市場調査レポート

治療クラスの概要:日本におけるバイオジェネリック時代の到来 - 外国産抗体バイオシミラーの歓迎の時は間近

Emergence Of Biogenerics Era In Japan: It's Time to Welcome antibody Biosimilars of Foreign Origins Soon!

発行 MP Advisors 商品コード 296613
出版日 ページ情報 英文 31 Pages
納期: 即日から翌営業日
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治療クラスの概要:日本におけるバイオジェネリック時代の到来 - 外国産抗体バイオシミラーの歓迎の時は間近 Emergence Of Biogenerics Era In Japan: It's Time to Welcome antibody Biosimilars of Foreign Origins Soon!
出版日: 2014年02月25日 ページ情報: 英文 31 Pages
概要

3製品・8社が参入する日本のバイオシミラー市場は、バイオシミラーの新たな段階へ突入すると見られています。

当レポートでは、日本のバイオシミラー市場における将来の競合情勢について調査し、市場の全体的な魅力の評価、同市場で成功するための主な決定因子などを分析しており、主な市場参入企業のプロファイル、今後の展望をまとめ、概略下記の構成でお届けいたします。

投資テーマ

日本におけるバイオジェネリック情勢の進化

フィルグラスチム(FILGRASTIM)バイオシミラー分野における競争の激化

  • 日本化薬/Tevaは海外の着実な臨床的証拠を使用
  • 富士製薬/持田製薬は市場を獲得するため「メイド・イン・ジャパン」を位置づける
  • 長時間作用型を準備する本家

レミケード(インフリキシマブ:INFLIXIMAB)バイオシミラーの参入はCY2014年の予測

  • DPC対象病院におけるレミケードの使用
  • 認定適応症に求められるレミケードバイオシミラー

日本独特の障壁&促進因子

バイオシミラーの展望

規制ガイドライン:要点

  • 日本の要件:参考製品
  • 日本の要件:互換性/代用品
  • 日本の要件:ファーマコビジランス
  • 日本の要件:バイオシミラー向けPMS
  • ソマトロピンBs
  • エポエチンアルファBs
  • フィルグラスチム

バイオシミラー分野に参入している主な日本企業

  • JCRファーマ
  • Meiji Seika ファルマ
  • 協和キリン富士フイルムバイオロジクス
  • 日医工
  • 持田製薬
  • ニプロファーマ
  • 陽進堂
  • 日本化薬
  • 田辺三菱製薬
  • 沢井製薬
  • 東和薬品
  • 第一三共
  • UMNファーマ
  • キッセイ薬品
  • 協和発酵キリン
  • あすか製薬
  • 東洋紡バイオロジックス

付録1:日本のバイオシミラー分野における統合活動

付録2:バイオシミラーガイドライン:国別

目次
Product Code: TC14022202

With three products and eight players already in market - Japan biosimilar market will enter new phase of biosimilars with first ‘mab' approval expected in 2014. This approval (Remicade- FY03/13A sales ¥73.5, infiximab from Nippon Kayaku by YE 14) will be marked as a milestone development because - 1.) it will open antibody biosimilar market in Japan, and 2.) the approval will be based largely from overseas data.

~ ¥200b worth of biologic products is going off patent by 2015 and this value exceeds ~ ¥400b if we include products that will see their patent expiries by 2021 in Japan (Table 1). There are number of reasons to believe that follow-on-biologics or biosimilars will not replicate the lethargic growth story of generic - preliminary because the much higher cost of biologic therapy brings significant burden on patients despite relatively low co-pay in Japan - and this will push individuals and DPC Hospitals to use biogeneric products to a greater extent unlike generic drugs. Secondly, the regulatory supports are going to be stringent enough to ensure quality measures and minimizing the ‘not made in Japan' factor from prescriber's and user's mindsets.

Anticipating this opportunity and favorable macro forces as compared to generics, a number of companies aim to exploit this - Japan has seen a flood like consolidation and partnering activities in biosimilar space (Table 2, Annexure I). While a dozen+ companies have already laid their road map for biosimilars space, at this time we see doz, JCR, Meiji Seika Pharma, Fuji Film Kyowa Kirin Biologics, Nippon Kayaku, Nichi Iko, Yoshindo etc. to be amongst the key players in biogenerics business in Japan.

