株式会社グローバルインフォメーション
TEL: 044-952-0102
表紙
市場調査レポート

欧州のバイオシミラー市場:産業動向、市場シェア、市場規模、成長、市場機会、予測

Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024

発行 IMARC Services Private Limited 商品コード 693023
出版日 ページ情報 英文 140 Pages
納期: 2-3営業日
価格
本日の銀行送金レート: 1USD=109.81円で換算しております。
Back to Top
欧州のバイオシミラー市場:産業動向、市場シェア、市場規模、成長、市場機会、予測 Biosimilar Market in Europe: Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024
出版日: 2019年02月11日 ページ情報: 英文 140 Pages
概要

欧州のバイオシミラー市場は、2017年に20億1,300万米ドルと評価され、2017年から2023年にかけては29%のCAGRで推移し、2023年までに91億7,300米ドル規模の市場に成長することが予測されています。

当レポートでは、欧州のバイオシミラー市場を調査し、市場の概要、産業動向、価格分析、国・種類・適応症・製造形態・地域別の販売額および市場シェアの分析と予測、市場の成長要因および課題、競合情勢、主要企業のプロファイルなど、包括的な情報を提供しています。

第1章 序文

第2章 調査範囲と調査手法

第3章 エグゼクティブサマリー

第4章 イントロダクション

第5章 欧州のバイオシミラー市場

  • 市場概要
  • 市場の沿革、現状、将来動向
  • 市場内訳:国別
  • 市場内訳:種類別
  • 市場内訳:適応症別
  • 市場内訳:製造形態別
  • 特許概要
  • 市場予測

第6章 欧州のバイオシミラー市場:地域別

  • イタリア
    • 市場成果
    • 主要企業と製品
    • 市場予測
  • ドイツ
  • フランス
  • 英国
  • スペイン
  • その他

第7章 欧州のバイオシミラー市場:種類別

  • インフリキシマブ
  • インスリングラルギン
  • エポエチンアルファ
  • エタネルセプト
  • フィルグラスチム
  • ソマトロピン
  • リツキシマブ
  • フォリトロピンアルファ

第8章 欧州のバイオシミラー市場:製造形態別

  • 自社製造
  • 受託製造

第9章 欧州のバイオシミラー市場:適応症別

  • 自己免疫疾患
  • 血液疾患
  • 糖尿病
  • 腫瘍
  • 成長ホルモン欠損症
  • 女性の不妊症

第10章 SWOT分析

  • 強味
  • 弱み
  • 機会
  • 脅威

第11章 バリューチェーン分析

  • 先発医薬品の特長
  • 研究開発
  • 製品開発
  • 最終製品の組成
  • マーケティング・流通販売

第12章 ファイブフォース分析

第13章 価格分析

  • 価格指標
  • 価格動向
  • 利益率の分析

第14章 ジェネリック医薬品製造工場の設立要件

  • 製造工程
  • 原料の要件
  • 原料の図
  • 土地・施工の要件
  • 機械・インフラの要件
  • 機械の図
  • 工場の設計
  • 包装の要件
  • ユーティリティの要件
  • 労働力の要件

第15章 競合環境

  • 市場構造
  • 主要企業
  • 企業プロファイル
    • Novartis
    • Pfizer
    • Teva
    • Celltrion
    • Merck Sharp & Dohme
    • Samsung Bioepis
    • Eli Lilly
    • Accord Healthcare Ltd.
    • Amgen
    • Boehringer Ingelheim
    • Hexal Ag
    • Apotex
    • Stada Arzneimittel Ag
    • Ratiopharm
    • Mylan

