By Alycea Wood and Kamran Zamanian, Ph.D., iData Research Inc.
When choosing a treatment option for orthopedic procedures, biomaterials have become widely popular. Biomaterials are biomedical materials that can be safely implanted or injected into the body and are, more often than not, a form of biologically active tissue themselves.1 Their prevalence in orthopedic procedures is largely attributed to their ability to mimic the structure or properties of osseous tissue. Many products can offer a number of beneficial properties, such as promoting bone growth within the body (osteoinduction), promoting bone growth on the biomaterials scaffold (osteoconduction), or inducing the differentiation of stem cells into osseous tissue (osteogenesis).2,3 The orthopedic biomaterials market includes bone graft substitutes, growth factors, cellular allografts, cell therapy, hyaluronic acid viscosupplementation, and even cartilage repair devices. The U.S. orthopedic biomaterials market saw a dramatic dip and subsequent rebound in market value in 2020 and 2021 as a result of the COVID-19 pandemic. After recovery, the market is projected to see a consistently steady growth in value within the next few years. This growth is expected to be seen across all market segments apart from cellular allograft devices (Figure 1).4
Figure 1: Orthopedic biomaterials market growth trends by market segment, U.S., 20192028. Access iDatas U.S. Orthopedic Biomaterials report to view more granular data.
Cellular allografts may consist of either allograft bone (donated bone tissue) in conjunction with adipose-derived adult stem cells or viable cells within a cortical cancellous bone matrix.4,5 In both scenarios, the devices provide osteoconduction, osteoinduction, and osteogenesis to the site of implantation. Historically, this market had seen promising growth because of the optimal environment for bone growth they can provide.6 The cellular allograft market is projected to see a much slower rate of growth in market value in the next few years despite its market potential due to increased constraints on the market itself. These include, but are not limited to, direct federal restriction on product research, cost of product development, and product recalls.4
There is a strong interest in the scientific community in embryonic stem cell (ESC) research, which is largely due to ESCs high differentiability when compared to adult stem cell (ASC) lines.7 The development of new cellular allograft products, and the resulting growth in the market, is dependent on continued research into realizing the full medical potential of stem cell use. In 2019, the Trump administration eliminated federal funding of research relying on ESC tissue and instituted the National Institutes of Health (NIH) Human Fetal Tissue Research Ethics Advisory Board. This negatively impacted a large number of studies in progress while restricting the ability of new projects to commence.8,9,10 While the board was in effect, it rejected all but one application for funding.11 In April 2021, the Biden administration removed both the board and the restrictions on current projects, allowing federally funded research using ESC to continue.12 This was not the first instance where restrictions were placed and then removed on ESC research. In March 2009, President Obama signed an executive order to overturn the Bush administrations restriction on ESC research.13
The repeated restrictions on ESC research have a number of long-term ramifications in the development and implementation of new, effective cellular allograft treatments. Scientists may need to divert their research efforts away from stem cells and into less turbulent fields, and the progress of product development slows down as studies have funding pulled; this may contribute to increased hesitancy by end users to use stem cell products. Reduced research efforts, funding, and faith in stem cell products will continue to limit the growth of the cellular allograft market.
Cellular allografts tend to be notably more expensive than others within the broader cell-based biomaterials market. When compared to the cell therapy market, which uses either concentrated platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC) in its treatment, the cellular allograft average selling price (ASP) sits over three times higher (Figure 2).3
Figure 2: The average selling price (ASP) of the cellular allograft & cell therapy markets, U.S., 20182028. Access iDatas U.S. Orthopedic Biomaterials report to view more granular data.
The ASP of the cellular allograft market is so high because of the prohibitively expensive cost of developing new products. During the development process, reliable efficacy of a new product is uncertain, and using protein markers to help distinguish stem cell types can be very challenging.4,14 The increased cost of product development acts as a significant barrier to parties looking to enter the U.S. cellular allograft market. The result is fewer products entering and rejuvenating the market, and existing products sit at prohibitively high prices as they have low direct competition.4 The high cost of cellular allograft products hinders new entrants from introducing products and prevents end users from being able to afford existing ones. A broader consequence of this is end users turning to more affordable orthopedic biomaterial types to reduce procedural costs.
