DNA Sequencing Market Heats Up With Illumina-BGI Battle

As Complete Genomics sought to boost its resources with a partnership with a Chinese biotechnology concern, a rival company has made a competitive bid.   Illumina  said last week that the company made a competing bid for Complete Genomics Inc. at a 5% premium over what Chinese firm BGI-Shenzhen has offered shareholders.   Previous to the offer, Complete Genomics agreed to be acquired.   

Complete Genomics said  that Illumina's bid  wasn't in the best interests of the stockholders, because a potential deal would likely not achieve antitrust clearance. Complete Genomics and Illumina compete  for whole human genome sequencing as an outsourced service.

The competition is indicative of the attention that companies are giving the DNA Sequencing market, as expected clinical application drive development of new systems and applications.  Kalorama Information's report on The  DNA Sequencing Equipment and Services Market  provides complete forecasts for systems and consumables used in DNA Sequencing.  It also contains company profiles, grant trends and other information.  The report can be found at: http://www.kaloramainformation.com/DNA-Sequencing-Equipment-7118427/

Using 'Good' Epigenetics To Combat 'Bad' Epigenetics

From our author K. John Morrow some disturbing news and also a sense of where may be in the future for epigenetics..  “There are two deeply disturbing properties of epigenetic inheritance that have been receiving much attention of late,” Morrow says.   “The first is the ability of certain classes of chemicals to cause epigenetic changes that can be transmitted transgenerationally. The second is the propensity of genetically stable tumor cells to display great epigenetic variation, driving their evolution and malignancy.”

Morrow, author of Kalorama’s Epigenetics market research report notes that.  Manikkam et al [PLOS ONE 7(9):e46249] report that Dioxin, a potent epimutagen, can induce multiple adult onset disease in the F3 generation when administered to gestating female rats. In another important study Ujvari and coworkers (Proc Biol Sci. 2012 Nov 7. [Epub ahead of print]) find that a bizarre transmissable facial cancer in the Tasmanian Devil, although genomically stable, undergoes extensive epigenetic changes that drive its tumorigenicity. Because of this variability the tumors evolves over time, and these changes can be transmitted to other animals through bodily contact. This rare marsupial has been pushed to the edge of extinction by this cancer.

"Connecting these two sets of observations, it seems highly possible that exposure of human populations to epimutagenic agents could induce rapidly evolving and extremely lethal cancers. Moreover, it is also possible that subsequent generations could inherit this genetic alteration."

Epigenetic investigations have focused largely on use of therapies that target methylation site next to controller elements of various oncogenes, as described in a recent Kalorama report. There is a high probability that combining epigenetic drugs with conventional therapies could stop tumor growth and at the same time slow down the uncontrolled variability of cancer that enables it to outrun therapeutic intervention.

At the same time, there is a pressing need for studies that investigate the role of environmental epimutagens in driving disease in both animal and  human populations.    

Kalorama Identifies 5 Areas Next Gen Sequencing Will Impact Healthcare

The idea of a patient’s DNA being routinely tested by a next-generation sequencer to help a doctor make a diagnosis may seem a bit futuristic right now.  We suggest that sequencers are expected to see usage in at least five clinical areas over the next several years.   At the same time, we warn, there are unpredictable variables which will affect the timing for each clinical application, including science, regulation and economics, not to mention the strengths and weaknesses of different sequencing technologies.

 Kalorama recently released a white paper titled "Next-Generation Sequencing Moves Into Clinical Applications" covering some of these perspectives, following the third edition of its full market research report on this industry, DNA Sequencing Equipment and Services Markets.

"There are several clinical areas where next-generation sequencers are likely to see rapid growth, causing the overall segment to become a large fraction of the sequencer market within five years," said Justin Saeks, Kalorama analyst and author of the report.  

According to Kalorama Information, these areas include:

• ·         cancer diagnostics and treatment
• ·         HLA/ MHC typing
• ·         neonatal and prenatal testing
• ·         pathogen detection
• ·         pharmacogenetics.

