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Roche Diagnostics Sales Grow 6 Percent in 2016

This article has been updated with information from Roche's earnings presentation.

NEW YORK (GenomeWeb) – Roche today reported that its 2016 diagnostics revenues grew 6 percent year over year, driven by strong immunodiagnostics product sales within its centralized and point-of-care solutions business.

The company reported CHF 50.58 billion ($51.09 billion) in 2016 revenues, up 5 percent from CHF 48.15 billion in 2015. At constant exchange rates, the firm's revenues grew 4 percent year over year.

Roche's Diagnostics division reported revenues of CHF 11.47 billion, up from CHF 10.81 billion in the prior year. At constant exchange rates, diagnostics revenues were up 7 percent.

In 2016, the firm launched an immunodiagnostic instrument, the Cobas e 801, which represents a "major step forward in realizing the connected laboratory," Roche CEO Severin Schwan said in a statement.

During a webcast of the firm's earnings presentation today, Schwan said that immunodiagnostics is among the firm's biggest diagnostic segments, and the Cobas e 801 "puts testing in this field on a completely new level." The company has received "extremely good feedback" on the product in Europe, and it has plans to initiate a US launch in Q3 this year, he added.

Within Roche Diagnostics, centralized and point-of-care solutions revenues, which together made up the brunt of the business' sales, were up 8 percent to CHF 6.70 billion, led by the Asia-Pacific region, where revenues in China were up 23 percent on a constant exchange rate. In integrated serum work area solutions, which is part of the centralized and point-of-care solutions division, immunodiagnostics product revenues were up 13 percent, and clinical chemistry product revenues were up 6 percent.

Roche's molecular diagnostics product revenues, including sequencing, were up 7 percent over 2015 to CHF 1.85 billion, led by the Asia-Pacific region. In virology, part of molecular diagnostics, revenues were up 9 percent with contributions from products employed in the diagnosis and monitoring of hepatitis and HIV load. Also within molecular diagnostics, human papillomavirus screening revenues were up 8 percent, and blood screening grew 5 percent.

The firm's tissue diagnostics revenues grew 15 percent in 2016 to CHF 914 million, driven by strong product sales in North America. Within this segment, revenues in the advanced staining portfolio and in primary staining were up 9 percent and 21 percent respectively, Roche said. Companion diagnostic sales, also part of tissue diagnostics, surged by 46 percent.

Roche's diabetes care revenues were down 5 percent year over year to CHF 2.02 billion, primarily due to continued price pressure in the US, the firm said.

For Roche's Diagnostics business, 2016 was a very good year for sales and pipeline progression, but it was challenging for the bottom line, Roland Diggelmann, CEO of Roche Diagnostics, said during the webcast.

Continued pressure on the diabetes business, primarily in the US, contributed to the bottom-line drag. It was due to reimbursement cuts that were introduced three years ago, but still have an impact on new contracts, he added.

Diggelmann noted that by combining revenues of just the centralized, molecular, and tissue segments, diagnostics business growth was up 9 percent, which is "far ahead of the market," and these segments contributed CHF 700 million in additional sales in 2016.

Roche reported net income of CHF 9.73 billion, compared to CHF 9.06 billion in 2015. Core earnings per share was CHF 14.53.

Roche said that in 2016, it added nine key instruments and tests to its diagnostics portfolio, further "supporting laboratories’ efforts to increase efficiency."

In addition to the Cobas e 801 immunoassay module, the firm launched the CoaguChek INRange system to monitor vitamin K antagonist therapy, and the Accu-Chek Guide, a next-generation blood glucose monitoring system.

The US Food and Drug Administration approved two companion diagnostics — the Ventana PD-L1 (SP142) test, which is a complementary diagnostic that determines PD-L1 status of patients with bladder and lung cancer, and the Cobas EGFR Mutation test v2, which is a companion diagnostic for the lung cancer medicine Tarceva.

The FDA also granted premarket clearance and a Clinical Laboratory Improvements Amendments (CLIA) waiver for the Cobas Liat Influenza A/B & RSV test, a point of-care test that extends molecular testing on the Liat system beyond influenza A/B and Streptococcus A to include respiratory syncytial virus. Additionally, the FDA approved Roche tests for the detection of Zika virus, the firm said.

In 2016, Roche's Pharmaceutical division revenues were up 5 percent to CHF 39.10 billion from CHF 37.33 billion.

The firm said that in 2017, it expects overall sales to grow by low- to mid-single digits at constant exchange rates, and it expects that core earnings per share will grow broadly in line with sales.