Any product recalls within the U.S. orthopedic biomaterials market, especially within cell-based therapies, will negatively impact the use of cellular allografts. This impact is amplified when a recall occurs within the market segment itself, which was seen in the cellular allograft market as recently as June 2021. On June 2, 2021, Aziyo Biologics recalled its product FiberCel following a number of patients contracting tuberculosis.15 Recalls deter the use of cell-based products through increased distrust in the safety of the products themselves, potential public backlash against the specific product itself or, in the market more broadly, reduced reimbursement from health insurance providers as well as the introduction of more restrictive FDA protocols. This is another reason why effective, safe, cell-based products are necessary for the cellular allograft market to move forward.
Conclusion
Federal research restrictions, high development costs, and product recalls all negatively impact the growth of the cellular allograft market in the United States. These constraints contribute to the projected low growth rate in market value in the coming years despite the potential uses for stem cell therapies. To shift the tide back toward growth, the cellular allograft space will need consistent research progress through large-scale studies, more affordable product development, and strict enforcement of sanitization protocols for existing products to prevent future product recalls. The large therapeutic potential of stem cell therapy has been discussed extensively in scientific and popular literature, but it may take a while to realize it.
References
About The Authors:
Alycea Wood is a research analyst at iData Research. She develops and composes syndicated research projects regarding the medical device industry, and published the U.S. Orthopedic Biomaterials report series.
Kamran Zamanian, Ph.D., is CEO and founding partner of iData Research. He has spent over 20 years working in the market research industry with a dedication to the study of medical devices used in the health of patients all over the globe.
About iData Research
For 16 years, iData Research has been a strong advocate for data-driven decision-making within the global medical device, dental, and pharmaceutical industries. By providing custom research and consulting solutions, iData empowers its clients to trust the source of data and make important strategic decisions with confidence.
Original post:
The Impact Of Market Restrictions On The US Stem Cell Biomaterials Market - Med Device Online
- Overcoming Tendonitis: How Stem Cell Treatments Are Revolutionizing Athlete Rehabilitation - Medical Tourism Magazine - February 21st, 2024
- Unproven Stem Cell Treatments Offer Hope & Risks - Healthline - January 4th, 2023
- Stem Cell or Bone Marrow Transplant Side Effects - American Cancer Society - November 24th, 2022
- Stem cell: $137 million buys more clinical trials, shared labs ... - November 24th, 2022
- Stem Cells Australia | Australian research, stem cell treatments and ... - October 29th, 2022
- What is a Bone Marrow Transplant (Stem Cell Transplant)? - Cancer.Net - October 29th, 2022
- Cameron Mathison Is Undergoing Stem Cell Treatments - October 4th, 2022
- Hiltzik: A judge undermines the FDA on stem cells - Los Angeles Times - October 4th, 2022
- Mesoblast Submits New Information to FDA IND File in Response to Items in the CRL to the Remestemcel-L BLA for SR-aGVHD - GlobeNewswire - October 4th, 2022
- 15 Years of Heart - Newswise - October 4th, 2022
- QC Kinetix (The Heights) Helping Patients Heal Better from Joint Pain Through Houston Heights Sports Medicine - Yahoo Finance - October 4th, 2022
- Sources - Minnesota Timberwolves' Karl-Anthony Towns was on bed rest for days due to throat infection - ESPN - October 4th, 2022
- Innovative spaces and an expert team help Childrens Hospital New Orleans set the standard in cancer care - NOLA.com - September 25th, 2022
