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

  • 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
    • Treatment Drivers and Goals
      • Key Findings: Attribute Importance
      • Key Findings: Stated vs. Derived Importance
    • Product Performance Against Treatment Drivers and Goals
      • Key Findings
    • Assessment of Unmet Need
      • Key Findings: Unmet Need in Renal Anemia
      • Key Findings: Unmet Need in Renal Anemia and Related Indications
    • 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
      • Attribute Importance and Part-Worth Utilities
        • Renal Anemia Target Product Profile: Attribute-Level Part-Worth Utilities
      • Conjoint Analysis-Based Simulations of Market Scenarios
        • Scenario 1
        • Scenario 2
    • Appendix
      • 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), 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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