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市場調查報告書

生技仿製藥的全球市場:2015-2025年

Global Biosimilars Market, 2015 - 2025

出版商 ROOTS ANALYSIS 商品編碼 336174
出版日期 內容資訊 英文 462 Pages
商品交期: 最快1-2個工作天內
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生技仿製藥的全球市場:2015-2025年 Global Biosimilars Market, 2015 - 2025
出版日期: 2015年07月22日 內容資訊: 英文 462 Pages
簡介

由於以對慢性疾病的效用擴大與資本密集型生產為特長,生技仿製藥的全球市場顯示著堅實的成長。生技藥品需求踏實增大,製藥公司有助於對於投資報酬率最大化的新藥銷售策略重視的狀態下,生技藥品治療改變了致命消耗性疾病的應對法。可是,由於產品非常高額,價格降低成為時代的需要。

本報告以生技仿製藥的全球市場為焦點,提供2015-2025年的期間預測、其主要特長、市場預測、市場發展的影響要素及課題、主要加入企業等相關分析資訊彙整。

第1章 序

  • 報告的對象範圍
  • 調查方法
  • 各章的概要

第2章 摘要整理

第3章 簡介

  • 現狀及背景
  • 生技藥品 - 概要
  • 生技仿製藥和生技改良藥 - 定義
  • 生技仿製藥和創新者產品的不同點
  • 生技仿製藥和非專利的不同點
  • 生技仿製藥的必要性
  • 生技仿製藥 - 成本節約的可能性
  • 生技仿製藥的製造
  • 生技仿製藥的時間與成本
  • 生技仿製藥開發的品質考察
  • 臨床實驗設計
  • 醫藥品的安全性監視和風險管理
  • 生技仿製藥的行銷
  • 安全和免疫抗原性
  • 生技仿製藥的命名
  • 生技仿製藥的處方

第4章 生技仿製藥 - 先進國家市場

  • 本章的概要
  • 美國的生技仿製藥
  • 美國的生技仿製藥市場 - 概要
  • 美國 - 生技仿製藥開發的主要企業
    • Hospira
    • Amgen
    • Eli Lilly
    • Pfizer
  • 歐洲的生技仿製藥
    • 歐洲的核准途徑
    • 歐洲的法規指南
    • 歐洲共同體(EU)的生技仿製藥的演進
  • 歐洲生技仿製藥市場概要
    • 歐洲的生技仿製藥市場 - 各開發階段區分
    • 歐洲的生技仿製藥市場 - 各產品類型區分
    • 歐洲的生技仿製藥市場 - 各症狀區分
  • 歐洲:生技仿製藥開發的主要企業
    • Sandoz
    • Stada Arzneimittel
    • BioXpress Therapeutics
  • 日本的生技仿製藥市場概要
    • 日本的生技仿製藥市場 - 各開發階段區分
    • 日本的生技仿製藥市場 - 各產品類型區分
    • 日本的生技仿製藥市場 - 各症狀區分
  • 日本:生技仿製藥開發的主要企業
    • 日本化藥
    • Gene Techno Science
    • JCR製藥
  • 其他的市場

第5章 生技仿製藥 - 新興市場

  • 本章的概要
  • 新興市場上商機
  • 新興市場上法規的考察
  • 中國的生技仿製藥市場概要
    • 中國的生技仿製藥市場 - 各開發階段區分
    • 中國的生技仿製藥市場 - 各產品類型區分
    • 中國的生技仿製藥市場 - 各症狀區分
  • 中國:生技仿製藥開發的主要企業
    • Fosun Pharma
    • CP Guojian Pharmaceutical
  • 印度的生技仿製藥市場概要
    • 生物仿製藥核準的法規指南
      • 印度的生技仿製藥市場 - 各開發階段區分
      • 印度的生技仿製藥市場 - 各產品類型區分
      • 印度的生技仿製藥市場 - 各症狀區分
  • 印度:生技仿製藥開發的主要企業
    • Dr. Reddy's Laboratories
    • Inbiopro
    • Wockhardt
    • Biocon
    • ZydusCadila
    • Reliance Life Sciences
  • 巴西
    • 巴西的核准途徑
    • 巴西的生技仿製藥市場概要
      • 巴西的生技仿製藥市場 - 各開發階段區分
      • 巴西的生技仿製藥市場 - 各產品類型區分
      • 巴西的生技仿製藥市場 - 各症狀區分
  • 韓國
    • 韓國的生技仿製藥市場概要
      • 韓國的生技仿製藥市場 - 各開發階段區分
      • 韓國的生技仿製藥市場 - 各產品類型區分
      • 韓國的生技仿製藥市場 - 各症狀區分
  • 阿根廷
    • 阿根廷的生技仿製藥市場概要
      • 阿根廷的生技仿製藥市場 - 各開發階段區分
      • 阿根廷的生技仿製藥市場 - 各產品類型區分
      • 阿根廷的生技仿製藥市場 - 各症狀區分

第6章 全球市場概要

  • 本章的概要
  • 生技仿製藥 - 資料庫
  • 生技仿製藥 - 各地區區分
  • 生技仿製藥 - 各開發階段區分
  • 生技仿製藥 - 各產品類型區分
  • 生技仿製藥 - 各症狀區分
  • 生技仿製藥的主要的標的
  • 生技仿製藥開發的主要企業

第7章 市場動態

  • 本章的概要
  • 推動要素
    • 目前的專利失效
    • 疾病模式的變化與生物製品需求的擴大
    • 突飛猛進的醫療費
  • 課題
    • 功效和安全的問題
    • 自動置換的未整備
    • 成本複雜的製造工程
    • 生物分析技術上的課題
    • 臨床研究的困難

第8章 單株抗體生技仿製藥

  • 本章的概要
  • 單株抗體(mAb)生技仿製藥開發的課題
  • 法規指南
  • 生技仿製藥mAb的免疫抗原性
  • 新興市場上商機
  • Infliximab的認證 - 重要的契機
  • mAb生技仿製藥的主要標靶藥物
    • Rituximab
    • Infliximab
    • Trastuzumab
    • Adalimumab
    • 依那西普(Etanercept)
  • 其他的單株抗體生技仿製藥

第9章 胰島素生技仿製藥

  • 本章的概要
  • 胰島素 - 定義與分類
  • 對象患者層
    • 糖尿病患者
    • 基礎胰島素服用者
  • 胰島素生技仿製藥:潛力市場
  • 作用的機制
  • 高額的胰島素治療費 - 生技仿製藥利用基礎推動要素
  • 對胰島素生技仿製藥的法規指南
    • 非臨床研究
    • 臨床研究
  • 胰島素生技仿製藥 - 認證申請撤回數量
  • 胰島素注射液
    • Actrapid
    • Insulatard
    • 市售生技仿製藥
    • Wosulin
    • Insugen
  • 胰島素類似物
    • Insulin Glargine
    • Insulin Lispro
    • Insulin Aspart

第10章 生技仿製藥干擾素

  • 本章的概要
  • 生技仿製藥干擾素 - 前途困難
  • 法規
    • α干擾素
    • Interferon betas
  • 干擾素類
    • 干擾素Alpha- 2a
    • α干擾素-2b
    • Interferon betas-1a
    • Interferon betas-1b
    • pegInterferon betas-1a
    • peg干擾素Alpha- 2a
    • pegα干擾素-2b

第11章 其他有力生技仿製藥市場

  • 本章的概要
  • Filgrastim
  • Pegfilgrastim
  • 開發平台上的生技仿製藥
    • 促血紅細胞生長素類
    • 生長激素

第12章 最新發展

  • 生技仿製藥產業內的聯盟契約
  • 生技仿製藥的投資

第13章 生技仿製藥的外包化

  • 本章的概要
  • 生技仿製藥外包化的必要性
  • 生技仿製藥帶給受託製造廠商(CMO)的影響
  • 增強成本效果的生技仿製藥
  • 生技仿製藥市場上受託製造廠商與委外研發機構(CRO)的存在感
  • 技術趨勢

第14章 市場預測

  • 本章的概要
  • 預測方法
  • 生技仿製藥的全球市場:2020年及2025年
  • 單株抗體生技仿製藥市場:2020年及2025年
  • 胰島素生技仿製藥市場預測:2020年及2025年
  • 干擾素生技仿製藥市場預測:2020年及2025年
  • G-CSF/ GM-CSF生技仿製藥市場預測:2020年及2025年
  • 促血紅細胞生長素生技仿製藥市場預測:2020年及2025年

第15章 結論

  • 生技仿製藥 - 巨大的機會
  • 主要市場推動、阻礙因素
  • 急速浮上的單株抗體生技仿製藥
  • 大幅度成長迫近的多元化環境

第16章 採訪筆記本

第17章 附錄 1:表格形式資料

第18章 附錄 2:企業、團體一覽

圖表一覽

目錄
Product Code: RA10044

Characterised by increased utility in chronic diseases and capital intensive manufacturing, the global biopharmaceutical market is expanding robustly. As the demand for biologics is increasing continuously, manufacturers are on the lookout for novel strategies that will help them attain maximum returns on investment.Derived from biological elements, biologic medications have transformed the treatment paradigm of life threatening, debilitating diseases. However, such drugs come at staggering prices in the market. Hence, cheaper biological products have become an economic and healthcare requisite.

