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市場調查報告書
商品編碼
1790412

美國氣霧劑市場規模、佔有率和趨勢分析報告:按類型、分銷管道和細分市場預測,2025 年至 2033 年

U.S. Erleada Market Size, Share & Trends Analysis Report By Type (Branded, Generic), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies), And Segment Forecasts, Key Companies, And Competitive Analysis, 2025 - 2033

出版日期: | 出版商: Grand View Research | 英文 120 Pages | 商品交期: 2-10個工作天內

價格

市場規模與趨勢:

預計 2024 年美國充氣藥物市值將達 12.8 億美元,到 2033 年將達到 25 億美元,2025 年至 2033 年的複合年成長率為 7.44%。

前列腺癌發病率上升、新型荷爾蒙療法日益普及以及優惠的報銷政策推動了市場成長。市場主要集中在擁有先進腫瘤科設施的都市區醫療中心,但由於可近性提高,農村地區也具有成長潛力。品牌藥 Erleada 是市場主導學名藥預計專利到期後將面臨學名藥的競爭。

由於專科治療需求,醫院藥房在分銷方面處於領先地位。關鍵趨勢包括聯合治療的進步以及用於病患監測的數位健康整合。 Erleada 在美國市場保持強勁地位,得益於其在非轉移性去勢抗性前列腺癌 (nmCRPC) 和轉移性去勢敏感型前列腺癌 (mCSPC) 治療中的加速核准。該藥物受益於被納入最新的 NCCN 和 AUA 臨床指南,這些指南推薦使用下一代雄激素受體抑制劑治療這些適應症。由於醫療保險和私人保險公司的廣泛報銷支持,Erleada 已廣泛應用於泌尿系統和腫瘤內科。

美國的處方模式也反映出偏好口服療法,因為這種療法可以延緩疾病進展並避免化療,這有助於該藥物在社區和醫院環境中的持續採用。儘管面臨來自 Xtandi 和 Nubeqa 等其他雄激素受體通路抑制劑的競爭,但 Erleada 憑藉其雙標籤產品和楊森針對大型腫瘤實踐網路的定向推廣,仍然保持了相當大的市場佔有率。處方數量保持穩定,但由於競爭加劇和處方偏好,成長放緩。隨著專利獨佔權於 2031 年到期,預計將有長期的學名藥進入計劃,儘管截至 2025 年中期尚未推出任何學名藥。市場進入因地區和計劃類型而異,並且在某些付款人計劃中需要事先核准要求和逐步治療通訊協定。

ERLEADA 的廣泛應用得益於其被納入美國主要治療指南,包括 NCCN 和 AUA。這些核准使其在社區和學術腫瘤科室的處方量持續穩定。此外,ERLEADA 同時核准抗性前列腺癌 (nmCRPC) 和間質性前列腺癌 (mCSPC),進一步拓展了其在前列腺癌治療途徑中的地位,使其能夠實現早期治療並支持長期持續治療。

在美國,ErleadA 的報銷環境依然良好,其在聯邦醫療保險 D 部分、私人保險公司和退伍軍人事務部醫療體系的覆蓋範圍不斷擴大。楊森的可近性計劃和共付額援助舉措進一步降低了患者的經濟障礙。此外,ErleadA 始終是首選處方藥,這為其帶來了持續的處方成長勢頭,尤其是在用藥量大的泌尿系統網路。美國ErleadA 市場正受到向基於價值的醫療模式轉變的影響,這種模式優先考慮那些能夠證明長期臨床和經濟效益的治療方案。

TITAN 試驗的臨床結果顯示,死亡風險降低 33%(HR 0.67),這鞏固了 Erleada 在聯邦醫療保險 (Medicare) 和商業健康保險計劃中的有利地位。 2024 年,聯邦醫療保險優勢計劃 (Medicare Advantage) 證實,接受 Erleada 治療的 nmCRPC 患者的住院率顯著降低,這進一步鞏固了 Erleada 相比其他替代療法在現實世界中的效用。為了保持競爭力並應對未來學名藥帶來的定價壓力,相關人員正致力於擴大現實世界數據收集和醫療保健提供者教育計劃,以支持循證處方並最佳化治療整合。

在美國,Erleadine 面臨著來自其他核准用於類似適應症的雄性激素受體抑制劑(包括 Xtandi 和 Nubeqa)日益激烈的競爭。給藥方案、安全性和付款人主導的處方決策的差異影響著醫師的偏好和處方行為。在某些地區,快速核准和分步治療要求有利於替代藥物,儘管臨床療效具有可比性,但這限制了 Erleadine 的市場佔有率成長。

目錄

第1章調查方法與範圍

第2章執行摘要

第3章 早期讀者市場變數、趨勢與範圍

  • 市場體系展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 商業環境分析
    • 產業分析-波特五力分析
    • PESTLE分析
    • 管道分析
    • 專利到期分析
    • 定價分析

