INTRAMEDULLARY NAIL MARKET ANALYSIS

Global Intramedullary Nail Market size is expected to reach USD 1,325.5 million by 2030, from USD 794.8 million in 2023, at a CAGR of 7.6% during the forecast period. Intramedullary nails are metal rods that are inserted into the medullary canal of long bones to stabilize fractures. The market is driven by the rising incidence of musculoskeletal conditions that requires fixation surgeries. The intramedullary nail market is segmented into product type, material type, indication, age group, end user, and region. By product type, the trochanteric nails segment held the largest share in 2022 owing to the high use of these nails for hip fracture fixation.

Global Intramedullary Nail Market- Regional Insights

• North America is expected to be the largest market for Intramedullary Nail Market during the forecast period, accounting for over 35.8% of the market share in 2022. The growth of the market in North America is attributed to the rising geriatric population and subsequent increase in fracture incidence.
• The Europe market is expected to be the second-largest market for Intramedullary Nail Market, accounting for over 28.7% of the market share in 2022. The growth of the market in Europe is attributed to the presence of key players and supportive reimbursement policies.
• The Asia Pacific market is expected to be the fastest-growing market for Intramedullary Nail Market, with a CAGR of over 8.0% during the forecast period. The growth of the market in Asia Pacific is attributed to the increasing healthcare expenditure and awareness.

Figure 1. Global Intramedullary Nail Market Share (%), by Region, 2023

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Analyst’s View

The global intramedullary nails market is expected to see steady growth over the forecast period driven by rising prevalence of bone fractures globally. The demand for advanced intramedullary nails such as titanium elastic nails and hydroxyapatite-coated nails is increasing among surgeons owing to benefits such as rigidity, biological compatibility and minimized stress-shielding. Developing regions such as Asia Pacific and Latin America are likely to be the major revenue generators going forward due to improving healthcare infrastructure and increasing disposable incomes in these regions.

Global Intramedullary Nail Market- Drivers

• Rising Prevalence of Bone Fractures: A bone fracture is the medical definition for a broken bone. Fractures are usually caused by traumas like falls, car accidents, or sports injuries. But some medical conditions and repetitive forces (like running) can increase risk for certain types of fractures such as femoral fracture, tibia fracture, osteoporosis, etc. For instance, in September 2022, according to data provided by Osteoporosis Australia, a national non-for-profit organization, 4.74 million Australians over 50 years of age (66% of people over 50) has osteoporosis or osteopenia or poor bone health. Based on the 4.74 million Australians with poor bone health, 22% have osteoporosis and 78% has osteopenia. By 2022, it is estimated there were 6.2 million Australians over the age of 50 with osteoporosis or osteopenia, 31% increase from 2012.
• Increasing Product Launches By Key Market Players: Increasing organic growth strategies such as product launches by key market players to expand their product portfolio is expected to drive the market growth over the forecast period. For instance, in September 2022, Stryker, a medical device company, announced the launch of Gamma4 System. The newest Gamma System provides surgeons with the next generation of Stryker’s intramedullary nailing system. The Gamma4 System is indicated for the treatment of stable and unstable fractures as well as for stabilization of bones and correction of bone deformities in the intracapsular, trochanteric, subtrochanteric and shaft regions of the femur (including osteoporotic and osteopenic bone).

Global Intramedullary Nail Market- Opportunities

• Development of Biodegradable Intramedullary Nails: Biodegradable IM nails eliminate the need for removal surgery, reducing patient trauma and healthcare costs. Companies are investing in developing nails using biodegradable materials like magnesium alloys.
• Rising Demand for Minimally Invasive Surgeries: The preference for minimally invasive IM nail fixation using smaller incisions is increasing among patients. Key players are focusing on advancing minimally invasive intramedullary nailing techniques.
• Increasing Product Approval: Increasing organic growth strategies such as product approvals by regulatory authorities to expand the market players product portfolio is expected to create lucrative opportunity in global intramedullary nail market growth over the forecast period. For instance, on January 19, 2023, Conventus Flower Orthopedics, a medical device company, announced that it had received the U.S. FDA 510(k) clearance for the Flex-Thread Ulna Intramedullary (IM) Nail System. The Flex-Thread Ulna IM Nail is intended for use in the fixation of fractures and osteotomies of the ulna. The first and only flexible, threaded ulna IM nail will be available in a wide range of diameters and lengths.
• Increasing Awareness Campaign: Increasing awareness campaign for bone related diseases such as osteoporosis, bone fracture, etc. is expected to create lucrative opportunity in global intramedullary nail market growth over the forecast period. For instance, in April 2022, International Osteoporosis Foundation, a non-governmental organization, announced LiftOffForBoneHealth, an exciting new online public awareness campaign in cooperation with the European Space Agency (ESA), an intergovernmental organization, through the awareness campaign, International Osteoporosis Foundation, encouraging people all over the world to engage in regular weight-bearing and resistance exercises that help to build and maintain strong bones for life. The programme educated the general public regarding the importance of maintaining bone mineral density to prevent osteoporosis.

