Pirtobrutinib Sales Forecast, and Market Size Analysis - 2034
상품코드:1909221
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
피르토브루티닙 성장 촉진요인
1. 시장 점유율 확대와 신규 환자 수 증가
Eli Lilly가 개발한 피르토브루티닙(제이피르카)은 차세대 비공유(가역적) BTK 억제제로 B세포 악성종양 시장에서 입지를 넓혀가고 있습니다.
특히, 치료 옵션이 역사적으로 제한적이었던 공유 결합형 BTK 억제제를 이전에 노출된 중증 사전 치료 환자들 사이에서 신규 환자 시작이 증가하고 있습니다.
내성 메커니즘에 대한 강력한 의사 교육에 의해 지원되는 Lilly의 혈액 종양에 특화된 상업 전략은 재발 및 난치성(R/R) 환자층에서 조기 채택을 추진하고 있습니다.
2. 주요 적응증의 확대
만성 림프구성 백혈병/소세포성 림프종(CLL/SLL) : 피르토브루티닙은 공유결합형 BTK 억제제 치료 중 진행되거나 내약성이 없는 환자를 위한 핵심 치료제로 자리매김했으며, 지속적인 반응 데이터로 뒷받침됩니다.
맨틀 세포 림프종(MCL) : 재발/불응성 MCL에서의 초기 승인 및 강력한 임상 활성으로 피르토브루티닙은 후기 치료 단계에서 중요한 옵션으로 자리매김했습니다.
기타 B세포 악성종양 : 진행 중인 연구에서 피르토브루티닙의 변연부 림프종, 여포성 림프종, 왈덴 스트렘 마크로글로불린혈증에 대한 평가가 진행 중입니다.
조기 치료 라인 및 병용 전략 : 파이프라인 개발에는 조기 치료 라인의 연구와 베네토크럭스 및 항-CD20 항체와 같은 약물과의 병용 연구가 포함되어 시장 규모가 크게 확대될 수 있습니다.
3. 지리적 확대
미국을 핵심 시장으로 : 승인 취득 후에도 미국은 주요 시장이며, 학술 기관 및 지역 암 진료 시설의 높은 채택률에 지지되고 있습니다.
세계 전개 계획 : 유럽 및 기타 선진국 시장에의 전개를 지원하기 위해, 규제 당국에의 신청 및 임상 프로그램을 진행하고 있습니다. 이 시장에서는 BTK 억제제의 사용이 이미 정착되어 있습니다.
아시아태평양의 성장 가능성 : 혈액 악성 종양의 진단 속도 상승과 표적 요법에 대한 접근성 향상으로 아시아태평양은 장기적인 성장 기회로 자리 잡고 있습니다.
4. 신규 적응증 승인
신속 승인 : 피르토브루티닙은 높은 미충족 요구를 가진 재발 및 난치성(R/R) 환자 인구에서 확실한 연주 효율을 기반으로 주요 적응증에서 신속 승인을 받았습니다.
적응증 확대 가능성 : 진행 중인 확인 임상시험은 완전 승인을 지원하고 초기 치료 단계로의 적응증 확장을 목표로 설계되었습니다.
매출 다각화 : B세포 악성종양 전반에 걸친 추가 승인은 릴리의 종양학 포트폴리오와 장기적 매출 흐름을 크게 확장시킬 것입니다.
5. 혈액암 영역의 견조한 판매 수량의 기세
BTK 노출 환자군에서의 높은 미충족 수요 : 공유결합형 BTK 억제제 치료 후 재발한 환자들은 제한된 치료 대안을 가진 증가하는 환자군을 나타냅니다.
설득력 있는 임상 프로파일 : 높은 전주 효율, BTK 내성 돌연변이(C481 포함)에 대한 효능, 양호한 내약성이 지속적인 처방세를 주도하고 있습니다.
확대하는 실제 임상 사용 : 학술 기관과 지역 의료 기관 모두에서 실제 임상 사용이 증가하고 의사의 신뢰를 강화하고 판매 수량의 성장을 지원합니다.