第4章美國早期閱讀市場:類型業務分析

  • 2024 年及 2033 年各類型市場佔有率
  • 類型細分儀表板
  • 按類型分類的市場規模、預測和趨勢分析(2021-2033 年)
  • 品牌
  • 非專利的

第5章美國早期閱讀市場:通路業務分析

  • 2024年及2033年分銷通路市場佔有率
  • 分銷通路細分儀表板
  • 按分銷管道分類的市場規模、預測和趨勢分析(2021-2033 年)
  • 醫院藥房
  • 零售藥局
  • 其他

第6章 競爭態勢

  • 參與者概覽
  • 企業市場分析
  • 公司分類
  • 戰略地圖
  • 公司簡介/上市公司
    • Janssen Biotech, Inc.
    • Zydus Lifesciences
Product Code: GVR-4-68040-662-0

Market Size & Trends:

The U.S. erleada market size was estimated at USD 1.28 billion in 2024 and is projected to reach USD 2.5 billion by 2033, registering a CAGR of 7.44% from 2025 to 2033. Growth is driven by rising prostate cancer prevalence, increasing adoption of novel hormonal therapies, and favorable reimbursement policies. The market is concentrated in urban healthcare centers with advanced oncology facilities, while rural areas show potential for growth due to improving access. Branded Erleada dominates, but generic competition is expected post-patent expiry.

Hospital pharmacies lead distribution due to specialized treatment needs. Key trends include advancements in combination therapies and digital health integration for patient monitoring. Erleada has maintained a strong market position in the U.S. due to its early approval for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). The drug benefits from inclusion in updated NCCN and AUA clinical guidelines, which recommend next-generation androgen receptor inhibitors for these indications. Utilization has been supported by the broad reimbursement coverage from Medicare and commercial payers, which has led to widespread adoption in urology and oncology practices.

U.S. prescribing patterns also reflect a preference for oral therapies that delay progression and avoid chemotherapy, contributing to consistent uptake in both community and hospital settings. Despite competition from other androgen receptor pathway inhibitors such as Xtandi and Nubeqa, Erleada retains a significant share due to its dual-label advantage and Janssen's targeted promotion to high-volume oncology networks. Prescription volume has been stable, although growth has moderated due to increased competition and formulary-based preferences. The expiration of patent exclusivity in 2031 is expected to shape long-term planning for generic entry, but no generic versions are available as of mid-2025. Market access is influenced by prior authorization requirements and step therapy protocols in some payer systems, which vary by region and plan type.

Erleada's inclusion in major U.S. treatment guidelines such as those by the NCCN and AUA has significantly driven its adoption. These endorsements have led to consistent prescribing across community and academic oncology settings. In addition, its dual approval for nmCRPC and mCSPC has allowed broader positioning within the prostate cancer treatment pathway, enabling early-line use and supporting continuous therapy over longer durations.

The U.S. reimbursement environment for Erleada remains favorable, with coverage extended across Medicare Part D, commercial insurers, and VA healthcare systems. Access programs and co-pay assistance initiatives by Janssen have further reduced financial barriers for patients. The consistent formulary placement of Erleada in preferred drug tiers has contributed to sustained prescribing momentum, especially in high-volume urology networks. The U.S. market for Erleada is shaped by the shift toward value-based care models, where payers prioritize treatments that demonstrate long-term clinical and economic benefits.

Clinical outcomes from the TITAN trial, such as the 33% reduction in mortality risk (HR 0.67), have supported its favorable positioning among Medicare and commercial plans. In 2024, Medicare Advantage programs observed a measurable decline in hospitalizations among nmCRPC patients treated with Erleada, reinforcing its real-world utility over some alternative therapies. To sustain competitive positioning and manage future pricing pressures from potential generics, stakeholders focus on expanding real-world data collection and provider education initiatives to support evidence-based prescribing and optimize treatment integration.

Erleada faces growing competition in the U.S. from other androgen receptor inhibitors, notably Xtandi and Nubeqa, which are also approved for similar indications. Differences in dosing schedules, safety profiles, and payer-driven formulary decisions have influenced physician preferences and prescribing dynamics. Prior authorizations or step therapy requirements favor alternate agents in certain regions, limiting Erleada's market share expansion despite clinical comparability.