図表リスト

図表

List of Figures

  • Figure 1: Europe: Biosimilar Market: Sales Value (in Million US$), 2012-2018
  • Figure 2: Europe: Biosimilar Market: Breakup by Molecule (in %), 2018
  • Figure 3: Europe: Biosimilar Market: Breakup by Manufacturer (in %), 2018
  • Figure 4: Europe: Biosimilar Market: Breakup by Indication (in %), 2018
  • Figure 5: Europe: Biosimilar Market: Breakup by Country (in %), 2018
  • Figure 6: Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
  • Figure 7: Italy: Biosimilar Market: Sales Value (in Million US$), 2012-2018
  • Figure 8: Italy: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
  • Figure 9: Germany: Biosimilar Market: Sales Value (in Million US$), 2012-2018
  • Figure 10: Germany: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
  • Figure 11: France: Biosimilar Market: Sales Value (in Million US$), 2012-2018
  • Figure 12: France: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
  • Figure 13: United Kingdom: Biosimilar Market: Sales Value (in Million US$), 2012-2018
  • Figure 14: United Kingdom: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
  • Figure 15: Spain: Biosimilar Market: Sales Value (in Million US$), 2012-2018
  • Figure 16: Spain: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
  • Figure 17: Rest of Europe: Biosimilar Market: Sales Value (in Million US$), 2012-2018
  • Figure 18: Rest of Europe: Biosimilar Market Forecast: Sales Value (in Million US$), 2019-2024
  • Figure 19: Europe: Rituximab Biosimilar Market: Sales Value (in Million US$), 2017
  • Figure 20: Europe: Infliximab Biosimilar Market: Sales Value (in Million US$), 2015 - 2017
  • Figure 21: Europe: Insulin Glargine Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
  • Figure 22: Europe: Epoetin Alfa Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
  • Figure 23: Europe: Filgrastim Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
  • Figure 24: Europe: Somatropin Biosimilar Market: Sales Value (in Million US$), 2012 - 2017
  • Figure 25: Europe: Etanercept Biosimilar Market: Sales Value (in Million US$), 2016 & 2017
  • Figure 26: Europe: Follitropin Alfa Biosimilar Market: Sales Value (in Million US$), 2015 - 2017
  • Figure 27: Europe: Biosimilar Market (In-House Manufacturing): Sales Value (in Million US$), 2012-2018
  • Figure 28: Europe: Biosimilar Market Forecast (In-House Manufacturing): Sales Value (in Million US$), 2019-2024
  • Figure 29: Europe: Biosimilar Market (Contract Manufacturing): Sales Value (in Million US$), 2012-2018
  • Figure 30: Europe: Biosimilar Market Forecast (Contract Manufacturing): Sales Value (in Million US$), 2019-2024
  • Figure 31: Europe: Biosimilar Market (Autoimmune Diseases): Sales Value (in Million US$), 2011-2018
  • Figure 32: Europe: Biosimilar Market Forecast (Autoimmune Diseases): Sales Value (in Million US$), 2019-2024
  • Figure 33: Europe: Biosimilar Market (Blood Disorders): Sales Value (in Million US$), 2011-2018
  • Figure 34: Europe: Biosimilar Market Forecast (Blood Disorders): Sales Value (in Million US$), 2019-2024
  • Figure 35: Europe: Biosimilar Market (Diabetes): Sales Value (in Million US$), 2011-2018
  • Figure 36: Europe: Biosimilar Market Forecast (Diabetes): Sales Value (in Million US$), 2019-2024
  • Figure 37: Europe: Biosimilar Market (Oncology): Sales Value (in Million US$), 2011-2018
  • Figure 38: Europe: Biosimilar Market Forecast (Oncology): Sales Value (in Million US$), 2019-2024
  • Figure 39: Europe: Biosimilar Market (Growth Deficiency): Sales Value (in Million US$), 2011-2018
  • Figure 40: Europe: Biosimilar Market Forecast (Growth Deficiency): Sales Value (in Million US$), 2019-2024
  • Figure 41: Europe: Biosimilar Market (Female Infertility): Sales Value (in Million US$), 2011-2018
  • Figure 42: Europe: Biosimilar Market Forecast (Female Infertility): Sales Value (in Million US$), 2019-2024
  • Figure 43: Europe: Biosimilar Industry: SWOT Analysis
  • Figure 44: Europe: Biosimilar Industry: Value Chain Analysis
  • Figure 45: Europe: Biosimilar Industry: Porter's Five Forces Analysis
  • Figure 46: Biosimilar Manufacturing: Detailed Process Flow

