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市場調查報告書

歐洲的生技仿製藥市場及開發平台分析

Europe Biosimilars Market & Pipeline Insight

出版商 KuicK Research 商品編碼 315669
出版日期 內容資訊 英文 360 Pages
商品交期: 最快1-2個工作天內
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歐洲的生技仿製藥市場及開發平台分析 Europe Biosimilars Market & Pipeline Insight
出版日期: 2014年10月08日 內容資訊: 英文 360 Pages
簡介

生技仿製藥對歐洲的製藥產業來說是以最有前途的市場部門之一崛起。主要的重量級醫藥品的專利失效,及各國政府的政策性支援(容易遵守的法規結構,及藥價、醫療費給付的經濟支援等),支援著市場成長。但,由於各生技仿製藥產品的開發、生產可能性的差異,普遍認為繼續進行市場細分化、市場利基化和對特定產品的特殊化、集中。

本報告提供歐洲各國的生技仿製藥產品市場趨勢,及開發平台產品的開發情形相關分析、整體地區及各國的市場結構與趨勢、及到目前為止的生技仿製藥產品的認證流程、生技仿製藥開發、銷售的指南、開發中產品的目前開發情形、產品單位(共93個產品)的詳細開發情形、已上市生技仿製藥產品(共17個產品)銷售情形的資訊,為您概述為以下內容。

第1章 歐洲的生技仿製藥市場概要

  • 目前市場方案
  • 生技仿製藥的臨床實驗平台概要

第2章 各國生技仿製藥市場趨勢分析

  • 奧地利
  • 比利時
  • 法國
  • 德國
  • 匈牙利
  • 義大利
  • 挪威
  • 波蘭
  • 西班牙
  • 瑞典
  • 瑞士
  • 英國

第3章 歐洲的生技仿製藥引進的流程

  • 生長激素(2006年)
  • 紅血球生成素(2007年)
  • G-CSF(2008年)
  • 單株抗體(2013年)
  • 促濾泡素(2013年)
  • 胰島素(2015年)

第4章 歐洲的生技仿製藥的風險管理計劃及安全法規方案

第5章 歐洲的生技仿製藥市場動態

  • 良好的市場參數
    • Bolar保障條款(Bolar Provisions)支援生技仿製藥開發
    • 開拓專利失效的生技仿製藥市場
    • 醫療費給付政策
    • 投資層級的擴大
    • 製造能力
    • 研究開發(R&D)支出額
  • 在市場成長時的課題

第6章 歐洲的生技仿製藥市場未來展望

第7章 法規、認證機關:歐洲藥品管理局(EMA)及歐洲醫藥品委員會(CHMP)

第8章 生技仿製藥的開發、銷售的認證指南

  • 含r-hFSH,類似的生物醫藥品的開發
  • 含干擾素(interferon)β,類似的生物醫藥品
  • 生物內臨床利用的單株抗體的抗原性評估
  • 含單株抗體,類似的生物醫藥品
  • 包含基因改造型促血紅細胞生長素,類似的生物醫藥品
  • 包含基因改造型人類溶解性胰島素,類似的生物醫藥品
  • 含生長激素,類似的生物醫藥品
  • 含生物科技來源的蛋白質為活性物質,類似的生物醫藥品
  • 生物科技來源的治療性蛋白質的抗原性評估
  • 變更製造工程之後的,生物科技來源醫藥品的同等性

第9章 歐洲的生技仿製藥的臨床實驗平台:各相(階段)、適應症、企業、國家

  • 不明
  • 研究階段
  • 前臨床階段
  • 臨床階段
  • 第一階段
  • 第二/三階段
  • 第二階段
  • 第三階段
  • 認證前
  • 已認證

第10章 已上市生技仿製藥的考察:各相、適應症、企業、國家

第11章 開發資訊沒被效勞的生技仿製藥臨床實驗平台

  • 無開發方向的項目
  • 開發中止的項目

第12章 競爭環境

  • Apotex
  • Celltrion Healthcare
  • Hexal
  • Hospira
  • Finox Biotech
  • Medice Arzneimittel Putter
  • Sandoz
  • Stada Arzneimittel
  • Teva Pharma

圖表一覽

目錄

Biosimilars have emerged as one of the most promising segment of the European pharmaceutical industry in recent years. The biosimilars segment has been experiencing a steady growth driven by patent expiration of blockbuster drugs, amenable regulatory framework, economic incentives along with favorable pricing and reimbursement policies adopted across multiple markets in Europe. The current biosimilars market is highly fragmented in nature due to their accessibility in various therapeutic categories. The European biosimilars market is divided into various categories: Granulocyte-colony stimulating factor (G-CSF or GCSF), erythropoiesis-stimulating agents (ESAs) and somatropin biosimilars, Insulin, mAbs and follitropin. The present market fragmentation is driven by the availability of particular biosimilar products which were introduced over a decade ago. These products created niche among them and resulted in inclination toward a particular segments over a period of time.

