시장보고서
상품코드
2044636

리툭시맙(Rituximab) : 판매 예측 및 시장 규모(2034년)

Rituximab Sales Forecast, and Market Size Analysis - 2034

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

    
    
    




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한글목차
영문목차

리툭시맙의 성장을 이끄는 주요 요인들

1. 종양 및 자가면역질환에서 광범위하게 확립된 적응증

  • 리툭시맙은 다음과 같은 질환에 널리 사용되고 있습니다.
  • 비호지킨림프종(NHL), 만성림프구성백혈병(CLL)
  • 류마티스 관절염 및 기타 자가면역질환
  • 종양 분야는 여전히 주요 매출 기여 분야이며, 표준 치료 요법으로 자리 잡고 있습니다.
  • 다양한 적응증에 사용: 규모가 크고 다양한 환자층에 적용 가능
  • 경쟁 환경에서도 안정적인 수요 유지

2. 탄탄한 과거 상업적 기반(최대 매출은 수십억 달러 규모)

  • Roche의 전 세계 매출:
  • 2018년: 약 53억 달러, 2019년: 약 50억 달러(종양 부문)
  • 특허 만료 이후에도 리툭시맙은 오리지널과 바이오시밀러 모두에서 여전히 큰 매출을 유지하고 있습니다.
  • 광범위한 환자 및 처방 의사 기반: 지속 가능한 수익원
  • 잘 구축된 인프라가 지속적인 보급을 뒷받침하고 있습니다.

3. 장기적 유효성 및 안전성 입증(임상적 신뢰)

  • 리툭시맙은 암 치료제로 승인된 최초의 단일클론항체이며, 수십 년간의 실제 임상 데이터를 보유하고 있습니다.
  • 광범위한 장기 추적 조사를 통해 다음과 같은 사실이 입증되었습니다.
  • 림프종에서 생존기간 연장
  • 자가면역질환의 지속적인 질병 조절
  • 의사들의 높은 신뢰도: 치료 가이드라인의 지속적인 권장 사항
  • 항 CD20 클래스에서 벤치마크 치료제로서의 역할

4. 바이오시밀러 확대를 통한 물량 중심의 성장

  • 특허 만료:
  • EU : 2013년경, 미국 : 2018년경
  • 바이오시밀러 도입으로 다음이 진행됩니다.
  • 일부 지역에서는 30-50% 가격 인하
  • 신흥 시장 접근성 향상
  • 신약 매출은 감소하는 반면, 총 환자 수는 대폭 증가
  • 특히 아시아 및 중남미 시장에서 시장 침투 확대 달성

5. 병용요법 및 새로운 치료 패러다임에서의 지속적인 사용

  • 리툭시맙은 다음과 같은 치료법에서 여전히 핵심적인 역할을 하고 있습니다.
  • 화학면역요법 요법(예: R-CHOP)
  • 표적치료제 및 면역치료제와의 병용
  • 현재 진행 중인 조사에서는 다음과 같은 사항을 검토하고 있습니다.
  • 복용량 최적화
  • 새로운 병용요법

리툭시맙의 최근 동향

  • 2025년 12월, 새로운 임상시험에서 브루톤형 티로신 키나아제(BTK) 억제제인 피르토브루티닙(pirtobrutinib)이 치료 경험이 없는 만성 림프구성 백혈병(CLL) 및 소림프구성 림프종(SLL) 환자에서 bendamustine + rituximab(BR) 요법 대비 무진행 생존율을 개선하고, 더 나은 안전성 프로파일을 보이며, 우수한 내약성을 확인했습니다. 이 데이터는 제67회 미국혈액학회(American Society of Hematology, ASH) 연례총회 및 전시회에서 발표되었습니다.

이 보고서는 미국, EU4(독일, 프랑스, 이탈리아, 이탈리아, 스페인, 영국, 일본 등 주요 7개국(미국, EU4, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)의 리툭시맙 시장 동향을 조사하고 만성 림프구성 백혈병, 여포성 림프종, 다발성 혈관염 육아종증, 특발성 혈소판 감소성 자반증, 림프 증식성 질환, 현미경적 다발성 혈관염 등 이미 승인된 적응증과 잠재적인 적응증에 대한 종합적인 인사이트를 제공합니다. 승인된 적응증과 맨틀세포 림프종과 같은 잠재적 적응증에 대한 종합적인 인사이트를 제공합니다.