6. 경쟁 우위성과 시장 동향
비공유 결합형 BTK 억제 : 피르토브루티닙의 가역적 결합 특성은 BTK 내성 변이에 대한 활성을 발휘하여 1세대 및 2세대 공유 결합형 BTK 억제제와의 차별화를 실현하고 있습니다.
우수한 안전성 및 내약성 : 기존 BTK 억제제에 비해 심장 및 출혈 관련 이상반응 발생률이 낮아 장기 사용 적합성이 향상됩니다.
정밀 종양학으로의 전환 : 분자 프로파일링 및 내성 기반 치료 순차적 적용의 증가가 피르토브루티닙의 포지셔닝을 뒷받침합니다.
실제 임상 증거(RWE)의 역할 확대 : RWE는 지불자 신뢰 강화, 치료 순차적 적용 최적화, 광범위한 채택 지원에 핵심적 역할을 할 것입니다.
본 보고서는 주요 7개국(미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국)의 만성 림프성 백혈병, 맨틀 세포 림프종 등의 승인된 적응증, 비호지킨 림프종, 변연대 B 세포 림프종, 왈덴 스트렘 마크로글로불린혈증 등의 잠재적 적응증에 대한 피르토브루티니. 본 보고서는 2020년부터 2034년까지의 7개국에서 피르토브루티닙의 기존 사용 상황, 진입 전망, 승인된 적응증의 실적에 대한 상세한 분석, 승인된 적응증의 피르토브루티닙의 상세한 설명을 제시합니다. 또한 이 제품의 매출 예측, 작용기전(MoA), 투여량 및 투여 방법, 규제상의 이정표를 포함한 연구개발 및 기타 개발 활동에 대한 통찰을 제공합니다. 또한 과거 및 현재의 피르토브루티닙의 실적, 미래 시장 평가, 주요 7개국 시장 예측 분석, SWOT 분석, 분석가의 견해, 경쟁업체의 종합적인 개요, 각 적응증에 대한 기타 신흥 치료법의 개요, 피르토브루티닙의 매출 예측 분석, 시장 주도 요인 등도 정리했습니다.
목차
제1장 보고서 개요
제2장 만성 림프성 백혈병, 맨틀 세포 림프종 등의 승인된 적응증, 비호지킨 림프종, 변연대 B 세포 림프종, 왈덴 스트렘 마크로글로불린혈증 등의 잠재적 적응증에 대한 피르토브루티닙의 개요
제품 상세
임상 개발
임상 연구
임상시험 정보
안전성과 유효성
기타 개발 활동
제품 프로파일
제3장 피르토브루티닙 : 경쟁 구도(시판 중인 치료제)
제4장 피르토브루티닙 : 경쟁 구도(개발 후기 치료제)
제5장 피르토브루티닙 : 시장 평가
승인된 적응증에 대한 시장 전망
주요 7개국 분석
승인된 적응증에 대한 주요 7개국 시장 규모
국가별 시장 분석
미국
독일
영국
제6장 피르토브루티닙 : SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 정보
제12장 보고서 구매 옵션
HBR
영문 목차
영문목차
Key Factors Driving Pirtobrutinib Growth
1. Market Share Gains and New Patient Starts
Pirtobrutinib (Jaypirca), developed by Eli Lilly, is gaining traction in the B-cell malignancies market as a next-generation, non-covalent (reversible) BTK inhibitor.
New patient starts are increasing, particularly among heavily pretreated patients with prior exposure to covalent BTK inhibitors, where treatment options have historically been limited.
Lilly's focused hematology-oncology commercial strategy, supported by strong physician education around resistance mechanisms, is driving early adoption in relapsed/refractory (R/R) settings.
2. Expansion Across Key Indications
Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL): Pirtobrutinib is positioned as a key therapy for patients who have progressed on or are intolerant to covalent BTK inhibitors, supported by durable response data.
Mantle Cell Lymphoma (MCL): Initial approval and strong clinical activity in R/R MCL have established pirtobrutinib as an important option in later lines of therapy.
Other B-Cell Malignancies: Ongoing studies are evaluating pirtobrutinib in marginal zone lymphoma, follicular lymphoma, and Waldenstrom's macroglobulinemia.
