Global Balloon Kyphoplasty Devices Market - 2022-2029
Market Overview
The global balloon kyphoplasty devices market size was valued US$ 607.2 million in 2021 and is estimated to reach US$ 894.3 million by 2029, growing at a CAGR of 5.81% during the forecast period (2022-2029).
Balloon kyphoplasty is a minimally invasive procedure intended to repair vertebral compression fractures (VCFs) by stabilizing the fractures. It treats pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions. The main advantage of balloon kyphoplasty that differentiates it from vertebroplasty is that the vertebral height is restored while treating the fracture through balloon Kyphoplasty.
Market Dynamics
The balloon kyphoplasty devices market is driven by the rising prevalence of osteoporosis, which increases the demand for balloon kyphoplasty devices globally.
Increasing prevalence of osteoporosis and rising R&D activities are expected to drive market growth.
Osteoporosis the and osteoporotic fractures are a major public health problem globally. Osteoporosis develops, density decreases, and the body reabsorbs more bone tissue and produces less to replace it. According to the International Osteoporosis Foundation 2020, osteoporosis is the main cause of VCF, which causes more than 8.9 million fractures each year, i.e., one osteoporotic fracture every three seconds. Osteoporotic vertebral compression fractures (OVCF) comprise a major health problem that decreases life quality and increases back pain. Osteoporosis accounts for about 85% of overall VCF cases. In the US, it decreases life quality and increases seoporosis-related fractures. About eight million women have osteoporosis, and about 22 million are at risk of developing the disease. Around 700,000 vertebral body fractures are diagnosed annually in the US, with 115,000 being admitted to hospitals for treatment. At least one in two women and one in four men in the US suffer from osteoporosis-related fractures. Osteoporosis is responsible for two million broken bones and $19 billion in related costs every year. By 2025, it is predicted that osteoporosis will be responsible for approx.—three million fractures and US$25.3 billion in costs annually.
Vertebral compression fractures (VCF) are also caused by metastatic bone disease, metastatic spinal tumors, multiple myeloma, and traumatic injuries. Individuals with VCF undergo either vertebroplasty or kyphoplasty to rectify the condition. Balloon kyphoplasty (KP) is a procedure wherein a deflated balloon is inserted into the vertebral body through the pedicle and then inflated to restore the height of a collapsed vertebral body. The usage of balloon devices makes kyphoplasty different from vertebroplasty. The gradual inflation of balloon and devices insertion helps restore the pre-facture shape and height of the vertebral bodies. Hence, the rising demand for the diagnosis and treatment of vertebral fractures is projected to drive the global market during the forecast period.
Besides, growing technological advancements in the devices, increasing R&D investment by major players, and strategic alliances among major companies are some of the other factors boosting the growth of the balloon kyphoplasty devices market globally. For instance, PanMed U.S., based in Florida, launched the CurvePlus, a curved kyphoplasty device that allows the simplest, quickest, most complete curved kyphoplasty procedure. It is FDA approved and is only one that permits both balloon and cement to pass through curved needle to fill injured vertebra.
Risk of cement leakage and unawareness are expected to hamper the market growth.
The risk of cement leakage and rare occurrence of stroke, low awareness towards balloon kyphoplasty and stringent regulatory guidelines are expected to hinder the growth of the market.
Industry Analysis
The global balloon kyphoplasty devices market provides in-depth analysis of the market based on various industry factors such as porter’s five forces, regulatory analysis, supply chain analysis, pricing analysis, epidemiology, unmet needs, reimbursement scenario and technological innovations.
Segment Analysis
Balloon and inflation devices segment is expected to hold the largest market share in global balloon kyphoplasty devices market
On the basis of component type, the global balloon kyphoplasty devices market is segmented into balloons & inflation devices, bone access tools, bone cement & delivery systems, and accessories. Among these, balloon and inflation devices for recovery of fractures accounted for the largest market share due to the rising demand for these devices in complicated fracture cases. In addition, manufacturers are innovating new technologically advanced products, which are contributing to the major share of this segment during the forecast period.
Medtronic has launched the new Kyphon Xpander II IBT System, which includes the Kyphon Xpander II Inflatable Bone Tamp (IBT) and the Kyphon Inflation Syringe manufactured by Medtronic is used for the treatment of vertebral compression fractures. It is combined with the Kyphon Inflation Syringe, which provides ease of use to customers for use during a balloon kyphoplasty procedure.
Geographical Analysis
North America region holds the largest market share in the global balloon kyphoplasty devices market
North America holds the dominant market share for balloon kyphoplasty devices. Due to the rising number of vertebral compression fracture cases in the U.S., growing geriatric population, technological advancement in balloon kyphoplasty devices, it is expected to maintain the growth over the forecast period well-established health care infrastructure, and high diagnosis & treatment rates of fractures. Osteoporosis, a condition characterized by low bone mass and deterioration in the microarchitecture of bone tissue, causes more than 700,000 spinal fractures each year in the U.S. (2019). The prevalence of osteoporosis is projected to rise in the United States from approximately 13 million people to more than 16 million people by 2022. Though osteoporosis is mostly associated with women, it is also diagnosed in men, who account for an estimated 1 in 5 Americans who have osteoporosis. According to the Centers for Disease Control and Prevention (2021), in the US, 5.1% of men (65 years of age & over) are diagnosed with osteoporosis of the femur neck or lumbar spine, and 24.5% of women 65 years of age & over are diagnosed with osteoporosis of the femur neck or lumbar spine. With the rising number of osteoporosis cases in this region, the demand for diagnosis and treatment is increasing, which results in the e growth of the balloon kyphoplasty market in this region.
Competitive Landscape
The balloon kyphoplasty devices market is highly competitive with presence of large number of players including Medtronic, Stryker, Johnson & Johnson (DePuy Synthes), Cook Medical, Zimmer Biomet, CareFusion, Tecres, Bone Support, AOI Medical, and Benvenue Medical.
The key players are adopting various growth strategies such as product launches, mergers & acquisitions, partnerships, and collaborations which are contributing to the growth of the balloon kyphoplasty devices market globally. For instance,
• In Sep 2022, Aurora Spine Corporation announced approval of its novel lumbar spinal stenosis by FDA. Indicating its usage with Aurora ZIP Platform.
• In Jul 2022, Zavation Medical Products announced approval of its novel expandable lumbar interbody fusion device, eZspand Lateral by FDA.
• In Jun 2022, Onkos surgical announced agreement with Stryker for acquiring Juvenile Tumour System, a prosthetic system for bone cancer pediatric patients.
• In Jun 2022, Stryker announced approval of Q guidance system by FDA. It is advance planning guidance system that is intra-operative and is utilized during spinal surgery.
• In May 2021, Safe Orthopaedics, a company offering innovative ranges of sterile implants combined with their single-use instruments for back surgery, announced CE mark approval for its novel treatment for osteoporotic patients known as Hickory.
Key Companies to Watch
Medtronic:
Overview: Medtronic plc is an American company that operates in U.S. and manufactures and markets medical device headquarters in Minneapolis, US. It is operational in around 140 countries and 90,000 people are employed there.
Product Portfolio:
Kyphon Balloon Kyphoplasty: With the help of orthopaedic balloons, it restores correct angular deformity and vertebral height from the vertebral compression fractures that are cause due to cancer, osteoporosis and benign lesion.
Key Developments: In May 2020, Medtronic announced U.S. launch of kyphon assisted directional cannula for using it with balloon kyphoplasty products for the treatment of vertebral compression fractures due to cancer and osteoporosis.
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