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コンパニオン診断と医薬品の効果的な販売・マーケティング戦略

Effective Sales and Marketing Strategies for Drugs with Companion Diagnostics

発行 FirstWord 商品コード 273174
出版日 ページ情報 英文 69 Pages
納期: 即日から翌営業日
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コンパニオン診断と医薬品の効果的な販売・マーケティング戦略 Effective Sales and Marketing Strategies for Drugs with Companion Diagnostics
出版日: 2013年05月29日 ページ情報: 英文 69 Pages
概要

コンパニオン診断の商業的メリットを十分に活用するために、製薬企業はその創薬・マーケティング戦略を根本から考え直す必要があります。

当レポートでは、コンパニオン診断とその医薬品の商業化について調査し、効果的な販売・マーケティング戦略について分析しており、商業化アプローチ、診断規制の影響、および価格・医療費償還問題などを取り上げ、さまざまなケーススタディを提示しながら、概略以下の構成でお届けいたします。

エグゼクティブサマリー

イントロダクション

オーダーメイド医療:大きな可能性を持った新興市場

  • 製薬R&D戦略における変化の余地
  • リスクのあるRx(処方薬)/CDx(コンパニオン診断薬)共同開発モデル
    • ケーススタディ:Zelborafはメラノーマ市場に急速に浸透

商業化には組織的アプローチが必要

  • ラボは忘れられたステークホルダー
  • 価値命題が鍵
  • セールス・マーケティングチームは特定の市場ニーズへ対応することが必要
  • 教育、教育、教育
    • ケーススタディ:Boehringer Ingelheimの'Let's Test'プログラムは肺がん向けバイオマーカー試験への認識を高める

商業化戦略に影響するさまざなま診断規制

  • 米国の医薬品ラベルはCDxの選択に結びつく
  • 欧州の規制
  • ラボ開発検査vs.キット
    • ケーススタディ:LDTからQiagenのKRASアッセイへの転換
    • LDTは欧州市場で支持される
    • ケーススタディ:BCR-ABL1検査を標準化するための研究が実施中
  • 検査の課題
    • ケーススタディ:乳がん患者におけるHER2検査の基準設定の課題
    • ケーススタディ:肺がん治療パラダイムの変化

価格・医療費償還は市場アクセスへの障害として残る

  • 価値命題の医療費償還への連結
    • ケーススタディ:EGFR-TK変異体のNICE評価オプション
  • 複合モダリティが将来の商業化モデルを提示

結論

調査手法・確認事項

目次

To fully exploit the commercial advantages of companion diagnostics, Pharma companies need to rethink fundamentally their drug development and marketing strategies.

Everyone is a winner with companion diagnostics. The ability to accurately diagnose specific patient subsets is allowing drugs to be targeted only at those patients who will respond to treatment. Patients benefit from effective treatment and reduced side effects. Payers benefit from drugs that are now only used in patients for whom they are effective whilst the pharma industry, cautious about the potential impact of lower prescribing volumes, can benefit in the long term from effectively positioning its product.

Despite these advantages there remain a number of challenges for the sector. Regulation has failed to keep up with the speed of market development, differing cultural preferences - sharply contrasted in the US and Europe - are affecting take up, not all stakeholders are sufficiently informed and onboard while the uncertain reimbursement status in some markets is frustrating the sector's development. What can Pharma and Diagnostic companies do to effect change?

Report benefits

Through detailed case studies and expert industry input this invaluable report identifies the essential ingredients needed to successfully market a biologic drug and its companion diagnostic. Old models of selling and branding need to be adapted to the new market realities and partnership working with wider stakeholder education and integrated sales training all have a part to play. Learn from the experience and insights of front line experts from industry leading companies such as Pfizer, Boehringer Ingelheim, Qiagen and Diaceutics.

