Sternal Closure Systems Market 2024 – Market Size & Segments Analysis, Industry Trends, Manufacturers Analysis, Opportunities and Forecast 2032

The sternal closure systems are the medical devices that are designed to provide stability and support to the sternum after the surgery surgical procedures like open-heart surgery or thoracic surgeries. The systems consist of plates, wires, screws and other fixing devices, used to provide support and secure the sternum after it has been divided during surgery. The most common method uses a stainless-steel wire cerclage, the wires are placed around the sternum and the ends are twisted together. It plays a crucial role in providing proper healing, reduces the risk of infection and separation of sternum and maintains the integrity of the chest, facilitating the patient's recovery.

MARKET OVERVIEW

The global market valuation of Sternal Closure Systems market was valued at approximately USD 1.7 billion in 2023 and is projected to reach USD 2.8 Billion in 2032 exhibiting a CAGR of 3.9% during the forecast period of 2024-2032. Sternal Closure Systems plays an important role in providing support to the sternum after thoracic surgeries and reduces the risk of infection. The market is aligned with healthcare sector, which makes it a sustainable and growing market.

GROWTH DRIVERS

The increasing frequency of cardiothoracic surgeries globally fuels the demand of these systems as they are crucial in ensuring the patient’s recovery post-surgery. The American Heart Association (AHA) states that about 350,000–500,000 cardiac surgeries are performed in the United States annually. According to a new cardiac surgery market study by iData Research, the number of cardiac surgeries exceeds 900,000 procedures each year in the United States with projections for the number to reach 1.3 million by 2029. The technological advancements in the sternal closure techniques including R&D to introduce enhanced and more effective sternal closure systems, contributes towards market growth. Evonik venture capital invested in the Circumfix Solutions, as US based startup, designed a sternal closure instrument to improve patients recovery.

The growing aging population is one of the significant drivers of the market as old people are more incident to cardiac surgeries. According to the World Health Organization (WHO), the number of people aged 60 and older in the world's population is increasing at an unprecedented rate. In 2020, 1 billion people worldwide were 60 or older, and that number is expected to rise to 1.4 billion by 2030 and 2.1 billion by 2050. This means that by 2030, one in six people globally will be 60 or older, and by 2050, the number of people aged 80 or older is expected to triple to 426 million. The increasing budgets in developed and emerging countries allows the access to advanced surgical technologies including sternal closure systems. According to WHO, there is a sharp increase in government spending on health at all country income levels underpinned the rise in health spending to a new high of US $9 trillion, approximately 11% of global GDP.

The World Bank states that there is immense out-of-pocket health spending, defined as exceeding 10% of a household budget, continues to rise, around more than one billion people, about 14% of the global population, experienced such large out-of-pocket payments relative to their budgets. The regulatory bodies like FDA and EMEA emphasizes on patients safety and optimal outcomes through struct regulations and guidelines, leading towards enhanced focus on patients safety and quality control, this leads the market towards growth.  For instance, the Valkyrie thoracic fixation system received 510(k) clearance from the U.S. FDA, the system was developed for usage in the fixation and stabilization of chest wall fractures, including sternal fixation following sternotomy, in March 2021. 

MARKET SEGMENTATION:

·         By Product– Closure Devices (wires, plates and screws, cables and clips) and Bone Cement

·         By Procedure – Median Sternotomy, Hemi sternotomy, Bilateral Thoracosternotomy

·         By Material- Titanium, stainless steel, polyether ether Ketone

·         By Region- North America, Europe, Asia Pacific, The Middle East and Africa, South America

Sternal Closure Systems Market Segment By Product Segment Review:

The closure devices are critical for ensuring the stability and healing of the sternum after thoracic surgery and in this segment, it includes wires plates and screws cables and clips. The sternal wires are the traditional methods that are used to close the sternum post-surgery and are usually made of stainless steel and wrapped around the sternum to hold the two halves together. The plates and screws are used for rigid fixation as they provide better stabilization as compared to the external wires. These systems are designed to provide better alignment and faster healing.

