Abbott's LIMS system has won over a client that is likely to bring it a fair amount of attention in the marketplace. According to a Chicago Sun-Times news story, the Food and Drug Administration has decided to use Abbott's STARLIMS technology.
Starlims was acquired by Abbott in 2010 for $123 million. It is built from the ground up as an entirely web based LIMS application. The system leverages XML and other advanced Internet technologies to facilitate data management and decision-making within the lab and across the enterprise. It requires no client-side installation or maintenance.
Abbott is among several clinical diagnostic companies who have also moved into LIMS:
In March 2010, Thermo Fisher launched its software-as-a-service (SaaS),
enterprise-class LIMS. Thermo Scientific LIMS-on-Demand allows organizations to
leverage the benefits of a LIMS solution without the time and cost typical of on-premise software installation. With the on-demand offering, the software can be cost-effectively delivered as a service.
Roche acquired Swisslab in 2008. Swisslab LIS together with the Lauris module is targeted to large core laboratories and specialty laboratories in areas such as microbiology, blood banking, newborn screening, pathology, histology, transfusion management, genetics and HLA typing, as well as point-of-care integration and quality management.
We expect 1 billion dollars in this market by 2015, as reported among several findings in our LIMS market research report. Kalorama Information's report on this topic.
Monday, January 23, 2012
Wednesday, January 18, 2012
Thousands More Vaccine Doses May Be Needed
More doses will be demanded than the vaccine industry can produce now with its current capacity. The vaccine industry produced an estimated 23 billion doses in 2010, and demand should be ready to produce another 12-15 thousand by 2015. This is the result of increased population, the popularity of adult vaccines, expected new products, and vaccines in developing nations. We detailed this in our latest report on Vaccine Production.
To produce that amount of vaccine doses, the industry must improve its process. We suspect that cell-based and plant-based forms of vaccine production will see increases. We think the existing egg-based production may have to switch to a more logistically sound method for the increased flu vaccine demand. And we suspect outsourcing will be come more common.
Five companies dominate the global market for vaccine development and production. Smaller firms are developing new vaccines and novel production technologies.
The five key vendors have the production infrastructure, regulatory knowledge and contacts, and distribution systems for global delivery of needed vaccines. All improvements in products and processes are expected to involve GlaxoSmithKline, Sanofi Pasteur, Merck, Pfizer, and Novartis, either as developers, partners, or acquirers. Look for them to seek more partners in the future to provide the vaccines demanded.
To produce that amount of vaccine doses, the industry must improve its process. We suspect that cell-based and plant-based forms of vaccine production will see increases. We think the existing egg-based production may have to switch to a more logistically sound method for the increased flu vaccine demand. And we suspect outsourcing will be come more common.
Five companies dominate the global market for vaccine development and production. Smaller firms are developing new vaccines and novel production technologies.
The five key vendors have the production infrastructure, regulatory knowledge and contacts, and distribution systems for global delivery of needed vaccines. All improvements in products and processes are expected to involve GlaxoSmithKline, Sanofi Pasteur, Merck, Pfizer, and Novartis, either as developers, partners, or acquirers. Look for them to seek more partners in the future to provide the vaccines demanded.
Gastric Banding Goes to 'Next Tier' of Patients
As covered in Healthcare Finance News, Kalorama projects an increase in the GI device market due to an increased amount of gastric bypass and gastric banding surgeries.
Of note is that surgical candidates are moving beyond the morbidly obese candidates, those over 100 pounds overweight, and moving to the 'next tier' candidates; those who persistently have trouble despite diet and exercise.
Sales of banding systems, staples, endoscopes and other devices will benefit from the trend.
Kalorama's full market research report on the topic is available on Kalorama's website.
Of note is that surgical candidates are moving beyond the morbidly obese candidates, those over 100 pounds overweight, and moving to the 'next tier' candidates; those who persistently have trouble despite diet and exercise.
Sales of banding systems, staples, endoscopes and other devices will benefit from the trend.
Kalorama's full market research report on the topic is available on Kalorama's website.
Thursday, January 5, 2012
Outsourcing Encourages New Drug Pipeline
One third of pharmaceutical clinical trials are outsourced, as referenced in a story in Pharma Times which quoted Kalorama Information's research on this topic.