Key Quotes:

“This is a multidisciplinary approach. This is really a joint effort between global colleagues who want to ensure that there is a global strategy being implemented from the launch perspective, so the same drug and same test are being launched across the globe.” - Dr. Carole Welsch, associate director, regional marketing of personalised healthcare at Qiagen North America.

“The group sitting beside the physician and therefore often helping the physician take the decision around what the test result was is the laboratorian and pathologist - not the diagnostic company, not the payer, not the regulator, but the lab. The labs are the ones that are in the frontline.” - Peter Keeling, chief executive officer, Diaceutics.

“The whole concept of personalised medicine is that you're selecting in the clinical trial this patient population, so there needs to be a diagnostic technology and platform that's used in those pivotal Phase III trials, the registration trials, that's going to be part of your label. Therefore thinking about this is definitely something that has to come early in your clinical development programme when you think about the Dx technology platform that's going to be most appropriate not only for the clinical trial programme to select the patients but also to ensure that that technology or technical platform is going to be widely available so that it's not going to be a barrier to patients once the drug's approved.” - Andy Schmeltz, US region president, oncology business unit, Pfizer.

This report will help you to:

  • Appreciate the complex and evolving regulatory environment which is shaping the market
  • Understand why clinical laboratories are critical in ensuring wide adoption
  • Incorporate joint working at an early stage to ensure harmonised approval with integrated marketing messages and programmes
  • Develop education programmes which will support patient confidence and clinician support
  • Introduce support and marketing structures which encourage diagnostic testing

‘Effective sales and marketing strategies for drugs with companion diagnostics’ answers key questions such as:

  • How can you work with laboratories to ensure that companion diagnostics are seen positively and not competitively?
  • What role can patient advocacy groups play?
  • At what development stage should Pharma and Diagnostics teams be working together?
  • To what degree should the value proposition of the brand be related to the role of the accompanying diagnostic?
  • What alternatives are there to company funding of testing in markets where diagnostic reimbursement is not available?

Expert Views Include:

  • Dr. Austin Finley, consultant, RxDxExperts (US)
  • Susan Holz, associate director of public relations, Boehringer Ingelheim (US)
  • Peter Keeling, chief executive office, Diaceutics (Northern Ireland)
  • Kevin Lokay, vice-president and business unit head, oncology, Boehringer Ingelheim (US)
  • Andy Schmeltz, US region president, oncology business unit, Pfizer
  • Dr. Thomas Theuringer, director public relations, Qiagen (Germany)
  • Dr. Carole Welsch, associate director, regional marketing of personalised healthcare, North America, Qiagen

Table of Contents

Executive summary

Introduction

  • Rx meets Dx: challenges and opportunities
  • Regulatory inconsistencies
  • Transitioning from development to successful commercialisation

Personalised medicine - an emerging market with significant potential

  • Room for changes in pharmaceutical R&D strategies
  • Rx/CDx co-development model not without risk
    • Case study: Zelboraf rapidly penetrates melanoma market

Commercialisation requires a co-ordinated approach

  • ...labs the forgotten stakeholder
  • The value proposition is key
  • Sales and marketing teams need to address specific market needs
  • Education, education, education
    • Case study: Boehringer Ingelheim's ‘Let's Test' programme raising awareness of biomarker testing for lung cancer

Diverse diagnostic regulations influencing commercialisation strategies

  • US drug label linked to CDx choice
  • EU regulations
  • Lab-developed tests versus kits
    • Case study: Conversion from LDTs to Qiagen's KRAS assay
    • LDTs find favour in the European market
    • Case study: Study underway to standardise BCR-ABL1 testing
  • The testing challenge
    • Case study: Challenges in setting the standard for testing HER2 in breast cancer patients
    • Case study: Changing the lung cancer treatment paradigm

Pricing and reimbursement remain barriers to market access

  • Linking the value proposition to reimbursement
    • Case study: NICE assessment of EGFR-TK mutation testing options
  • Multiple modalities point to future commercialisation models

Conclusions

Methodology and acknowledgements

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