Wednesday, December 26, 2012

Retail Clinics: Build It, They Will Come?

The site of the American Medical Association Journal noted our study of adults ( and the results that more adults are visiting clinics.  The AMA is no friend to retail clinics, and has strong criticism of them for breaking the continuance of care, as a patient may see a doctor, then visit a clinic, then see a doctor again, without each entity knowing about the other visit.  Once of the things that Amednews noted is that usage is up where more clinics are located.  Patients will visit if a clinic is near their home and makes themselves available as a physicians' office.

Several studies have found that patients who live near retail clinics are more likely to use them. According to Merchant Medicine, a retail medicine consultancy based in Shoreview, Minn., 1,420 retail clinics operated in 39 states as of early December. In October 2006, there were 202 such clinics across the country.

Monday, December 17, 2012

Patient Satisfaction May Impact Testing Markets

In the Kalorama Linked In Group we discuss the pressures of patient satisfaction for doctors and healthcare organizations.

Our discussion is based on an article in The American Medical News of the American Medical Association. regarding the focus on keeping patients happy in healthcare organizations.  The AMA article relates the pressure that doctors feel to keep patients happy, which is often in direct conflict with treatment procedures and According to one physician quoted in the article:

"If I feel the patient is not an appropriate candidate for opioids, I should say no,” she says. “But in the back of my mind, the question can arise, ‘What will the patient do with that?’ Especially since the No. 1 question on our patient-satisfaction survey is, ‘Are you happy with the way the physician treated your pain?’ ”

This is an especially important trend because  patient satisfaction could have a direct impact on doctor's salaries, according to the article.

For Dr. Zgierska and a growing number of physicians, saying no could carry a price tag. The University of Wisconsin Medical Foundation, the clinical practice organization for UW faculty physicians, recently created a new compensation plan for its primary care doctors. They can receive a 5% increase in their base pay if they meet benchmarks on certain performance measures, including patient-satisfaction metrics.

If this trend holds that patient satisfaction is winning out over cost-cutting. We note that it could have interesting ramifications for diagnostic market forecasts.  Diagnostics is expected to be a cost saver - the idea is that tests save because you test a patient for appropriate treatment before using.  But if doctors skip steps for patient satisfaction reasons, this may hurt testing markets.    At the highest level, the idea of advanced pharmacogenomic testing is to reduce costs by keeping a therapeutic to patients most able to use.  But there again if the introduction of a companion test causes patient satisfaction problems.

Our personalized medicine report takes a look at market for diagnostic tests intended to target a specific patient with the most effective therapy.

Tuesday, December 11, 2012

Mixed Reviews on Final Medical Device Tax Rules

Is the medical device industry full of cheer about the newly-defined healthcare tax parameters?  Yes and no.  The IRS released its guidelines for how the 2.3% excise tax associated with the Patient Protection and Affordable Care Act of 2010 will be implemented.  This was anticipated by an industry that is soon to face the impact of the taxes.  The guidelines were met with a mixed reaction from device companies.   Some breathed a sigh of relief, others still are concerned about the tax's impact.

On one hand, the IRS waived some late fees and clarified the policy on prepackaged kits (in most cases, if a product within a kit already incurred a tax liability, companies would not be double-taxed.) and clarified on combination drugs (in most cases, combo drug/device products would not be taxed.  

On the other hand, some things the industry wanted such as a delay in implementation, a waiver for dental products, and an exemption for leased products were rejected by the IRS.

Major device companies still say profits and layoffs will be impacted by the tax.  Cook Medical's CEO recently indicated his company would not expand manufacturing in the United States given the tax policy.

Kalorama Information's The Global Market for Medical Devices 3rd Edition examines the overall medical device market and assesses the impact of the tax on several companies.    

