시장보고서
상품코드
2064045

ZEPOSIA : 판매 예측 및 시장 규모(2034년)

ZEPOSIA Sales Forecast, and Market Size Analysis - 2034

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 30 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




■ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송일정은 문의해 주시기 바랍니다.

가격
PDF (Single User License) help
PDF 보고서를 1명만 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 2,750 금액 안내 화살표 ₩ 4,096,000
PDF & Excel (2-3 User License) help
PDF 및 Excel 보고서를 동일 사업장에서 3명까지 이용할 수 있는 라이선스입니다. PDF·Excel 내 텍스트 등의 복사 및 붙여넣기는 가능하나, 사내 이용으로만 제한됩니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 3,438 금액 안내 화살표 ₩ 5,121,000
PDF & Excel (Site License) help
PDF 및 Excel 보고서를 동일 사업장(소재지) 내 모든 분이 이용할 수 있는 라이선스입니다. PDF·Excel 내 텍스트 등의 복사 및 붙여넣기는 가능하나, 사내 이용으로만 제한됩니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 4,813 금액 안내 화살표 ₩ 7,170,000
PDF & Excel (Global License) help
PDF 및 Excel 보고서를 동일 기업의 모든 분이 이용할 수 있는 라이선스입니다. PDF·Excel 내 텍스트 등의 복사 및 붙여넣기는 가능하나, 사내 이용으로만 제한됩니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 6,188 금액 안내 화살표 ₩ 9,218,000
※ 부가세 별도
한글목차
영문목차

ZEPOSIA의 성장을 이끄는 주요 요인

1. 견실한 상업적 성장과 매출 기반의 확대

브리스톨 마이어스 스큅은 2024년 ZEPOSIA의 전 세계 매출이 약 5억 6,600만 달러에 달했다고 보고했습니다. 이는 2023년 매출인 4억 3,400만 달러와 비교했을 때, 전년 대비 약 30%의 성장률을 보여주고 있습니다. 미국내 매출은 4억 300만 달러에 달했으며, 해외 매출은 1억 6,300만 달러로 확대되었습니다. 이는 다발성 경화증(MS) 및 궤양성 대장염(UC) 두 적응증 모두에서 이 치료법의 채택이 확대되고 있음을 반영합니다.

2. 두 가지 적응증의 승인으로 대상 환자층이 확대됨

ZEPOSIA는 다음과 같은 적응증에 대해 승인되었습니다.

  • 재발성 다발성 경화증(RMS)
  • 중등도에서 중증의 활동성 궤양성 대장염(UC)

신경계 및 소화기 분야 모두에서 승인을 획득함에 따라 처방 기회가 대폭 확대되었습니다. FDA는 2020년에 ZEPOSIA의 다발성 경화증(MS) 적응증을 최초로 승인한 데 이어, 2021년에는 궤양성 대장염(UC) 적응증을 승인했습니다.

3. 하루 1회 경구 투여로 인한 편의성

ZEPOSIA의 1일 1회 경구 투여는 다발성 경화증(MS)이나 궤양성 대장염(UC)에 일반적으로 사용되는 주사용 생물제제나 정맥 주입 요법에 비해 경쟁상 큰 이점을 제공합니다. 이러한 편의성은 특히 수액 치료 센터를 방문하거나 주사 요법을 피하고자 하는 환자들에게서 복약 순응도 강화과 의사의 선호로 이어집니다.

4. 차별화된 선택적 S1P 작용 기전이 안전성 포지셔닝을 지원

ZEPOSIA는 S1P 수용체 1과 5를 선택적으로 표적으로 하며, 더 광범위한 심혈관계 부작용과 관련된 수용체에 대한 작용은 제한적입니다. 브리스톨 마이어스 스큅(Bristol Myers Squibb)은 이 약물을 고도로 선택적인 S1P 조절제로 규정하고 있으며, 기존의 S1P 치료법에 비해 내약성이 향상될 가능성이 있습니다.

