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市場調查報告書

相關利益者的見解:生物醫藥品產業的技術創新

Stakeholder Perspectives: Innovation within the Biopharma Industry

出版商 FirstWord 商品編碼 296270
出版日期 內容資訊 英文 99 Pages
商品交期: 最快1-2個工作天內
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相關利益者的見解:生物醫藥品產業的技術創新 Stakeholder Perspectives: Innovation within the Biopharma Industry
出版日期: 2014年02月19日 內容資訊: 英文 99 Pages
簡介

本報告以生物醫藥品產業的技術創新為焦點,提供產業的特徵及技術創新趨勢、主要的相關利益者、參與企業的機會及未來的成長方案等彙整資料,為您概述為以下內容。

第1章 摘要整理

第2章 調查方法與調查目的

第3章 生物醫藥品產業的技術創新

  • 概要
  • 現今生物醫藥品產業的特徵
    • 研究開發的輸出與投資額不相稱
    • 在分子層級的差異化成為更大問題
    • 生物科技成為簽引生物醫藥品市場成長的因素
    • 找尋全球化與成長及技術創新的新領域
    • 競爭加劇,尤其是學名藥領域
    • 法律規章的認證更困難
    • 付款者對藥價、給付,及獲得的影響力持續增大
    • 健康科技評估使新產品的上市推遲
    • M&A、授權,及多樣化開始用於成長策略
  • 現今的生物醫藥品產業的技術創新
    • 技術創新的革命
    • 生物醫藥品技術創新定義
    • 生物醫藥品技術創新的投資
    • 生物醫藥品技術創新的基準
    • 生物醫藥品技術創新的主要推動因素和阻礙要素
      • 政策與法律規章
      • 網路、聯盟、聯合
      • 企業規模與策略

第4章 技術創新生態系統的主要相關利益者

  • 概要
  • 生物醫藥品的技術創新生態系統中主要活躍的東西
  • 生物醫藥品的技術創新生態系統的作用、責任,及態度
  • 未來的展望

第5章 現在及未來的生物醫藥品對企業來說的機會

  • "超越藥丸"策略:是時候開始關注結果而不是產品了嗎
  • 生技仿製藥:真的可以不影響品質就改善生技藥品的獲得嗎
  • 基因治療:疾病管理的未來
  • 醫藥品網路:生物醫藥品產業的新衣
  • 個人化醫療:規則,而不是例外
  • 再生醫療:要談太早了嗎
  • 針對性預防:智慧科技成為疾病預防的下個策略嗎

第6章 未來的生物醫藥品產業相關的方案基礎分析

  • 概要
  • 所謂方案
  • 所謂帶動本報告的重要方案
  • 重要的討論事項
  • 4個方案
  • 專家的見解

第7章 結論

附錄

目錄

What does innovation mean within the biopharma industry? How much you spend on R&D? How many products you bring to market? How many New Molecular Entities (NME) you have in research?

Within the biopharma industry, R&D output is at odds with R&D investment. Between 1950 and 2010, the number of new molecules (including both biologics and small molecules) brought to market by the biopharma industry, per billion dollars of R&D expenditure, fell by a factor of 100 in inflation adjusted terms. Innovation, it seems, is getting increasingly expensive while the prospect of blockbuster income to pay for it is getting rarer. Something has to change.

So...what are the issues we need to consider?

  • New molecular entity (NME) output is not an accurate reflection of the state of innovation : new ways of measuring innovation within the biopharma industry are needed. Current methods of measuring NME output from either the FDA or EMA provide only a snapshot of what regulatory agencies deem approvable. The industry needs to move beyond NME output as a measure of innovation, taking into account provider, purchaser and user metrics including pipeline activity, clinical success, regulatory approval, patient access, satisfaction of unmet need and overall value to society;
  • Collaboration is critical to success : Industry must leverage the experience, skills and insights from a diverse range of stakeholders such as physicians, patients and payers - this is critical to the future of innovation. But collaboration needs to be smart. Biopharma companies must collaborate only when the expected outcome adds value to society, contributes to better patient outcomes and supports commercial goals;
  • Companies need to be brave : constantly mining a 'comfort zone' of known approaches leads to complacency and limits innovation. While many believe that all of the 'low hanging fruit' have been taken there is another perspective: that there is plenty of fruit left on the tree and companies just need the bravery and vision to look for them.

