Danaher Corporation (Danaher) operates as a global science and technology company to improve human health.
Danaher comprises more than 15 operating companies with positions in the biotechnology, life sciences, and diagnostics sectors, organized under three segments (Biotechnology, Life Sciences, and Diagnostics). United by the DANAHER BUSINESS SYSTEM (‘DBS’), the company's businesses are typically characterized by a high level of products and services that are sold on a recurring basis, primari...
Danaher Corporation (Danaher) operates as a global science and technology company to improve human health.
Danaher comprises more than 15 operating companies with positions in the biotechnology, life sciences, and diagnostics sectors, organized under three segments (Biotechnology, Life Sciences, and Diagnostics). United by the DANAHER BUSINESS SYSTEM (‘DBS’), the company's businesses are typically characterized by a high level of products and services that are sold on a recurring basis, primarily through a direct sales model, and to a geographically diverse customer base. The company's research and development, manufacturing, sales, distribution, service, and administrative facilities are located in various countries.
The company strives to create shareholder value primarily through three strategic priorities: strengthening its competitive advantage through consistent application of DBS tools and culture; enhancing its portfolio in attractive science and technology markets through strategic capital allocation; and consistently attracting and retaining exceptional talent.
Sales in 2024 by geographic destination (geographic destination refers to the geographic area where the final sale to the company’s unaffiliated customer is made) as a percentage of total 2024 sales were: North America, 43% (including 42% in the United States); Western Europe, 23%; other developed markets, 5%; and high-growth markets, 29%. The company defines North America as the United States and Canada. The company defines high-growth markets as Eastern Europe, the Middle East, Africa, Latin America (including Mexico), and Asia (with the exception of Japan, Australia, and New Zealand). The company defines developed markets as all markets of the world that are not high-growth markets.
Segments
Biotechnology
The Biotechnology segment includes the bioprocessing and discovery and medical businesses and offers a broad range of equipment, consumables, and services that are primarily used by customers to advance and accelerate the research, development, manufacture, and delivery of biological medicines. The company’s solutions support a broad range of biotherapeutics, including monoclonal antibodies, recombinant proteins, replacement therapies, such as insulin and vaccines, as well as novel cell, gene, mRNA, and other nucleic acid therapies. Sales in 2024 for this segment by geographic destination (as a percentage of total 2024 sales) were: North America, 33%; Western Europe, 34%; other developed markets, 5%; and high-growth markets, 28%.
The company established the Biotechnology segment through the acquisition of Pall and expanded the business through the acquisition of Cytiva.
The Biotechnology segment consists of the following businesses:
Bioprocessing—The bioprocessing business is a provider of technologies, consumables, services, and solutions that advance, accelerate, and integrate the development and manufacture of therapeutics. These therapeutics include protein-based and other biological therapies, as well as a new emerging class of highly-targeted therapies, such as cell and gene therapies and nucleic acid-based therapies. The business offers tools, solutions, and services to support biomanufacturers across their workflows from the earliest stages of process development to large-scale commercial and turn-key manufacturing. The bioprocessing business’ offering includes cell line and cell culture media development services; cell culture media, process liquids, and buffers for manufacturing; chromatography resins; filtration technologies; aseptic fill finish; as well as single-use hardware and consumables; and services, such as the design and installation of full manufacturing suites. The bioprocessing business’ offerings in data connectivity and automation, advanced process training, process development services, and equipment services are designed to help customers develop more optimized, compliant processes, and ensure continuous performance. Typical users of these products and services include pharmaceutical and biopharmaceutical companies, translational medicine institutions, biotechnology companies, and contract manufacturing organizations.
Discovery and Medical—The discovery and medical business is a provider of solutions to accelerate biotherapeutic research and discovery through high-quality sample preparation and reliable diagnostic assays, in addition to ensuring sterility and safety in medical liquids and gases. The business provides solutions and technologies for: lab filtration, separation, and purification; lab-scale protein purification and analytical tools to support bio-molecular analysis, identification, and characterization; reagents, membranes, and services for diagnostic and assay development; and healthcare filtration solutions for drug delivery and patient care. Typical users of these products include professionals in the areas of academic, translational, and commercial research, medical diagnostics, clinical care, and biopharmaceutical development.
