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市場調查報告書

全世界的專門製藥企業和正在變成日本的大型製藥企業

Japan Pharma Outlook 2016: JP Giants leaning in for becoming a Speciality Global Pharma

出版商 MP Advisors 商品編碼 355094
出版日期 內容資訊 英文 91 Pages
商品交期: 最快1-2個工作天內
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全世界的專門製藥企業和正在變成日本的大型製藥企業 Japan Pharma Outlook 2016: JP Giants leaning in for becoming a Speciality Global Pharma
出版日期: 2016年03月10日 內容資訊: 英文 91 Pages
簡介

本報告提供日本的大生物醫藥品企業12間公司的重點治療領域,表現著為了在策略的變化,開發平台(管線),及主要的促進成長因素相關分析,國內市場維持的,以及全球性擴大的策略性的活動相關見解。

目錄

中外製藥:癌症專利權的將使永續的成長明亮嗎

第一三共:來到Olmetec的專利懸崖 - 明顯需要敏捷的R&D策略

Kyowa Hakko Kirin:開發平台新聞 KW6002, KRN-23...決策全球性擴大

Meiji Seika:「起飛」後容易達成醫藥品的「Step up」

田邊三菱:以美國市場為目標的具野心的中期計劃促進中規模的M&A

日本化藥:Filgrastim、Remicade、Herceptin - 製造生技仿製藥的領導者

鹽野義製藥:智慧管理使Crestor懸崖管理順暢

武田藥品工業:成為全球性專業公司的趨勢

Nippon Chemipher:利益的改善

澤井製藥:正製造在日本成為挑戰者的 Para-IV/505b(2)

東和藥品:「直銷模式」 - 抵抗TEVA和武田藥品的非專利巨大企業的優秀方法

目錄
Product Code: 4488

Sakigake designation - A Push from government to “Innovate”!

“Essential drugs” exemption from Z2 rule- Balancing long listed pricing pressure!

Authorized Generics, Biosimilars, and Patent Litigations - Avenues to grow in JP Generic market!

Increasing decline in long listed products sales, and a few success in R & D in the last decade had put JP giants under pressure to refocus on Innovation with specialty therapy area to strengthen their global presence. Eisai Ajinomoto JV, Teva-Takeda partnership for Speciality Generics is the actions in this direction. Fast track approval based on “Sakigake” designation is the step by PMDA/MHLW to encourage JP Pharmas to research in the area of high unmet medical need/orphan disease where US biotech has taken a successful leap in last decade.

In innovation space, Nivolumab, Alectinib, Dolutegravir global success again demonstrate ability of JP pharma/university research house to contribute Pharma Innovation, while encouraging regulatory environment for “Regenerative Medicine Drug Development” and “Drug Repurposing” will make Japan front runner in this space. From late stage pipeline/new launch, Mirogabalin approval in Neuropathic Pain, Brintellix Cognition label expansion, Edoxaban uptake in EU, Alectinib uptake in US and ACE-910 approval for hemophilia will decide Japanese Innovator growth in Global market. The biennial price cut scheduled in April-2016 will balance Innovation premium with long listed price cut (Z2 rule) to increase R & D productivity.

In next 3 years, ¥950b drugs will go off patent in Japan- and as happened in 2015, substantial volume growth due to new patent expiry opportunities will help Japanese generic companies to withstand NHI pricing pressure. Consolidation activities like Teva-Takeda JV -will make this growing domestic generic market more competitive and companies with “direct sales model” may fetch upper hand due to less dependence on wholesale distribution channel. Challenging Alimta patent and Evista patent against Lilly in Japan, and Livalo ANDA filing in US by JP Generic companies is indicative of the changing breadth of the JP generic giants from launching generics in Japan to becoming a patent challenger- Intellectual property rights challenging generic company. This is a step towards finding its place against the world generic players in the coming time. Successful launch of Blopress AG, Plavix AG in last few years stamps Authorized Generics as one of the attractive opportunity for Generic players in Japan. Encouraging Uptake of Filgrastim BS and Lantus BS in Japan is indicative of Japan to be the next important market after EU in the next five years for growth of Biosimilar players. In contrast, there is a very slow uptake post launch of Remicade biosimilar (~1% volume share).

In this report- we analyzed therapy focus, changing Strategies, pipeline and key growth drivers of 12 major Japanese biopharma companies (Pure play innovators/ Innovators+ Generics/Pure play generics) and detailed our view on their strategic action to withstand in domestic market and expand globally with their interest for inlicensing external innovation from the globe for increasing R&D productivity and priorities on M & A side.

