Global Orthobiologics Market – Industry Trends and Forecast to 2031

Orthobiologics Market Analysis and Size

The global orthobiologics market is witnessing significant growth driven by rising incidences of musculoskeletal disorders, advancements in regenerative medicine, and increasing demand for minimally invasive surgeries. Key factors include expanding geriatric population, technological innovations in orthopedic treatments, and growing awareness about the benefits of biologics in orthopedic procedures, fostering market expansion.

Global orthobiologics market size was valued at USD 8.85 billion in 2023 and is projected to reach USD 14.00 billion by 2031, with a CAGR of 5.9% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Report Scope and Market Segmentation       

Market Definition

Orthobiologics refers to the use of biological substances, such as cells, growth factors, and other biologically active materials, to help facilitate the healing and regeneration of musculoskeletal tissues, such as bones, cartilage, muscles, ligaments, and tendons. These substances can be derived from natural sources within the body (autologous) or external sources (allogeneic or synthetic). Orthobiologics are used in various orthopedic treatments, including bone grafting, spinal fusion, and cartilage repair.                                     

Orthobiologics Market Dynamics

Drivers

• Rising Demand for Minimally Invasive Surgeries

The preference for minimally invasive surgical procedures is on the rise, driven by their associated benefits such as shorter recovery times, reduced post-operative pain, and lower risk of complications compared to traditional open surgeries. This trend is fueling the demand for bone grafts and substitutes that are compatible with minimally invasive techniques. These grafts and substitutes need to be easily implantable through small incisions and provide adequate support for bone healing and regeneration in minimally invasive procedures, thus driving innovation and development in the orthobiologics market.

• Increasing Prevalence of Orthopedic Conditions

The incidence of orthopedic conditions such as fractures, osteoarthritis, and sports injuries is increasing globally. This rise is attributed to lifestyle changes, including sedentary habits, dietary factors, and the prevalence of sports and recreational activities. As these conditions become more widespread, the demand for bone grafts and substitutes is also growing. Orthobiologics, by enhancing the body's natural healing mechanisms, are playing a crucial role in addressing these conditions, improving patient outcomes, and drive the market growth.

Opportunities

• Growing Adoption of Regenerative Medicine 

The field of regenerative medicine, encompassing therapies such as stem cell therapy and growth factor-based treatments, is experiencing a surge in adoption. These innovative approaches hold immense potential for tissue regeneration and repair, particularly in orthopedic applications. Stem cells, for instance, can differentiate into various cell types, aiding in the regeneration of bone and cartilage tissues. Growth factor-based treatments can stimulate the body's natural healing processes, promoting tissue growth and repair. The increasing acceptance of these regenerative therapies among patients and healthcare providers is creating significant growth opportunities for the orthobiologics market, driving research and development in this field.  

• Rising Aging Population  

The global population is aging at a rapid pace, with a significant portion of the elderly population experiencing musculoskeletal disorders such as osteoarthritis, fractures, and degenerative spine conditions. As individuals age, their bones and joints undergo degenerative changes, leading to an increased need for orthopedic interventions. This demographic trend presents a substantial opportunity for the orthobiologics market, as older individuals often require bone grafts and substitutes to support orthopedic procedures. The development of orthobiologic products tailored to the specific needs of the elderly population, such as enhanced bone healing and reduced recovery times, creates new opportunities for the market.

Restraints/Challenges

• Stringent Regulatory Approval Processes 

Regulatory bodies, such as the FDA in the U.S. and the EMA in Europe, require extensive preclinical and clinical data to demonstrate the safety and efficacy of orthobiologic products. These approval processes can be time-consuming and expensive, delaying market entry and increasing development costs. Furthermore, regulatory requirements may vary across regions, adding complexity for companies seeking to market their products globally. Compliance with these stringent regulations is crucial for ensuring patient safety and product quality but can be a barrier to entry for smaller companies or those with limited resources. The market is subject to rigorous regulatory scrutiny and approval processes, which can pose challenges for market expansion.       

