시장보고서
상품코드
2052054

TEZSPIRE : 판매 예측 및 시장 규모(2034년)

TEZSPIRE 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

TEZSPIRE의 성장을 이끄는 주요 요인들

1. 광범위한 중증 천식 환자에서 입증된 임상적 가치

  • TEZSPIRE는 호산구 수와 알레르기 상태에 관계없이 바이오마커에 따른 하위 그룹 전체에서 천식 악화를 유의하게 감소시키는 것으로 나타나 광범위한 중증 천식 환자군에 대한 치료 효과를 입증했습니다. 이러한 환자 유형에 관계없이 폭넓게 인정받는 효능은 이 약의 강력한 채택과 처방의사의 신뢰를 지원하고 있습니다.

2. 견고하고 확장되는 상업적 모멘텀

  • 2025년, TEZSPIRE의 매출은 전년 대비 약 52% 증가했습니다. 이는 치료 시작 환자 수 증가에 따른 판매량 증가가 견인한 것으로 분석됩니다.
  • 2025년 4분기 TEZSPIRE의 매출은 약 4억 7,400만 달러로 전년 동기 대비 60% 증가했습니다. 이 증가의 주요 요인은 판매량 증가에 기인합니다.
  • 애널리스트 보고서에 따르면 Amgen과 AstraZeneca의 TEZSPIRE 프랜차이즈는 2024년 전 세계에서 약 15억 달러에서 20억 달러의 매출을 창출 할 것으로 예상되며, 이는 출시 후 빠른 시장 침투를 반영합니다.

    테즈스파이어는 출시 초기 단계를 벗어나 상업적 성장을 가속화하고 있으며, 두 자릿수 판매량 증가는 치료 시작 환자 수 증가와 시장 침투 확대가 이루어지고 있음을 보여줍니다.

3. 적응증 확대 및 시장 접근성 확대

  • FDA는 중증 천식에 이어 두 번째 적응증으로 코 폴립을 동반한 만성 부비동염에 대한 TEZSPIRE를 승인하여 대상 환자군을 대폭 확대했습니다.
  • 이번 적응증 확대는 미충족 수요가 존재하는 또 다른 큰 염증성 질환 영역에 진입할 수 있으며, 장기적인 성장 전망을 강화하고 광범위한 상업적 보급을 지원할 수 있을 것입니다.

4. 미충족 수요에 대한 대응과 폭넓은 적응증 환자층

  • 중증 천식은 전 세계에서 많은 환자가 존재하는 질환으로, 기존 치료법으로 증상을 충분히 조절하지 못하는 환자가 다수 존재합니다. TEZSPIRE의 적용대상이 광범위하므로 다른 생물제제로 충분한 조절이 되지 않거나, 바이오마커에 따른 적응증 제한으로 다른 치료법이 적용되지 않는 환자들에게 중요한 치료 옵션이 될 수 있습니다.
  • 의사들을 대상으로 한 설문조사에 따르면 중증 천식, 특히 다른 생물제제로 최적의 조절이 이루어지지 않는 환자들의 미충족 수요가 여전히 존재하며, 이는 테즈스피어의 채택 확대에 더욱 박차를 가하고 있습니다.

5. 시장 성장의 순풍과 예측 동향

  • 테즈스피어가 경쟁하는 글로벌 중증 천식 치료제 시장은 규모가 크고 지속적으로 성장하고 있으며, 2025년 약 243억 달러에서 2035년 약 399억 6,000만 달러로 확대될 것으로 예상됩니다. 이러한 성장은 진단율 증가, 생물제제의 보급, 난치성 환자의 미충족 수요에 의해 주도되고 있습니다.

