Size and Growth of Tissue Engineering and Cell Therapy in the U.S., Europe, Asia/Pacific and Rest of World

The global market for tissue engineering and cell therapy products is set to more than quadruple from 2009 to 2018. Products in cell therapy and tissue engineering include includes bioengineered products that are themselves cells or are actively stimulating cell growth or regeneration, products that often represent a combination of biotechnology, medical device and pharmaceutical technologies.

The largest segment in the overall market for regenerative medicine technologies and products comprises orthopedic applications. Other key sectors are cardiac and vascular disease, neurological diseases, diabetes, inflammatory diseases and dental decay and injury.

Factors that are expected to influence this market and its explosive growth include political forces, government funding, clinical trial results, fluctuating industry investment and an increasing awareness among both physicians and the general public of the accessibility of cell therapies for medical applications. The reversal of the U.S. government's ban on federal funding for embryonic stem cell research has given researchers sponsored with federal funding increased access to additional lines of embryonic stem cells. This is expected to result in an increase in the number of research projects being conducted and thus possibly hasten the commercialization of certain products.

Another factor that has influenced the advancement of regenerative technologies is found in China, where the Chinese government has encouraged and sponsored cutting-edge (and some have complained ethically questionable) research. While China’s Ministry of Health has since (in May 2009) established a policy requiring proof of safety and efficacy studies for all gene and stem cell therapies, the fact remains that this research in China has spurred the advancement of (or at least awareness of) newer applications and capabilities of gene and stem cell therapy in medicine.

Meanwhile, tighter regulatory environments in other areas of Asia (particularly Japan) will serve to temper the overall growth of commercialized tissue and cell therapy–based products in that region. Nonetheless, the growth rate in the Asia/Pacific region is expected to be a healthy 20%.

Meanwhile, growth rates in Europe and other areas outside the United States and Asia/Pacific (rest of world or ROW) are expected to be roughly to growth of the market in Asia. This reflects the fact that European and developing market regulatory requirements allow products to be commercialized more rapidly in those regions. While the rate of growth in the United States for this time period is expected to be slower, this is only due to its larger size and its position ahead of other markets on the classic market growth curve.  Nonetheless, some in Europe worry that research in the United States will accelerate at a more rapid pace now that U.S. researchers have access to additional lines of stem cells. The fear is that this will allow development in regenerative medicine technologies to threaten an eclipse of the gains made in Europe in the past several years.

See Report #S520.

Companies currently marketing cell therapy and tissue engineering in cancer

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.

Source: MedMarket Diligence, LLC; Report #S520.

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.

New Approach to Angiogenesis for Tissue Engineered Bypass

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:

See New Method To Grow Arteries Could Lead To ‘Biological Bypass’ For Heart Disease:

"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.

Posted via email from medmarket’s posterous

Development challenges in cell and tissue engineered products

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.

Orthopedic and skin tissue/cell therapy developments

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
  • Bioregeneration matrix
  • 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
  • Orthopedic applications (bone fractures, degenerative joint cartilage, damaged intervertebral discs)
  • Orthopedic regenerative medicine biomaterials
  • Orthopedic scaffolds
  • Osteoarthritis pain relief
  • Personalized orthopedic stem cell therapy
  • Regeneration of myoblasts; stem cells to replace cartilage, bone
  • Regenerative medicine (glial cells, cardiomyocytes, islets, chondrocytes, osteoblasts, hepatocytes)
  • Regenerative stem cell transplantation
  • Scaffold for human tissue regeneration in the lab
  • Scaffold for spinal bone regeneration
  • Scaffold-free living cartilage implant for knee applications
  • Testing a genetically engineered human protein in patients with moderate to severe low back pain
  • Tissue regeneration for reconstructive, soft and hard tissue

Skin / Integumentary cell/tissue select technologies in development:

  • Allogeneic adult stem cells, protein therapeutics, gene silencing for wound ulcers and other applications
  • Amino acid peptide for diabetic foot ulcer healing
  • Artificial epidermis
  • Biomaterial for wound healing and tissue regeneration
  • Cell therapy for scar reduction
  • Cellular implants for the regeneration of damaged skin (aesthetics)
  • Genetically engineered biomaterials for wounds and other applications
  • Lyphoderm human keratinocytes for chronic wounds
  • Osteoarthritis pain relief
  • Regenerative stem cell transplantation
  • Stem cells to replace skin cells (substitute skin)
  • Therapeutic for wound closure
  • Tissue reinforcement and repair

Source: Report #S520, MedMarket Diligence, LLC

Cardiovascular and vascular cell therapy and tissue engineering

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
  • Myocardial Infarction
  • 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:

3DM Inc., Aastrom Bioscience Inc., Advanced Cell Technology, Inc., AdvanSource Biomaterials, Aldagen, Inc., Angioblast Systems, Inc., Angiotech Pharmaceuticals, Inc., Arteriocyte Medical Systems, Inc., Athersys, Inc., Baxter International Inc., BeFutur Biotechnologies, Bio Nova International, Bioheart Inc., California Stem Cell Inc., Capstone Therapeutics, CellSeed, Inc., Cook Group, CryoLife, Inc., Cytograft Tissue Engineering, Cytori Therapeutics Inc., ES Cell International, Garnet BioTherapeutics, Genzyme Corporation, Geron Corporation, Humacyte, Kensey Nash, Medtronic, Mesoblast Limited, MG Biotherapeutics, LLC, Miltenyi Biotec, NellOne Therapeutics, Inc., Organovo, Osiris Therapeutics Inc., Pluristem Therapeutics, Inc., ReNeuron Ltd., Stem Cell Therapy International, Inc. / Histostem, Targeted Genetics Corporation, Tepha Inc., and TriStem Corporation

See "Tissue Engineering, Cell Therapy & Transplantation Worldwide, 2009-2018." Report #S520.

Orthopedics and Skin/Integumentary with most clinical applications in tissue engineering and cell therapy

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."

Cell Therapy and Advances in Vascular Medicine

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,  “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.

 From link 

More than a dozen companies have cell therapy products on the market for treatment of cardiovascular and vascular diseases.  (See Report #S520 from MedMarket Diligence.)  Many more have products actively in development at the preclinical and clinical stage, with products nearing U.S. and European approval.

Report: Worldwide Tissue Engineering & Cell Therapy Market at $6.9 billion

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

Source: MedMarket Diligence, LLC, Report #S520

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.

Big Business in Cell Therapy & Tissue Engineering

The global market for products in cell therapy and tissue engineering has ballooned from a nascent market only a few years ago to big business, currently pushing almost $7 billion annually.

Source: Report #S520

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."