- Stem Cell Transplantation: What it Is, Process & Procedure - September 16th, 2022
- New stem cell therapy provides long-term brain protection against ALS - Study Finds - September 8th, 2022
- $150 Million Gift Takes Stem Cell Research to New Heights - University of California San Diego - September 8th, 2022
- Seattle biotech company is the first to receive approval to test B cell gene therapy in humans - GeekWire - September 8th, 2022
- Kite's CAR T-cell Therapy Tecartus Granted European Marketing Authorization for the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia... - September 8th, 2022
- Could Stem-Cell Based Therapy Treat Type-1 Diabetes? A New Study Demonstrates the Treatments Potential - SciTechDaily - August 30th, 2022
- Orchard Therapeutics Announces Multiple Presentations at 2022 SSIEM Annual Symposium Highlighting Neurometabolic Disease Portfolio - GlobeNewswire - August 30th, 2022
- Global Cancer Stem Cells Market Estimated to Reach $1,722.7 Million by 2026 and Grow at 10.3% CAGR in the 2019 to 2026 Timeframe | [180-Pages] Report... - August 22nd, 2022
- Getting a Stem Cell or Bone Marrow Transplant - American Cancer Society - August 14th, 2022
- Stem cell therapy to be used in treatment of long COVID by Panacell Biotech - Labiotech.eu - August 14th, 2022
- Selma Blair 'Stopped Looking in the Mirror' After MS Treatments - TooFab - August 14th, 2022
- ElevateBio Announces the Formation of a New Company With George Daley, M.D., Ph.D., and Boston Childrens Hospital to Develop iPSC-Derived Allogeneic... - August 5th, 2022
- Stem Cells Are Needed To Treat Life-Threatening Diseases - Longevity LIVE - Longevity LIVE - July 19th, 2022
- Stem Cell Hair Transplant: What Is It and When Will It Be Available? - July 11th, 2022
- Stem cell treatments and regulation - a quick guide for consumers - July 11th, 2022
- Tisch Multiple Sclerosis Research Center of New York Study Featured in BioSpace - Business Wire - July 3rd, 2022
- NorthX Biologics expands to Cell Therapy: Partnership with Alder Therapeutics and new manufacturing site on Karolinska campus - GlobeNewswire - June 22nd, 2022
- Japan's five hottest biotech companies in healthcare - Labiotech.eu - June 22nd, 2022
- Sickle cell beta thalassemia: Causes, symptoms, and treatments - Medical News Today - June 22nd, 2022
- Umoja Biopharma Presents Data on its Engineered Induced Pluripotent Stem Cell Platform at the 2022 International Society for Stem Cell Research Annual... - June 22nd, 2022
- Six Things to Know About Stem Cell Treatment - HealthTechZone - May 15th, 2022
- CU Anschutz center for cell-based therapy gets $200 million expansion - The Denver Post - May 15th, 2022
- Differentiation therapy, Hox genes and Abemaciclib Research update 13th May - Brain Tumour Research - May 15th, 2022
- Here's the No. 1 Reason to Buy Vertex Pharmaceuticals Now - The Motley Fool - May 15th, 2022
- To help cope with the world's oldest population, Japan is investing in transplanted iPS stem cells - CBS News - April 19th, 2022
- Stem cell cure for lower back pain is all in the 'hiPS' - Study Finds - April 19th, 2022
- Versant-backed startup launches with plans to broaden cell therapy's reach - BioPharma Dive - April 19th, 2022
- CAR NK-Cell Therapy Is Quickly Growing in Immunotherapy - Targeted Oncology - April 19th, 2022
- Robert Vonderheide Appointed to Second Five-Year Term as Director of the Abramson Cancer Center - U Penn - April 19th, 2022
- Signaling Pathways and Targeted Therapies for Stem Cells in Prostate Cancer - DocWire News - April 19th, 2022
- Is Stem Cell Therapy Right for You? - Health Essentials from Cleveland Clinic - April 6th, 2022
- Cleveland Cord Blood Center and Deverra Therapeutics Announce Agreement - PR Newswire - April 6th, 2022
- Early Treatment Matters More Than Ever in Multiple Myeloma, Kumar Says - AJMC.com Managed Markets Network - April 6th, 2022