Thursday, December 6, 2012

The Next Wave in Cancer Treatment

 Historically, cancer treatments have been very invasive and detrimental to the body as a whole. However, there are numerous new techniques available for those with cancer that are not as invasive and detrimental to the body as a whole. These treatments range from the severely alternative to the more traditional.   Kinase Inhibitors are one of these treatments known to mitigate the spread of cancerous cells.   In the past, the treatment of choice was to remove the cancer and as much of the surrounding normal tissue as possible. Therefore most of the surgical procedures used were considered to be radical in nature. In the mid-1950s even though the radical procedures were technically sophisticated, the mortality rates associated with certain cancer sites were not improving. Many cancers that were thought to be local disease processes were found to be systemic diseases with metastatic lesions located in anatomic sites other than the site of the primary disease. On analysis of these findings, it became obvious that surgery alone regardless of the extent of the procedure was not an effective treatment for every type of cancer. 

There have been many cancer therapeutics approved over the last 50+ years for a wide range of cancer indications. The largest numbers of treatments approved are for breast cancer, leukemia, lung cancer, and lymphoma. 
The market for one type of these treatments, kinase inhibitors is heating up.   Although the market is becoming more established and several billion dollar drugs have emerged this segment has enormous room for growth.  

Several factors continue to influence the double-digit growth this market has experienced, including the continued success of targeted therapy in cancer treatment, rising incidence of cancer, and increased cost for newly approved therapies in the advanced treatment area.   

Our new Kalorama Information market research report – The Next Wave in Cancer Treatment--Kinase Inhibitors - is focused on a growing area of cancer treatment, kinase inhibitors. Several cancers are being treated with these newer therapies, which provide a focus of cancer profiled in this report, including:

  • Breast
  • Colorectal
  • Head/Neck
  • Kidney
  • Leukemia
  • Liver
  • Lung
  • Melanoma
  • Ovarian
  • Pancreatic
  • Prostate
  • Stomach


Friday, November 30, 2012

DNA Sequencing Market Report Cited in Live Scientist

An article in Live Scientist quotes Kalorama Information's DNA Sequencing Report 

The market for DNA sequencers increased in the last year with the introduction of new systems and a growing demand for sequencing, according to Kalorama Information.

The healthcare market research publisher said that the introductions of the Ion Torrent PGM, PacBio RS and MiSeq grew the sequencer market nearly 5 per cent to US$560m (EUR429m) in 2011. More new technologies are expected from Ion Torrent as well as from Oxford Nanopore that may further change the market and introduce price changes, according to Kalorama's report, 'DNA sequencing equipment and services markets, 3rd edition'.

"This was getting to be a stable market, but that changed in the last two years," said Justin Saeks, Kalorama analyst and author of the report. "Now it's more volatile and complicated; we think customers will acquire new systems, but pricing and feature preferences will get interesting."

More here

View our report on DNA Sequencing.

Monday, November 26, 2012

Kalorama Finds 21% of U.S. Adults Have Visited a Retail Clinic

 The number of adults who are familiar with retail clinics and have used them has increased greatly in the past five years, according to Kalorama Information.  The healthcare market research firm conducted a survey of 2,000 U.S. adults and found  21.3% of those surveyed have visited a retail clinic.  The Kalorama survey result is a significant increase over polls six years ago which showed less than 10%.     
Take Care Clinic Locations in Atlanta

We've studied retail clinics in depth since 2007.  We attribute the result to the growth of stores at top retail chains, growth of clinic traffic and the bunching of clinics in certain cities.  The finding was made in our complete market research survey on retail clinics, Retail Clinics 2012: Growth of Stores, Consumer Opinion Surveys, Winning Competitors, Supplier Sales of Products to Clinics, Clinic Sales Forecasts and Trends.
Retail clinics, also called convenience clinics, are mostly located in drug stores but also in retailers such as Walmarts and Targets, grocery stores and even malls.

  The basic premise is that they take advantage of the retailers traffic, and provide defined services generally though a nurse practitioner or a physician assistant..  Especially attractive to customers, they offer walk in service, better hours than the average physician office, and lower costs.  The concept survived the recession, the opposition of medical associations and state legislatures.  A shortage of primary care physicians, rising concerns about access and costs, and now a health reform plan which has so met political and constitutional challenges, is expected to send new patients to clinics.   

 This and the ever-older Baby Boomer population have combined to create a unique prescription for success.  Most importantly, drug stores embraced the concept and the two largest drugstore chains in the United States, CVS and Walgreens are behind the concept. 

