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次の波に乗る:バイオシミラーからCMOが受ける恩恵

PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition

発行 GlobalData 商品コード 758949
出版日 ページ情報 英文 74 Pages
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次の波に乗る:バイオシミラーからCMOが受ける恩恵 PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition
出版日: 2018年12月03日 ページ情報: 英文 74 Pages
概要

バイオシミラーは、生物製剤の価格を下げるという点で、医療関係者や患者にとって期待できる解決策です。また、多くの患者に早期治療の機会を提供します。

当レポートでは、バイオシミラーについて調査分析し、市場機会、パイプライン、受託生産サービスの見通しなどについて、体系的な情報を提供しています。

第1章 エグゼクティブサマリー

第2章 イントロダクション

第3章 バイオシミラーの機会

第4章 承認済みバイオシミラー

第5章 市場浸透

  • バイオシミラーの取り込みにおける地域差
  • バイオシミラー vs. イノベーターの市場シェア
  • 新規患者アクセス

第6章 バイオシミラーのパイプライン

第7章 バイオシミラーの調達方法

  • 合弁事業
  • 生産能力と規模
  • API区分
  • 地域とパートナーシップ
  • CDMOの分析と試験

第8章 注記

第9章 付録

図表

List of Tables

  • Table 1: FDA-Approved Biosimilars and Their API Manufacturing Contracts 11
  • Table 2: FDA-Approved Biosimilars and Their Dose Manufacturing Contracts 13
  • Table 3: FDA-Approved Biosimilars and Their Packaging Contracts 15
  • Table 4: EMA-Approved Biosimilars and Their API Manufacturing Contracts 17
  • Table 5: EMA-Approved Biosimilars and Their Dose Manufacturing Contracts 21
  • Table 6: EMA-Approved Biosimilars and Their Packaging Contracts 25
  • Table 7: Waves of Biosimilar Opportunity by EU Patent Expiry of Biologic Innovators 59
  • Table 8: Waves of Biosimilar Opportunity by US Patent Expiry of Biologic Innovators 67

List of Figures

  • Figure 1: Waves of Biosimilar Opportunity by EU Patent Expiry of Innovator Biologics 8
  • Figure 2: Market Share Forecast by Class for UC in the US, 2016 30
  • Figure 3: Biosimilars in Clinical Development 37
  • Figure 4: Biosimilar Clinical Development by Sponsor Type 39
  • Figure 5: Biosimilar Clinical Development by Sponsor HQ Location 40
  • Figure 6: Outsourcing of Biosimilar Approvals, EU 43
  • Figure 7: Proportion of API Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018 44
  • Figure 8: Proportion of Dose Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018 44
  • Figure 9: Outsourcing of Biosimilar Approvals, US 46
  • Figure 10: Proportion of API Outsourcing of Biosimilar Approvals, US 46
  • Figure 11: Proportion of Dose Outsourcing of Biosimilar Approvals, US 47
  • Figure 12: Manufacturing of FDA- and EMA-Approved Biosimilars by Molecule Type 50
目次
Product Code: GDPS0023MAR

Biosimilars represent a promising solution to healthcare stakeholders and patients in bringing down the costs of biologics and thus providing some respite for cash-strapped payers. For this reason, they also offer the opportunity to treat more patients, and earlier, than more expensive innovator biologics.

The EMA has already approved 51 biosimilars, while the FDA lags behind with 17 approvals but is catching up in the eight years since it created a review pathway. These approvals mostly consist of recombinant proteins, the majority of which are monoclonal antibodies (mAbs).

As more innovator biologics reach their patent expiry, there is a greater opportunity for biopharmaceutical companies to develop biosimilars and for CMOs to benefit from the consequent manufacturing demand. These biologic patent expirations are occurring in four distinct waves. We are currently in the second wave of biologic patent expirations, with products including Humira (adalimumab), Herceptin (trastuzumab), and Remicade (infliximab) losing patent protection, leading to biosimilar approval applications.

The third and fourth waves of innovator biologic patents will expire in the next decade; in anticipation, drug makers are pursuing 106 biosimilars through clinical development for US and EU markets alone. This includes 15 biosimilars of Humira (adalimumab) and 19 biosimilar versions of Avastin (bevacizumab) alone. A full 57% (52) of those programs are in Phase III development or Pre-Registration stage.

The majority of these near-term development projects are in the hands of large-cap companies with the resources for potential significant in-house manufacturing capability. If CMOs are to benefit greatly from the coming third and fourth waves of biosimilars, with patents expiring from 2019, they will need to develop effective strategies to provide an attractive alternative to in-house manufacturing, and to stand out from their CMO competitors.

To assess the degree to which CMOs can benefit from the biosimilar boom, the report "PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition", addresses the following questions:

Key Questions Answered

  • What biosimilars are marketed in the US and EU?
  • How is biosimilar manufacturing and packaging outsourced?
  • What therapies are in the biosimilar pipeline?
  • In what regions is biosimilar development concentrated?
  • How does biosimilar manufacturing differ by molecule type?
  • When will innovator biologic patents expire, allowing biosimilar development?
  • What proportion of biosimilar manufacturing is kept in-house?
  • How will contract analytical testing services be affected by the rise of biosimilars?

Key Benefits

  • To describe and evaluate the biosimilar market opportunity for CDMOs and CMOs
  • To describe the network of CDMOs that currently manufacture for the biosimilar market
  • To assess the outlook for buyers and sellers of contract manufacturing services for biosimilars, including factors influencing client decisions about whether to manufacture in-house or outsource

Scope

Detailed view of -

  • Marketed Innovator Biologics.
  • Marketed Biosimilars.
  • Innovator Biologic Patent Expiries and Waves of Biosimilar Opportunity.
  • Biosimilar Clinical Pipeline.
  • Existing CDMO Contracts for Biosimilars for API, Dose and Packaging.

Reasons to buy

  • This 74-page report gives important, expert insight you won't find in any other source. 20 tables and figures throughout the report illustrate major points and trends. This report is required reading for -
  • CMO executives who must have deep understanding of the biosimilar marketplace to make strategic planning and investment decisions.
  • Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
  • Pharmaceutical and Biotech companies involved in the development of innovator biologics or biosimilars.
  • Investors that need a deeper understanding of the market to identify and value potential investment targets.

Table of Contents

1. Executive Summary 4

2. Introduction 6

3. The Biosimilar Opportunity 7

4. Approved Biosimilars 10

5. Market Penetration 29

  • Regional Variability in Biosimilar Uptake 32
  • Biosimilar vs. Innovator Market Share 34
  • New Patient Access 35

6. The Biosimilar Pipeline 36

7. Sourcing Arrangements for Biosimilars 42

  • Joint Ventures 48
  • Capacity and scale 52
  • API Segmentation 52
  • Geography and Partnerships 53
  • Analytic and Testing CDMOs 54

8. Notes on Methodology 56

9. Appendix 57

  • 9.1 Bibliography 57
  • 9.2 Primary Research - Key Opinion Leaders in this Report 58
  • 9.3 Additional Tables 59
  • 9.4 About the Authors 75
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