- Mesenchymal stem/stromal cell therapy for COVID-19 pneumonia: potential mechanisms, current clinical evidence, and future perspectives - DocWire News - March 25th, 2022
- A Holistic Review on the Current and Future Status of Biology-Driven and Broad-Spectrum Therapeutic Options for Medulloblastoma - Cureus - March 25th, 2022
- Current Strategies and the Potential of CAR T-Cell Therapy in Relapsed and Refractory MCL - AJMC.com Managed Markets Network - March 25th, 2022
- 'I wouldn't be here': Virginia girl, celebrating 11 years in remission, credits St. Jude with saving her life - News 3 WTKR Norfolk - March 25th, 2022
- This weird mouse with a tuft of human hair could be the future of a stem cell treatment for baldness - Boing Boing - January 20th, 2022
- 5 questions facing gene therapy in 2022 - BioPharma Dive - January 20th, 2022
- How Stem Cell and Bone Marrow Transplants Are Used to ... - January 5th, 2022
- The Stem Cell Transplant Process - UChicago Medicine - January 5th, 2022
- Next Chapters: How Northern California blood recipients are doing years after donors helped save their lives - KCRA Sacramento - January 5th, 2022
- Exclusive: Ronnie Coleman on Recent Weight Gain, Current Strength, and Health Progress - BarBend - January 5th, 2022
- Orchard Therapeutics Reports Third Quarter 2021 Financial Results and Highlights Recent ... - KULR-TV - November 8th, 2021
- Managing superficial pyoderma with light therapy - DVM 360 - October 28th, 2021
- New Treatments and Tips for Dealing With Blood Cancer - Curetoday.com - October 28th, 2021
- Orchard Therapeutics Outlines Comprehensive Presence at the - GlobeNewswire - October 16th, 2021
- Taking aim at the brain, Takeda strikes up cell therapy R&D alliance with Immusoft - MedCity News - October 16th, 2021
- FTC Follows Through On Prioritizing Investigations Into False Advertising In Healthcare Markets - Media, Telecoms, IT, Entertainment - United States -... - October 16th, 2021
- FDA Warns About Stem Cell Therapies | FDA - October 5th, 2021
- Anja Health Disrupts Cord Blood Banking with Heartfelt Founding Story and Ground-Breaking Mission - Digital Journal - October 5th, 2021
- Kite's Tecartus is First CAR T Therapy Approved for Adults with B-Cell ALL - Clinical OMICs News - October 5th, 2021
- Prolymphocytic Leukemia: What Is It and How Is It Treated? - Healthline - August 31st, 2021
- Researchers Gaze into Space to Envision Future of Regenerative Medicine - UPMC & Pitt Health Sciences News Blog - UPMC - August 18th, 2021
- Acute Myeloid Leukemia Treatment: What You Need to Know - Healthline - August 18th, 2021
- Study Calls for COVID-19 Vaccination in Patients With Cancer to Enable Optimal Treatment Delivery During Pandemic - OncLive - August 18th, 2021
- A Third Dose of the COVID-19 Vaccine Recommended for Some Cancer Patients With Weakened Immune Systems - On Cancer - Memorial Sloan Kettering - August 18th, 2021
- Stem cells: What they are and what they do - Mayo Clinic - June 6th, 2021
- Stem Cell Therapy for Knee Pain: What Patients Should Know - June 6th, 2021
- Study clarifies the impact of getting old on hematopoietic stem cells - Microbioz India - December 26th, 2020
- Stem Cell Therapy Shows 2-year Benefit for Progressive MS Patients in Phase 1 Trial - Multiple Sclerosis News Today - December 22nd, 2020
- New Combination Therapy Tested By Children's May Offer Hope For Leukemia Patients - WVXU - December 22nd, 2020
- Physio Logic Brings Cutting-edge Regenerative Treatments for Sport Injuries and Arthritis to New York City - PRNewswire - December 22nd, 2020
- For Patients With HMA-Resistant MDS, What Are Their Options? - AJMC.com Managed Markets Network - December 22nd, 2020
- In COVID-19 Clinical Trials, Experts from Baptist Health's Cancer Institutes Treat Patients With Mild or Severe Symptoms - Baptist Health South... - December 22nd, 2020
- SPONSORED: 12 Charities of Christmas - Anthony Nolan - The Courier - December 22nd, 2020
- California's Proposition 14: short in the arm for stem cell research - BioNews - December 14th, 2020