GLOBAL ROOT CANAL FILES MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2024-2031)

The global root canal files market was valued at US$ 267.9 Mn in 2023 and is expected to reach US$ 371 Mn by 2031, growing at a compound annual growth rate (CAGR) of 4.1% from 2024 to 2031.

Root canal files are one of the most crucial instruments that are used in root canal treatment. They are used to mechanically shape and clean the infected root canal system. There are multiple types of files available which differ in material, design, taper, and tip design. Stainless steel files are the most common but newer nickel-titanium alloy files are also gaining popularity due to their flexibility and ability to follow root canal anatomy.

Files are further classified based on cross-sectional design as conventional (K-file), H-file or Hedstrom file which has a triangular cross section and rotary files which have varying cross sections like Hero Shaper, ProTaper, Mtwo, and others. Conventional files provide greater tactile sense but are more prone to ledging whereas rotary files prepare canals more quickly with reduced risk of ledging but lack tactile feedback. The choice of file also depends on other factors like root canal anatomy, curvature, location and extent of infection. While files help clean and shape the canal, an improper use can cause problems like canal transportation, zipping, perforation or fractured instrument. Operators must undergo special training to handle different file systems safely and master critical skills like access preparation, length determination and cleaning & shaping motion.

Global Root Canal Files Market- Regional Insights

• North America is the largest market for root canal files, with a share of 35% market share in 2022; this is due to factors like high dental healthcare expenditure and presence of leading manufacturers in the region. U.S.accounts for the largest share due to growing geriatric population and their vulnerability to dental issues. Presence of leading manufacturers such as Dentsply Sirona, a Dental equipment and supplies manufacturing company, Brasseler USA, a dental material suppler, and Danaher Corporation, Conglomerate company, has enabled easy access to innovative products for dental practitioners across the region.
• Asia Pacific is the second largest market for root canal files market, due to increasing disposable incomes, growing medical tourism and expansion activities of leading market players. In particular, China and India are emerging as highly lucrative markets. While China accounts for the largest population base with growing cases of dental caries, India has witnessed a surge in dental tourists arriving for affordable advanced treatments. Rising awareness regarding oral health and availability of low-cost procedures have boosted visits of foreign patients in Asia. This has urged companies to strengthen their distribution channels while also setting up local manufacturing units to better address the burgeoning demand. With significant unmet needs and focus on dental investments, Asia Pacific region will continue dominating the growth prospects of global root canal files market over the forecast period.
• Europe is the third-largest market for root canal files, with a market share of 20% in 2022; this is due to the increase in prevalence of dental caries and other periodontal diseases among the population in European countries. According to the World Health Organization (WHO), over 60% of adults aged 65-74 years in western European nations have dental caries in their permanent teeth. The extensive use of rotaryNiTi files for shaping and cleaning of root canals by European dentists has propelled the demand.

Figure 1. Global Root Canal Files Market Share (%), By Region, 2024

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Analyst View

Global root canal files market is expected to witness steady growth over the forecast period driven by the increasing prevalence of dental caries and periodontal diseases. Rising medical tourism in low cost countries coupled with growing dental care infrastructure and awareness will further aid in the market expansion. Moreover, technological advancements leading to the development of new innovative file designs like 3D printed nickel-titanium files with improved flexibility, increased resistance to fatigue and fracture, and better canal debridement ability are expected to boost adoption.

However, high costs that are associated with root canal procedures and dearth of consumer awareness regarding oral healthcare in underdeveloped regions may impede the market growth to some extent. Similarly, lack of comprehensive dental insurance coverage in many countries also acts as a restraint.

The North American region dominates the global market but Asia Pacific is projected to witness the fastest growth due to rapidly developing economies, rising disposable incomes, and increasing medical tourism in the region. Growth will also be driven by expanding dental healthcare infrastructure and growing awareness regarding oral hygiene. Within Asia, India and China are expected to offer lucrative opportunities for key market players with the large patient pool and improving medical facilities in these countries. Overall, with rising dental issues and growing importance given to oral healthcare, the root canal files market is anticipated to experience steady expansion globally in the near future.

