Commercial success in tissue engineering, cell therapy and transplantation

Tissue engineering involves taking either autologous, allogeneic or xenogeneic cells and redirecting those cells to carry out fundamental processes. Often the researcher will use a biomaterial matrix and seed the cells into this matrix. The redirection may take the form of stimulating the cells to become stem cells or precursor cells, or it may mean genetic modification of those cells. The processes which may be carried out seem almost infinite in variety: from regenerating heart muscle cells (myocytes) damaged from a heart attack, to regrowing islet cells to answer the body’s need for insulin and glucose regulation, to regrowing a thumb, including bone, cartilage, vasculature and skin. According to current industry and academic research, the potential exists to cure neurological and immunological disorders such as Parkinson’s, multiple sclerosis, and many cancers; to regrow most or all of an organ that has been damaged through disease or trauma, including the kidney, liver, intestine, bone, skin and pancreas; to take a cell sample from a patient and grow it into a new tooth bud which can be transplanted into the patient’s jaw to replace a missing tooth; and to grow blood vessels for use in coronary artery bypass graft, thereby avoiding the surgical process and pain inherent in harvesting the saphenous vein. It seems that tissue engineering and cell therapy may find applications in every system in the body.

At least 250 companies in the US, Europe and the Far East are working in tissue engineering and regenerative medicine. The larger pharmaceutical and medical device companies have initially been cautious about investing in and/or developing tissue engineering therapeutics, but a consensus recognizes that a full consideration of the device or drug industry's competitive landscape is incomplete if not factoring the possibilities of tissue engineered or cell therapy solutions.

tissue-pieThe US alone spends nearly $35 billion annually to care for patients with end stage organ failure. The alternatives are basically organ transplant, living on indefinite hold with an organ substitute such as kidney dialysis, if such a substitute exists, or death. According to the United Network for Organ Sharing (UNOS), at any one time in the US there are some 80,000 people waiting for donated organs, many of whom die before a suitable organ or tissue becomes available. If a suitable organ can be procured, the transplant procedure itself is very expensive, and not always successful. If it succeeds and the organ functions as intended, then the patient usually must take expensive immuno-suppressive drugs for life. Physicians and researchers have long sought other means to treat these patients, and tissue engineering is one avenue of significant promise.

The major areas of clinical need for alternative treatments are generally also those areas most attractive to companies, which must ultimately recoup their heavy research and development investments. These areas include cardiology, neurology, orthopedics, urology, skin, dental and organ replacement and regeneration.

Research and development in tissue engineering and cell therapy have been accelerating, which has led to a steady stream of commercial developments, including product launches.  The existing market therefore already stands at over $500 million and the growth curve on the markets for these technologies does not appear to be leveling soon, with compound annual growth rates for the aggregate of tissue/cell therapy markets exceeding 20%.

The global market for tissue engineering, cell therapy and tissue/organ transplantation is the subject of pending report #S520, from MedMarket Diligence.

Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018

Publishing a new report in December 2009:  Tissue Engineering, Cell Therapy and Transplantation:

Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018.

This report examines the status of technologies, applications and markets for tissue engineering, cell therapy and tissue/cell transplantation. The report reviews therapeutic tissue engineering, tissue reconstruction, cell therapies, tissue/organ transplantation and related technologies under various stages of development at over 150 companies. The report details the technology development, projected market introduction dates and/or current and forecast market size and competitor shares for products being developed to address major causes of death and disease spanning applications in cardiovascular, neurological, orthopaedic, urological, skin, dental, ophthalmological, gastroointestinal, organ transplant, cancer and others. The report details the status of product development and assesses the current and forecast worldwide market for tissue engineering, cell therapy and transplantation.

The report provides market size and share data, with forecast market data to 2018, for the U.S., Europe, Asia/Pacific and Rest of World.

The report establishes the current worldwide market size for major technology segments as a baseline for and projecting growth in the market over a ten-year forecast and assesses and projects the composition of the market as technologies gain or lose relative market performance over this period. 