Amongst the impending patent cliffs, shrinking drug pipelines and increasing pressure to reduce treatment costs, biosimilars are poised to capture an unprecedented position in the biopharmaceutical industry. Supported by numerous factors including the recent progression in the regulatory landscape, the biosimilars market is witnessing an increased extent of adoption and heightened investment and deal making activity.

Biosimilars have currently attained a small portion of their anticipated future potential. The real commercial prospects lie in the two leading innovator biologics markets, the US and Europe, which account for a major proportion of the global spending on biologics. Europe, with the introduction of regulatory guidance in 2005 and the first biosimilar authorisation in 2006, is well ahead of the US. Till date, there are 16 marketed biosimilar products in Europe. However, in the recent years, the US has witnessed tremendous progression in terms of the advances in the regulatory landscape.

The involvement of generic manufacturers and R&D based pharmaceutical and biotechnology companies has led to the emergence of a diversified competitive marketplace. Realizing the huge commercial prospects, several innovator biotech companies are actively engaged in the development of biosimilars. In addition, this segment has become lucrative for other companies such as Fujifilm and Samsung. The contribution by such players does ensure a fresh inflow of money to fund development programs.

Overall, with the learning curve for biosimilars still evolving, the market offers huge growth opportunities along with demanding requirements in terms of clinical development, manufacturing and marketing authorisation. Driven by an extensive pipeline, contribution of numerous pharmaceutical players and the huge market opportunity likely to unfold in the US and EU, the biosimilars industry is poised to witness an unrivalled market uptake.

The ‘Global Biosimilars Market, 2015 - 2025' report provides an extensive study of the rapidly growing biosimilars market. With the blockbuster biologics losing patent protection and biotechnology industry striving to minimize costs, biosimilars are being viewed as viable substitutes to the highly expensive biological medications. The study presents an in-depth review of the developments in established markets and emerging regions, with respect to the market landscape, global and local players, regulatory scenario and emerging opportunities. It provides a detailed analysis of the worldwide pipeline of biosimilars on key parameters such as product categories, indications, biosimilar targets and status of development.

The study presents a comprehensive view of key product classes into which biosimilars can be categorized; these include monoclonal antibodies (mAbs), insulin, interferons, G-CSF/ GM-CSF, erythropoietins and others. We have highlighted some of the important aspects specific to these product categories including regulatory guidelines, development challenges, marketed / pipeline biosimilars, sales data (where available) and information on patent expiry of the reference products.

The report assesses some of the key drivers that have governed the evolution of biosimilars market over the past several years along with an elaborate discussion on the future trends that will shape the market in the coming years. One of the focus areas of this study is to estimate size of the future opportunity in the biosimilars market over the next decade, segmented on the basis of geographical clusters and product categories.

The study also provides information on some of the most recent activities in this market; amongst others, these include growing collaborations, investment activity and technological advancements. In addition to some of the well-known benefits and a promising outlook, the study also highlights considerable challenges currently prevalent in the market. Examples of such challenges include manufacturing complexities, heterogeneous regulatory framework, and associated safety and efficacy issues. Nevertheless, these challenges are paving the way for new strategies and technological improvements, which will indeed be advantageous in the long run.

The report provides market forecasts for the time period 2020 and 2025. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.

Example Highlights

  • 1. The market is driven by the presence of a growing pipeline; during our research, we identified over 600 biosimilar products across various product categories covering mAbs, insulin, interferons amongst others.
  • 2. Specifically, mAb biosimilars being developed for multiple diseases form a sizeable proportion of the preclinical/clinical development pipeline. In our pipeline, we reviewed around 200 mAb biosimilars. Neupogen, Enbrel and Humira, owing to their staggering revenues, are examples of some of the most popular target reference products.
  • 3. The emerging pharmaceutical markets of Asia, Latin America and Eastern Europe, with benefits such as lower labour costs, access to regional / domestic markets and, most importantly, relaxed regulatory requirements serve as attractive destinations for biosimilars research and commercialisation. This geographical cluster currently dominates the market with respect to the number of approved products.
  • 4. In order to exploit the advantages of combined resources and use licensed assets, stakeholders have announced numerous collaborations in the recent past. During our research, we identified around 70 partnerships which have taken place in the biosimilar market over the last few years.
  • 5. Looking at the ongoing focus, the market is well positioned to achieve a robust growth in the coming decade as the number of patent expiries grows and the legal and regulatory squabbles are sorted out; based on a very comprehensive analysis, we have projected the market to be worth USD 32 billion worldwide by 2025.
  • 6. Although emerging markets have been on a fast track in the recent past, the desired market uptake in the US and Europe will drive the market to attain its peak potential.

Research Methodology

Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

  • Annual reports
  • Investor presentations
  • SEC filings
  • Industry databases
  • News releases from company websites
  • Government policy documents
  • Other analysts' opinion reports

While the focus has been on forecasting the market over the coming nine years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

Chapter Outlines

Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on where the biosimilars market is headed in the mid-long term.

Chapter 3 provides a general overview on biosimilars, along with their comparison with generic and innovator products. We have also explained the manufacturing and marketing specifications of biosimilars along with information on other aspects such as naming and prescription. The chapter also presents a discussion around the time and cost of biosimilars, clinical trial designs and highlights quality considerations and safety and immunogenicity concerns.

Chapter 4 discusses the trends, regulatory landscape, historical evolution, current market scenario and key players in the three developed markets of the US, Europe and Japan.

Chapter 5 focuses on the evolution of biosimilars in the emerging markets providing information on regulatory framework, current landscape and leading players. The emerging regions we have considered in our analysis include China, India, Brazil, Korea, Mexico and Argentina.

Chapter 6 provides a detailed analysis of the worldwide pipeline of biosimilars. An in-depth review including distribution of the biosimilar products by product category, indication, biosimilar targets, status of development, geography and developers has been covered.

Chapter 7 highlights the key growth drivers and restraints to the biosimilars market. Some of the primary market drivers include growing healthcare expenses and impending patent expiries of the blockbuster biologic drugs.

Chapter 8 focuses on mAb biosimilars with respect to the regulatory developments, challenges and profiles of key target reference products and their biosimilar portfolio. Each profile provides an overview on the drug, background and history of development, indications and dosage forms, sales data, patent status and list of marketed and clinical/preclinical development pipeline of biosimilars.

Chapter 9 provides information on insulin biosimilars in terms of target patient population, global insulin market, regulatory guidelines and profiles of key target reference products and their biosimilar portfolio.

Chapter 10 provides details on interferon biosimilars covering the challenges, regulatory guidelines and profiles of key target reference products and their biosimilar portfolio.

Chapter 11 covers the other important biosimilar product classes; these include G-CSF/GM-CSF, erythropoietins and somatropins, providing information on key target reference products and their biosimilar portfolio.

Chapter 12 analyses recent developments in the biosimilars field. It contains information about partnerships that have taken place in the past few years and a section on the investment activities and technological trends which have recently shaped the market.

Chapter 13 focuses on outsourcing of biosimilars, a major growth opportunity for contract manufacturers. The chapter provides an overview of CMOs which are actively engaged in the biosimilars market and the upcoming opportunities which are likely to generate significant interest in the wider contract manufacturing market.

Chapter 14 presents the detailed forecast for the biosimilars market for the time period 2020 and 2025, segmented by geographic clusters and product categories.

Chapter 15 summarises the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapter 16 is a collection of transcripts of interviews conducted during the course of this study.

Chapter 17 is an appendix which provides tabulated data and numbers for all the figures provided in the report.

Chapter 18 is an appendix which provides a list of companies and organisations mentioned in the report.

Table of Contents

1. Preface

  • 1.1. Scope of the Report
  • 1.2. Research Methodology
  • 1.3. Chapter Outlines

2. Executive Summary

3. Introduction

  • 3.1. Context and Background
  • 3.2. Biologics: An Overview
  • 3.3. Biosimilars and Biobetters: Definition
  • 3.4. Difference between Biosimilar and Innovator Product
  • 3.5. Difference between Biosimilar and Generic
  • 3.6. The Need for Biosimilars
  • 3.7. Biosimilars: Cost Saving Potential
  • 3.8. Manufacturing of Biosimilars
    • 3.8.1. Expression Systems
      • 3.8.1.1. Bacterial Protein Expression System
      • 3.8.1.2. Yeast Protein Expression System
      • 3.8.1.3. Mammalian Protein Expression System
      • 3.8.1.4. Insect Protein Expression System
      • 3.8.1.5. Plant Protein Expression System
  • 3.9. Time and Cost of Biosimilars
  • 3.10. Quality Considerations for Development of Biosimilars
  • 3.11. Clinical Trial Design
  • 3.12. Pharmacovigilance and Risk Management
  • 3.13. Marketing of Biosimilars
  • 3.14. Safety and Immunogenicity
  • 3.15. Naming of Biosimilars
  • 3.16. Prescription of Biosimilars

