The global orthobiologics market size was valued at USD 7.63 billion in 2021. The market is projected to grow from USD 8.56 billion in 2022 to USD 12.33 billion by 2029, exhibiting a CAGR of 5.4% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with orthobiologics experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global market exhibited a decline of 10.6% in 2020 as compared to 2019.
Orthobiologics and regenerative medicines are often made from substances naturally found in the body and used to help injuries heal more quickly. These products are used in orthopedic procedures to improve the healing of broken bones and injured muscles, ligaments, and tendons.
One of the most significant driving factors of the market is the increasing incidence of several bone diseases such as bone infections (osteomyelitis) and bone tumors (malignant and benign). Apart from these, several other incidents and conditions require the administration of biologics. These conditions include different types of trauma – complex and simple, bone lesions, and bone fractures. In such conditions, orthopedic biologic products often act as an optimum treatment solution for the repair of bone defects, thereby supporting the overall market growth. Furthermore, the orthobiologics market is expected to grow during the forecast period owing to the increasing use of stem-cell-based allografts in various orthopedic procedures.
COVID-19 Pandemic Adversely Impacted the Market due to Declining Patient Visits
The COVID-19 outbreak has negatively impacted the demand for orthobiologic products due to decreased patient volume. Some of the key industry players experienced a considerable decline in revenues during the COVID-19 pandemic. The rearrangement of healthcare resources, decreasing number of patient visits to emergency care and outpatient settings, and supply chain challenges obstructed the sales of orthobiologics worldwide, particularly during the first six months of 2020. In terms of revenue, the global market decreased by -10.6% in 2020 as compared to 2019.
In 2020, the companies operating in the market also witnessed a considerable drop in their revenues. For instance, Orthofix Medical Inc. registered a decline of -11.6% in total revenues generated in 2020 as compared to 2019. The biologics segment of the company witnessed a decline of -15.3% in 2020.
However, patient volumes started increasing during Q3-Q4 2020 as the rules & regulations executed by the U.S. government were relaxed. However, the increase in patient volume was still lower than that in 2019. In 2021, the patient volume rebounded in the U.S. The recovery of patient volume in 2021 was attributed to higher vaccination coverage among the general population and implementation of strong guidelines & COVID-19 protocols in public places. This factor led to an increase in demand for orthobiologics in 2021. Moreover, the total revenues generated by Orthofix Medical Inc. in 2021 increased by 14.2% compared to 2020. Therefore, the continuation of services led to a significant market recovery in 2021.
Increasing Use of Viscosupplements for Delaying Total Knee Replacement to Boost its Adoption
Viscosupplements are used for the treatment of osteoarthritis. They play an important role in recovering the rheological properties of synovial fluid, improving function, achieving analgesia, and regenerating the joint cartilage articular.
The adoption of viscosupplements has increased over the past few years due to its high effectiveness in delaying total knee replacement procedures.
- For instance, according to a research study published by Springer Nature Switzerland AG in 2019, the median time to total knee replacement surgery was delayed by more than 1 year in patients receiving one dose of hyaluronic acid injection.
Moreover, an increasing number of patient population suffering from osteoarthritis worldwide is one of the major contributors to the increased demand for viscosupplements.
Growing Cases of Orthopedic Injuries to Enhance Market Growth
A rapid rise in the incidence of orthopedic injuries and musculoskeletal diseases leading to agonizing physical pain and limited mobility is the primary factor likely to surge the demand for orthobiologic products during the forecast period.
- For instance, according to statistics by the American Academy of Orthopedic Surgeons, more than 6.8 million patients with orthopedic injuries come to medical attention every year in the U.S. alone. This large patient pool requiring treatment for orthopedic injuries may boost the market growth in the projected years.
Moreover, a substantial rise in the incidence of osteoporosis disease categorized by low bone to mass density ratio and physical weakening of bone tissues is responsible for the increasing prevalence of hip and backbone fractures. This factor is anticipated to propel market growth in the coming years.
- According to the data published by the National Institute of Health (NIH) in 2018, around 53.0 million of the population in the U.S. are estimated to have osteoporosis. They are susceptible to a higher risk of this disease due to low bone-to-mass ratio.
Such rising incidence of osteoporosis and increasing orthopedic injuries among the U.S. population are expected to drive the market growth.
Increasing Number of Product Launches to Enhance Market Growth
The growing incidence of bone disorders has augmented the demand for orthobiologics products across the globe. The high demand for these products has stimulated the market players to introduce various orthobiologics products such as allograft, bone growth factors, and synthetic bone substitutes.
- For instance, in January 2020, Royal Biologics announced the launch of MAGNUS, a dimethyl sulfoxide (DMSO) free viable cellular bone allograft.