List of Tables

  • Table 1: Europe: Sales and Patent Expiry of Blockbuster Biological Drugs (in Million US$)
  • Table 2: Biosimilar vs. Innovators Drug Development
  • Table 3: Biosimilar vs. Biologics Manufacturing
  • Table 4: Europe: Biosimilar Market: Key Industry Highlights, 2018 and 2024
  • Table 5: Europe: Biosimilar Market: Patent Landscape
  • Table 6: Europe: Biosimilar Market: Price Comparison Between Biosimilar and Originator Drugs
  • Table 7: Europe: Biosimilar Market Forecast: Breakup by Region (in Million US$), 2019-2024
  • Table 8: Europe: Biosimilar Market: Key Players and Biosimilars
  • Table 9: Italy: Biosimilar Market: Key Players and Biosimilars
  • Table 10: Germany: Biosimilar Market: Key Players and Biosimilars
  • Table 11: France: Biosimilar Market: Key Players and Biosimilars
  • Table 12: United Kingdom: Biosimilar Market: Key Players and Biosimilars
  • Table 13: Spain: Biosimilar Market: Key Players and Biosimilars
  • Table 14: Europe: Rituximab: Brand & Biosimilar Market Overview
  • Table 15: Europe: Infliximab: Brand & Biosimilar Market Overview
  • Table 16: Europe: Insulin Glargine: Brand & Biosimilar Market Overview
  • Table 17: Europe: Epoetin Alfa: Brand & Biosimilar Market Overview
  • Table 18: Europe: Filgrastim: Brand & Biosimilar Market Overview
  • Table 19: Europe: Somatropin: Brand & Biosimilar Market Overview
  • Table 20: Europe: Etanercept: Brand & Biosimilar Market Overview
  • Table 21: Europe: Follitropin Alfa: Brand & Biosimilar Market Overview
  • Table 22: Europe: Biosimilar Market Forecast: Breakup by Manufacturing Type (in Million US$), 2019-2024
  • Table 23: Europe: Biosimilar Market Forecast: Breakup by Indication (in Million US$), 2019-2024
  • Table 24: Biosimilar Manufacturing Plant: Raw Material Requirements
  • Table 25: Biosimilar Manufacturing Plant: Land and Construction Requirements
  • Table 26: Biosimilar Manufacturing Plant: Machinery Requirements
  • Table 27: Biosimilar Manufacturing Plant: Manpower Requirements
  • Table 28: Europe: Biosimilar Market: Competitive Structure
  • Table 29: Europe: Biosimilar Market: Key Players
目次
Product Code: SR1018G64_Report

The biosimilar market in Europe reached a value of US$ 2,934.6 Million in 2018. The market is further projected to reach a value of US$ 11,663.1 Million by 2024, growing at a CAGR of 24.9% during 2019-2024. The European biosimilar market represents the most mature in the world and continues to rally momentum. This market is expected to grow robustly in the next five years, as a number blockbuster biologics are scheduled to lose patent protection in Europe.

Biosimilars are biotherapeutic products which are similar to already licensed reference biologics, in terms of quality, safety and efficiency. Biosimilar manufacturers wait till the patent of the reference product expires and then seek approval from the regulatory authorities in order to produce their biosimilar versions. These manufacturers use the state-of-the-art technology for comparing the characteristics, such as purity, chemical identity and bioactivity, of the proposed biosimilar to its reference product. In 2005, a science-based regulatory framework was established in the European Union (EU) for ensuring the production of high-quality biosimilars. Later in 2006, the European Medicines Agency (EMA) approved the first biosimilar medicine, Omnitrope. Since then, a number of biosimilars belonging to various therapeutic classes have been approved in Europe.

Biosimilars Market in Europe: Drivers

Biosimilars are less expensive than their branded counterparts as they do not require extensive research and testing which saves both money and time; thereby lowering the costs. Moreover, they also have short marketing times as launching a biosimilar does not require extensive marketing as the safety and efficacy profile of their branded counterparts have already been established.

