With Thousands of Medical Apps Available, Revenues Grow

This Fierce Healthcare article cites Kalorama's growth rate of 25% for medical app's revenue growth, and talks about the amount and variety of medical apps available:

Mobile healthcare and medical app downloads should reach 44 million by the end of this year, rising to 142 million in 2016, but the percentage of people who have downloaded one has remained at 10 percent for the past two years. In that time, the number of health apps has grown from 2,993 in the beginning of 2010 to 13,619 in April of 2012, according to World of DTC Marketing.

The article goes on to say that the not only for financial and medical benefits, but to actively engage with patients.

Kalorama has reviewed the market for medical apps and forecasted trends in the future.  The report can be found here
 

 

Re-Purposed Jeopardy Super Computer One Example of BioInformatics in IVD

According to our analyst Shara Rosen in her new report BioInformatics in IVD: " In February 2013, IBM’s Watson supercomputer graduated from its medical residency and is being offered commercially to doctors and health insurance companies.  IBM Corp., the health insurer WellPoint Inc. and Memorial Sloan-Kettering Cancer Center (MSKCC) announced two Watson-based applications -- one to help diagnose and treat lung cancer and one to help manage health insurance decisions and claims.

Both applications take advantage of the speed, huge database and language skill the computer demonstrated in defeating the best human Jeopardy! players on television.  

 In both applications, doctors or insurance company workers will access Watson through a tablet or computer. Watson will compare a patient's medical records to what it has learned and make several recommendations (not make a decision) in decreasing order of confidence.  

In the insurance program, it will consider what treatment should be authorized for payment.  WellPoint is already using the insurance application in Indiana, Kentucky, Ohio and Wisconsin. It will be selling both applications - at prices still to be negotiated - and will compensate IBM under a contract between the two companies.

In the cancer program, the computer will be considering what treatment is most likely to succeed. The system uses Watson's computational and natural language processing abilities as well as MSKCC's clinical expertise and cancer information to create an evidence-based decision support system that will help doctors create personalized cancer diagnostics and make treatment recommendations for their patients that are based on current evidence, the partners said.

The partners have already launched the first application to help diagnose and treat lung cancer, which will focus on treatment based on information in MSKCC’s electronic health record, which includes genomic and molecular information, clinicians' notes and observations, and relevant published literature.  

 The lung cancer program is being adopted by two medical groups, the Maine Center for Cancer Medicine and WestMed in New York's Westchester County.

Applications for breast, prostate, and colorectal cancers are in development"

Prontonix Decision May Indicate Trend of Protecting Pharma

A NJ court has moved to protect the pharmaceutical industry in a way that surprised some industry experts.  Teva  Industries Ltd and Sun Pharmaceutical Industries Ltd would pay $2.15 billion to settle a patent suit related to its acid-reflux drug.  According to Kalorama, this is an unusual court case that represents a protective view of pharma in a economically shrinking environment. 
"There may be a trend to improve protection for brand pharma as the interest in development has slowed in the area," said Kalorama pharmaceutical analyst Melissa Elder.
 
The Prontonix suit is the first instance of generic drugmakers paying damages for marketing a copy of an existing drug for which patents have yet to expire.   The tactic has been called 'at-risk' launch.  The Pfizer drug, Protonix, recorded peak annual revenue of almost $2 billion in 2007, before sales plunged following the launch of generic versions by Teva in 2007 and Sun Pharma in 2008.

 The patent covering the active ingredient in Protonix -- pantoprazole -- expired in January 2011.
was unique among these types of lawsuits as it involved a "composition of matter patent" - one of the stronger patent protections.

TEVA's Revenues were 18 billion in 2011 according to Kalorama Information's Knowledge Center.

 

Supreme Court BRCA Decision Is Good For Testing Industry

From Kalorama's lead diagnostic analyst Shara Rosen:

"Hoots of joy could be heard at molecular test providers, worldwide. Finally the seven-year patent dispute surrounding BRCA testing had come to an end. Myriad Genetics’ (Salt Lake City, UT) strategy to enforce its IP on BRCA testing has been a source of many lawsuits since 2006.  On that Thursday, the U.S.  Supreme Court ruled that human genes cannot be patented. 

KALORAMA ANALYST SHARA ROSEN WEIGHS IN
ON MYRIAD DECISION

 Therefore, Myriad Genetics’ 17-year monopoly on BRCA testing for genetic risk for breast, ovarian cancer has come to an end.  Labs, everywhere, are now free to include the BRCA gene in their test menus or test panels.  

On the other hand, Myriad has worked diligently to promote BRCA testing and its BRACAnalysis test.  For example, in 2008/09 Myriad ran a BRACAnalysis Direct-to-Consumer Campaign in the southern region of the United States, principally Texas and Florida.

