets. It operates through three business segments: Life Sciences & Applied Markets, Diagnostics & Genomics, and Agilent CrossLab. The company offers IVD reagents through its Diagnostics & Genomics segment. This segment offers active pharmaceutical ingredients (APIs) for oligo-based therapeutics and solutions, including reagents, instruments, software, and consumables. The company distributes these products mainly to laboratories, hospital labs, and molecular diagnostic companies. Through its Dako brand, Agilent offers diagnostic antibodies, reagents, instruments, and software.

The company has a direct presence through research & development and manufacturing sites in the U.S., Australia, China, Denmark, Germany, Italy, Japan, Malaysia, Singapore, and the U.K. With its subsidiaries and strong distribution network, the company also has a presence across North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Some of its subsidiaries operating in the IVD reagent market are Agilent Technologies Australia Pty Ltd (Mexico), Agilent Technologies UK Limited (U.K.), Agilent Technologies Singapore Pte. Ltd. (Singapore), Agilent Technologies Italia S.p.A. (Italy), and Agilent Technologies International B.V. (Netherlands).

Abcam plc (U.K.)

Founded in 1998 and headquartered in Cambridge, U.K., Abcam plc. is a producer, distributor, and seller of protein research tools that analyze living cell components at the molecular level. The company offers highly validated binders and assays to address important targets in critical biological pathways. In the IVD reagents market, the company offers research-grade antibodies & IVD antibodies, agonists, antagonists, activators, inhibitors, and proteins & peptides. Using its proprietary RabMAb technology, the company has developed many high-quality monoclonal antibodies for IVD IHC pathology.

The company has R&D and manufacturing sites, sales, and distribution channels across the U.S., the U.K., the Netherlands, China, Japan, Australia, and Singapore.

 Hologic Inc. (U.S.)

Founded in 1985 and headquartered in Massachusetts, U.S., Hologic, Inc. is a medical technology company that develops, manufactures, and supplies medical imaging systems, diagnostic products, and surgical products. Hologic offers its products and solutions to clinical laboratories, hospitals, surgeons, and healthcare providers. The company operates through four business segments: Diagnostics, Breast Health, GYN Surgical, and Skeletal Health. The company provides IVD reagents through its Diagnostics segment.

The company offers its products through direct sales, service personnel, and a network of independent distributors and sales representatives. The company has a geographical presence in the U.K., Costa Rica, the U.S., Europe, Asia-Pacific, and other countries through manufacturing facilities and sales & service offices. Some of the subsidiaries operating in the IVD reagent market are Hologic Canada ULC (Canada), Hologic (Hainan) Medical Co., Ltd. (China), Hologic Deutschland GmbH (Germany), Hologic IP LTD (U.K.), Hologic Medical Technologies (Beijing) Co., Ltd. (China), Hologic Medicor GmbH (Germany), and Hologic Medicor Suisse GmbH (Switzerland).

QIAGEN N.V. (Netherlands)

Founded in 1984 and headquartered in Venlo, Netherlands, QIAGEN N.V. is engaged in developing and selling instruments, consumables, and digital bioinformatics solutions for oncology, infectious diseases, sexual & reproductive health, TB management, precision diagnostics, and point-of-care testing research. The company operates in two business segments: Molecular Diagnostics and Life Sciences. The company operates in the IVD reagents market through the Molecular Diagnostics segment by providing assays and reagents used to diagnose cancer and infectious diseases.

QIAGEN offers its products to more than 500,000 customers and has 35 subsidiaries operating across 25 countries through sales and manufacturing offices and operational sites, including the U.S., Canada, Germany, Spain, the U.K., France, Italy, the Netherlands, Sweden, Turkey, Sweden, Brazil, Mexico, China, Hong Kong, Taiwan, South Korea, India, and South Africa. Qiagen has manufacturing and production facilities in the U.S., Germany, China, and the U.K.

The company has a strong distribution network through its partners across 60 countries worldwide, and some of the subsidiaries operating in the IVD reagent market are QIAGEN K.K. (Japan), QIAGEN Australia Holding Pty. Ltd., QIAGEN Beverly, Inc. (U.S.), QIAGEN Deutschland Holding GmbH (Germany), QIAGEN Ltd. (U.K.), QIAGEN S.r.l (Italy), and QIAGEN Finance Ltd. (Ireland).

Meticulous Research in its latest publication on In Vitro Diagnostic (IVD) Reagents Market has predicted the growth of 5.4% during the forecast year 2023-2030.

Beckman Coulter Inc. (A Subsidiary of Danaher Corporation) (U.S.)

Founded in 1935 and headquartered in California, U.S., Beckman Coulter, Inc. is majorly engaged in the clinical diagnostics industry. The company offers clinical diagnostic products and solutions, automation systems, and clinical information management tools to enhance the diagnostic laboratory’s role in improving patient diagnosis and treatment processes. In 2011, Beckman Coulter was acquired by Danaher Corporation (U.S.), and all its operations are now conducted under Danaher’s Life Sciences and Diagnostics business segments.

Danaher operates through four business segments: Life Sciences, Biotechnology, Diagnostics, and Environmental & Applied Solutions. The company offers IVD reagents through its Diagnostics. The company has research and development, manufacturing, sales, distribution, service, and administrative facilities in more than 60 countries across the globe. The company has manufacturing facilities for diagnostic products in North America, Europe, Asia, and Australia. Also, the Diagnostics business sales are primarily through direct sales personnel and, to a lesser extent, independent distributors.

