Bio-Rad Laboratories, Inc. (Bio-Rad) operates as a multinational developer, manufacturer, and worldwide distributor of its own life science research and clinical diagnostics products.
Bio-Rad develops, manufactures, and supplies life science research, healthcare, analytical chemistry, and other markets with a broad range of products and systems used to separate complex chemical and biological materials, and to identify, analyze, and purify their components.
The company has direct distribution...
Bio-Rad Laboratories, Inc. (Bio-Rad) operates as a multinational developer, manufacturer, and worldwide distributor of its own life science research and clinical diagnostics products.
Bio-Rad develops, manufactures, and supplies life science research, healthcare, analytical chemistry, and other markets with a broad range of products and systems used to separate complex chemical and biological materials, and to identify, analyze, and purify their components.
The company has direct distribution channels in various countries outside the United States through subsidiaries whose focus is sales, customer service, and product distribution. In some locations outside and inside these countries, sales efforts are supplemented by distributors and agents.
Business Segments
Bio-Rad operates in two industry segments designated as Life Science and Clinical Diagnostics. Both segments operate worldwide. The Life Science segment and the Clinical Diagnostics segment generated 40% and 60%, respectively, of the company's consolidated net sales for the year ended December 31, 2024. The company generated approximately 41% of its consolidated net sales for the year ended December 31, 2024, from the U.S., and approximately 59% from its international locations, with Europe being the company's largest international region.
Life Science
The Life Science segment is at the forefront of discovery, creating advanced tools to answer complex biological questions. These instruments, systems, reagents, and consumables are typically used to separate, purify, characterize, or quantify biological materials, such as cells, proteins, and nucleic acids, in the research laboratory or biopharmaceutical laboratory. They are also used in biopharmaceutical manufacturing, quality control processes, food safety, and science education applications. The company is focused on the translational research market segment where its products help accelerate the timelines from discovery in the lab to use in the clinic and with patients. The principal life science customers of the company include universities and medical schools, industrial research organizations, government agencies, pharmaceutical manufacturers, biotechnology researchers, food producers, and food testing laboratories.
Clinical Diagnostics
The Clinical Diagnostics segment designs, manufactures, markets, and supports test systems, informatics systems, test kits, and specialized quality controls that serve clinical laboratories in the global diagnostics market. The company's products currently address specific niches within the in vitro diagnostics (‘IVD’) test market, and it seeks to focus on the higher-margin, higher-growth segments of this market.
The company supplies several thousand products that cover several hundred clinical diagnostic tests to the IVD test market. Its products consist of reagents, instruments, and software, typically provided to customers as an integrated package to allow them to generate reproducible test results. The principal clinical diagnostic customers of the company include hospital laboratories, diagnostic reference laboratories, transfusion laboratories, and physician office laboratories.
Patents, Trademarks, and Licenses
The company owns over 2,150 U.S. and international patents and numerous trademarks. It also holds licenses under U.S. and foreign patents owned by third parties, and pays royalties on the sales of certain products under these licenses. In addition, the company also receives royalties for licenses of its intellectual property.
Sales and Marketing
The company conducts its worldwide operations through an extensive direct sales force. It also uses a range of sales and marketing intermediaries (‘SMIs’) in its international markets. The types of SMIs utilized include distributors, agents, brokers, and resellers. The company has programs and policies in place with its SMIs requiring their compliance with all applicable laws, including adhering to its anti-corruption standards to ensure a transparent sale to its customers.
The worldwide customer base of the company includes university and research institutions, hospital, public health, and commercial laboratories, diagnostic manufacturers, and companies in the biotechnology, pharmaceutical, chemical, and food industries.
The company's sales are affected by a number of external factors. For example, a number of its customers, particularly in the Life Science segment, are substantially dependent on government grants and research contracts for their funding. In the Clinical Diagnostics segment, the company is constrained by government reimbursement for many of its products.
Competition
The Life Science segment of the company does not face the same competitors for all of its products due to the breadth of its portfolio and specialization of its product lines. Major competitors in this market include Becton Dickinson, Danaher, Merck KGaA, Qiagen N.V., and Thermo Fisher Scientific.
Major competitors for the company's products in the Clinical Diagnostics segment include Abbott Laboratories, Becton Dickinson, bioMérieux, Danaher, DiaSorin, Werfen, QuidelOrtho, Roche, Siemens Healthineers, Thermo Fisher Scientific, and Tosoh.
Research and Development
The company’s consolidated research and development (R&D) expense included $295.9 million for the year ended December 31, 2024.
Regulatory Matters
The development, testing, manufacturing, marketing, post-market surveillance, distribution, advertising, and labeling of certain of the company's products (primarily diagnostic and donor screening products) are subject to regulation in the United States by the Center for Devices and Radiological Health (‘CDRH’) and/or the Center for Biologics Evaluation and Research (‘CBER’) of the U.S. Food and Drug Administration (FDA), and in other jurisdictions by state and foreign government authorities.
Bio-Rad's IVD products meet the applicable requirements of the European Union in-vitro Diagnostics Regulation (‘EU IVDR’).
The company's manufacturing facilities, as well as those of certain suppliers, are subject to periodic inspections by the FDA and other regulatory bodies to verify compliance with regulatory requirements. Similar inspections are performed by Notified Bodies to verify compliance with applicable International Organization for Standardization (‘ISO’) standards (e.g., ISO 13485:2016), requirements under the Medical Device Single Audit Program (‘MDSAP’) applicable to regulatory requirements of Australia, Brazil, Canada, Japan, and the U.S., and/or medical device regulations and requirements from the countries in which the company distributes products, and other specified audits by regulatory authorities.
Investment in Sartorius AG
Sartorius AG (‘Sartorius’) is an international laboratory and process technology provider for the biotech, pharmaceutical, and food industries. It operates in two divisions – Bioprocess Solutions Division and Lab Products & Services Division.
As of December 31, 2024, the company owned Sartorius, representing approximately 38% of the outstanding ordinary shares (excluding treasury shares) and 28% of the preference shares of Sartorius.
History
Bio-Rad Laboratories, Inc. was founded in 1952. The company was incorporated in 1975.