이 보고서는 2020년에서 2034년까지 승인된 적응증에 대한 리툭시맙의 기존 사용 현황, 잠재적 적응증에 대한 진입 전망, 시장 성과에 대한 상세한 분석과 함께 승인된 적응증과 잠재적 적응증에 대한 리툭시맙에 대한 자세한 설명을 제공합니다. 리툭시맙(Rituximab)의 매출 예측, 작용기전(MoA), 용량 및 투여방법, 규제 마일스톤을 포함한 연구개발(R&D), 기타 활동, 향후 시장 평가, SWOT 분석, 애널리스트 견해, 경쟁 구도, 각 적응증별 다른 신흥 치료제 개요, 시장 성장 촉진요인 등에 대해 조사 분석했습니다.에 대해서도 분석했습니다.

자주 묻는 질문

  • 리툭시맙의 주요 적응증은 무엇인가요?
  • 리툭시맙의 과거 매출 규모는 어떻게 되나요?
  • 리툭시맙의 장기적 유효성과 안전성은 어떻게 입증되었나요?
  • 리툭시맙의 바이오시밀러 도입이 시장에 미친 영향은 무엇인가요?
  • 리툭시맙의 최근 임상시험 결과는 어떤가요?

목차

제1장 보고서 개요

제2장 리툭시맙 개요 : 만성 림프성 백혈병, 여포성 림프종, 다발 혈관염성 육아종증, 특발성 혈소판 감소성 자반병, 림프액 증식성 질환, 현미경적 다발 혈관염 등의 승인된 적응증 및 맨틀 세포 림프종 등의 잠재적 적응증

제3장 리툭시맙 : 경쟁 구도(출시 치료제)

제4장 리툭시맙 : 경쟁 구도(후기 개발 단계 신흥 치료제)

제5장 리툭시맙 : 시장 평가

제6장 리툭시맙 : SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight에 대해

제12장 보고서 구입 옵션

LSH 26.06.08

Key Factors Driving Rituximab Growth

1. Broad, well-established indications across oncology and autoimmune diseases

  • Rituximab is widely used in:
  • Non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)
  • Rheumatoid arthritis and other autoimmune diseases
  • Oncology remains the dominant revenue contributor, embedded in standard-of-care regimens.
  • Multi-indication use -> large, diversified patient base
  • Sustains demand despite competition

2. Strong historical commercial base (multi-billion dollar peak sales)

  • Global sales (Roche):
  • ~$5.3B in 2018 -> ~$5.0B in 2019 (oncology segment)
  • Even after patent expiry, rituximab continues to generate significant global revenues across branded + biosimilars
  • Large installed base of patients and prescribers -> durable revenue stream
  • Established infrastructure supports continued uptake

3. Proven long-term efficacy and safety (clinical trust)

  • Rituximab was the first monoclonal antibody approved for cancer, with decades of real-world data.
  • Extensive long-term follow-up studies reinforce:
  • Survival benefits in lymphoma
  • Durable disease control in autoimmune disorders
  • High physician confidence -> continued preference in treatment guidelines
  • Acts as a benchmark therapy in anti-CD20 class

4. Expansion via biosimilars -> volume-driven growth

  • Patent expiry:
  • EU: ~2013 | US: ~2018
  • Biosimilars have driven:
  • 30-50% price reductions in some regions
  • Increased accessibility in emerging markets
  • While branded revenues decline, total patient volume increases significantly
  • Expands global market penetration (especially Asia, Latin America)

5. Continued use in combination regimens and new treatment paradigms

  • Rituximab remains a backbone in:
  • Chemo-immunotherapy regimens (e.g., R-CHOP)
  • Combination with targeted agents and immunotherapies
  • Ongoing research explores:
  • Optimized dosing
  • New combinations

Rituximab Recent Developments

  • In December 2025, In a new trial, the Bruton tyrosine kinase (BTK) inhibitor pirtobrutinib increased the rate of survival without disease progression and was well tolerated with a more favorable safety profile when compared with bendamustine plus rituximab (BR) in patients with previously untreated chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The data were presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

"Rituximab Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Rituximab for approved indication like Chronic lymphocytic leukaemia, Follicular lymphoma, Granulomatosis with polyangiitis, Idiopathic thrombocytopenic purpura, Lymphoproliferative disorders, and Microscopic polyangiitis; as well as potential indication like Mantle-cell lymphoma etc. in the 7MM. A detailed picture of Rituximab'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 Rituximab for approved and potential indications. The Rituximab market report provides insights about Rituximab'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 Rituximab performance, future market assessments inclusive of the Rituximab 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 Rituximab sales forecasts, along with factors driving its market.