The report is described, with preliminary table of contents, at link.

Pace of investment in medical technology: up, down, static

The level of investment in medical technology has been erratic of late, with July and August financings each totaling in excess of $400 million, while October financings barely crossed $200 million (and would have been much less if not for a $40 million by Direct Flow Medical and $55 million by TransEnterix).  See the trend.  

November medtech financings have gotten off to a good start (at almost $200 million by mid-month), but short of a pre-Thanksgiving holiday venture capital investment surge (would that there was such a thing), total venture capital funding to medtech will likely hit the flat trend of around $300 million. The biggest fundings include the following:

  • $30M, Fate Therapeutics, Inc., has raised $30 million in a Series B financing (induced pluripotent stem cell technology platform)
  • $30M, Entellus Medical, Inc., has raised $30 million in a series D funding (less invasive treatment of sinusits)
  • $27M, Spinal Modulation, Inc., has raised $27.4 million in a Series C financing (therapeutic devices for treatment of chronic pain)
  • $21M, On-Q-ity has raised $21 million in a Series A round (cancer cell detection and testing platform)
  • $16M, Activaero GmbH has raised $16 million in a Series A financing (pulmonary drug delivery device)

Medtech: Where is the opportunity?

The areas of greatest opportunity in medtech are those which have already demonstrated they have plenty of upside, even if a robust number of competitors have already begun targeting them.

Areas of the strongest market growth in medical technologies that we are seeing have emerged out of the major segments we have tracked in recent analyses.  These fall into the following areas:

  • Coronary Stents.  The area of highest growth is the emerging segment of bioabsorbable stents.  These target the goal of having a lower profile in their impact on the body and are hoped to have the best anti-restenosis performance of stents. Bare metal stents (unless they are designed as per Palmaz, if his premise holds up), will simply see declines. Report
  • Wound Management.  The biggest growth areas in this market are in foam dressings, the use of physical therapies (e.g., negative pressure wound therapy) and the use of growth factors.  Even some relatively novel wound dressing types (film dressings, hydrogels, non-adherents, anti-microbials) are on a relative basis just not showing much growth. Report
  • Sealants/Glues/Wound Closure.  Fibrin sealants, high-strength medical adhesives (cyanoacrylates to some degree but more importantly bio-based glues) and anti-adhesion products are on a path of high sustained growth as these products make a real impact in managing surgical and traumatic wounds.  Sutures and staples, ironically, would be in faster decline if it weren't for the growth in the adjunctive use of sealants/glues on suture/staple lines to ensure tight closure. Report
  • Ablation Technologies.  Nearly every segment of ablation technologies are showing strong, double-digit annual growth. These include microwave, thermal, cryogenic, radiofrequency (RF), and ultrasonic.  There is lesser growth in hydromechanical, laser, electrosurgery/electrocautery and radiation therapy systems for ablation. Report
  • Spine Surgery.  Traditional spine surgery, in terms of fusion (without dynamic stabilization) is taking a serious hit as products like annulus repair, nucleus replacement, interspinous process spacers and total disc replacement offer better outcomes.  Vertebroplasty had hinted at having great promise until lackluster, even poor, reults at trials deflated the hopes of developers. Report

If not otherwise mentioned, those medtech segments that demonstrate, with laser clarity, benefits associated with lowered cost, improved outcomes from a long-term perspective and minimal invasiveness will likewise fall into the category of growth markets and opportunity.

Tissue engineering and cell therapy now more commercial than academic

Over a hundred active companies.

One of the avenues of tremendous therapeutic potential is tissue engineering and cell therapy.  Admittedly, these two disciplines cover a great deal of ground and even individually are represented by many different scientific methods.  Still, their successes draw from common scientific threads, which have seen many advances in yielding potential applications that have converted to successful clinical applications.  So many therapeutic benefits are to varying degrees already within our grasp, or about to be so.  (Contrast this with gene therapy, a discipline of enormous potential, but still disappointingly distant.) Tissue engineered skin, urinary bladders and more structures are offering therapeutic solutions where previously there was either none or just greatly compromised quality of life. Medicine is increasing developing along lines that leverage the latent power of the human body to regenerate and heal.  

