The market for products worldwide in the management of diabetes is the subject of an analysis done by MMD at the end of 2005. While a plethora of studies are available on markets for diabetes-related products, our analysis succeeds uniquely by looking at both established and developing technologies with a more critical eye and doing so in a global analysis.
Worldwide Diabetes Market 2004
Insulin therapy devices
This $24 billion global market — big enough as it stands — represents only the tip of the potential market iceberg, for several important reasons.For the majority of Type 2 diabetes, the adult onset segment, is an undiagnosed, untreated population
A huge pent-up demand exists for improved treatment due to the need for frequent testing (finger pricks) and insulin administrations (pen/syringe)
A huge payer demand exists for effective treatment (read high patient compliance) that reduces the incidence of costly complications
Advancements in diagnosis OR treatment that lead to (pick one) improved quality of life or reduced rate of complication leading to even a modest increase in the penetration of the Type 2 undiagnosed will be a huge boon to the market
So, the technologies being pursued with aggressive energy include:
closed loop pump/monitor systems (“artificial pancreas”)
stem cells (“cure”)
It is very diffiicult to discern between those analyses of the diabetes market that are largely driven by spreadsheet formulas and those that both grind out the hard numbers and apply real insight to determine the defensible timing and impact of technology developments.
Our intention and our belief is that our hard work has produced the latter.
News came out last week (published in Lancet) on the successes achieved by well-known researcher Dr. Anthony Atala, professor at the Wake Forest Institute of Regenerative Medicine, in the development of pediatric bladders engineered from patients’ own cells. The development of bioengineered organs, which faces many technological hurdles but also holds tremendous promise, was part of our report, Tissue Engineering, Cell Therapy and Transplantation, published in 2005. There is lengthy waiting lists for organs of all types, and even those patients who are lucky enough to receive transplanted organs are then faced with the ongoing requirement to take immunosuppressive drugs to prevent rejection.Dr. Atala envisaged the solution, but was stymied in bringing it to reality and is only now, after some 16 years of research, succeeding in being able to harvest the right patient cells, culture them ex vivo to grow from one million cells to 1.5 billion cells, apply them to a protein scaffold and reimplant them back in the patients.
Dr. Atala is on the Board of Directors for Tengion (http://www.tengion.com), a company developing the technology. From Tengion’s website:
Tengionâ€™s technology of creating a neo-organ, such as a neo-bladder, starts when a surgeon sends the patient’s biopsy to Tengion. Tengion’s scientists identify and multiply the patient’s own healthy progenitor cells, and then place these cells on a structure that is shaped like the needed organ or tissue (a bioresorbable scaffold). The resulting neo-organ becomes ready for implantation after a period of maturation. The surgeon then implants the neo-organ in the patient’s body, where it integrates with the rest of the body and becomes functional. By contrast, the current therapy for urinary bladder reconstruction, Augmentation Cystoplasty, dates from the 1890â€™s and is associated with acute and chronic risks and complications.
Organ replacements are a ripe area of development in the field of tissue engineering and cell therapy (again, see our report). The intrinsic value of bioengineering tissues/organs from the patient’s own cells is unquestioned, given the organ shortages, the need for immunosuppressants and other constrains of organ donation, as noted.What makes Dr. Atala’s success noteworthy is that tissue engineering of this type is among the most promising of medical technologies insofar as its ability to dramatically change treatment options for serious diseases. The initial tissue engineering successes were limited to less complex anatomical structures, such as skin, but has been expanded to include bone, cardiac tissue and other tissues with more complex functional and structural roles. Moreover, Dr. Atala’s work is like the “rising tide that floats all boats,” in that the process of isolating the appropriate cell types, optimizing their conditions for growth and applying them to scaffolds or matrices to form the transplantable organ structures can be replicated by researchers focused on other organ types.