5. 확대되는 궤양성 대장염(UC) 시장과 첨단 경구 치료법에 대한 수요

UC 시장은 생물제제 및 JAK 억제제와 경쟁할 수 있는 표적 경구 치료제로의 전환이 급속히 진행되고 있습니다. 제3상 주요 임상시험인 TRUE NORTH 시험에서, ZEPOSIA는 바이오의약품으로 이미 치료받은 적이 있는 환자를 포함한 중등도 내지 중증의 궤양성 대장염 환자에서 관해 유도 및 유지 양측 모두에서 유효성을 입증했습니다. 이에 따라 소화기 전문의의 채용이 확대되고 있습니다.

ZEPOSIA의 최근 동향

  • 2024년 9월, 브리스톨 마이어스 스큅(Bristol Myers Squibb)은 제3상 DAYBREAK 임상시험의 새로운 데이터를 발표했습니다. 이에 따르면 재발성 다발성 경화증 환자를 대상으로 ZEPOSIA(오자니모드) 치료를 실시한 경우, 비맹검 연장 임상시험(OLE)에서도 뇌 용적 감소율의 저하가 지속되는 것으로 나타났습니다. 이러한 결과에 따르면 ZEPOSIA로 최대 5년간 지속 치료를 받은 환자에서 60개월 시점까지 전체 뇌 용적(WBV) 감소율이 낮고 안정된 것으로 나타났습니다.

이 보고서는 주요 7개국(미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본)에서 ZEPOSIA의 동향을 조사하여, 다발성 경화증 및 궤양성 대장염과 같은 승인된 적응증은 물론 크론병 등의 잠재적 적응증에 관한 포괄적인 인사이트를 제공합니다.

이 보고서에서는 2020-2034년 승인된 적응증에 대한 기존 사용 현황, 잠재적 적응증으로의 진출 전망, 시장 성과에 대한 상세한 분석과 더불어, 승인된 적응증 및 잠재적 적응증에 대한 ZEPOSIA의 상세한 설명이 제공됩니다. 또한 ZEPOSIA의 매출 전망, 작용 기전(MoA), 투여량 및 투여 방법, 규제 관련 주요 단계 등을 포함한 연구개발 및 기타 활동에 대한 인사이트, 향후 시장 평가, SWOT 분석, 애널리스트의 견해, 경쟁 구도, 각 적응증별 기타 신흥 치료제에 대한 개요, 시장을 촉진하는 요인에 대해서도 분석하고 있습니다.

자주 묻는 질문

  • ZEPOSIA의 2024년 전 세계 매출 규모는 얼마인가요?
  • ZEPOSIA의 2023년 매출과 비교했을 때 성장률은 어떻게 되나요?
  • ZEPOSIA의 승인된 적응증은 무엇인가요?
  • ZEPOSIA의 투여 방식은 어떤 장점이 있나요?
  • ZEPOSIA의 안전성 포지셔닝은 어떻게 되나요?
  • ZEPOSIA의 궤양성 대장염 시장에서의 경쟁력은 무엇인가요?

목차

제1장 리포트 개요

제2장 ZEPOSIA의 개요 : 다발성 경화증 및 궤양성 대장염 등의 승인된 적응증 및 크론병 등의 잠재적 적응증

제3장 ZEPOSIA : 경쟁 구도(출시 치료제)

제4장 ZEPOSIA : 경쟁 구도(후기 개발 단계 신규 치료제)

제5장 ZEPOSIA : 시장 평가

제6장 ZEPOSIA : SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

KSA 26.06.26

Key Factors Driving ZEPOSIA Growth

1. Strong Commercial Growth and Expanding Revenue Base

Bristol Myers Squibb reported worldwide ZEPOSIA sales of approximately $566 million in 2024, representing about 30% year-over-year growth versus 2023 sales of $434 million. U.S. sales reached $403 million, while international revenue grew to $163 million, reflecting improving uptake across both MS and UC indications.

2. Dual Approved Indications Expand Addressable Patient Pool

ZEPOSIA is approved for:

  • Relapsing forms of multiple sclerosis (RMS)
  • Moderately-to-severely active ulcerative colitis (UC)

Having approvals in both neurology and gastroenterology significantly broadens prescribing opportunities. The FDA first approved ZEPOSIA for MS in 2020 and later approved it for UC in 2021.