MedMarket Diligence is undertaking a review of tissue engineering and cell therapy companies.  When we last provided an analysis of the status of technologies and applications, back in 2005, we highlighted a striking number of companies, a good share of which were more academic than commercial.  But now, even with our more critical view yielding a smaller number of active companies, we find a very strong industry, with many approvals, pending approvals and technologies with outstanding near-term potential.

Below, find a list of our preliminarily identified active tissue engineering and cell therapy companies:

3DM Inc., Aastrom Bioscience Inc., Acorda Therapeutics Inc., Advanced Cell Technology, Inc., Advanced Medical Solutions PLC, AdvanSource Biomaterials, Aeolus Pharmaceuticals, Alexion Pharmaceuticals, Angiotech Pharmaceuticals, Inc., Ariad Pharmaceuticals Inc., Avax Technologies Inc., Avita Medical Limited, Baxter International Inc., BD Biosciences, BeFutur Biotechnologies, Biocomposites, Biocoral Inc., Bioheart Inc., BioHybrid Technologies, BioLife Solutions Inc., Biomet, Inc., BioMimetic Pharmaceuticals, Bio Nova International, BioSyntech, BioTissue Technologies GmbH, Bio-Vascular Inc., Bose Corporation, Boston Scientific Corporation, BrainStorm Cell Therapeutics, Inc., Breonics Perfusion Technologies, Inc., BTG International Ltd, California Stem Cells Inc., Capstone Therapeutics, Celgene Corporation, CellECT Bio Inc., Cell Genesys Inc., CellSeed, Inc., CellTran Ltd., Cerco Medical, Chiron, Chromos Molecular Systems, Inc., co.don AG, ConMed Linvatec Biomaterials, Inc., Cook Group, CorCell, Inc., Cryo-Cell International, Inc., CryoLife, Inc., Curis Inc., Cyclacel Pharmaceuticals, Inc., Cytograft Tissue Engineering, Cytomatrix LLC, Cytori Therapeutics Inc., ES Cell International, Exactech, Inc., Excorp Medical, Inc., FibroGen, Inc., Fidia Advanced Biopolymers, Forticell Bioscience, Inc., Gamida Cell Ltd., Garnet BioTherapeutics, Genta, Inc., Genetix Ltd, Genetix Pharmaceuticals Inc., GenVec, Inc., Genzyme Corporation, Genzyme Biosurgery, Genzyme Oncology, Geron Corporation, HemoCleanse, Inc., HepaLife Technologies, Inc., Hospira, Inion Ltd, Innogenetics, InnovaCell Biotechnologie GmbH, Integra LifeSciences Inc., Interface Biologics Inc., ISTO Technologies Inc., Ixion Biotechnology Inc., Johnson & Johnson Inc. (Ethicon, DePuy), Kensey Nash, Keratec, LifebankUSA, LifeCell Inc., LifeStem Inc. (Calba Tech, Inc.), Living Cell Technologies Ltd., Lonza Group Ltd., MacroPore Biosurgery Inc., MaxCyte, Medtronic, MG Biotherapeutics, LLC, MicroIslet Inc., Musculoskeletal Transplant Foundation, Natural Implant, NeuroGeneration, Inc., NeuroNova AB, Neurotech, Novartis International AG, Novocell Inc., Novo Nordisk A/B, OncoMed Pharmaceuticals, Organogenesis Inc., Ortho Biotech, Orthovita, OSI Pharmaceuticals, Osiris Therapeutics Inc., Osteotech, Pioneer Surgical Technologies, Polyganics BV, Poly-Med, Inc., Protein Polymer Technologies Inc., Progenitor Cell Therapy Inc., ProNeuron Biotechnologies, Inc., ReGen Biologics Inc., RTI Biologics, Inc., ReInnervate Ltd., ReNeuron Ltd., Revivicor, Inc., Sanofi-Aventis, Sciperio Inc., Selective Genetics, Sernova Corp., Smith & Nephew Ltd., Stem Cell Pharma Inc., StemCells Inc., Stem Cell Sciences UK Ltd., StemCell Technologies Inc., Stryker Corporation, Synovis Life Technologies, Inc., Targeted Genetics Corporation, TEI Biosciences Inc., Tepha Inc., Theratechnologies Inc., TiGenix N.V., Tissuemed Ltd., Titan Pharmaceuticals Inc., Tolerrx, Inc., Transition Therapeutics Inc, TriStem Corporation, Vesta Therapeutics, ViaCell, Inc., Vital Therapies, Inc., Vitrolife AB.


