IVIG Growth in Check, But Space Reeks of Anticipation
pgresearchThursday, June 24th, 2010
The IVIG/plasma marketplace seems relatively stable at this time, despite a history of supply issues, rampant off-label use, and attempts at consolidation within the space. The PGR network reports slow and steady growth across the major players - BAX, CSL Behring, and TLCR, although parts appear to be moving in the direction of a major ramp-up.
Of the products currently available, subcutaneous formulations continue to gain share, but the true potential for the market lies in the ability of these products to treat neurological disorders, such as Alzheimer’s. Until this indication is granted FDA approval, insurance companies will attempt to contain costs from high volume off-label use. BAX, CSL Behring, and Talecris/Grifolz have all made efforts to expand their sales forces and ensure that product is available in the hope that when it is approved for Alzheimers they will be able to reap the rewards.
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Tags: baxter inc, baxter international inc, csl behring, IVIG, talecris biotherapeutics, talecris plasma
Posted in Allison Hsieh, Health Care, Uncategorized | No Comments »
Peripheral Atherectomy Industry: CSI’s Diamondback 360 still gaining on ev3’s SilverHawk
Allison HsiehWednesday, April 7th, 2010
PGR network indicates that while the SilverHawk is still the market leader in the peripheral atherectomy space, physicians often choose the Diamondback over the Silverhawk, particularly in cases below-the-knee. The SilverHawk, EVVV’s pioneering endovascular surgical device from its acquisition of FoxHollow, has been facing competition from new players in the market over the past few years, most notably from Cardiovascular Systems, Inc.’s (CSII) Diamondback 360 and Pathway Medical’s Jetstream G2. The Jetstream does not seem to be making an impression on the market, but the SilverHawk and Diamondback continue to carve out their respective niche markets, further shifting market share.
Tags: cardiovascular systems inc, CSII, diamondback 360, diamondback 360 csi, ev3, ev3 medical, EVVV, foxhollow technologies, medical device companies, pathway medical technologies, silverhawk, silverhawk athrectomy, silverhawk ev3
Posted in Allison Hsieh, Author, Health Care, Health Care Services | No Comments »
But has it got legs? EHR & RCM system deals on the rise
pgresearchWednesday, December 16th, 2009
After a brief lull due to capital budget freezes and uncertainty around the specifics of the HITECH Act, there appears to be real progress in the adoption of Electronic Health Records (EHRs) and Revenue Cycle Management (RCM) systems.
A combination of HITECH money, an increasing number of Pay-for-Performance programs and favorable financing options from IT vendors is driving the adoption of EHRs. And, with a clearer definition of Meaningful Use, even more deals are expected to close.
Our network reports an obvious increase in deals in Q4; activity that is expected to continue to ramp up through late Q1 and into early Q2 as pressure increases to be online by the 2011 deadline.
So, has this activity got legs or is it a one-time spike for the major players – MDRX, QSII, MCK, ATHN? Too early to say, frankly, but of these names ATHN appears best positioned to sustain growth with a best-of-breed RCM product and a market focus that includes sectors such as large physicians’ groups that do not directly benefit from the stimulus plan.
Tags: EMR, Healthcare IT
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Let the genomics revolution continue…
pgresearchTuesday, December 1st, 2009
After delays and speculation over the release of more stimulus money for genomics research, the National Institute of General Medical Sciences/NIH granted $42.3 million to 14 research teams last week. http://bit.ly/4OtM5U
Up until this announcement, most experts in the next-generation sequencing space had been underwhelmed by the support received by labs. They expected a lot more funding to be made available in 2010, and this has been manifested in these Grand Opportunity grants. While this is definitely a win for the research industry, there are still questions from those in the sequencing space of how much money will actually be invested in a technology that has yet to prove a significant ROI. Pharmaceutical companies, especially with their tighter research budgets, are gun-shy after being burned from their investments in microarray and genomics technologies. But for the long-term thinkers, there is no doubt that the sequencing and gene expression platforms from ILMN, LIFE, Roche, and other up-and-coming companies will transform biomedical research and personalized medicine.
With most of the business coming from research labs, and with an unprecedented amount of grant writing observed by the PGR network, all the major players in the sequencing and gene expression space are expected to benefit from the stimulus funding. In addition to research labs, small biotechs and services companies that recognize the power of these tools are popping up and will reap the rewards as DNA, RNA, and protein analysis becomes a ubiquitous practice in developing diagnostics and drug development. In a time when pharmaceutical and hospital spending is down, the research arm is where the future lies.
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After EMRs, what’s next?