3. Convenient Once-Daily Oral Administration

ZEPOSIA's once-daily oral dosing offers a major competitive advantage over injectable biologics and infusion therapies commonly used in MS and UC. This convenience supports patient adherence and physician preference, particularly among patients seeking to avoid infusion centers or injectable therapies.

4. Differentiated, Selective S1P Mechanism Supports Safety Positioning

ZEPOSIA selectively targets S1P receptors 1 and 5 with limited activity on receptors associated with broader cardiovascular adverse effects. Bristol Myers Squibb positions the drug as a highly selective S1P modulator, potentially improving tolerability compared with earlier-generation S1P therapies.

5. Growing Ulcerative Colitis Market and Demand for Advanced Oral Therapies

The UC market is rapidly shifting toward targeted oral therapies that can compete with biologics and JAK inhibitors. In the pivotal Phase III TRUE NORTH study, ZEPOSIA demonstrated efficacy in both induction and maintenance of remission in moderate-to-severe UC patients, including biologic-experienced patients. This has supported increasing gastroenterologist adoption.

ZEPOSIA Recent Developments

  • In September 2024, Bristol Myers Squibb announced new data from the Phase III DAYBREAK trial demonstrating that decreased rates of brain volume loss were sustained in the open-label extension (OLE) for patients treated with ZEPOSIA (ozanimod) for relapsing forms of multiple sclerosis. These findings showed that patients receiving continuous Zepoisia treatment for up to five years experienced low and stable rates of whole brain volume (WBV) loss through Month 60.

"ZEPOSIA Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of ZEPOSIA for approved indication like Multiple sclerosis and Ulcerative colitis; as well as potential indication like Crohn's disease in the 7MM. A detailed picture of ZEPOSIA's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the ZEPOSIA for approved and potential indications. The ZEPOSIA market report provides insights about ZEPOSIA's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current ZEPOSIA performance, future market assessments inclusive of the ZEPOSIA market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of ZEPOSIA sales forecasts, along with factors driving its market.

ZEPOSIA Drug Summary

ZEPOSIA is an oral sphingosine 1-phosphate (S1P) receptor modulator developed by Bristol Myers Squibb for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as moderately to severely active ulcerative colitis (UC) in adults. The drug contains the active ingredient ozanimod, which selectively binds to S1P receptor subtypes 1 and 5, reducing lymphocyte migration into the central nervous system and inflamed gastrointestinal tissue, thereby helping control immune-mediated inflammation. Administered orally once daily following a 7-day dose titration schedule, ZEPOSIA offers a convenient non-biologic treatment option with demonstrated efficacy in reducing relapse rates in MS and inducing and maintaining remission in UC. Clinical studies such as SUNBEAM, RADIANCE, and TRUE NORTH supported its approvals by showing significant improvements in disease activity and long-term disease control, while its safety profile is generally characterized by transient bradycardia, elevated liver enzymes, infection risk, and lymphocyte count reduction requiring monitoring before and during treatment. The report provides ZEPOSIA's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the ZEPOSIA Market Report

The report provides insights into:

  • A comprehensive product overview including the ZEPOSIA MoA, description, dosage and administration, research and development activities in approved indications like Multiple sclerosis and Ulcerative colitis; as well as potential indication like Crohn's disease.
  • Elaborated details on ZEPOSIA regulatory milestones and other development activities have been provided in ZEPOSIA market report.
  • The report also highlights ZEPOSIA's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
  • The ZEPOSIA market report also covers the patents information, generic entry and impact on cost cut.
  • The ZEPOSIA market report contains current and forecasted ZEPOSIA sales for approved and potential indications till 2034.
  • Comprehensive coverage of the late-stage emerging therapies for respective indications.
  • The ZEPOSIA market report also features the SWOT analysis with analyst views for ZEPOSIA in approved and potential indications.

Methodology:

The ZEPOSIA market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

ZEPOSIA Analytical Perspective by DelveInsight

  • In-depth ZEPOSIA Market Assessment

This ZEPOSIA sales market forecast report provides a detailed market assessment of ZEPOSIA for approved indication like Multiple sclerosis and Ulcerative colitis; as well as potential indication like Crohn's disease in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted ZEPOSIA sales data uptil 2034.