Customers served by the Biotechnology segment select products based on several factors, including product quality and reliability, the product’s capacity to enhance productivity and flexibility, innovation (particularly productivity and sensitivity improvements), product performance and ergonomics, access to advanced technical expertise, service, and support network, and other factors. The businesses in Danaher’s Biotechnology segment market their products and services under several key brands, including CYTIVA and PALL. Manufacturing facilities are located in North America, Europe, and Asia. The business sells to customers through direct sales personnel and independent distributors.
Life Sciences
The Life Sciences segment offers a broad range of instruments, consumables, services, and software that are primarily used by customers to study the basic building blocks of life, including DNA and RNA, nucleic acid, proteins, metabolites, and cells, in order to understand the causes of disease, identify new therapies, and test and manufacture new drugs, vaccines, and gene editing technologies. Additionally, the segment provides products and consumables used to filter and remove contaminants from a variety of liquids and gases in many end-market applications. Sales in 2024 for this segment by geographic destination (as a percentage of total 2024 sales) were: North America, 44%; Western Europe, 21%; other developed markets, 7%; and high-growth markets, 28%.
The company established the life sciences business through the acquisition of Leica Microsystems and has expanded the business through numerous subsequent acquisitions, including the acquisitions of AB Sciex, Molecular Devices, Beckman Coulter, Pall, Phenomenex, IDT, Aldevron, and Abcam.
The Life Sciences segment consists of the following businesses:
Flow Cytometry and Lab Automation Solutions—The flow cytometry and lab automation solutions business offers workflow instruments and consumables that help researchers analyze genomic, protein, and cellular information. Key product areas include sample preparation equipment, such as centrifugation and consumables; liquid handling automation instruments and associated consumables; flow cytometry instrumentation and associated antibodies and reagents; particle counting and characterization instrumentation; and genomic sample preparation. Researchers use these products to study biological function in the pursuit of basic research, as well as therapeutic and diagnostic development. Typical users include pharmaceutical and biotechnology companies, universities, medical schools, and research institutions, and in some cases, industrial manufacturers.
Mass Spectrometry—The mass spectrometry business is a global provider of high-end mass spectrometers, bioanalytical measurement systems, as well as related consumables, software, and services. Mass spectrometry is a technique for identifying, analyzing, and quantifying elements, chemical compounds, and biological molecules, individually or in complex mixtures. The business’ mass spectrometer systems and related products are used in numerous applications, such as drug discovery and clinical development of therapeutics, as well as in basic research, clinical testing, food and beverage quality testing, and environmental testing. Typical users of these mass spectrometry and related products include molecular biologists, bioanalytical chemists, toxicologists, and forensic scientists, as well as quality assurance and quality control technicians.
Microscopy—The microscopy business is a global provider of professional microscopes designed to capture, manipulate, and preserve images, and enhance the user’s visualization and analysis of microscopic structures. The company’s microscopy products include laser scanning (confocal) microscopes, compound microscopes, and related equipment, surgical and other stereo microscopes, and specimen preparation products for electron microscopy. Typical users of these products include research, medical, and surgical professionals operating in research and pathology laboratories, academic settings, and surgical theaters.
Protein Consumables—The protein consumables business, which is a supplier in the proteomics market, provides highly validated antibodies, reagents, biomarkers, and assays to address targets in biological pathways that are critical for advancing drug discovery, life sciences research, diagnostics, and drug discovery. Researchers use these products to study biological pathways critical for scientific research, diagnostics, and drug discovery. Typical users of these products include scientists and researchers in academic institutions, research institutes, and in pharmaceutical, biotechnology, and diagnostics companies.
Filtration—The filtration, separation, and purification technologies business is a provider of products used to remove solid, liquid, and gaseous contaminants from a variety of liquids and gases, primarily through the sale of filtration consumables and associated hardware. The business’ technologies enhance the quality and efficiency of manufacturing processes and prolong equipment life in applications, such as microelectronics, aircraft, oil refineries, power generation turbines, and petrochemical plants. The business also serves the filtration needs of the food and beverage markets, helping customers ensure the quality and safety of their products while lowering operating costs and minimizing waste.