Allison HsiehFriday, October 30th, 2009
Signs are pointing to an economic recovery in the healthcare sector. PGR’s network of hospital administrators and purchasing executives indicate that capital budget freezes, while not at normal levels, have loosened up a bit. Evidence of this is best seen, if anywhere, in the allocation of funding for Electronic Medical Record (EMR) platforms, which is a direct result of the stimulus plan that was approved earlier this year. With Q2 revenue numbers in for players like QSII and MDRX, it looks like hospitals and physician practices are progressing nicely into the information age.
Now that purchases and implementation are underway, what’s next? Patient records will be electronic, but there is a plethora of data that needs to be integrated into these EMRs, as well. Imaging data, pacemaker readings, pathology diagnoses, and diagnostics results are just a few of the areas that will need to be seamlessly entered into a patient’s record. So, manufacturers of these devices and equipment are ramping up to develop the technologies to bring this data online.
It is too early to tell if this will be a game-changing differentiator for certain manufacturers, but they are certainly hoping so, especially in more mature markets. A good example is in the implantable cardiac defibrillator (ICD) market, where the three main players have come out with remote monitoring capabilities of these devices, which can sync with a hospital’s EMR platform. In an effort to minimize medical costs, CMS is encouraging remote monitoring practices by reimbursing for a higher amount, versus monitoring a patient through an office visit. Each manufacturer has a remote monitoring technology that works with different devices and can speak to an EMR platform with varying ease, but as doctors transition to this practice, this may influence their preference for a given manufacturer. Regardless, device and equipment manufacturers must stay on top of the technology from the IT perspective to avoid drowning in the wave of EMRs.
Tags: Healthcare IT; EMR;
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Would you vaccinate your son against HPV?
Allison HsiehThursday, September 10th, 2009
Vaccines for Sexually Transmitted Diseases (STDs) are tricky. But it is a business that Merck and GlaxoSmithKline have invested significant capital, and assumedly expect a large return. Merck’s Gardasil has been on the market for about 3 years and targets four strains of human papillomavirus that are linked to cervical cancer. While it is currently approved for girls and women aged 9 to 26, the FDA recommended approval this week for boys and men of the same age range.
It is interesting to see how much impact this potential label expansion will have. Earlier this year, Merck lowered its revenue projections for 2009 to $1.1 billion and the company is scrambling to grow a market that seems to have reached a threshold. While the company may still be pushing for mandated vaccination, they have reached most of the girls that will likely be vaccinated. The >$300 cost in this economic environment probably does not help the matter either. In addition, the public may be weary of a vaccine that does not yet have long-term data and may have hidden side effects.
When it comes to boys, will parents choose to vaccinate them? Is the risk of genital warts high enough to warrant such an expensive vaccine? Merck is a marketing powerhouse, but preventing genital warts conveys a very different sentiment than preventing cervical cancer. The high cost and lack of long-term data are still issues. Competition from GlaxoSmithKline’s Cervarix will also present a challenge. For these reasons, I think it will be very difficult for Merck to capitalize on a label expansion for boys, especially relative to the amount they invested to carry out these studies and to go through the approval process. Time will tell if they are able to work some magic.
Tags: Gardasil, HPV Vaccine, Merck
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Vertebroplasty: A Procedure Not for the Masses
Allison HsiehWednesday, August 19th, 2009
The Wall Street Journal recently reported on a study published in the NEJM that showed no clinical benefit from vertebroplasty versus placebo. How much impact will it really have? Unlike Vioxx or Tysabri, it’s not like the procedure has been shown to cause harm or adverse events among patients. There is no risk of it being pulled from the market, and the major spine companies (Depuy/JNJ, Synthes, Medtronic/Kyphon) will still be permitted to market the technology. Surgeons and patients will testify to the benefits it provides for the pain associated with vertebral compression fractures, regardless of what the study showed. In the current environment, though, the focus is on eliminating unnecessary healthcare costs. If vertebroplasty is not shown to provide a medical benefit in a study like this, should Medicare pay for it?
Many cast doubt on the accuracy of the study. The sample size was too small, patient selection was biased, measurement of pain cannot be accurate… When it comes down to it, a definitive study that accounts for these errors will need to be conducted before drastic cuts in reimbursement are likely to be taken. That said, the attention the study has garnered will likely make surgeons think twice before choosing vertebroplasty for a patient.
A comparison can be made between this situation and the ENHANCE study that came out in January 2008. When the ENHANCE study was released showing that Vytorin was no more effective than simvastatin monotherapy, the same questions surfaced. What would happen to Vytorin’s formulary status and reimbursement? The PGR network indicated that the status would likely remain unchanged, but the biggest impact would be from a decrease in the number of new prescriptions written for the drug.
