Epigenetics: New Kid on the Block in Cancer Therapeutics

Monoclonal antibodies, the shining star in the anti-cancer therapeutics firmament, are faced with some new competition. While epigenetic therapeutics have been around for a while, a raft of new clinical trials are in progress, and with any luck the next few years will see a number of FDA approvals for these agents. 

As was pointed out at recent symposium (Third World Epigenetics Summit, Boston, July 24-26), epigenetic drugs offer a number of important advantages over other forms of cancer treatment. First of all, their mechanism of action is well understood, as they target a specific enzyme in the oncogenic process. Secondly, they are small molecules, which means they can be taken orally, saving the patient discomfort, cost and inconvenience. 

Thirdly, there are already FDA-approved epigenetic anti-cancer drugs available, such as azacytidine, and trials can combine an approved drug with one of the compounds under evaluation. And finally, epigenetic drugs, unlike traditional antimitotic agents, are specific in their targeting. Rather than blasting away, machine gun style, at the objective, they aim at a very specific reaction site within the cell. So far their side effects have proven to be relatively minor.

The last century of the war on cancer certainly serves as a powerful admonition against irrational exuberance, but at this stage there is certainly reason for positive beliefs, and the coming trials will be closely followed.

Our report on Epigenetics is available from Kalorama Information at our website.                              

BD Max MRSA Earns Moderately Complex Rating

This Genome Web article highlights yet another entry into the MRSA testing world - BD's assay has just received moderate CLIA.   Already with FDA approval, this additional rating allows the test to be performed by a qualified laboratory technician, which means that hospitals can perform the test and do not need to send it to a central lab for processing.  

This is critical for what has become the most successful of the molecular tests, those that can test for an infection to determine if a patient needs isolation or special drugs.   This information is needed fast, so slower testing methods, even if cheaper, are not as useful as molecular solutions.   Once, bold predictions were made about molecular testing markets (yes, even in some cases by Kalorama's reports earlier in the last decade) but for the most part we and other market watchers have observed over the years how it has been hospital infection testing that has met the growth expectations while cheaper methods are stubborn in other areas of medicine.  

Kalorama's Report, 'Hospital Infection Markets,' details the developments in this market and forecasts revenues for the next five years.  

Why Drug Discovery Is Being Outsourced

Drug development is a high-cost and risky business, since only a fraction of the therapeutic targets selected for study will actually yield products that obtain regulatory approval from the FDA. The average drug can take ten or more years to progress from the discovery phase to the clinic, with only one compound out of 10,000 evolving into a viable product.  Typically a majority of compounds do not proceed further than the pre-clinical stage, with only five in five-thousand advancing, before moving onto clinical (human) testing, which includes multiple phases, a plethora of regulations imposed by the FDA and the need for large batches of volunteers.

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Advances in molecular biology and the emergence of new-generation biological therapies has led to an increasing complex drug discovery since the 1990s. These advances, along with the emergence of new technologies, have made it unsustainable for companies to undertake all drug discovery functions in-house. Therefore, the industry has chosen to outsource core drug discovery functions more frequently.

Specifically, the need for clinical outsourcing is being driven by declining R&D budgets; overall expenditures on discovering and developing new drugs by PhRMA members increased nearly 10% in 2010 to reach $50.7 billion; the 2010 rise was short-lived as PhRMA estimates R&D spending dropped just over 2% to $49.5 billion in 2011.  In order to accommodate shrinking budgets and the demand for new market drugs, companies have turned to outsourcing to manage their core functions, which has  resulted in time and cost savings as well as financial and operational flexibility. 

For outsourced nations and pharmaceutical companies, it's a win-win for drug discovery, which requires technical expertise in the areas of molecular biology, ultra-high throughput screening, molecular and behavioral pharmacology, and combinatorial, medicinal, and analytical chemistry.  University and higher education programs throughout BRIC nations have focused heavily on developing a skilled workers in these and many other relative fields.  In addition, crossover and new advancements in chemistry, molecular biology, pharmacology, microbiology, and biochemistry has resulted in the evolution of new methodologies and their application in drug discovery. These new technologies come with the promise of generating greater numbers of more effective drugs, while maintaining or reducing current costs.

Fears of intellectual property protection have been outweighed by advantageous, low-cost of outsourcing drug discovery, in addition to allowing pharmaceutical companies the ability to leverage new technologies and scientific expertise.

Kalorama's report on Drug Discovery Outsourcing can be found at:  http://www.kaloramainformation.com/Outsourcing-Drug-Discovery-6948227/

Kalorama Publishes 8th Edition of Comprehensive IVD Market Research Report

Every two years, our lead diagnostic analyst Shara Rosen produces a complete, 1000+ page, 27 chapter survey of the market for in vitro diagnostics.  The report is large but is designed to provide a great value for market research report buyers who can benefit from having one 'go-to' book for their IVD needs.  This report includes every subsection of clinical diagnostics including Histology, Hematology, Immunoassays, Molecular Testing, Microbiology, Virology, Blood Testing, Point of Care and other.  This year, the 8th edition comes at a time of change in the industry.