The MedMarket Diligence report is pending a preliminary publication date.


UCSF, Osiris start cardiac stem cell study for heart attack

Perhaps in no other market is it more imperative for current competitors to keep their eyes on the horizon than in the market for treatments of coronary artery disease. As I have ranted previously (search "coronary artery disease" on this blog), alternative treatments stretch from device to surgery to biotech and options too difficult to categorize. And the options continue to grow. In the biotech area, cell therapy has moved to human studies:


Researchers at UCSF Medical Center started enrolling patients in an early-stage adult stem cell therapy, developed by Osiris Therapeutics Inc., for first-time heart attack patients. (Continued at link.)


Currently, the majority of coronary artery disease treatments are captured by coronary artery bypass grafting ot angioplasty/stenting. These options are likely to remain the most used for some time, with technology development on both sides (bioabsorbable and other stents versus minimally invasive bypass, etc.), but manufacturers must keep their eyes open as clinical research extends on the horizon into non-surgical or even non-interventional options.

See the MedMarket Diligence report #C245 on "Coronary Stents Worldwide".

Posted via email from medmarket’s posterous


Purchase for download:  Report #C245, "Worldwide Coronary Stents 2009, PDF" — $2,850.00
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Advanced wound management by product type for acute, chronic wounds

In treatment of acute and chronic wounds, the advanced wound technologies developed by manufacturers provide benefits that facilitate healing, minimize infection and provide other benefits toward reduced cost, less pain, faster healing and combinations of these and other benefits. Advanced products in wound care include film dressings, hydrocolloids, foam dressings, alginate dressings, hydrogels, non-adherent dressings, antimicrobial dressings, cleansing and debridement products, tissue engineered products, pharmacological products, (including pain control, antibiotics, growth factors, non-growth factor modulators, gene therapy, and scarring modulators), physical treatments (like pressure devices, hydrotherapy, electrical stimulation, electromagnetic stimulation, ultraviolet therapy, hyperbaric oxygen therapy, mechanically assisted wound closure devices, ultrasound, laser and information systems. Some of these product categories are well established; others are in development.



Source:  MedMarket Diligence, LLC, Report #S247

Many wound management product types have established measurable markets by virtue of both their clinical benefit and the sheer number of patients, such that no one wound management type dominates the market.   This is true for wound management markets in the all countries.  For example, see the distribution, above, of the 2008 advanced wound management market in the U.S., Germany and Japan.  The U.S., of course, dominates the global wound management market, although the aggregate of Western Europe markets (not shown) is growing to represent a market comparable in size to the U.S.

Published September 2009, "Worldwide Wound Management Market, 2008-2017."

Purchase for download: "Wound Management 2009 (PDF)" — $3,250.00
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Transmyocardial revascularization and autologous stem cells

Among the wide range of options that are available or under development for the treatment of coronary artery disease, one that has not drawn a great deal of attention is transmyocardial revascularization (TMR).  In TMR, a laser is use to drill multiple (15-40) millimeter sized channels through the myocardium in order to increase blood flow for patients with angina who may not be good candidates for bypass grafting. 