Genomic Medicines—The genomic medicines businesses are providers of custom nucleic acid products for the life sciences industry, primarily through the manufacture of custom DNA and RNA oligonucleotides and gene fragments utilizing a proprietary manufacturing ecosystem. The businesses have developed proprietary technologies for genomics applications, such as next-generation sequencing, CRISPR genome editing, qPCR, and RNA interference. Additionally, the businesses are a manufacturer of high-quality plasmid DNA, RNA, and proteins. These products are used in the research, development, and manufacture of gene and cell therapies, DNA and RNA vaccines, and gene editing technologies. Typical users of these products include professionals in the areas of academic and commercial research, agriculture, medical diagnostics, pharmaceutical development, biotechnology companies, and research institutions across discovery, clinical, and commercial applications.
Customers served by the Life Sciences segment select products based on a number of factors, including product quality and reliability, the product’s capacity to enhance productivity, innovation (particularly productivity and sensitivity improvements), product performance and ergonomics, access to a qualified service and support network, and other factors. The businesses in Danaher’s Life Sciences segment market their products and services under key brands, including ABCAM, ALDEVRON, BECKMAN COULTER, GENEDATA, IDT, LEICA MICROSYSTEMS, MOLECULAR DEVICES, PALL, PHENOMENEX, and SCIEX. Manufacturing facilities are located in North America, Europe, and Asia. The business sells to customers through direct sales personnel and independent distributors.
Diagnostics
The Diagnostics segment offers clinical instruments, consumables, software, and services that hospitals, physicians’ offices, reference laboratories, and other critical care settings use to diagnose disease and make treatment decisions. Sales in 2024 for this segment by geographic destination (as a percentage of total 2024 sales) were: North America, 50%; Western Europe, 16%; other developed markets, 4%; and high-growth markets, 30%.
The company established the diagnostics business through the acquisition of Radiometer and expanded the business through numerous subsequent acquisitions, including the acquisitions of Vision Systems, Beckman Coulter, Iris International, and Aperio Technologies, HemoCue, Devicor Medical Products, the clinical microbiology business of Siemens Healthcare Diagnostics, and Cepheid. The Diagnostics segment consists of the clinical diagnostics businesses (consisting of the core lab - clinical, acute care diagnostics, and pathology diagnostics businesses) and the molecular diagnostics business:
Core Lab - Clinical—The clinical lab business is a manufacturer and marketer of biomedical testing instruments, systems, and related consumables that are used to evaluate and analyze samples made up of body fluids and cells. The information generated is used to diagnose disease, guide and monitor treatment and therapy, assist in managing chronic disease, and assess patient status in hospital, outpatient, and physicians’ office settings. The business offers instrumentation, services, and related consumables in the areas of clinical chemistry, immunoassay, hematology, and microbiology. The business also offers automation systems that reduce manual operation and associated costs and errors from the pre-analytical through post-analytical stages, including sample barcoding/information tracking, centrifugation, aliquoting, storage, and conveyance. These systems, along with the instruments the business provides, are controlled through laboratory-level software that enables laboratory managers to monitor samples, results, and lab efficiency. Typical users of the segment’s core lab products include hospitals, physicians’ offices, reference laboratories, and pharmaceutical clinical trial laboratories.
Molecular Diagnostics—The molecular diagnostics business is a provider of biomedical testing instruments, systems, software, and related consumables that enable DNA-based testing for organisms and genetic-based diseases. These products integrate and automate the complicated and time-intensive steps associated with DNA-based testing (including sample preparation and DNA amplification and detection) to allow the testing to be performed in both laboratory and non-laboratory environments with minimal training and infrastructure. These products also include systems that commonly test for healthcare-associated infections, respiratory disease, sexual health, and virology.
Acute Care Diagnostics—The acute care diagnostics business is a worldwide provider of instruments, software, and related consumables and services that are used in both laboratory and point-of-care environments to rapidly measure critical parameters, including blood gases, electrolytes, metabolites, and cardiac markers, as well as for anemia and high-sensitivity glucose testing. Typical users of these products include hospital central laboratories, intensive care units, hospital operating rooms, hospital emergency rooms, physicians’ office laboratories, and blood banks.