Kalorama notes these areas are progressing gradually, due to the regulatory process, the complexity of the science, and the medical community's cautious approach with new tests.  Eventually, the technology is expected to gain significant momentum in healthcare, possibly more rapidly in Europe's easier regulatory environment, as the complex issues are addressed and the individual systems become proven in their applications.  

Kalorama suggests that different areas can have different requirements in terms of read length, accuracy, coverage, throughput, run time, sample size and other features, which may result in niches. For example, cancer applications might have specific needs for higher accuracy/ coverage, longer read length, and/ or single cell capability due to the large variety of cancers, the large genetic aberrations, and the heterogeneity of the tissue often involved, respectively. Over time, medical discoveries a long with technological advances in hardware, software, and reagents will continue to change this landscape.

"The continuing drop in sequencer and consumables costs, along with increases in performance, are the primary drivers of adoption into new applications," Saeks said. "But the exponential drop in the cost of sequencing may slow the revenue growth in the near term, as the complex factors affecting adoption will likely take some time to shake out."

A range of new challenges and questions are also likely to manifest in unforeseen ways, for example, relating to ethical, legal, and social aspects. Along with the scientific challenges, these may take ten years or more to address before a tipping point is reached. But in the long term, sequencers are eventually expected to become ubiquitous in healthcare, with patients having the DNA in their circulating blood tested regularly. In the meantime, instrument suppliers, diagnostics companies, and clinical labs will need to consider how the various trends will impact these applications in the rapidly changing market.

Kalorama Information's report, DNA Sequencing Equipment and Services Markets, 3rd Edition, contains a deeper discussion of some of these trends, a review of products currently on the market, and competitive positions of players. In addition to analyzing DNA sequencer sales and making forecasts for future sales, it also looks at sequencer consumables and services sales. The report can be found at http://www.kaloramainformation.com/DNA-Sequencing-Equipment-7118427/

New "Bio Fabrics" To the Rescue For Hernia Repair

Increased incidence of hernia and a need for better repair materials is driving the 3.5 billion dollar hernia repair market, according to our latest report,  Hernia Repair Device Markets and Procedures, which  indicates that the market has experienced steady demand which ha sbeen consistent from year to year -  4.8% growth on average since 2008.. 

A hernia is the protrusion of an organ or part of an organ through a defect in supporting structures that normally contain it. The National Center for Health Statistics estimates that about 5 million people in the United States have an abdominal hernia. It is also a common problem for other parts of the world.  Europe authorities estimate that approximately 2 million individuals experience hernias and Asia and rest of world individuals experience another 1 million.  A hernia may occur naturally from a patient’s supporting structures, or it may be acquired from an injury or from a lung issue that leads to a persistant cough.    Most occur in the inguinal or femoral region; however, umbilical, ventral, and hiatal hernias also occur.

Herniorrhaphy is one of the most common surgical procedures with over 1 million performed annually and more than 80 percent were ambulatory cases. Only a fraction of these people seeks treatment. It is generally thought that 3% of the general population will have or develop some type of abdominal wall hernia, thus driving the need for procedures and better equipment that will help reduce reoccurrence. 

“In the past ten years, the application of bio-textiles for implants has greatly developed in the new field of tissue engineering.  New product innovation, a steady demand for superior products by surgeons, and increasing procedure volumes will likely fuel growth over the next five years.”

Composite mesh with absorbable and non-absorbable barriers for intraperitioneal placement, lightweight macroporous mesh and xenogeneic and allogeneic biological meshes are several of these novel materials discussed in Kalorama’s report.  B Braun Aesculap, Biomerix Corporation, ConMed, Cook, Covidien and Ethicon are among the companies in this market. 

The report, Hernia Repair Device Markets and Procedures contains profiles of these companies and discussions of new products, forecast for specific device markets, and trends that market-watchers will want to keep track of.  The report can be found at Kalorama Information’s website at: http://www.kaloramainformation.com/Hernia-Repair-Device-7214035/

Will Election Change Healthcare Policy?

Perhaps you are one of many Americans going to vote today with a 'shopping list' of issues that cause you to like or dislike President Obama or Governor Romney.

At least one major medical association thinks healthcare should NOT be one of them.