The other side of the survey result, of course, is that nearly eighty percent have not visited a clinic There has been improvement in popular opinion, though there is still room to grow.  Almost all surveys show high satisfaction with retail clinics.   There are over 1,300 retail clinics, and we expect that number to grow, but growth in the amount of stores that house clinics has never been linear, and store count went down in the midst of the recession.   Stores have struggled with getting patients in summer and spring months.   Some well-known chains closed clinics in their stores.  These developments could produce a misinterpretation that the concept was on the decline.  But there are counter-developments to such a decline.  Prestigious academic medical centers entered the retail clinic business at the same time a number of chains dropped the idea.   

Physician practice and urgent care competition, labor shortages, competition for retail space and even limited non-clinic drugstore care options such as flu shot stations administered by pharmacies and patient management are limiting growth of clinics in stores.  

Kalorama’s report, Retail Clinics 2012 is a detailed look at the market for clinics in retail settings.  The report can be obtained at  

Tuesday, November 20, 2012

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:

Thursday, November 15, 2012

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.    

Tuesday, November 13, 2012

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

Thursday, November 8, 2012

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:

Tuesday, November 6, 2012

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

Monday, November 5, 2012

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.

Thursday, November 1, 2012

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 talks about some of the recent changes and which industry sectors benefit.

Wednesday, October 24, 2012

Europe - Next Big EMR Opportunity?

EU Nations Seek to Upgrade Old Systems
Europe may provide opportunity for EMR software companies as European healthcare systems update systems. The European Electronic medical records (EMR) market reached revenues of $6.8 billion in 2012. An established market in some countries and implementation issues in other countries have keep revenue growth at a modest rate of 3% but that’s expected to double in the coming years, according to our new report, EMR in Europe. 

The report identifies the opportunity for EMR companies in each European company. According to its findings, IT integration in Europe is varied depending on the country. Electronic Medical Records have been used for over 10 years in some countries such as the Nordic countries. However, in other countries such as the UK, Germany, France and Spain, EMR adoption is on course with the United States. 

Kalorama finds a fractured but growing market with a lack of pan-European players. Several factors are driving the European EMR market including a growing elderly population, rapid development of medical technology and cost. There is a strong drive to reduce avoidable medical errors thus improving overall quality of care and facilitate sharing of patient information, as well. 

Also driving the adoption of EMR is meeting the legal requirements mandated by the health governing bodies within individual countries to improve security and privacy provisions, complying with government funded policies and increasing organizational performance. 
But there are challenges too, that the report identifies. Key barriers to adoption of EMRs in Europe include lack of funds, time issues, cooperation of users, complexity of the systems and evaluation of need. These barriers differ from country to country but do create stumbling blocks for implementation. The report details how some companies have worked around these barriers to compete. 

Kalorama Information’s market research survey, EMR in Europe details some of the ways that EMR firms can benefit from partnerships and marketing strategies in Europe, and details EMR penetration and the opportunity market for EMR in each country.  

Tuesday, October 23, 2012

Decreasing Cost of Sequencing to Drive Clinical Applications

 Continuing improvements in next-generation sequencer technologies are causing revolutionary changes in biomedical research, which are gradually translating into new clinical applications.  The NIH has taken notice, and has shifted resources from basic research to more medically-oriented projects.  As the cost of systems and consumables continues to drop, this has followed an exponential trend similar to Moore’s Law with computer chips and transistors. 

The trend of decreasing cost has actually been accelerating on a logarithmic scale; if it continues, it would lead to a cost of only $10 per genome in around five years.   Benchtop next-generation sequencers are now priced at $50k to $100k, compared to the $500k to $700k for higher end systems. 

The ability to pool multiple individuals’ samples in one run has allowed further savings of time and money.  As a result, sequencers are expected to see widespread adoption in the next several years into a much broader range of clinical applications than before, as the scientific and regulatory hurdles are gradually addressed.  The following areasprovide some examples of the clinical areas showing promise.
  • Cancer
  • Neo-Natal
  • HLA/MHC Complex
  • Pathogen Detection and Subtyping 
Our report on DNA Sequencing Equipment and Services Covers These Trends and More..

