세계 궤양성 대장염 시장 규모는 2024년 82억 달러에 달했습니다. 향후 IMARC Group은 이 시장이 2033년까지 125억 달러에 달하고, 2025-2033년 연평균 성장률(CAGR)은 4.82%를 보일 것으로 전망하고 있습니다. 이 시장은 유병률 증가, 치료법 발전, 정부 지원 정책 등에 힘입어 성장하고 있습니다. 또한, 선진국과 신흥국 시장에서 혁신적인 치료법에 대한 세계 인식이 높아지면서 시장에 추가적인 부가가치를 창출하고 있습니다.
주요 시장 성장 촉진요인 : 전 세계 궤양성 대장염 환자 수의 급증, 염증성 장 질환의 존재에 대한 인식이 환자들 사이에서 혁신적인 치료법과 진단법에 대한 수요를 자극하고 있습니다. 또한, 기술 발전, 생물학적 제제의 확대, 새로운 치료법의 발명으로 시장 개척이 강화되고 있습니다. 선진국과 신흥국의 의료비 지출 증가도 시장 확대를 촉진하고 있습니다.
주요 시장 동향 : 궤양성 대장염 치료에서 유전적, 환경적, 표현형적 특징에 따른 맞춤형 치료법을 강조하는 개인맞춤형 의료 트렌드가 강화되고 있습니다. 또한, 중증 환자 관리를 위한 생물학적 제제 및 바이오시밀러의 채택 확대가 이 시장에서 제약업계의 방향성에 큰 영향을 미치고 있습니다.
지리적 동향 : 북미는 선진화된 의료 시설, 높은 의료비, 잘 발달된 제약회사로 인해 궤양성 대장염 시장을 선도하고 있습니다. 그러나 아시아태평양은 의료 시설 증가, 환자의 인식 개선, 중국, 인도 등 의료 관광의 중심지이기 때문에 큰 발전이 예상됩니다.
경쟁 구도: 궤양성 대장염(궤양성 대장염) 시장의 주요 시장 참여자는 Abbott Laboratories,AbbVie Inc. GlaxoSmithKline plc, Johnson &Johnson, Merck &Co.
과제와 기회: 이 시장의 주요 과제는 높은 치료 비용으로, 특히 생물학적 제제의 경우 저소득 국가에서는 접근의 장벽이 될 수 있습니다. 또 다른 요인은 신약 승인 절차가 까다롭고 시간이 오래 걸리기 때문에 새로운 치료법 시장 진입이 지연될 수 있다는 점입니다. 이러한 어려움에도 불구하고, 이러한 어려움은 기회를 창출할 수 있는 기반이 될 수 있습니다. 비용 효율적인 치료법을 개발하고 승인 절차를 간소화하는 것은 전 세계 기업들에게 도움이 될 수 있습니다.
궤양성 대장염의 유병률 증가
궤양성 대장염의 유병률 증가, 염증성 장 질환에 대한 인식의 확산은 환자들 사이에서 혁신적인 치료법과 진단법에 대한 수요를 자극하고 있습니다. 또한, 기술 발전, 생물학적 제제의 확대, 새로운 치료법의 발명으로 시장 개척이 강화되고 있습니다. NATIONAL LIBRARY OF MEDICINE에 따르면, 궤양성 대장염의 연간 발병률은 10만 명당 9-20명이며, 유병률은 15만 명당 1.5명으로 추정됩니다. 유병률은 10만 명당 156-291명입니다.
치료의 발전
궤양성 대장염 치료는 생물학적 제제 및 저분자 의약품의 개발로 크게 발전했습니다. 이러한 발전이 가져온 긍정적인 분위기는 시장과 관련하여 더 유리한 요인을 만들어 내고 있습니다. 한편으로는 진단 기술의 발전과 새로운 표적 치료 접근법의 개발이 보다 효과적인 치료법 개발로 인한 채택 증가로 인해 시장에 긍정적인 영향을 미치고 있습니다. 예를 들어, 화이자는 2023년 미국 식품의약국(FDA)이 중등도에서 중증의 성인 스핑고신-1-인산(S1P) 수용체 조절제인 VELSIPITY(TM)(에트라시모드)를 1일 1회 경구 투여로 승인했다고 발표했습니다.
정부 및 규제 당국의 지원
정부의 우호적인 정책과 의료비 지출 증가는 궤양성 대장염 시장 성장에 큰 영향을 미칠 것입니다. 규제 당국의 승인은 효과적인 신약의 신속한 시장 진입을 촉진하고 환자에게 첨단 치료 옵션을 제공할 수 있습니다. 또한, 일부 정부는 연구 개발에 대한 자금 지원을 강화하고 제약 회사가 궤양성 대장염에 대한 혁신적인 치료법에 투자하도록 장려하고 있으며, 이는 시장 성장을 더욱 촉진하고 있습니다.
The global ulcerative colitis market size reached USD 8.2 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 12.5 Billion by 2033, exhibiting a growth rate (CAGR) of 4.82% during 2025-2033. The market is experiencing growth due to rising disease prevalence, advancements in medical treatments, and supportive government policies. Moreover, increasing global awareness regarding innovative therapies in developed and developing regions is further adding value to the market.
