Regenerative medicine is one the fastest emerging fields of medicine, as it adopts stem cells for treatment. Orthopedics is one of the fields of regenerative medicine, which adopts natural healing process by stimulating regeneration of cells in the musculoskeletal system. Moreover, with increasing age or injury, sometimes the optimum amount of stem cells that are needed to maintain the normal function is not delivered to the region. The goal of regenerative medicine is to amplify this natural repair system to keep pace with the demands of the patients.
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Moreover, technological advances in surgical techniques along with the U.S. FDA approvals and launches of new implant materials have revolutionized the field of orthopedic surgery in last few decades. Total joint replacements and the use technologically advanced osteosynthetic implants are some of the examples of orthopedic surgery. Histogen Inc. is one of the manufacturer of orthopedic regenerative medicine and its product Human Extracellular matrix (hECM) is anti-inflammatory, angiogenic, and can stimulate growth of stem cells in damaged areas to induce tissue regeneration. Moreover, it has demonstrated its ability to regenerate mature cartilage and well vascularized bone, indicating great therapeutic potential in sports medicine, spinal disc repair, orthopedic, and dental areas. Other manufacturers operating in the global orthopedic regenerative medicine market include Curasan, Inc., Carmell Therapeutics Corporation, and others.
Global Orthopedic Regenerative Medicine Market Drivers
Leading manufacturers are focused product development in the global orthopedic regenerative medicine market. For instance, Carmell Therapeutics has started a clinical trial and received clearance from the U.S. Food and Drug Administration (U.S. FDA) for Investigational New Drug Application (INDA) in January 2020, for the company’s first product, which is a bone healing accelerant (BHA), (study start date- November 2019 – estimated completion date February 2020). Currently the study is in the phase II of the clinical trials.
Moreover, Personalized Stem Cells, Inc. (“PSC”), a human adipose-derived stem cell company, submitted an Investigational New Drug Application (IND) to the U.S. FDA approval for utilizing patients own adipose-derived stem cells to treat their osteoarthritis. (Study start date – September 2019 – estimated completion date August 2020), currently the trial is in Phase 1.
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Rising prevalence of bone disorders and its impact on the population has been reported world-wide. For instance, according to National Center for Biotechnology Information (NCBI), January 2020, incidence of Achilles tendon rupture in the global population is around 5 to 10 per 100,000 people, and it is expected to increase.
Moreover, over 80% of the ruptures occur during recreational sports and around 10% of patients, who sustain an Achilles tendon rupture had pre-existing Achilles tendon problems. In addition, according to the World Health Organization (WHO) statistics, 2016, rheumatoid arthritis tends to strike during the most productive years of adulthood, between the ages of 20 and 40, and it is a chronic disabling condition that causes pain and deformity. The prevalence of rheumatoid arthritis varies between 0.3% – 1% in the global population and is more common in women and in developed countries. According to the same source, it is estimated that 9.6% of men and 18.0% of women aged over 60 years suffer from symptomatic osteoarthritis globally.
Global Orthopedic Regenerative Medicine Market Restraints
Furthermore, following factors are responsible for restraining the global orthopedic regenerative medicine market growth over the forecast period. New small molecule drugs are launched by market players for the treatment of bone disorders. For instance, the U.S. Food and Drug Administration (U.S. FDA) approved romosozumab (Evenity), in 2019 for the treatment of osteoporosis in postmenopausal women, who are at a high risk of bone fractures. The medicine works by boosting bone formation in women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have not benefited from other types of osteoporosis therapies. Such small molecule drugs are cheaper as compared to the cell therapy process. Therefore, the affordability factor may act as the restraining factor for the global orthopedic regenerative medicine market restraints.
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Moreover, from legal and ethical point of view, research involving human embryonic cells is highly controversial and many countries are reviewing their legislation and application of allogeneic pluripotent cells inheres a distinct oncogenic potential that currently forbids the application in patients and these adult stem cells show differentiation potential to tissues of their origin. This factor is expected to hamper market growth over the forecast period.
Global Orthopedic Regenerative Medicine Market Regional Analysis
North America is expected to hold dominant position in the global orthopedic regenerative medicine market over the forecast period, owing to presence of several manufacturers in North America due to large customer base. For instance, Royal Biologics launched Magnus viable cellular bone matrix in January 2020, which is an osteoconductive bone scaffold and is composed of demineralized cortical, mineralized cortical, and cancellous bone that is stored in a DMSO-free cryoprotectant. The microparticulate bone scaffold size ranges from 100-300 μm and induces simultaneous activity of osteoclasts and osteoblasts, demonstrating rapid healing of bone defects.
Anika Therapeutics, Inc. Conducted a clinical trial (start date – December 2015 and expected completion date – December 2021, currently the trial is in the phase III) for hyalofast, a biodegradable, 3D, hyaluronic acid-based (HA-based) scaffold with autologous bone marrow aspirate concentrate (BMAC). It has been reported from the study that patients, who utilized Hyalofast with BMAC in a one-step arthroscopic procedure were able to naturally regenerate hyaline-like cartilage with a minimally invasive and cost-effective procedure.
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Highest prevalence of bone related disorders has been reported in North America. For instance, according to the statistics by WHO, in U.S., by the year 2040, around 78.4 million adults aged 18 years and older will have doctor-diagnosed arthritis, compared to 54.4 million adults in 2013-2015. Two-thirds of the population with arthritis will comprise of women. Moreover, according to the Center for Disease and Prevention (CDC) statistics, 2016, in the U.S, around 5.1% of men and 24.5% of women, both the groups in the age range of 65 years and above were diagnosed with osteoporosis of the femur neck or lumbar spine.
Global Orthopedic Regenerative Medicine Market Key Players
Key players operating in the global orthopedic regenerative medicine market include Curasan, Inc., Carmell Therapeutics Corporation, Anika Therapeutics, Inc., Conatus Pharmaceuticals Inc., Histogen Inc., Royal Biologics, Ortho Regenerative Technologies, Inc., Swiss Biomed Orthopaedics AG, Osiris Therapeutics, Inc., and Octane Medical Inc.
By Procedure –
- Cell Therapy
- Tissue Engineering
By Cell Type
- Induced Pluripotent Stem Cells (iPSCs)
- Adult Stem Cells
- Tissue Specific Progenitor Stem Cells (TSPSCs),
- Mesenchymal Stem Cells (MSCs)
- Umbilical Cord Stem Cells (UCSCs)
- Bone Marrow Stem Cells (BMSCs)
- Bone Marrow
- Umbilical Cord Blood
- Adipose Tissue
- Amniotic Fluid
- Tendons Repair
- Cartilage Repair
- Bone Repair
- Ligament Repair
- Spine Repair
- North America
- Latin America
- Asia Pacific
- Middle East
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