This FirstView advisory report - the first in a major new series - provides everyone interested in the dynamics of biopharma innovation with a robust understanding of the issues, opinions and insights that are shaping the current environment, and the events that could lead to a change in the future. Every aspect of the report is informed by expert insight gathered from 60-minute interviews with 16 key opinion leaders (KOLs), payers and senior industry executives from leading companies from across Europe and the US.

Experts share their insights on...

  • The impact of innovation within biotechnology over the last 15-20 years
  • A view of what a world without biologics would have looked like
  • The pros and cons of biological therapies
  • Where biologics have been best received and where there is still resistance
  • The role that industry played, and needs to play, within the 'innovation ecosystem'
  • The important and growing roles of key stakeholder groups
  • Attitudes toward innovation within industry
  • New technologies and innovations that are exciting industry at the moment, and hypotheses about the future of innovation and roles in driving it forward

This report tackles the pressing innovation issues and questions

  • What does biopharma innovation mean?
  • Where is innovation coming from?
  • How can the lessons of the last few decades be used to guide future biopharma innovation?
  • What will be the future trends in biopharma innovation?
  • How has biopharma innovation been measured in the past, and do new ways of measuring innovation need to be developed?
  • What must biopharma companies focus on in order to remain competitive and deliver innovation that is truly valued by society?
  • Which companies are currently viewed as being leaders of innovation within the pharmaceutical industry?
  • What disruptive technologies and market dynamics are likely to impact the rate of innovation within the biopharma industry?
  • What do KOLs, payers and industry stakeholders view as critical for biopharma companies to focus on in order to maintain shareholder returns and deliver customer value?

Whether you work in big pharma, a drug discovery company, patient advocacy group or regulatory body, this report Stakeholder Perspectives: Innovation within the Biopharma Industry provides a thought provoking assessment of how we can better cost-effectively develop and bring biopharmaceuticals to the market in a timely manner.

Expert Interviewed For This Reoprt

This report benefits from the considered insight of leading clinicians, payers and senior industry experts. These include:

  • KOL's with relevant clinical, regulatory, scientific and commercial experience, scientific publications, involvement in clinical trials and their record of presenting at high profile international conferences.
  • Payers with relevant (and recent) experience of deciding on the reimbursement of expensive biological therapies in areas such as oncology, inflammatory conditions, orphan diseases and infectious diseases.
  • Senior industry executives with current (or recent) experience in innovation, strategy, business development, licensing, competitive intelligence and long-term planning.

Their names have been kept confidential to provide contributors with a secure forum in which they could share their candid opinions and views.

Key Opinion Leaders

  • Rheumatologist, UK
  • Rheumatologist, Germany
  • Rheumatologist, US
  • Oncologist, US

Payers

  • Director, Managed Care Organization
  • Former Pharmacy Director, Harvard Pilgrim Health
  • Director, Health Insurance (Germany)
  • Head of Medicines Management, CCG (UK)

Industry Experts

  • Former Head of Innovation at Eli Lilly
  • Senior Manager, Boehringer Ingelheim
  • Head of Innovation, Merck Serono
  • Scientific Advisor, Innogen Institute
  • VP Strategy & Operations, Janssen R&D
  • Global Head, Innovation & Partnerships, Roche
  • Two senior executives from a large EU-based biotech firm

Who Should Read This Report And Why

FirstView's Stakeholder Perspectives: Innovation within the Biopharma Industry is a 'must read' for industry executives working in the areas of innovation strategy, business development & licensing, competitive intelligence, long-term planning, market access, R&D, partnering & alliance management, and emerging markets. Each stakeholder group will be able to use the insight delivered in the report to:

  • Review aims, objectives and goals of current innovation strategy, and what (on the basis of the way the market is evolving) will be the critical success factors for future success;
  • Reassess business development and licensing needs, aims and objectives to ensure that all future deals are accretive in terms of their ability to deliver innovative products to the market;
  • Review external competitor strategies with a view to ensuring internal stakeholders are kept up to speed with market and competitive developments;
  • Perform internal scenario analyses of various opportunities (e.g. gene therapy, regenerative medicine and technology opportunities) to see what will be needed to leverage the opportunity, and to understand what potential future business models will be needed;
  • Review relationships with payers, asking the question 'are we providing the right data to payers for our innovative products'?
  • Review current clinical trial strategies to improve the effectiveness of clinical trials, making them faster, smarter and cheaper, and review regulatory strategies based on increased regulatory hurdles;
  • Get a better understanding of what critical attributes are needed in partners when assessing collaborations and joint ventures;
  • Engage in portfolio optimisation work in emerging markets to ensure that needs of the market are being addressed by current portfolio; if not, review opportunities to in-license, partner, divest assets.

