Ortho Clinical Diagnostics Holdings plc provides in-vitro diagnostics (IVD) solutions to the clinical laboratory and transfusion medicine communities.
The company maintains a commercial presence in more than 130 countries and territories. The company’s instruments, assays, reagents and other consumables are used in hospitals, laboratories, clinics, blood banks and donor centers worldwide. The company is globally operated with manufacturing facilities in the United States and the United Kingdom,...
Ortho Clinical Diagnostics Holdings plc provides in-vitro diagnostics (IVD) solutions to the clinical laboratory and transfusion medicine communities.
The company maintains a commercial presence in more than 130 countries and territories. The company’s instruments, assays, reagents and other consumables are used in hospitals, laboratories, clinics, blood banks and donor centers worldwide. The company is globally operated with manufacturing facilities in the United States and the United Kingdom, and sales centers, administrative offices and warehouses located throughout the world.
As a leader in IVD, the company impacts approximately 800,000 patients every day. The company is dedicated to improving outcomes for these patients and saving lives through providing diagnostic testing solutions to the clinical laboratory and transfusion medicine communities. The company’s global infrastructure and commercial reach allow it to serve these markets with significant scale. The company supports its customers with high quality diagnostic instrumentation, a broad test portfolio and market leading service. The company’s products deliver consistently fast, accurate and reliable results that allow clinicians to make better-informed treatment decisions.
The company’s solutions are central to the operations of hospitals, clinics, blood banks and donor centers around the world, where they are used to help diagnose certain conditions, such as cancer or heart attacks, and infectious diseases, such as hepatitis, HIV, and most recently, COVID-19, where it has launched four antibody tests and an antigen test, and it is actively expanding its menu of tests to address the global pandemic.
The company operates two lines of business, Clinical Laboratories and Transfusion Medicine, which together generate its core revenue:
Clinical Laboratories: Focused on clinical chemistry, which is the measurement of target chemicals in bodily fluids for the evaluation of health and the clinical management of patients; immunoassay instruments, which test the measurement of proteins as they act as antigens in the spread of disease, antibodies in the immune response spurred by disease, or markers of proper organ function and health; and testing to detect and monitor disease progression across a broad spectrum of therapeutic areas, and includes grant revenue related to development of its coronavirus (COVID-19) antibody and antigen tests.
Transfusion Medicine: Focused on immunohematology instruments and tests used for blood typing to ensure patient-donor compatibility in blood transfusions; and donor screening instruments and tests used for blood and plasma screening for infectious diseases for customers primarily in the United States.
Strategy
The key elements of the company’s strategy to accelerate and sustain revenue growth and operating leverage include focusing relentlessly on maximizing Lifetime Customer Value (LCV); providing an unparalleled customer experience to retain and attract its existing and new customers; leveraging its global footprint to deliver innovative solutions to meet its customers’ needs in both developed and emerging markets; creating meaningful product innovation through menu expansion, development of novel instruments and enhancement of automation and informatics; and pursuing business development opportunities, partnerships and strategic acquisitions to enter adjacencies or expand its business units.
Products, Pipeline and Services
The company’s revenue is driven by a razor-razor blade business model. Through this model, the company generally sells or places instruments under long-term contracts, which support the ongoing sale of its assays, reagents and consumables. The company’s instruments are closed systems, requiring customers to purchase the assays, reagents and consumables from it. These sales generate a high proportion of recurring revenues. As of January 2, 2022, the company had an installed base of approximately 21,000 instruments.
Clinical Laboratories
The company has been a pioneer of important technological advances in clinical diagnostics, including its unique dry slide technology, which offers customers superior test performance with clear ease-of-use advantages and lower total cost of ownership. The company’s slides are very stable. The company carries a comprehensive clinical chemistry test menu, and dry slides has long shelf life with lower laboratory shelf space required. The company’s dry slide chemistry is well positioned for rising environmental concerns given its eco-friendly profile with no water usage and significantly reduced clinical waste and biohazard.
The company’s flagship Clinical Laboratories platform is the VITROS family of instruments, which includes a series of clinical chemistry, immunoassay and integrated (combined chemistry and immunoassay) systems and automation and middleware solutions. The VITROS instruments run a wide range of assays, from infectious diseases, sepsis, cardiovascular conditions and anemia, to bone disease, diabetes, drugs of abuse/toxicology, oncology and renal disease. The company has six VITROS instrument analyzers that provide standardized performance and are still sufficiently flexible to meet the needs of its customers across the spectrum of laboratory sizes and volumes. The company’s VITROS instruments are placed in centralized, higher-throughput testing sites (hospitals and laboratories) and decentralized, lower-throughput sites (physician offices, clinics and specialty settings).
