세계 소화관 스텐트 시장 규모는 2023년 5억 1,583만 달러에서 2024년부터 2031년까지 예측 기간 동안 5.35%의 CAGR로 2031년에는 7억 8,268만 달러 규모로 성장할 것으로 예상됩니다.
소화관 스텐트 시장은 위장 장애 및 소화기 질환의 유병률 증가, 최소 침습적 수술에 대한 선호도 증가 등의 원동력으로 인해 괄목할 만한 성장을 기록할 것으로 예측됩니다. 소화기 질환의 유병률은 소화기 질환에 걸릴 위험이 높은 노인 인구의 증가, 가공식품을 포함한 건강에 해로운 음식의 과다 섭취 등 여러 가지 요인으로 인해 증가하고 있습니다. 또한 식습관 변화, 생활습관 변화, 병원성 세균, 가공식품 및 초밥과 같은 날 음식 섭취 등의 요인으로 인해 위장 장애가 증가하고 있습니다. 의료기기, 특히 스텐트 설계 및 재료의 기술 발전도 시장 성장을 더욱 촉진하고 있습니다. 자기 확장형 금속 스텐트와 같은 첨단 소재의 사용으로 최소 수술용 소화관 스텐트의 인기가 더욱 높아지고 있습니다. 반면, 높은 수술 비용과 신흥국에서의 제한적인 상환으로 인한 경제적 문제는 시장 성장을 저해하는 요인입니다. 의료기기 승인 및 개발에 대한 엄격한 규제는 주요 업체들의 사업 확장을 방해하기도 합니다. 이러한 문제에도 불구하고, 시장은 향후 비약적인 성장을 보일 것으로 예상됩니다.
위장 질환의 유병률 증가
위장 질환 및 소화기 질환의 유병률은 증가 추세에 있으며, 라이프스타일의 변화가 큰 요인으로 작용하고 있습니다. 이러한 증가는 빠르게 변화하는 라이프스타일, 식습관의 변화, COVID-19의 영향으로 인한 스트레스와 같은 요인과 관련이 있습니다. 과민성 대장 증후군(IBS), 위식도 역류질환(GERD), 대장암과 같은 특정 질환의 발병률이 눈에 띄게 증가하고 있습니다. 이러한 질환을 관리하기 위해서는 균형 잡힌 식단, 규칙적인 운동, 충분한 수면과 같은 생활습관 개선이 권장됩니다. 이러한 질환은 때때로 소화관 막힘으로 이어져 스텐트를 사용하여 외과적으로 제거하기도 합니다. 미국 국립 당뇨병 및 소화기 및 신장 질환 연구소(National Institute of Diabetes and Digestive and Kidney Diseases, NIDDK)에 따르면, 미국 내 약 6,000만 명에서 7,000만 명이 소화관 질환을 앓고 있어 소화관 스텐트 수요가 증가할 것으로 예상됩니다.
최소침습적 수술에 대한 선호도 증가
최소침습적 수술에 대한 선호도가 높아지면서 소화관 스텐트 수요를 견인하고 있습니다. 최소침습적 소화관 수술은 기존 개복 수술에 비해 효과적이고 입원 기간이 짧으며, 수술 후 사망률이 낮고 회복이 빠르다는 장점으로 인해 선호되고 있습니다. 생분해성 스텐트, 약물 용출성 스텐트 등의 기술 개발과 신흥국 의료 부문의 성장은 최소침습 수술의 인기를 더욱 높여 소화관 스텐트 시장의 성장을 견인하고 있습니다.
세계 소화관 스텐트 시장을 조사했으며, 시장 정의와 개요, 시장 규모 추이 및 예측, 각종 부문별·지역별 상세 분석, 산업 구조, 시장 성장에 영향을 미치는 요인 분석, 사례 연구, 경쟁 상황, 주요 기업 개요 등의 정보를 정리하여 전해드립니다.
