September 2019

Physicians treating renal anemia are limited to iron supplements and erythropoiesis-stimulating agents (ESAs), which, although effective, have significant drawbacks. The hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitors are expected to launch during the study period and appear to be able to effectively, safely, and conveniently improve renal anemia. However, to succeed, these novel therapies will have to convince physicians and payers of their safety and efficacy benefits compared with current therapies. In addition, HIF-PH inhibitors will face reimbursement hurdles, competition from biosimilar ESAs, and an increasingly stringent regulatory environment. Given that the drug development pipeline for renal anemia is relatively weak, substantial unmet need and considerable market opportunity remain.

QUESTIONS ANSWERED

  • What are the treatment drivers and goals for renal anemia?
  • What drug attributes are key influences, which have limited impact, and which are hidden opportunities?
  • How do ESAs perform on key treatment drivers and goals for renal anemia?
  • What are the prevailing areas of unmet need and opportunity in renal anemia?
  • What trade-offs across different clinical attributes and price are acceptable to U.S. and European nephrologists for a hypothetical new renal anemia drug?

Markets covered: United States, United Kingdom, France, Germany

Primary research: Survey of 61 U.S. and 30 European nephrologists fielded in June 2019.

Key companies: Roche, Amgen, Janssen, Akebia Therapeutics, Otsuka Pharmaceuticals, Astellas Pharma, AstraZeneca, GlaxoSmithKline, Bayer, Fibrogen, Japan Tobacco

Key drugs: Aranesp, Mircera, Procrit/Epogen/Eprex/Erypo, HIF-PH inhibitors, ESAs.

KEY METRICS INCLUDED

  • Target Product Profile (TPP) simulator based on conjoint analysis methodology.
  • Stated versus derived importance of product attributes on prescribing behavior.
  • Assessment of current drug performance against treatment drivers and goals.
  • Physician perceptions of unmet needs in the indication and related indications.
  • Analysis of remaining drug development opportunities.

PRODUCT DESCRIPTION

Unmet Need supports clinical development decisions by identifying key attributes and assessing areas of unmet need for a specific disease or subpopulation. Based on surveys with U.S. and European physicians, this report provides insight into key treatment drivers and goals, the performance of current therapies, and the remaining commercial opportunities. Two market scenarios are profiled in detail by DRG experts, and additional customized market scenarios can be evaluated with the corresponding TPP simulator.

