QuidelOrtho Corporation provides diagnostic testing solutions. The company’s global infrastructure and commercial reach support its customers across more than 130 countries and territories with quality diagnostics, a broad test portfolio and market-leading service. The company operates globally with manufacturing facilities in the U.S. and the U.K. and with sales centers, administrative offices and warehouses located throughout the world.
The company sells its products directly to end users thr...
QuidelOrtho Corporation provides diagnostic testing solutions. The company’s global infrastructure and commercial reach support its customers across more than 130 countries and territories with quality diagnostics, a broad test portfolio and market-leading service. The company operates globally with manufacturing facilities in the U.S. and the U.K. and with sales centers, administrative offices and warehouses located throughout the world.
The company sells its products directly to end users through a direct sales force and through a network of distributors, for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, leading universities, retail clinics, pharmacies, wellness screening centers, other POC settings, blood banks and donor centers, as well as for individual, non-professional, OTC use.
The company manages its business geographically to better align with the market dynamics of the specific geographic regions in which it operates. Japan and Asia Pacific operating segments were combined into one segment: JPAC. North America, EMEA and China are the company’s segments. The company generates its revenue in the following business units: Labs, Transfusion Medicine (Immunohematology and Donor Screening product categories), Point of Care and Molecular Diagnostics. The company also generates non-core revenue, including through its contract manufacturing business and certain business collaborations.
Business Units and Products
The company provides diagnostic testing solutions under various brand names, including among others, the following: AdenoPlus, BIOVUE, FreshCells, InflammaDry, Lyra, MeterPro, MicroVue, Ortho, Ortho Clinical Diagnostics, Ortho Connect, Ortho Optix, Ortho Plus, ORTHO VISION, QuickVue, Quidel, QuidelOrtho, QVue, Savanna, Sofia, Solana, Thyretain, Triage, ValuMetrix, Virena and VITROS.
The company generates product revenue in the following business units:
Labs
Clinical chemistry laboratory instruments and tests, which measure target chemicals in bodily fluids for the evaluation of health and the clinical management of patients. Immunoassay laboratory instruments and tests, which measure 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. Testing to detect and monitor disease progression across a broad spectrum of therapeutic areas. Specialized diagnostic solutions. Other product revenues primarily from contract manufacturing. Collaboration and license agreements pursuant to which the company derives collaboration and royalty revenues.
Molecular Diagnostics
Tests for PCR thermocyclers with reduced process time and ready-to-use reagent configurations. Molecular amplification systems with the ability to run multiple assays at the same time and tests for infectious disease diagnostics. Sample-to-result molecular instruments and tests for syndromic infectious disease diagnostics.
Point of Care
Instruments and tests to provide rapid results across a broad continuum of POC settings, including tests for professional healthcare providers and tests that can be performed at home. Tests that are run on a range of portable, POC analyzers. Tests that are visually read.
Transfusion Medicine
Transfusion Medicine business unit includes two product categories. Immunohematology instruments and tests used for blood typing and antibody identification to help confirm patient-donor compatibility in blood transfusions. Donor Screening instruments and tests used for blood and plasma screening for infectious diseases for global customers.
Global Services
In addition to the products the company provides, its services are a critical element of how it delivers value to its customers. As of December 29, 2024, the company had approximately 1,100 service teammates globally. The company employs highly trained service professionals, including laboratory specialists with advanced qualifications.
The company’s highly valued suite of solutions include:
Guarantee 98% up-time to the company’s e-connected U.S. customers-High instrument reliability and a proactive maintenance program.
E-CONNECTIVITY Remote Monitoring Software-More than 75% 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.
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-Five 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 help achieve the highest levels of reliability.
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.
Aquant AI-A field-based machine fed tool used to troubleshoot instrument issues with standardized solutions.
The company also provides its Virena wireless cellular data management and surveillance system that operates as a cloud-based solution connecting Sofia and Solana instruments across a healthcare system and automatically transmitting de-identified test results to a secure database.
Digital Solutions and Innovation
The company is building its enterprise digital product strategy, platform and portfolio, which the company believes help improve its customers’ clinical and operational outcomes. The company focuses on enabling its customers to deliver smart, connected care across a variety of clinical environments. The company strives to connect its instruments to healthcare providers, labs and policymakers through proprietary and third-party solutions, creating valuable data assets. The company’s portfolio of workflow automation solutions, such as Ortho Connect, Ortho Plus and myVirena, help simplify the testing and instrument management process. The company also actively developing other products designed to help personalize and elevate individual test results, such as the QVue companion mobile application for its COVID-19 at-home tests, potentially resulting in specific clinical insights or actions.
Competitors
Some of the company’s principal competitors include among others, Abbott Laboratories, Roche, Thermo Fisher Scientific, Danaher, Siemens Healthineers, Diasorin, Bio-Rad, Hologic, Qiagen, Becton-Dickinson, bioMerieux and Revitty. Some of these competitors have substantially greater financial, marketing and other resources than it has.
