Between 2025 and 2035, the increase in the submucosal lifting agent market will be greatly helped by the use of innovative endoscopic procedures and the increasing frequency of gastrointestinal disorders. The industry is forecast to grow at a robust CAGR of 6.9%, thereby reaching USD 122.2 million by 2025 and its estimated industry value of USD 222.6 million in 2035.
Based on application, the report scope includes submucosal lifting agents in polyps and tumors resection, where demand for submucosal lifting agents is likely to be influenced by the increasing penetration of minimally invasive procedures in gastroenterology.
The growing number of cases of colorectal cancer worldwide further fuels the demand for efficient endoscopic treatments. The major industry players are concentrating on R&D activities that enhance procedural efficiency by producing biocompatible and long-lasting lifting agents.
In addition, it is growing due to supportive regulatory approvals and increasing healthcare spending in emerging industries. Asia-Pacific is anticipated as the fastest developing region because of growing recognition and improved health care infrastructure, and North America and Europe will proceed dominating the industry share. The constantly improving technologies, therefore, stimulate industry growth over the next decade.
| Metric | Value |
|---|---|
| Market Size (2025E) | USD 122.2 million |
| Market Value (2035F) | USD 222.6 million |
| CAGR (2025 to 2035) | 6.9% |
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Evolution in Submucosal Lifting Agent Industry Landscape
| 2020 to 2024 | 2025 to 2035 |
|---|---|
| Moderate growth due to rising endoscopic procedures | Accelerated growth with wider adoption of advanced lifting agents |
| Traditional agents with shorter lifting duration | Next-generation agents with enhanced biocompatibility and longer effect |
| Gradual approvals in key regions like the USA and Europe | Streamlined approval processes and expanded approvals in emerging industries |
| Limited to advanced healthcare facilities | Widespread adoption across hospitals and ambulatory centers |
| Rising colorectal cancer cases and demand for minimally invasive procedures | Continued increase in gastrointestinal diseases and technological advancements |
| Dominated by a few key players | Increased competition with new entrants and product innovations |
| Strong presence in North America and Europe | Rapid growth in Asia-Pacific and Latin America |
| Initial R&D investments in novel lifting agents | Higher investments in bioengineered and long-lasting solutions |
| Limited access in developing regions | Improved accessibility and affordability in emerging industries |
FMI conducted a comprehensive submucosal lifting agent industry survey involving stakeholders, including healthcare professionals, manufacturers, and regulatory bodies. The survey was conducted for the purpose of gaining insights regarding the current industry dynamics, challenges, and future growth prospects.
It was one of the few studies highlighting the emerging trend of increasing demand for minimally invasive procedures, which necessitated effective agents for submucosal lifting. These agents should play the role of a good partner to help patients increase the safety and efficacy of endoscopic resections in clinical practice, healthcare professionals said. Manufacturers noted ongoing R&D efforts toward innovation and product formulation improvements with a special emphasis on biocompatibility and long-lasting lifting effect.
Those are two key findings from a survey of regulatory bodies that took part in the survey described during a presentation about a EUREKA staff background paper. They cited a shift towards stricter assessments to confirm the safety of the patients being treated, which has led manufacturers to comply with higher standards and more thorough clinical trials. This change is expected to enhance the trust and actual usage of new submucosal lifting agents in clinics.
Overall, the FMI survey was reflective of a general spirit among stakeholders to shore up existing challenges and take advantage of emerging opportunities. Collectively, these insights point to a favorable outlook for the submucosal lifting agent industry, enabled by the advent of technology, along with a common ground towards improving patient outcomes.