Earlier-Line and Combination Strategies: Pipeline development includes studies in earlier treatment lines and in combination with agents such as venetoclax and anti-CD20 antibodies, which could significantly expand market reach.
3. Geographic Expansion
United States as the Anchor Market: The U.S. remains the primary market following regulatory approvals, supported by strong uptake in academic and community oncology settings.
Global Expansion Plans: Regulatory filings and clinical programs support expansion into Europe and other developed markets, where BTK inhibitor use is well established.
Asia-Pacific Growth Potential: Rising diagnosis rates of hematologic malignancies and improved access to targeted therapies position Asia-Pacific as a long-term growth opportunity.
4. New Indication Approvals
Accelerated Approvals: Pirtobrutinib received accelerated approval in key indications based on robust response rates in R/R populations with high unmet need.
Label Expansion Potential: Ongoing confirmatory trials are designed to support full approval and broaden indications into earlier lines of therapy.
Revenue Diversification: Additional approvals across B-cell malignancies would significantly expand Lilly's oncology portfolio and long-term revenue streams.
5. Strong Hematologic Oncology Volume Momentum
High Unmet Need in BTK-Exposed Patients: Patients who relapse after covalent BTK inhibitors represent a growing population with limited therapeutic alternatives.
Compelling Clinical Profile: High overall response rates, activity across BTK resistance mutations (including C481), and favorable tolerability are driving sustained prescription momentum.
Growing Real-World Utilization: Increasing real-world use in both academic and community settings is reinforcing physician confidence and supporting volume growth.
6. Competitive Differentiation and Market Trends
Non-Covalent BTK Inhibition: Pirtobrutinib's reversible binding enables activity against BTK resistance mutations, differentiating it from first-generation and second-generation covalent BTK inhibitors.
Favorable Safety and Tolerability: Lower rates of cardiac and bleeding-related adverse events relative to earlier BTK inhibitors improve suitability for long-term use.
Shift Toward Precision Oncology: Increasing use of molecular profiling and resistance-driven treatment sequencing supports pirtobrutinib's positioning.
Growing Role of Real-World Evidence (RWE): RWE will be critical in reinforcing payer confidence, optimizing treatment sequencing, and supporting broader adoption.
Pirtobrutinib Recent Developments
In December 2025, Eli Lilly and Company announced that the US Food and Drug Administration (FDA) granted approval to Jaypirca (Pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor. This FDA action expands the Jaypirca label to include patients earlier in their treatment course and also converts the December 2023 accelerated approval for later-line CLL/SLL to a traditional approval.
"Pirtobrutinib Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Pirtobrutinib for approved indication like Chronic lymphocytic leukaemia; Mantle-cell lymphoma; as well as potential indications like Non-Hodgkin's lymphoma; Marginal zone B-cell lymphoma; and Waldenstrom's macroglobulinaemia in the 7MM. A detailed picture of Pirtobrutinib'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 Pirtobrutinib for approved and potential indications. The Pirtobrutinib market report provides insights about Pirtobrutinib'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 Pirtobrutinib performance, future market assessments inclusive of the Pirtobrutinib 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 Pirtobrutinib sales forecasts, along with factors driving its market.
Pirtobrutinib Drug Summary
Pirtobrutinib (Jaypirca) is an oral, highly selective, non-covalent inhibitor of Bruton's tyrosine kinase (BTK) developed by Eli Lilly for relapsed or refractory B-cell malignancies. Unlike covalent BTK inhibitors such as ibrutinib or acalabrutinib that rely on binding to the C481 cysteine residue, pirtobrutinib reversibly binds to the ATP-binding pocket of BTK, maintaining potent inhibition even against C481 mutations, which are common resistance mechanisms, thereby blocking BCR signaling, B-cell proliferation, and survival in lymphomas. FDA-approved in 2023 for mantle cell lymphoma after >=2 prior therapies and expanded in 2024 for chronic lymphocytic leukemia/small lymphocytic lymphoma after BTKi exposure, it offers once-daily dosing (200 mg) with a favorable profile, lower rates of cardiac toxicities like atrial fibrillation, and efficacy in heavily pretreated patients. The report provides Pirtobrutinib's sales, growth barriers and drivers, post usage and approvals in multiple indications.