Global Root Canal Files Market- Drivers

• Increasing demand for root canal treatment procedures: Global root canal files market has been witnessing significant growth over the past few years due to the rising incidence of dental caries and other dental diseases globally. Root canal treatment procedures are minimally invasive surgeries aimed at saving a tooth that is badly decayed or infected. These procedures involve cleaning and shaping the infected root canal system and filling it later to prevent any reinfection.
• According to the data provided by the World Health Organization (WHO), oral diseases affect at least 3.9 Bn people worldwide with caries of permanent teeth being the most prevalent condition globally. Untreated tooth decay has been estimated to be present in over half of those aged 12 years and older. With increasing sugar consumption, adoption of sedentary lifestyles and lack of access to proper dental care in many parts of the world, the prevalence of dental caries and other dental issues has risen substantially. This has significantly driven up the demand for root canal procedures worldwide in turn boosting the adoption of root canal files which are necessary instruments used during these surgeries to efficiently clean and shape the root canals.
• Growing elderly population prone to tooth diseases: Global aging population is growing at an unprecedented rate which is expected to propel the growth of root canal files market in the near future. According to the data provided by World Health Organization (WHO), the number of people aged 60 years or above is projected to double from current 12% to 22% of global population by 2050. Older individuals are more susceptible to dental problems like tooth decay, gum disease, and tooth loss. Root canal treatment is commonly required for advanced dental issues like deep decay, infection or traumatic injury to the tooth pulp.
• With more numbers of geriatric populations worldwide, the demand for endodontic procedures is bound to increase significantly. Age-related poor oral hygiene, reduced saliva flow, chronic illnesses and intake of multiple medications increases the risks of dental caries and periodontal diseases in older people. Once the tooth pulp gets inflamed or infected, root canal treatment stands the only viable option to save the natural tooth. During such root canal procedure, specialized endodontic files help in thorough cleaning and shaping of root canal system. Their varied taper, design and functional properties aid clinicians in complete debridement and three-dimensional obturation of root canals.
• Advancements in endodontic technologies: Advancements in endodontic technologies are significantly contributing to the growth of the global root canal files market. In the past decade, there have been major innovations in materials and design of root canal files that have improved the efficacy, safety, and ease of root canal procedures. Modern rotary nickel-titanium files have revolutionized root canal shaping by making the process much faster and predictable as compared to manual stainless steel files. The super-elastic properties of nickel-titanium allow the files to maintain their original shape even after negotiating sharp root canal curvatures. This helps achieve a standard tapered canal shape with minimal risk of procedural errors like ledging, transportation or instrument separation.
• Contemporary file systems with varied tapers and tips are tailored for different canal anatomies. Manufacturers have also implemented technologies like M-wire, Gold-wire, controlled memory, and others to further enhance the flexibility and cyclic fatigue resistance of nickel-titanium. These advancements have enabled clinicians to effectively shape complex root canal systems in less time. With growing preference for root canal treatment over extraction, especially among aged populations, demand for premium endodontic files has been consistently rising.
• On the manufacturing front, integration of Computer-aided design (CAD) and computer-aided manufacturing (CAM) technology and 3D printing has allowed customization of root canal files as per individual tooth structure. Upcoming generations of 'single-use' nickel titanium and polymer files promise added advantages like reduced procedural errors and cross-contamination risks. With continued investments in research and development (R&D), next-gen file systems will likely deliver even better cleaning and shaping outcomes. This will further encourage endodontic treatments and increase marketing of high-value consumables among dental practitioners across nations. Overall, technological evolution tailored towards improved clinical efficiency and outcomes remains the primary driver propelling the root canal files market to greater heights in the future.

Global Root Canal Files Market- Opportunities

Emergence of nickel-titanium alloys to manufacture advanced files: Emergence of nickel-titanium alloys to manufacture advanced root canal files presents a great opportunity for growth in the global market. Nickel-titanium which is commonly known as nitinol, provides unique properties that allow for significant innovations in file design. Nitinol files are more flexible and resistant to fatigue as compared to traditional stainless steel files. This enhanced flexibility enables nitinol files to better conform to the complex internal anatomy of root canals, which improves cleaning and shaping effectiveness while reducing the risk of procedural errors like ledge formation, zip distortion, or instrument separation inside small and curved canals.

