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Clinical Laboratories and Pathology Groups

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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Any change of ownership in the fifth largest in vitro diagnostics company would represent a major development in the medical laboratory testing marketplace

Medical laboratory managers may see more consolidation in the in vitro diagnostics market if executives at Johnson & Johnson (NYSE: JNJ) decide to sell its Ortho Clinical Diagnostics (OCD) unit. This decision was announced earlier this week during J&J’s conference call to discuss its fourth quarter 2012 financial report.

Ortho Clinical Diagnostics is considered the fifth largest IVD company. Thus, any sale or spin-off of this $2 billion enterprise will be a significant development for the clinical laboratory and pathology testing industry.

J&J Might Decide to Keep OCD

J&J is “exploring all options, including a possible divestiture” of its OCD division, J&J’s Chairman and CEO Alex Gorsky said during the conference call with investment analysts on Tuesday (January 22). While considering the possibility of selling or spinning off the unit, Gorsky also said the company was not certain that it would make any deal at all, according to The Deal. J&J is only “initiating the first steps,” in a possible divestiture, Gorsky added.


It would be a major event for the clinical laboratory industry if executives at Johnson & Johnson Company were to decide to sell, or spin off, Ortho Clinical Diagnostics, its $2 billion business unit that sells clinical diagnostics and blood-banking products. During its fourth quarter 2012 conference call, J&J executives disclosed that they are assessing strategic options for Ortho Clinical Diagnostics. (Photo copyright

“We will be exploring all options, including a possible divestiture… We remain committed to exploring ways in which diagnostics can fuel our growth, such as the work we’re doing in companion diagnostics that support our pharmaceutical pipeline as well as the point-of-care diagnostics …” Gorsky said, according to a transcript of the call published by Seeking Alpha

J&J executives believe the OCD division “could have greater potential from operating as part of another organization with a focus that is more closely aligned with its core strengths, or as a standalone company,” Gorsky added. This thinking was the result of a review by J&J executives of the operations of all units, he said.

Goal of Holding a Market Share That is Number 1 or Number 2

“When you look at diagnostics, we have good technology and a lot of good businesses, but they are not No. 1 or 2 in the market,” Gorsky commented, according to a report by In addition, Gorsky suggested that the division is unlikely to become more competitive, given what products OCD has in its pipeline, reported SeekingAlpha.

Looking ahead, J&J’s growth is likely to come “…in an area outside of clinical diagnostics, such as molecular diagnostics, biomarkers, some of the other things that we’re already working on with some of our oncology programs,” Gorsky added.

Headquartered in Raritan, N.J., the OCD unit has a research and development center in Rochester, New York, where it has about 1,100 employees, according to the Rochester Democrat and Chronicle. “Ortho Clinical’s roots date back to 1994, when J&J bought Eastman Kodak Co.’s clinical diagnostics business,” the newspaper reported.

Competing in the Clinical Laboratory Diagnostics Market

Morningstar analyst Debbie Wang told Reuters that the OCD unit had relatively slow growth and was not a market leader, making it difficult to compete in clinical diagnostics. OCD had $2.07 billion in sales of diagnostic tests and blood-screening supplies last year, down 4.4% from $2.16 billion in 2011, the company reported.

If J&J sells OCD, it is likely to be of interest to one of the three fastest-growing companies in the IVD sector. Those companies are Danaher Corporation (NYSE:DHR), Hologic, Inc. (NASDAQ: HOLX), and Alere Inc. (NYSE: ALR). (See The Dark Report, “More IVD Consolidation As Danaher Acquires Iris,” October 8, 2012.)

These three companies are leading the move toward consolidation in the IVD manufacturing sector, a trend that has been ongoing for 20 years. The most recent examples of this trend were Danaher’s acquisition in November 2012 of Iris International for $338 million. And about two years ago, (in February 2011), Danaher acquired Beckman Coulter, Inc. for $6.8 billion.

Alere also has acquired numerous companies over the past few years. It spent $263 million to buy Epocal, a maker of blood analysis systems, and $76 million to buy Concateno, a company that makes drugs-of-abuse tests.

The third IVD heavyweight is Hologic, Inc., of Bedford, Massachusetts, which paid $3.8 billion to acquire Gen-Probe Inc., a molecular diagnostics company in San Diego, California, in 2012. Hologic also bought Third Wave Technologies, of Madison, Wisconsin, in 2008 for $580 million.

Immediate Sale or Divestiture of OCD Is Not Imminent

Pathologists and clinical laboratory managers need to keep in mind that J&J executives are quite specific in stating that they are only exploring their options and may decide to keep Ortho Clinical Diagnostics. Thus, it is not likely that an immediate sale or divestiture is likely.

Furthermore, what was not discussed by either J&J executives or financial analysts is what role the Accountable Care Act’s new 2.3% tax on medical devices will have on the finances of Ortho Clinical Diagnostics. At $2 billion in annual revenues, that tax could potentially reduce OCD’s net profit by $46 million per year. For a slow growth business unit, that reduction in profit contribution may be a significant factor in why J&J executives were willing to publically state their interest in considering the sale or spin-off of OCD at this time.

—By Joe Burns

Related Information:

Johnson & Johnson CEO Discusses Q4 2012 Results – Earnings Call Transcript

J&J might sell its Ortho Clinical Diagnostics division

Ortho-Clinical Diagnostics may be sold or spun off

J&J to consider sale of Ortho Clinical Diagnostics

Cytyc to be Acquired by Hologic

Beckman Coulter Acquired by Danaher as In Vitro Diagnostics Industry Consolidates

THE DARK REPORT: More IVD Consolidation As Danaher Acquires Iris