Table of Contents

  • CHUGAI: Sustainable Growth from Oncology Franchisee is Evident!
    • Kadcyla Superiority over Tykerb will increase the market size of 2nd/3rd line breast cancer beyond current levels
    • Change in Chugai Roche business agreement- For pipeline drug Global development- and to be the first in Class
  • Table 1: DEALS DONE BY CHUGAI PHARMA IN 2013-2014-2015
  • Chugai: KEY MILESTONES
  • DAIICHI SANKYO: Upcoming Olmetec Patent Cliff - A Definite Need for Swift R & D Strategy!
    • Japan Olmetec patent cliff (2019) manageable through growth from Memary, Nexium and Lixiana
  • Chart 1: Daiichi Sankyo - Efficacy Results of Mirogabalin vs. Lyrica/Pregabalin
  • Chart 2: Daiichi Sankyo - Efficacy comparison of Quizartinib vs. ASP-2215
  • Chart 3: Daiichi Sankyo - US TRX of each NOAC since launch
  • Chart 4: Daiichi Sankyo - New NOAC share vs. Warfarin- Warfarin still holds >60% share in US
  • Daiichi Sankyo: KEY MILESTONES
  • KYOWA HAKKO KIRIN: News flow from Pipeline - KW6002, KRN-23...will decide Global Expansion!
    • KHK in Biosimilar- Gearing up for a Bigger Pie- AZN JV is the first step
  • Table 1: KHK-Outlook 2016 - Competitive landscape of Biologics in Severe Asthma
  • Table 2: KHK-Outlook 2016 - PARKINSON'S DISEASE-COMPETITIVE LANDSCAPE OF RECENTLY LAUNCHED PD DRUGS IN JAPAN
  • Table 3: Kyowa Hakko Kirin - GLOBAL PIPELINE AND OUR COMMENTS
  • Table 4: Kyowa Hakko Kirin - DEALS DONE BY KHK IN 2013-2014-2015
  • Table 5: Kyowa Hakko Kirin - POTELLIGENT TECHNOLOGY
  • KHK: KEY MILESTONES
  • MEIJI SEIKA: Post “TAKE OFF” - Will Easily Achieve “STEP UP” Due to Pharma !
    • Pharma business growth - a key to achieve Next medium term plan-STEP up 15-17:
    • Antidepressant and Anti Infectives - Innovation wheels of Meiji Seika Pharma - Market share expansion in Japan will sustain near term growth, while outlicensing of pipeline assets for overseas market may provide surprises in 2016-2017
    • Medreich Acquisition - Global revenue base growth expected by expanding CMO and CDMO business
  • Table 1: Meiji Seika - PHARMA -GROWING ARM OF MEIJI - CONTRIBUTION ON SALES
  • Table 2: Meiji Seika - R&D PIPELINE
  • Table 3: Meiji Seika - MEIJI SEIKA OVERSEAS R&D ACTIVITY
  • MITSUBISHI TANABE: Ambiguous Mid Term Plan‘20 Targets for US market will drive Mid size M & A!
    • M& A for strengthening its US business and uptake & approval of Radicut in ALS in US
    • Gilenya- Steady growth helps it to achieve $3.5b peak sales WW by 2018/2019
  • Chart 1: Mitsubishi TanabeUS - Prescription Trend of Gilenya
  • Chart 2: Mitsubishi Tanabe US - Prescription Trend of SGLT2 inhibitors
  • Chart 3: Mitsubishi Tanabe US-Prescription Trend of SGLT2 inhibitors
  • Table 1: Mitsubishi Tanabe SGLT -2 INHIBITORS AND DPPIV PLAYERS IN JAPAN
  • KEY MILESTONE
  • NIPPON KAYAKU: Filgrastim, Remicade and then Herceptin - Biosimilar Leader in the making!
    • Pioneering ‘New Age' of Biosimilars by First launching Remicade biosimilar in Japan - A slow start but situation will change
    • Nippon Kayaku- An Oncology specialist - Equipped well enough for succeeding in biosimilar market
  • Table 1: Nippon Kayaku - BUSINESS SEGMENTS: SALES BREAK UP
  • Table 2: Nippon Kayaku - Operating Income by segment
  • Table 3: Nippon Kayaku - NIPPON KAYAKU:PIPELINE CANDIDATES OTHER THAN BIOSIMILAR
  • Table 4: Nippon Kayaku - BIOGENERICS STATUS
  • Table 5: Nippon Kayaku - FILGRASTIM: COMPETITIVE LANDSCAPE