4. Biosimilars: Developed Markets

  • 4.1. Chapter Overview
  • 4.2. Biosimilars in the US
    • 4.2.1. Regulatory Landscape in the US
    • 4.2.2. Approval Pathway for Biosimilars in the US
    • 4.2.3. Approaches to Gain Regulatory Authorisations in the US
    • 4.2.4. Purple Book
    • 4.2.5. Biosimilar Pricing in the US
  • 4.3. The US Biosimilar Market Overview
    • 4.3.1. The US Biosimilar Market: Distribution by Status of Development
    • 4.3.2. The US Biosimilar Market: Distribution by Product Category
    • 4.3.3. The US Biosimilar Market: Distribution by Indication
  • 4.4. The US: Leading Biosimilar Developers
    • 4.4.1. Hospira
      • 4.4.1.1. Company Overview
      • 4.4.1.2. Financial Performance
      • 4.4.1.3. Biosimilars Drug Portfolio
      • 4.4.1.4. Partnerships
    • 4.4.2. Amgen
      • 4.4.2.1. Company Overview
      • 4.4.2.2. Financial Performance
      • 4.4.2.3. Development and Manufacturing of Biosimilars
      • 4.4.2.4. Biosimilar Drug Portfolio
      • 4.4.2.5. Partnerships
      • 4.4.2.6. Developments
    • 4.4.3. Eli Lilly
      • 4.4.3.1. Company Overview
      • 4.4.3.2. Financial Performance
      • 4.4.3.3. Biosimilars Drug Portfolio
      • 4.4.3.4. Partnerships
    • 4.4.4. Harvest Moon Pharmaceuticals
      • 4.4.4.1. Company Overview
      • 4.4.4.2. Biosimilars Drug Portfolio
    • 4.4.5. Pfizer
      • 4.4.5.1. Company Overview
      • 4.4.5.2. Financial Performance
      • 4.4.5.3. Development and Manufacturing of Biosimilars
      • 4.4.5.4. Biosimilars Drug Portfolio
      • 4.4.5.5. Partnerships
  • 4.5. Biosimilars in Europe
    • 4.5.1. Approval Pathways in Europe
    • 4.5.2. Regulatory Guidelines in Europe
    • 4.5.3. Evolution of Biosimilars in EU
  • 4.6. Europe Biosimilar Market Overview
    • 4.6.1. Europe Biosimilar Market: Distribution by Status of Development
    • 4.6.2. Europe Biosimilar Market: Distribution by Product Category
    • 4.6.3. Europe Biosimilar Market: Distribution by Indication
  • 4.7. Europe: Leading Biosimilar Developers
    • 4.7.1. Sandoz
      • 4.7.1.1. Company Overview
      • 4.7.1.2. Financial Performance
      • 4.7.1.3. Development and Manufacturing of biosimilars
      • 4.7.1.4. Biosimilars Drug Portfolio
      • 4.7.1.5. Partnerships
    • 4.7.2. Stada Arzneimittel
      • 4.7.2.1. Company Overview
      • 4.7.2.2. Financial Performance
      • 4.7.2.3. Biosimilars Drug Portfolio
      • 4.7.2.4. Partnerships
    • 4.7.3. BioXpress Therapeutics
      • 4.7.3.1. Company Overview
      • 4.7.3.2. Biosimilars Drug Portfolio
      • 4.7.3.3. Partnerships
  • 4.8. Japan Biosimilar Market Overview
    • 4.8.1. Japan Biosimilar Market: Distribution by Status of Development
    • 4.8.2. Japan Biosimilar Market: Distribution by Product Category
    • 4.8.3. Japan Biosimilar Market: Distribution by Indication
  • 4.9. Japan: Leading Biosimilar Developers
    • 4.9.1. Nippon Kayaku
      • 4.9.1.1. Company Overview
      • 4.9.1.2. Financial Performance
      • 4.9.1.3. Biosimilars Drug Portfolio
      • 4.9.1.4. Partnerships
    • 4.9.2. Gene Techno Science
      • 4.9.2.1. Company Overview
      • 4.9.2.2. Financial Performance
      • 4.9.2.3. Development and Manufacturing
      • 4.9.2.4. Biosimilars Drug Portfolio
      • 4.9.2.5. Partnerships
    • 4.9.3. JCR Pharmaceuticals
      • 4.9.3.1. Company Overview
      • 4.9.3.2. Financial Performance
      • 4.9.3.3. Biosimilars drug portfolio
      • 4.9.3.4. Partnerships
  • 4.10. Other Markets

5. Biosimilars: Emerging Markets

  • 5.1. Chapter Overview
  • 5.2. Opportunities in Emerging Markets
  • 5.3. Regulatory Considerations in Emerging Markets
  • 5.4. China Biosimilar Market Overview
    • 5.4.1. Chinese Biosimilar Market: Distribution by Status of Development
    • 5.4.2. Chinese Biosimilar Market: Distribution by Product Category
    • 5.4.3. Chinese Biosimilar Market: Distribution by Indication
  • 5.5. China: Leading Biosimilar Developers
    • 5.5.1. Fosun Pharma
      • 5.5.1.1. Company Overview
      • 5.5.1.2. Financial Performance
      • 5.5.1.3. Development and Manufacturing
      • 5.5.1.4 Biosimilars Product Portfolio
    • 5.5.2. CP Guojian Pharmaceutical
      • 5.5.2.1. Company Overview
      • 5.5.2.2. Biosimilars Product Portfolio
  • 5.6. India Biosimilar Market Overview
    • 5.6.1. Regulatory Guidelines for Approval of biosimilars
      • 5.6.2. Indian Biosimilar Market: Distribution by Status of Development
      • 5.6.3. Indian Biosimilar Market: Distribution by Product Category
      • 5.6.4. Indian Biosimilar Market: Distribution by Indication
  • 5.7. India: Leading Biosimilar Developers
    • 5.7.1. Dr. Reddy's Laboratories
      • 5.7.1.1. Company Overview
      • 5.7.1.2. Financial Performance
      • 5.7.1.3. Biosimilars Product Portfolio
      • 5.7.1.4. Partnerships
    • 5.7.2. Inbiopro
      • 5.7.2.1. Company Overview
      • 5.7.2.2. Biosimilars Product Portfolio
    • 5.7.3. Wockhardt
      • 5.7.3.1. Company Overview
      • 5.7.3.2. Financial Performance
      • 5.7.3.3. Biosimilars Product Portfolio
    • 5.7.4. Biocon
      • 5.7.4.1. Company Overview
      • 5.7.4.2. Financial Performance
      • 5.7.4.3. Biosimilars Product Portfolio
    • 5.7.5. ZydusCadila
      • 5.7.5.1. Company Overview
      • 5.7.5.2. Biosimilars Product Portfolio
      • 5.7.5.3. Partnerships
    • 5.7.6. Reliance Life Sciences
      • 5.7.6.1. Company Overview
      • 5.7.6.2. Biosimilars Product Portfolio
      • 5.7.6.3. Partnerships
  • 5.8. Brazil
    • 5.8.1. Approval Pathway in Brazil
    • 5.8.2. Brazil Biosimilar Market Overview
      • 5.8.2.1. Brazil Biosimilar Market: Distribution by Status of Development
      • 5.8.2.2. Brazil Biosimilar Market: Distribution by Product Category
      • 5.8.2.3. Brazil Biosimilar Market: Distribution by Indication
  • 5.9. Korea
    • 5.9.1. Korea Biosimilar Market Overview
      • 5.9.1.1. Korean Biosimilar Market: Distribution by Status of Development
      • 5.9.1.2. Korean Biosimilar Market: Distribution by Product Category
      • 5.9.1.3. Korean Biosimilar Market: Distribution by Indication
  • 5.10. Mexico
    • 5.10.1. Mexico Biosimilar Market Overview
      • 5.10.1.1. Mexican Biosimilar Market: Distribution by Status of Development
      • 5.10.1.2. Mexican Biosimilar Market: Distribution by Product Category
      • 5.10.1.3. Mexican Biosimilar Market: Distribution by Indication
  • 5.11. Argentina
    • 5.11.1. Argentina Biosimilar Market Overview
      • 5.11.1.1. Argentina Biosimilar Market: Distribution by Status of Development
      • 5.11.1.2. Argentina Biosimilar Market: Distribution by Product Category
      • 5.11.1.3. Argentina Biosimilar Market: Distribution by Indication

6. Global Market Overview

  • 6.1. Chapter Overview
  • 6.2. Biosimilars: Database
  • 6.3. Biosimilars: Distribution by Geography
  • 6.4. Biosimilars: Distribution by Status of Development
  • 6.5. Biosimilars: Distribution by Product Category
  • 6.6. Biosimilars: Distribution by Indication
  • 6.7. Leading Biosimilar Targets
  • 6.8. Leading Biosimilar Developers

7. Market Dynamics

  • 7.1. Chapter Overview
  • 7.2. Drivers
    • 7.2.1. Impending Patent Expiry
    • 7.2.2. Shift in Disease Patterns and Increasing demand for biologics
    • 7.2.3. Soaring Healthcare Costs
  • 7.3. Challenges
    • 7.3.1. Efficacy and Safety Concerns
    • 7.3.2. Lack of Automatic Substitution
    • 7.3.3. Cost and Complexity Involved in Manufacturing
    • 7.3.4. Bioanalytical Challenges
    • 7.3.5. Difficulties in Clinical Studies