The company launched the next generation of VITROS instruments—the XT 7600 integrated system and XT 3400 clinical chemistry analyzer—in 2018 and 2019, respectively. Both instruments deploy a highly accurate, digital reflectometer that measures test results and takes advantage of new XT chemistry slides, combining two tests that are frequently used together, and improving the economics for the company and its customers.
The company’s Clinical Laboratories assay menu is quite broad, covering 24 different therapeutic areas and approximately 90% of a typical laboratory’s testing needs. In Greater China, for example, the company is the clinical chemistry market leader in separate STAT testing laboratories that seek rapid, high-performing assays to drive rapid clinical decisions.
Standalone CC Instruments: High efficiency scalable analyzers that run the company’s broad menu of general and special chemistry tests, including its differentiated dry chemistry Microslides, with no external water supply required. Examples include VITROS 350 Chemistry System; VITROS XT3400 Chemistry System; and VITROS 4600 Chemistry System.
Standalone IA Instruments: Random access, scalable throughput analyzers that run the company’s broad immunoassay menu with no external water supply required. Examples include VITROS ECiQ Immunodiagnostic System and VITROS 3600 Immunodiagnostic System.
Integrated Instruments (CC+IA): Random access, high throughput analyzers that run its expansive chemistry and immunoassay test menu within the same unit with no external water supply required. Examples include VITROS 5600 Integrated System and VITROS XT7600 Integrated System.
Dry Chemistry Slides and XT Multi-Slides: Differentiated dry Microslide technology avoids the potential variability caused by water impurities and the frequent calibration common in wet chemistry products. XT slides deliver higher efficiency with two tests per slide. Example is VITROS XT MicroSlide Clinical Chemistry Technology.
Acute Care—Cardiac and Sepsis Markers for ED/ICU: Critical care assays that help deliver accurate, reliable results in acute care situations. Examples include VITROS Immunodiagnostic Products High-sensitivity Troponin; VITROS Immunodiagnostic Products NT-proBNP II; and VITROS Immunodiagnostic Products B•R•A•H•M•S PCT (Procalcitonin).
Infectious Diseases—Assays for Patient Management and Blood Donor Screening: High performing assays to identify presence of antigen and antibodies across a wide spectrum of infectious diseases. Examples include VITROS HIV Combo Immunodiagnostic Assay; VITROS Anti-HCV Immunodiagnostic Assay; VITROS Anti-SARS-CoV-2 IgG Immunodiagnostic Assay; VITROS Anti-SARS-CoV-2 Total Immunodiagnostic Assay; and VITROS SARS-CoV-2 Antigen Immunodiagnostic Assay.
Other Key Assays: Microtip assays offer a wide range of special chemistry testing using wet reagents but with no external water supply needed. Example is VITROS HbA1c MicroTip Assay.
Transfusion Medicine
Immunohematology
In Immunohematology, the company is the global market leader based on the strength of its instruments and assays. The company’s flagship IH analyzers are the ORTHO VISION and ORTHO VISION Max systems that automate blood typing and serology disease screening for blood banks. ORTHO VISION was originally launched in 2015, followed by the ORTHO VISION Max and the Next Gen ORTHO VISION Swift, which is designed to be faster, quieter and even more cyber-secure than previous generations of the company’s products. ORTHO VISION has been extremely successful in driving workflow simplification and automation for the customer. In addition, the company sells the semi-automated Ortho Workstation for blood bank customers that have lower volumes or need for test automation.
In fiscal 2021, the company launched its enhanced ORTHO VISION Swift and ORTHO VISION Max Swift Analyzers systems that automate blood typing and serology disease screening for blood banks. Additionally, in fiscal 2021, the company launched the ORTHO OPTIX reader in North America. OPTIX is targeted at blood banks who desire greater precision reading their manual test results and is designed to provide improved software and integration with laboratory information systems, improved workflow and 99.9% concordance with ORTHO VISION test results. OPTIX provides an entry point for customers that want to move from manual to semi-automated testing.