Major Market Drivers: The surging number of ulcerative colitis globally, and the awareness about the existence of inflammatory bowel diseases, stimulate the demand for innovative treatments and diagnostic methods among patients. In addition, technological progress, the expansion of biologics and the invention of new therapies intensify market development. The growing expenditure on healthcare in developed and developing countries also promotes market enlargement.
Key Market Trends: There is an increasing trend toward personalized medicine in treating ulcerative colitis, emphasizing customized therapeutic methods based on genetic, environmental, and phenotypic characteristics. Furthermore, the increased adoption of biologics and biosimilars for managing severe cases is significantly influencing the direction of the pharmaceutical industry in this market.
Geographical Trends: North America leads the ulcerative colitis market due to advanced healthcare facilities, high healthcare expenditure, and established pharmaceutical companies. However, Asia Pacific is anticipated to develop at a significant rate, given the increased health facilities, patient awareness, and medical tourism centering the region, such as China and India.
Competitive Landscape: Some of the major market players in the ulcerative colitis industry include Abbott Laboratories, AbbVie Inc., AstraZeneca plc, Bristol-Myers Squibb Company, Eli Lilly and Company, F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc, Johnson & Johnson, Merck & Co. Inc., Pfizer Inc., Takeda Pharmaceutical Company Limited, and Teva Pharmaceutical Industries Ltd. among many others.
Challenges and Opportunities: The primary challenge of the market is the high cost of treatment, which may create barriers to access in low-income countries, particularly when biologics are involved. Another factor is the labor-intensive and lengthy drug approval process, which could delay new treatments from entering the market. Despite its severity, the challenge can serve as a basis for opportunities. Developing cost-effective therapies and streamlining the approval process can become beneficial for businesses across the globe.
Increasing Prevalence of Ulcerative Colitis
The growth in the prevalence of ulcerative colitis, as well as the spread of awareness about the existence of inflammatory bowel diseases, stimulates the demand for innovative treatments and diagnostic methods among patients. In addition, technological progress, the expansion of biologics, and the invention of new therapies intensify market development. The growing expenditure on healthcare in developed and developing countries also promotes market enlargement. According to the NATIONAL LIBRARY OF MEDICINE, ulcerative colitis has an incidence of 9 to 20 cases per 100,000 persons per year. Its prevalence is 156 to 291 cases per 100,000 persons per year.
Advancements in Medical Treatments
Medical treatment of ulcerative colitis has come a long way with the development of biologics and small-molecule drugs. The positive spirit brought about by this progress has created more favorable market-related factors. On the one hand, advances in diagnostic technologies and the development of new targeted treatment approaches have positively affected the market due to increased adoption driven by the development of more effective treatments. For instance, Pfizer Inc. in 2023 announced that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY(TM) (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC).
Government and Regulatory Support
Favorable government policies and increased healthcare spending significantly impact the ulcerative colitis market growth. With regulatory approvals facilitating the rapid market entry of new and effective drugs, patients gain access to advanced treatment options. Additionally, several governments have ramped up funding for research and development, encouraging pharmaceutical companies to invest in innovative therapies for ulcerative colitis, which further stimulates market growth.
Mild UC accounts for the majority of the market share
The mild ulcerative colitis segment dominates owing to the greater prevalence of mild cases compared to moderate and severe forms. Patients with mild UC generally experience fewer symptoms, which can typically be managed with oral medications, such as aminosalicylates. It benefits from numerous first-line treatment options that are less expensive and have fewer side effects, making them accessible and favored by patients and healthcare providers. The availability of effective and affordable treatments contributes significantly to the dominance of this segment in increasing the overall ulcerative colitis market demand. Mild ulcerative colitis is treated with mesalamine (5-aminosalicylic acid, 5-ASA) and other UC medications across all countries. As per the American College of Gastroenterology (ACG) treatment instruction, ulcerative colitis (UC) is categorized as mild in patients who have fewer than four (4) bowel movements per day, minimal bleeding, and no appreciable urgency or abdominal pain. In comparative studies of 2.4 g and 4.8 g daily doses of mesalamine, it was found that patients with mild disease will improve with 2.4 g and 4.8 g doses of mesalamine.
Ulcerative proctitis holds the largest share in the industry
Ulcerative proctitis is considered the mildest due to the inflammation being confined to the rectum. Patients usually experience such symptoms as rectal bleeding, urgency, and tenesmus. As per the study by Matthew Mutch, in Shackelford's Surgery of the Alimentary Tract, 2 Volume Set (Eighth Edition), 2019, patients with ulcerative pancolitis for more than 8 years are at higher risk of colorectal cancer, with the risk ranging from 0.5% to 1% per year. The localized nature of symptoms is why it is easier to treat the condition with medicines that require the closest interaction with the perished area rather than using more invasive and less patient-friendly systemic treatment. The focused treatment combines fewer systemic side effects, which is why patients prefer using suppositories or enemas as treatment. Facing better treatment opportunities, patients with ulcerative proctitis have a very good prognosis. Hence, the demand for quality treatments is growing.
