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市場調查報告書

治療層級概要:日本的生物非專利時代的來到 - 歡迎外國產抗體生技仿製藥的時刻逼近

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

出版商 MP Advisors 商品編碼 296613
出版日期 內容資訊 英文 31 Pages
商品交期: 最快1-2個工作天內
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治療層級概要:日本的生物非專利時代的來到 - 歡迎外國產抗體生技仿製藥的時刻逼近 Emergence Of Biogenerics Era In Japan: It's Time to Welcome antibody Biosimilars of Foreign Origins Soon!
出版日期: 2014年02月25日 內容資訊: 英文 31 Pages
簡介

有3個產品、8家公司加入的日本生技仿製藥市場,一般認為生技仿製藥突入新的階段。

本報告提供日本的生技仿製藥市場上未來的競爭情形相關調查、市場整體魅力的評估、該市場成功的主要決策因素等分析、主要打入市場企業簡介、今後展望彙整,為您概述為以下內容。

投資題目

日本的生物非專利形勢的演進

FILGRASTIM生技仿製藥領域的競爭加劇

  • 日本化藥/Teva使用海外踏實的臨床性證據
  • 富士製藥/持田製藥為了獲得市場定位「made in Japan」
  • 準備長效型的創始者

預測REMICADE(INFLIXIMAB)生技仿製藥的進入為CY2014年

  • DPC對象醫院的REMICADE的使用
  • 認證適應症所需的Remicade biosimilar

日本獨特的障礙&促進要素

生技仿製藥的展望

法規指南:要點

  • 日本的必要條件:參考產品
  • 日本的必要條件:兼容性/替代品
  • 日本的必要條件:藥物安全檢測
  • 日本的必要條件:生技仿製藥之PMS
  • 生長激素Bs
  • 紅血球生成素 Alpha Bs
  • Filgrastim

進入生技仿製藥領域的主要日本企業

  • JCR製藥
  • Meiji Seika Pharma
  • Fuji Film Kyowa Kirin Biologics
  • Nichi-Iko Pharmaceutical
  • 持田製藥
  • Nipro Pharma
  • 陽進堂
  • 日本化藥
  • 田邊三菱製藥
  • 澤井製藥
  • 東和藥品
  • 第一三共
  • UMN製藥
  • Kissei藥品
  • Kyowa Hakko Kirin
  • 飛鳥製藥
  • Toyobo Biologics

附錄1:日本的生技仿製藥領域的整合活動

附錄2:生技仿製藥指南:各國

目錄
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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