Government policies significantly influence the development, approval, and commercialization of submucosal lifting agents. Regulations vary by country, affecting industry dynamics differently across regions. Below is a table outlining specific regulations by country:
| Countries | Regulations Impacting the Submucosal Lifting Agent Industry |
|---|---|
| United States | The Food and Drug Administration (FDA) classifies submucosal lifting agents as Class II medical devices, requiring 510(k) preindustry notification. Recent recalls, such as the Class 2 Device Recall of Boston Scientific's ORISE Gel, highlight the FDA's stringent monitoring to ensure safety and efficacy. |
| European Union | The European Medicines Agency (EMA) oversees the approval process, with devices needing to meet the Medical Device Regulation (MDR) standards. The MDR emphasizes clinical evaluation and post-industry surveillance, impacting how manufacturers conduct trials and monitor product performance. |
| Japan | The Pharmaceuticals and Medical Devices Agency (PMDA) regulates medical devices, including submucosal lifting agents. The approval process involves rigorous clinical testing and quality assurance measures, aligning with global standards to ensure patient safety. |
| China | The National Medical Products Administration (NMPA) requires local clinical trials for medical devices, including submucosal lifting agents, even if they are approved elsewhere. This regulation affects the timeline and strategy for foreign manufacturers entering the Chinese industry. |
| India | The Central Drugs Standard Control Organization (CDSCO) classifies these agents under medical devices, necessitating adherence to the Medical Device Rules, 2017. Recent efforts to harmonize with international standards aim to streamline approvals and boost industry growth. |
| Category | Details |
|---|---|
| Leading Companies | Dentsply Sirona; KaVo Dental; EMS Dental; ACTEON Group; Hu-Friedy |
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The submucosal lifting agent industry is a subset of the medical device and biotechnology industry in general, and an integral part of the endoscopic and minimally invasive surgical device segment. Such agents can be utilized in gastrointestinal (GI) endoscopy, especially in procedures such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), facilitating polyp and early-stage tumor resection.
The Macro-Economic View (2025 to 2035)
The industry for submucosal lifting agents is likely to witness steady growth, attributed to the rising incidence rates of colorectal cancer, growing adoption of minimally invasive procedures, and advances in endoscopic technologies. Demand for efficient lifting agents is anticipated to be on the rise due to global healthcare systems focusing on cost beneficial and outpatient base treatments. Economic trends such as healthcare expenditure, reimbursement policies as well as regulatory changes also impact global industry.
The industry in North America and Europe will lead due to well-established healthcare infrastructure and early adoption of advanced technologies, while Asia-Pacific will record fastest growth on account of improving healthcare facilities and increasing awareness regarding gastrointestinal diseases. And government policies and reimbursement structures will continue to be essential for industry penetration, especially in emerging economies.
Furthermore, the competition will also be defined by mergers, acquisitions, and R&D investments and the push for innovative, stable, and biocompatible formulations. In this changing landscape, where global health priorities are gradually moving in favor of preventive care and early disease detection, the demand for advanced submucosal lifting agents is expected to rise significantly in the annual outlook period (2023-2035), ensuring healthy industry growth through 2035.
The current submucosal lifting agent products are also evolving as scientists develop more efficient ingredient formulations for both procedural efficiency and patient outcomes. Lifting Agent innovation has previously opted for class vectors - this includes Poloxamer 188 and Polyoxyl-15-hydroxystearate, Gellan gum and Polysaccharide, Sodium Hyaluronate, Cellulose, Absorbable Starch Polymers, and Poloxamers.
These ingredients work on achieving a better viscosity, retention time, and biocompatibility, all of which are considered key to an efficient submucosal elevation in endoscopy. Companies are developing more stable and long-lasting formulations to improve precision and reduce complications. With demand for advanced lifting agents set to rise as healthcare providers look for solutions that offer improved lesion removal with minimal tissue damage.
Regulatory expectations and sustainability goals are also driving companies towards biodegradable and naturally derived ingredients. New product launches Core Competencies that will Shape the Competitive Landscape During the Forecast PeriodClinical trials and Regulatory approvals.
The indication for use of submucosal lifting agents is generally limited to treatment of polyps, adenomas, early-stage carcinoma, and gastrointestinal mucosal lesions. Increasing cases of colorectal and gastrointestinal cancers are driving the wider use of these agents in endoscopic procedures that are rapidly gaining popularity due to their minimally invasive nature.
Healthcare professionals are focusing on the rapid diagnosis and elimination of precancerous lesions, thus driving the demand for better lifting solutions. This has caught the attention of endoscopists around the world for the potential of these agents to create a safer working environment during polyp and adenoma resections.
These applications will continue to grow steadily as ESD and EMR techniques are more advanced. New methods that combine artificial intelligence for lesion detection may also help increase adoption by enhancing procedural accuracy. The continued demand for precise and effective submucosal lifting will be one of the main factors influencing purchasing decisions, as healthcare institutions will prefer those products that show consistent results and better handling characteristics.
Since a significant volume of endoscopic procedures are performed for gastrointestinal ailments in hospitals, they are the leading end users of submucosal lifting agents. The prestigious medical facilities and large hospitals which have a dedicated gastroenterology department are investing in state-of-the-art lifting agents for better patient outcomes and shorter procedure time. It is being more commonly used by specialty clinics in developed areas, where outpatient endoscopic techniques are rising.
