Tissue engineering and cell therapy market

Stem cell therapy has the potential to treat a broad range of acute and chronic degenerative diseases. These applications include: hematopoietic cells for blood diseases and cancer, myocardial and endothelial vascular tissue for cardiovascular disease, congestive heart failure, myocardial infarction and other cardiovascular disease skin cells for dermatological conditions, retinal pigment epithelium cells as treatment for macular degeneration and retinal pigmentosis, neural cells for spinal cord injury, Parkinson's disease and other neurodegenerative diseases, pancreatic islet ß cells for diabetes, liver cells for hepatitis and cirrhosis, cartilage cells for arthritis, and lung cells for a variety of pulmonary diseases. As populations age in developed countries, the need to treat increasing numbers of people with these disorders is likewise increasing.

With increased attention being paid to the need for these technologies, researchers have been reporting promising results in several areas.

In results reported in 2009, scientists from MIT found that stem cells can improve stem cells’ ability to regenerate vascular tissue by equipping them with genes that produce extra growth factors. These results were produced in mice; specially developed nanoparticles were used to deliver vascular endothelial growth factor to stem cells removed from the mouses’ bone marrow. The enhanced stem cells were then implanted into damaged tissue, where they regenerated blood vessles near the injury, thus allowing the damaged tissue to survive.

Other results reported in 2009 (Proceedings of the National Academy of Sciences, September 2009) showed researchers have had some success in engineering human tissue patches for cardiovascular repair. These clinicians (from the University of Washington, led by Dr. Charles Murry) created disk-shaped patches measuring less than a millimeter up to a half-inch in diameter decided to examine the possibility of creating new tissue with supply lines for oxygen and nutrients needed by living cells. Previously, heart tissue patches composed of only heart muscle cells could not grow big enough or survive long enough to adhere to the heart once implanted. Researchers added to the heart muscle cell mixture two other types of cells similar to those inside blood vessels and cells that provide vascular muscular support. All of the heart muscle cells were derived from embryonic stem cells or a variety of more mature sources such as umbilical cord blood. The result was seen in the formation of tissue containing tiny blood vessels.

On the orthopedic front, adult stem cells were used to regrow a 14-year-old boy’s missing cheekbones at the Cincinnati Children’s Hospital Medical Center. The technique used reengineered autologous stem cells.

In another example, scientists at the University of Bristol developed new scaffolds that can be used to grow such tissues as skin, nerves and cartilage. They built the scaffolds by using proteins from alpha helices to create long fibers (hydrogelating self-assembling fibers or hydrogels).

Unmet Clinical Needs

Allotransplantation (the transplanting of donated organs or tissues from a cadaver or a living donor) works effectively but has a couple of significant drawbacks. First, the number of organs available for donation is always far smaller than the number of organs and tissues needed by patients. According to the U.S. Department of Health and Human Services, there were more than 102,000 people in the United States alone waiting for donated organs in 2007; many of those on the waiting list die before a suitable organ or tissue becomes available. Secondly, even when an organ becomes available, organ transplant is a very expensive procedure. In addition, if the procedure is successful, the transplant recipient may often need to take immunosuppressive drugs, sometimes for life. Yet another factor in the equation is the cost of keeping patients alive while awaiting a donor, or caring for them until they die if no donor is found.  

One solution to this would be to use genetically designed pigs, animals whose organs would present minimal immunologic reaction to the host. Such animals (the pig is often cited because most of its internal organs are similar to human organs) could potentially present an unlimited supply of organs for donation to and implantation in humans. 

Designing a genetically engineered pig that is capable of carrying human immune proteins has been the focus of select researchers at the Shanghai Institute of Biochemistry and Cell Biology. Results published in 2009 in the Journal of Molecular Cell Biology showed how the scientists successfully reprogrammed pig skin and bone marrow cells into an embryo-like state with the potential to form every type of body tissue. The successful creation of pig pluripotent stem cells would enable engineering of transgenic animals for organ transplantation purposes. The embryonic or induced stem cellscould be used to modify the immune-related genes in the pig to make the pig’s organs compatible to the human immune system, thus allowing the pigs to be used as organ donors without triggering an adverse reaction from the patient’s own immune system.