Global gastrointestinal stent market is projected to witness a CAGR of 5.35% during the forecast period 2024-2031, growing from USD 515.83 million in 2023 to USD 782.68 million in 2031. The gastrointestinal stent market is anticipated to register notable growth under driving forces like the rising prevalence of gastrointestinal disorders and digestive diseases, and the increasing preference for minimally invasive surgical procedures. The prevalence of gastrointestinal disorders is rising due to several factors, such as the growing geriatric population, which is at high risk of catching digestive problems, and high intake of unhealthy food, including processed food. Gastrointestinal disorders are also increasing due to factors such as changing food habits, lifestyle changes, pathogens, and intake of processed food and raw meat, for example, sushi. Technological advancements in the design and material of medical devices, specifically stents, have further enhanced the market growth. The use of advanced materials, such as self-expanding metal stents, has further increased the popularity of gastrointestinal stents for minimally surgical procedures. However, affordability issues due to high procedure costs and limited reimbursement in developing countries hinder market growth. Stringent regulations for the approval and development of medical devices sometimes hinder the expansion of key players. Despite these challenges, the market is expected to grow exponentially in future years.
For instance, in October 2020, Olympus Corporation, which is a global technology leader in delivering innovative medical and surgical solutions announced the commercial launch of HANAROSTENT Esophagus TTS self-expanding metal stents (SEMS). The product is made by M.I. Tech and distribution is being taken care of by Olympus in the United States. The Through-the-Scope (TTS) esophageal stent helps achieve luminal patency in different clinical applications. It is designed to be used in the palliative treatment of trachea-esophageal fistula and esophageal stricture which are caused due to malignant tumors.
Rising Prevalence of Gastrointestinal Disorders
The prevalence of gastrointestinal disorders and digestive diseases is on the rise, with lifestyle changes being a significant contributing factor. This increase is associated with factors such as fast-paced lifestyles, poor dietary habits, and stress, including the impact of the COVID-19 pandemic. Specific conditions like irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), and colorectal cancer are notably increasing in incidence. Lifestyle modifications such as maintaining a balanced diet, regular exercise, and adequate sleep are recommended to help manage these conditions. These conditions sometimes lead to blockage of the GI tract which is surgically removed using stents. With the rising gastrointestinal disease prevalence, the market is expected to expand under the growing demand for GI stents. For instance, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), around 60 to 70 million United States population is affected by digestive diseases.
As per Agappe Diagnostics, in India, about 18% of people reported having digestive problems in 2020. Men were slightly more likely to report these issues (18%) compared to women (17%). As men get older, the number of people reporting digestive problems increases significantly, especially in those aged 75 and above (20%). People with higher education levels had a lower chance of reporting digestive problems (men: 16%, women: 10%). Those who had never worked or were unemployed had a higher prevalence of digestive issues (19%). Adults with certain chronic conditions, such as stroke and arthritis, were also more likely to report digestive problems.
Increasing Preference for Minimally Invasive Surgical Procedures
The increasing preference for minimally invasive surgical procedures is driving the demand for gastrointestinal stents. Minimally invasive gastrointestinal surgeries are preferred due to their effectiveness, shorter hospital stays, lower postoperative mortality rates, and quicker recovery compared to traditional open surgeries. Advancements in technology, such as the development of biodegradable and drug-eluting stents, and the growing healthcare sector in emerging economies further contribute to the popularity of minimally invasive surgical procedures enhancing the expansion of the gastrointestinal stent market. Market players actively present innovative products for the market to expand. For instance, in May 2023, Olympus Corporation received FDA clearance for its innovative EVIS X1 endoscopy system. The system includes the GIF-1100 scope, which can be used in the upper digestive tract (esophagus, stomach, and duodenum), and the CF-HQ1100DL/I colonovideoscope, intended for use in the lower digestive tract (anus, rectum, sigmoid colon, colon, and ileocecal valve).
Dominance of Biliary Stent Segment
Biliary stents are frequently utilized in gastroenterology interventions. They are effective in treating jaundice caused by both benign and malignant conditions. These stents, made of plastic or metal, are inserted by specialists. The selection of stent material relies on the obstruction cause, with metal stents being more cost-effective for inoperable malignant cases. Manufacturers are also actively involved in innovation and product development to cater to the market requisite. For instance, in November 2021, Boston Scientific Corporation, a United States-based company, gained regulatory approval (FDA and CE mark) for its AdvanixTM Biliary Plastic Stents. These stents serve as medical devices to address benign biliary strictures, suspected or confirmed biliary malignancies (tumors), and biliary stone disease. Currently, healthcare providers in Europe and other international markets have access to these stents, and Boston Scientific intends to introduce them in the United States during the first quarter of 2022.