Am I the only one who gets frustrated when finding that most references to “technology” are limited only to discussions of computers? I know it’s a combination of the investment industry (which in this respect seems remarkably lazy) seeking to simplify the world so that it can post prognostications without using many words . . . “technology stocks are up on positive news from Microsoft.”But for the love of Thomas Edison, technology isn’t only computers! It’s bridges, medical devices, rockets, medical devices, automobiles, medical devices…
What are you going to get more excited about, a piece of hardware that can ultimately only handle or transfer information in some unique way, or a medical device that saves a life or even just dramatically improves it?
People innately don’t undestand medicine and they can’t be faulted for it. At the same time, it is inherenly in the interest of physicians to mystify the science. Instead of saying, “your child is bleeding from the lungs and we don’t know why,” they say, “your child has a confirmed diagnosis of idiopathic pediatriac pulmonary hemorrhage” as if by their multisyllabic discourse they have gotten a firm handle on the problem.
But there is good information out there, and it’s getting better just as the healthcare consumer is yearning for it. Now, I’m pretty healthcare savvy, but when people call me up and ask what I think of some obscure symptom, I suggest (after telling them to call their DOCTOR) they take a look at WebMD. As for sites that are less, consumer-oriented, I like sites like MedGadget, for the fact that the site’s authors are (apparently) a group of young MDs and that this leads them to a youthful enthusiasm for new stuff, even an appreciation of the technologies’ missteps (see Patently Silly which I came across awhile back and recently saw on MedGadget’s site) and others. If you’re in the medical product industry, however, I absolutely have to recommend my own site, MedMarket Diligence.
We’re working on finalizing this report. It shouldn’t be a surprise to anyone who has looked at the nanotech “industry” over the past couple years (we did a report three years ago) that it is the most hyped, promise-filled industry that has kept forestalling investors and any other interested parties from seeing concrete successes. Producing a report on this subject that achieves even the least resemblance to realistic timelines or realizable potential demands a diligent, critical eye to filter out the unlikely-to-ever-be-fulfilled potential.
Having said that, even the most conservative analyst would have to look at this industry and recognize that, REVENUES ASIDE, the industry is exploding with activity. The number of companies pursuing applications in nanotech and MEMS is huge. When you then distill the content down to focus only on those in the medical arena, the numbers are still huge.
There is revenue, too, and it is growing steadily toward that hockey stick upward shot that will take place, well, I’m not saying yet… We’re still applying our analysis and tracking multiple technologies approaching the launch pad.
* * *
Micro- and Nano-Medicine: Technologies, Applications, Industry, and Markets Worldwide
Â· 250 pagesÂ· 45 ExhibitsÂ· 72 Company ProfilesÂ· Pub. Date April 2006Â· Report #T625
The Report will be a detailed assessment of the products and technologies under development in the nanometer scale and micrometer scale levels with clinical applications, and an assessment of the market potential for products/technologies to be successfully commercialized for use in clinical practice within a ten year forecast period. This assessment will identify the technological, market, regulatory or other hurdles to be crossed en route to commercialization. The report will provide particular emphasis in detailing the current activities and status of product development at active companies. The analysis will be directed toward revealing specific opportunities for current or hopeful competitors.
In my previous post, I went generous and added the startups I planned to include in our March publication. I hav subsequently realized I was being too generous, as I keep finding out that many people in the medical product industry are clamoring for new technology/ideas, but (partly because of the interest) the small medical technology companies are increasingly inclined toward stealth. SOOO, it behooves me to try to recoup the costs I have incurrent in my hard-earned effort at ferretting out these little company gems. So, I’ve published a compilation of the startups I have identified who have been founded from January 2005 to March 2006.As good readers of this blog (sigh), I will be more than happy to reward you with occasional free listings of those companies.
See the new Startup report/listing described here.
Normally, I would not do this (add subscription content to this blog), but I thought I would drop a list of some new companies (from my Startups table in MedMarkets that I publish every month). Here are the ones from the upcoming March issue. For reference, my goal is to find companies that have been founded in the past month (not when they say they were founded, but when their corporate filings were done — a harsher measure of how “new” they are). Sometimes I’ll go a little farther back and publish on companies who have done an exceptional job at staying in stealth mode, but who have suddenly become apparent to me. If they are new to me (I am constantly looking), then maybe my customers haven’t heard of them either.
