Orthopedic Biomaterial Bone Graft Market To Increase With Stem Cell Therapy Market Growth
By Dr. Kamran Zamanian, Brett McKitterick, and Dylan Freeze, iData Research Inc.
Stem cells derived from embryonic sources have a high degree of therapeutic potential because such immature cells have not yet undergone differentiation: the process of maturation. There are many ethical issues involved with human embryonic stem cell research, despite the regenerative benefits of this form of therapy.
Embryonic stem cell research has only begun to take shape over the past decade. This is in large part due to the long product development times associated with stem cells. The only products currently available in the market consist of mesenchymal stem cells. Within the U.S. orthopedic biomaterials market, research and product development have focused on bone marrow, stem cells, bone graft substitutes, growth factor bone grafts, platelet-rich plasma, hyaluronic acid, cartilage repair, and spinal machined bone allografts.
The Market Impact Of Stem Cell Bone Grafts
One of the applications of stem cell grafts is its use in the spine. The high average selling price associated with stem cell grafts is well accepted in the spine market due to its commercialized nature. Both the U.S. lumbar and cervical stem cell graft markets are projected to grow at double digit growth rates through 2021. Bone grafts, in general, replicate a scaffold for cells to grow onto, thus signaling bone growth from autogenous tissue, and enabling the graft itself to generate new bone.
Historically, autograft procedures have been the usual treatment for bone replacement, but unfortunately, this technique requires a second incision, resulting in greater pain, increased surgical time, and greater overall cost. Due to the great regenerative potential of stem cell bone grafts, they have become the standard for which graft substitutes are compared. Furthermore, stem cell bone grafts have no possibility of rejection or infection from foreign tissue.
When substituting an autograft, a demineralized bone matrix (DBM) or a synthetic graft may be used. Other options are bone grafts combined with recombinant growth factors, or bone grafts that provide viable stem cells. There is a great deal of interest in the use of stem cell grafts, where new products and innovations will likely fuel procedure growth for stem cells — especially as they start being used in procedures throughout the rest of the body.
Orthopedic Bone Graft Substitute Market Growth By Segment
Regaining Growth In the Bone Substitutes Market
The bone graft substitute market has been shifting away from allograft usage to more lucrative DBM and synthetic grafts. Part of the shift towards DBM and synthetic grafts has been due to the decline in the popularity of Medtronic’s growth factor bone graft product, Infuse.
In some cases, cell therapy may be used in conjunction with bone grafts for improved bone growth. Nevertheless, the trend in the cell therapies market is trending toward injections for soft tissue treatments like ligament repair. This is partially the reason why the growth of DBM, synthetic, and stem cell graft markets has been so strong over the past three years. The demineralized bone graft market has begun to trend towards commoditization as it becomes more difficult for manufacturers to determine novel uses for their products. With the rise in popularity of orthopedic cell therapy products, total surgical costs have increased, forcing a necessary decrease in bone graft prices. Despite the core issues associated with Infuse, the market is expected to regain growth by 2017.
Market Potential Of Stem Cell Bone Grafts
The fastest growing segments in the U.S. orthopedic biomaterials market are the stem cell bone graft and concentrated bone marrow markets. Though DBM and synthetics have improved in effectiveness, stem cell grafts are seeing the greatest growth within the orthopedic biomaterial bone graft market. This is in large part due to the fact that stem cells offer the greatest regenerative potential for healing bone.
The stem cell graft market is expected to continue to grow as surgeons realize the regenerative potential of stem cells and their great ability to aid bone repair. The higher average selling price (ASP) of stem cells over bone graft substitutes and growth factor grafts contributes to the market size, but it is their therapeutic potential that will fuel market growth the most.
The stem cell bone graft market is currently experiencing a shift away from autograft and allograft procedures. The potential of demineralized bone matrix, synthetic, and stem cell grafts for greater bone repair has brought these grafts to the forefront of the bone graft market. Once research and development costs have been recouped and prices fall, there may be further market growth if surgeons find other applicable uses for stem cell grafts.
