|
시장보고서
상품코드
2082897
위마비 : 시장 인사이트, 역학 및 시장 예측(2036년)Gastroparesis - Market Insight, Epidemiology, and Market Forecast - 2036 |
||||||
DelveInsight
미국 위마비 시장 규모 및 전망
본 위마비 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 현황에 대한 종합적인 분석을 제공합니다. 위마비 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입률 분석을 평가하는 한편, 세계 각 지역의 상세한 시장 규모 평가 및 성장률 예측(과거 데이터 및 2022년-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 위마비 분야에서 주요 미충족 요구 사항을 부각시키고, 경쟁 구도와 임상 환경을 분석하여 고부가가치의 성장 기회를 도출하는 한편, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.
당뇨병 유병률 증가
위마비는 당뇨병, 특히 장기간 지속되는 증상과 밀접한 관련이 있습니다. 전 세계적으로 당뇨병 유병률이 증가함에 따라 위마비 환자 수도 늘어나고 있으며, 진단 및 치료에 대한 수요가 높아지고 있습니다.
고령화
고령자는 위마비를 비롯한 위장 질환에 걸리기 쉬운 경향이 있습니다. 고령 인구 증가는 환자 수 증가와 의료 수요 증가에 크게 기여하고 있습니다.
충족되지 않은 의료 수요
현재의 치료법으로는 증상 완화가 제한적인 경우가 많으며, 부작용이 동반되기도 합니다. 보다 효과적이고 안전한 치료법에 대한 수요가 혁신과 시장의 관심을 지속적으로 견인하고 있습니다.
위마비의 개요와 진단
위 배출 지연증은 기계적인 폐색이 없음에도 불구하고 위 내용물의 배출이 지연되는 것을 특징으로 하는 만성 위장 질환입니다. 장기간 당뇨병을 앓고 있는 사람들에게서 흔히 나타나지만, 수술 후 합병증, 약물, 또는 특발성 원인에 의해서도 발병할 수 있습니다. 환자는 일반적으로 메스꺼움, 구토, 조기 포만감, 복부 팽만감, 복통을 호소하며, 이러한 증상은 영양 상태와 삶의 질에 중대한 영향을 미칠 수 있습니다. 이 질환은 특히 당뇨병 환자의 경우, 영양실조, 탈수, 혈당 변동과 같은 합병증을 유발할 우려가 있습니다. 이러한 만성적이고 재발하기 쉬운 특성 때문에 장기적인 관리와 경과 관찰이 필요한 경우가 많습니다.
진단을 위해서는 기계적 폐색을 배제하고, 위 배출 지연을 확인해야 합니다. 일반적인 검사 방법으로는 위 배출 신티그래피(골드 스탠다드), 호기 검사, 상부 내시경 검사 등이 있습니다. 의사는 또한 당뇨병 등의 근본적인 원인을 평가하고, 위 운동 기능을 저해할 가능성이 있는 약물을 확인하는 등, 위마비로 진단하기 전에 종합적인 평가를 실시합니다. 복잡한 증상의 경우, 무선 운동 기능 캡슐이나 영상 검사 등의 추가 검사가 실시되기도 합니다. 위마비를, 유사한 증상을 보이는 다른 기능성 위장 장애와 구별하기 위해서는 정확한 진단이 필수적입니다.
위마비의 현재 치료 현황
치료는 증상 관리, 식이요법, 그리고 위 운동 기능 개선에 중점을 두고 있습니다. 환자분들께는 소량으로 저지방·저섬유질 식사를 섭취하도록 지도합니다. 약물 요법에는 위마비에 대해 FDA가 유일하게 승인한 약물인 메토클로프라미드(GIMOTI)와, 적응증 외로 사용되는 에리스로마이신 등의 운동 촉진제 및 구토 억제제가 포함됩니다. 구토 억제제 등 기타 대증 요법 약물은 메스꺼움이나 구토를 억제하는 데 도움이 될 수 있습니다. 중증 또는 난치성 환자의 경우, 영양 상태를 유지하고 삶의 질(QOL)을 향상시키기 위해 위 전기 자극, 공장루 영양 튜브, 또는 외과적 시술 등의 치료 옵션이 고려될 수 있습니다. 환자의 반응에는 개인차가 있으므로, 지속적인 경과 관찰과 맞춤형 치료 계획이 필수적입니다.