Rituximab Drug Summary

Rituximab is a chimeric monoclonal antibody developed by Genentech and Roche that targets the CD20 antigen expressed on B lymphocytes, leading to B-cell depletion through mechanisms such as complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis. It is widely used for the treatment of B-cell malignancies (including non-Hodgkin lymphoma and chronic lymphocytic leukemia) as well as autoimmune diseases such as rheumatoid arthritis, granulomatosis with polyangiitis, and pemphigus vulgaris. Administered via intravenous infusion (with some subcutaneous formulations available), rituximab has demonstrated durable efficacy in reducing disease activity and inducing remission; however, its use is associated with risks such as infusion reactions, infections, and rare cases of progressive multifocal leukoencephalopathy (PML). As one of the first successful targeted biologics, rituximab has become a cornerstone therapy across oncology and immunology, with numerous biosimilars expanding its global accessibility. The report provides Rituximab's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Rituximab Market Report

The report provides insights into:

  • A comprehensive product overview including the Rituximab MoA, description, dosage and administration, research and development activities in approved indications like Chronic lymphocytic leukaemia, Follicular lymphoma, Granulomatosis with polyangiitis, Idiopathic thrombocytopenic purpura, Lymphoproliferative disorders, and Microscopic polyangiitis; as well as potential indication like Mantle-cell lymphoma etc..
  • Elaborated details on Rituximab regulatory milestones and other development activities have been provided in Rituximab market report.
  • The report also highlights Rituximab'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 Rituximab market report also covers the patents information, generic entry and impact on cost cut.
  • The Rituximab market report contains current and forecasted Rituximab sales for approved and potential indications till 2034.
  • Comprehensive coverage of the late-stage emerging therapies for respective indications.
  • The Rituximab market report also features the SWOT analysis with analyst views for Rituximab in approved and potential indications.

Methodology:

The Rituximab 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.

Rituximab Analytical Perspective by DelveInsight

  • In-depth Rituximab Market Assessment

This Rituximab sales market forecast report provides a detailed market assessment of Rituximab for approved indication like Chronic lymphocytic leukaemia, Follicular lymphoma, Granulomatosis with polyangiitis, Idiopathic thrombocytopenic purpura, Lymphoproliferative disorders, and Microscopic polyangiitis; as well as potential indication like Mantle-cell lymphoma etc. 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 Rituximab sales data uptil 2034.

  • Rituximab Clinical Assessment

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

Rituximab 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.

Rituximab Market Potential & Revenue Forecast

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

Rituximab Competitive Intelligence

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

Rituximab Regulatory & Commercial Milestones

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

Rituximab Clinical Differentiation

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

Rituximab Market Report Highlights

  • In the coming years, the Rituximab 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 Rituximab companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Rituximab's dominance.
  • Other emerging products for Chronic lymphocytic leukaemia, Follicular lymphoma, Granulomatosis with polyangiitis, Idiopathic thrombocytopenic purpura, Lymphoproliferative disorders, and Microscopic polyangiitis; as well as potential indication like Mantle-cell lymphoma etc. are expected to give tough market competition to Rituximab 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 Rituximab in approved and potential indications.
  • Analyse Rituximab cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
  • Our in-depth analysis of the forecasted Rituximab sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Rituximab in approved and potential indications.

Key Questions:

  • What is the class of therapy, route of administration and mechanism of action of Rituximab? How strong is Rituximab's clinical and commercial performance?
  • What is Rituximab's clinical trial status in each individual indications such as Chronic lymphocytic leukaemia, Follicular lymphoma, Granulomatosis with polyangiitis, Idiopathic thrombocytopenic purpura, Lymphoproliferative disorders, and Microscopic polyangiitis; as well as potential indication like Mantle-cell lymphoma etc. and study completion date?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Rituximab Manufacturers?
  • What are the key designations that have been granted to Rituximab for approved and potential indications? How are they going to impact Rituximab's penetration in various geographies?
  • What is the current and forecasted Rituximab market scenario for approved and potential indications? What are the key assumptions behind the forecast?
  • What are the current and forecasted sales of Rituximab 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 Rituximab 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 Rituximab? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Rituximab Overview in approved indications like Chronic lymphocytic leukaemia, Follicular lymphoma, Granulomatosis with polyangiitis, Idiopathic thrombocytopenic purpura, Lymphoproliferative disorders, and Microscopic polyangiitis; as well as potential indication like Mantle-cell lymphoma etc.

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

3. Rituximab Competitive Landscape (Marketed Therapies)

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

5. Rituximab Market Assessment

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

6. Rituximab 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

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