Friday, October 12, 2012

Meningitis Outbreak Points to Need for Anti Fungals

Most of the discussion of infection treatment centers around anti-bacterials, particularly the common 'antibiotics' prescribed for a number of infections.  Fungal infections get less attention, but can be just as dangerous.  The destruction of bacteria through antibiotic use may actually have increased the fungal infection incidence, as Kalorama discusses in its anti-infective report.  
A recent outbreak may enlarge the perception of these type of infections and treatments.  There have recently been news reports that patients may have received contaminated steroid injections from the New England Compounding Center for treatments in their ankles, knees and other joints, and may present signs of infection.
Officials had previously said most of those at risk received epidural steroid injections to relieve back pain.   The Centers for Disease Control and Prevention (CDC) said it was alerted to one case of a person who may have developed a fungal infection after receiving a steroid injection in his or her ankle. The case hasn't been confirmed to be caused by a fungus,but the person received the same steroid injection as the confirmed fungal meningitis cases and is showing symptoms consistent with a fungal infection. According to CBS News:
The CDC said there are 170 reported infections tied to an 11-state meningitis outbreak, including 14 people who died.In total, up to 14,000 people may have received the contaminated injections, said health officials; previous estimates suggested that number was closer to 13,000 patients. The CDC reported it has successfully tracked down nearly 12,000 of these patients -- about 90 percent -- to inform them of their risk.

There are a number of treatments for fungal infections.  Our report on Antiinfective Markets  details the  products, revenues and companies involved in treatment of infections including fungal diseases.

Thursday, October 11, 2012

Clinical Nutrition - Growing World Market

With so many developments in clinical nutrition, you may have noticed that Kalorama has moved to a yearly publication schedule on its Clinical Nutrition report.  The aging of the population means a strong market continues for products that can fortify patients and supply needed food to those patients with compromised digestive functions.

We focus on three areas:

Enteral - this is oral food, yes drinks like ENSURE(TM)  and BOOST (TM) as well as other products.  

Parenteral - food that can only be delivered through a feeding tube.

Infant - Infant nutrition products 

As is true of so many healthcare markets, American companies are focusing on emerging markets in India, China, Pakistan, Brazil and other countries where the population is growing and healthcare systems are requiring more.

Kalorama's new report can be found here:
The World Market for Clinical Nutrition Products (Infant, Parenteral and Enteral Foods), 5th Edition 

Friday, October 5, 2012

Helping Physicians See Beyond The Human Eye

For the medicine of decades ago, a simple X-ray was enough for diagnosis.  For an increasing amount of known biomarkers, the human eye even when aided by an x-ray is not enough. Advances in molecular biology improved the understanding of many diseases and natural processes and helped fuel the development of imaging techniques that diagnose disease on the molecular, or biological, level -- based on the interaction of proteins and other cellular-level compounds. These imaging modalities assess the molecular basis of cell function and dysfunction.      Molecular imaging techniques include nuclear medicine imaging -- positron emission tomography (PET) and single photon emission computed tomography (SPECT) and combination PET/CT and SPECT/CT techniques – as well as ultrasound, magnetic resonance imaging (MRI) and computed tomography (CT) imaging that are used with molecular imaging agents.  Molecular imaging makes it possible to take a personalized approach to detecting and managing an illness. In this manner, patients benefit from earlier, more accurate diagnoses and safer, more effective treatments. 
       Molecular imaging techniques are based on technologies that have an intrinsically high resolution, which makes it possible to detect low concentrations of target biomolecules found in tissue.  The key to growth and finding more clinical applications for molecular imaging is the development of new and more specific biomarkers. Specific molecular biomarkers will allow physicians to transition from treating the illness to treating the illness in the individual, opening up a new paradigm in health care. 
     It is possible to predict the best treatment options by characterizing, through molecular imaging techniques, the disease in an individual. Individualized treatment plans will optimize patient outcomes because those patients who are not predicted, or expected, to respond to a specific therapy will not receive that treatment. Researchers can predict whether a medicine might be effective, ineffective, or toxic in certain individuals. Moreover, health care costs will decrease as a result of properly utilizing resources.Tests and examinations that can help doctors diagnose disease earlier and the most appropriate treatment are in order. Such tests, including imaging diagnostics, can lessen health care expenses and improve patient prognosis. Annual growth for molecular imaging modalities through 2015 will be good as the knowledge which molecular modalities have to offer will spur use of these imaging systems, and research will lead to greater Diagnostic use in the clinic. 
      Molecular imaging has evolved into a pillar of molecular medicine. It combines functional imaging with structural imaging so that specific in-vivo molecular processes can be identified and spatially pinpointed, often with the use of imaging contrast agents that bind to specific biological proteins. Molecular imaging is undertaking diagnostic and treatment roles as it enables physicians to pinpoint the locations of disease and track the progress of therapies. The same contrast agents used to highlight disease sites may even be able to carry drugs that can be selectively unleashed precisely where they are needed.

