US Pedicle Screw Market to Grow at a CAGR of 6.79% to reach US$ 610.85 million from 2022 to 2030

[Research Report] The US pedicle screw market size is expected to grow from US$ 361.28 million in 2022 to US$ 610.85 million by 2030; it is estimated to register a CAGR of 6.79% from 2022 to 2030.

 

Analyst’s ViewPoint

The US pedicle screw market analysis explains market drivers such as the susceptibility of aging population to spinal disorders and the rising number of spinal surgeries using pedicle screw system. Further, product launches, expansions, collaborations, and partnerships among market players and use of robotics for navigation during screw placement are expected to introduce new trends in the market during 2022–2030. Based on product type, the polyaxial pedicle screw system segment accounted for the largest share in 2022. Based on application, the thoracolumbar fracture segment dominated the market by accounting maximum share. By surgery type segment, the open surgery segment is likely to account for a considerable share of the US pedicle screw market during the forecast period. Based on end user, the hospitals segment is expected to account for a maximum share of the US pedicle screw market during 2022–2030.

Pedicle screws are threaded titanium or stainless-steel implants that are fastened through the vertebral pedicles located at the back of spinal bones. Pedicle screws help secure rods and/or plates to the spinal segment during a spinal fusion surgery. The screw act as an anchor point and are typically positioned at 2 or 3 consecutive spinal segments connected by a short rod.

Market Insights

Susceptibility of Aging Population to Spinal Disorders

 

The geriatric population is more susceptible to spinal disorders such as degenerative disc diseases, osteoarthritis, scoliosis, spinal tumors, and spinal stenosis. The natural wear and tear of the spine, associated with aging, can lead to several spinal disorders. Moreover, this demographic group poses a unique challenge to spine surgeons due to multiple frailty, comorbidities, decreased nutritional status, and higher probability of postoperative complications. According to the World Health Organization (WHO) data published in October 2022, ~80% of the elderly population would be living in low-and middle-income countries by 2050. Moreover, it is anticipated that the pace of this population aging would be much faster than the pace reported in the past. Pedicle screws are widely used during surgical procedures performed to correct vertebral fracture, vertebral deformity, spinal trauma, spinal tumor, etc. Thus, pedicle screw systems are gaining traction owing to the rising elderly population, which is prone to various spinal disorders. The following figure depicts the cumulative incidence rate (%) among the aging population in two groups, i.e., age under 70 (Group A) and age 70 and older (Group B). Vertebral fracture cases after posterior fusion surgery were higher in Group A than in Group B. Pedicle screws are widely used during surgical procedures performed to correct vertebral fracture, vertebral deformity, spinal trauma, spinal tumor, etc. According to the US Census Bureau 2023 report, the elderly population in the US has grown rapidly in the last few decades. During 2010–2020, the population aged 65 and above saw the largest and fastest growth since the decade of 1880–1890; this population reached 55.8 million or 16.8% of the total population in 2020. This upsurge is primarily attributed to the aging of baby boomers, born between 1946 and 1964.

Fig 1: Number of Patients at Risk of Vertebral Fractures

Source: Nakahashi et al. BMC Musculoskeletal Disorders,2019

Postoperative vertebral fractures with pedicle screw fixation are relatively common complications among ageing population. The surgical management of vertebral fractures and spinal disorders often requires pedicle screw fixation. For instance, surgical management of scoliosis includes the decompression of neutral elements and fusion to realign the spinal segment pedicle screw system.

Future Trend

Use of Robotics for Navigation During Screw Placement

In recent years, the pedicle screw market has witnessed the advent of robotic navigation, especially in minimally invasive spinal surgeries (MISS) has led to an improvement in the accuracy of pedicle screw placement, as robotics aid in screw trajectory planning, size, and real-time visualization during the surgery. In surgeries related to lumbar interbody fusion, the applications of robotics have reached beyond pedicle screw placement. According to an article published in the Journal of Bone and Joint Surgery in 2020, robotic devices facilitate the placement of pedicle screws in patients with difficult anatomy, resulting in increased procedure accuracy, feasibility, and efficiency. The US FDA has approved the use of robotics to analyze the ideal trajectory for pedicle screw placement. The robotic devices serve as a semiactive surgical assistive tool that allows surgeons to broaden their ability to treat patients.