8. Monoclonal Antibody Biosimilars

  • 8.1. Chapter Overview
  • 8.2. Challenges in mAb Biosimilar Development
  • 8.3. Regulatory Guidelines
  • 8.4. Immunogenicity of Biosimilar mAbs
  • 8.5. Opportunities in Emerging Markets
  • 8.6. Approval of Infliximab: An Important Milestone
  • 8.7. Leading mAb Biosimilar Targets
    • 8.7.1. Rituximab
      • 8.7.1.1. Drug Overview
      • 8.7.1.2. Background and History of Development
      • 8.7.1.3. Indications and Dosage Forms
      • 8.7.1.4. Target Population
      • 8.7.1.5. Sales, 1999 - 2014
      • 8.7.1.6. Patent Status
      • 8.7.1.7. Marketed Biosimilars
      • 8.7.1.8. Pipeline Biosimilars
      • 8.7.1.9. Discontinued Efforts
      • 8.7.1.10. Challenges
    • 8.7.2. Infliximab
      • 8.7.2.1. Drug Overview
      • 8.7.2.2. Background and History of Development
      • 8.7.2.3. Indications and Dosage Forms
      • 8.7.2.4. Sales
      • 8.7.2.5. Patent Status
      • 8.7.2.6. Marketed Biosimilars
      • 8.7.2.7. Pipeline Biosimilars
    • 8.7.3. Trastuzumab
      • 8.7.3.1. Drug Overview
      • 8.7.3.2. Background and History of Development
      • 8.7.3.3. Indications and Dosage Forms
      • 8.7.3.4. Target Population
      • 8.7.3.5. Sales, 1999 - 2014
      • 8.7.3.6. Patent Status
      • 8.7.3.7. Marketed Biosimilars
      • 8.7.3.8. Pipeline Biosimilars
    • 8.7.4. Adalimumab
      • 8.7.4.1. Drug Overview
      • 8.7.4.2. Indications and Dosage Forms
      • 8.7.4.3. Sales, 2003 - 2014
      • 8.7.4.4. Patent Status
      • 8.7.4.5. Marketed Biosimilars
      • 8.7.4.6. Pipeline Biosimilars
    • 8.7.5. Etanercept
      • 8.7.5.1. Drug Overview
      • 8.7.5.2. Background and History of Development
      • 8.7.5.3. Indications and Dosage Forms
      • 8.7.5.4. Sales, 2002 - 2014
      • 8.7.5.5. Patent Status
      • 8.7.5.6. Marketed Biosimilars
      • 8.7.5.7. Pipeline Biosimilars
  • 8.8. Other mAb Biosimilars

9. Insulin Biosimilars

  • 9.1. Chapter Overview
  • 9.2. Insulin: Definition and Classification
  • 9.3. Target Patient Population
    • 9.3.1. Diabetes
    • 9.3.2. Basal Insulin Users
  • 9.4. Insulin Biosimilars: Potential Market
    • 9.4.1. Global Insulin Market
  • 9.5. Mechanism of Action
  • 9.6. High cost of Insulin Therapy: The Key Driver in Biosimilar Uptake
  • 9.7. Regulatory Guidelines for Insulin Biosimilars
    • 9.7.1. Non Clinical Studies
      • 9.7.1.1. Pharmacodynamic Studies
      • 9.7.1.2. Toxicological Studies
    • 9.7.2. Clinical Studies
      • 9.7.2.1. Pharmacology Studies
      • 9.7.2.2. Clinical Efficacy
      • 9.7.2.3. Clinical Safety
  • 9.8. Insulin Biosimilars: Authorisation Application Withdrawals
  • 9.9. Human Insulin
    • 9.9.1. Actrapid
      • 9.9.1.1. Drug Overview
      • 9.9.1.2. Background and History of Development
      • 9.9.1.3. Indications and Dosage Forms
    • 9.9.2. Insulatard
      • 9.9.2.1. Drug Overview
      • 9.9.2.2. Background and History of Development
      • 9.9.2.3. Indications and Dosage Forms
    • 9.9.3. Marketed Biosimilars
    • 9.9.4. Wosulin
      • 9.9.4.1. History of Development
    • 9.9.5. Insugen
      • 9.9.5.1. History of Development
      • 9.9.5.2. Pipeline Biosimilars
  • 9.10. Insulin Analogues
    • 9.10.1. Insulin Glargine
      • 9.10.1.1. Drug Overview
      • 9.10.1.2. Background and History of Development
      • 9.10.1.3. Indications and Dosage Forms
      • 9.10.1.4. Patent Status
      • 9.10.1.5. Marketed Biosimilars
      • 9.10.1.6. Abasaglar
      • 9.10.1.7. Basalog
      • 9.10.1.8. Glaritus
      • 9.10.1.9. Pipeline Biosimilars
    • 9.10.2. Insulin Lispro
      • 9.10.2.1. Drug Overview
      • 9.10.2.2. Background and History of Development
      • 9.10.2.3. Indications and Dosage Forms
      • 9.10.2.4. Patent Status
      • 9.10.2.5. Insulin Lispro: Biosimilars
    • 9.10.3. Insulin Aspart
      • 9.10.3.1. Drug Overview
      • 9.10.3.2. Background and History of Development
      • 9.10.3.3. Indications and Dosage Forms
      • 9.10.3.4. Insulin Aspart: Biosimilars

10. Biosimilar Interferons

  • 10.1. Chapter Overview
  • 10.2. Biosimilar Interferons: A Challenging Road Ahead
  • 10.3. Regulations
    • 10.3.1. Interferon Alpha
      • 10.3.1.1. Non-Clinical Studies
      • 10.3.1.2. Clinical Studies
    • 10.3.2. Interferon Beta
      • 10.3.2.1. Non Clinical Studies
      • 10.3.2.2. Clinical Studies
  • 10.4. Interferons
    • 10.4.1. Interferon alfa-2a
      • 10.4.1.1. Drug Overview
      • 10.4.1.2. Background and History of Development
      • 10.4.1.3. Indications and Dosage Forms
      • 10.4.1.4. Patent Status
      • 10.4.1.5. Marketed Biosimilars
    • 10.4.2. Interferon alfa-2b
      • 10.4.2.1. Drug Overview
      • 10.4.2.2. Background and History of Development
      • 10.4.2.3. Indications and Dosage Forms
      • 10.4.2.4. Patent Status
      • 10.4.2.5. Marketed Biosimilars
      • 10.4.2.6. Pipeline Biosimilars
    • 10.4.3. Interferon beta-1a
      • 10.4.3.1. Drug Overview
      • 10.4.3.2. Background and History of Development
      • 10.4.3.3. Indications and Dosage Forms
      • 10.4.3.4. Sales
      • 10.4.3.5. Patent Status
      • 10.4.3.6. Marketed Biosimilars
      • 10.4.3.7. Pipeline Biosimilars
    • 10.4.4. Interferon beta-1b
      • 10.4.4.1. Drug Overview
      • 10.4.4.2. Background and History of Development
      • 10.4.4.3. Indications and Dosage Forms
      • 10.4.4.4. Sales
      • 10.4.4.5. Patent Status
      • 10.4.4.6. Marketed Biosimilars
      • 10.4.4.7. Pipeline Biosimilars
    • 10.4.5. Peginterferon beta-1a
      • 10.4.5.1. Drug Overview
      • 10.4.5.2. Background and History of Development
      • 10.4.5.3. Indications and Dosage Forms
      • 10.4.5.4. Sales
      • 10.4.5.5. Patent Status
      • 10.4.5.6. Pipeline Biosimilars
    • 10.4.6. Peginterferon alfa-2a
      • 10.4.6.1. Drug Overview
      • 10.4.6.2. Background and History of Development
      • 10.4.6.3. Indications and Dosage Forms
      • 10.4.6.4. Sales
      • 10.4.6.5. Patent Status
      • 10.4.6.6. Marketed Biosimilars
      • 10.4.6.7. Pipeline Biosimilars
    • 10.4.7. Peginterferon alfa-2b
      • 10.4.7.1. Drug Overview
      • 10.4.7.2. Background and History of Development
      • 10.4.7.3. Indications and Dosage Forms
      • 10.4.7.4. Sales
      • 10.4.7.5. Patent Status
      • 10.4.7.6. Marketed Biosimilars
      • 10.4.7.7. Pipeline Biosimilars

11. Other Leading Biosimilar Markets

  • 11.1. Chapter Overview
  • 11.2. Filgrastim
    • 11.2.1. Drug Overview
    • 11.2.2. Background and History of Development
    • 11.2.3. Indications
    • 11.2.4. Dosage and Administration
    • 11.2.5. Sales
    • 11.2.6. Patent Status
    • 11.2.7. Marketed Biosimilars
    • 11.2.8. Pipeline Biosimilars
  • 11.3. Pegfilgrastim
    • 11.3.1. Drug Overview
    • 11.3.2. Background and History of Development
    • 11.3.3. Indications and Dosage Forms
    • 11.3.4. Sales, 2003-2013
    • 11.3.5. Patent Status
    • 11.3.6. Marketed Biosimilars
  • 11.3.7. Pipeline Biosimilars
  • 11.4. Erythropoietins
    • 11.4.1. Epoetin alfa
      • 11.4.1.1. Drug Overview
      • 11.4.1.2. Background and History of Development
      • 11.4.1.3. Indications and Dosage Forms
      • 11.4.1.4. Sales
      • 11.4.1.5. Patent Status
      • 11.4.1.6. Marketed Biosimilars
      • 11.4.1.7. Pipeline Biosimilars
    • 11.4.2. Other Erythropoietins: Biosimilars
    • 11.4.3. Darbepoetin Alfa
      • 11.4.3.1. Drug Overview
      • 11.4.3.2. Background and History of Development
      • 11.4.3.3. Indications and Dosage Forms
      • 11.4.3.4. Sales
      • 11.4.3.5. Patent Status
      • 11.4.3.6. Marketed Biosimilars
      • 11.4.3.7. Pipeline Biosimilars
  • 11.5. Somatropin
    • 11.5.1. Drug Overview
    • 11.5.2. Indications and Dosage Forms
    • 11.5.3. Marketed Biosimilars
    • 11.5.5. Pipeline Biosimilars