The cables are an alternative of the sternal wires which provides more flexible and less invasive option and are made up of biocompatible materials like polyester or polymer coated stainless steel. These cables are less complicated as they are easy to adjust and easy to remove.  The sternal clips are used for sternal closure by offering a quick and easy solution for external fixation, these are designed to hold the sternum securely. The bone cement is used as an adjunct to mechanical closure to enhance the stability and healing of the sternum. They are mainly made up of polymethyl methacrylate and it used in patients with poor bone quality. It fills gaps and defects the sternum and provides additional support and stability to it.

Sternal Closure Systems Market Segment By Procedure Segment Review:

Median sternotomy is the most common surgical approach to excess the heart and thoracic organs, a vertical incision is made along the sternum which divides which is then divided to provide wide access to the chest cavity. It is widely used in open-heart surgeries like clear artery bypass grafting, heart valve repair or replacement and heart transplants. Hemi sternotomy a partial incision. Is made on the sternum, which provides less invasive access as compared to full median sternotomy. 

It is used for less extensive thoracic surgeries like aortic valve replacement and congenital heart defect repairs. The bilateral thoracosternotomy is also known as clamshell incision where bilateral incisions are made on either side of the sternum and are connected through transverse cut. This procedure is commonly used in bilateral lung transplants trauma surgeries. These procedures requires robust and specialized closure system for stability and support.

Sternal Closure Systems Market Segment By Material Segment Review:

Titanium is known for its strength to weight ratio, corrosion resistance and biocompatibility. It is nontoxic and not rejected by the body which makes it an ideal material for sternal closure systems like plates, screws and wires. The light weight reduces the discomfort and corrosion resistance ensures the longevity. Stainless steel is known for its strength and durability, these are commonly used in wires, clips, plates and screws for sternal closure. The widespread availability and easy to manufacture makes it an attractive option for the development of sternal closure systems. PEEK is a high-performance thermoplastic with excellent mechanical properties, biocompatibility and are resistant to chemical and thermal degradation.

Sternal Closure Systems Market Regional Analysis:

North America is a significant market driven by the factors like the region’s robust and advanced healthcare sector. The increasing incidence of cardiac surgeries creates opportunities market. Europe is another significant marker driven by the factors like the government struct laws and regulations that are focused towards patient safety and overall well being outcome. Asia Pacific is a rapidly growing market due to the presence of large population base coupled with increasing incidence of cardiovascular diseases. The Middle East and Africa is a growing market due to factors like investments in infrastructure including healthcare infrastructure. South America is a promising market due to the urbanization and industrialization.

Key Challenges:

The global supply chain disruptions like word 19 pandemic have affected the manufacturing and distribution of medical devices which may pose a delaying or shortage challenges for the market. The limited healthcare funding in developing regions may strict the adoption of advanced sternal closure systems because of budget constraints. Ensuring and obtaining regulatory approval for new sternal closure devices may be a lengthy and complex process which involves extensive clinical trials and compliance with strict standards which causes delays in market entry and adoption. The post operative infection is one of major concern or challenge regarding surgeries and inadequate closer techniques or materials may increase the risk of infection.

Competitive Landscape:

In the highly competitive Sternal Closure Systems, companies are investing heavily in research and development to innovate and improve the product and services. They are also collaborating, forming strategic partnerships, or acquiring other companies to gain access to new market segments, enhance distribution networks, and increase market share. Recent developments includes – NEOS Surgery launched STERN Fix made up of carbon Peek Matrix, in 2021. Granulab lunched Prosteomax, in May 2022. A&E Medical Corporation received product approval for its Tritium Sternal Cable Plate System, In March 2021.

Global Key Players:

·         Able medical Devices

·         ABYRX

·         Acumed LLC

·         B. Braun

·         Changzhou Watson Medical Appliance Co., Ltd.

·         CircumFix Solutions, Inc

·         DePuy Synthes

·         Idear SRL

·         Invibio Biomaterial solutions

·         Jeil Medical Corporation

·         Kinamed Incorporated

·         KLS MArtin Group

·         Lotus Surgicals

·         Medicon eG

·         Medxpert GmbH

·         NEOS Surgery

·         Neuromedex GmbH

·         Ortolog Medical

·         Peters Surgical

·         Prasidia

·         Stryker

·         Teleflex Incorporated

·         TTK Healthcare Ltd

·         Zimmer Biomet