In the same way, the PGR network indicates that the number of vertebroplasty and kyphoplasty procedures will likely go down, regardless of reimbursement cuts. Physicians will be more careful when choosing patients for the procedure (some patient types do really benefit), especially given the increased scrutiny that comes with a procedure that they may be financially incentivized to do. While companies were once able to get away with marketing their products to the masses, they do not want to be hit with independent studies such as this. The shift is towards defining the patient profile more accurately and taking a more personalized approach to medicine. How this will play out is still a big question, but it will start with more narrowly defined patient populations in clinical studies and an increased emphasis on pharmacogenomics.
Tags: medical devices, spine, vertebroplasty
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The State of R&D: Pharma, Biotech, CRO’s
Allison HsiehFriday, July 31st, 2009
The whole is greater than the sum of its parts - unless you’re talking about the pharma industry. Evidence of the industry’s deconstruction are everywhere, as pharma companies struggle to increase efficiencies and cut costs. Gone are the days when R&D, manufacturing, clinical trials, and sales/marketing were all done under one roof. Instead, companies are realizing the economies of scale that come with specialized services that do one thing. Outsourcing to these companies is on the rise. Will this outsourcing wave eventually cycle back to a wave of consolidation? Possibly. But one thing at a time…
We are in the golden age of the Contract Research Organization (CRO), as the role of companies like Covance, Charles River Laboratories, and WuXi in China becomes more concrete. The breadth of work being sent to CRO’s is expanding, as primary chemistry, synthesis, and purification are being outsourced, among other assays. In addition, as pharma companies are forced to reduce headcount, the talent pool is ripe for the picking from qualified scientists who know what pharma companies need. CRO’s are also benefiting from the divestiture of pharma’s research labs, as exemplified by Covance’s acquisition of research labs from Merck and Lilly in the past year and the ensuing research contracts that were signed. The future of the industry is becoming clearer.
Where does biotech fit into all of this? They are still a source of compounds for in-licensing by big pharma - particularly when large resources are needed for their development. In other words, pharma is still the sugar daddy of the industry. Everyone is more cost conscious, though, and many biotech companies have figured out the benefits of outsourcing the majority of their R&D and preclinical work. The trend is likely to continue, again to the benefit of CRO’s.
Tags: biotech, contract research organizations, pharma
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Physician data mining should be legit in the information age
pgresearchMonday, June 22nd, 2009
IMS is fighting a law prohibiting the collection of prescribing data from physicians in New Hampshire, Vermont, and potentially a host of other states. (BusinessWeek Article) The law, which takes effect July 1 in Vermont, is being appealed by IMS this Tuesday, June 23. While timely with the current debates on healthcare reform, these laws do not address any core issue related to the country’s healthcare problems.
You can blame any number of inefficiencies in the healthcare system on medical error, lack of preventative care, antiquated medical record keeping, uninsured patients, etc. An obvious scapegoat is the pharmaceutical companies, as well - who, while spending billions of dollars on marketing their drugs, do, ultimately, provide therapeutics that improve the lives of many. But wait. This is not an issue of whether or not pharmaceutical marketing strategies are economically efficient practices. It is a question of whether or not companies like IMS and SDI should be able to aggregate this data and sell it to customers, like pharmaceutical companies.
If access to physician prescribing data is cut off, I see a few ways (off the top of my head) that pharmaceutical companies will get around it - because assuredly, they will find a way:
1) Pharma companies may throw more money at the system in order to gain mindshare among a less-targeted pool of prospective physician prescribers and patients (hire more sales people - whose jobs are now more difficult than ever, increase direct-to-consumer advertising, boost marketing activity at conferences, host events to build brand loyalty, etc.)
2) While IMS has an opt-out strategy, what about market research organizations who recruit an army of physicians to opt in to provide this data? A number of physicians would like to protect their privacy, but I would think just as many - if not more - would be okay providing this information, especially if they were a) compensated for it and/or b) given the opportunity to try new or competitive therapeutics that were not on their radar. Pharma companies would pay top dollar for a replacement for IMS, if it were no longer available.
By restricting the collection of this information, it does not getting to the root of the problem. Pharmaceutical marketing teams will still find a way to influence physician prescribing habits and will spend the money because it results in higher sales. For example, generic competition is definitely putting pressure on the pharma space, but in addition to sales force downsizing, we hear about companies cutting back on R&D and halting some clinical trials in order to focus their resources on activities that will turn a more near-term profit. Based on this, marketing would be the last to go. This is not a sustainable solution.
The data provided by organizations like IMS is valuable and should be available for marketing teams to optimize their strategy. If the concern is that healthcare costs are driven up because of this data, the problems that need to be addressed are physician decision-making or marketing practices, not access to third-party information providers.
Tags: IMS Health, Pharmaceutical Marketing
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