12. Recent Developments

  • 12.1. Partnerships in the Biosimilars Industry
    • 12.1.1. Growing Trend of Partnerships
    • 12.1.2. Celltrion Leads the Partnership Activity
  • 12.2. Investments in Biosimilars

13. Outsourcing of Biosimilars

  • 13.1. Chapter Overview
  • 13.2. Need for Outsourcing Biosimilars
  • 13.3. Impact of Biosimilars on the CMOs
  • 13.4. Biosimilars to Drive Cost Effectiveness
  • 13.5. Presence of CMOs and CROs in the Biosimilars Market
  • 13.6. Technology Trends

14. Market Forecast

  • 14.1. Chapter Overview
  • 14.2. Forecast Methodology
  • 14.3. Global Biosimilars Market, 2020 and 2025
  • 14.4. mAb Biosimilars Market, 2020 and 2025
  • 14.5. Insulin Biosimilars Market Forecast, 2020 and 2025
  • 14.6. Interferon Biosimilars Market Forecast, 2020 and 2025
  • 14.7. G-CSF/ GM-CSF Biosimilars Market Forecast, 2020 and 2025
  • 14.8. Erythropoietin Biosimilars Market Forecast, 2020 and 2025

15. Conclusion

  • 15.1. Biosimilars: A Mammoth Opportunity
  • 15.2. Key Market Drivers and Restraints
  • 15.3. mAb Biosimilars to Rise Substantially
  • 15.4. A Diversified Landscape on the Cusp of Significant Growth

16. Interview Transcripts

17. Appendix 1: Tabulated Data

18. Appendix 2: List of Companies and Organisations

List of Figures:

  • Figure 3.1: Numbers of Biologics Approved by the USFDA, 2009-2015
  • Figure 3.2: Biosimilars: Definition
  • Figure 3.3: Need for Biosimilars
  • Figure 3.4: Types of Expression Systems
  • Figure 3.5: Biosimilar Development: Sequential Steps
  • Figure 3.6: Innovator Biologic and Biosimilar Development Timeline
  • Figure 3.7: Clinical Trial Design for Biosimilars
  • Figure 4.1: Evolution of Biosimilars in the US
  • Figure 4.2: Biosimilar Development and Approval Pathway
  • Figure 4.3: The US Biosimilar Market: Distribution by Status of Development
  • Figure 4.4: The US Biosimilar Market: Distribution by Product Category
  • Figure 4.5: The US Biosimilar Market: Distribution by Indication
  • Figure 4.6: Hospira: Revenues, 2010-2014 (USD Billion)
  • Figure 4.7: Hospira Revenues: Distribution by Business Segments, 2014 (USD Billion, %)
  • Figure 4.8: Amgen: Revenues, 2010-2014 (USD Billion)
  • Figure 4.9: Eli Lilly: Revenues, 2010-2014 (USD Billion)
  • Figure 4.10: Eli Lilly Revenues: Distribution by Business Segments, 2014 (USD Billion, %)
  • Figure 4.11: Pfizer: Revenues, 2010-2014 (USD Billion)
  • Figure 4.12: Pfizer Revenues: Distribution by Business Segments, 2014 (USD Billion %)
  • Figure 4.13: Summary of the European Biosimilar Guidelines
  • Figure 4.14: EMA Guidelines for Biosimilars
  • Figure 4.15: Evolution of Biosimilars in Europe
  • Figure 4.15: The EU Biosimilar Market: Distribution by Status of Development
  • Figure 4.16: The EU Biosimilar Market: Distribution by Product Category
  • Figure 4.17: The EU Biosimilar Market: Distribution by Indication
  • Figure 4.18: Sandoz: Revenues, 2010-2014 (USD Billion)
  • Figure 4.19: Sandoz Revenues: Distribution by Business Segments, 2014 (USD Billion, %)
  • Figure 4.20: Sandoz: Revenues Generated by Biosimilars, 2010-2014 (USD Million)
  • Figure 4.21: Stada: Revenues, 2010 - 2014 (EUR Billion)
  • Figure 4.22: Stada Revenues: Distribution by Business Segments, 2014 (EUR Billion, %)
  • Figure 4.23: Japan Biosimilar Market: Distribution by Status of Development
  • Figure 4.24: Japan Biosimilar Market: Distribution by Product Category
  • Figure 4.25: Japan Biosimilar Market: Distribution by Indication
  • Figure 4.26: Nippon Kayaku: Revenues, FY 2010/11 - FY 2014/15 (JPY Billion)
  • Figure 4.27: Gene Techno Science: Revenues, FY 2010/11 - FY 2014/15 (JPY Million)
  • Figure 4.28: JCR Pharmaceuticals: Revenues, 2009-2014 (JPY Billion)
  • Figure 4.29: JCR Pharmaceuticals Revenues: Distribution by Business Segments, FY 2013/14 (JPY Billion)
  • Figure 5.1: China Biosimilar Market: Distribution by Status of Development
  • Figure 5.2: China Biosimilar Market: Distribution by Product Category
  • Figure 5.3: China Biosimilar Market: Distribution by Indication
  • Figure 5.4: Fosun Pharma Revenues: Distribution by Business Segments, 2014 (RMB Billion)
  • Figure 5.5: Indian Biosimilar Market: Distribution by Status of Development
  • Figure 5.6: Indian Biosimilar Market: Distribution by Product Category
  • Figure 5.7: Indian Biosimilar Market: Distribution by Indication
  • Figure 5.8: Dr. Reddy's Laboratories Revenues: Distribution by Business Divisions, FY 2013/14 (INR Billion)
  • Figure 5.9: Wockhardt: Revenues, FY2010/11- FY2014/15 (INR Billion)
  • Figure 5.10: Biocon Revenues: Distribution by Business Segments, FY 2014/15 (INR Billion)
  • Figure 5.11: Brazil Biosimilar Market: Distribution by Status of Development
  • Figure 5.12: Brazil Biosimilar Market: Distribution by Product Category
  • Figure 5.13: Brazil Biosimilar Market: Distribution by Indication
  • Figure 5.14: Korean Biosimilar Market: Distribution by Status of Development
  • Figure 5.15: Korean Biosimilar Market: Distribution by Product Category
  • Figure 5.16: Korean Biosimilar Market: Distribution by Indication
  • Figure 5.17: Mexican Biosimilar Market: Distribution by Status of Development
  • Figure 5.18: Mexican Biosimilar Market: Distribution by Product Category
  • Figure 5.19: Mexican Biosimilar Market: Distribution by Indication
  • Figure 5.20: Argentina Biosimilar Market: Distribution by Status of Development
  • Figure 5.21: Argentina Biosimilar Market: Distribution by Product Category
  • Figure 5.22: Argentina Biosimilar Market: Distribution by Indication
  • Figure 6.1: Global Biosimilars Market: Distribution By Geography
  • Figure 6.2: Global Biosimilars Market: Distribution by Status of Development
  • Figure 6.3: Global Biosimilars Market: Distribution by Product Category
  • Figure 6.4: Global Biosimilars Market: Distribution by Indication
  • Figure 6.5: Leading Biosimilar Targets
  • Figure 6.6: Leading Biosimilar Developers
  • Figure 7.1: Top Selling Biologics: Estimated Patent Expiry
  • Figure 8.1: Rituxan/MabThera: Target Population for Follicular NHL
  • Figure 8.2: Rituxan/MabThera: Target Population for Diffuse Large B-cell NHL
  • Figure 8.3: Rituxan/MabThera: Target Population for CLL
  • Figure 8.4: Rituximab Sales, 1999 - 2014 (CHF Billion)
  • Figure 8.5: Rituximab: Regional Sales, 2012-2014 (USD Billion)
  • Figure 8.6: Infliximab: Sales, 2006-2014 (USD Billion)
  • Figure 8.7: Inflectra: Overview of Clinical Studies
  • Figure 8.8: HER2 Expression in Breast Cancer Patients (%)
  • Figure 8.9: Herceptin Sales, 1999 - 2014 (CHF Billion)
  • Figure 8.10: Herzuma: Clinical Trials Overview
  • Figure 8.11: Humira Global Sales, 2003-2014 (USD Billion)
  • Figure 8.12: Enbrel US Sales, 2002-2014 (USD Million)
  • Figure 9.1: Classification of Human Insulin andAnalogs
  • Figure 9.2: Diabetes: Worldwide Prevalence and Diagnosis (Million)
  • Figure 9.3: Diabetes: Prevalence and Diagnosed Cases by Region/Countries (2014), Million
  • Figure 9.4: Worldwide, 2013: Distribution by Type (USD Billion, %)
  • Figure 9.5: US Insulin Market: Distribution by Type (%)
  • Figure 9.6: Western Europe Insulin Market: Distribution by Type (%)
  • Figure 9.7: Wosulin: Clinical Trials Overview
  • Figure 10.1: Avonex and Rebif: Sales, 2007-2014 (USD Billion)
  • Figure 10.2: Betaferon/Betaseron and Extavia: Sales, 2007-2014 (USD Billion)
  • Figure 10.3: Pegasys: Sales, 2005-2014 (CHF Billion)
  • Figure 10.4: PegIntron: Sales, 2009-2014 (USD Billion)
  • Figure 11.1: Neupogen: Sales, 1997-2014 (USD Billion)
  • Figure 11.2: Neulasta Sales, 2003 - 2014 (USD Billion)
  • Figure 11.3: Epogen and Procrit/ Eprex: Sales, 2005-2014 (USD Billion)
  • Figure 11.4: Aranesp: Sales, 2004-2014 (USD Billion)
  • Figure 12.1: Biosimilars: Cumulative Partnerships by Year, Pre 2010 - 2015
  • Figure 12.2: Biosimilars: Leading Players by Partnerships
  • Figure 14.1: Global Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
  • Figure 14.2: Global Biosimilars Market Forecast: Distribution by Product Category, 2020 and 2025 (USD Billion)
  • Figure 14.3: Global mAb Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
  • Figure 14.4: Global Insulin Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
  • Figure 14.5: Global Interferon Biosimilars Market: Distribution by Region, 2020 and 2025 (USD Billion)
  • Figure 14.6: Global G-CSF/GM-CSF Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
  • Figure 14.7: Global Erythropoietin Biosimilars Market: Distribution by Region, 2020 and 2025 (USD Billion)
  • Figure 15.1: Biosimilars: Key Market Drivers and Restraints