• Limited Availability of Donor Grafts

The availability of donor grafts, particularly autografts sourced from the patient's own body, is limited and can vary depending on factors such as tissue type and quality. This limitation is further exacerbated in regions with strict regulations on tissue donation, where the supply of donor grafts may be insufficient to meet demand. Additionally, the use of allografts (grafts sourced from a donor) is subject to stringent screening and processing requirements to minimize the risk of disease transmission and graft rejection. These factors can pose challenges for healthcare providers and patients seeking access to bone grafts and substitutes, particularly in cases where autografts are preferred but not readily available, creating challenges for market growth.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Developments

• In November 2021, three primary FDA approval pathways were identified for bone grafts and substitutes, which are essential for mending nonunions, malunions, and bone defects. Among FDA-approved bioactive molecules for bone regeneration, a notable example is the peptide P-15
• In September 2021, Locate Bio, a company focused on regenerative medicine with a focus on orthobiologics, has secured an oversubscribed £10 million equity investment in a funding round co-led by current shareholder Mercia Asset Management and new investor BGF. The funds will be utilized to further progress Locate Bio’s proprietary pipeline of regenerative orthobiologics products towards patients, with key clinical and regulatory milestones expected to drive growth over the next two years. This investment brings Locate Bio's total funds raised to over £18 million. The company's primary product in development, LDGraft, is a controlled-release rhBMP-2 treatment for degenerative disc disease

Orthobiologics Market Scope

The market is segmented on the basis of product, application, type, and end-user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Product

• Demineralized Bone Matrix (DBM)
• Allograft
• Bone Morphogenetic Protein (BPM)
• Viscosupplementation Products
• Synthetic Bone Substitutes
• Others

Application

• Osteoarthritis and Degenerative Arthritis
• Spinal Fusion Fracture Recovery
• Soft Tissue Injuries
• Maxillofacial and Dental Applications

Type

• Knee
• Ankle
• Hip
• Wrist and Shoulder
• Spine
• Others

End-User

• Hospitals and Ambulatory Centers
• Research and Academic Institute
• Dental Clinics

Orthobiologics Market Regional Analysis/Insights

The market is analyzed and market size insights and trends are provided by country, product, application, type, and end-user as referenced above.

The countries covered in the market are U.S., Canada, Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, rest of Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, rest of Asia-Pacific, Saudi Arabia, U.A.E., South Africa, Egypt, Israel, rest of Middle East and Africa, Brazil, Argentina, and rest of South America.

North America is expected to dominate the market due to the presence of key players and a rising incidence of orthopedic conditions. In addition, the increasing elderly population is expected to drive further market growth.

Asia-Pacific is expected to witness significant growth during the forecast period due to increasing awareness among physicians. Moreover, the growth in healthcare expenditure and disposable income is anticipated to propel market growth.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure Growth Installed base and New Technology Penetration

The market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the market. The data is available for historic period 2016-2021.

Competitive Landscape and Orthobiologics Market Share Analysis

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Some of the major players operating in the market are:

• XTANT MEDICAL (U.S.)
• Arthrex, Inc. (U.S.)
• SeaSpine (U.S.)
• NuVasive, Inc. (U.S.)
• Bioventus (U.S.)
• Kuros Biosciences (Switzerland)
• K2M, Inc. (U.S.)
• RTI Surgical Holdings, Inc. (U.S.)
• Orthofix Holdings, Inc. (U.S.)
• Globus Medical Inc (U.S.)
• Harvest Technologies (U.S.)
• Zimmer Biomet (U.S.)
• Stryker (U.S.)
• Medtronic (Ireland)
• DePuy Synthes (U.S.)
• Sanofi (France)
• SEIKAGAKU CORPORATION (Japan)
• Locate Bio Ltd. (U.K.)
• MTF Biologics (U.S.)
• Alphatec Spine, Inc. (U.S.)
• Exactech, Inc. (U.S.)

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