Table of Contents

Chapter 1 Executive summary

  • The impact of innovation within biotechnology on society has been significant, and more is on the way
  • Current methods of measuring innovation, with a focus on new molecular entity (NME) approvals, need refining to provide a more holistic view
  • The state of innovation within the biopharma industry is not as bad as people make out, but improvements need to be made
  • Biopharma's destiny is in the hands of the industry, but support from other key stakeholder groups is essential for continued progress...
  • Bravery, collaboration and visionary leadership are at the heart of the future of innovation...

Chapter 2 Research methodology, aims and objectives

  • Research methodology
  • Research aims and objectives

Chapter 3 Innovation within the biopharma industry

  • Overview
  • Defining characteristics of today's biopharma industry
    • R&D output is at odds with R&D spending
    • Differentiation at the molecular level is becoming more challenging
    • Biotechnology has become the growth engine for the biopharma market
    • Globalisation and the search for new avenues of growth and innovation
    • Competition is intensifying, particularly from generics
    • Passing regulatory muster is getting more and more difficult
    • Payer influence on drug pricing, reimbursement and access continues to grow
    • Health technology assessments slow new product uptake
    • M&A, licensing and diversification continue to be used as growth strategies
  • Innovation in today's biobiopharma industry
    • The innovation revolution
    • Defining biopharma innovation
    • Investing in biopharma innovation
    • Benchmarking biopharma innovation
    • Key drivers and resistors of biopharma innovation
      • Policy and regulation
      • Networks, alliances and collaboration
      • Company size and strategy

Chapter 4 Key stakeholders within the innovation ecosystem

  • Overview
  • Key actors within the biopharma innovation ecosystem
  • Key roles, responsibilities and attitudes within the biopharma innovation ecosystem
    • Industry needs to move out of its comfort zone and go searching for innovation, as current innovation models are broken
    • Patients have a pivotal role in driving innovation; keep asking for innovative therapies, but make sure you're compliant with your therapy and educated on what treatment options are available
    • Payers and health technology assessment bodies must remain open minded and supportive of innovation whenever possible, but never lose sight of their fiduciary duty
    • Physicians have a responsibility to provide robust medical advice to the industry and maintain the current open and transparent environment for high quality clinical research
    • Regulators need to ensure that the regulations evolve at the same pace as the science, thereby allowing companies to take risks on innovative approaches
  • Future perspectives

Chapter 5 Opportunities for biopharma companies, both now and for the future

  • 'Beyond the pill' strategies: is it time to start focusing on outcomes instead of products?
  • Biosimilars: can they really provide better access to biologics with no sacrifice on quality?
  • Gene therapy: the future of disease management?
  • Networked pharma: the biopharma industry's new clothes?
  • Personalised medicine: the rule rather than the exception?
  • Regenerative medicine: too early to tell?
  • Targeted prevention: will smart technology be the next strategy in disease prevention?

Chapter 6 A scenario-based analysis of the potential future of the biopharma industry

  • Overview
  • What are scenarios?
  • What are the critical scenario drivers for this report?
  • Key considerations
  • The four potential scenarios
    • 'Take me to the Promised Land'
      • Potential implications for the various key stakeholder groups within the innovation ecosystem
    • 'A Fish out of Water'
      • Potential implications for the various key stakeholder groups within the innovation ecosystem
    • 'Snakes & Ladders'
      • Possible implications for the various key stakeholder groups within the innovation ecosystem
    • 'A Storm in a Teacup'
      • Possible implications for the various key stakeholder groups within the innovation ecosystem
  • The expert view; all scenarios are feasible, it just depends on the market and the disease...

Chapter 7 Concluding remarks

  • Suggestions for biopharma's 'tool box'
    • Bravery
    • Collaboration
    • Leadership

Appendix

  • Experts interviewed for this research
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