  • Table 6: Nippon Kayaku - TOP TEN MOST EXPENSIVE DRUGS PROCURED BY TOKYO MEDICAL HOSPITAL
  • SHIONOGI: SMART MANAGEMENT SET TO MANAGE CRESTOR CLIFF SMOOTHLY!
  • Chart 1: Shionogi- US TRX trend of Triumeq/Stribild- June 5th 2015
  • Chart 2: Shionogi - US NRX trend of Triumeq/Stribild
  • Chart 3: Shionogi - US TRX trend of Integrase inhibitors
  • Table 1: Shionogi - SINGLE TRIAL DATA- Triumeq vs. Atripla - Shionogi- Late stage pipeline analysis of the global candidates
  • Table 3: Shionogi - Global competitive landscape for Treatment of Thrombocytopenia- Recently approved drugs + Late stage pipeline
  • Table 4: Shionogi - Global Clinical data comparison of late stage oral TPO mimetics for treatment of Thrombocytopenia associated with chronic liver disease
  • Table 5: Shionogi - Shionogi- Late stage Pipeline Analysis of Global Candidates
  • Table 6: Shionogi - Shionogi- Early stage Pipeline Analysis - Out licensing Opportunities
  • Table 7: Shionogi - Shionogi- Late stage Pipeline Analysis - Japan Near term Opportunities
  • Table 8: Shionogi - DEALS DONE BY SHIONOGI IN 2013-14-15
  • TAKEDA: LEANING TOWARDS BEING A GLOBAL SPECIALTY P
  • Chart 1: Takeda - Long listed Product JV with TEVA in Japan
  • Table 1: Takeda - VORTIOXETINE - MAJOR DEPRESSIVE DISORDER - LATE STAGE PIPELINE DRUGS- PhIII
  • Table 2: Takeda - VORTIOXETINE - MAJOR DEPRESSIVE DISORDER - DRUGS DISCONTINUED IN THE RECENT PAST
  • Table 3: Takeda - VORTIOXETINE - MAJOR DEPRESSIVE DISORDER - COMPETITIVE LANDSCAPE - Key advantages of Vedolizumab (MLN0002) are
  • Table 4: Takeda - COMPETITIVE LANDSCAPE - MLN 0002/VEDOLIZUMAB VS. MARKETED mAb IN ULCERATIVE COLITIS
  • Table 5: Takeda - Competitive Landscape - MLN 0002/VEDOLIZUMAB VS. MARKETED mAb IN CROHN'S DISEASE
  • Table 6: Takeda - Takeda MLN 0002/Vedolizumab Clinical trial Program
  • Ninlaro (MLN-9708, PhIII, Multiple Myeloma) -Uptake in US is key to watch in 2016
  • Table 7: Takeda - Ninlaro- Tentative Filing and approval timeline - For Each Indication - Multiple Myeloma
  • KEY MILESTONES
  • NIPPON CHEMIPHAR: Margin improvement - Key to lift up!
  • Table 1: Nippon Chemiphar SALES BREAK UP
  • Table 2: Nippon Chemiphar
  • INNOVATORS WITH SIGNIFICANT PRESENCE IN GENERIC BUSINESS
  • Annexure 1: Expected Key Changes of New NHI Pricing System- April 2016
  • SAWAI: Para-IV/505b(2) challenger of Japan in the making!
  • Table 1: Sawai - GRADUALLY IMPROVING WHOLESALER BASE
  • Table 2: Sawai - BALANCED PRIMARY CARE PRODUCTS-MIX
  • Table 3: Sawai - BETTER PERFORMANCE BY NEW PRODUCTS
  • Table 4: Sawai - VALUE OF PRODUCTS GOING OFF PATENT IN NEXT 3 YEARS
  • Table 4: Sawai - VALUE OF PRODUCTS GOING OFF PATENT IN NEXT 3 YEARS
  • Figure 1: Sawai - MEDIUM TO LONG TERM VISION
  • Figure 2: Sawai - Generic Market Size (Volume Basis)
  • Annexure 1: Expected Key Changes of New NHI Pricing System- April 2016
  • TOWA: “Direct Sales Model”- A better way to withstand Teva-Takeda Generic Giant?
  • Table 1: Towa - DIRECT SALES ON RISE
  • Chart 1: Towa - CONSTANTLY INCREASING CAPEX
  • Table 2: Towa - KEY LAUNCHES OF 2015 AND MAJOR LAUNCHES EXPECTED IN THE NEXT TWO YEARS
  • Table 3: Towa - STEADY PERFORMANCE OF KEY PRODUCTS IN LAST THREE YEARS - SALES ¥b
  • Annexure 1: Key Features of April-14 NHI Pricing System
  • Annexure 2: Expected Key Changes of New NHI Pricing System- April 2016
  • Annexure 3: MARKET SURVEY 2015 - DIFFERENCE BETWEEN NHI PRICE vs. MARKET PRICE OF GENERICS IN JAPAN
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