Another solution would be, of course, tissue engineering and cell therapy. There are hundreds of companies working in the field of tissue engineering, expanding the procedures, devices, cell-based products, biomaterial-based products and other products for the repair and regeneration of damaged tissues.

See the current (2011) market for tissue engineering and cell therapy by area of clinical focus.

Source: MedMarket Diligence, LLC; Report #S520, "Tissue Engineering, Cell Therapy and Transplantation: Products, Technologies & Market Opportunities, Worldwide, 2009-2018."

 

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Spine surgery largely unfazed by recent market challenges

Few medical device markets have demonstrated the kind of staying power — prices, procedure growth, market growth — shown by spine surgical technologies.  The swelling caseload of new patients, the persistent clinical need and the stream of innovations from manufacturers in this arena have enabled growth rates that have not recently been seen in most other device markets.

Of course, the market has been pinched by insurer pushback on some procedures (e.g., fusion when degenerative disc disease is involved), price pressures on some established devices and, in the U.S., regulatory reform that is long in coming.

A definite kind of demand inelasticity exists in spine disorders and trauma that has enabled it to be an area in which manufacturers have been able to succeed despite the capital restrictions and recessionary forces that have plagued markets since at least 2008.

Spine surgery technologies are comprised of the following discrete segments:

  • Posterior Pedicle Screw Fusion Systems
  • Anterior Cervical Plate Systems
  • Anterior Thoracolumbar Plate Systems
  • Anterior Lumbar Interbody Fusion (ALIF) devices
  • Transforaminal Lumbar Interbody Fusion (TLIF) devices
  • Posterior Lumbar Interbody Fusion (PLIF) devices
  • Axial Lumbar Interbody Fusion (AxiaLIF) devices
  • Interspinous Process Spacer (ISP)
  • Cervical Artificial Discs
  • Lumbar Artificial Discs
  • Vertebroplasty
  • Balloon Kyphoplasty
  • Allografts
  • Demineralized Bone Matrix (DBM)
  • Bone Morphogenetic Proteins (BMPs)

Below is an exhibit (drawn from the 2011 MedMarket Diligence worldwide report on spine surgery) illustrating the different growth in spine surgery technology segments.

Source: MedMarket Diligence Report #M520.

Posterior pedicle screw fusion systems currently represent the largest share of the global spine technology market, a dominance that will persist through the forecast period based on its large established base. However, as is evident in the uptake of new spine technologies, there is ample opportunity for participants in all but a few sectors that are declining in absolute or relative terms.

Allograft market segments in worldwide orthopedic biomaterials market

Allografts are the main “traditional” orthopaedic biomaterials. This market segment includes bone allografts (fresh, or freeze-dried bone; also demineralized bone) and soft-tissue allografts, including cartilage, tendons and meniscus.

segment-allograft-growthThe global market for all allografts in 2006 is estimated at $1.5 billion, with bone allografts contributing half of that, soft-tissue allografts $500 million, and demineralized bone the remaining $250 million. The segment size and growth are shown at right..

Growth in the allograft market to 2011 will show a doubling in the ligament and cartilage segments, even greater growth in meniscus, but relatively slow growth in bone allografts. The reason for the anticipated surge in soft-tissue allografts is the increasing demand for repair procedures related to growth in more active lifestyles among affluent younger people. Bone allografts, by contrast, face increasing competition from synthetic bone substitutes and there is a continuing shortage of donor material.


Data is drawn from MedMarket Diligence report #M625, "Emerging Trends, Technologies and Opportunities in the Markets for Orthopedic Biomaterials, Worldwide."

 

Orthopedic biomaterials market growth strongest in U.S.

Growth in the U.S. market for orthopedic biomaterials is expected to be somewhat faster than in Europe and significantly greater than in the developing world, partly because new biomaterials are relatively expensive and their uptake is related, in general terms, to GDP. Newly-emerging technologies such as bone morphogenetic proteins (BMPs) are expected to grow at rates up to 30-35% per annum during the forecast period (2007-2011), although their contribution to the overall orthopaedic biomaterials market will be relatively modest, since they are starting from a small base. Overall, the U.S. market for orthopaedic biomaterials is expected to grow by approximately 12% per annum over the next five years.