Several blockbuster biologics are expected to lose their patent protection over the next 5 to 10 years. This expiration of patents and other intellectual property rights is expected to create huge opportunities for biosimilar manufacturers.

The European population is ageing with around one fifth of the total EU population above 65 years of age. There has resulted in a significant increase in the burden of lifestyle diseases in the region. The prevalence of diseases such as diabetes, autoimmune diseases, oncology, etc. has been increasing rapidly in Europe. This is also expected to propel the market growth during the next few years.

As a result of rising healthcare costs, governments across a number of European countries have formulated policies incentivising physicians, pharmacists and patients in favour of biosimilars over branded biologics.

Market Summary:

  • Country-wise, the market has been segmented into Italy, Germany, United Kingdom, France, Spain and Others. In 2018, Italy represented the largest market for biosimilars in Europe.
  • The report has analysed the market on the basis of molecule. In 2018, Infliximab dominated the market, accounting for the highest sales. Other major molecules include Insulin Glargine, Epoetin Alfa, Etanercept, Filgrastim, Somatropin, Rituximab, Follitropin Alfa, etc.
  • The report has also analysed the market on the basis of indication. Autoimmune diseases represented the biggest indication for biosimilars in 2018. Other major indications include oncology, autoimmune diseases, blood disorders, growth deficiency, diabetes, etc.
  • On the basis of manufacturing type, the report has segmented the market into in-house manufacturing and contract manufacturing. In 2018, in-house manufacturing accounted for a higher share.

Some of the leading players operating in the European biosimilars market include:

  • Novartis
  • Pfizer
  • Teva
  • Celltrion
  • Samsung Bioepis
  • Amgen
  • Apotex
  • Ratiopharm
  • Mylan
  • Merck Sharp & Dohme
  • Eli Lilly
  • Accord Healthcare Ltd
  • Boehringer Ingelheim
  • Hexal Ag
  • Stada Arzneimittel Ag
  • This report provides a deep insight into the European biosimilars market covering all its essential aspects. This ranges from macro overview of the market to micro details of the industry performance, recent trends, key market drivers and challenges, SWOT analysis, Porter's five forces analysis, value chain analysis, etc. This report is a must-read for entrepreneurs, investors, researchers, consultants, business strategists, and all those who have any kind of stake or are planning to foray into the European biosimilars market in any manner.

Key Questions Answered in This Report:

  • How has the European biosimilars market performed so far and how will it perform in the coming years?
  • What are the key regional markets in the European biosimilars industry?
  • What are the major molecule types in the European biosimilars industry?
  • What is the share of in-house manufacturing vs. contract manufacturing in the European biosimilars industry?
  • What are the various indications in the European biosimilars industry?
  • What are the price trends of biosimilars?
  • What are the various stages in the value chain of the European biosimilars industry?
  • What are the key driving factors and challenges in the European biosimilars industry?
  • What is the structure of the European biosimilars industry and who are the key players?
  • What is the degree of competition in the European biosimilars industry?
  • What are the key requirements for setting up a biosimilar manufacturing plant?
  • How are biosimilars manufactured?
  • What are the machinery requirements for setting up a biosimilar manufacturing plant?
  • What is the capital cost for setting up a biosimilar manufacturing plant?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Europe Biosimilars Market - Introduction

  • 4.1 Overview
  • 4.2 WHO and EMA Terminology on Biosimilars
  • 4.3 Biosimilars and Generics
  • 4.4 Biosimilars and Branded Biological Products

5 Europe Biosimilars Market

  • 5.1 Market Overview
  • 5.2 Historical and Current Market Trends
  • 5.3 Market Breakup by Country
  • 5.4 Market Breakup by Molecule
  • 5.5 Market Breakup by Indication
  • 5.6 Market Breakup by Manufacturing Type
  • 5.7 Patent Landscape
  • 5.8 Market Forecast