With a preference shift from patients towards minimally invasive procedure delivery in an ambulatory environment, a demand from surgical centers is growing. As such, these procedures focus on low-cost solutions for improved safety, reinforcing the need for lifting agents in their toolbox. With an advanced landscape, the industry is expected to be propelled by a rising number of specialist endoscopy centers, especially in the Asia-Pacific and Latin America region.
As new clinical protocols come into play, including the need to lift patients in isolation, healthcare providers are searching for lifting agents that will meet their requirements, forcing manufacturers to create tailored solutions for various care modalities. Technologies for advanced gastrointestinal treatment will become more prevalent in facilities, which will further change the end-user landscape.
The submucosal lifting agent industry is expected to have lucrative growth opportunities owing to the technological upgrades in the endoscopic procedures, rising cases of gastrointestinal disorders and the global trend of minimally invasive treatment. Emerging industries in Asia-Pacific, Latin America, and the Middle East are becoming hotspots for expansion owing to the improving healthcare infrastructure and rising patient awareness.
The growing use of artificial intelligence (AI) and robotics in endoscopic surgeries will also contribute to the use of effective lifting agents that can enable more accurate and safe resections. Additionally, a growing trend in the industry is towards biodegradable and longer acting formulations that provide longer tissue elevation, minimizing the need for repeat injections in the course of a procedure.
With this, companies need to associate with healthcare organizations and research organizations for the next generation of lifting agents. Fuelling clinical trials and getting necessary regulatory approvals in major industries such as United States, Europe & Japan, will help garner faster acceptance and adoption.
Investments and partnerships with local distributors in industries with developing economies may also yield positive results through increased industry penetration and improved accessibility. Instead, manufacturers must also stress sustainability by creating eco-conscious formulations that meet the global trend toward regulatory action for safer and more biodegradable medical supplies.
Consider price structures that are cost-efficient but high performing enough to service both premium and budget industry segments. This will facilitate a competitive edge through value-based solutions such as discounted or bundled products with complementary endoscopic tools. The uptake will also depend heavily on digital marketing aimed at endoscopists and healthcare professionals.
Regulatory compliance still dominates, and companies need to take a proactive approach to the changing guidelines to avoid industry entry barriers. Innovations, global expansion, and strategic partnerships addressing clinical needs and economic constraints are the key factors expected to shape the submucosal lifting agent industry over the forecast period.
In the United States, the retraction of submucosal lifting agents' industry is projected to experience growth at a CAGR of 6.8% over the period of 2025-2035. A robust healthcare infrastructure in the country, rising preference for minimally invasive procedures, and increasing awareness regarding early cancer detection, are driving the country’s industry expansion.
The high incidence of colonic disorders provides a potential factor driving the demand for efficient lifting agents which augment the efficacy of the endoscopic mucosal resection (EMR) or endoscopic submucosal-dissection (ESD) procedures. As a result, the FDA's regulatory oversight increases the rigorous standards new formulations must meet for safety and efficacy, impacting the competitive dynamics.
Major players are investing in research and clinical trials to create next-generation biodegradable and long-lasting agents. In addition, leading medical device companies and increasing healthcare spending are also contributing to this end.
The submucosal lifting agent industry in Germany is expected to grow at a CAGR of 7.9% during the period of 2025-2035. It is a major industry owing to the advanced medical infrastructure and emphasis on minimally invasive treatment. As hospitals and surgical centers have quickly adopted endoscopic technologies, there will long be a focus on effective high-performance lifting agents that provide reliable submucosal elevation and minimization of complications during lesion removal.
The Federal Institute for Drugs and Medical Devices (BfArM) holds regulatory oversight keeping a check on the efficacy and safety of products, likening the industry competitiveness. Now companies are working on research partnerships and clinical trials in Germany to launch innovative lifting agents aimed at European health care providers. Furthermore, the demand for efficient gastrointestinal treatment solutions is being propelled by the accelerating aging population and by the rising screening programs.
In the United Kingdom, the projected growth rate for the submucosal lifting agent industry is 6.3% CAGR, during the period of 2025 to 2035. The healthcare sector in Japan is mainly concentrated on early cancer diagnosis and minimally invasive treatment methods, thus driving the demand for sophisticated lifting agents. In fact, hospitals and specialty clinics are now increasingly adopting these more precise solutions to help increase procedure efficiency and improve surgical safety.