• In 2022, Beijing TINAVI Medical Technologies introduced TiRobot, an orthopedic robot developed as a new technology to aid in minimally invasive, percutaneous pedicle screw placement. This technique is accurate and safe, potentially reducing intraoperative blood loss, shortening operative time, improving fixation accuracy, and reducing surgical risk in the aging population.
• In May 2021, CUREXO Corp., a medical robot specialist company, received a US FDA license for developing the CUVIS-Spine spinal surgery robot. It is a next-generation spinal surgery robot that guides the insertion of a pedicle screw and functions according to the surgery plan by using a high-precision robot arm, wireless one-step navigation based on a real-time OTS sensor to confer precise, safe, and faster operations. CUVIS-Spine also minimizes the filming and reduces the radiation exposure of patients and medical staff.
• In May 2022, Altus Spine, a pioneer in the development and innovation of medical devices used in spinal correction surgeries, announced FDA 510 (K) clearance for Monaco HA Pedicle Screw System. This system comprises a low-profile construct and insertion devices, featuring an optimized surface intended for enhanced fixation. This surfaced is made of calcium and phosphorous to enhance the fixation of a pedicle screw into the surrounding bone.

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US Pedicle Screw Market: Strategic Insights

Market Size Value in	US$ 361.28 million in 2022
Market Size Value by	US$ 610.85 million by 2030
Growth rate	CAGR of 6.79% from 2022 to 2030
Forecast Period	2022-2030
Base Year	2022

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Report Segmentation and Scope

 

Product Type-Based Insights

Based on product type, the US pedicle screw market is segmented into polyaxial pedicle screw system, monoaxial pedicle screw system, and other pedicle screw systems. The polyaxial pedicle screw system segment held the largest market share in 2022 and is expected to record a significant CAGR during 2022–2030. Polyaxial pedicle screw systems are used in spinal surgeries designed to stabilize and immobilize the spine. Screws are anchored in the pedicle, which are small bony projections on the vertebral bodies. This type of screw can move in multiple directions, giving surgeons greater flexibility during pedicle placement. In recent years, minimally invasive surgery has been a preferred approach for spinal surgeries using posterior pedicle screw fixation.

Companies Offering Polyaxial Pedicle Screw Systems

Companies	Polyaxial Pedicle Screw System
Auxien Medical	VERTAUX – Polyaxial Pedicle Screw with Cap
Stryker	Xia3
B. Braun	S4 Spinal System (Monoaxial and Polyaxial)
Zimmer Biomet	Vital Spinal Fixation System

Source: Company Websites and The Insight Partners Analysis

The increasing number of spinal surgeries performed and technological advancements in polyaxial pedicle screw systems coupled with rising number of minimally invasive surgeries is expected to bolster the growth of the market for this product type.

Application-Based Insights

Based on application, the global US pedicle screw market is segmented into thoracolumbar fracture, spinal tumor, failed spinal fusion, scoliosis, and spondylitis. The thoracolumbar fracture segment held the largest market share in 2022 and is anticipated to register the highest CAGR during 2022–2030. Thoracolumbar fractures can significantly affect the quality of life, resulting in neurological deficits, deformities, and pain. According to an article published in Orthopaedic Surgery in 2020, spinal fractures account for 32.8/100,000 per population, and thoracolumbar fractures account for ~90% of spinal fractures. In addition, nearly 20% of these fractures are burst fractures due to axial pressure. Most of the thoracolumbar fractures occur between T11 and L2, a stress concentration area.

Pedicle screws are mostly used to correct thoracolumbar burst fractures and are considered the gold standard for spinal internal fixation in posterior surgery. The commonly used pedicle screw systems comprise 4 nails and 2 rods. A large number of biochemical studies have been carried out using pedicle screws. Although pedicle screw fixation has been proven advantageous in correcting spinal fractures, the disadvantage of screw loosening persists in patients with osteoporosis, leading to the failure of the correction procedure.

Surgery Type-Based Insights

In terms of surgery type, the US pedicle screw market is bifurcated into open surgery and minimal invasive surgery. The open surgery segment held a larger share of the market in 2022 and the minimally invasive segment is anticipated to register a higher CAGR during 2022–2030.