6 Market Breakup by Country

  • 6.1 Italy
    • 6.1.1 Market Performance
    • 6.1.2 Key Players and Biosimilars
    • 6.1.3 Market Forecast
  • 6.2 Germany
    • 6.2.1 Market Performance
    • 6.2.2 Key Players and Biosimilars
    • 6.2.3 Market Forecast
  • 6.3 France
    • 6.3.1 Market Performance
    • 6.3.2 Key Players and Biosimilars
    • 6.3.3 Market Forecast
  • 6.4 United Kingdom
    • 6.4.1 Market Performance
    • 6.4.2 Key Players and Biosimilars
    • 6.4.3 Market Forecast
  • 6.5 Spain
    • 6.5.1 Market Performance
    • 6.5.2 Key Players and Biosimilars
    • 6.5.3 Market Forecast
  • 6.6 Rest of Europe
    • 6.6.1 Market Performance
    • 6.6.2 Market Forecast

7 Market Breakup by Molecule

  • 7.1 Infliximab
  • 7.2 Insulin Glargine
  • 7.3 Epoetin Alfa
  • 7.4 Etanercept
  • 7.5 Filgrastim
  • 7.6 Somatropin
  • 7.7 Rituximab
  • 7.8 Follitropin Alfa

8 Market Breakup by Manufacturing Type

  • 8.1 In-house Manufacturing
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Contract Manufacturing
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast

9 Market Breakup by Indication

  • 9.1 Auto-Immune Diseases
  • 9.2 Blood Disorder
  • 9.3 Diabetes
  • 9.4 Oncology
  • 9.5 Growth Deficiency
  • 9.6 Female Infertility

10 European Biosimilar Market: SWOT Analysis

  • 10.1 Overview
  • 10.2 Strengths
  • 10.3 Weaknesses
  • 10.4 Opportunities
  • 10.5 Threats

11 European Biosimilar Market: Value Chain Analysis

  • 11.1 Characterizing the Existing Innovator Drug
  • 11.2 Research and Development
    • 11.2.1 Characterization of Biosimilars
    • 11.2.2 Developing a Unique Cell Line
  • 11.3 Product Development
    • 11.3.1 Pre-Testing
    • 11.3.2 Intermediary Clinical Testing (PK/PD)
    • 11.3.3 Confirmatory Clinical Phase-III
  • 11.4 Final Product Formulation
  • 11.5 Marketing and Distribution

12 Porter's Five Forces Analysis

  • 12.1 Overview
  • 12.2 Bargaining Power of Buyers
  • 12.3 Bargaining Power of Suppliers
  • 12.4 Degree of Competition
  • 12.5 Threat of New Entrants
  • 12.6 Threat of Substitutes

13 Price Analysis

  • 13.1 Key Price Indicators
  • 13.2 Price Trends

14 Requirements for Setting Up a Generic Drug Manufacturing Plant

  • 14.1 Manufacturing Process
  • 14.2 Raw Material Requirements
  • 14.3 Raw Material Pictures
  • 14.4 Land and Construction Requirements
  • 14.5 Machinery and Infrastructure Requirements
  • 14.6 Machinery Pictures
  • 14.7 Plant Layout
  • 14.8 Packaging Requirements
  • 14.9 Utility Requirements
  • 14.10 Manpower Requirements

15 Competitive Landscape

  • 15.1 Market Structure
  • 15.2 Key Players
  • 15.3 Profiles of Key Players
    • 15.3.1 Novartis
    • 15.3.2 Pfizer
    • 15.3.3 Teva
    • 15.3.4 Celltrion
    • 15.3.5 Merck Sharp & Dohme
    • 15.3.6 Samsung Bioepis
    • 15.3.7 Eli Lilly
    • 15.3.8 Accord Healthcare Ltd.
    • 15.3.9 Amgen
    • 15.3.10 Boehringer Ingelheim
    • 15.3.11 Hexal Ag
    • 15.3.12 Apotex
    • 15.3.13 Stada Arzneimittel Ag
    • 15.3.14 Ratiopharm
    • 15.3.15 Mylan

Back to Top