Pathology Diagnostics—The pathology diagnostics business is a player in the anatomical pathology industry, offering a comprehensive suite of instrumentation and related consumables used across the entire workflow of a pathology laboratory. The anatomical pathology diagnostics products include chemical and immuno-staining instruments, reagents, antibodies, and consumables; tissue embedding, processing, and slicing (microtomes) instruments and related reagents and consumables; slide cover-slipping and slide/cassette marking instruments; imaging instrumentation, including slide scanners, microscopes, and cameras; software solutions to store, share, and analyze pathology images digitally; and minimally invasive, vacuum-assisted breast biopsy and lesion excision instruments and breast surgery localization solutions. Typical users of these products include pathologists, lab managers, and researchers.
Customers served by the Diagnostics segment select products based on a number of factors, including product quality and reliability, the scope of tests, the accuracy and speed of the product, the product’s ability to enhance productivity, ease of use, total cost of ownership, and access to a highly qualified service and support network. The businesses in Danaher’s Diagnostics segment market their products and services under key brands, including BECKMAN COULTER, CEPHEID, HEMOCUE, LEICA BIOSYSTEMS, MAMMOTOME, and RADIOMETER. Manufacturing facilities are located in North America, Europe, Asia, and Australia. The business sells to customers primarily through direct sales personnel and, to a lesser extent, through independent distributors.
Regulatory Matters
Many of the company’s products are classified as medical devices and are subject to restrictions under domestic and foreign laws, rules, regulations, self-regulatory codes, circulars, and orders, including, but not limited to, the U.S. Food, Drug, and Cosmetic Act (the ‘FDCA’). The FDCA requires these products, when sold in the United States, to be safe and effective for their intended uses and to comply with the regulations administered by the U.S. Food and Drug Administration (‘FDA’).
The company is required to adhere to the Current Good Manufacturing Practices (‘CGMP’) requirements, as set forth in the Quality Systems Regulation (‘QSR’), which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation, and other quality assurance procedures during all phases of the design and manufacturing process.
The company must also comply with post-market surveillance regulations, including medical device reporting (‘MDR’) requirements, which require that it review and report to the FDA.
In the European Union (‘EU’), the company’s products are subject to the medical device and in vitro medical device laws of the various member states, which for many years were based on Directives of the European Commission.
The company is also subject to the U.S. Foreign Corrupt Practices Act and various healthcare-related laws regulating fraud and abuse, research and development, pricing and sales and marketing practices, and the privacy and security of health information, including the U.S. federal regulations. Many states, foreign countries, and supranational bodies have also adopted laws and regulations similar to, and in some cases more stringent than, the U.S. federal regulations, including the UK Bribery Act and similar anti-bribery laws.
Many of the company’s healthcare-related products are purchased by healthcare providers that typically bill various third-party payers, such as governmental healthcare programs (e.g., Medicare, Medicaid, and comparable non-U.S. programs), private insurance plans, and managed care plans, for the healthcare services provided to their patients. The ability of the company’s customers to obtain appropriate reimbursement for products and services from third-party payers is critical because it affects, which products customers purchase and the prices they are willing to pay. As a result, many of the company’s healthcare-related products are subject to regulation regarding quality and cost by the U.S. Department of Health and Human Services (‘HHS’), including the Centers for Medicare & Medicaid Services (‘CMS’), as well as comparable state and non-U.S. agencies responsible for reimbursement and regulation of healthcare goods and services, including laws and regulations related to kickbacks, false claims, self-referrals, and healthcare fraud.
The U.S. Federal Anti-Kickback Statute prohibits persons or entities from knowingly and willfully soliciting, offering, receiving, or providing remuneration (including any kickback or bribe), directly or indirectly, in exchange for or to induce either the referral of an individual, or the furnishing or arranging for a good or service, for which payment may be made in whole or in part under a federal healthcare program, such as Medicare or Medicaid.