Kalorama Information's report on molecular imaging breaks down developments in molecular imaging and provides company profiles and trends in the market



Tuesday, October 2, 2012

So Called "Junk DNA" May Be Useful After All

Since the sequencing of the human and other genomes in the 1990s, it has been recognized that large sections of the genome did not appear to be coding for genes that produced protein products. This observation earned these regions the unfortunate title of “junk DNA”. Recent studies, however have put to rest the notion that organisms cart around a load of useless DNA sequences. It is now evident that these megabases of DNA are essential for controlling the flow of genetic information, and that these regions carry networks of epigenetic and genetic regulatory genes coordinating this activity.

A slew of papers published simultaneously in Nature and Science have revealed the complexity of the genome’s regulatory networks.  Starting in 2003, the ENCODE project revealed  that 76% of the genome is transcribed into RNA molecules that do not translate into proteins. These RNAs are involved gene regulation by combining with and blocked specific messenger RNA molecules. These regulatory RNA molecules travel to different sites within the cell where they exert their controlling influences.

In addition, the researchers identified genes that code for regulatory proteins that influence gene activity by binding to specific sites within the DNA. These proteins frequently exert their regulatory power by binding to the histones, a class of DNA-associated proteins that form part of the epigenome.

While these studies are building an understanding genetic regulation and its complexities in humans, they are also aiding in our analysis of disease processes. The investigators identified many genetic regulatory variants related to diseases such as diabetes, bipolar disorder, Parkinson’s disease and lupus. The researchers further state that they have uncovered regulatory DNA variation in a variety of pathological states, revealing important insights into the origins of these conditions.

The understanding genomic and epigenomic regulatory networks in human disease represents a new paradigm and a basis for the development of radical new drug therapies.

A more detailed look at the role of epigenetics in clinical medicine and epigenetics in drug discovery is the subject of a recent Kalorama report, Epigenetics, a complete market research survey of the nascent epigenetic industry authored by K. John Morrow, Jr. PhD.

Monday, October 1, 2012

Pagano Story Demonstrates That EMR is not the Only Privacy Concern

EMR gets slammed quite often as a potential privacy pitfall, but patient privacy-protected information is often unfortunately leaked whether the information is in an electronic record or not.  The story behind a major news story involving an NFL coach, broken today, demonstrates how, despite all the talk about electronic medical records as a privacy concern, there is just as much privacy danger from those old fashioned sources as well.

Word of mouth of healthcare providers can be just as effective in leaking details of a patient's conditions, despite privacy concerns.   Celebrities are often the victim of an anonymous nurse or lab technician handling HIPPA-protected information in an unprofessional manner.

Chuck Pagano, coach of the Indianapolis Colts was diagnosed with a treatable form of leukemia that will keep him off the sideline of his NFL team for a few months, according to media reports.    He is a popular coach and there are hopes for a fast recovery.

What we find interesting about the story, coming from a healthcare IT viewpoint, is that the reporter Bob Kravitz, the reporter at the Indianapolis Star  who broke the story, obtained the information through a privacy violation that had nothing to do with computers.  He told ESPN radio that he obtained the story when he went to buy a new car.  The salesman told him about it, saying he heard it from a friend who knew someone who treated him at the hospital.