Table of contents

  • Renal Anemia - Unmet Need - Detailed, Expanded Analysis (US & EU)
    • Introduction
      • Overview
      • Methodology
      • Rationale for Treatment Drivers and Goals Selection
        • Efficacy
        • Safety and Tolerability
        • Convenience of Administration
        • Nonclinical Factors
      • Rationale for Drug Selection
        • Products for Renal Anemia
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Relative Importance of Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Surveyed Nephrologists' Prescribing Decisions in Renal Anemia
      • Importance of Efficacy Attributes to Prescribing Decisions in Renal Anemia: United States
      • Importance of Efficacy Attributes to Prescribing Decisions in Renal Anemia: Europe
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Renal Anemia: United States
      • Importance of Safety and Tolerability Attributes to Prescribing Decisions in Renal Anemia: Europe
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Renal Anemia: United States
      • Importance of Convenience of Administration Attributes to Prescribing Decisions in Renal Anemia: Europe
      • Importance of Nonclinical Factors to Prescribing Decisions in Renal Anemia: United States
      • Importance of Nonclinical Factors to Prescribing Decisions in Renal Anemia: Europe
      • Key Findings: Stated vs. Derived Importance
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Renal Anemia: United States
      • Stated vs. Derived Importance of Key Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Attributes to Prescribing Decisions in Renal Anemia: Europe
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
      • Overall Performance of Key Therapies for Renal Anemia: United States
      • Overall Performance of Key Therapies for Renal Anemia: Europe
      • Mean Overall Performance of Key Therapies for Renal Anemia: United States and Europe
      • Relative Performance of Key Therapies for Renal Anemia Across Select Efficacy Attributes: United States
      • Relative Performance of Key Therapies for Renal Anemia Across Select Efficacy Attributes: Europe
      • Relative Performance of Key Therapies for Renal Anemia Across Select Safety and Tolerability Attributes: United States
      • Relative Performance of Key Therapies for Renal Anemia Across Select Safety and Tolerability Attributes: Europe
      • Relative Performance of Key Therapies for Renal Anemia Across Select Convenience of Administration Attributes: United States
      • Relative Performance of Key Therapies for Renal Anemia Across Select Convenience of Administration Attributes: Europe
      • Relative Performance of Key Therapies for Renal Anemia Across Select Nonclinical Attributes: United States
      • Relative Performance of Key Therapies for Renal Anemia Across Select Nonclinical Attributes: Europe
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Renal Anemia
      • Surveyed Nephrologists’ Satisfaction with the Performance of Key Therapies for Renal Anemia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: United States
      • Surveyed Nephrologists’ Satisfaction with the Performance of Key Therapies for Renal Anemia on Efficacy, Safety and Tolerability, Convenience of Administration, and Nonclinical Factors: Europe
      • Surveyed Nephrologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Renal Anemia: United States
      • Surveyed Nephrologists' Ascribed Level of Unmet Need Across Key Efficacy Attributes in Renal Anemia: Europe
      • Surveyed Nephrologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Renal Anemia: United States
      • Surveyed Nephrologists' Ascribed Level of Unmet Need Across Key Safety and Tolerability Attributes in Renal Anemia: Europe
      • Surveyed Nephrologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Renal Anemia: United States
      • Surveyed Nephrologists' Ascribed Level of Unmet Need Across Key Convenience of Administration Attributes in Renal Anemia: Europe
      • Surveyed Nephrologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Renal Anemia: United States
      • Surveyed Nephrologists' Ascribed Level of Unmet Need Across Key Nonclinical Factors in Renal Anemia: Europe
      • Key Findings: Unmet Need in Renal Anemia and Related Indications
      • Surveyed Nephrologists' Ascribed Level of Unmet Need in Renal Anemia and Related Indications: United States
      • Surveyed Nephrologists' Ascribed Level of Unmet Need in Renal Anemia and Related Indications: Europe
    • Opportunity Analysis
      • Areas of Opportunity in the Renal Anemia Market and Emerging Therapy Insights
        • Opportunity: Agent with an Efficacy Advantage in Improving Hb levels
        • Opportunity: An Agent with a Lower Risk of Adverse Cardiovascular Events
    • Target Product Profiles
      • Assessing Drug Development Opportunities
      • Target Product Profile Methodology
        • Attributes and Attribute Levels
        • Attributes of Key Current and Late-Phase Emerging Therapies for Renal Anemia
      • Attribute Importance and Part-Worth Utilities
        • Renal Anemia Target Product Profile: Attribute Importance
        • Mean Increase in Hb Level
        • Percentage of Patients Maintaining Target Hb Range
        • Effect on Need for Iron Supplements
        • Effect on Need for RBC Transfusions
        • Risk of Adverse Cardiovascular Events
        • Dosing Burden
        • Price per Treated Day
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Renal Anemia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 1
        • Renal Anemia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 1
        • Renal Anemia Market Simulations: Target Product Profiles Included in Scenario 1
        • Renal Anemia Market Simulations: Share of Preference of Target Product Profiles Included in Scenario 2
        • Renal Anemia Market Simulations: Likelihood to Prescribe Target Product Profiles Included in Scenario 2
        • Renal Anemia Market Simulations: Target Product Profiles Included in Scenario 2
    • Appendix
      • Key Abbreviations
      • Bibliography

Author(s): Kahkashan Resham, Ph.D

Kahkashan Resham is a senior research associate in the Cardiovascular, Metabolic and Renal disorders team at Decision Resources Group. Her current work is focused on writing treatment algorithm reports, key opinion leader identification, clinical trial pipeline pulls, as well as secondary research across multiple cardiovascular and metabolic indications.

Prior to joining DRG, Resham obtained her doctorate in Pharmacology from National Institute of Pharmaceutical Education and Research (NIPER), S.A.S. Nagar, India. She completed her M. Pharm. from the NIPER Hyderabad and was awarded a gold medal for securing 1st rank in the Institute. She holds a bachelor’s degree in Pharmacy from Birla Institute of Technology, Ranchi, India. Resham has also published several peer-reviewed research articles in the area of drug metabolism, diabetes and chemotherapy-induced peripheral neuropathic pain.


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