Aragon Surgical, Inc.
Palo Alto, CA
Surgical device platform designed to reduce OR time
Jean Paul Rasschaert
Minimally invasive device to prevent strokes in atrial fibrillation
John Dunning, President
Santa Fe, NM
Undisclosed device for treatment of a variety of diseases
Device for facilitating corneal transplantation
John Krusinski, President & CEO
Liquid crystal sensor for bacteria and viruses
Transtimulation Research, Inc.
Oklahoma City, OK
Intestinal pacing for obesity
Aragon Surgical, LLC â€” Palo Alto, CA; no URL EpiTeK, Inc. â€” Pittsburgh, PA; http://epitek.com (under construction) i25Tech, Inc. â€” Santa Fe, NM; http://i25tech.com (under construction) Keramed, Inc. â€” Cupertino, CA; http://keramed.com (under construction) Oringen, LLC â€” Tallmadge, OH; no URL Transtimulation Research Inc. â€” Oklahoma City, OK; no URL
In the healthcare arena, I keep finding it amazing how so many technologies that are different in so many ways are changing the definitions of what constitutes a medical device. I came across this article on cartilage paste in March issue of Arthroscopy: Journal of Arthroscopyâ€“Related Surgery. Now, while this is not a new technology, it does represent the kind of marriage of technologies that happens frequently these days in the medical field. I then came across details of a Tallmadge, OH, company called Oringen, which has licensed a technology (from Northeastern Ohio Universities College of Medicine and Kent State University) to be developed into a liquid crystal sensor for detection of bacteria and viruses (Pathogen Detection Systems of Boulder, Colorado, has also licensed the technology).I am not an obligatory cheerleader for technology, because I really do believe that in the U.S. we have spent far too much on healthcare without it producing the intended or necessary improvements in quality of life. Too frequently, “innovations” have just resulted in higher premiums for us all. However, when you consider the steady progression of materials technologies, nanotechnologies, cell/tissue engineering technologies, the development of drug/device hybrids and other technologies, it becomes difficult to imagine a clinical problem that isn’t destined to be solved by medical technology. This may be wildly optimistic and ignore the lessons of history, but this sense of optimism is the driving force (that, and its associated commercial success!) behind the great diversity of medical technologies being pursued in different applications.
In a final move that seemed (at least in the eyes of some industry analysts) as likely to be designed to increase J&J‘s price tag for the acquisition of Guidant as it was an actual competitive bid, Boston Scientific had this month upped its bid to $27 billion ($80 per share), and when the midnight (January 24) deadline passed without J&J responding with another offer, it now appears likely that the winner in this bidding war will be Boston Scientific. Guidant has accepted Boston Scientific’s offer and terminated the agreement to be acquired by J&J. For its part, J&J issued a statement saying, “it had determed not to increase its last offer for Guidant Corp., because to do so would not have been in the best interest of its shareholders.”Confidence is high in the likelihood of BSX making a success of this, given the related deal with Abbott (to acquire Guidant’s vascular business), the fit with Boston Scientific and, at least in general, the relative value of the acquisition price tag and the Guidant revenue streams and balance sheets. But one has to give pause to this and consider several points:
J&J is as experienced in acquisitions as any monolith out there and it viewed the $27B price tag as too high. Do they know something that BSX doesn’t?
BSX and J&J have been bitter rivals in the DES market and one can’t help but wonder if the rivalry hasn’t clouded BSX’s judgment, making this little more than a pyrrhic victory for BSX. A loss for J&J does not equate with a win for BSX.
The combined BSX/GDT business now has $12 billion in debt, a hefty burden that can only be lightened by market performance (oh yes, see “Guidant Defibrillator Recalls”).
It’s very hard not to think back to the Time/Warner acquistion of AOL, and in that case Time/Warner did not have a competitor who balked at the value of the deal, and we all know how well the AOL acquisition worked for T/W.