One of the most promising factors responsible for the development of biosimilars market is the patent expiration of reference drugs. The European biosimilars market is experiencing tremendous growth as blockbuster biologic drugs are going off-patent. The entry of new biosimilars due to patent expiry into various therapeutic indications has created a new category for the biosimilars. For instance, Ely Lily and Boehringer Ingelheim have already got marketing authorization of their biosimilar insulin in June'2014 even as the current diabetes drug (Lantus) marketed by Sanofi will go off patent in February'2015.

The competitive pricing and reimbursement policies adopted by country specific regulators are also promoting the introduction of biosimilars in European market. The newly introduced biosimilars are approximately 20-30% cheaper and hence results in high level of acceptability among patients and physicians in comparison to originator molecule. The benefits of using the biosimilars include reimbursement provided by many governments which further decreases the financial burden from the patients as result of which they do not revert to originator molecules.

Currently there are 18 biosimilars available in European market and more than 90 are in multiple phases of development in clinical pipeline. Majority of the available biosimilars are approved for the treatment of indication like Cancer, Kidney Failure and Anemia. Approved Biosimilars in Europe:

Abseamed (epoetin alfa), Bemfola (follitropin alfa), Binocrit (epoetin alfa), Biograstim (filgrastim), Epoetin Alfa Hexal (epoetin alfa), Filgrastim Hexal (filgrastim), Grastofil (filgrastim), Inflectra (infliximab), Nivestim (filgrastim), Omnitrope (somatropin), Ovaleap (follitropin alfa), Ratiograstim (filgrastim), Remsima (infliximab), Retacrit (epoetin zeta), Silapo (epoetin zeta), Tevagrastim (filgrastim), Zarzio (filgrastim), Wepox (epoetin alfa)

"Europe Biosimilars Market & Pipeline Insight" Report Highlight:

  • Biosimilars Market Overview & Trend Analysis by Country
  • Biosimilars Introduction Timeline in Europe
  • Biosimilars Development & Market Authorization Guidelines
  • Biosimilars Clinical Pipeline by Phase, Indication, Company & Country
  • Marketed Biosimilars Clinical Insight by Phase, Indication, Company & Country
  • Europe Biosimilars Pipeline: 93 Biosimilars
  • Marketed Biosimilars: 18 Biosimilars (17 Approved by EMA & 1 in Ukraine)

Table of Contents

1. Europe Biosimilars Market Overview

  • 1.1 Current Market Scenario
  • 1.2 Biosimilars Clinical Pipeline Overview

2. Europe Biosimilars Market Trend Analysis by Country

  • 2.1 Austria
  • 2.2 Belgium
  • 2.3 France
  • 2.4 Germany
  • 2.5 Hungary
  • 2.6 Italy
  • 2.7 Norway
  • 2.8 Poland
  • 2.9 Spain
  • 2.10 Sweden
  • 2.11 Switzerland
  • 2.12 UK

3. Biosimilars Introduction Timeline in Europe

  • 3.1 Growth Hormones in 2006
  • 3.2 Epoetin in 2007
  • 3.3 G-CSF in 2008
  • 3.4 Monoclonal Antibodies in 2013
  • 3.5 Follitropin in 2013
  • 3.6 Insulin in 2015

4. Europe Biosimilars Risk Management Planning & Safety Regulation Scenario

5. Europe Biosimilars Market Dynamics

  • 5.1 Favorable Market Parameters
    • 5.1.1 Bolar Provisions Supporting Biosimilars Development
    • 5.1.2 Patent Expiry to Tap European Biosimilars Markets
    • 5.1.3 Reimbursement Policies
    • 5.1.4 Increasing Level of Investments
    • 5.1.5 Manufacturing Capabilities
    • 5.1.6 R&D Expertise
  • 5.2 Market Growth Challenges