It is also noteworthy that large global player, which currently look silent in Japan ........

In this piece, we attempt to evaluate the future competitive landscape (Table 3) of the Biosimilars space in Japan, assess the overall attractiveness of the same, and try to identify the key determinates to succeed in this space. At this point, we do not arrive at any investment recommendations from the sector

Table of Contents

INVESTMENT THESIS

  • Table 1: Opening Opportunities in Biosimilar Space
  • Table 2: Japanese Companies in The Biosimilar Space
  • Table 3: Japan Biosimilar Pipeline- Expected Competition

EVOLVING BIOGENERIC LANDSCAPE IN JAPAN

  • Table 4: Launched Biogenerics in Japan
  • Table 5: Top 10 Small molecules vs. Top 10 biologics in Japan

INTENSIFIED COMPETITION IN FILGRASTIM BIOSIMILAR SPACE

  • Nippon Kayaku/Teva Use Robust Clinical Evidences From Overseas
  • Fuji Pharma/Mochida Positions ‘Made In Japan' To Capture Market
  • Table 6: Filgrastim: Originator vs. Biosimilar Price
  • Table 7: Filgrastim: Competitive Landscape
  • The Originator Preparing To Bring Long-Acting Version

REMICADE (INFLIXIMAB) BIOSIMILAR ENTRY EXPECTED IN CY 2014

  • Remicade use in DPC hospitals
  • Remicade biosimilar expected approval Indications
  • Table 8: Clinical Data Comparison Of CT-P13 Vs. INX in RA
  • Table 9: Pipeline Remicade Biosimilar In Japan
  • Table 10: Saving through Remicade biosimilar to Patients

JAPAN SPECIFIC HURDLES & DRIVERS

  • Table 11: Likely launch schedule of select biosimilars

Price Difference and DPC Hospitals Business Are Key Drivers Differentiating.

Biosimilars Outlook

  • Table 12: Co-Pay Slabs in Japan
  • Table 13: Savings through Biosimilars
  • Table 14: Pricing of Key Biologics in Japan

Regulatory Guidelines: Key Take away

  • JP Requirement: Reference Product
  • JP Requirement: Interchangeability/Substitution:
  • JP Requirement: Pharmacovigilance:
  • JP Requirement: Pms For Biosimilar
  • Somatropin Bs
  • Epoetin Alfa Bs
  • Filgrastim

SELECT JAPANESE COMPANIES VENTURING INTO BIOGENERICS SPACE

  • JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners (Table 15)
  • Meiji Seika Pharma (MSP) - Ahead of Peers on Trastuzumab Race (Table16)
  • Fuji Film Kyowa Kirin Biologics (FF-KKH) - Looking Beyond Domestic Opportunities (Table 17)
  • 1. Nichi-Iko - Aspiring To Go Overseas Markets As Well (Table 18)
  • 2. Mochida: Revving Up Collaboration Efforts (Table 19)
  • 3. Nipro Pharma: Not Much Development Following First Success
  • 4. Yoshindo: A ‘Three Step' Approach to Build a ‘Bio Company'
  • 5. Nippon Kayaku - Pioneering ‘New Age' Of Biosimilars (Table 20)
  • 6. Mitsubishi Tanabe: Late Entrant But With Many Strengths
  • 7. Sawai: Wait & Watch' Strategy Continues
  • 8. Towa: May Venture the Space by 2016
  • 9. Daiichi Sankyo - Premium Generics Business Will Prioritize Biosimilars
  • 10. Umn Pharma - Transforming Vaccines Heritage into New Generation Biologics
  • 11. Kissei: Intensified Efforts to Build EPO Franchise
  • 12. Kyowa Hakko Kirin: Gearing up for Bigger Pie
  • 13. Aska Pharmaceuticals - Barriers To Gain From Partner's Pipeline
  • 14. Toyobo Biologics - Eying At Biosimilars CMO Business

Annexure-1: Consolidation Activities In Biosimilar Space In Japan

Annexure-2: Biosimilar Guidelines Adopted By Various Countries

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