Privacy is one of the concerns for EMR systems, but it is a broader issue that has many aspects to address.  Reports of violations, such as lost laptops or inappropriate access of records are commonly reported. Most hospitals, likely aware of extant potential for privacy violations with or without EMR, have not allowed concerns to reduce their enthusiasm for paperless medicine.   EMR systems continue to be expanded at major US healthcare systems.  .  EMR 2012 details the market for these systems and the reasons behind this growth.  

Thursday, September 27, 2012

Vaccine Sales Drop For First Time in Over a Decade

At Kalorama we've sometimes been seen as promoters of the vaccine business, because we do yearly reports, and we have identified vaccines as the future growth area of pharmaceuticals in a time where 'blockbuster' single-molecule drugs are not plentiful.  We insist we call it like it is, and over the past decade it's simply the case that vaccines have been growing.  In 2011 however, given the over stockpiling of influenza vaccine in 2010, the market dropped about 30% according to our latest report.  So I suppose, we have a good objectivity test here.  When the market is down, as it now appears it was in 2011, we report that as well.   However, the interest, buzz and comparative growth prospects of vaccines have not declined.  R&D interest from top pharma presages a good future for these products.

In our report, Vaccines 2012, we demonstrate how the decline should be short lived, and what products are immune to the decline in the overall market.  

Tuesday, September 25, 2012

Good Viruses? Yes, Thanks to DNA Sequencing

Genetic Engineering News, one of Kalorama's favorite sources of information in the biopharma world, (and an avid user of Kalorama's Market Estimates) carries a story on the discovery of viruses that have a positive function.  In this case, they are referring to 'viruses that can zap zits.'  Which in practice means, isolated phages of virus have been found using heavy sequencers which can kill  P. acnes --  that elusive bacteria responsible for acne.
According to the article: 
After isolating, then sequencing the genomes of 11 Propionibacterium acnes phages, a team of researchers from the University of California (UCLA). and the University of Pittsburgh says it found similarities between the phages that may make them suitable against P. acnes, the bacterium believed responsible for the zits so many have long tried to zap.
What's significant about this article is that discovery of these type of treatments is only possible through DNA Sequencing.  The more research 'hits' that we see in the coming years, the more funding agencies will take an interest in sequencing research labs.  We needn't add that this is especially true where the target is one of heavy consumer interest.  These type of discoveries will increase the relevance of systems and drive the market for innovative, faster systems with more read length.  Kalorama's new report  details the current state of DNA Sequencing Equipment Markets.

Tuesday, September 18, 2012

Some Parts of Healthcare Reform Not Dependent on Election

Romney or Obama?   Well for a good deal of healthcare and the way it operates it may not matter.  Yes this runs against a lot of the conventional wisdom and certainly cable news talk.  As our Kalorama KeyPoint LinkedIn site article details, there are a number of provisions of healthcare reform that are already underway or will be underway shortly, and the take within the hospital community is that even a repeal would not 'change the changes' that hospitals are expected to face very much.   Besides since so many hospitals are making changes in the direction of the policies in healthcare reform such as population-based care and increased technology, repeal may not broadly change what some entities are doing.

The following parts of President Obama's healthcare reform legislation are likely to still be a component of Federal healthcare policy even if the act is repealed by a future Congress and President, though their presence may not be as obvious:

  • Decreasing reimbursements for primary care 
  • Transition to ICD 10
  • IT incentives for EMR purchasing and requirements / penalties for non-compliance
  • ACOs already likely underway are unlikely to be terminated.  While new ACOs may not form in a repeal, there is a likelhood of  move a pay-for-value system as opposed to strictly a pay-for-volume system
These are changes that while they are in the law and may be technically removed in a repeal, are likely to be parts of any President's healthcare policy anyway, unless an unexpectedly large amount of funding for healthcare is appropriated.  

Dartmouth Hitchock's Director of Clinical Services sums it up pretty well.   "Organizational priorities will not be affected if health reform is repealed, which I do not believe will happen."

