美国气雾剂市场规模、份额和趋势分析报告：按类型、分销管道和细分市场预测，2025 年至 2033 年

市场规模与趋势：

预计 2024 年美国充气药物市值将达 12.8 亿美元，到 2033 年将达到 25 亿美元，2025 年至 2033 年的复合年增长率为 7.44%。

前列腺癌发病率上升、新型荷尔蒙疗法日益普及以及优惠的报销政策推动了市场成长。市场主要集中在拥有先进肿瘤科设施的都市区医疗中心，但由于可近性提高，农村地区也具有成长潜力。品牌药 Erleada 是市场主导学名药预计专利到期后将面临仿製药的竞争。

由于专科治疗需求，医院药房在分销方面处于领先地位。关键趋势包括联合治疗的进步以及用于病患监测的数位健康整合。 Erleada 在美国市场保持强劲地位，得益于其在非转移性去势抗性前列腺癌 (nmCRPC) 和转移性去势敏感型前列腺癌 (mCSPC) 治疗中的加速核准。该药物受益于被纳入最新的 NCCN 和 AUA 临床指南，这些指南推荐使用下一代雄激素受体抑制剂治疗这些适应症。由于医疗保险和私人保险公司的广泛报销支持，Erleada 已广泛应用于泌尿系统和肿瘤内科。

美国的处方模式也反映出偏好口服疗法，因为这种疗法可以延缓疾病进展并避免化疗，这有助于该药物在社区和医院环境中的持续采用。儘管面临来自 Xtandi 和 Nubeqa 等其他雄激素受体通路抑制剂的竞争，但 Erleada 凭藉其双标籤产品和杨森针对大型肿瘤实践网络的定向推广，仍然保持了相当大的市场份额。处方数量保持稳定，但由于竞争加剧和处方偏好，成长放缓。随着专利独占权于 2031 年到期，预计将有长期的学名药进入计划，儘管截至 2025 年中期尚未推出任何学名药。市场进入因地区和计划类型而异，并且在某些付款人计划中需要事先核准要求和逐步治疗通讯协定。

ERLEADA 的广泛应用得益于其被纳入美国主要治疗指南，包括 NCCN 和 AUA。这些核准使其在社区和学术肿瘤科室的处方量持续稳定。此外，ERLEADA 同时核准抗性前列腺癌 (nmCRPC) 和间质性前列腺癌 (mCSPC)，进一步拓展了其在前列腺癌治疗途径中的地位，使其能够实现早期治疗并支持长期持续治疗。

在美国，ErleadA 的报销环境依然良好，其在联邦医疗保险 D 部分、私人保险公司和退伍军人事务部医疗体系的覆盖范围不断扩大。杨森的可近性计划和共付额援助倡议进一步降低了患者的经济障碍。此外，ErleadA 始终是首选处方药，这为其带来了持续的处方增长势头，尤其是在用药量大的泌尿系统网络。美国ErleadA 市场正受到向基于价值的医疗模式转变的影响，这种模式优先考虑那些能够证明长期临床和经济效益的治疗方案。

TITAN 试验的临床结果显示，死亡风险降低 33%（HR 0.67），这巩固了 Erleada 在联邦医疗保险 (Medicare) 和商业健康保险计划中的有利地位。 2024 年，联邦医疗保险优势计划 (Medicare Advantage) 证实，接受 Erleada 治疗的 nmCRPC 患者的住院率显着降低，这进一步巩固了 Erleada 相比其他替代疗法在现实世界中的效用。为了保持竞争力并应对未来学名药带来的定价压力，相关人员正致力于扩大现实世界数据收集和医疗保健提供者教育计划，以支持循证处方并优化治疗整合。

在美国，Erleadine 面临着来自其他核准用于类似适应症的雄性激素受体抑制剂（包括 Xtandi 和 Nubeqa）日益激烈的竞争。给药方案、安全性和付款人主导的处方决策的差异影响着医师的偏好和处方行为。在某些地区，快速核准和分步治疗要求有利于替代药物，儘管临床疗效具有可比性，但这限制了 Erleadine 的市场占有率增长。

目录

第一章调查方法与范围

第二章执行摘要

第三章 早期读者市场变数、趋势与范围

• 市场体系展望
• 市场动态
  • 市场驱动因素分析
  • 市场限制因素分析
• 商业环境分析
  • 产业分析-波特五力分析
  • PESTLE分析
  • 管道分析
  • 专利到期分析
  • 定价分析

第四章美国早期阅读市场：类型业务分析

• 2024 年及 2033 年各类型市场占有率
• 类型细分仪表板
• 按类型分類的市场规模、预测和趋势分析（2021-2033 年）
• 品牌
• 非专利的

第五章美国早期阅读市场：通路业务分析

• 2024年及2033年分销通路市场占有率
• 分销通路细分仪表板
• 按分销管道分類的市场规模、预测和趋势分析（2021-2033 年）
• 医院药房
• 零售药局
• 其他的

第六章 竞争态势

• 参与者概览
• 企业市场分析
• 公司分类
• 战略地图
• 公司简介/上市公司
  • Janssen Biotech, Inc.
  • Zydus Lifesciences

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