Increased flexibility and strength of nitinol has allowed manufacturers to design new file types such as twisted files, self-adjusting files, and variable taper files that can clean the root canal more efficiently. For example, twisted files feature unique properties like asymmetry and radial land areas that aid in removing debris from the root canal walls. Manufacturers are continuously developing new file designs with advanced metallurgical properties to suit the needs of different canal morphologies. Improved outcomes, reduced procedural errors and greater consistency achieved with Nitinol-based advanced files are expected to drive significant growth in their adoption rate among dentists globally.

Growing demand for endodontic retreatment: Global root canal files market is well positioned for sustained growth driven by increasing demand for endodontic retreatment procedures worldwide. According to the data provided by the WHO, around 2.4 Bn people suffer from untreated tooth decay globally and this highlights the need for effective root canal treatment.

With growing awareness about oral healthcare and rise in disposable incomes especially in developing nations, more patients are opting for root canal retreatment when initial treatment fails or reinfection occurs in previously treated teeth. Retreatment has become quite common as the success rate of initial root canal procedures can range from 80-95% depending on several factors. This ups the risk of potential reinfection over time. As retreatment aims to further disinfect and clean the complex root canal system, it requires specialized endodontic files to safely and effectively remove previous fillings or debris.

Collectively, increasing disease prevalence, awareness, ability to pay and ageing population dynamics are expected to fuel explosive uptake of endodontic retreatment services internationally. Manufacturers of root canal files would do well to tap into this demand from both developed and developing countries through customized product offerings and expansive distribution networks. Innovation into new file designs that enhance clinical effectiveness and ease-of-use would strengthen competitive advantage in a field with noteworthy headroom for continued growth.

Rising dental tourism in emerging markets: Dental tourism in emerging markets is expected to provide major growth opportunities for the global root canal files market. Countries such as India, Mexico, Hungary, and Turkey are actively promoting medical tourism to boost their healthcare industries. These nations offer high quality dental care at significantly lower costs as compared to developed countries in Europe and North America. The favorable pricing has led to a continuous rise in the number of international patients travelling to these emerging destinations for dental treatments over the past few years. According to a report by Patients Beyond Borders, in 2020, India and Thailand witnessed a 15-20% year-on-year increase in incoming medical tourists between 2017 to 2019. A major portion of these were for advanced dental procedures such as root canal therapy, dental implants, and crowns. This has considerably augmented the demand for associated consumables including root canal files. Moreover, ongoing infrastructure investments by governments to further boost healthcare accessibility and global accreditations are expected to draw even more foreign patients in the near future.

The rapid expansion of dental clinics and hospitals catering to international clientele bodes well for stakeholders in the root canal files market. Safety regulations and standards mandated by organizations like the Joint Commission International have strengthened confidence among medical travelers. Sustained demand from both domestic patients and from abroad will spur continued product innovation. Newer file designs and techniques to enable minimally invasive and faster treatments are being increasingly adopted. Rising dental tourism in emerging nations is certainly opening profitable growth avenues for market players in the near future.

Global Root Canal Files Market- Trends

Shift from stainless steel to controlled memory files: Shift from conventional stainless steel root canal files to controlled memory file systems is having a significant influence on the global endodontic file market. Controlled memory file systems are increasingly being adopted by endodontists as they offer improved safety, flexibility, and accuracy over traditional stainless steel alternatives. Made from nickel-titanium alloy, controlled memory files have an inherent shape memory and return to their original shape after being deformed, thereby reducing the risk of tools separating in the canal. This provides dentists a greater degree of precision and control during root canal procedures.

Controlled memory files also improve clinical efficiency. Their unique design allows for greater volumes of dentin to be removed with each filing stroke as compared to stainless steel instruments. Furthermore, controlled memory file systems are designed to maintain the original canal shape, thus preventing unnecessary removal of tooth structure. As a result, procedures can be completed in less chair-time which benefits both dentists and patients. Major companies have introduced single-use controlled memory file systems which eliminates any risks of cross-contamination between patients. This has been an important factor during the COVID-19 pandemic, according to the American Dental Association.