Moreover, a few market players are focusing on the launch of antibiotic-eluting bone void fillers to treat bone diseases, thereby spurring the overall market growth. Furthermore, a strong pipeline of market players for orthobiologics is expected to contribute to market growth in the long run.
- In April 2020, Biocomposites announced that its product offering of STIMULAN gained a new CE Mark approval to mix antibiotics such as vancomycin, tobramycin, and gentamicin in bone void fillers, which can be used as a treatment option in the management of infected bone and soft tissues.
Strong focus of companies on introducing products for bone void filling is anticipated to drive the market over the analysis period.
Issues Associated with Bone Morphogenetic Proteins and Clinical Limitations of Several Orthobiologics to Limit Market Growth
Medtronics INFUSE is the only bone morphogenetic protein available in the market. This product gained significant popularity after receiving the U.S. FDA approval in 2002 for its use in spinal fusion procedures.
However, several years after the approval of INFUSE, Medtronic has been facing increased scrutiny for its BMP. The reasons associated with this scrutiny are the off-label use of INFUSE and serious complications associated with the product.
- For instance, INFUSE can lead to serious side effects such as infection, urinary problems, bone and nerve injury, male sterility, and possibly increased cancer risk. Such side effects associated with this product are expected to hamper its sales, thereby limiting the overall market growth.
Moreover, bone graft substitutes with some clinical limitations, such as adverse tissue reaction, incomplete or lack of bone formation, and infection of soft tissue and bone, are expected to limit the market growth during the forecast period.
By Product Type Analysis
To know how our report can help streamline your business, Speak to Analyst
Viscosupplements Segment to Dominate Due to Increased Adoption
By product type, the orthobiologics market is divided into viscosupplements, bone growth factors, Demineralized Bone Matrix (DBM), synthetic bone substitutes, cellular allograft, allografts, and others.
The viscosupplements segment accounted for a dominant global market share in 2021. This factor is primarily attributed to the increasing prevalence of knee osteoarthritis and degenerative arthritis, specifically among the rising geriatric population. Enhancements in reimbursements policies regarding approvals on viscosupplements are supporting the growth of this segment. Recent market approvals and the entry of new manufacturers are some of the other factors supporting the highest shares of the segment.
The synthetic bone substitutes segment is anticipated to expand at the highest CAGR during the forecast period. The highest segmental growth is due to the increasing adoption of synthetic bone grafts in developed geographies such as the U.S. and Europe. Moreover, a gradual shift of healthcare professionals from traditional bone grafts to synthetic bone graft substitutes and the rising focus of manufacturers on the launch of new products are expected to propel the segmental growth.
- For instance, in January 2020, OrthoPediatrics Corp. launched QuickPack, a fully synthetic bone graft substitute in the U.S. The product has high viscosity, calcium phosphate cement that closely mimics the mineral phase of natural bone.
By Application Analysis
Spinal Fusion Segment to Hold Significant Market Share Due to a Large Number of Spinal Surgeries Performed
Based on application, the market is classified into spinal fusion, maxillofacial & dental, soft tissue repair, reconstructive & fracture surgery, and others. The spinal fusion segment dominated the global market in 2021. The segments large share is due to the increasing number of spinal fusion surgeries being performed across the globe. Moreover, key companies with extensive product portfolio of orthobiologic products for spinal fusion application area and increasing approvals for new products for spinal fusion procedures are expected to boost the segmental growth in the coming years.
- For instance, in May 2021, Prosidyan received the CE mark certifications for its fibergaft bone graft substitutes, which are intended for spinal fusion procedures.
In 2021, the reconstructive & fracture surgery segment held the second-largest market share and is anticipated to grow at a moderate CAGR during the projected years, 2022-2029. The segmental growth is majorly due to increasing fracture cases worldwide due to surge in osteoporosis prevalence.
- For instance, the International Osteoporosis Foundation stated that worldwide, osteoporosis causes more than 8.9 million fractures annually. Increasing number of fracture recovery cases suggests the high use of orthobiologic products, thereby supporting the segmental growth.
By End-user Analysis
Hospitals & ASCs Segment to Hold Significant Market Share Due to Large Patient Volumes
Based on end-user, the market is divided into specialty clinics, hospitals & ASCs, and others.
The hospitals & ASCs segment held a dominant share in 2021. The dominance is due to the high number of patient visits and robust number of orthopedic procedures conducted in hospitals worldwide. Furthermore, an upsurge in the number of hospitals across developed and developing countries and the rising prevalence of joint complications and spinal disorders are driving the segmental growth.