6. 작용기전 및 광범위한 효능으로 차별화를 꾀함

  • TEZSPIRE의 작용기전인 흉선간질림프구증식인자(TSLP) 저해는 염증 캐스케이드의 최상류에서 작용하여 여러 천식 경로의 상류 조절을 가능하게 합니다. 이는 보다 표적화된 생물제제와는 대조적으로, 중증 천식의 다양한 표현형에 대한 사용 확대에 기여합니다.
  • 호산구 및 알레르기성 페노유형에 대한 제한이 없는 광범위한 적응증은 중요한 차별화 요소로, 임상에서 1차 또는 2차 선택 생물제제로 채택될 수 있는 원동력이 되고 있습니다.

TEZSPIRE의 최근 동향

  • 2025년 3월, 암젠과 아스트라제네카는 코 폴립을 동반한 만성 부비동염(CRSwNP) 치료제로서 TEZSPIRE에 대한 등록 임상 3상 WAYPOINT 시험의 전체 결과를 발표했습니다.

본 임상시험에서 이 치료법은 52주 시점에 코 폴립과 코 막힘의 중증도를 감소시켰으며, 수술의 필요성과 전신 코르티코스테로이드의 사용도 감소시키는 것으로 나타났습니다.

  • 2025년 10월, 암젠과 아스트라제네카는 미국 FDA가 12세 이상의 성인 및 소아 환자에서 잘 조절되지 않는 비강 폴립을 동반한 만성 부비동염(CRSwNP)의 추가 유지요법으로 테즈스피어(R)(tezepelumab-ekko)를 승인했다고 발표했습니다. 를 승인했다고 발표했습니다. TEZSPIRE는 흉선 간질성 림프구 생성 인자(TSLP)를 표적으로 하는 CRSwNP에 대해 승인된 최초이자 유일한 생물제제입니다.

이 보고서는 미국, EU4(독일, 프랑스, 이탈리아, 스페인, 이탈리아, 스페인, 영국, 일본 등 주요 7개국(미국, EU4, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)에서의 테즈스피어(TEZSPIRE) 동향을 조사해 천식, 비부비동염 등 승인된 적응증과 만성폐쇄성폐질환(COPD), 호산구성식도염, 만성 두드러기 등 잠재적 적응증에 대한 포괄적인 인사이트를 제공합니다. 포괄적인 인사이트를 제공합니다.

이 보고서는 2020-2034년 TEZSPIRE의 기존 사용 현황, 잠재적 적응증 진입 전망, 시장 성과에 대한 상세한 분석과 함께 승인된 적응증 및 잠재적 적응증에 대한 TEZSPIRE에 대한 자세한 설명을 제공합니다. 또한 TEZSPIRE의 매출 예측, 작용기전(MoA), 용량 및 투여방법, 규제 마일스톤을 포함한 연구개발, 기타 활동, 미래 시장 평가, SWOT 분석, 애널리스트 견해, 경쟁 상황, 각 적응증별 다른 신흥 치료제에 대한 개요, 시장을 촉진하는 요인에 대해서도 분석하고 있습니다.

목차

제1장 리포트 개요

제2장 TEZSPIRE 개요 : 천식 및 비부비동염 등의 승인된 적응증과 만성폐쇄성폐질환(COPD), 호산구성 식도염, 만성 두드러기 등의 잠재적 적응증

제3장 TEZSPIRE : 경쟁 구도(출시 치료제)

제4장 TEZSPIRE : 경쟁 구도(후기 개발 단계 신규 치료제)

제5장 TEZSPIRE : 시장 평가

제6장 TEZSPIRE : SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

KSA

Key Factors Driving TEZSPIRE Growth

1. Demonstrated Clinical Value Across Broad Severe Asthma Populations

  • TEZSPIRE has shown significant reductions in asthma exacerbations across biomarker subgroups, irrespective of eosinophil levels or allergic status - supporting treatment of a broad severe asthma population. This broad efficacy across patient types underpins strong adoption and prescriber confidence.

2. Strong and Growing Commercial Momentum

  • In 2025, TEZSPIRE sales increased ~52% year-over-year, driven by volume growth as more patients initiated therapy.
  • In the Q4 2025 period, TEZSPIRE generated ~USD 474 million in sales, a 60% year-over-year rise, with volume increases as the primary driver.
  • Analysts have reported that the combined Amgen/AstraZeneca TEZSPIRE franchise likely generated between ~USD 1.5 billion and USD 2 billion in 2024 revenues globally, reflecting rapid market uptake following launch.