Scope of the Pirtobrutinib Market Report
The report provides insights into:
A comprehensive product overview including the Pirtobrutinib MoA, description, dosage and administration, research and development activities in approved indications like Chronic lymphocytic leukaemia; Mantle-cell lymphoma; as well as potential indications like Non-Hodgkin's lymphoma; Marginal zone B-cell lymphoma; and Waldenstrom's macroglobulinaemia.
Elaborated details on Pirtobrutinib regulatory milestones and other development activities have been provided in Pirtobrutinib market report.
The report also highlights Pirtobrutinib'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 Pirtobrutinib market report also covers the patents information, generic entry and impact on cost cut.
The Pirtobrutinib market report contains current and forecasted Pirtobrutinib sales for approved and potential indications till 2034.
Comprehensive coverage of the late-stage emerging therapies for respective indications.
The Pirtobrutinib market report also features the SWOT analysis with analyst views for Pirtobrutinib in approved and potential indications.
Methodology:
The Pirtobrutinib 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.
Pirtobrutinib Analytical Perspective by DelveInsight
In-depth Pirtobrutinib Market Assessment
This Pirtobrutinib sales market forecast report provides a detailed market assessment of Pirtobrutinib for approved indication like Chronic lymphocytic leukaemia; Mantle-cell lymphoma; as well as potential indications like Non-Hodgkin's lymphoma; Marginal zone B-cell lymphoma; and Waldenstrom's macroglobulinaemia 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 Pirtobrutinib sales data uptil 2034.
Pirtobrutinib Clinical Assessment
The Pirtobrutinib market report provides the clinical trials information of Pirtobrutinib for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.
Pirtobrutinib 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.
Pirtobrutinib Market Potential & Revenue Forecast
Projected market size for the Pirtobrutinib and its key indications
Commercial partnerships, licensing deals, and M&A activity
Pirtobrutinib Clinical Differentiation
Pirtobrutinib Efficacy & safety advantages over existing drugs
Pirtobrutinib Unique selling points
Pirtobrutinib Market Report Highlights
In the coming years, the Pirtobrutinib 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 Pirtobrutinib companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Pirtobrutinib's dominance.
Other emerging products for Chronic lymphocytic leukaemia; Mantle-cell lymphoma; as well as potential indications like Non-Hodgkin's lymphoma; Marginal zone B-cell lymphoma; and Waldenstrom's macroglobulinaemia are expected to give tough market competition to Pirtobrutinib 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 Pirtobrutinib in approved and potential indications.
Analyse Pirtobrutinib cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
Our in-depth analysis of the forecasted Pirtobrutinib sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Pirtobrutinib in approved and potential indications.
Key Questions:
What is the class of therapy, route of administration and mechanism of action of Pirtobrutinib? How strong is Pirtobrutinib's clinical and commercial performance?
What is Pirtobrutinib's clinical trial status in each individual indications such as Chronic lymphocytic leukaemia; Mantle-cell lymphoma; as well as potential indications like Non-Hodgkin's lymphoma; Marginal zone B-cell lymphoma; and Waldenstrom's macroglobulinaemia and study completion date?
What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Pirtobrutinib Manufacturers?
What are the key designations that have been granted to Pirtobrutinib for approved and potential indications? How are they going to impact Pirtobrutinib's penetration in various geographies?
What is the current and forecasted Pirtobrutinib market scenario for approved and potential indications? What are the key assumptions behind the forecast?
What are the current and forecasted sales of Pirtobrutinib 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 Pirtobrutinib 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 Pirtobrutinib? What is the duration of therapy and what are the geographical variations in cost per patient?
Table of Contents
1. Report Introduction
2. Pirtobrutinib Overview in approved indications like Chronic lymphocytic leukaemia; Mantle-cell lymphoma; as well as potential indications like Non-Hodgkin's lymphoma; Marginal zone B-cell lymphoma; and Waldenstrom's macroglobulinaemia