Global Intramedullary Nail Market- Trends

• Rising Popularity of Intramedullary Lengthening Nails: Intramedullary lengthening nails allow for gradual, controlled limb lengthening while avoiding external frames. Their adoption for limb deformities in children and short stature is rising. For instance, in February 2021, Orthofix Medical Inc., a medical device company with a spine and extremities focus, announced the U.S. and European full market launch of the FITBONE intramedullary lengthening system for limb lengthening and deformity correction of the femur and tibia bones. The FITBONE intramedullary lengthening nail is a fully implantable system for correcting leg length and deformity discrepancies.
• Technological Integration for Reduced Radiation: Navigation technology integration in IM nailing procedures enables real-time fracture reduction monitoring and reduces intraoperative imaging and radiation exposure. For instance, in April 24, 2023, Paragon 28, Inc. announced the launch of its Phantom Metatarsal Shortening System which features a first in-kind intramedullary device for fixation of in-line shortening osteotomies of the lesser metatarsals. These osteotomies are preformed to prevent metatarsalgia and floating toe, two of the most frequently addressed foot and ankle pathologies.
• Increasing Adoption of Robot-Assisted Surgeries: Robotic-arm assisted implantation of IM nails enables precision nail placement and reduces surgery time and radiation exposure. The adoption of robotic surgery is rising across healthcare facilities.
• Emergence of Online Portals for Intramedullary Nails: Leading manufacturers are selling IM nails through online portals, enabling easy accessibility for healthcare facilities. This is especially beneficial for facilities in remote areas.

Global Intramedullary Nail Market Restraints

• Challenges and Risk Factor Associated with Intramedullary Nailing: Intramedullary nailing is commonly used to fix the long bone fractures such as femoral fracture, tibia fracture, etc. There are various challenges and risk factors associated with intramedullary nailing. Some challenges include iatrogenic fractures, straightening of the femur, medial gap opening, leg-length discrepancy, penetration of the distal anterior femoral cortex, delayed union, and nonunion, instability of the inserted nail, shortening, soft tissues irritation over entry points  [usually longer sized nail], etc. For instance, on April 9, 2023, according to data provided by MDPI (Multidisciplinary Digital Publishing Institute) Journal, a publisher of open access scientific journals, Chungnam National University College of Medicine, Republic of Korea and Korea Worker’s Compensation & Welfare Service Daejeon Hospital, Republic of Korea conducted a study on Risk Factors Associated with Intraoperative Iatrogenic Fracture in Patients Undergoing Intramedullary Nailing for Atypical Femoral Fractures with Marked Anterior and Lateral Bowing. This was a retrospective cross-sectional study of 136 patients with atypical femoral fractures (AFFs) treated with intramedullary nailing between June 2008 and December 2017
• Product Recall: Increasing product recall by various key players operating in the intramedullary nail market will result in restraining the overall market growth in the coming years. For instance,  in January 2022, according to data provided by the U.S. Food and Drug Administration, Conventus Flower Orthopedics, an early-stage company focused on delivering a new standard of care for fracture treatment in the orthopaedic extremities, issued urgent recall of product Flex-Thread TM Distal Fibula Intramedullary Nail System (Lot Number: 11090 UDI: 00840118117548). The reason for recall was Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set was available.
• Lack of Reimbursement in Emerging Markets: The lack of insurance coverage and reimbursement for fracture fixation surgeries in developing regions limits the adoption of intramedullary nails. Patients in these countries often cannot afford the procedure cost.