위마비에 대한 역학 분석 및 예측과 관련된 주요 조사 결과
위마비의 치료는 그동안 식이요법, 구토 억제제, 운동 촉진제 등의 대증요법에 의존해 왔습니다. 치료 과정에서 중요한 전환점이 된 것은 도파민 수용체 길항 작용을 통해 위 운동성을 높이는 메토클로프라미드(GIMOTI)의 승인입니다. 그 효과에도 불구하고, 장기 사용은 안전성 문제로 인해 제한되고 있어, 내약성이 더 높고 지속성이 있는 치료법의 필요성이 부각되고 있습니다.
위마비의 치료 파이프라인은 점차 발전하고 있으며, 새로운 작용기전을 통해 위장 운동 기능 및 증상 조절을 목표로 하는 임상시험용 약물이 개발되고 있습니다. 선택적 5-HT4 수용체 작용제인 나로나프리드(ATI-7505)는 기존 약물에 비해 심장에 대한 안전성을 높이는 동시에 위 내용물의 배출을 촉진하는 것을 목적으로 개발이 진행되고 있습니다. CIN-102(데우돈페리돈)은 중추신경계에 미치는 부작용을 줄이면서 운동 촉진 효과를 발휘하는 것을 목표로 하고 있습니다. 또한, NG101(메토피마진)에 대해서도 구토 억제 작용에 대한 연구가 진행 중이며, 위마비와 관련된 지속적인 메스꺼움이나 구토를 완화할 가능성이 있습니다.
전반적으로, 보다 안전하고 표적화된 치료법의 등장과 더불어 진단 능력의 향상 및 질환에 대한 인식 제고에 힘입어, 2022년부터 2036년에 걸쳐 주요 7개국 전체에서 꾸준한 시장 성장이 예상되며, 이는 기존 제품 및 파이프라인 후보들에게 큰 상업적 기회를 가져다줄 것으로 전망됩니다.
전반적으로, 위마비 치료 분야의 혁신은 운동 촉진 작용이나 구토 억제 작용 등 상호 보완적인 작용기전을 표적으로 하는 이미 승인되었거나 개발 중인 저분자 치료제에 의해 주도되고 있습니다. 개발 파이프라인의 후보 약물이 개발 단계를 거치면서, 메토클로프라미드 이외의 치료 옵션을 확대하여 중요한 미충족 의료 수요를 충족시키는 동시에, 주요 지역 전반에 걸쳐 꾸준한 시장 성장을 뒷받침할 것으로 기대됩니다.
Gastroparesis Market Size and Forecast in the US
DelveInsight's 'Gastroparesis - Market Insights, Epidemiology and Market Forecast - 2036' report delivers an in-depth understanding of the gastroparesis, historical and forecasted epidemiology, as well as the gastroparesis market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.
The gastroparesis market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates gastroparesis patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in gastroparesis and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.
Key Factors Driving the Gastroparesis Market
Rising Prevalence of Diabetes
Gastroparesis is strongly linked to diabetes, particularly long-standing cases. As diabetes rates increase globally, the number of gastroparesis patients grows, boosting demand for diagnosis and treatment.
Aging Population
Older adults are more prone to gastrointestinal disorders, including gastroparesis. The growing elderly population contributes significantly to rising case numbers and healthcare demand.
Unmet Medical Needs
Current treatments often provide limited relief and may have side effects. The need for more effective and safer therapies continues to drive innovation and market interest.
