The Problem
It is no secret in the biopharmaceutical industry that a new drug’s clinical improvement is strongly predictive of the share of patients it achieves. Consequently, drugs that offer little clinical improvement expose developers to commercial risk.
Many organizations, while aware of this problem, continue to lack a proven methodology to identify and quantify that risk. This exposes them to the possibility of advancing undifferentiated drugs that will experience low market access and vulnerability to future competition.
The Solution
Equinox Group has quantified the relationship between clinical improvement and patient share by comparing the magnitude of improvement delivered vs. share achieved in the real world in a large set of historical drug launches. Clinical improvement reflects advances in efficacy, safety, tolerability, dosing, and patient outcomes. Our metric for clinical improvement includes all of these domains and measures the percent reduction in medical need the new drug offers relative to the standard of care. We call that measure of improvement “Clinical Innovation”.
Measuring Clinical Innovation: A Data-Driven Approach
For 30 years, Equinox Group has used a validated, data-driven approach to measure the clinical innovation offered by new drugs across hundreds of indications. See this two-minute video explanation:
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The Link to Commercial Potential
Over many years we have re-evaluated the relationship between clinical innovation and patient share; it has been remarkably stable over time. Below is a table of historical drug launches and where they score in the Equinox Group framework.
As a rule of thumb,
High Innovation: Drugs that offer 10% or more clinical innovation nearly always dominate the branded segments of their markets.
Medium Innovation: Drugs with 5% to 10% innovation usually compete well.
Low Innovation: Drugs with 0-5% improvement are in a gray zone and may be seen as undifferentiated, especially by payers.
Lack of Innovation: Drugs with negative clinical innovation nearly always get low patient shares and disappointing sales.
How Much Clinical Innovation is Enough?
The clinical attributes anticipated in early R&D programs are rarely realized by the end of development. As time goes on, assets often acquire “warts,” whether it be unexpected side effects, lower than expected efficacy, or both. Programs that start with modest clinical aspirations are likely to offer unacceptable levels of innovation at launch. We call this phenomenon “attribute drift.”
We recommend that drug development teams aim to achieve clinical innovation of at least 5% to reduce exposure to attribute drift and the commercial risks described in the beginning of this paper. Our tools allow teams to tie the expected clinical attributes of a new drug first to its level of clinical innovation, and then to patient share to forecast revenue potential.
The Take-Home
Equinox Group’s proven method to measure clinical innovation and predict peak-year patient share for target product profiles is accurate. It’s also less expensive, more flexible, and quicker to execute than conventional market research-based techniques. We use this approach to inform decisions about individual programs (pipeline and BD), to help therapeutic area teams set aspirations, and to inform R&D portfolio assessments.
Who Are We?
Since 1995, Equinox Group has provided analytics to support R&D decisions at biopharmaceutical firms, assessing the potential of drugs from discovery to launch. Our validated techniques will save you time and money, as well as overcome the deficiencies of traditional market research.
We have evaluated thousands of drug profiles across hundreds of indications in oncology, immunology, rare diseases, cardio-metabolic disorders, infectious disease, neurology, pulmonology, urology, ophthalmology, and endocrine disorders. We also have tailored methods to solve the unique analytical challenges that arise in oncology and rare diseases.
Using this methodology, we have developed a suite of tools to inform whatever R&D decisions you’re facing in any stage of development, including: setting indication priorities, supporting go/no-go decisions, assessing market access and pricing potential, share forecasting, and patient flow modeling.