U.S. Erleada Market Report Segmentation

This report forecasts revenue growth at a country level and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. Erleada market report based on type and distribution channel:

  • Type Outlook (Revenue, USD Million, 2021 - 2033)
  • Branded
  • Generic
  • Distribution Channel Outlook (Revenue, USD Million, 2021 - 2033)
  • Hospital Pharmacies
  • Retail Pharmacies
  • Others

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Type
    • 1.2.2. Distribution Channel
  • 1.3. Estimates and Forecast Timeline
  • 1.4. Research Methodology
  • 1.5. Information Procurement
    • 1.5.1. Purchased Database
    • 1.5.2. GVR's Internal Database
    • 1.5.3. Secondary Sources
    • 1.5.4. Primary Research
  • 1.6. Information Analysis
    • 1.6.1. Data Analysis Models
  • 1.7. Market Formulation & Data Visualization
  • 1.8. Model Details
    • 1.8.1. Commodity Flow Analysis
  • 1.9. List of Secondary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Snapshot
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. Erleada Market Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
    • 3.2.2. Market Restraint Analysis
  • 3.3. Business Environment Analysis
    • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
      • 3.3.1.1. Supplier Power
      • 3.3.1.2. Buyer Power
      • 3.3.1.3. Substitution Threat
      • 3.3.1.4. Threat of New Entrants
      • 3.3.1.5. Competitive Rivalry
    • 3.3.2. PESTLE Analysis
    • 3.3.3. Pipeline Analysis
    • 3.3.4. Patent Expiry Analysis
    • 3.3.5. Pricing Analysis

Chapter 4. U.S. Erleada Market: Type Business Analysis

  • 4.1. Type Market Share, 2024 & 2033
  • 4.2. Type Segment Dashboard
  • 4.3. Market Size & Forecasts and Trend Analysis, by Type, 2021 to 2033 (USD Million)
  • 4.4. Branded
    • 4.4.1. Branded Market, 2021 - 2033 (USD Million)
  • 4.5. Generic
    • 4.5.1. Generic Market, 2021 - 2033 (USD Million)

Chapter 5. U.S. Erleada Market: Distribution Channel Business Analysis

  • 5.1. Distribution Channel Market Share, 2024 & 2033
  • 5.2. Distribution Channel Segment Dashboard
  • 5.3. Market Size & Forecasts and Trend Analysis, by Distribution Channel, 2021 to 2033 (USD Million)
  • 5.4. Hospital Pharmacies
    • 5.4.1. Hospital Pharmacies Market, 2021 - 2033 (USD Million)
  • 5.5. Retail Pharmacies
    • 5.5.1. Retail Pharmacies Market, 2021 - 2033 (USD Million)
  • 5.6. Others
    • 5.6.1. Others Market, 2021 - 2033 (USD Million)

Chapter 6. Competitive Landscape

  • 6.1. Participant Overview
  • 6.2. Company Market Position Analysis
  • 6.3. Company Categorization
  • 6.4. Strategy Mapping
  • 6.5. Company Profiles/Listing
    • 6.5.1. Janssen Biotech, Inc.
      • 6.5.1.1. Overview
      • 6.5.1.2. Financial Performance
      • 6.5.1.3. Product Benchmarking
      • 6.5.1.4. Strategic Initiatives
  • 6.6. Zydus Lifesciences
      • 6.6.1.1. Overview
      • 6.6.1.2. Financial Performance
      • 6.6.1.3. Product Benchmarking
      • 6.6.1.4. Strategic Initiatives

List of Tables

  • Table 1 List of secondary sources
  • Table 2 List of abbreviations
  • Table 3 U.S. Erleada market, by region, 2021 - 2033 (USD Million)
  • Table 4 U.S. Erleada market, by type, 2021 - 2033 (USD Million)
  • Table 5 U.S. Erleada market, by distribution channel, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 Erleada market segmentation
  • Fig. 2 Market research process
  • Fig. 3 Data triangulation techniques
  • Fig. 4 Primary research pattern
  • Fig. 5 Market research approaches
  • Fig. 6 Value-chain-based sizing & forecasting
  • Fig. 7 Market formulation & validation
  • Fig. 8 Market snapshot
  • Fig. 9 Therapeutic approach and application outlook (USD Million)
  • Fig. 10 Competitive landscape
  • Fig. 11 U.S. Erleada market dynamics
  • Fig. 12 U.S. Erleada market: Porter's five forces analysis
  • Fig. 13 U.S. Erleada market: PESTLE analysis
  • Fig. 14 Type market, 2021 - 2033 (USD Million)
  • Fig. 15 Branded market, 2021 - 2033 (USD Million)
  • Fig. 16 Generic market, 2021 - 2033 (USD Million)
  • Fig. 17 Distribution Channel market, 2021 - 2033 (USD Million)
  • Fig. 18 Hospital Pharmacies market, 2021 - 2033 (USD Million)
  • Fig. 19 Retail Pharmacies market, 2021 - 2033 (USD Million)
  • Fig. 20 Others market, 2021 - 2033 (USD Million)
  • Fig. 21 U.S. Erleada market revenue, by region
  • Fig. 22 Regional marketplace: Key takeaways
  • Fig. 23 U.S. Erleada market, 2021 - 2033 (USD Million)
  • Fig. 24 U.S. country dynamics
  • Fig. 25 Company categorization
  • Fig. 26 Company market position analysis
  • Fig. 27 Strategic framework