Gastroparesis Overview and Diagnosis
Gastroparesis is a chronic gastrointestinal disorder characterized by delayed gastric emptying without any mechanical obstruction. It commonly occurs in people with long-standing diabetes but can also arise from post-surgical complications, medications, or idiopathic causes. Patients typically experience nausea, vomiting, early satiety, bloating, and abdominal pain, which can significantly impact nutrition and quality of life. The condition can lead to complications such as malnutrition, dehydration, and erratic blood glucose levels, particularly in diabetic patients. Its chronic and relapsing nature often requires long-term management and monitoring.
Diagnosis involves ruling out mechanical obstruction and confirming delayed gastric emptying. Common tools include gastric emptying scintigraphy (the gold standard), breath tests, and upper endoscopy. Physicians also assess underlying causes such as diabetes and review medications that may impair gastric motility, ensuring a comprehensive evaluation before confirming gastroparesis. Additional tests like wireless motility capsules and imaging studies may be used in complex cases. Accurate diagnosis is crucial to differentiate gastroparesis from other functional gastrointestinal disorders with similar symptoms.
Current Gastroparesis Treatment Landscape
Treatment focuses on symptom management, dietary modifications, and improving gastric motility. Patients are advised to consume small, low-fat, low-fiber meals. Pharmacologic therapy includes prokinetic and antiemetic agents such as Metoclopramide (GIMOTI), the only FDA-approved drug specifically indicated for gastroparesis, and Erythromycin, used off-label. Other supportive medications, like antiemetics, may help control nausea and vomiting. In severe or refractory cases, options such as gastric electrical stimulation, jejunostomy feeding tubes, or surgical interventions may be considered to maintain nutrition and improve quality of life. Continuous monitoring and individualized treatment plans are essential due to variability in patient response.
Gastroparesis Unmet Needs
The section "unmet needs of gastroparesis" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.
Key Findings from Gastroparesis Epidemiological Analysis and Forecast
Gastroparesis Drug Analysis & Competitive Landscape
The gastroparesis drug chapter provides a detailed, market-focused review of the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the gastroparesis treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the gastroparesis therapeutics market.
Approved Therapies for Gastroparesis
Metoclopramide (GIMOTI): EVOKE Pharma/EVERSANA
GIMOTI nasal spray is the first and only FDA-approved non-oral treatment for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide hydrochloride is the active ingredient in GIMOTI. It is a dopamine antagonist, 5-HT3 antagonist, and 5-HT4 agonist with promotility and anti-emetic effects, for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. In June 2020, the US FDA approved metoclopramide (GIMOTI) nasal spray. In January 2020, EVOKE Pharma entered into a commercial services agreement with Eversana Life Sciences Services for the commercialization of GIMOTI. According to the Eversana Agreement, Eversana will commercialize and distribute GIMOTI in the US.
Gastroparesis Pipeline Analysis
Naronapride (ATI-7505): Renexxion
Naronapride is an investigational gastrointestinal prokinetic drug. It is designed to treat disorders of gut motility, including gastroparesis. Naronapride works through a differentiated dual mechanism of action- 5-HT4 receptor agonism and dopamine D2 receptor antagonism. Inhibiting D2 receptors removes the "brakes" on the motility of the gut. The high 5-HT4 receptor selectivity minimizes the potential for off-target pharmacological effects. Its dual mechanism of action, minimal systemic bioavailability, and differentiated pharmaceutical and pharmacokinetic profile are designed to deliver targeted activity within the GI tract while limiting systemic exposure. In October 2021, Renexxion Ireland announced that it had entered into a Licensing and Collaboration Agreement with Dr. Falk Pharma GmbH to jointly develop and commercialize Naronapride, a unique late-stage GI prokinetic, initially for gastroparesis.
Gastroparesis Key Players, Market Leaders, and Emerging Companies
Gastroparesis Drug Updates
The treatment landscape for gastroparesis has historically relied on symptomatic management, including dietary modifications, antiemetics, and prokinetic agents. A key milestone in therapy is the approval of metoclopramide (GIMOTI), which enhances gastric motility through dopamine receptor antagonism. Despite its effectiveness, long-term use is limited by safety concerns, highlighting the need for better-tolerated and more durable therapies.