An article by attorneys written for the Journal of the American Medical Association, JAMA.   opines that healthcare reform is unlikely to change as a result of the election, citing for instance that a President must 'take care to faithfully execute the laws.'  thus important parts of the healthcare reform bill signed in 2010 would still have to be enforced regardless of who is President.  Also while the individual mandate would be a tax that a President Romney could hypothetically ask the IRS to 'not make a priority' the tax would have to be collected per the law.

What about repealing the law?  JAMA says this:

“Repealing and replacing” the ACA is unlikely, requiring Obama to lose the presidency and Republicans to hold the House and 60 Senate seats to prevent a filibuster. An alternative approach, through the budget reconciliation process, cannot be filibustered. However, the budget reconciliation process would face fierce Democratic challenges under the “Byrd Rule,” which requires the Senate parliamentarian to determine whether all aspects of the law have direct—not merely incidental—effects on federal revenue or spending.²

At Kalorama Information, we do tend to see what is of most interest to healthcare executives as a result of their market research buying.   We cannot say that a lot of buying is centered around healthcare reform policy changes.  Most executives know that either as part of President Obama's healthcare plan or a new President's austerity program that may have to come in the future anyway to control costs, they are likely to face reimbursement cuts that will impact device markets.  

There is one portion of the law that Kalorama believes may get some attention if the President is not re-elected, though even this is the medical device tax much maligned in the industry.  A combination of House Republicans and moderate Senate Democrats might take this issue on, especially with two large device companies in the state of two Democratic Senators, Minnesota.  Even this is speculation, as the device tax repeal would add to deficit spending, not a popular idea in Washington at this time.

Kalorama's White Paper - Healthcare Reform Winners and Losers is available from www.kaloramainformation.com

Infusion Pumps Key to Healing and Cutting Hospital Stays.

If you need to go to the hospital for a pressing medical condition, this unknown device may be the very thing that keeps you alive and facilitates your treatment.  It also may be the key to getting you out of the hospital faster. It is an infusion pump.

Infusion pumps are used to infuse necessary fluids, which include medications and/or nutrients, to a patient's circulatory system. They are often used in situations where continuous monitoring and treatment by a nurse or other health staff would be expensive, impractical, or unreliable. They are used for everything from very simple requirements such as rehydration to more complex requirements such as those needed for chemotherapy and pain management. Accuracy and consistency when delivering medications and other fluids are essential due to the possibility of severe consequences.

 Who makes these systems.   Some companies are large, others small innovators.  More than 100 companies participate in the infusion pump market. These include well-known companies such as Abbott, Medtronic, Fresenius, CareFusion, Johnson & Johnson (Animas) and Baxter. However, a number of companies specialize in certain areas. Among these companies are Insulet whose OmniPod delivers insulin without tubing, MRI safe pumps from IRadimed, enteral feeding pumps from Moog and I-Flow home care pumps.

As this article in Virtual Strategy Magazine notes, the market for these systems is increasing in size.  http://www.virtual-strategy.com/2012/11/02/opportunity-new-entrants-and-innovators-infusion-pump-market-kalorama-reports

Hospitals Battle with Physician Offices For Medicare Funds

You would certainly notice a difference if you go to a physicians office versus when you go to hospital.   More patients, a different waiting area, different equipment, more staff, different types of doctors.   

But Medicare does not see the same difference you do.  Or so it appears...

Last month, the Medicare Payment Advisory Commission (MedPAC) the group that advises the Federal Government on medical payments addressed payment differences across settings.  According to MedPac, the federal government is paying too much for hospital servcies which can be performed as well at a physicians office.  

But hospitals note, we are not the same.  

As Fierce Healthcare notes.

"Hospitals are not physician offices and play a very different role in the communities they serve …," AHA Executive Vice President Rick Pollack wrote in a letter Friday. AHA pointed out that hospitals offer 24/7 access to care, safety nets for those who can't pay, as well as disaster response. "These critical roles, which [are] often taken for granted, represent an essential component of our nation's health and public safety infrastructure," Pollack said.

As part of Healthcare reform, increased cuts to providers will be likely.   The question then, is who takes the larger hit.   Our White Paper on Healthcare Reform, available for free at Kalorama Information.com talks about some of the recent changes and which industry sectors benefit.