Two systems have been approved by the FDA for use in the U.S., an Ho:YAG laser system by Cardiogenesis and a CO2 laser system by PLC Medical Systems.

The principal reason that TMR has not drawn much attention, coincident with the small number of FDA approvals, is the lack of good data demonstrating the direct benefit of TMR in relief of angina.  Indeed, some cardiologists suggest that any benefit of TMR in in relief of angina is either due to denervation of the tissue or a placebo effect (Allen et al; Anesthesiology Clin 2008;26:501–519).  However, five-year follow-up data (which take some of the steam out of placebo benefits), suggest that the channeling does indeed increase vascularization and associated benefit in both angina and perfusion.

A paper was presented at the 2009 European Society of Cardiology Congress on the use of PLC Medical Systems’ CO2 TMR laser in conjunction with autologous stem cells.  As described in The Medical News:

This study is designed to examine the safety and feasibility of transplanting stem cells during TMR used in combination with coronary bypass grafting in patients with end-stage heart failure. According to the initial results of the study, this procedure was effective in improving cardiac function, as assessed by echocardiography and magnetic resonance imaging prior to therapy and post surgery, as well as three, six and twelve months afterwards. In addition, the treatment thus far has proven feasible and safe; no intra- or post-operative major adverse cardiac events occurred in the patients enrolled in the study.

The great majority of treatments for ischemic heart disease are alternatively addressed by coronary artery bypass grafting (CABG) or the use of angioplasty, typically with stenting (most often with drug-eluting stents).  TMR represents a unique technology that may, alone or even in combination with CABG or with, as described above, the use of autologous stem cells, provide clinical benefit for a subset of patients whose ischemic heart disease contraindicates CABG or angioplasty/stent alone.

The MedMarket Diligence report #C245 addresses the "Worldwide Market for Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017."


Growth and penetration of drug-eluting, bare metal and absorbable stents

Currently, the market penetration for drug-eluting stent (DES) devices ranges in the neighborhood of 60% (as high as 90% in China) and is growing at more than 7% per year worldwide. By comparison, the worldwide market for all coronary stents is currently growing at nearly 6% while the market for bare metal stents (BMS) is growing at 3% per year. Compounded annually from 2008 to 2017, the market for all coronary stents is growing at 5.3%, DES at 4.4%, and BMS at 1.6%.

The market for fully biodegradable, absorbable stents is not likely to emerge until 2013-2014. Because study results so far have shown the leading absorbable stents to hold great promise in effectively treating atherosclerosis, growth rates are expected to run well into the double-digits, forecast to grow at compounded annual growth rates in the neighborhood for 15%–20% for the first five years or more.

The relatively brief history of coronary artery disease treatment, even including surgical intervention via CABG, has demonstrated that it has a remarkable propensity to evolve in surprising ways.  Surgical intervention, percutaneous intervention, the stent and drug-eluting stent solution to restenosis, the emergence of multiple invasive yet still surgical interventions, drug-coated angioplasty balloons, atherosclerotic plaque-reducing drugs, gene therapy, cell therapy…

The most forward-thinking competitors in the market for coronary artery disease (CAD) treatments have planned obsolescence in mind, whether they wish to or not.

The worldwide coronary stent market, and its larger CAD market, is part of Report #C245 from MedMarket Diligence.


Coronary stent types: drug-eluting, bare metal, others

In our May 2009 report (#C245) entitled, "Worldwide Market for Drug-Eluting, Bare and Other Coronary Stents, 2008-2017," we assess the current state of technology and product development, current and forecast markets, market shares and the manufacturer opportunities for all stent types used in the treatment of coronary artery disease (CAD).

Types of Coronary Stents and Selected Other Anti-Restenosis Devices


 Source: MedMarket Diligence, LLC, Report #C245.

 The report also provides a valuable context for the coronary stent market — the range of non-stent alternatives for treatment of CAD, including open and minimally invasive coronary artery bypass grafting (CABG), drug-eluting balloons, HDL therapy, gene therapy, cell therapy and others.