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米国のバイオシミラー (バイオ後続品) 市場:市場機会および臨床パイプラインの分析

US Biosimilars Market Opportunity & Clinical Pipeline Analysis

発行 KuicK Research 商品コード 351223
出版日 ページ情報 英文 330 Pages
納期: 即日から翌営業日
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米国のバイオシミラー (バイオ後続品) 市場:市場機会および臨床パイプラインの分析 US Biosimilars Market Opportunity & Clinical Pipeline Analysis
出版日: 2016年02月02日 ページ情報: 英文 330 Pages
概要

当レポートでは、米国のバイオシミラー (バイオ後続品) の市場を調査し、市場および製品の定義と概要、米国独自の市場環境、法規制、商業化の可能性の高いバイオシミラーのカテゴリー、主要薬剤の売上の推移、パイプラインの動向、主要事業者のプロファイルなどをまとめています。

第1章 米国のバイオシミラー市場:イントロダクション

第2章 米国のバイオシミラー:法規制シナリオ

第3章 米国のバイオシミラー市場独自の特徴

第4章 バイオシミラーの米国市場への影響

第5章 高い商業的可能性を持つ新たなバイオシミラーカテゴリー

  • 高い費用対効果
  • 競合
  • 適応性
  • バイオシミラーの性質
  • 高費用対効果の製造
  • バイオシミラーの容易な入手可能性

第6章 償還政策の米国のバイオシミラー市場への影響

第7章 バイオベター:バイオシミラーと生物学的製剤の中間的立場

第8章 米国のバイオシミラー市場の概要

  • 現在の市場シナリオ
  • 米国のバイオシミラーの臨床パイプライン:概要

第9章 Zarxio:米国で初めて承認されたバイオシミラー

第10章 米国のバイオシミラー市場のダイナミクス

  • R&D
  • バイオシミラーの需要の拡大
  • 特許切れ生物学的製剤の数の増加
  • それほど激しくない競合環境
  • 強力な臨床パイプライン
  • 多くの症状への適応の導入

第11章 米国のバイオシミラーの商業化における課題

第12章 米国のバイオシミラーの将来の展望

第13章 米国のバイオシミラー市場のガイドライン

  • 参照製品とのバイオシミラリティの実証に関する科学的考察
  • 治療用タンパク質製剤と参照製品のバイオシミラリティの実証における品質についての考察
  • 生物学的製剤の非専売名のネーミング
  • 参照製品とのバイオシミラリティの実証をサポートする臨床薬理データ

第14章 米国のバイオシミラー臨床パイプライン:企業・適応症・フェーズ別

  • 研究
  • 全臨床
  • 第I相
  • 第I/II相
  • 第II相
  • 第III相
  • 申請済み
  • 承認済み

第15章 臨床パイプラインにおける延期・中止のバイオシミラー

  • 報告なし
  • 中止
  • 登録前申請撤回

第16章 競合環境

  • Amgen
  • Apotex
  • Boehringer Ingelheim
  • Celltrion
  • Coherus BioSciences
  • Eli Lilly
  • EPIRUS Biopharmaceuticals
  • Finox Biotech
  • Harvest Moon Pharmaceuticals
  • Hospira
  • Intas Biopharmaceuticals
  • Juno Therepeutics (Opus Bio)
  • Merck
  • Momenta Pharmaceuticals
  • Mylan
  • Nora Therapeutics
  • Novartis
  • Oncobiologics
  • Pfenex
  • Pfizer
  • Sandoz
  • Wockhardt
目次

Pharmaceutical companies benefited from the revolution in biotechnology that hit US market in 1980's. Some of the blockbuster biologics have been introduced in market helping pharmaceutical companies to occupy major market shares. Their presence could be felt in every disease segment as they were improved with time. Over the years, biologics lost patent giving way to biosimilars. US is late entrant and its market is largely untouched by biosimilars resulting in lots of commercialization opportunities. Now, US has become center of attraction for generating significant revenues by introducing biosimilars in different disease categories. Future prospects of US biosimilars markets have yet to be deciphered as this market is at nascent stages offering unique opportunities and challenges.

Biosimilars in US has been approved after a long-time while they have been introduced in other places over a decade ago. Late entry in US market has prevented the patients from getting benefit of biosimilars. Also, spending on healthcare could have been mitigated but absence of proper regulatory framework prevented commercialization of biosimilars in US. Number of indication under biosimilar coverage are also less, single at present, which is going to have modest effect on US market. Number of indications will increase in coming years till then US biosimilar market is expected to grow at modest rates. Slow market growth is of great concern as it is also related to cost cutting by regulators in health care spending. US biosimilars market is at nascent stage and it would take few years to become suitable niche for biosimilars.