The company also has a partnership with Quotient Limited (Quotient) for the Immunohematology application of the MosaiQ analyzer, which is designed to employ a cutting-edge microarray technology to allow advanced multiplexing. MosaiQ multiplexing is expected to enable multiple tests to be run simultaneously on a single, low-volume patient sample and drive significantly higher test throughput, which would strengthen its position in the ultra-high throughput segment of the IH market. It also offers the potential for streamlined inventory management and concordant results across donor screening and pre-transfusion testing and matching.
The company’s Immunohematology instruments operate with two different modalities of test consumables. In the U.S., the company’s automated systems use patented ID-Micro Typing System (IS-MTS) gel cards and outside the U.S., the company sells BIOVUE cassettes that utilize column agglutination technology (CAT). Both approaches are designed to provide reliable test results and simplify test workflow. With the 2016 launch of ORTHO SERA reagents, the company offers a comprehensive test Immunohematology menu that covers more than 99% of most tested blood antigens and all the diseases regularly required for transfusion screening globally.
Donor Screening
The company’s Donor Screening business focuses on instruments and tests used for blood and plasma screening for infectious diseases for customers, which include some of the largest donor testing institutions, primarily in the U.S. In Donor Screening, the company’s core instrument offering is the ORTHO VERSEIA Integrated Processor (VIP)—an automated pipetting and processing system that brings together the ORTHO VERSEIA pipettor and ORTHO Summit Processor to enable end-to-end pipetting and processing. For Donor Screening, the company’s serology test menu covers the full range of blood types and a comprehensive set of infectious disease screens, including important tests for tropical diseases like Chagas’ that are critical for care in emerging markets.
Key Products—Transfusion Medicine
Immunohematology Manual and Semi-Automated: The only 2-in-1 blood testing system using reliable Column Agglutination Technology (CAT). The Reader delivers objective grading, results interpretation concordant with the ORTHO VISION Analyzer. Examples include Manual Blood Bank Reagents; ORTHO Workstation; and ORTHO OPTIX Reader.
Immunohematology Automated: A suite of automated instrument solutions connected with an optional middleware software that bridges the gap between instruments and hospital information technology (IT) networks. Examples include ORTHO VISION Swift Analyzer; ORTHO VISION Max Swift Analyzer; ORTHO CONNECT Middleware; ORTHO PROVUE; and ORTHO AUTOVUE.
Immunohematology BIOVUE: Safe test format that can be used manually or with the fully automated analyzers, the ORTHO BIOVUE cassette is easy to use and ideal for both routine and specialized immunohematology testing. Example is BIOVUE Cassettes.
Immunohematology ID-MTS Gel Cards: Safe test format that can be used manually or with the fully automated analyzers. The ID-MTS Gel card is easy to use and ideal for both routine and specialized immunohematology testing. Example is ID-MTS Gel Cards.
Immunohematology Key Screening and Typing Assays: BIOVUE and ID-MTS product lines offer comprehensive testing solutions, including Type and screen, Donor confirmation, Antibody screening and identification, Rh phenotype, Rare antigen testing, and DAT. Examples include Anti-Fya, Anti-Fyb, Anti-Jka, Anti-Jkb, Anti-S, Anti-s, Anti-K, Anti-D (IAT), Anti-D (DVI), Anti-P1, Anti-Lea, Anti-Leb and Anti-N.
The U.S. Donor Screening: Ultra-high throughput Donor Testing platform capable of 264 tests per hour. Designed to run a comprehensive panel of highly sensitive and specific assays for use in Donor Testing. Examples include ORTHO VERSEIA Integrated Processor, ORTHO HBc ELISA, ORTHO T. cruzi ELISA, and ORTHO HCV 3.0 ELISA.
Services
In addition to the products the company provides, ORTHOCARE services are a critical element of how it delivers value to its customers. As of January 2, 2022, the company had approximately 980 service teammates globally. The company’s highly valued suite of ORTHOCARE service offerings includes:
Guarantee 98% up-time to the company’s the U.S. customers—high instrument reliability and a proactive maintenance program.
E-CONNECTIVITY Remote Monitoring Software—More than 80% of the company’s installed base of VITROS 5600, XT 7600 and ORTHO VISION platforms are e-connected, enabling remote monitoring and improved analyzer availability.
Laboratory Informatics—Solutions designed to deliver incremental value to the laboratory, including inventory planning, laboratory productivity metrics and technical documentation.
ValuMetrix—A highly valued consulting service proven to increase laboratory workflow, productivity and laboratory service levels utilizing lean principles and process excellence. This service offering provides actionable insights into demand for new products, services and workflow.