The Health Insurance Portability and Accountability Act of 1996 (‘HIPAA’) prohibits knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private payors, or falsifying, concealing, or covering up a material fact or making any materially false, fictitious, or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items, or services. In addition, HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, restricts the use and disclosure of patient identifiable health information, mandates the adoption of standards relating to the privacy and security of patient identifiable health information, and requires the reporting of certain security breaches with respect to such information. Similar to the U.S. Federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the healthcare fraud statute implemented under HIPAA or specific intent to violate it in order to have committed a violation.
The False Claims Act imposes liability on any person or entity that, among other things, knowingly presents, or causes to be presented, a false or fraudulent claim for payment by a federal healthcare program, knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent claim, or knowingly makes a false statement to avoid, decrease, or conceal an obligation to pay money to the U.S. federal government. The qui tam provisions of the False Claims Act allow a private individual to bring actions on behalf of the federal government alleging that the defendant has submitted a false claim to the federal government, and to share in any monetary recovery. In addition, the government may assert that a claim, including items and services resulting from a violation of the U.S. Federal Anti-Kickback Statute, constitutes a false or fraudulent claim for purposes of the civil False Claims Act.
The federal Civil Monetary Penalties Law prohibits, among other things, the offering or transferring of remuneration to a Medicare or Medicaid beneficiary that the person knows or should know is likely to influence the beneficiary’s selection of a particular supplier of Medicare or Medicaid payable items or services.
The Open Payments Act requires manufacturers of medical devices covered under Medicare, Medicaid, or the Children’s Health Insurance Program (subject to certain exceptions) to record payments and other transfers of value to a broad range of healthcare providers and teaching hospitals, and to report this data, as well as ownership and investment interests held by the physicians and their immediate family members, to HHS for subsequent public disclosure. Similar reporting requirements have also been enacted on the state level, and an increasing number of countries either have adopted or are considering similar laws requiring transparency of interactions with healthcare professionals.
In addition, some of the in vitro diagnostic drugs-of-abuse assays and reagents sold by the company’s subsidiaries contain small amounts of controlled substances, and as a result, some of the company’s facilities are inspected periodically by the United States Drug Enforcement Administration to assess whether the company properly handles, stores, and disposes of controlled substances in the manufacture of those products.
The European Union’s General Data Protection Regulation (‘GDPR’) imposes significant restrictions on how the company collects, transmits, processes, and retains personal data, including, among other things, in certain circumstances a requirement for almost immediate notice of data breaches to supervisory authorities, with significant fines for non-compliance. In the U.S., HIPAA privacy and security rules require certain of the company’s operations to maintain controls to protect the availability and confidentiality of patient health information, individual states regulate data breach and security requirements, and multiple governmental bodies assert authority over aspects of the protection of personal privacy.
The company is required to comply with various the U.S. export/import control and economic sanctions laws, including:
The International Traffic in Arms Regulations administered by the U.S. Department of State, Directorate of Defense Trade Controls, which, among other things, imposes license requirements on the export from the United States of defense articles and defense services listed on the U.S. Munitions List;
The Export Administration Regulations administered by the U.S. Department of Commerce, Bureau of Industry and Security, which, among other things, impose licensing requirements on the export, in-country transfer, and re-export of certain dual-use goods, technology, and software (which are items that have both commercial and military, or proliferation applications);
The regulations administered by the U.S. Department of Treasury, Office of Foreign Assets Control, which implement economic sanctions imposed against designated countries, governments, and persons based on the United States foreign policy and national security considerations; and
The import regulatory activities of the U.S. Customs and Border Protection and other the U.S. government agencies.
International Operations
The company’s products and services are available worldwide, and its principal markets outside the U.S. are in Europe and Asia.
Most of the company’s sales in non-U.S. markets are made by its subsidiaries located outside the U.S., though the company also sells from the U.S. into non-U.S. markets through various representatives and distributors, and in some cases, directly. In countries with low sales volumes, the company generally sells through representatives and distributors.
History
The company was founded in 1969. It was incorporated in 1986. The company was formerly known as DMG, Inc. and changed its name to Diversified Mortgage Investors, Inc. in 1978. Further, the company changed its name to Danaher Corporation in 1984.