Tools that help achieve long-lasting submucosal elevation are especially needed now that many endoscopic procedures are being done on an outpatient basis. The technologies required in their development should not run contrary to regulatory frameworks set out by the Medicines and Healthcare products Regulatory Agency (MHRA), which maintain compliance with safety standards and promote innovation by manufacturers.
The expansion of the industry is due to the increase in colorectal cancer screening programs and encouraging gastrointestinal health by the government. Moreover, product availability and industry penetration are expected to be enhanced due to strategic alliances between domestic and foreign companies.
Surgical adhesive registration in Japan between 2025 and 2035 is estimated to have 6.0 percent compound annual growth rate (CAGR) in Japan's submucosal lifting agent industry. Interestingly, the country is known for a high level of focus on technological innovation and advanced healthcare infrastructure, signifying as a global hub.
Gastrointestinal diseases prevalence is high due to urban lifestyle, which has led to an increase in endoscopic procedures infusion rate, leading to high-performance lifting agent demand. Hospitals and surgical centers are investing in solutions that improve procedural precision and shorten patient recovery.
The Pharmaceuticals and Medical Devices Agency (PMDA) is a key part of this process, responsible for vetting new products and monitoring their effectiveness and safety. Japan coats the cutting edge of R&D, with new generation lifting agents being developed by Japanese manufacturers to enhance clinical outcomes further. Moreover, collaborative efforts with global companies are encouraging improving product quality and availability in different regions.
The submucosal lifting agent industry in China is projected to expand at a CAGR of 7.2% between 2025 and 2035. Rising investment in the healthcare sector, growing awareness about colorectal cancer screening, and a rising number of endoscopic procedures are propelling industry growth. Gastrointestinal treatment in the hospitals and specialty centers across the country is being integrated with advanced technologies to improve the healthcare infrastructure.
Product approvals are handled by NMPA, which confirms that lifting agents match international safety standards. Local manufacturers focus on research for cost-effective and high-quality formulations, and international companies penetrate through strategic alliances.
The strengthening trend in preventive healthcare and early-stage cancer detection is projected to fuel substantial industry expansion over the forecast years. Moreover, synergistic government policies and rising healthcare expenditure are providing profitable opportunities for local as well as international players in China.
The submucosal lifting agent industry in India is expected to register a 10.0% CAGR between 2025 and 2035, thereby emerging as one of the fastest developing industries across the globe. There is a surge in investment levels within the country’s healthcare sector - reflected in an increase of endoscopic procedures and improvement in access to gastrointestinal treatment.
Ability to perform bendable ligation provides minimal invasive surgical procedure increase the need of effective lifters such factors help to rise consciousness towards colorectal cancer with other gastrointestinal diseases has led demand for effective vessels that are improve process of minimally invasive surgical procedures.
The regulatory environment, overseen by the Central Drugs Standard Control Organization (CDSCO), is adapting to balance the need for product safety and efficacy with the desire to promote innovation. Various overseas organizations are rapidly increasing their investments in India in association with domestic distributors and hospitals.
Combined with the government’s push for healthcare access, and an increasing penchant for medical tourism, demand for advanced medical solutions is booming. The continual growth of endoscopic procedures will, therefore, lead to India emerging as a major contributor to the growth of the global submucosal lifting agent industry.
Submucosal lifting agents are used in endoscopic procedures to elevate lesions, polyps, and tumors from the mucosal layer of the gastrointestinal tract, making their removal safer and more effective.
The rising prevalence of gastrointestinal diseases, increasing adoption of minimally invasive endoscopic procedures, and advancements in lifting agent formulations are key factors driving industry growth.
Asia-Pacific, particularly China and India, is expected to witness the highest growth due to increasing healthcare investments, rising awareness about colorectal cancer, and improving access to advanced medical technologies.
Recent innovations include biodegradable lifting agents, longer-lasting formulations for extended elevation, and agents with enhanced viscosity to improve endoscopic resection efficiency.
Regulatory bodies such as the FDA, EMA, and NMPA set stringent safety and efficacy standards for new products, influencing approval timelines and shaping competition among manufacturers.
Poloxamer 188 and Polyoxyl-15-hydroxystearate, Gellan gum and Polysaccharide, Sodium Hyaluronate, Cellulose, Absorbable Starch Polymers, Poloxamers
Polyps, Adenomas, Early-stage Cancers, Gastrointestinal Mucosal Lesions, Others
Hospitals, Specialty Clinics, Surgical Centers, Others
North America, Latin America, Europe, South Asia, East Asia, Oceania, Middle East and Africa (MEA)
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Submucosal Lifting Agent Market
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