6. Future Prospectus of Biosimilars in Europe

7. Regulatory & Approval Authorities: EMA & CHMP

8. Biosimilars Development & Market Authorization Guidelines

  • 8.1 Development of Similar Biological Medicinal Products Containing r-hFSH
  • 8.2 Similar Biological Medicinal Products Containing Interferon Beta
  • 8.3 Immunogenicity Assessment of Monoclonal Antibodies Intended For In Vivo Clinical Use
  • 8.4 Similar Biological Medicinal Products Containing Monoclonal Antibodies
  • 8.5 Similar Biological Medicinal Products Containing Recombinant Erythropoietins
  • 8.6 Similar Medicinal Products Containing Recombinant Human Soluble Insulin
  • 8.7 Similar Medicinal Products Containing Somatropin
  • 8.8 Similar Biological Medicinal Products Containing Biotechnology Derived Proteins as Active Substance
  • 8.9 Immunogenicity Assessment of Biotechnology-Derived Therapeutic Proteins
  • 8.10 Comparability of Biotechnology-Derived Medicinal Products After A Change In The Manufacturing Process

9. Europe Biosimilars Clinical Pipeline by Phase, Indication, Company & Country

  • 9.1 Unknown
  • 9.2 Research
  • 9.3 Preclinical
  • 9.4 Clinical
  • 9.5 Phase-I
  • 9.6 Phase-I/II
  • 9.7 Phase-II
  • 9.8 Phase-III
  • 9.9 Preregistration
  • 9.10 Registered

10. Marketed Biosimilars Clinical Insight by Phase, Indication, Company & Country

11. No Development Reported in Biosimilars Clinical Pipeline

  • 11.1 No Development Reported
  • 11.2 Discontinued

12. Competitive Landscape

  • 12.1 Apotex
  • 12.2 Celltrion Healthcare
  • 12.3 Hexal
  • 12.4 Hospira
  • 12.5 Finox Biotech
  • 12.6 Medice Arzneimittel Pütter
  • 12.7 Sandoz
  • 12.8 Stada Arzneimittel
  • 12.9 Teva Pharma
  • Figure 1-1: Europe - Biosimilars Market Opportunity (US$ Million), 2014-2020
  • Figure 1-2: Factors Responsible for Growth of Biosimilars Market in Europe
  • Figure 1-3: Europe Biosimilar Pipeline by Phase (%), 2014
  • Figure 1-4: Europe Biosimilar Pipeline by Phase (Number), 2014
  • Figure 1-5: No Development Reported in Biosimilar Pipeline by Phase (%), 2014
  • Figure 1-6: No Development Reported in Biosimilar Pipeline by Phase (Number), 2014
  • Figure 1-7: Suspended Biosimilar Pipeline by Phase (%), 2014
  • Figure 1-8: Suspended Biosimilar Pipeline by Phase (%), 2014
  • Figure 3-1 Biosimilar Product Approval Timeline in Europe
  • Figure 3-2: Europe Biosimilars Market Emerging Segment
  • Figure 3-3: Approved Biosimilars by Segment
  • Figure 3-4: HGH Biosimilars Approved & Available in European Market
  • Figure 3-5: EPO Biosimilars Approved & Available in European Market
  • Figure 3-6: G-CSF Biosimilars Approved & Available in European Market
  • Figure 3-7: mAbs Biosimilars Approved & Available in European Market
  • Figure 3-8: Follitropin Biosimilars Approved & Available in European Market
  • Figure 3-9: Insulin Biosimilars Approved & Available in European Market
  • Figure 4-1: Safety Evaluation of Biosimilars after Marketing Approval in Europe
  • Figure 4-2: Risk Management of Biosimilars
  • Figure 4-3: Overview of Demonstrating Biosimilarity
  • Figure 5-1: Bolar Provision for the Development of Biosimilars in Europe
  • Figure 5-2: Effects of Reimbursement Policies on Healthcare System
  • Figure 5-3: Available Biosimilars in Market by Company & Segment
  • Figure 5-4: Drivers for Success in European Biosimilars Market
  • Figure 5-5: Market Growth Challenges
  • Figure 7-1: Regulatory Timeline for the Approval of Biosimilars
  • Figure 7-2: Schematic Overview of Biosimilar Approval in EU
  • Figure 7-3: Biosimilars Development Process
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