Business Strategy
The company is driven to transform diagnostics into action for more people in more places. To achieve this, the company serves a broad range of market segments across the healthcare continuum, from large, centralized laboratories to physicians’ offices and other decentralized settings. While these care settings have traditionally been less integrated, the healthcare landscape continues to become more integrated.
In the near term, the company focuses on a set of strategic initiatives across its lines of business and geographies to improve the underlying business and deliver greater stockholder value.
The company’s near-term priorities include capturing market share in high-value profit pools where the company holds a strong competitive position; building a culture focused on driving sales growth, profitability, cash flow and returns for stockholders; aligning incentive structures with both customer and stockholder value creation; and developing and executing a comprehensive talent management strategy.
Research and Development
For the year ended December 31, 2024, the company’s research and development expense included $218.7 million.
Sales, Marketing and Distribution
The company’s business strategy is designed to serve the continuum of healthcare delivery needs globally, from POC clinicians located in doctor’s office practices, to moderately complex POLs, and to highly complex hospitals, laboratories and blood and plasma centers. Within the inherent operational diversity of these various segments, its focus on differentiating itself and enhancing the company’s market leadership by specializing in the diagnosis and monitoring of select disease states, conditions and wellness categories.
Certain of the company’s revenue is driven by a ‘razor/razor blade’ business model. Through this model, the company generally sells or place instruments under long-term contracts, which support the ongoing sale of its assays, reagents and consumables. Under this model, its customers are required to purchase the assays, reagents and consumables from the company. These sales generate a high proportion of the company’s recurring revenues.
The company’s sales team is consists of highly skilled and experienced professionals. The company sells products globally and market and distribute products worldwide in a variety of ways, including through a mix of direct, indirect and hybrid distribution strategies.
Across the company’s global footprint, it 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 a combination of direct sales and third-party distributors in emerging markets, such as China, Asia Pacific, the Middle East, Africa, Eastern Europe and Latin America, as the company believes this model is more commercially effective in those regions. The company’s primary distribution centers are in North America and Europe.
In North America, the company uses a sales force for each of its business units. The company’s North America distribution strategy takes into account the highly fragmented POC market, with many small or medium-sized customers. To reach customers using POC diagnostic tests, a network of national and regional distributors is employed, as well as the company owns sales force. In the past few years, it has evolved the company’s North America sales force to be specialized as product experts and invested in new business development roles strategically to expand its market footprint in independent reference laboratory, urgent care and oncology markets. This sales force works closely with the company’s key distributors to drive market penetration of its products.
In Europe, the company employees support sales and marketing activities in key countries, such as Germany, Italy, France and the U.K. In addition, it has created shared service centers in Galway, Ireland, Prague, Czech Republic and Strasbourg, France to support general and administrative, technical support and customer service functions in Europe.
In China and the Asia Pacific region, which includes Japan and India, the company’s employees support sales and marketing activities, primarily for the Point of Care, Labs and Transfusion Medicine business units. In addition, the company have created shared service centers in Shanghai, China and Hyderabad, India to support general and administrative, technical support and customer service functions.
In Latin America, the company employees support sales and marketing activities in key countries, such as Brazil and Mexico.
The company’s global team strives to deliver best-in-class customer service and support by surrounding its customers with devoted and experienced professionals. The company’s call center team and field application specialists serve as the first line of contact for its customers and are available to provide customer training and ongoing customer support. In addition, the company’s network of field engineers is responsible for installing its instruments and providing onsite customer support if necessary. The company’s marketing strategy focuses on efforts to demonstrate that its key product portfolios are supported by clinical validation and health economic and outcomes research that show that its tests deliver fast, results.
The company derives a significant portion of its total revenues from a few customers and distributors.
Seasonality
Revenues from the company’s respiratory products are subject to, and significantly affected by, the seasonal demands of the cold, flu and RSV seasons, which are typically more prevalent during the fall and winter. Historically, revenues from the company’s influenza products have varied from year to year based, in large part, on the severity, length and timing of the onset of the cold, flu and RSV seasons.
Government Regulations
Some of the company’s respiratory products were initially authorized by the FDA under EUAs and such EUAs remain in effect until the relevant EUA declaration under Section 564 of the FDCA is terminated or the FDA otherwise revokes a specific EUA.
Any devices the company manufactures or distributes pursuant to the U.S. Food and Drug Administration (FDA) clearance or approvals are subject to continuing regulation by the FDA and certain state agencies, including adherence to Quality System Regulation (QSR) relating to testing, control, documentation and other quality assurance requirements.
The company’s initial focus for obtaining marketing approval outside the U.S. is typically in the EU, Australia, Brazil, Canada, China, Japan and the U.K. EU regulations and directives generally classify healthcare products either as medicinal products, medical devices or IVDs.
The company’s subject to the U.S. Foreign Corrupt Practices Act (FCPA), the U.K. Bribery Act of 2010 (the ‘Bribery Act’), the Brazilian Anti-Bribery Act (also known as the Brazilian Clean Company Act) and various other similar anti-corruption and anti-bribery laws.
History
QuidelOrtho Corporation was founded in 1979. The company was incorporated in 1979.