Adoption of digital radiography and CBCT in endodontic treatment: Growing use of digital radiography and Cone-beam Computed Tomography imaging in endodontic treatment is significantly impacting the root canal files market. These advanced digital imaging modalities provide dentists with a clear and highly accurate view of the root canal system and surrounding tissues. This enables more effective diagnosis and treatment planning as compared to conventional 2D X-rays. Dentists can better visualize the root canal anatomy, identify additional canals that may be present, and detect periapical lesions or fractures. As a result, they are able to select the most appropriate root canal file sizes and instruments that are needed to completely shape the complex root canal system. This tailored approach allows for more successful root canal procedures and fewer repeat treatments or extra appointments.

The higher diagnostic value and treatment guidance provided by digital radiography and CBCT is increasing their adoption rates among dentists. For example, according to the Indian Dental Association, over 60% of private dentists in major Indian cities had incorporated CBCT into their practices till 2021. With more accurate pre-operative images, endodontists require a wider variety of specialized root canal file designs, tapers and sizes to match the unique anatomical complexities seen on scans. This is driving product innovation within the root canal files market, with manufacturers developing new file types optimized for different canal morphologies. Suppliers are also expanding their file assortments to offer dentists greater flexibility in selecting the correct root canal instruments. Rise in predictable endodontic treatments has made patients more willing to undergo root canal therapy, thereby increasing demand.

Increased demand for esthetic post and core restorations: The demand for esthetic dental procedures has been continuously rising in the recent years across the globe. Patients are increasingly opting for advanced dental procedures that can restore their smile and improve their overall appearance. This rising interest in esthetics has significantly influenced the root canal treatment procedures as well. Earlier, the main aim of root canal treatment was to relieve pain and save the natural tooth. However, along with treating the infection and saving the tooth, equal emphasis is being given to the esthetic outcome of the treatment.

This trend has prompted dental practitioners to look for advanced root canal treatment options and files that can help provide esthetically pleasing restorations post treatment. Traditionally, root canal files were designed only to effectively clean and shape the root canal system. But, manufacturers are also focusing on developing files that cause minimal damage to the tooth structure during cleaning and preparation. This helps preserve the natural tooth structure and gives room for fitting esthetic post and core buildups or crowns. For example, manufacturers have introduced novel file designs made of nickel-titanium alloy that have improved flexibility, shape memory and hygienic properties. According to the data provided by the American Association of Endodontists, in 2021, some new file designs have non-cutting safety tips and varying tapers along the length that allow smooth navigation of the intricate root canal anatomy without risk of ledging or transportation.

Global Root Canal Files Market- Restraints

High cost of root canal procedures: One of the major factors restraining the growth of the global root canal files market is the high cost of root canal procedures. Root canal treatment is considered as a costly dental procedure due to the involvement of various consumables and instruments required to complete the treatment. The average cost of a root canal in the U.S. ranges from US$500 to US$1000 per tooth depending on the complexity of the procedure. This wide price range makes the treatment unaffordable for many people with lack of dental insurance. In 2020, according to a report provided by the World Health Organization, around 3.5 Bn people worldwide lack access to safe and affordable dental The high treatment expenses discourage people from seeking root canal treatment until the condition becomes extremely painful. This ultimately impacts the demand for root canal files negatively.

The cost of root canal files itself contributes significantly to the overall treatment expenses. Root canal files are classified as single-use instruments that need to be discarded after each procedure as per standard protocols to avoid cross-contamination. This means increased instrument consumption directly translates to increased costs.

In conclusion, the high financial burden that is associated with root canal procedures, largely due to the single-use consumables, acts as a key restraining factor for the global root canal files market. This discourages people from seeking timely treatment.

Counterbalance: The cost of the root canal procedure needs to be made affordable after considering all necessary factors, so that it can be easily treated among the population.

Risk of file separation inside root canals during procedures: The risk of file separation inside root canals during endodontic procedures poses a major challenge for the growth of the global root canal files market. When endodontic files like K-files or H-files separate inside narrow and curved root canals during cleaning and shaping, it can significantly complicate the treatment procedure. File separation may require additional instruments and clinic visits to retrieve the separated fragment, thus leading to increased treatment cost and time for both dentists and patients.