Figure 2. Intramedullary Nail Market Share (%), By Product Type, 2023

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Recent Developments

New product launches

• On March 7, 2023, X-Bolt, an emerging innovator of orthopedic devices, announced that its hip fracture solution, the Pro-X1 Trochanteric Nail, had received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The Pro-X1 Trochanteric Nailing System is intended for use in fracture fixation in the femur in adults with osteopenia or osteoporosis.
• In November 2022, Enovis Corporation, a medical technology company, announced the introduction of the DynaNail Helix, the latest addition to the DynaNail family and Enovis’ expansive suite of foot and ankle products. DynaNail Helix is designed to achieve sustained dynamic compression for subtalar fusion with an innovative, anatomically friendly design and simple, screw-like insertion.
• In September 2021, Orthofix Medical Inc., a medical device company focused on spine and orthopedics, announced the first U.S. pediatric patient implanted with the Fitbone intramedullary lengthening system implant for limb lengthening of the femur and tibia bones. The Fitbone system was used in pediatric and adult and was available in a 9mm, 11mm, and 13mm sizes to address the specific needs of patients.
• In October 2021, ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, announced that 10,000 metacarpal fractures has been successfully treated with the INnate Intramedullary Threaded Nail. INnate is an intramedullary threaded nail designed specifically for minimally invasive fixation of metacarpal fractures.

Acquisition and partnerships

• In April, DJO, a subsidiary of Colfax and a leading provider of medical technologies, announced that it had completed the acquisition of MedShape, Inc., a privately held orthopedic medical device company. MedShape provides innovative surgical solutions for foot and ankle surgeons using its patented superelastic nickel titanium (NiTiNOL) shape memory alloy and shape memory polymer technologies.
• In July, Orthofix Medical Inc., a medical device company, and LimaCorporate S.p.A., a global orthopedic company, announced a licensing partnership for the U.S. market to provide a novel solution for patients with the challenging condition of chronic high dislocation of the hip. The partnership combines the unique limb-lengthening technology of Orthofix’s patented Fitbone intramedullary nail system with LimaCorporate’s proprietary, patient specific, 3D-printed pelvic fixation device.
• In February, Orthofix Medical Inc., a global medical device company focused on musculoskeletal healing products, announced that it had completed the acquisition of assets associated with the FITBONE intramedullary lengthening system for limb lengthening of the femur and tibia bones for fusionless surgery to treat early onset scoliosis from Wittenstein SE, a privately-held Germany-based company.
• In September, Medartis Inc., a specialized orthopaedic company for head and extremity surgery, announced that it had entered into a distribution partnership with the Field Orthopaedics, an Australia-based orthopaedic start-up. This strategic partnership includes the addition of the NX Nail system to Medartis’ comprehensive hand portfolio. The NX Nail system addresses the growing need of surgeons for an efficient, less invasive treatment that enables rapid recovery of patients after a finger fracture.

Top companies in Global Intramedullary Nail Market

• Zimmer Biomet
• Smith & Nephew
• Stryker
• Bioventus LLC
• Braun SE
• Medtronic
• Globus Medical
• Orthofix US LLC
• Johnson & Johnson Services, Inc.
• Globus Medical
• OrthoXel
• Tasarimmed Tıbbi Mamuller San. Tic A.Åž.
• Changzhou Waston Medical Appliance Co., Ltd.
• MEDIN, A.S., CarboFix Orthopedics Ltd.
• Advanced Orthopaedic Solutions
• ChM z o.o
• Bioretec Ltd.
• Citieffe s.r.l
• GWS Surgical LLP
• GPC Medical Ltd
• Jiangsu BANA Medical Technology Co., Ltd
• Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Weigao group
• Conventus Flower Orthopedics
• Normmed Medical
• X-Bolt Orthopaedics
• TRUEMED

Definition: The intramedullary nail market refers to the global market for intramedullary nails, which are metal rods surgically inserted into the marrow canal of fractured long bones. Intramedullary nails, often called IM nails, provide stability and alignment to fractures to allow mobilization during the healing process. They are most commonly used to treat fractures in the femur, tibia, and humerus bones.