Cancer is a significant opportunity for the development of tissue engineering and cell therapies, but it is more than just an opportunity currently, since many companies are active and the market for cancer cell/tissue therapies already stands at nearly $500 million.
Currently, OSI Pharmaceuticals has a commanding lead in this area, with its Tarceva being used for pancreatic and non-small cell lung carcinoma. Overall, the market is controlled by a limited number of players, but many others are in development.
The MedMarket Diligence report #S520, "Worldwide Tissue Engineering, Cell Therapy and Transplantation Market, 2009-2018", covers the developments, products, technologies, markets and companies active in the area of cell therapies and tissue engineering for cancer. Cancer types covered are the full range encompassing urology, neurology, Ob/Gyn, orthopedic/bone, gastrointestinal/gastroenterology, head & neck, hemotopoietic, and respiratory.
There are countless disorders, diseases, trauma and other conditions of the human body that can be addressed, in principle, by cellular and tissue-based solutions. These may be due to damage to cells and tissues, such as in burn wounds, skin ulcers, bone fractures and defects and similar conditions in which cell/tissue structure (e.g., skin, bone) is damaged or diseased. These may also be diseases in which more complex cellular function is at the root, like the insulin-producing islet cells of the pancreas are damaged or destroyed as in diabetes. And these may also be diseases in which specifically-induced cell and tissue growth may simply “bypass” the disease’s effects, such as in the stimulated growth of new blood vessels (“angiogenesis”) to literally bypass occluded arteries in ischemic heart disease:
The use of growth factors for angiogenesis has been under evaluation and development for some time. However, in the April 2010 issue of “Journal of Clinical Investigation”, researchers at Yale School of Medicine report on a new method to simply influence a naturally occurring signaling pathway that otherwise inhibits the growth of new blood vessels:
"Successfully growing new arteries could provide a biological option for patients facing bypass surgery," said lead author of the study Michael Simons, M.D., chief of the Section of Cardiology at Yale School of Medicine.
In the past, researchers used growth factors – proteins that stimulate the growth of cells – to grow new arteries, but this method was unsuccessful. Simons and his team studied mice and zebrafish to see if they could simulate arterial formation by switching on and off two signaling pathways – ERK1/2 and P13K.
"We found that there is a cross-talk between the two signaling pathways. One half of the signaling pathway inhibits the other. When we inhibit this mechanism, we are able to grow arteries," said Simons. "Instead of using growth factors, we stopped the inhibitor mechanism by using a drug that targets a particular enzyme called P13-kinase inhibitor."
"Because we’ve located this inhibitory pathway, it opens the possibility of developing a new class of medication to grow new arteries," Simons added. "The next step is to test this finding in a human clinical trial."
Cell therapy and tissue engineering is a broad category of disciplines focused on solving conditions with the involvement, or stimulated growth of, cells and tissues. See Report #S520 from MedMarket Diligence, LLC.
The biggest hurdle remaining to the creation of viable, commercialized embryonic or adult stem cells is to develop the ability to differentiate cells into various types of cells and to determine how these differentiated cells behave when cultivated in large numbers in the laboratory. In many cases, researchers are still uncertain whether the cells retain their characteristics over time or if they will degenerate into a different or earlier version of a cell. For instance, it is unknown whether stem cells halt differentiation upon intravenous administration or if they will continue to differentiate as designed. While isolated instances of successful regeneration or repair have been reported, the task remains to replicate these successful therapies on a large scale.
Researchers have come to realize that cells cannot simply be laid out in a designed pattern and expected to grow into functional tissue. This is because the cells need specific structural, mechanical and chemical cues to guide cell morphology, migration and proliferation, to regulate cell differentiation, and to modulate cellular processes.
Research and development in this field is expensive; the burn rate is frequently $25 million–$40 million per year, with years of research and testing required before market launch, if indeed that is ever achieved. More than one company has had to declare bankruptcy and either close the doors for good, or reorganize and attempt to find additional funding (Advanced Tissue Sciences, Algenix, Artecel, Cell Based Delivery, to name a few), or sell its assets to another company before making its big breakthrough.
Once a technological breakthrough has been achieved, the company then faces the costs and uncertainties associated with regulatory hurdles, primarily clinical testing. If and when the clinical trials proceed with positive results and market launch appears possible, then the company needs to hire and train a sales force, or must make the strategic decision to give away part of the potential winnings by forming an alliance with a medical device or pharmaceutical company that has the sales network already in place. Also, before launch, the company must prepare to gear up its manufacturing capabilities, again meeting stringent good manufacturing requirements as required in the country of manufacture. Other tasks yet to be completed include acquisition of resources, acquisition of regulatory marketing approval.
From "Tissue Engineering, Cell Therapy and Transplantation, 2009-2018", February 2010; Report #S520.
With the initial markets for cell therapy and tissue engineering being best represented by clinical applications in orthopedics and skin/integumentary, a sampling of technologies at various states of development within each is worth considering for insights into likely near-term market impact.
Below are select technologies under development by companies in cell therapy and tissue engineering. While these are not approved, many are well along in the development/approval process, plus many of the companies developing them already have products on the market.