"Diagnostic laboratory technology has changed dramatically in the past few years, due to the publication of the human genome project and advances in functional genomics, bioinformatics, miniaturization and microelectronics," says author Shara Rosen, R.T., M.B.A.  "Not three years ago it would have been almost inconceivable to see research technologies such as genome sequencing and mass spectroscopy play a pivotal role in improving lab medicine.  Their influence is felt in personalized medicine, inherited diseases, pathogen detection, antibiotic resistance testing, blood banking and much more to come."

In the 8th edition, which came in at 1400 pages Rosen has picked up on the trend of many new entrants to the IVD industry in the molecular, microbiology and point of care fields.  She profiled nearly 500 companies.    Careful attention was paid to big trends, such as the incorporation of test instruments to IT systems and

IVD is a worldwide business, and the purpose of The Worldwide Market for In Vitro Diagnostic Tests has always been to survey the entire world market and put it in a context.  While the US is a large healthcare market, much of the dynamism occurs in other areas. Many of the most interesting developments are occurring in emerging markets. As part of its coverage, the report breaks down the entire IVD market for the following regions.

• North America
• Europe (EU countries)
• Eastern Europe
• South America
• Asia (China and India)
• Rest of World

The author and the Publisher of Kalorama attended the American Association for Clinical Chemistry Meeting in Los Angeles, CA this year and was able to incorporate findings from that meeting into the report.  

For more information about the report or to order, please visit Kalorama Information's website at  http://www.kaloramainformation.com/Worldwide-Vitro-Diagnostic-6859416/

Information Week on Kalorama Patient Monitoring

We expect fast revenue growth in patient monitoring systems that have advanced features such as remote and wireless capability and in this interview with our analyst Melissa Elder in Information Week, in a story on remote patient monitoring the point was made clear.  These systems are growing as organizations seek to streamline operations, save money and comply with EMR requirements.

Patient-involved healthcare is on the rise and wireless technologies have catered to this trend," Elder said in an interview with InformationWeek Healthcare. "Some of the challenges [at healthcare delivery organizations] can be somewhat offset by implementing newer patient monitoring technologies capable of not only monitoring patients, but sorting data, and automatically updating patient records. This allows health staff to provide care more efficiently and also monitor patients in off-site locations."


Our full report on Patient Monitoring, including market sizes and forecasts and profiles of key companies, can be found here:

EMR: With Checks Come Checks

With the reimbursement for use of EMR systems comes some paperwork responsibility that will need to be performed by hospitals, group practices and individual physicians who received EMR incentive checks in the past years.  The hospitals and providers that received checks from the government for EMR services now must document their use of EMR, according to this Fierce Healthcare story.   Garden City, N.Y.-based accounting firm of firm of Figliozzi and Company has begun auditing recipients of EMR checks one behalf of the Centers for Medicare Services (CMS). 


 The audits have been conducted after the Government Accounting Office (GAO) indicated that CMS's use of automatic checks for meaningful use requirements was not satisfactory to meet the requirements of the original law.  At this time there hasn't been reaction from major associations but it's likely these compliance costs will add at least slightly to the burden of implementing EMR. 


Kalorama's report on this topic can be found here.

50 Billion-Dollar IVD Industry Goes to LA

This week the IVD industry is showcased at the Los Angeles Convention Center at the American Association for Clinical Chemistry (AACC).   As evident here, the clinical diagnostic industry is growing; Kalorama's estimate of this market is that it has grown to 50 billion dollars, an increase of 6 billion dollars from two years ago when we did our last edition.

The growth in the industry is reflected in the size of the show; with two full exhibit halls and over 500 exhibitor companies, 20,000 people total, were at the AACC meeting industry has outgrown some of the smaller city convention centers and can only be held in the larger convention centers such as LA, Houston, Chicago or Atlanta.

This year as in other years, we are noticing a few trends that we will end up highlighting in our reports

-Diagnostic systems, particularly glucose meters attached to cell phone technology are being launched by many companies.  The presence of a speaker who was a marathon runner using a continuous glucose meter, something that would be impossible for a diabetic with a standard treatment was noted.

-Big emphasis on IT systems.  Major companies are competing on better IT systems in their core lab products and smaller IT companies have gone from small booth to big presence at this meeting.

-Molecular testing particularly for infectious diseases and HAI testing continue to dominate.

-Service and consulting remain viable products and are part of the offerings at major companies.  OrthoClinical markets its instruments along with a ValueMetrix enhanced value consulting service to maximize productivity in lab operations.

-Continued increased presence from Chinese manufacturers competing with immunoanalyzers, hematology analyzers and other equipment.

-Beckman Coulter's large presence in the entrance of the meeting with video walls and several instruments on display indicates that it is continuing to dominate as a brand on its own despite the recent purchase by Danaher.  Astronaut Mike Kelley, husband of Congresswoman Gabby Giffords was a notable presence for floor traffic at this convention on Tuesday when he spoke about his experience with PSA testing.