List of Tables

  • Table 3.1: Marketed Biologics, 2014 and 2015
  • Table 3.2: Difference Between Generic, Biosimilar and Reference Biologic Products
  • Table 3.3: Assays for Product Characterisation
  • Table 4.1: FDA Draft Guidelines on Biosimilars
  • Table 4.2: Biologics Price Competition and Innovation Act (BPCIA) Requirements
  • Table 4.3: Hospira: Late-Stage Development Pipeline
  • Table 4.4: Inflectra/Remsima: Clinical Trials in the US
  • Table 4.5: Retacrit: Clinical Trials in the US
  • Table 4.6: Credima/Herzuma: Clinical Trials in the EU and RoW
  • Table 4.7: Amgen: Late-Stage Development Pipeline
  • Table 4.8: ABP 501: Clinical Trials in the US, EU and RoW
  • Table 4.9: ABP 980: Clinical Trials in the EU and RoW
  • Table 4.10: ABP 215: Clinical Trials in the US, EU and RoW
  • Table 4.11: ABP 798: Clinical Trials in the US, EU and RoW
  • Table 4.12: Amgen: Early-Stage Development Pipeline
  • Table 4.13: Pfizer: Late-Stage Development Pipeline
  • Table 4.14: PF-05280014: Clinical Trials in the US, EU, Japan and RoW
  • Table 4.15: PF-05280586: Clinical Trials in the US, EU, Japan and RoW
  • Table 4.16: PF-06438179: Clinical Trials in the US, EU and RoW
  • Table 4.17: PF-06439535: Clinical Trials in the US, EU and RoW
  • Table 4.18: Guidelines issued by EMA and International Partners
  • Table 4.19: Sandoz: Late-Stage Development Pipeline
  • Table 4.20: GP 2017: Clinical Trials in the US and EU
  • Table 4.21: GP 2015: Clinical Trials in the EU and RoW
  • Table 4.22: LA-EP 2006: Clinical Trials in the US, EU and RoW
  • Table 4.23: GP 2013: Clinical Trials in the US, EU, Japan and RoW
  • Table 4.24: HX 575 (SC): Clinical Trials in the US and EU
  • Table 4.25: BioXpress Therapeutics: Biosimilars Pipeline
  • Table 4.26: Gene Techno Science: Biosimilars Pipeline
  • Table 4.27: JR-013: Available Forms and their Prices
  • Table 4.28: Countries with Regulatory Guidelines for Biosimilars
  • Table 5.1: Difference between Chinese Final Regulatory Guidelines on Biosimilars and its Previous Draft
  • Table 5.2: Fosun Pharma: Late-Stage Development Pipeline
  • Table 5.3: Fosun Pharma: Early-Stage Development Pipeline
  • Table 5.4: Dr. Reddy's Laboratories: Marketed Biosimilars
  • Table 5.5: Inbiopro: Marketed Biosimilars
  • Table 5.6: Inbiopro: Pipeline Biosimilars
  • Table 5.7: Wockhardt: Marketed Biosimilars
  • Table 5.8: Biocon: Marketed Biosimilars
  • Table 5.9: Biocon: Late-Stage Development Pipeline
  • Table 5.10: Biocon: Early-Stage Development Pipeline
  • Table 5.11: ZydusCadila: Marketed Biosimilars
  • Table 5.12: ZydusCadila: Biosimilar Pipeline
  • Table 5.13: Reliance Life Sciences: Marketed Biosimilars
  • Table 6.1: Global List of Marketed and Pipeline Biosimilars
  • Table 7.1: Best Selling Biologics: Revenues
  • Table 8.1: Rituximab: Marketed Biosimilars
  • Table 8.2: Rituximab: Pipeline Biosimilars
  • Table 8.3: Infliximab: Dosage Regimen
  • Table 8.4: Infliximab: Marketed Biosimilars
  • Table 8.5: Inflectra: Product Specifications
  • Table 8.6: Infliximab: Pipeline Biosimilars
  • Table 8.7: Trastuzumab: Marketed Biosimilars
  • Table 8.8: Biosimilars Pipeline: Trastuzumab
  • Table 8.9: Adalimumab: Pipeline Biosimilars
  • Table 8.10: Etanercept: Marketed Biosimilars
  • Table 8.11: Etanercept: Pipeline Biosimilars
  • Table 8.12: Other mAb Biosimilars
  • Table 9.1: Biosimilar Insulins: Withdrawn Applications
  • Table 9.2: Human Insulin: Marketed Biosimilars
  • Table 9.3: Human Insulin: Pipeline Biosimilars
  • Table 9.4: Insulin Glargine: Marketed Biosimilars
  • Table 9.5: Insulin Glargine: Pipeline Biosimilars
  • Table 9.6: Insulin Lispro: Biosimilars
  • Table 9.7: Insulin Aspart: Biosimilars
  • Table 10.1: Types of Interferons
  • Table 10.2: Interferon alfa-2a: Marketed Biosimilars
  • Table 10.3: Intron A: Dosage Forms for Various Indications
  • Table 10.4: Interferon alfa-2b: Marketed Biosimilars
  • Table 10.5: Interferon alfa-2b: Pipeline Biosimilars
  • Table 10.6: Interferon beta-1a: Marketed Biosimilars
  • Table 10.7: Interferon beta-1a: Pipeline Biosimilars
  • Table 10.8: Interferon beta-1b: Marketed Biosimilars
  • Table 10.9: Interferon beta-1b: Pipeline Biosimilars
  • Table 10.10: Peginterferon alfa-2a: Marketed Biosimilars
  • Table 10.11: Peginterferon alfa-2a: Pipeline Biosimilars
  • Table 10.12: Peginterferon alfa-2b: Marketed Biosimilars
  • Table 10.13: Peginterferon alfa-2b: Pipeline Biosimilars
  • Table 11.1: Neupogen: Recommended Dosage
  • Table 11.2: Filgrastim: Marketed Biosimilars
  • Table 11.3: Filgrastim: Pipeline Biosimilars
  • Table 11.4: Pegfilgrastim: Marketed Biosimilars
  • Table 11.5: Pegfilgrastim: Pipeline Biosimilars
  • Table 11.6: Epoetin Alfa: Marketed Biosimilars
  • Table 11.7: Epoetin Alfa: Pipeline Biosimilars
  • Table 11.8: Other Erythropoietins: Biosimilars
  • Table 11.9: Darbepoetin Alfa: Marketed Biosimilars
  • Table 11.10: Darbepoetin Alfa: Pipeline Biosimilars
  • Table 11.11: Somatropin: Marketed Biosimilars
  • Table 11.12: Somatropin: Pipeline Biosimilars
  • Table 12.1: Instances of Partnerships in the Biosimilars Industry
  • Table 13.1: Contract Service Providers in Biosimilars
  • Table 17.1: Numbers of Biologics Approved by the USFDA, 2009-2015
  • Table 17.2: The US Biosimilar Market: Distribution by Status of Development
  • Table 17.3: The US Biosimilar Market: Distribution by Product Category
  • Table 17.4: The US Biosimilar Market: Distribution by Indication
  • Table 17.5: Hospira: Revenues, 2010-2014 (USD Billion)
  • Table 17.6: Hospira Revenues: Distribution by Business Segments, 2014 (USD Billion, %)
  • Table 17.7: Amgen: Revenues, 2010 -2014 (USD Billion)
  • Table 17.8: Eli Lilly: Revenues, 2010-2014 (USD Billion)
  • Table 17.9: Eli Lilly Revenues: Distribution by Business Segments(USD Billion)
