Thoracolumbar Spine Devices Market

Market Overview

The global thoracolumbar spine devices market size was valued at USD 8.45 Billion in 2022. It is projected to reach USD 12.67 Billion by 2031, growing at a CAGR of 4.6% during the forecast period (2023-2031). The thoracolumbar spine devices market is primarily attributable to rising cases of spinal disorders worldwide as this device helps treat such ailments. The surging prevalence of the geriatric population worldwide, who are more prone to develop spinal diseases, is also expected to augment the market expansion. Moreover, the novel spine devices developed by the major participants are gaining regulatory approval at an accelerating rate, thereby creating opportunities for market growth.

The term "thoracolumbar spine devices" commonly denotes medical equipment specifically engineered for application in the thoracolumbar portion of the spinal column. The thoracolumbar spine encompasses the thoracic and lumbar sections of the vertebral column. Thoracolumbar spinal devices are employed to deliver consistent support to the spine and prevent flexion of the thoracic region.

The treatment or support of certain medical diseases or injuries in this particular region may necessitate using specialist devices. Various devices can be utilized for the thoracolumbar spine, encompassing orthopedic braces, spinal fusion devices, pedicle screws and hooks, intervertebral disc prostheses, spinal cord stimulators, and vertebral compression fracture treatment devices. The choice of appropriate devices depends on the specific characteristics and extent of the spinal condition or injury. 

Market Dynamics

Global Thoracolumbar Spine Devices Market Drivers:

Rising Prevalence of Spinal Disorders

There has been a worldwide increase in the incidence of spinal disorders, including degenerative disc disease, herniated discs, and spinal stenosis. For instance, the article in NCBI reports that lumbar degenerative spine disease affects approximately 266 million individuals globally, accounting for 3.63% of the population. Moreover, the diagnosis of pathological disc degeneration is established in around 400 million persons, which accounts for approximately 5.5% of the worldwide population.

Additionally, spinal stenosis is found to affect approximately 102 million individuals annually, accounting for 1.4% of the global population. Similarly, according to the US Bone and Joint Initiative, back pain is considered the significant cause of disability in Americans. As a result, the demand for thoracolumbar spine devices intended to treat these conditions has increased, thereby driving the global thoracolumbar spine devices market.

Global Thoracolumbar Spine Devices Market Restraint:

High Cost of Devices

Thoracolumbar spine devices frequently incorporate advanced technologies and utilize advanced materials, resulting in elevated production expenses. For instance, the cost of a single pedicle screw ranges from USD 400 to USD 1,843, while an anterior cervical plate is priced at approximately between USD 540 and USD 2,388. Similarly, on average, spinal surgery exceeds a total cost of USD 25000.

Furthermore, the excessive expenses associated with healthcare can impose restrictions on patients' ability to obtain necessary medical services, especially in areas with limited healthcare funding or in markets where reimbursement regulations are unfavorable. All these factors are expected to restrict the market growth.

Global Thoracolumbar Spine Devices Market Opportunities:

Increasing Regulatory Approvals

The key players are increasingly receiving regulatory approvals for their novel spine devices. For instance, in January 2022, NuVasive, Inc. (NASDAQ: NUVA), an industry leader in minimally disruptive, procedurally integrated solutions that are revolutionizing spine surgery, announced that it was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) to expand the indications of use for Attrax® Putty, a comprehensive thoracolumbar interbody portfolio designed specifically for spine surgery.

Similarly, in December 2018, a medical device manufacturer specializing in developing, producing, and marketing cutting-edge spinal solutions, Nexxt Spine LLC, announced the official introduction of its SAXXONY® Posterior Cervical Thoracic System. The U.S. FDA granted 510(k) approval for this system, which uses posterior screw fixation to stabilize cervical (C1 to C7) and thoracic (T1 to T3) spinal segments in patients with degenerative disease, deformity, tumor, or trauma. Such approvals are expected to create opportunities for market growth.

Regional Analysis

Based on region, the global thoracolumbar spine devices aura market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa. 

North America Dominates the Global Market

North America is the most significant global thoracolumbar spine devices market shareholder and is expected to expand substantially during the forecast period. The dominant portion of the North American market can be ascribed to a firmly established healthcare infrastructure, a notable prevalence of spine-related illnesses, and an early embrace of cutting-edge spine technologies. For instance, based on a study published in 2019 by the National Spinal Cord Injury Statistical Center, it was found that the yearly occurrence of spinal cord injury (SCI) in the U.S. is estimated to be roughly 54 instances per million individuals, resulting in an approximate total of 17,730 new cases annually. The estimated population impacted by spinal cord injury (SCI) in the United States is approximately 291,000 individuals. This is expected to expedite regional market growth.

Furthermore, the key players are introducing new products, and their implantation procedures are also being performed in this region. For instance, in September 2023, Spinal implant manufacturer DeGen Medical, Inc. designated Drs. Peter Derman and Alexander Satin of Texas Back Institute were the first surgeons to perform Solar AM™ implant implantations. Recent operations at the Texas Health Center for Diagnostics and Surgery in Plano, Texas, involved executing the procedures. Texas Back Institute is one of the world's preeminent independent academic spine institutes that combines multiple disciplines. Solar AM™, the most recent addition to the Puri-Ti™ portfolio from DeGen Medical, offers instrumentation and implants for anterior lumbar interbody fusion (ALIF) procedures. Such factors are expected to augment the market expansion.