  • ZEPOSIA Clinical Assessment

The ZEPOSIA market report provides the clinical trials information of ZEPOSIA for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

ZEPOSIA Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

ZEPOSIA Market Potential & Revenue Forecast

  • Projected market size for the ZEPOSIA and its key indications
  • Estimated ZEPOSIA sales potential (ZEPOSIA peak sales forecasts)
  • ZEPOSIA Pricing strategies and reimbursement landscape

ZEPOSIA Competitive Intelligence

  • Number of competing drugs in development (pipeline analysis)
  • ZEPOSIA Market positioning compared to existing treatments
  • ZEPOSIA Strengths & weaknesses relative to competitors

ZEPOSIA Regulatory & Commercial Milestones

  • ZEPOSIA Key regulatory approvals & expected launch timelines
  • Commercial partnerships, licensing deals, and M&A activity

ZEPOSIA Clinical Differentiation

  • ZEPOSIA Efficacy & safety advantages over existing drugs
  • ZEPOSIA Unique selling points

ZEPOSIA Market Report Highlights

  • In the coming years, the ZEPOSIA market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
  • The ZEPOSIA companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence ZEPOSIA's dominance.
  • Other emerging products for Multiple sclerosis and Ulcerative colitis; as well as potential indication like Crohn's disease are expected to give tough market competition to ZEPOSIA and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of ZEPOSIA in approved and potential indications.
  • Analyse ZEPOSIA cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
  • Our in-depth analysis of the forecasted ZEPOSIA sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of ZEPOSIA in approved and potential indications.

Key Questions:

  • What is the class of therapy, route of administration and mechanism of action of ZEPOSIA? How strong is ZEPOSIA's clinical and commercial performance?
  • What is ZEPOSIA's clinical trial status in each individual indications such as Multiple sclerosis and Ulcerative colitis; as well as potential indication like Crohn's disease and study completion date?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the ZEPOSIA Manufacturers?
  • What are the key designations that have been granted to ZEPOSIA for approved and potential indications? How are they going to impact ZEPOSIA's penetration in various geographies?
  • What is the current and forecasted ZEPOSIA market scenario for approved and potential indications? What are the key assumptions behind the forecast?
  • What are the current and forecasted sales of ZEPOSIA in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
  • What are the other emerging products available and how are these giving competition to ZEPOSIA for approved and potential indications?
  • Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
  • How cost-effective is ZEPOSIA? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. ZEPOSIA Overview in approved indications like Multiple sclerosis and Ulcerative colitis; as well as potential indication like Crohn's disease

  • 2.1. Product Detail
  • 2.2. ZEPOSIA Clinical Development
    • 2.2.1. ZEPOSIA Clinical studies
    • 2.2.2. ZEPOSIA Clinical trials information
    • 2.2.3. Safety and efficacy
  • 2.3. Other Developmental Activities
  • 2.4. Product Profile

3. ZEPOSIA Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging ZEPOSIA Therapies)

5. ZEPOSIA Market Assessment

  • 5.1. ZEPOSIA Market Outlook in approved and potential indications
  • 5.2. 7MM Analysis
    • 5.2.1. ZEPOSIA Market Size in the 7MM for approved and potential indications
  • 5.3. Country-wise Market Analysis
    • 5.3.1. ZEPOSIA Market Size in the United States for approved and potential indications
    • 5.3.2. ZEPOSIA Market Size in Germany for approved and potential indications
    • 5.3.3. ZEPOSIA Market Size in France for approved and potential indications
    • 5.3.4. ZEPOSIA Market Size in Italy for approved and potential indications
    • 5.3.5. ZEPOSIA Market Size in Spain for approved and potential indications
    • 5.3.6. ZEPOSIA Market Size in the United Kingdom for approved and potential indications
    • 5.3.7. ZEPOSIA Market Size in Japan for approved and potential indications

6. ZEPOSIA SWOT Analysis

7. Analysts' Views

8. Appendix

  • 8.1. Bibliography
  • 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options

샘플 요청 목록
0 건의 상품을 선택 중
목록 보기
전체삭제
문의
원하시는 정보를
찾아 드릴까요?
문의주시면 필요한 정보를
신속하게 찾아드릴게요.
02-2025-2992
email
문의하기