  • Table 17.10: Pfizer: Revenues, 2010-2014 (USD Billion)
  • Table 17.11: Pfizer Revenues: Distribution by Business Segments, 2014 (USD Billion)
  • Table 17.12: The EU Biosimilar Market: Distribution by Status of Development
  • Table 17.13: The EU Biosimilar Market: Distribution by Product Category
  • Table 17.14: The EU Biosimilar Market: Distribution by Indication
  • Table 17.15: Sandoz: Revenues, 2010-2014 (USD Billion)
  • Table 17.16: Sandoz: Revenues by Business Segments, 2014 (USD Billion, %)
  • Table 17.17: Sandoz: Revenues Generated by Biosimilars, 2010-2014 (USD Million)
  • Table 17.18: Stada: Revenues, 2010 -2014 (EUR Billion)
  • Table 17.19: Stada Revenues: Distribution by Business Segments, 2014 (EUR Billion)
  • Table 17.20: Japan Biosimilar Market: Distribution by Status of Development
  • Table 17.21: Japan Biosimilar Market: Distribution by Product Category
  • Table 17.22: Japan Biosimilar Market: Distribution by Indication
  • Table 17.23: Nippon Kayaku: Revenues, FY 2010/11 - FY 2014/15 (JPY Billion)
  • Table 17.24: Gene Techno Science: Revenues, FY 2010/11 - FY 2014/15 (JPY Million)
  • Table 17.25: JCR Pharmaceuticals: Revenues, 2009- 2014 (JPY Billion)
  • Table 17.26: JCR Pharmaceuticals Revenues: Distribution by Business Segments, FY 2013/14 (JPY Billion)
  • Table 17.27: Chinese Biosimilar Market: Distribution by Status of Development
  • Table 17.28: Chinese Biosimilar Market: Distribution by Product Category
  • Table 17.29: Chinese Biosimilar Market: Distribution by Indication
  • Table 17.30: Fosun Pharma Revenues: Distribution by Business Segments, 2014 (RMB Billion)
  • Table 17.31: Indian Biosimilar Market: Distribution by Status of Development
  • Table 17.32: Indian Biosimilar Market: Distribution by Product Category
  • Table 17.33: Indian Biosimilar Market: Distribution by Indication
  • Table 17.34: Dr. Reddy's Laboratories Revenues: Distribution by Business Segments, FY 2013/14 (INR Billion)
  • Table 17.35: Wockhardt: Revenues, FY2010/11- FY2014/15 (INR Billion)
  • Table 17.36: Biocon Revenues: Distribution by Business Segments, FY2014/15 (INR Billion)
  • Table 17.37: Brazil Biosimilar Market: Distribution by Status of Development
  • Table 17.38: Brazil Biosimilar Market: Distribution by Product Category
  • Table 17.39: Brazil Biosimilar Market: Distribution by Indication
  • Table 17.40: Korean Biosimilar Market: Distribution by Status of Development
  • Table 17.41: Korean Biosimilar Market: Distribution by Product Category
  • Table 17.42: Korean Biosimilar Market: Distribution by Indication
  • Table 17.43: Mexican Biosimilar Market: Distribution by Status of Development
  • Table 17.44: Mexican Biosimilar Market: Distribution by Product Category
  • Table 17.45: Mexican Biosimilar Market: Distribution by Indication
  • Table 17.46: Argentina Biosimilar Market: Distribution by Status of Development
  • Table 17.47: Argentina Biosimilar Market: Distribution by Product Category
  • Table 17.48: Argentina Biosimilar Market: Distribution by Indication
  • Table 17.49: Global Biosimilars Market: Distribution By Geography
  • Table 17.50: Global Biosimilars Market: Biosimilars: Distribution by Status of Development
  • Table 17.51: Global Biosimilars Market: Distribution by Product category
  • Table 17.52: Global Biosimilars Market: Distribution by Indication
  • Table 17.53: Leading Biosimilar Targets
  • Table 17.54: Leading Biosimilar Developers
  • Table 17.55: Rituxan/MabThera: Target Population for Follicular NHL
  • Table 17.56: Rituxan/MabThera: Target Population for Diffuse Large B-cell NHL
  • Table 17.57: Rituxan/MabThera: Target Population for CLL
  • Table 17.58: Rituximab Sales, 1999 - 2014 (CHF Billion)
  • Table 17.59: Rituximab: Regional Sales, 2012-2014 (USD Billion)
  • Table 17.60: Infliximab: Sales, 2006-2014(USD Billion)
  • Table 17.61: HER2 Expression in Breast Cancer Patients (%)
  • Table 17.62: Herceptin Sales, 1999 - 2014 (CHF Billion)
  • Table 17.63: Humira Global Sales, 2003-2014 (USD Billion)
  • Table 17.64: Enbrel US Sales, 2002-2014 (USD Million)
  • Table 17.65: Diabetes: Worldwide Prevalence and Diagnosis
  • Table 17.66: Diabetes: Prevalence by Region/Countries (2014), Million
  • Table 17.67: Diabetes: Diagnosed Cases by Region/Countries (2014), Million
  • Table 17.68: Worldwide Insulin Market, 2013: Distribution by Type (USD Billion, %)
  • Table 17.69: US Insulin Market: Distribution by Type (%)
  • Table 17.70: Western Europe Insulin Market: Distribution by Type (%)
  • Table 17.71: Avonex and Rebif: Sales, 2007-2014 (USD Billion)
  • Table 17.72: Betaferon/ Betaseron and Extavia: Sales, 2007-2014 (USD Billion)
  • Table 17.73: PegIntron: Sales, 2009-2014 (USD Billion)
  • Table 17.74: Pegasys: Sales, 2005-2014 (CHF Billion)
  • Table 17.75: PegIntron: Sales, 2009-2014 (USD Billion)
  • Table 17.76: Neupogen: Sales, 1997-2014
  • Table 17.77: Neulasta Sales, 2003 - 2013 (USD Billion)
  • Table 17.78: Epogen and Procrit/ Eprex: Sales, 2005-2014 (USD Billion)
  • Table 17.79: Aranesp: Sales, 2004-2014 (USD billion)
  • Table 17.80: Biosimilars: Cumulative Partnerships by Year, Pre 2010 - 2015
  • Table 17.81: Biosimilars: Leading Players by Partnerships
  • Table 17.82: Global Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
  • Table 17.83: Global Biosimilars Market Forecast: Distribution by Product Category, 2020 and 2025 (USD Billion)
  • Table 17.84: Global mAb Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
  • Table 17.85: Global Insulin Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
  • Table 17.86: Global Interferon Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
  • Table 17.87: Global G-CSF/ GM-CSF Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)
  • Table 17.88: Global Erythropoietin Biosimilars Market Forecast: Distribution by Region, 2020 and 2025 (USD Billion)

