Summary

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

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Table of Contents

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