SPINAL FUSION DEVICES MARKET ANALYSIS

Spinal fusion devices are used in spinal surgeries for patients suffering from various spinal diseases such as degenerative disc disease (DDD) and herniated disc. Spinal fusion devices are implanted into the spinal cord of the patient. The U.S. Food & Drug Administration (FDA) has placed spinal fusion devices under Class II of medical devices category. Moderate to severe spine problems need to be treated with surgical approach such as spinal fusion wherein the spinal vertebrae are either removed and fixated with implants or fused with the help of various fusion methods. Quality of life can be improved by spinal fusion surgeries. Rising prevalence of spinal cord diseases is expected to increase adoption of these surgeries.

The global spinal fusion devices market is estimated to be valued at US$ 9.175.04 million in 2022 and is expected to exhibit a CAGR of 4.6% during the forecast period (2022-2030).

Figure 1. Global Spinal Fusion Devices Market Share (%), by Procedure Type, 2022

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Rapid product launch and frequent approval of novel spinal fusion devices are expected to drive growth of the global spinal fusion market

Rapid product launch and frequent approval of novel spinal fusion are expected to drive the global spinal fusion market. For instance, in 2017, Stryker’s Spine division launched Serrato pedicle screw, a unique dual-lead screw intended for use in the non-cervical spine. For instance, in May 2022, Accelus Robotics Private Limited, based in India, a medical technology company focused on accelerating the adoption of minimally invasive surgery (MIS) as the standard of care in spine, launched first procedures performed utilizing its TiHawk7 expandable interbody cage. TiHawk7 is the latest addition to Accelus’s FlareHawk Interbody Fusion System portfolio of spinal fusion cages and features a new ultra-low profile with titanium at the bony interface. The first TiHawk7 procedure was performed by Dr. Micah Smith, an orthopedic surgery specialist with Ortho NorthEast in Fort Wayne, Ind.

Figure 2.Global Spinal Fusion Devices Market Share (%), by Region, 2022

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Increasing prevalence of spinal deformities is expected to drive growth of the global spinal fusion device market.

Factors responsible for spinal deformities include weight, diet, smoking, and other lifestyle factors. Early onset of degenerative spinal changes is attributed to the toxins in cigarette smoke damaging the cartilage of spine. For instance, in February 2020, according to data published by National Health Portal of India, every year 250,000-500,000 people suffer from Spinal Cord Injury (SCI) globally. Majority of these cases are due to preventable causes such as road traffic accidents, falls, violence. Premature deaths are two to five times more common in people with (Spinal Cord Injury) SCI than people without a spinal cord injury. In India, approximately 1.5 million people live with Spinal Cord Injury. Approximate 20,000 new cases of   Spinal Cord Injury (SCI) are added every year and 60-70% of them are illiterate, poor villagers in India. Majority of them are males in the age group of 16-30 years, signifying higher incidence in young, active and productive population of the society.

Global Spinal Fusion Devices Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization had declared it a public health emergency on January 30, 2020.

COVID-19 can affect the economy in three main ways: by directly affecting production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, U.A.E., Egypt, and others, are facing problems with regards to the transportation of drugs from one place to another. Due to the COVID-19 outbreak, there have been severe disruptions to the global economy, including to major companies in the spinal instrumentation and implant market.

However, the COVID-19 pandemic had a negative impact on the global spinal fusion device market, owing to the increased stress of patients infected with COVID-19 infection in Hospitals. For instance, according to an article published by the National Center for Biotechnology Information, in August 2020, hospitals experienced rapid overcrowding by COVID-19 patients, many spinal surgeons were called upon to care for the Covid-19 patients. Coinciding with this significant shift in clinical role were the cancellations of elective surgery cases as well as the postponement of interventional spinal procedures and surgeries. Reasons for such cancellations are two-fold: to decrease patient and provider exposure to COVID-19, and conserving personal protective equipment and other valuable resources.

Global Spinal Fusion Devices Market: Key Developments

In 1 June 2022, Camber Spine, a leading innovator in spine and medical technologies has announced that it is entering into the next phase of the complete national launch of the SPIRA-P Posterior Lumbar Spacer and has recently commercialized its Spira-T Oblique Posterior Lumbar Spacer. Part of Camber’s SPIRA product platform, the SPIRA-P Posterior Lumbar Spacer is versatile to accommodate open and minimally invasive PLIF or TLIF procedures and features a patented open architecture design for optimal endplate load distribution. Additionally, its uniquely designed surface allows for cell adhesion and bone cell proliferation while its interconnected porosity design mimics bone.

In June 8 2022, SeaSpine Holdings Corporation, a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced the full commercial launch of its 3D-printed WaveForm TO (TLIF Oblique) Interbody System. WaveForm TO was designed for both PLIF (posterior lumbar interbody fusion) and TLIF (transforaminal lumbar interbody fusion) procedures.

Global Spinal Fusion Devices Market: Restraint

The major factors that hinder growth of the global Spinal Fusion Devices market include unfavorable reimbursement scenarios and stringent regulatory approval procedure. For instance, in July 2019, according to article published by National Center for Biotechnology Information, challenges in the design and regulatory approval of 3D-printed surgical implants of spinal fusion device were explained. Two patients with semiurgent cases of spinal instability presented to hospital in the Netherlands. In case 1, severe kyphotic deformity of the thoracic spine due to neurofibromatosis type 1 had led to incomplete paralysis, and a strong metallic strut extending from C6 to T11 was deemed necessary to provide long-term anterior support. It was challenging situation for doctors and physicians in carrying out this difficult surge’s.

Key Players

Major players operating in the global spinal fusion devices market include  Zimmer Biomet Holdings, Inc., Stryker Corporation, Inc., Exactech, Inc., Orthofix International N.V., Globus Medical, Inc., NuVasive, Inc., Medtronic Plc., Depuy Synthes, B. Braun ,Melsungen AG, Wenzel Spine, Inc., K2M Group Holdings, Inc., Centinel Spine, Inc., and Spineart Geneva SA.