Biologics have dominated the US market for several decades due to absence of worthy competitor in different disease segment. In coming years, this situation is expected to change as biosimilars are expected to be commercialized. Zarxio, first US biosimilar, has created lot of enthusiasm among masses but some physicians, investigators and payers have reservation against biosimilars. This scenario may cause hindrance in uptake of biosimilars in coming years. To increase acceptance rates, biosimilar developers have to produce head-to-data confirming pharmacological efficacy. Biosimilars are also expected to have higher cost-effectiveness promoting patients to switch from biologics. In this way, biosimilar developers would be able to generate more revenues by developing positive attitude towards biosimilars.

Newly developed biosimilars in US market are expected to face hard time as regulations are not in place. Both patient and payers are expected to suffer from this issue that has to be resolved as soon as possible. Implication of new rules is expected to take some time as lots of issues have to be solved. Naming of biosimilars and assigning of appropriate billing code is one of the fore most necessities. This situation is likely to deteriorate when monoclonal antibodies will be introduced in US market. Substitution and reimbursement will become easy if clear demarcation is made between which molecule belongs to which category. Regulators are likely to resolve these issues in coming years as they have just entered in biosimilars segment.

“US Biosimilars Market Opportunity & Clinical Pipeline Analysis” Report Highlight:

  • US Biosimilars Market Introduction
  • US Biosimilars Regulatory Scenario
  • Unique Features of US Biosimilars Market
  • Impact of Biosimilars in US Market
  • Impact of Reimbursement Policies on US Biosimilars Market
  • Zarxio: First Approved Biosimilar in US
  • US Biosimilar Clinical Pipeline By Company, Indication & Phase
  • US Biosimilar Clinical Pipeline: 104 Biosimilars
  • Marketed Biosimilars: 1 Biosimilar

Table of Contents

1. US Biosimilars Market Introduction

2. US Biosimilars Regulatory Scenario

3. Unique Features of US Biosimilars Market

4. Impact of Biosimilars in US Market

5. New Biosimilar Categories with High Commercialization Potential

  • 5.1. High Cost-Effectiveness
  • 5.2. Competition
  • 5.3. Nature of Indication
  • 5.4. Nature of Biosimilars
  • 5.5. Cost-Effective Production
  • 5.6. Readily Availability of Biosimilars

6. Impact of Reimbursement Policies on US Biosimilars Market

7. Biobetters: Middle Ground between Biosimilars & Biologics

8. US Biosimilars Market Overview

  • 8.1. Current Market Scenario
  • 8.2. US Biosimilar Clincal Pipeline Overview

9. Zarxio: First Approved Biosimilar in US

10. US Biosimilars Market Dynamics

  • 10.1. Research & Development
  • 10.2. Increasing Demand for Biosimilars
  • 10.3. Increasing Numbers Off-Patent Biologics
  • 10.4. Lesser Competition
  • 10.5. Strong Clinical Pipeline
  • 10.6. Large Number of Indications to be Introduced

11. US Biosimilars Commercialization Challenges

12. US Biosimilars Future Prospects

13. US Biosimilars Market Guidelines

  • 13.1. Scientific Considerations in Demonstration Biosimilarity to a Reference Product
  • 13.2. Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product
  • 13.3. Nonproprietary Naming of Biological Products
  • 13.4. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

14. US Biosimilar Clinical Pipeline By Company, Indication & Phase

  • 14.1. Research
  • 14.2. Preclinical
  • 14.3. Phase-I
  • 14.4. Phase-I/II
  • 14.5. Phase-II
  • 14.6. Phase-III
  • 14.7. Preregistration
  • 14.8. Registered

15. Suspended & Discontued Biosimialrs in Clinical Pipeline

  • 15.1. No Development Reported
  • 15.2. Discountinued
  • 15.3. Preregistration Submission Withdrawal
  • 16. Competitive Landscape
  • 16.1. Amgen
  • 16.2. Apotex
  • 16.3. Boehringer Ingelheim
  • 16.4. Celltrion
  • 16.5. Coherus BioSciences
  • 16.6. Eli Lilly
  • 16.7. EPIRUS Biopharmaceuticals
  • 16.8. Finox Biotech
  • 16.9. Harvest Moon Pharmaceuticals
  • 16.10. Hospira
  • 16.11. Intas Biopharmaceuticals
  • 16.12. Juno Therepeutics (Opus Bio)
  • 16.13. Merck
  • 16.14. Momenta Pharmaceuticals
  • 16.15. Mylan
  • 16.16. Nora Therapeutics
  • 16.17. Novartis
  • 16.18. Oncobiologics
  • 16.19. Pfenex
  • 16.20. Pfizer
  • 16.21. Sandoz
  • 16.22. Wockhardt