Biologics represents the leading market segment
Biologics represent the largest segment in the market. The key reasons for the popularity of this therapy type involve its high efficiency in reducing inflammation and achieving and maintaining remission in patients suffering from moderate to severe disease. These protein-containing drugs work by aiming at particular parts of the immune system that encourage developing inflammation in the body. The increasing demand for biologics is explained by the growing number of approvals and biosimilars, which will make these drugs more available and less costly. For illustration purposes, in March 2024, Johnson & Johnson unveiled the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration pursuing approval of TREMFYA(R) (guselkumab) to treat adult patients with moderately to severely active ulcerative colitis. It is supported by data from the Phase 3 QUASAR program evaluating the efficacy and safety of TREMFYA(R) to treat patients with moderately to severely active UC who had an inadequate response or intolerance to traditional therapy, prior biologics and/or JAK inhibitors.
Anti-TNF biologics exhibits a clear dominance in the market
The market is currently dominated by anti-TNF biologics, primarily due to their ability to control inflammation and sustain remission in patients with moderate-to-severe conditions. Anti-TNF biologics are accustomed to neutralizing the action of a protein in the body known as TNF that causes inflammation, making them a preferable option for patients who are not treated with monotherapy. In addition, the established success of anti-TNF biologics in patient quality of life would agree with these results, despite concerns about costs and side effects.
Injectable dominates the market
Injectable medications hold a prominent position in the ulcerative colitis market revenue, primarily due to their capacity to deliver treatments directly to the bloodstream, effectively bypassing the digestive system. This category includes biologics such as infliximab and adalimumab, which are particularly used for moderate to severe cases. The preference for injectables stems from their rapid action and high efficacy, especially beneficial for patients who do not respond to oral medications. Additionally, the less frequent dosing requirement compared to oral medications enhances the appeal of injectables, making them a popular choice in managing ulcerative colitis and contributing to their substantial market share. Top of FormFor instance, in 2023, the Food and Drug Administration (FDA) indicated that the subcutaneous administration of vedolizumab is an approvable maintenance therapy for moderate to severe ulcerative colitis following intravenous infusion. It is the only FDA-approved biologic in ulcerative colitis maintenance therapy that is based on IV and SC dose-approved medication.
Hospital pharmacies are the predominant market segment
Hospital pharmacies constitute the largest segment in the ulcerative colitis market forecast. Their pivotal role in distributing treatments stems from their proximity to patient care settings and their responsibilities in administering and monitoring therapies. Hospitals are often the first to receive new drug approvals, positioning them as primary channels for distributing advanced therapeutics. This segment benefits from direct interactions with pharmaceutical manufacturers and often engages in price negotiations, which can significantly influence treatment accessibility and adoption rates among patients. For instance, the Apollo Hospital pharmacy business is about to touch 10,000 crore in revenue this year with 5,790 pharmacies, Apollo is the largest pharmacy chain, adding 400-500 stores each year.
North America leads the market, accounting for the largest ulcerative colitis market share
The market research report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.
North America dominates the ulcerative colitis market on account of the high occurrence of the disorder, superior medical facilities, and extensive funding for R&D activities. The American and Canadian health systems ensure the substantial usage of progressive treatments, and private insurance plans and campaigns further enhance the consumer understanding of products. Companies in the pharmaceutical and biotech sectors accelerate the development of innovative treatment methods. They integrate the most successful ones into their treatment protocols at an early stage, advancing the market. At present, ulcerative colitis has an incidence of 9 to 20 cases per 100,000 persons per year and 156 to 291 cases per 100,000 persons per year as per National Institute of Health (NIH). Ulcerative colitis market recent opportunities include numerous key players collaborating to expand their market growth. For instance, Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceuticals Industries Ltd., and Sanofi collaborated to create and co-commercialize asset TEV'574, to treat Ulcerative Colitis and Crohn's Disease.
The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the keyword industry include Abbott Laboratories, AbbVie Inc., AstraZeneca plc, Bristol-Myers Squibb Company, Eli Lilly and Company, F. Hoffmann-La Roche Ltd., GlaxoSmithKline plc, Johnson & Johnson, Merck & Co. Inc., Pfizer Inc., Takeda Pharmaceutical Company Limited, Teva Pharmaceutical Industries Ltd.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
Leading players in the ulcerative colitis market recent developments include the development of advanced biologics and small molecule therapies, improved drug delivery systems, and expansion into untapped markets. The leading players are also involved in strategic initiatives such as partnerships, mergers, acquisitions, and increasing investment in research and innovation to enhance treatment efficacies. These efforts are aimed at boosting market share and addressing the unmet needs in ulcerative colitis management. Besides this, Pfizer Inc. unveiled that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for VELSIPITY(TM) (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator. This medication is intended for the treatment of patients aged 16 and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological agent.
November 2021: Bristol Myers Squibb received European Commission approval for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis.Top of Form
March 2024: AbbVie Inc., and Landos Biopharma Inc. unveiled that AbbVie entered into a definitive agreement that provides for the acquisition of Landos, a clinical-stage biopharmaceutical corporation keen on developing advanced novel oral therapeutics for individuals with autoimmune disorders.