Self-Expandable Metal Stents is the Preferred Material
Self-expandable metal stents are commonly used in gastrointestinal stenting due to several advantages. They are small enough to be delivered through an endoscope, allowing for minimally invasive procedures. These can be coated with chemicals to prevent tumor ingrowth, making them suitable for treating defects in the GI tract caused by conditions like perforations. Compared to older plastic stents, self-expandable metal stents offer a convenient insertion technique, lower complication rates, and better compliance. These stents are designed to be permanent solutions, often used in advanced-stage cancers where surgical removal is not feasible. For instance, in May 2019, Olympus revealed two new HANAROSTENT (Self-Expanding Metal Stents) at the Digestive Disease Week (DDW) 2019 conference, expanding its EndoTherapy portfolio. These new stents are manufactured by M.I. Tech and exclusively distributed by Olympus in the U.S. after receiving the 510(K) clearance. The HANAROSTENT LowAx Colonic and Duodenal Uncovered Stents cater to advanced procedures and provide specialized stent options for colorectal conditions.
North America to be the Dominating Region
North America's advanced healthcare infrastructure, increased awareness of gastrointestinal health issues, and a growing elderly population contribute to its dominant position in the market. Factors such as a high incidence of gastrointestinal diseases, a favorable reimbursement scenario, and the presence of key market players contribute to its market dominance. FDA approvals and government support for medical device development further enhance the market growth. The major factor contributing to lead in North America is the high incidence of digestive diseases like inflammatory bowel diseases. For instance, as per an article published in Gastroenterology AGA in July 2023, inflammatory bowel disease is diagnosed in more than 0.7% of Americans while age and sex-standardized incidence of inflammatory bowel disease per 100,000 person per years was estimated to be 10.9.
Future Market Scenario (2024-2031F)
The evolution of gastrointestinal stents showcases a progressive approach towards addressing complex GI conditions through advanced design innovations. Current efforts are geared towards refining existing stent types, such as metal, plastic, and biodegradable options. One focus is on anti-migratory features that prevent stents from moving within the body, reducing potential complications. Additionally, drug-eluting stents are being developed to deliver medications directly to targeted regions, helping to combat tumor growth. Another exciting advancement is the combination of radioactive stents with brachytherapy, showing promise in extending patient survival rates. As these technologies progress, they aim to minimize complications and enhance patient outcomes associated with gastrointestinal stents. For instance, QualiMed Innovative Medizinprodukte GmbH's Biodegradable Balloon-Expandable Biliary Stent System is under clinical investigation and is anticipated to be completed in mid-2024.
Key Players Landscape and Outlook
Boston Scientific Corporation, Olympus Corporation, Merit Medical Systems, Medtronic Plc, Terumo Corporation, Johnson & Johnson Services, Inc., 3M Inc., are some of the renowned players of the gastrointestinal stent market. The market is dominated by large key players who are actively involved in the research and development of innovative products. The recent acquisition of Taewoong Medical has significantly increased the market share of Olympus Corporation. Despite the developments, there have been reports of cancellation of deals in the market.
In February 2023, Olympus Corporation, a medtech company, announced the acquisition of Taewoong Medical Co., a South Korean manufacturer of medical devices, particularly gastrointestinal metallic stents. This acquisition aims to enhance Olympus's GI EndoTherapy product portfolio, ultimately improving patient outcomes through comprehensive solutions. Taewoong will receive approximately USD 370 million in cash with USD 255.5 million paid at closing and up to USD 114.5 million based on achieving future milestones.
In May 2023, Boston Scientific canceled its planned USD 230 million acquisition of South Korean medical technology company M.I.Tech which was responsible for gastrointestinal and airway stents in Boston. The deal, which would have given Boston Scientific a 64% stake in M.I.Tech, was announced in June 2022. Boston Scientific cited regulatory obstacles as the reason for ending the acquisition. The original agreement involved Boston Scientific paying 14,500 won per M.I.Tech share, totaling 291.2 billion won. The acquisition was expected to close in the second half of 2022.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.