Friday, September 14, 2012

Beyond Nicoderm: Transdermal Patches See Growth

It is anticipated that the transdermal/transmucosal drug delivery market will  continue to grow beyond the smoking cessation technology that first brought them to the marketplace, according to Kalorama Information's just-published report on this topic.   The market for drugs that use technologies to deliver therapeutics through the skin is expected to be driven by various factors including the loss of patent protection for blockbuster drugs and the need to avoid the first pass effects  of oral drug delivery. 

Additionally, with an added focus on active transdermal technologies, new applications will likely cause a resurgence of interest in transdermal delivery of products. Recent advances in biotechnology and molecular biology have resulted in a large number of novel molecules with the potential to revolutionize the treatment and prevention of disease. However, such potential is severely compromised by significant obstacles to delivery these drugs into the body. These obstacles mean that drug delivery and targeting is now recognized as the key to effective development of many therapeutics. Transdermal and transmucosal drug delivery systems continue to gain market acceptance as a preferred method of administration.

 Interest in transdermal/transmucosal drug delivery dropped until the early 1970s. In 1981 the first dermal patches, Transderm-Scop for scopolamine (ALZA) and the Transderm-Nitro (ALZA), were launched on the market. Nitro-Dur (Key) and Nitro-Disc (Searle) followed in 1982, and in 1985, Boehringer Ingelheim released Catapress-TTS for clonidine, using ALZA’s drug delivery technology. This spurred a number of transdermal product offerings including::   Estraderm (CIBA) for estradiol, Duragesic (Janssen) for fentanyl, Testoderm (ALZA) for testosterone, Minitran (3M) for nitroglycerin.

These products and more are covered in The World Market for Transdermal Drugs, from Kalorama Information.  

Thursday, September 13, 2012

ADME/Tox Services a Growing Market

Among the many services not commonly outsourced is early toxicology. While far from perfect, early ADME provides useful predictive information.  There are assays designed to show how cells and organ systems can deal with the absorption, distribution, metabolism and excretion of the compounds of interest. New assays are being introduced that are even more efficient predictors of compound performance.   It is in the toxicology stage of ADME/Tox – where the pitfalls lie. 

Unlike ADME (which describes how a compound will perform in an organism), toxicity deals with how that compound will damage or kill that organism. The downside of unfavorable toxicity is a lot more serious.  Unfortunately, pharmaceutical companies have found this out the hard way.  Several unfavorable events have emerged in the past few years which are largely attributed to the toxicity of a drug, including Vioxx and Baycol.

 At first glance, drug discovery can appear to be a straightforward process of screening compound candidates, optimizing leads, performing pre-clinical evaluations and then, with these steps completed, clinical trials can begin. The reality is not so neat. These activities often overlap, merge, and conflict with each other. So ADME (Absorption, Distribution, Metabolism, Excretion) and Toxicology are not simply a step in lead optimization, they are actually an integral part of an ongoing process, and increasingly the industry is seeing it that way.  

Kalorama's recent report, Early Toxicology Markets and Approaches, focuses on markets for early toxicology testing services. The objective of this report is to focus the reader’s attention on the issues and opportunities related to early toxicology testing in drug discovery. It begins with an overview of drug discovery, ADMET, and early toxicology testing. It continues with some of the ways big pharmaceutical developers dealwith early toxicology.  Several areas are covered, including:
For the purposes of reporting market size and growth forecasts, the report segments the market into the following:
In Silico Approaches
Data Mining Tools
In Vitro Assays and Platforms
Biochemical Assays
Cellular Assays
Instruments & Platforms
In Vivo Testing
Mice & Traditional Animals
Zebrafish Models
Other Animals
Human Microdosing
Early Tox Services
In Silico Services
In Vitro Services
In Vivo Services

For information or to order:

Tuesday, September 11, 2012

Healthcare Finance News On Kalorama HAI Market Estimate

Healthcare Finance News has issued an article citing Kalorama's market estimate numbers  on hospital acquired infection testing.  Indeed, diagnostics is a big growth opportunity in this area as hospitals are under pressure to determine which patients have an HAI and isolate and or treat them.  