According to a study published by the Journal of Endodontics, in 2021, file separation occurred in 4% to 10% of root canal treatments. Another study published by Dental Traumatology in 2020, analyzed 18 clinical trials involving over 6,000 root canal treatments and reported an overall file separation incidence of 6.3%. More commonly, file separations have been seen to occur in teeth with narrow and curved root canals, like mandibular premolars and maxillary and mandibular molars. This poses high risks especially for inexperienced endodontic practitioners. The associated procedural complications and need for retrieval surgeries have led to reduced confidence levels among dentists and patients regarding conventional root canal treatments.

The possibility of file separation has driven the demand for advanced endodontic file designs with superior flexibility, cyclic fatigue resistance, and improved metallurgical properties. However, developing such innovative file systems requires significant investments in research and development (R&D). The high costs involved act as an entry barrier for new players in this market. Even established vendors remain hesitant to rapidly scale up production volumes without thoroughly validating the clinical safety and performance of new file designs through long-term testing. This overall restrains the pace of new product introductions and expansions for companies operating in the global root canal files market.

Figure 2. Global Root Canal Files Market Share (%), By Product, 2024

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Recent Developments

• In September 2024, Zarc4Endo, a medical technology manufacturer, launched its product BlueShaper PRO at the 21st Biennial Congress of the European Society of Endodontology (ESE), a flagship event held from September 06, 2024 to September 09, 2024. The introduction of BlueShaper PRO marks a milestone in endodontics and solidifies Zarc4Endo’s position as a leader in innovation in the field of endodontics.
• In November 2022, Kerr Dental, a medical device company, launched its novel ZenFlex ONE reciprocating file, featuring a counter-clockwise flute. The new file is said to offer a simple solution for endodontic specialists and general practitioners performing root canal procedures. The ZenFlex ONE is designed to be used with Kerr motors as well as other reciprocating motion motors and has been tested to demonstrate more flexibility and resistance to cyclic fatigue.
• In May 2022, Septodont, a manufacturer of dental anesthetics, announced a new bioceramic root canal sealer – BioRoot Flow. Clinical advantages of this proprietary hydraulic sealer technology include:
  • Creates an alkaline environment unfavorable for bacterial growth
  • Long-lasting Ca release essential for bioactivity and mineral tag formation
  • Ample working time of >60 minutes for multi-rooted molars
  • Pure mineral formulation (eugenol- and resin-free) eliminates shrinkage, microleakage and staining
  • Can be used with warm and cold obturation techniques
  • Easy and fast to removal when retreating, and others

Acquisition and partnerships

• In March 2022, Benco Dental Supply Company, a dentistry company announced its partnership with Overjet, a global leader in dental artificial intelligence (AI). Overjet offers a U.S. FDA-cleared dental artificial intelligence platform that can accurately deliver clinical insights to improve the quality of patient care and practice performance. Through the collaboration with Benco Dental Supply Company, this software will be accessible to dentists across the U.S.
• In February 2022, Young Innovations, Inc., dental equipment and supplies manufacturing company, announced the acquisition of Medical Purchasing Solutions, a leading supplier of pharmaceuticals and other surgical supplies that meet the needs of the growing oral pain management, oral surgery, and dental implant markets. This acquisition of Medical Purchasing Solutions reflects the company’s continued commitment to invest in the oral surgery market.
• In February 2022, Benco Dental Supply Company announced the acquisition of Popp Dental Supply, a supplier of dental products. Popp Dental Supply was represented in transaction by Connect the Dents, LLC, a dental-specific M&A Advisory company based in New York, U.S.

Top Companies in Global Root Canal Files Market

• Henry Schein, Inc.
• Benco Dental Supply Company
• Young Innovations, Inc.
• Carestream Health
• PDT, Inc.
• Dentsply Sirona
• Acteon
• Ultradent Products Inc.
• Convergent Dental, Inc.
• Midmark Corporation
• BEGO GmbH & Co. KG

Definition: Root canal files are an essential tool that is used for endodontic treatment or root canal therapy. They are a set of small precision hand instruments that is used to shape, clean, and remove diseased or damaged pulp from the root canal system of a tooth.