TEZSPIRE has moved beyond early launch phases into accelerating commercial growth, with double-digit volume expansion indicating expanding patient starts and market penetration.

3. Expanding Indications and Market Access

  • The FDA has approved TEZSPIRE for chronic rhinosinusitis with nasal polyps, a second indication beyond severe asthma, greatly expanding its addressable patient pool.
  • This label expansion taps into another large inflammatory disease category with unmet needs, strengthening long-term growth prospects and supporting broader commercial uptake.

4. Addressing Unmet Need and Broad Patient Eligibility

  • Severe asthma affects a substantial global population, with many patients remaining uncontrolled on existing therapies. The broad eligibility of TEZSPIRE positions it as a key therapy for patients inadequately controlled on other biologics or those ineligible under biomarker-restricted labels.
  • Physician surveys indicate persistent unmet need in severe asthma, especially in patients who have not achieved optimal control on other biologics, further boosting TEZSPIRE's potential adoption.

5. Market Growth Tailwinds and Forecast Dynamics

  • The global severe asthma treatment market - where TEZSPIRE competes - is large and growing, expected to expand from ~USD 24.3 billion in 2025 to ~USD 39.96 billion by 2035. Growth is driven by increasing diagnosis rates, biologic uptake, and unmet needs in refractory patients.

6. Differentiation Through Mechanism and Broad Efficacy

  • TEZSPIRE's mechanism of blocking thymic stromal lymphopoietin (TSLP) acts at the top of the inflammatory cascade, offering upstream modulation of multiple asthma pathways. This contrasts with more targeted biologics, helping expand its use across severe asthma phenotypes.
  • Its broad label - without eosinophil or allergic phenotype restrictions - is a key differentiator and supports adoption as a first-or second-line biologic in clinical practice.

TEZSPIRE Recent Developments

  • In March 2025, Amgen and AstraZeneca reported complete outcomes from the registrational Phase III WAYPOINT trial of TEZSPIRE for treating chronic rhinosinusitis with nasal polyps (CRSwNP).

The trial showed that treatment with the therapy decreased the severity of nasal polyps and congestion at week 52, as well as the need for surgery and the use of systemic corticosteroid.

  • In October 2025, Amgen and AstraZeneca announced that the US Food and Drug Administration (FDA) approved TEZSPIRE(R) (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. TEZSPIRE is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin (TSLP).

"TEZSPIRE Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of TEZSPIRE for approved indication like Asthma and Rhinosinusitis; as well as potential indications like Chronic obstructive pulmonary disease; Eosinophilic oesophagitis, and Chronic urticaria in the 7MM. A detailed picture of TEZSPIRE'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 TEZSPIRE for approved and potential indications. The TEZSPIRE market report provides insights about TEZSPIRE'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 TEZSPIRE performance, future market assessments inclusive of the TEZSPIRE 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 TEZSPIRE sales forecasts, along with factors driving its market.

TEZSPIRE Drug Summary

TEZSPIRE (tezepelumab-ekko) is a first-in-class human monoclonal antibody (IgG2λ) that selectively inhibits thymic stromal lymphopoietin (TSLP), an epithelial cytokine upstream in Type 2 and non-Type 2 inflammatory pathways involved in severe asthma pathogenesis. Indicated as an add-on maintenance therapy for adults and adolescents aged 12 years and older with severe asthma inadequately controlled on high-dose inhaled corticosteroids plus another controller medication, it reduces exacerbations, improves lung function, and enhances asthma control regardless of eosinophil or FeNO levels; it is not for acute bronchospasm relief. Recently approved as add-on therapy with intranasal corticosteroids for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults unresponsive to systemic corticosteroids or surgery, TEZSPIRE is administered subcutaneously every 4 weeks (210 mg via pre-filled pen or syringe) by healthcare professionals initially, with patients trainable for self-administration. The sterile, preservative-free solution contains tezepelumab-ekko (210 mg/1.91 mL) with inactive ingredients like glacial acetic acid, L-proline, polysorbate 80, sodium hydroxide, and water for injection. Developed by AstraZeneca and Amgen, it was FDA-approved for asthma in December 2021 and expanded for CRSwNP in 2025. The report provides TEZSPIRE's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the TEZSPIRE Market Report