The U.S. market is the best-documented of the world’s regional markets for orthopaedic biomaterials, and U.S.-specific data are to be found later in this section, under discussions of the market by surgical procedures and classes of biomaterials.

ortho-biomaterials-pie1

Source:  MedMarket Diligence Report #S625.

 

Although the "other" category is the largest category included in this overall market, and has been included because of both "biomaterials" aspect of these technologies and their clinical utility in orthopedic applications, these products are part of the larger market for sealing, adhesion, hemostasis and prevention of post-surgical adhesions.  (The market for these products are addressed separately in the MedMarket Diligence report #S175, "Worldwide Sealants, Glues and Wound Closure, 2009-2013".)

 

 

Orthopedic Biomaterials, Worldwide Market Segmentation

Biomaterial is an abbreviated form of the term biocompatible material, which can be defined as “a synthetic or natural material used to replace part of a living system or to function in intimate contact with living tissue”. Biomaterials are intended to interface with biological systems; they may be viable or non-viable. Artificial hips, vascular stents, artificial pacemakers and catheters are all made from different biomaterials.

The category of biomaterials now generally includes biomimetic materials – synthetic constructs with compositions and properties similar to biological materials. Calcium hydroxyapatite, used as a coating on artificial hips, is a typical example; it is used as a bone replacement and facilitates attachment of an implant to living bone. The term “orthopaedic biomaterials” applies, clearly, to biomaterials used to replace, augment, heal or otherwise enhance the function of bone which is damaged or deficient as a result of disease or trauma.

The orthopaedic biomaterials field is like a cake that can be cut in various ways; for example by the types of materials used, the different structures involved, and by the clinical uses to which they are put. And of course the business of orthopaedic biomaterials can involve analysis of the market (actual and potential) and of the industry which supplies these materials and the devices of which they are made.  Segmentation of the orthopedic biomaterials market can be made as follows:

  • Bone
  • Polymers
  • Ceramics
  • Other Orthopedic Biomaterials
    • Growth Factors
    • Surgical Sealants and Glues
    • Tissue Engineering

 

Below is the geographic segmentation of the worldwide market for orthopedic biomaterials (drawn from Report #M625):

 
The current valuation of the orthopaedic biomaterials segment is around $5 billion, representing over 17% of the orthopaedic total. It is also estimated that this market segment will grow at over 13% per year, which is more than double the rate for the overall orthopaedics market. At this rate the biomaterials segment will achieve a value of $9.4 billion by 2011 and will represent 28% of all orthopaedic product sales.

 


Drawn from “Emerging Trends, Technologies and Opportunities in the Markets for Orthopedic Biomaterials, Worldwide,” report #M625. This report may be purchased online or via Google Checkout, below. 
 

























Spine fusion companies, by technology

Surgeons performing instrumented spinal fusion procedures implant various configurations of plates, rods, screws, cages, and other medical hardware to stabilize the spine and facilitate proper vertebral bone fusion. These fixation systems can be implanted via anterior (from the front) or posterior (from the back) approaches, depending on the clinical indication. Most fusion systems are made of carbon fiber, titanium, titanium alloy, or PEEK (polyetheretherketone), are “low-profile” in that they are efficiently trim, and are designed to resist screw pull-out or other kinds of component detachment, slippage or accordion-like collapse into other vertebrae. The fusion systems are also designed for ease of implantation and adjustment, and often allow the surgeon to customize the assembly and screw tensions during surgery. These systems are generally classified as standard or traditional instrumentation, interbody fusion devices (IBFDs) or structural allograft implants.

Fusion Device Companies

Source:  MedMarket Diligence, LLC; Report #M510, “Spine Surgery Worldwide, 2008-2017: Products, Technologies, Markets and Opportunities.”  Published March 2008.  See link for details.  Available for purchase Online.