This probably will not be news to employees of pharmaceutical company R&D departments, facing cost pressures and at the same time, a need to keep up with increasing demands for new products. But outside observers to pharma markets may not be aware that outsourcing is more and more common, and not just on Phase I. Phase III and post-approval phases are a growth area for outsourcing.
Internally from customers and from news media we have received the question: is outsourcing safe? Particularly where an offshore service is involved. Actually although it may appear that non-US trials are not safe for drugs entering the US market, one has to consider that nations such as Russia and India, patients are less exposed to pharmaceuticals in general and thus trial results can be more earnest and less subject to interference either from other drugs taken by the patient or by patient perception. We've also been asked: Is it only to save money? Not always. The outsourcing companies are actually getting better than branded pharmaceutical marketers in some cases at conducting a trial. Even where it's hard to measure comparative talent, there's no dispute that CROs and AMCs can handle more volume.
Kalorama's report on this topic contains more information on the the market size for contract research in clinical trials, what entities are conducting trials and what regions trials are being held.
This probably will not be news to employees of pharmaceutical company R&D departments, facing cost pressures and at the same time, a need to keep up with increasing demands for new products. But outside observers to pharma markets may not be aware that outsourcing is more and more common, and not just on Phase I. Phase III and post-approval phases are a growth area for outsourcing.
Internally from customers and from news media we have received the question: is outsourcing safe? Particularly where an offshore service is involved. Actually although it may appear that non-US trials are not safe for drugs entering the US market, one has to consider that nations such as Russia and India, patients are less exposed to pharmaceuticals in general and thus trial results can be more earnest and less subject to interference either from other drugs taken by the patient or by patient perception. We've also been asked: Is it only to save money? Not always. The outsourcing companies are actually getting better than branded pharmaceutical marketers in some cases at conducting a trial. Even where it's hard to measure comparative talent, there's no dispute that CROs and AMCs can handle more volume.
Kalorama's report on this topic contains more information on the the market size for contract research in clinical trials, what entities are conducting trials and what regions trials are being held.
Thursday, December 22, 2011
Alere Acquires MAS; Enhances its Diagnostic IT Offering
The trend of in vitro diagnostic companies fortifying their information managment system profile continues, as more and more hospitals need lab systems that can report to an EMR. News this month that Charlottesville-based Medical Automation Systems (MAS), a major provider of information management systems for point-of-care testing, has been acquired by Massachusetts-based Alere Inc.
In 2010, Abbot acquired Starlims Technologies for 123 million dollars. The companies software was already used by more than 500 labs.
Kalorama Information expects a $850 million dollar market for Lab Information Systems. Kalorama Information's report on Laboratory Information Systems contains breakdowns of the market for LIS products by hardware and software, and discusses the major players and trends in the industry. The report can be found on its website.
In 2010, Abbot acquired Starlims Technologies for 123 million dollars. The companies software was already used by more than 500 labs.
Kalorama Information expects a $850 million dollar market for Lab Information Systems. Kalorama Information's report on Laboratory Information Systems contains breakdowns of the market for LIS products by hardware and software, and discusses the major players and trends in the industry. The report can be found on its website.
Tuesday, December 20, 2011
Arizona Hospital Sends Patients Home Early, With a Droid Phone
As noted in Fierce Healthcare , Flagstaff Medical Center is releasing patients with heart failure and providing them with a smartphone. The program uses advanced 3G wireless technology and health-monitoring devices to enhance the care of patients with congestive heart failure (CHF) or other related conditions. Zephyr Technology and Verizon Wireless are partners in this effort.
FH notes that each of Flagstaff's monitoring kits include: 3G-enabled Motorola Droid X2 smart phone with a mobile application that allows patients to rapidly record and send information to the medical center via a secure Internet portal; an oxygen and pulse monitor; blood pressure cuff; and weight scale. Additional items in the kit may include an advanced Zephyr health-monitoring system to measure other vital signs such as breathing rate, skin temperature, activity and posture.
We expect programs like these to become routine. Kalorama Information has reported on these type of applications and the growth of handheld devices in heatlhcare in its <i>Handhelds in Healthcare</i> Report. The report includes profiles of relevant companies.