List of Companies

The following companies and organisations have been mentioned in the report:

  • 1. 3S Bio Inc.
  • 2. Abbott
  • 3. AbZ Pharma
  • 4. Accord Healthcare Ltd.
  • 5. Actavis
  • 6. Aequus BioPharma
  • 7. AET Biotech
  • 8. Agila Biotech
  • 9. Alvartis Pharma
  • 10. Alvogen
  • 11. Amega Biotech
  • 12. Amgen
  • 13. Anhui Anke Biotechnology (Group) Co., Ltd
  • 14. Anika Therapeutics
  • 15. ANMAT (Argentina)
  • 16. Apotex
  • 17. Aprogen Inc.
  • 18. AryoGen
  • 19. ASKA Pharmaceutical Co. Ltd.
  • 20. Aspen Pharmacare Australia
  • 21. Avesthagen
  • 22. Axicorp GmbH
  • 23. AXXO GmbH
  • 24. Barr Pharmaceuticals
  • 25. Baxter International
  • 26. Bayer Healthcare
  • 27. Beacon Pharmaceuticals Ltd.
  • 28. Beijing Four Rings Bio-Pharmaceutical
  • 29. Beijing ShuangLu Pharmaceutical Co., Ltd.
  • 30. Bharat Serums
  • 31. Binex
  • 32. Bio Process
  • 33. Bio Profarma SA
  • 34. Bio Sidus SA
  • 35. Biocad
  • 36. BioCeuticalsArzneimittel AG
  • 37. BioCND Inc.
  • 38. Biocon
  • 39. Biogaran
  • 40. Biogen Idec
  • 41. BioGenomics
  • 42. BioMarin
  • 43. Bionovis
  • 44. Biosano Laboratories
  • 45. Biotechpharma
  • 46. Bioton
  • 47. Bioviz
  • 48. BioXpress Therapeutics
  • 49. BlauFarmaceutica
  • 50. Blue Stream Laboratories
  • 51. BMS
  • 52. Boehringer Ingelheim
  • 53. Boston Oncology, LLC
  • 54. Cadila Pharmaceuticals
  • 55. Cangene
  • 56. Catalent
  • 57. CCL Pharmaceuticals
  • 58. CCM Duopharma Biotech Bhd
  • 59. Cell Therapeutics
  • 60. Cellectis
  • 61. Celltrion
  • 62. Celon
  • 63. Central Drugs Standard Control Organisation
  • 64. Chandra Bhagat Pharma
  • 65. Charles River Laboratories
  • 66. Chemical Company of Malaysia Berhad
  • 67. China Food and Drug Administration
  • 68. CHMP
  • 69. Chong Kun Dang Pharma
  • 70. Chugai Pharmaceuticals
  • 71. CIMAB
  • 72. Cinnagen
  • 73. Cipla
  • 74. CJ Healthcare
  • 75. Claris Lifesciences
  • 76. Clinigene International Pvt. Ltd.
  • 77. CMC Biologics
  • 78. Cobra Biologics
  • 79. COFEPRIS
  • 80. CoGenesys
  • 81. Coherus Biosciences
  • 82. Cook Pharmica
  • 83. Covance
  • 84. CP Guojian Pharmaceutical Co. Ltd
  • 85. CTI BioPharma
  • 86. Curaxys
  • 87. Dabur
  • 88. Daewoong Pharmaceutical Co. Ltd.
  • 89. Daiichi Sankyo
  • 90. Dong A Pharma
  • 91. Dongbao Enterprise Group Ltd.
  • 92. Dr. Reddy's Laboratories
  • 93. Dragon Pharmaceuticals Inc.
  • 94. Egis Pharmaceuticals
  • 95. Eli Lilly
  • 96. Elpen Pharmaceutical
  • 97. Emcure Pharmaceuticals
  • 98. Emergent Biosolutions
  • 99. Epirus Biopharmaceuticals
  • 100. Eurofins Central Global Laboratory
  • 101. Farmabion del Ecuador C.A
  • 102. Farmasa
  • 103. Finox Biotech
  • 104. Fiocruz
  • 105. Fosun Pharmaceutical
  • 106. Fougera Pharmaceuticals
  • 107. Fountain Biopharma Inc.
  • 108. Frontage Laboratories, Inc.
  • 109. Fuji Pharma
  • 110. Fujifilm Kyowa Kirin Biologics
  • 111. Fuso Pharmaceutical Industries
  • 112. Gambro
  • 113. Gan& Lee
  • 114. Gedeon Richter
  • 115. Gene Techno Science
  • 116. Genentech
  • 117. Generium
  • 118. GeneScience Pharmaceuticals
  • 119. Genexine
  • 120. Genhelix
  • 121. GenorBiopharma
  • 122. GlaxoSmithKline
  • 123. Goodwin Biotechnology
  • 124. Halozyme Therapeutics
  • 125. Handok Inc.
  • 126. Hangzhou Jiuyuan Gene Engineering Co., Ltd.
  • 127. Hanwha Chemicals
  • 128. Harvest Moon Pharmaceuticals
  • 129. HEC Pharm
  • 130. Henlius Biopharmaceuticals
  • 131. Hetero Drugs
  • 132. Hexal
  • 133. Hikma Pharmaceuticals
  • 134. Hindustan Antibiotics Limited
  • 135. Hospira
  • 136. Hualida Biotech
  • 137. HygeneBiopharm Co. Ltd.
  • 138. iBio Inc.
  • 139. IDDI
  • 140. IDEC Pharmaceuticals
  • 141. Inbiopro
  • 142. INC Research, LLC
  • 143. Incepta Pharmaceuticals Ltd.
  • 144. Inno Bio Ventures Sdn Bhd.
  • 145. Innogene
  • 146. Innovent Biologics
  • 147. Insmed
  • 148. Instituto Vital Brazil
  • 149. Intas Pharmaceuticals
  • 150. Intertek
  • 151. InVentiv Health
  • 152. Ipca Laboratories
  • 153. IsuAbxis
  • 154. Itochu Chemical Frontier Corporation
  • 155. Janssen Biotech
  • 156. JCR Pharmaceuticals
  • 157. Johnson & Johnson
  • 158. Julphar
  • 159. Kawsar Biotech Company
  • 160. Kee Pharma
  • 161. Kemwell Biopharma
  • 162. Kern Pharma
  • 163. Kissei Pharmaceuticals
  • 164. KlarvoyantBiogenics
  • 165. Kocak Pharma
  • 166. Kun Wha Pharmaceutical Company
  • 167. La Renon
  • 168. LaboratoriosVarifarma
  • 169. Landsteiner Laboratories
  • 170. LG Lifesciences
  • 171. Liomont
  • 172. LivzonMabpharm
  • 173. Lonza
  • 174. Lupin
  • 175. Mabion
  • 176. mAbxience S.A
  • 177. MannKind Corp
  • 178. Marvel Life Sciences
  • 179. Medicago
  • 180. MEDICE Arzneimittel Putter
  • 181. Meiji Seika Pharma Co., Ltd.
  • 182. Merck & Co
  • 183. Merck KGaA
  • 184. Merieux Alliance
  • 185. MGC Pharma
  • 186. Micro Labs
  • 187. Minapharm Pharmaceuticals
  • 188. Ministry for Health Labour and Welfare (MHLW),Japan
  • 189. Ministry of Food and Drug Safety (MFDS), Korea
  • 190. Mitsubishi Tanabe Pharma
  • 191. MJ BiopharmPvt. Ltd.
  • 192. Mochida Pharmaceutical
  • 193. Momenta Pharma
  • 194. MPI Research
  • 195. Mundipharma International Corporation
  • 196. Mylan
  • 197. Nanogen Biopharmaceuticals
  • 198. Napp Pharmaceuticals
  • 199. Natco Pharma
  • 200. National Health Surveillance Agency (ANVISA)
  • 201. National Institute for Health and Clinical Excellence
  • 202. NCPC Genentech Biotechnology Co. Ltd.
  • 203. Neiss Labs Pvt. Ltd.
  • 204. Neogenica Bioscience Ltd
  • 205. Neuclone
  • 206. Nichi-IkoPharmaceuticals
  • 207. Nippon Kayaku
  • 208. Novartis
  • 209. Novo Nordisk
  • 210. NPS Pharmaceuticals
  • 211. Oncobiologics
  • 212. OrygenBiotecnologia
  • 213. Panacea Biotec
  • 214. PanGen Biotech
  • 215. Paras Biopharmaceuticals
  • 216. Parexel
  • 217. Patheon
  • 218. Pfenex
  • 219. Pfizer
  • 220. Pharmaceutical Product Development Inc.
  • 221. Pharmacia
  • 222. PharmaPraxis
  • 223. PlantForm Corporation
  • 224. Pliva
  • 225. PLIVA
  • 226. Probiomed
  • 227. ProFibrix BV
  • 228. Prolong Pharmaceuticals
  • 229. Protalix Biotherapeutics
  • 230. Qilu Pharmaceutical Co., Ltd.
  • 231. Quintiles
  • 232. Raichem Lifesciences
  • 233. Ranbaxy
  • 234. Ratiopharm
  • 235. Reliance GeneMedix Plc
  • 236. Reliance Life Sciences
  • 237. RentschlerBiotechnologie GmbH
  • 238. RG Pharmaceutica
  • 239. RheinMinapharm
  • 240. Richter-Helm BioTec GmbH
  • 241. Roche
  • 242. RPG Life Sciences
  • 243. Salix Pharmaceuticals, Ltd.
  • 244. Samarth Life Sciences
  • 245. Samsung Bioepis
  • 246. Sandoz
  • 247. Sanofi Aventis
  • 248. Sanwa Kagaku Kenkyusho Co., Ltd.
  • 249. Schering-Plough
  • 250. Sci Gen Australia
  • 251. Sedico
  • 252. Serum Institute of India
  • 253. SGS Life Science Services
  • 254. Shandong KexingBioproducts Co., Ltd
  • 255. Shanghai Biomabs Pharmaceuticals Co Ltd
  • 256. Shanghai Celgen Bio-Pharmaceutical
  • 257. Shanghai CP Guojian Pharmaceutical
  • 258. Shanghai Fosun Pharmaceutical
  • 259. Shanghai Zhangjiang Biotechnology Limited Company
  • 260. Shantha Biotech
  • 261. Shreya Life Sciences
  • 262. Sicor Biotech
  • 263. Simcere Pharmaceutical Group
  • 264. South Korea's Ministry of Food and Drug Safety
  • 265. Spectrum Pharmaceuticals
  • 266. StadaArneimittel AG
  • 267. STC Biologics
  • 268. Stelis Biopharma
  • 269. Strides Arcolab Limited
  • 270. Symbiosis
  • 271. Synthon Pharmaceuticals
  • 272. Taj Pharmaceuticals
  • 273. Takeda Pharmaceuticals
  • 274. TCI Generics
  • 275. Tecpar
  • 276. Teva
  • 277. The Medicines Company
  • 278. Torrent Pharmaceuticals
  • 279. Toyota Tshuho Corp.
  • 280. TTK Healthcare
  • 281. UMN Pharma
  • 282. United Biotech
  • 283. United Therapeutics Corp
  • 284. USFDA
  • 285. USV Limited
  • 286. VHB Life Sciences Ltd.
  • 287. Virchow Biotech
  • 288. Viropro
  • 289. Warner-Lambert
  • 290. Watson Pharmaceuticals
  • 291. WHO
  • 292. WIL Research
  • 293. Wockhardt
  • 294. Wyeth
  • 295. Xiamen Amyotop Biotech
  • 296. Xian Janssen
  • 297. Yoshindo
  • 298. Zenyaku Kogyo
  • 299. Zhejiang Hisun Pharma
  • 300. Zhejiang Huahai Pharmaceutical Co. Ltd.
  • 301. ZhongshanHygeneBiopharm
  • 302. Zuventus Healthcare Ltd.
  • 303. ZydusCadila
  • 304. Zyphars Pharmaceuticals
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