The specialty clinics segment is projected to expand at a lucrative CAGR during the forecast period of 2022-2029. The increasing need for specialty care coupled with a growing number of specialty clinics across the developed markets for efficient management and treatment of bone defects is anticipated to contribute to the highest growth of the segment.
In terms of region, the North America accounted for the leading market share in 2021 and was valued at USD 3.65 billion in 2021. The rapid adoption of biologics for bone-related injuries & disorders and an increase in the introduction of synthetic products by market players are projected to fuel the market growth across the region. Moreover, a large patient population pool requiring orthobiologic products to fill bone voids and other bone defects is estimated to contribute to the market growth in North America.
In 2021, Europe held the second-largest share and is projected to expand at a considerable CAGR over the forecast period. The strong focus of market players on R&D investment and research activities, favorable health reimbursement for bone grafting procedures, and rising incidence of spinal injuries are expected to fuel the demand for orthobiologics in the coming years.
- For instance, in February 2020, BBS-Bioactive Bone Substitutes initiated a clinical investigation at the clinical centers in Finland and Poland. This study used ARTEBONE as a bone graft substitute in the ankle and subtler joints fusions. ARTEBONE showed no concerns related to safety and product-related complications. Such better results from the research activities are expected to boost the European market growth.
Factors, such as a strong potential patient pool, rising prevalence of bone diseases, and the under-penetration of the market in this region, are expected to contribute to the highest CAGR of the market in Asia Pacific.
The markets in Latin America and the Middle East & Africa are anticipated to expand at a moderate growth rate owing to the ongoing adoption of novel biologics, increasing awareness related to biologics used for orthopedic procedures, and growing focus on improving the healthcare infrastructure across these regions.
KEY INDUSTRY PLAYERS
Robust Product Portfolio of Medtronic and DePuy Synthes to Enhance its Market Position
In terms of the competitive landscape, the market is fragmented in nature. Major players, such as Medtronic, DePuy Synthes, MTF Biologics, Stryker, and Harvest Technologies Corporation, accounted for a significant orthobiologics market share in 2021.
Medtronic captured the highest market share in 2021, owing to the strong product portfolio of bone graft substitutes. Moreover, its constant focus on launching new orthobiologics with the aim of geographic expansion is expected to contribute to its highest share in the market.
- For instance, in February 2019, Medtronic announced the introduction of its Grafton Demineralized Bone Matrix (DBM) in Japan. This bone graft is used for spine and orthopedic procedures.
Moreover, other market players such as Stryker, SeaSpine Holdings Corporation, Anika Therapeutics, Inc., Zimmer Biomet, and Bioventus are consistently focusing on strategic initiatives to gain market share in the coming years.
- In January 2020, SeaSpine announced a distribution and licensing agreement with Restor 3D, Inc. The materials science technology of Restor 3D is expected to provide both clinical and economic advantages to the orthobiologic portfolio of SeaSpine, thereby spurring its growth in the market.
LIST OF KEY COMPANIES PROFILED:
- Medtronic (Ireland)
- Zimmer Biomet (U.S.)
- DePuy Synthes (Johnson & Johnson Services, Inc.) (U.S.)
- Stryker (U.S.)
- Anika Therapeutics, Inc. (U.S.)
- SeaSpine (U.S.)
- Bioventus (U.S.)
- RTI Surgical (U.S.)
- MTF Biologics (U.S.)
- Arthrex, Inc. (U.S.)
- Smith & Nephew (U.K.)
KEY INDUSTRY DEVELOPMENTS:
- March 2022 – MTF Biologics partnered with Bone Biologics Corporation. The partnership was aimed to distribute Bone Biologics Corporations Demineralized Bone Matrix (DBM) in the market.
- October 2021 – AlloSource launched AlloMend Extra-Large (XL) Acellular Dermal Matrix (ADM), the newest addition to the AlloMend product line. The introduction of this product is expected to expand its dermal graft portfolio.
- June 2021- Bioventus Inc. announced the launch of SIGNAFUSE bone graft, which is now available in a new strip format for orthobiologic solutions.
- July 2020- Spine Wave announced the successful market release of Tempest Allograft Bone Matrix and its entry into the spinal biologics market.
- October 2020- Orthofix Medical Inc. announced the launch of the O-Genesis graft delivery system and the AlloQuent structural allograft Q-Pack.
An Infographic Representation of Orthobiologics Market
The research report provides an in-depth analysis and outlook of the industry. It focuses on key aspects such as product types, application areas, and end-users. Besides this, it offers insights into the impact of COVID-19, market trends, and the prevalence of orthopedic disorders. Additionally, the report consists of several factors contributing to the orthobiologics market growth.
Report Scope & Segmentation
Value (USD billion)
By Product Type, Application, End-user, and Region
By Product Type