Five percent of admissions is a considerable incidence number, and we believe diagnostic companies will be busy working on innovative solutions which should keep growth strong in the next five years.  Top IVD companies are already involved in this area.  In our comments in the article, we addressed two of the most important HAIs that healthcare is facing.
“Some diseases are more of a priority. By and far, the most important of these are drug resistant tuberculosis (M. tuberculosis) and drug resistant S. aureus, which can also cause a deadly form of nosocomial pneumonia,” said Carlson. “These are the most serious and easily spread nosocomial infections. Therefore, the greatest amount of research and development effort is flowing toward the diagnosis and MDR differentiation of infections by these two bacteria…. Speed is essential in identifying these infections, and there are a host of tests out there, targeting specific infections and offering fast results,”  

Friday, September 7, 2012

DNA Sequencing Market Report Published

For the 3rd time since 2007, Kalorama has completed a full study of the DNA Sequencing market.  The market for DNA Sequencing has slowed a bit as stimulus fund monies were reduced and customers in major research centers cut purchases and used older systems as best they could, but  the introduction of new systems and continued demand will reverse this trend, according to Kalorama Information.  The healthcare market research publisher has reviewed the DNA Sequencing market since 2007 and in its latest study, says that the  introductions of the Ion Torrent PGM, PacBio RS and MiSeq grew the sequencer market 4.6% to $560 million dollars in 2011.    
     More new technologies expected from Ion Torrent as well as Oxford Nanopore may further change the market and introduce price changes, according to Kalorama’s report, DNA Sequencing andEquipment Markets, 3rd Edition.

Market Video

Spending a lot of time doing internal research can be avoided with well-targeted syndicated market research reports.   In many cases (especially in the area of vaccines and diagnostics) the work has been done for you.

An article in the Market Research Beat blog features our parent company Market's video which quickly explains what our company does for clients.   It is quite different from other websites selling content.

Tuesday, September 4, 2012

FDA Encouraging OTC Drug Switches

Ultimately, it's in everyone's interest to reduce healthcare costs.  This includes the Federal Government.  Thus, the FDA though an independent agency, has been encouraging OTC treatments where possible and safe in order to provide more treatments to patients at a lower cost.  They are accomplishing this through regulatory changes.  As commented on in Kalorama's recent report on OTC drugs, the FDA is continuing to review prescription drugs for potential switches...leading to a boost in the OTC market.  Several products are in discussions including those for pain, overactive bladder, an emergency kit for bacterial infections, cholesterol, high blood pressure and migraines.  

The FDA has outlined several methods of improving the flow of switches to the market including new ways of dosing existing Rx products, new indications for Rx products that may be suitable for OTC, and Rx-to-OTC switches for products reaching patent expirations and are OTC compatible.  

A meeting in November 2012 with the FDA will evaluate oxybutynin transdermal system for OTC use as a treatment for overactive bladder in women.

Kalorama Information’s report Over the Counter (OTC) Drug Markets includes incidence of conditions which are often treated with OTC medicines, health statistics related to the industry, birth rates, world population, populations by region and issues affecting the market as a whole. Information is presented as a worldwide overview, with special emphasis on the U.S., Japan, Germany, and other key markets. The market segments provide an overview of demographics, overview of products available in each region, market estimates and forecasts. Additionally, a competitive analysis of leading providers and profiles of providers is covered. Information on the report can be found at:

Friday, August 24, 2012

NIH Superbug Points to Need for Better HAI Testing and Therapies

According to a recent report, the NIH was plagued with a deadly bacteria strain known as a superbug and despite extraordinary steps such as walling off patients and removing the plumbing, they were unable to prevent several patient deaths do the contamination.   NIH is one of the best medical centers in America, and the acknowledgement of this bacteria strain has highlighted the need for better treatments and therapies for nosocomial infections.

The solution is partially to be found in new antibacterial treatments.  But developments have been slow and pharmaceutical industries need better incentives to produce antibacterials, according to our latest report on AntiInfectives report. 

Testing is also important as hospitals struggle to determine which patients to isolate. Fast results from molecular tests have led the way.   Kalorama's recent report, Hospital Acquired Infections: Testing Markets details the developments in the market for nosocomial diagnostics.