The report provides insights into:

  • A comprehensive product overview including the TEZSPIRE MoA, description, dosage and administration, research and development activities in approved indications like Asthma and Rhinosinusitis; as well as potential indications like Chronic obstructive pulmonary disease; Eosinophilic oesophagitis, and Chronic urticaria.
  • Elaborated details on TEZSPIRE regulatory milestones and other development activities have been provided in TEZSPIRE market report.
  • The report also highlights TEZSPIRE'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 TEZSPIRE market report also covers the patents information, generic entry and impact on cost cut.
  • The TEZSPIRE market report contains current and forecasted TEZSPIRE sales for approved and potential indications till 2034.
  • Comprehensive coverage of the late-stage emerging therapies for respective indications.
  • The TEZSPIRE market report also features the SWOT analysis with analyst views for TEZSPIRE in approved and potential indications.

Methodology:

The TEZSPIRE 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.

TEZSPIRE Analytical Perspective by DelveInsight

  • In-depth TEZSPIRE Market Assessment

This TEZSPIRE sales market forecast report provides a detailed market assessment of TEZSPIRE for approved indication like Asthma and Rhinosinusitis; as well as potential indications like Chronic obstructive pulmonary disease; Eosinophilic oesophagitis, and Chronic urticaria 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 TEZSPIRE sales data uptil 2034.

  • TEZSPIRE Clinical Assessment

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

TEZSPIRE 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.

TEZSPIRE Market Potential & Revenue Forecast

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

TEZSPIRE Competitive Intelligence

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

TEZSPIRE Regulatory & Commercial Milestones

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

TEZSPIRE Clinical Differentiation

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

TEZSPIRE Market Report Highlights

  • In the coming years, the TEZSPIRE 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 TEZSPIRE companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence TEZSPIRE's dominance.
  • Other emerging products for Asthma and Rhinosinusitis; as well as potential indications like Chronic obstructive pulmonary disease; Eosinophilic oesophagitis, and Chronic urticaria are expected to give tough market competition to TEZSPIRE 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 TEZSPIRE in approved and potential indications.
  • Analyse TEZSPIRE cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
  • Our in-depth analysis of the forecasted TEZSPIRE sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of TEZSPIRE in approved and potential indications.

Key Questions:

  • What is the class of therapy, route of administration and mechanism of action of TEZSPIRE? How strong is TEZSPIRE's clinical and commercial performance?
  • What is TEZSPIRE's clinical trial status in each individual indications such as Asthma and Rhinosinusitis; as well as potential indications like Chronic obstructive pulmonary disease; Eosinophilic oesophagitis, and Chronic urticaria and study completion date?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the TEZSPIRE Manufacturers?
  • What are the key designations that have been granted to TEZSPIRE for approved and potential indications? How are they going to impact TEZSPIRE's penetration in various geographies?
  • What is the current and forecasted TEZSPIRE market scenario for approved and potential indications? What are the key assumptions behind the forecast?
  • What are the current and forecasted sales of TEZSPIRE 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 TEZSPIRE 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 TEZSPIRE? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. TEZSPIRE Overview in approved indications like Asthma and Rhinosinusitis; as well as potential indications like Chronic obstructive pulmonary disease; Eosinophilic oesophagitis, and Chronic urticaria

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

3. TEZSPIRE Competitive Landscape (Marketed Therapies)

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

5. TEZSPIRE Market Assessment

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

6. TEZSPIRE 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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