Disruption or Advantage? Update on Companion Diagnostics

Introduction

Some naysayers disagree, but we regard companion diagnostics as a win-win scenario for all stakeholders. Companion diagnostics combines drug and diagnostic test development. The potential for effi cient drug development is huge because companion diagnostics can be used to predict drug response and treatment effi cacy- therefore, companion diagnostics are also the perfect means to fulfi llment of the promise of personalized medicine. But the advantages of companion diagnostics are only one side of the equation: they are also seen as disruptors of the pharmaceutical market that could restrict the size of treatable populations. Bringing the differing viewpoints together to form a unifi ed idea of what companion diagnostics really mean to the industry is a challenge, but one that companies must heed because companion diagnostics are making their mark-like it or not.

Questions Answered in This Report

• Regulatory and payer decisions on certain types of testing are increasingly infl uencing physician, patient, and
industry perspectives. For instance, how has the FDA's recent decision to alter the Vectibix and Erbitux labels affected industry dynamics?
• Companies that have developed companion diagnostics are viewed as valuable acquisition targets. Which
companies are attracting potential buyers? What is the perceived impact of these acquisitions on the overall strategies of pharmaceutical companies?
• The availability of companion diagnostics in oncology is greater than in other therapy areas. Why is oncology
such an attractive area for growth in personalized medicine? In what other areas is development of personalized medicine growing?

Scope

• Stakeholder analysis: Pharmaceutical companies, diagnostics companies, payers, regulatory agencies,
physicians, and patients.
• Recent trends and decisions: Regulating KRAS mutation tests, identifi cation of genetic markers of
response to Vanda's Fanapt (iloperidone), reimbursement for warfarin testing, partnering and dealmaking in companion diagnostics.
• Indications: Non-small-cell lung cancer (NSCLC), colorectal cancer (CRC), breast cancer, heart
failure, arthritis, depression, chronic myelogenous leukemia (CML).
• Company profi les: Pharmaceutical companies-Wyeth, Vanda Pharmaceuticals, Roche, Pfi zer,
Novartis, Johnson & Johnson, Eli Lilly, ARCA BioPharma, Amgen, and Abbott. Diagnostics companies- LabCorp, DxS, Dako, and Clinical Data.
• Outlook: Spectrum Expert Commentary on future growth, therapeutic area emphasis, the promise of personalized medicine

Please note, the PDF e-mail from publisher version of this report is for a global site license.