Minimally invasive surgeries (MIS) have gained traction owing to the rising application of technologically advanced robotic and image-guided (IG) surgeries. The market for the MIS segment is anticipated to grow six times faster as compared to the open surgeries segment during the forecast period. These surgeries are associated with less damage to the surrounding muscles, lower bleeding, minimum pain, faster recovery, and shorter hospital stays. At present, MIS is considered a common procedure for spinal fusion.

Key US pedicle screw market players are focusing on expanding their portfolios of product types supporting minimally invasive surgeries. In September 2021, Alphatec Holdings, Inc. launched the InVictus OsseoScrew spinal fixation system, which is an expandable pedicle screw system. Thus, with the growing preference for MIS among surgeons and patients, and the burgeoning prevalence of spinal cord degenerating diseases, the US pedicle screw market is set to pick pace during the forecast period.

End User-Based Insights

By end user, the market is segregated into hospitals, ambulatory surgical centers, and specialty clinics. The hospital segment held the largest share of the market in 2022 and is anticipated to register the highest CAGR in the US pedicle screw market during 2022–2030.

US Pedicle Screw Market, by Product Type – 2022 and 2030

Country Analysis

The growth of the US pedicle screw in the US is attributed due to unprecedented shift toward aging population prone to spinal disorders and rising number of spinal surgeries using pedicle screw systems. However, regulatory hurdles and challenges associated with pedicle screw fixation hinder the market growth.

Major market players operating in the US pedicle screw include DePuy Synthes, Stryker, and Intelivation Technologies. These companies engage in product type developments and launches to remain competitive in the market. In the US, technologically advanced pedicle screws are widely adopted for various minimally invasive and open surgeries.

Following is the list of major developments undertaken by the companies in the pedicle screw ecosystem:

• In May 2023, Intelivation Technologies launched a new minimally invasive pedicle screw system. The Golden Isles is a percutaneous system that improves procedural flexibility and visualization for surgeons, resulting in minimal soft tissue disruption in patients.
• In March 2022, SurGenTec, a US-based privately held company specializing in spine and orthopedic technology, received US FDA approval for its standalone spine fixation implant—the ION Screw.
• In February 2022, OsteoCentric Spine, LLC, announced its plans to enter the pedicle screw fixation market after executing a private-label deal with Altus Spine. The arrangement allows OsteoCentric to integrate an existing FDA-cleared system with its UnifiMI mechanical integration technology platform.
• In October 2020, Stryker announced that its Mesa Pedicle Screw (launched in 2006) reached the count of 1 million implantations globally. This system was featured during the North American Spine Society (NASS) annual meeting in 2020.

An increase in the number of cases of lumbar fracture, spinal deformities, and spinal tumors in the US population and technological advancements in pedicle screws favor the pedicle screw market. Lumbar fracture is the most common spinal fracture, which includes a complex injury and a high disability rate and causes serious psychological and economic stress in patients.

The report profiles leading players operating in the global US pedicle screw market. These include DePuy Synthes Inc, Zimmer Biomet Holdings Inc, Globus Medical Inc, B. Braun SE, Stryker Corp, Medtronic Plc, Surgalign Holdings Inc, NuVasive Inc, Orthofix Medical Inc, and Alphatec Holdings Inc.

• In August 2022, Surgalign Holdings, Inc. received FDA 510(k) approval of the CorteraTM Spinal Fixation System. This new flagship product from Surgalign is a key piece to the foundational portfolio designed to drive the company’s future growth over the next 10 years.
• In September 2021, Alphatec Holdings, Inc., a provider of innovative solutions dedicated to revolutionizing the approach to spine surgery, launched of the InVictus OsseoScrew Expandable Spinal Fixation System.

Company Profiles

• DePuy Synthes Inc            
• Zimmer Biomet Holdings Inc         
• Globus Medical Inc            
• B. Braun SE           
• Stryker Corp          
• Medtronic Plc          
• Surgalign Holdings Inc       
• NuVasive Inc          
• Orthofix Medical Inc
• Alphatec Holdings Inc