InBios International, Inc. (U.S.)

Founded in 1996 and headquartered in Washington, U.S., InBios International, Inc. is a biotechnology company that designs, develops, and manufactures immunodiagnostic devices for infectious diseases and biothreats. The company develops proprietary technologies, which are used to create rapid and ELISA-based immunodiagnostic assays. It offers FDA-cleared ELISA kits for Zika, dengue, and West Nile and rapid test kits for Chagas and leishmaniasis. The company also develops and manufactures highly specific antibodies and antigens for infectious disease research.

SDIX, LLC (U.S.)

Founded in 1990 and headquartered in Delaware, U.S., SDIX, LLC. is a biotechnology company that creates antibodies, antigens, and assays for the pharmaceutical and biotechnology markets. The company operates in the IVD reagents market by offering products such as Troponin I, Strep A, CRP, Apo A1, ApoB, Micro-albumin, immunoglobulins, and human serum calibrators. The company’s services include antiserum development and production in various species and a large-scale monoclonal antibody. The company provides over 40 CE-marked IVD reagents for immunohistochemistry applications, which are manufactured and sold in Europe and the U.S.

Bio-Techne Corporation (U.S.)

Founded in 1976 and headquartered in Minnesota, U.S., Bio-Techne Corporation develops, manufactures, and sells life science reagents, instruments, and services in the research and clinical diagnostic markets. The company operates in two segments: Protein Sciences and Diagnostics & Genomics. The company operates in the IVD reagent market through both these segments.

The Protein Sciences segment offers purified proteins and reagent solutions like cytokines and growth factors, antibodies, immunoassays, biologically active small molecule compounds, tissue culture reagents, and T-Cell activation technologies. The Genomics and Diagnostics segment develops and manufactures diagnostic products, which include FDA-regulated controls, calibrators, blood gas & clinical chemistry controls, and other reagents for OEM and clinical customers. The company operates in the IVD reagents market through its R&D Systems, Inc. brand and provides hematology controls & calibrators for use in hospitals and clinics.

The company has a direct presence through subsidiaries, manufacturing sites, offices, distribution channels, and direct operations across the U.K., the U.S., Canada, China, India, and France. Some of the subsidiaries operating in the IVD reagent market are Bionostics, Inc (U.S.), Bio-Techne China Co. Ltd (China), ProteinSimple Ltd. (Canada), Bio-Techne Ltd. (U.K.), and Bio-Techne France (France).

Bio-Synthesis Inc. (U.S.)

Founded in 1984 and headquartered in Texas, U.S., Bio-Synthesis Inc. offers high-quality nucleic acids, peptides, and other molecular biology products for the research, diagnostic, and therapeutic industries. The company is ISO 9001:2015 certified and follows GLP and GMP guidelines. The company’s product portfolio includes peptides, oligonucleotides, bioconjugation, proteins, and OEM services. The company also offers a complete range of peptide synthesis services ranging from bulk API peptides to high-throughput library peptides and array peptide preparation and unmodified or modified chemical oligonucleotides with defined sequences using a procedure known as Phosphoramidite solid-phase synthesis. The company offers a third generation of nucleic acid analogs—Bridged Nucleic Acid (BNA), which can be synthesized and spiked with DNA or RNA to modify the formation of nucleic acid helices.

The company has a presence across Egypt, Germany, Greece, Israel, Italy, Japan, Mexico, and the Netherlands.

RayBiotech, Inc. (U.S.)

Founded in 2001 and headquartered in Georgia, U.S., RayBiotech, Inc. is a life sciences company providing proteomic discovery tools to scientists and academic & research institutes. In the IVD reagents market, the company offers monoclonal, polyclonal primary antibodies, secondary antibodies, and proteins such as purified recombinant and native proteins, diverse tags, and expression hosts.

RayBiotech has a presence across Egypt, Kenya, Morocco, Namibia, Nigeria, South Africa, Tanzania, Tunisia, Uganda, China, India, Iraq, Russia, Pakistan, Qatar, Singapore, and the Philippines.

Sino Biological Inc. (China).

Established in 2007 and headquartered in Beijing, China, Sino Biological Inc. manufactures high-quality research reagents, including recombinant proteins, antibodies, and cDNA clones for basic, translational, and clinical research. The company develops technologies to produce and purify mouse monoclonal antibodies, rabbit polyclonal antibodies, and rabbit monoclonal antibodies. It also offers integrated services from gene cloning to protein expression, protein purification, and immunization for polyclonal or monoclonal antibody generation. The company has a direct presence in the U.S. and Europe.).

Oy Medix Biochemica Ab (Finland)

Founded in 1985 and headquartered in Espoo, Finland. The Oy Medix Biochemica Ab manufactures medical products. The company produces antibodies, antigens, and other critical IVD raw materials for IVD customers to manufacture the supporting materials and diagnostic tests. The company offers various products such as antibodies, antigens, enzymes, molecular diagnostic reagents, biospecimens, cardiac marker reagents, tropical disease research reagents, and SARS-CoV-2-related products. In the IVD reagents market, the company offers antibodies, biologicals, lipoproteins, and molecular reagents.

The company has a direct presence in 70 countries through manufacturing sites and offices in the U.S., France, Germany, and China.

Authoritative Research on the In Vitro Diagnostic (IVD) Reagents Market – Global Opportunity Analysis and Industry Forecast (2023-2030)

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