Global Technical Solution Center—Seven technical solution centers delivering first line support in over 15 languages, meaning the company can resolve service issues remotely without an on-site visit approximately two-thirds of the time.
Smart Service Mobile App—First in class technology enabled on iPhone and Android devices that allows the company’s service teams to receive up-to-date analyzer health checks, proactive alerts and performance monitoring to ensure the highest level of reliability is achieved.
Training and Education—Flexible educational resources for the lifetime of the customer relationship, including virtual technical training, continuing education and professional development.
Smart Start—Concierge implementation program led by certified project managers. Easier implementation using collaborative software to keep up to date with real- time progress reports, customized dashboards and status updates.
Merged Reality—Enables product experts to provide remote ‘side by side’ assistance to field service engineers and customers through mobile devices, including smart glasses. This allows both parties to see the same thing at the same time and provide guided instruction leading to better and faster fix rates.
Sales, Marketing and Distribution
The company uses manufacturing and distribution capabilities to produce and deliver diagnostic instruments and assays for hospitals, laboratories and blood and plasma centers worldwide. The company’s primary distribution center locations are centrally located in the U.S. and Europe, and have extended hours and efficient transportation processes.
In the U.S., the company uses a generalized sales force for Immunohematology and Clinical Laboratories and a separate specialist sales force for Donor Screening. Across this global footprint, the company operates a region-specific sales model. The company’s developed markets, specifically in North America and Western Europe, are served primarily through direct sales. However, the company generally utilizes third-party distributors in emerging markets, such as China, the Middle East, Africa and Eastern Europe as this model is more commercially effective.
Research and Development
The company’s research and development expense included $126.2 million for the year ended January 2, 2022.
Trademarks and Service Marks
The trademarks the company owns or has the right to use include among others, ORTHO, ORTHO CLINICAL DIAGNOSTICS, ORTHO VISION, BIOVUE and VITROS.
Intellectual Property
In the course of the company’s business, it has developed and will continue to develop proprietary products, technologies, software systems, processes and other intellectual property (IP). The company has applied for and/or obtained and maintains registrations in the U.S. and other countries numerous trademarks, including ORTHO CLINICAL DIAGNOSTICS, ORTHO, VITROS and ORTHO VISION.
As of January 2, 2022, the company owned approximately 665 patents and 1,125 trademarks, and it had approximately 44 trademark applications and more than 80 patent applications pending. The majority of the company’s patents and patent applications are in its Clinical Laboratories line of business.
Collaboration Arrangements
The company’s Joint Business is a collaboration with Grifols Diagnostic Solutions, Inc. (Grifols) relating to its Hepatitis and HIV diagnostics business. Grifols supplies the company with a portion of the antigens used in its production of these diagnostics products.
Competition
In the Clinical Laboratories market, the company’s principal competitors include Abbott Laboratories, Danaher Corporation, Roche, and Siemens Healthineers.
In the Transfusion Medicine market, the company’s principal competitors include Abbott Laboratories, Diasorin, and Roche in Donor Screening; and Bio-Rad and Immucor in Immunohematology.
Government Regulation
The company’s products and operations are subject to extensive regulation by the Food and Drug Administration (FDA) and other federal and state authorities in the U.S., as well as comparable authorities in foreign jurisdictions. In the U.S., the company’s products are regulated as either medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations, or as biological products under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) and their implementing regulations, each as amended and enforced by the FDA.
The majority of the company’s diagnostic products and analyzers are regulated by the FDA as medical devices in the U.S. The company markets the majority of its diagnostic products in the U.S. pursuant to 510(k) clearances and Premarket Approval application (PMA) approvals.
In the U.S., the company markets its VITROS Anti-SARS-CoV-2 IgG Antibody test and calibrators and controls and VITROS Anti-SARS-CoV-2 Total Antibody test and calibrators and controls pursuant to EUAs originally granted by the FDA in April 2020. The company markets its VITROS Anti-SARS-CoV-2 Antigen Test pursuant to an Emergency Use Authorization (EUA) originally granted by the FDA on January 11, 2021.
Certain of the company’s blood screening products are regulated by the FDA as biological products, also called biologics. In the U.S., biologics are subject to regulation under the FDCA, PHSA, and other federal, state, local and foreign statutes and regulations.
Biologic manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with current good manufacturing practice, which impose certain procedural and documentation requirements upon the company and its third-party manufacturers.
History
Ortho Clinical Diagnostics Holdings plc was founded in 1939. The company was incorporated in 2020.
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