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バイオシミラー (バイオ後続品):法規制上の枠組みとパイプライン分析

BIOSIMILARS - Regulatory Framework and Pipeline Analysis

発行 CBR Pharma Insights 商品コード 334084
出版日 ページ情報 英文 94 Pages
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バイオシミラー (バイオ後続品):法規制上の枠組みとパイプライン分析 BIOSIMILARS - Regulatory Framework and Pipeline Analysis
出版日: 2015年06月01日 ページ情報: 英文 94 Pages
概要

当レポートでは、バイオシミラー (バイオ後続品) の開発戦略に必要な法規制上の要件および枠組みについて地域・主要国別に調査し、市場成長の推進因子・阻害因子、開発中の薬剤の状況と開発段階・分子・治療エリア・適応症など各種パラメーター別の詳細、主な参入事業者のプロファイルなどもまとめています。

目次

  • エグゼクティブサマリー
  • イントロダクション
  • バイオシミラー産業の力学
    • 動向
    • 成長推進因子
    • 成長阻害因子
  • バイオシミラーの法規制:WHOガイダンス
  • 欧州のバイオシミラー
    • 概要
    • 法規制上の枠組み
    • 市場の展望
  • 米国のバイオシミラー
    • 概要
    • 法規制上の枠組み
    • 市場の展望
  • インドのバイオシミラー
    • 概要
    • 法規制上の枠組み
    • 市場の展望
  • 韓国のバイオシミラー
    • 概要
    • 法規制上の枠組み
    • 市場の展望
  • 日本のバイオシミラー
    • 概要
    • 法規制上の枠組み
    • 市場の展望
  • 中国のバイオシミラー
    • 概要
    • 法規制上の枠組み
    • 市場の展望
  • 主要参入企業
  • バイオシミラーのパイプライン分析
    • 概要
    • 開発ステージ別
    • 分子別
    • 治療エリア別
    • 適応症別
    • MoA/RoA別
    • 開発後期のバイオシミラー
    • 第II相パイプラインのバイオシミラー
    • 第I相パイプラインのバイオシミラー
目次
Product Code: GBI057CBR

Summary

Biosimilars are copied versions of biologics that offer a 20-50% reduction in cost compared with innovative biologic products. Biosimilars are getting the world wide attention as the cost of the innovative biologics are enormously high and even minimal reduction in price will reduce the healthcare spending substantially. All the countries are focusing on reducing the healthcare expenditure and biosimilars compliments to this goal. Biologic products are complex in structure and follow a complex manufacturing process thus, some variation exists between the reference product and its biosimilar. It is very important to assess the variations in biosimilars by comparing with reference product to ensure quality, non-clinical, and clinical properties, which has given rise to the regulatory requirements for biosimilars. Regulatory requirement for approving biosimilars varies across different regulatory bodies. However, all the countries have derived the basic theme from EMA and WHO guidelines for framing their regulatory structure. There is a need to harmonize the nomenclature of biosimilars, extrapolation of indications, and interchangeability of biosimilars with reference products across the regulatory bodies. Biosimilars market is developing and it could be well established with the pipeline that is poised to deliver a wave of biosimilars in the market in the near future

Scope

The scope of the report includes -

  • Introduction
  • Market dynamics: Trends, Drivers, and Barriers
  • WHO guidance for biosimilars
  • Regulatory overview, biosimilar guidelines, regulatory framework for biosimilars, and market outlook for: Europe, USA, India, South Korea, Japan and China.
  • Key players
  • Pipeline Analysis
  • Overview
  • By Stage of Development / Molecule / Therapy Area / Indication
  • Late-Stage / Phase II / Phase I Pipeline Biosimilars

Key Reasons to Purchase

The report will enhance your decision-making capability by allowing you to -

  • Understand the regulatory requirement and regulatory framework that facilitates effective product development strategy as biosimilars industry is currently highly focused, growing, and outpacing the growth rate of small molecule pharmaceutical market
  • Targeting geographies would be easy by comparing different regulatory frameworks; this would also provide a base for designing a strategy to enter the developed markets. Biosimilars are of interest in developed countries to reduce the healthcare expenditure
  • With the recent approvals of biosimilars by USFDA, the biosimilars market is going to grow and this report examines the post approval market landscape
  • Examine the biosimilars pipeline and specifies the products that are highly targeted, it also includes analysis of highly focused indications, mechanism of actions, and therapy areas in the pipeline
  • Analyze the details of the clinical pipeline that includes late stage products, Phase II, and Phase I products. Detailed understanding of the pipeline will help in targeting the products for development, rate the current products and predict the competition

Table of Contents

  • Executive Summary
  • Introduction
  • Biosimilars Industry Dynamics
    • Trends
    • Drivers
    • Restraints
  • Biosimilars Regulation: WHO's Guidance
  • Biosimilars in Europe
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in the US
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in India
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in South Korea
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in Japan
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Biosimilars in China
    • Overview
    • Regulatory Framework
    • Market Outlook
  • Key Market Players
  • Biosimilars Pipeline Analysis
    • Overview
    • By Stage of Development
    • By Molecule
    • By Therapy Area
    • By Indication
    • By MoA/RoA
    • Late-Stage Pipeline Biosimilars
    • Phase II Pipeline Biosimilars
    • Phase I Pipeline Biosimilars
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