Asia-Pacific is expected to witness lucrative expansion over the forecast period owing to prominent factors such as improving healthcare infrastructure and increasing government initiatives. Moreover, economic development in countries such as India and Japan is expected to contribute to market growth. Medical device manufacturers are currently developing novel goods that are leading to the emergence of unique therapeutic strategies and surgical procedures. For instance, in September 2019, RTI Surgical Holdings, Inc., a multinational company specializing in surgical implants, made a public announcement regarding the inaugural surgical procedure involving utilizing the HPSTM 2.0 Hybrid Performance System. This system, comprised of modular pedicle screws, is designed to provide hybrid, rigid, or dynamic posterior stabilization of the thoracolumbar spine across mono- and multi-segmental regions. The surgical procedure was conducted by a neurosurgeon with the esteemed title of Fellow of the Royal Australasian College of Surgeons. The surgery occurred at Sydney Adventist Hospital, Sydney, Australia. All these factors are boosting the market development.

Europe is anticipated to develop at a significant pace. This region is expanding steadily due to the favorable patient demographic, the high awareness of advanced treatment options and technologically advanced non-invasive orthopedic disorder treatment, and the availability of reimbursements for treatments. The market in the European region is growing because of the surging prevalence of spinal disorders and the availability of reimbursement coverage for spinal fusion surgeries in most European countries. In addition, the prevalence of spine disorders increases with age and is mainly prevalent in the 60–69 age group. The percentage of people over 50 comprises approximately 34% of the total population in Europe. This percentage is expected to increase by nearly 10% over the next 20 years. This aging population would require surgical treatment for spinal diseases, contributing to the high demand for thoracolumbar spine devices market growth.

Segmental Analysis

The global thoracolumbar spine devices market is bifurcated into product type, type of surgery, material, and end-user.

Based on product type, the global thoracolumbar spine devices market is bifurcated into spinal implants, spine biologics, and devices and instrumentation. 

Spinal implants encompass medical devices surgically inserted into the vertebral column to offer structural reinforcement, enhance stability, or treat certain spinal ailments. These implants are utilized in several surgical interventions for the management of spine-related diseases, accidents, or degenerative pathologies. The principal objective of spinal implants is to achieve spinal stabilization, alleviate pain, and enhance the overall functionality of the affected region. There exists a diverse array of spinal implants that have been specifically developed for a range of purposes. These implants can be classified into distinct classes, including pedicle screws, rods and plates, interbody devices, artificial discs, and cages.

Based on the type of surgery, the global thoracolumbar spine devices market is segmented into open surgery and minimally invasive surgery (MIS). 

Minimally invasive surgeries provide several advantages, such as faster recovery time, smaller incisions, reduced scarring and pain, increased accuracy, and shorter hospital stays. Such advantages are expected to drive the segment growth. Similarly, technological advances in minimally invasive surgical instruments are among the factors prompting market players to constantly launch and improve advanced devices. For instance, in March 2019, a global leader in musculoskeletal healthcare, Zimmer Biomet Holdings, Inc., announced 510(k) approval from the U.S. FDA for the ROSA® ONE Spine System, which assists in minimally invasive and complex spine surgeries using robotic technology.

Based on material, the global thoracolumbar spine devices market is bifurcated into titanium, biomaterials, stainless steel, and others. 

Titanium is extensively employed as a material in spinal implants owing to its exceptional biocompatibility, corrosion resistance, and strength. Titanium alloys, such as the Ti-6Al-4V alloy, are frequently employed due to their enhanced mechanical characteristics. Due to the several benefits associated with titanium, major stakeholders in the industry are actively introducing novel goods fabricated from this material. For instance, in June 2020, Xenco Medical, a surgical implant manufacturer, introduced the initial injection-molded titanium foam spinal implants. These implants are pre-attached to disposable instruments made of composite polymer material. Specifically, the implants are known as CancelleX porous titanium lumbar intrerbodies.

Based on end-users, the global thoracolumbar spine devices market is bifurcated into hospitals and clinics, academic institutes and research centers, ambulatory surgery centers, and others.

Hospitals and clinics hold a significant share of the thoracolumbar spine devices market, as most treatment is done in hospitals. Moreover, the growing number of hospitals across developing countries positively impacts the demand for thoracolumbar spine devices. For instance, as per the American Hospital Association Annual Survey 2021, in the United States, there were 1,805 rural community hospitals, 3,336 urban community hospitals, and 3,453 community hospitals in a system in 2019. Moreover, it is worth noting that the aggregate number of admissions across all hospitals in the United States throughout 2019 amounted to approximately 36,241,815.

Recent Developments

• January 2023- The U.S. Food and Drug Administration (FDA) granted icotec ag 510(k) approval to market the VADER® Pedicle System, which consists of BlackArmor® extended long Carbon/PEEK rods and Ø 4.5 mm pedicle screws. While offering supplementary alternatives for stabilizing the upper-thoracic spine region, the extended VADER® Pedicle System preserves its well-established utility and adaptability in open, cement-augmented, and MIS surgical procedures.
• October 2023-Johnson & Johnson MedTech announced the 510(k) clearances obtained by DePuy Synthes, The Orthopaedics Company of Johnson & Johnson, from the U.S. Food and Drug Administration (FDA). These clearances pertain to the TriALTIS™ Spine System, an innovative posterior thoracolumbar pedicle screw system that provides an extensive range of implants and sophisticated instrumentation specifically engineered to integrate with enabling technology.