List of Figures

  • Figure 1-1: Benefits of Biosimilar Introduction in US
  • Figure 1-2: Present Limitations of Biosimilars in US
  • Figure 1-3: FDA's Requirements for Biosimilar Products
  • Figure 2-1: Criterias for Similarity Formulated by Food and Drug Administration (FDA)
  • Figure 4-1: Global Sales of Neupogen/Neulasta (USD Million), 2012-2014
  • Figure 4-2: Global Sales of Epogen (USD Million), 2012-2014
  • Figure 4-3: Global Sales of Neulasta (USD Million), 2012-2014
  • Figure 4-4: Shares of Amgen Products Exposed to Biosimilars Competition (USD Million), 2014
  • Figure 5-1: Factors Responsible for Significant Revenue Generation
  • Figure 7-1: Properties of Biobetters
  • Figure 7-2: Few Advantages of Biobetters
  • Figure 7-3: Disadvantages of Biobetters
  • Figure 8-1: US- Estimated Humira Sales (USD Million), 2012-2014
  • Figure 8-2: Global Remicade Sales (USD Million), 2012-2014
  • Figure 8-3: US- MabThera/Rituxan Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014-Q3 2015
  • Figure 8-4: US-Herceptin Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014- Q3 2015
  • Figure 8-5: Global Herceptin Quarterly Constant Exchange Rate Sales Growth (USD Million), Q3 2014-Q3 2015
  • Figure 8-6: Estimated Global Aranesp Sales (USD Million), 2012-2014
  • Figure 8-7: US- Estimated Aranesp Sales (USD Million), 2012-2017
  • Figure 8-8: Estimated Sales of Selected Biologics Exposed to Biosimilars Competition, 2014 (USD Million)
  • Figure 8-9: Estimated Shares of Selected Biologics Exposed to Biosimilars Competition (USD Million), 2014
  • Figure 8-10: Rank of US among Different Diabetes Prone Countries
  • Figure 8-11: US Biosimilar Pipeline by Phase (%),2016
  • Figure 8-12: US Biosimilar Pipeline by Phase (Number),2016
  • Figure 8-13: No Development Reported US Biosimilar All Pipeline by Phase (%),2016
  • Figure 8-14: No Development Reported US Biosimilar All Pipeline by Phase (Number),2016
  • Figure 8-15: Discontinued US Biosimilar All Pipeline by Phase (%),2016
  • Figure 8-16: Discontinued US Biosimilar All Pipeline by Phase (Numbers),2016
  • Figure 16-1: Amgen Clinical Pipeline
  • Figure 16-2: Coherus Bioscience Clinical Pipeline
  • Figure 16-3: EPIRUS Biopharmaceuticals- Clinical Pipeline
  • Figure 16-4: Merck Clinical Pipeline
  • Figure 16-5: Novartis Clinical Pipeline
  • Figure 16-6: Oncobiologics-Clinical Pipeline
  • Figure 16-7: Pfenex Clinical Piepline
  • Figure 16-8: Sandoz Clinical Pipeline

List of Tables

  • Table 2-1: Major Regulatory Differences Related to Biosimilars in US & EU
  • Table 2-2: Differences between Biosimilars Applications & Biologics License Applications
  • Table 4-1: Comparison of Neupogen vs. Zarxio Cost
  • Table 4-2: Competition to Neupogen
  • Table 4-3: Amgen's Biosimilar Competitors in US
  • Table 4-4: Categories with Potential to Generate Significant Revenues in US Market
  • Table 5-1: Biosimilars under Food and Drug Administration (FDA) Review
  • Table 6-1: Categories of Medicare Plan
  • Table 6-2: Estimated Reimbursement of Zarxio according to Medicare B
  • Table 7-1: Few Examples of Biologics, Biosimilars and Biobetters
  • Table 8-1: Biosimilars with High Commercialization Potential in US, 2013-2024
  • Table 8-2: Companies Involved in Marketing of Rituximab
  • Table 8-3: Categories with High Potential for Biosimilar Revenue Generation
  • Table 16-1: Celltrion Clinical Pipeline
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