September 2009, Myriad launched a hereditary breast and ovarian cancer Public Awareness Campaign in Illinois, Indiana, Kentucky, Missouri and Ohio.  Also in September 2009, Myriad announced that its sales force will provide doctors the tools to provide counseling in- house and as a result physicians can bill insurers directly for this service.

It worked, Myriad reported “molecular diagnostic revenue for fiscal  2009 increased 47% to $326.5 million from $222.9 million in fiscal 2008. The revenue improvement in the 2009 fiscal year was due primarily to Myriad's increased sales and marketing efforts, which have resulted in higher demand for the Company's molecular diagnostic products.” Myriad’s BRACAnalysis test earned approximately $400 million in 2012.

Industry consensus is firm: the decision represents a victory for cancer patients, oncologists and cancer researchers.  Media headlines cited: the Supreme Court has ruled that human genes cannot be patented.  Myriad has shown a brave face emphasizing that it still has an exclusive patent on cDNA a synthetic form of genes that can be used to indicate an increased genetic risk of cancer.

So .. what now?  The Supreme Court ruling lead the headlines on Thursday and Friday, now Monday June 17 it is business as usual.  However, BRCA testing has become big business and several labs have already announced their BRCA services and so Myriad Genetics now faces competition.

More importantly, the ruling is sure to have far reaching impact on genetic research and medicine.  Since 1984, the U.S. Patent and Trademark Office had issued more than 40,000 patents related to genes and it is estimated that about 25% of human genes have been patented.  These patents are now invalid. That could open up huge opportunities in genetic disease research and the genetic testing for innumerable diseases.

Patents on diagnostic systems for gene testing remain enforceable.  

Thus the clear and well-balance ruling left the door open for intellectual property protection and incentives for innovation in genomic disease testing."

Shara Rosen is the author of The World Market for Cancer Diagnostics, 5th Edition: Precision Medicine Arrives.  

 

article on M2M Patient Monitoring cites Kalorama market estimate

"The healthcare industry is turning to M2M technology to track medicine delivery. A variety of devices have come to market over the years, many using a connected pillbox to monitor adherence to medication regimens, and in many cases sending out alerts when pills were missed. Now, a new partnership will use M2M to further drive innovation in this area."

 According to an article in Connected Magazine cites Kalorama's telemedicine numbers.  http://www.connectedworldmag.com/latestNews.aspx?id=NEWS130612061259190

Telemedicine Revenues More Than Double Since 2007

The telemedicine patient monitoring market grew from 4.2 billion in 2007 to over 10 billion dollars in 2012, according to Kalorama Information's analysis in a recent market research study that was printed  Becker's Hospital Review 

Kalorama defines telemedicine as a patient monitor used outside of an acute healthcare setting that can transmit vital signs or other information to a healthcare professional for interpretation or action, usually from a patient’s home. Two-way communication in audio or video, EMR data transfer advanced diagnostics are among the additional features that some of these devices provide. Unlike the market for systems used in hospitals, this market is more competitive and vendors are fragmented with a fair number of privately held companies. Compatibility between devices and applications is of primary concern. AMD, Philips, Second Opinion Telemedicine, Bosch, LifeWatch are among the many vendors operating in this market.  

 The aging of the population, increasing healthcare costs, dwindling healthcare resources, advancing technologies, and the proven cost effectiveness of patient monitoring. The report says that sales will be driven in new technologies as older monitoring equipment is replaced by wireless or remote monitors. Growth will increase over the forecast period as compatibility, privacy, and security issues continue to be resolved.

 

FDA To Act on LDTs?

As noted in this Forbes article, a recent ASCO meeting became the occasion for FDA commissioner Margaret Hamburg to suggest that the agency is judging some of the LDT cancer tests to be too important to medical decision making not to regulate.

LDTs, or lab developed tests, are performed not in a hospital lab or physician office.  They are sent out to central labs so they generally fall out of FDA's rules.  In the past, LDTs were used within a hospital system, one lab, a few physicians.  But as certain labs become known for tests, they are seeing broader usage and the companies that perform tests are seeing a healthy business. 

Commissioner Hamburg cited the example of OvaSure, which was marketed as a test to detect ovarian cancer   but was withdrawn from the market four months after it was launched because oncologists and the FDA found it was not effective.

Kalorama's report on this topic, The World Market for Cancer Diagnostics,

http://www.kaloramainformation.com/Cancer-Diagnostics-Edition-7560357/

is the fifth time Kalorama's analyst Shara Rosen, MBA, R.T. has taken a serious look at this market.  The report discusses LDTs and other trends, has revenue figures for key companies and forecasts the market.