Currently, stem cell grafts are only considered for use in spinal fusion. However, because of the potency of stem cells to be cultured into any tissue type, they offer the therapeutic potential to replace any tissue type without the need of a donor. The great range of possible applications for this regenerative “technology” will continue to generate strong interest for future product development.
Effects Of Cell Therapy In The Bone Graft Market
Orthopedic cell therapy products include platelet-rich plasma and bone marrow concentrate products which are used with bone grafts to provide growth factors or stem cells. Their complementary use with bone grafts is one of the main reasons why DBM and synthetic bone grafts have increased their market share, despite the decline in popularity of Infuse.
Platelets can provide improved osteoinductive characteristics to a bone graft, since they are able to release growth factors. Bone marrow concentrate, on the other hand, contains stem cells, and the process of concentrating them can be an extremely effective method of providing osteogenic properties to a bone graft.
As of 2014, the orthopedic cell therapy market was composed of the platelet-rich plasma and bone marrow concentration segments. The platelet-rich plasma market encompassed over 63 percent of the cell therapies market. However, the bone marrow concentration market is projected to grow much faster for the foreseeable future. In 2014, unit growth rose by over 16 percent. It is expected that by 2021, the platelet-rich plasma market will only hold a 55 percent share of the market.
Market growth can be attributed to the attractive average selling price compared to its alternative. The combined price of bone marrow concentrate and a DBM graft is approximately $2,500, while stem cell grafts are priced at $3,700.
It is commonly seen that new, innovative products that enter nearly any cell therapy market will be more expensive than existing therapies. This is especially true of bone grafts, because any potential entrant to the market will be compared to Infuse, or any other bone grafts that incorporate bone marrow concentrate or platelet-rich plasma.
Market Competition And Barriers
Currently, there is no direct competition for growth factor grafts, but there is plenty of external competition from demineralized, synthetic, and stem cell graft products. Growth in these markets will also face a potential inflection point, as it remains to be seen how much of the market will choose to return to or to adopt Infuse as a safe and efficacious product.
The platelet-rich plasma market has experienced rapid price decreases in response to competition generated from Arthrex’s release of their low-cost ACP system. Unlike allografts and DBM’s, where a portion of the final cost is used to recover the expense of processing donated material, synthetics generally have a lower value for cost of goods sold. This is also reflected in the lower barrier to entry for the synthetic portion of the market, which has more competitors in comparison to the allograft and DBM markets.
Competitors and their product lines competing in the stem cell bone graft market include NuVasive’s Osteocel, Orthofix’s Trinity, Biomet’s Cellentra, Allosource’s Allostem, and RTI’s map3. Indirect competition for the bone graft substitute market mainly comes from bone morphogenic proteins (BMPs). The motion preservation device market, which aims to stabilize the spine without vertebral fusion, also competes with the bone graft substitute market. The lack of direct competition will limit pricing pressures from within the market. This is to the advantage of competitors in recovering the large initial cost of development. In the case of Medtronic, the cost of developing Infuse was estimated to be between $550 million and $600 million.
The limited number of players in the bone graft substitute market is in large part due to the costly and lengthy FDA approval process. Perhaps as further precedents are set, more clinical evidence is made available, and the FDA becomes more accustomed to dealing with stem cell products, the approval process will be streamlined. Once entry barriers are overcome, there appears to be tremendous therapeutic and marketing potential to be had, and it is this vehicle that will likely drive bone graft substitute market growth for years to come.
For More Information
The information contained in this article is taken from a detailed and comprehensive report published by iData Research Inc. (www.idataresearch.com) entitled U.S. Orthopedic Biomaterials Market — 2015. For more information and a free synopsis of the above report, please contact iData Research at info@idataresearch.net.
iData Research is an international market research and consulting firm focused on providing market intelligence for the medical device, dental, and pharmaceutical industries.
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