The gastroparesis pipeline is gradually evolving, with investigational agents targeting gastrointestinal motility and symptom control through novel mechanisms. Naronapride (ATI-7505), a selective 5-HT4 receptor agonist, is being developed to enhance gastric emptying with improved cardiac safety versus earlier agents. CIN-102 (deudomperidone) aims to deliver prokinetic effects with fewer central nervous system side effects. NG101 (metopimazine) is also under investigation for its antiemetic action, potentially relieving persistent nausea and vomiting associated with gastroparesis.
Overall, the emergence of safer and more targeted therapies, along with improvements in diagnostic capabilities and increasing disease awareness, is projected to propel steady market growth across the 7MM from 2022 to 2036, yielding significant commercial opportunities for existing products and pipeline candidates.
Drug Class/Insights into Leading Emerging and Marketed Therapies in Gastroparesis (2022-2036 Forecast)
The gastroparesis market (2022-2036 forecast) is shifting toward mechanism-based therapies that aim to improve gastric motility and control core symptoms such as nausea and vomiting, rather than relying solely on general supportive care.
Overall, innovation in gastroparesis is driven by approved and investigational small-molecule therapies targeting complementary mechanisms, including prokinetic and antiemetic effects. As pipeline candidates advance, they are expected to broaden treatment options beyond metoclopramide, address key unmet needs, and support steady market growth across major regions.
Gastroparesis Drug Uptake
This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the gastroparesis drug's uptake, performance at peak, factors affecting performance during prime years of growth, patient uptake by therapy, and anticipated sales generated by each drug.
During the forecast period, the currently FDA-approved therapy Metoclopramide (GIMOTI) is expected to maintain baseline utilization as the first-line pharmacologic option. However, its uptake is likely to plateau due to safety concerns such as extrapyramidal side effects and limitations on long-term use. It will continue to be widely used in acute and short-term management, particularly in newly diagnosed patients and in settings where newer therapies are not yet accessible.
Among pipeline agents, Naronapride (ATI-7505) is expected to see gradual uptake as a next-generation 5-HT4 agonist, driven by its potential to improve gastric motility with a more favorable cardiovascular safety profile. CIN-102 (domperidone) is expected to follow a moderate adoption curve, particularly in regions where domperidone use is established, benefiting from improved pharmacokinetic stability and reduced CNS penetration. Its uptake will likely be driven by chronic symptom management needs. NG101 (metopimazine) is expected to achieve faster early adoption in select patient segments due to its strong antiemetic effect, positioning it as an add-on therapy for refractory nausea and vomiting. Overall uptake will depend on clinical efficacy, safety outcomes, and positioning alongside standard of care therapies.
Gastroparesis Therapies Price Scenario & Trends
Pricing and analogue assessment of gastroparesis therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, closest and most appropriate analogue selection for emerging therapies, and understanding of how pricing influences market gastroparesis, adherence, and long-term uptake.
The recommended dosage of GIMOTI for adults with acute and recurrent diabetic gastroparesis is one spray (15 mg) administered into one nostril, 30 minutes before each meal and at bedtime, up to a maximum of four times daily. Treatment duration ranges from 2 to 8 weeks, based on the patient's symptomatic response. A single bottle provides sufficient medication for 28 days of use at the maximum recommended frequency. The cost per bottle is approximately USD 2,276.03, resulting in an estimated total therapy cost of around USD 4,552 for an 8-week course.
Industry Experts and Physician Views for Gastroparesis
To keep up with the gastroparesis market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the Gastroparesis emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in gastroparesis, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.
DelveInsight's analysts connected with 15+ KOLs to gather insights at the country level. Centers such as the Duke Molecular Physiology Institute, Department of Nephrology, Hospital Universitario Fundacion Alcorcon, and Nippon Medical School, etc. were contacted. Their opinion helps understand and validate current and emerging gastroparesis therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in gastroparesis.
Qualitative Analysis: SWOT and Conjoint Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.
In the SWOT analysis of gastroparesis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.
Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.
The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.
Market Insights