FH notes that each of Flagstaff's monitoring kits include: 3G-enabled Motorola Droid X2 smart phone with a mobile application that allows patients to rapidly record and send information to the medical center via a secure Internet portal; an oxygen and pulse monitor; blood pressure cuff; and weight scale. Additional items in the kit may include an advanced Zephyr health-monitoring system to measure other vital signs such as breathing rate, skin temperature, activity and posture.
We expect programs like these to become routine. Kalorama Information has reported on these type of applications and the growth of handheld devices in heatlhcare in its <i>Handhelds in Healthcare</i> Report. The report includes profiles of relevant companies.
Thursday, December 8, 2011
Should a Molecular Test Be Treated As A Drug?
Promethus Lab's ability to patent a molecular test is at issue at the supreme court. Mayo Clinic produced a it's own version of Nestle's Prometheus's test for auto immune diseases and wished to offer it outside its lab. A district court sided with Mayo and invalidated the patents. Prometheus appealed to the U.S. Court of Appeals for the Federal Circuit, and that court ruled that what Prometheus patented was a "transformation" and thus could be patented.The Supreme Court will hear this case.
Fellow personalized testing company Myriad Genetic's amicus brief provides some insight into the possible industry impact of this case. Key to the industry argument, diagnostics should be treated as drugs are. Molecular tests are expensive to make, they involve a lot of trial and error and risk of failure, thus they should have patent protection so that the people who made the discovery of a connection can be compensated.
For example, while this Court has repeatedly
explained that “Einstein could not patent his
celebrated law that E = mc2; nor could Newton have
patented the law of gravity,” the Court has explicitly upheld
a patent claiming a
specific and practical application of the law of gravity.
Eibel Process Co. v. Minn. & Ont. Paper Co.,
The Federal Circut Court in 2010 rejected the claim that the process
Prometheus was seeking to patent was so abstract as to be non-patentable.
“[T]he claims
recite specific treatment steps, not just the
correlations themselves. And the steps involve a
particular application of the natural correlations: the
treatment of a specific disease by administering
specific drugs and measuring specific metabolite
This will be a court case to watch as it would have implications for pricing and development of molecular tests.
Fellow personalized testing company Myriad Genetic's amicus brief provides some insight into the possible industry impact of this case. Key to the industry argument, diagnostics should be treated as drugs are. Molecular tests are expensive to make, they involve a lot of trial and error and risk of failure, thus they should have patent protection so that the people who made the discovery of a connection can be compensated.
Much like in the pharmaceutical industry,In other words, if the court allows Mayo to win, they may be providing competition on this specific test, but who will be the company that will discover the next marker-drug connection? Further the Myriad Genetics amicus disputes the contention that Prometheus is attempting to patent a natural law.
personalized medicine research and development are
extremely costly and offer a very low rate of success.
The amount of time and effort required is
enormous. Additional clinical trials are required to
demonstrate the clinical utility of the discovered
correlation. Many trials are essentially equivalent to
pharmaceutical trials in both design and scope,
sometimes involving following patients for years to
determine long-term survival. Costs for research
tools such as reagents and laboratory equipment
(especially high-throughput platform equipment such
as microarray chips) can also be substantial,
especially since many of these reagents and platforms
are themselves patented products. For example,
researchers at Genomic Health reportedly spent well
over 100 million dollars and 7 years, including
numerous clinical studies involving hundreds of
patients, in bringing OncoType DX® to market.3
For example, while this Court has repeatedly
explained that “Einstein could not patent his
celebrated law that E = mc2; nor could Newton have
patented the law of gravity,” the Court has explicitly upheld
a patent claiming a
specific and practical application of the law of gravity.
Eibel Process Co. v. Minn. & Ont. Paper Co.,
The Federal Circut Court in 2010 rejected the claim that the process
Prometheus was seeking to patent was so abstract as to be non-patentable.
“[T]he claims
recite specific treatment steps, not just the
correlations themselves. And the steps involve a
particular application of the natural correlations: the
treatment of a specific disease by administering
specific drugs and measuring specific metabolite
This will be a court case to watch as it would have implications for pricing and development of molecular tests.
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