Orthopedic cell/tissue select technologies in development:
3-D cell growth matrix
Adult-derived stem cell therapies identified to improve the outcomes of cardiac, orthopedic and vascular surgeries
Anterior cruciate ligament repair
Autologous cartilage regeneration system
Autologous disc-derived chondrocyte transplantation for herniated discs
Bone and tissue cellular matrix (dental, ortho filler)
Bone graft augmentation
Bone repair cells for bone regeneration
Cartilage regeneration, tissue reinforcement and repair
Cellular implants for the regeneration of damaged or sick orthopedic tissues
Developing stem cell therapies for bone and joint disease
Engineered tissue graft for cartilage
Growth factor for osteoarthritis in knee
Human cartilage grown from adult stem cells
Identified potential applications in biomaterial bone grafts
Injectable for degenerative disc disease
Investigating marrow and other system for orthopedic applications including spinal fusion
Material for anterior cruciate ligament repair, scaffolds for rotator cuff tendon repair
In the medical technology arena, the markets that draw the most attention (i.e., investment) are those that have historically had the biggest successes (i.e., revenues) due to their ability to have big impact on clinical outcomes.
Therefore, a clinical field beginning to draw much "attention" is in applications of cell therapy and tissue engineering for a range of disorders and conditions in cardiology and vascular medicine, based on these areas having driven much investment/revenue historically.
Cardiovascular and vascular applications of cell/tissue engineering encompass treatments for:
Coronary Heart Disease
Congestive Heart Failure
Dysfunctional Heart Valves
Peripheral Vascular Disorders
Abdominal Aortic Aneurysm
Many companies have active initiatives in the development of cardiovascular and vascular cell therapies and tissue engineering, with products at the various stages of developmental/preclinical, clinical and even a handful of approved/marketed. These include:
The use of autologous, allogeneic and xenogeneic cells and tissues, the use of biomaterials, cell scaffolding and other approaches to tissue repair and regeneration has become part of arsenal of a number of clinical specialties, with high caseload and market revenue in these areas. In particular, orthopedics and skin applications are well established. And, while caseload in these areas grows to include more patients and patient types, the applications of cell therapies and tissue engineering are proliferating in use for diseases and conditions throughout a spectrum of clinical areas.
See the map below reflecting targeted applications of cell therapy and tissue engineering (click for larger version).
See Report #S520, "Tissue Engineering, Cell Therapy and Transplantation, 2009-2018."
The advances in the understanding and management of vascular — and cardiovascular — diseases over the past 50 years now empower cardiologists and other specialists with many options to achieve target outcomes. A succinct chapter, Â “Cell Therapy for Cardiovascular Disease” in the book, “Advances in Vascular Medicine”, highlights cell therapy’s growing role:
Advances in diagnosis and treatment have dramatically impacted morbidity and mortality from cardiovascular disease over the past several decades.1 The discovery in 1960 of stem cells capable of regeneration and repair sparked interest in a new mode of therapy for heart disease beyond pharmaceuticals and cardiac devices.2 Over the past 10 years, work has focused on five key cell types – the endothelial mononuclear progenitor cell, the autologous skeletal myoblast, the allogeneic mesenchymal stem cell, the resident cardiac stem cell, and the human embryonic stem cell – as potential therapeutic agents, which may further contribute to gains in treating cardiovascular disease. This chapter aims to review these cell types, their preclinical underpinnings, the nascent clinical studies, and limitations observed in their use.
More than a dozen companies have cell therapy products on the market for treatment of cardiovascular and vascular diseases. Â (SeeÂ Report #S520Â from MedMarket Diligence.) Â Many more have products actively in development at the preclinical and clinical stage, with products nearing U.S. and European approval.
Our research into the products, technologies, companies and markets for tissue engineering and cell therapy has revealed that the 2009 market was at $6.9 billion. The market has grown dramatically, in commercialized products and company activity, over the past few years and is on an accelerated growth rate as technology hurdles are overcome and clinical acceptance is gained in a wide range of applications spanning cardiology, neurology, orthpedics/musculoskeletal/spine, urology, skin/integumentary, dental/oral, organ replacement and preservation, ophthalmology, general/gastroenterology/gynecology, cancer and cord blood & cell banking.
Worldwide Tissue Engineering & Cell Therapy Market, by Segment, 2009
The report, described at link, details the activities, products and markets for these applications represented by almost 150 active companies. The report may be purchased for download at link. Until February 28, 2010, we're offering 10% off the purchase price of this report. Just order the report online and on checkout enter the coupon code "1266865321" to receive the 10% discount.
There are many well established medtech market competitors active in cell therapy and tissue engineering, including Medtronic, Baxter, Zimmer, Stryker, and Genzyme, but there are also a slew of of other participants with products on the market and in clinical trials. As is evident from the above, the predominant applications are in orthopedics, skin, cardiology and cancer, but aggressive growth is taking place in the other, emerging applications.
The market is developing through the progressive adoption of cell therapy and tissue engineering approaches to disease management in clinical applications globally. A predominance of the market is in the U.S. and Europe, but as the market evolves, the share of revenues from other markets is increasing.
See Report #S520 (publishing February 2010), "Worldwide Cell Therapy & Tissue Engineering Markets, 20098-2018."
The number of companies with approved products and measurable revenues in the field of cell therapy and tissue engineering has exceeded the expectation of many (though not all) in the industry.
Markets such as cell/tissue are often characterized by overestimated evaluations of commercial potential and underestimated consideration of the actual challenges. Indeed many technology challenges remain to be overcome if any significant portion of the purported potential of tissue engineering or cell therapy (in particular) is to be realized. Nonetheless, our estimate of only a few years ago (which were considered optimistic by some and conservative by others) has been eclipsed by the reality of substantial market growth, with 2009 revenues in cell therapy and tissue engineering at nearly $7 billion.
Source: Â In process (draft) projections by MedMarket Diligence, LLC; Report #S520.