CHF 5.19 Billion ($5.79 Billion)
Prior Fiscal: CHF 4.73 Billion
Percentage Change: +9.7%
R&D Expenditure: CHF 1.96B
Best FY22 Quarter: Q1 CHF 1.88B
Latest Quarter: Q1 CHF 773M
No. of Employees: 39,961

COVID-19 forever changed the healthcare space as well as some of the medical technology used to deliver care. Its impact accelerated the advancement of certain aspects, such as telehealth, while the general population was educated on the value of other areas, such as point-of-care testing. While a horrible situation for most of the world and something no one wants to repeat, it’s hard to argue there weren’t some positives as a result of the occurrence.

Another change that took place is how it altered the look of the MPO Top Company list. The pandemic put a spotlight on a company that had been previously absent from the list. While it’s uncertain if the firm would have previously made the list prior to COVID-19, it should have been on the list, given the financial impact made with the company’s point-of-care/at-home tests for the virus. Since the Roche Diagnostics division provides an array of technologies and solutions to be used by laboratories, healthcare providers, and patients, this report focuses specifically on two units that best align with medtech and not technology for the lab. The company’s Point of Care and Diabetes Care segments offer products used within hospitals, doctors’ offices, and the home.

Specifically, the Point of Care business offers diagnostic solutions used where care is delivered—the ER, physicians’ offices, and at patients’ homes. The offerings include blood gas and electrolyte tests, as well as COVID-19 Rapid Antigen tests. The coronavirus diagnostic products were the primary driver of the 17% growth in sales the unit enjoyed in FY22. These gains were primarily focused within the Asia-Pacific and North American regions. The end result translated to a sales figure of CHF 3.59 billion.

Sister segment Diabetes Care similarly focuses on diagnostic offerings used by both patients and healthcare professionals to help treat and manage the disease. Unfortunately, this unit saw a decline of 2% year-over-year to tally CHF 1.60 billion. Roche pointed to a rebate dispute from 2021 that was resolved during the 2022 fiscal as the reason for the fall. Outside of that issue, sales within the sector remained stable. Decreasing sales within the U.S. blood glucose monitoring market and major European markets (as those patients moved to continuous glucose monitoring systems) were offset by growth in demand in emerging markets, according to the company.

While the company will not see the revenue figures for its rapid antigen tests like it did during the pandemic, it is still making the product a highlight of its portfolio. In October, it introduced its next generation (version 2.0) of these tests, which gained a CE mark for self-test and professional use. With three new test configurations, an improved capture antibody, and the addition of a digital data sharing functionality not previously included, the introduction expands upon the firm’s already broad array of COVID-19 diagnostics.

“The continued evolution of the SARS-CoV-2 virus and COVID-19 pandemic reinforce the need for individuals and healthcare systems to have access to the most reliable rapid testing solutions possible,” said Thomas Schinecker, CEO, Roche Diagnostics. “As a leader in diagnostic innovation, we are proud to be one of the first among our industry to apply insights gained from the past two years toward a next-generation rapid test portfolio. These tests are ready to support global society as we navigate this next phase of the pandemic.”

The three tests are:

• • SARS-CoV-2 Rapid Antigen Test 2.0 (nasopharyngeal sampling)—In a prospective clinical study, this test showed a relative sensitivity of 99% and a relative specificity of 99.75%. The test is for professional use in near-patient testing environments.

• • SARS-CoV-2 Rapid Antigen Test 2.0 Nasal (nasal sampling)—In its prospective clinical studies, the product showed a relative sensitivity of 95.8% and a relative specificity of 100%. It is also for professional use in near-patient testing environments.

• • SARS-CoV-2 Antigen Self Test Nasal—This at-home diagnostic solution demonstrated a relative sensitivity of 95.8% and a relative specificity of 100% in prospective clinical studies.

The organization also launched two point-of-care solutions only a day apart at the start of the year. January saw the announcements of the cobas pulse system, a professional blood glucose management solution with mobile digital health capabilities, and the cobas infinity edge, an open digital ecosystem for point-of-care professionals.

The pulse system is a handheld blood glucose management device designed around the specific needs of healthcare professionals working in a range of care settings. It combines the form factor of a high-performance blood glucose meter with simple usability and expanded digital capabilities similar to that of a smartphone. The system is equipped with digital health applications based on the Android operating system that perform a range of clinically valuable functions—from clinical decision support to the measurement of vital signs and digital biomarkers.

As a cloud-based platform, the infinity edge connects patient test results, medical records, and third-party applications, allowing professionals to monitor patients’ health, adjust treatment protocols, and make quick data-driven patient care decisions anytime and anywhere within and across clinical settings. It also allows health professionals to access a marketplace of medically relevant applications to drive adoption of digital tools that improve patient care, by leveraging Roche’s network of third party developers.

Before the end of the year, Roche and Pfizer announced they were partnering on a solution for patients who test positive for COVID-19 to help them navigate risks, symptoms, testing, and treatment options. A QR code was added to the Pilot COVID-19 At-Home Test that directs individuals to covid19knowmore.com (a Pfizer website) to learn more about the virus, treatment, and testing.