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日本の製薬会社の将来展望:公認ジェネリック医薬品 (AG)、バイオシミラー、海外戦略への取り組みに向けた注目すべき1年

Japan Pharma Outlook 2015: 2015 -Year to Watch out for Authorized Generics (AGs), Biosimilars and Overseas Strategic Initiatives

発行 MP Advisors 商品コード 295953
出版日 ページ情報 英文 153 Pages
納期: 即日から翌営業日
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日本の製薬会社の将来展望:公認ジェネリック医薬品 (AG)、バイオシミラー、海外戦略への取り組みに向けた注目すべき1年 Japan Pharma Outlook 2015: 2015 -Year to Watch out for Authorized Generics (AGs), Biosimilars and Overseas Strategic Initiatives
出版日: 2015年01月27日 ページ情報: 英文 153 Pages

2014年4月の薬価改定は、革新的企業・ジェネリック企業の双方に打撃を与える結果となり、どの企業も新たな規制に対応するため国内市場戦略 (および海外市場戦略) の建て直しを図ることとなりました。革新的企業の場合は、AG (Authorized Generics:公認ジェネリック医薬品) 制度を活用してジェネリック企業と対抗し、長期的な売上高を維持する、という選択肢もあります。日本ではAGの様式・規制がまだ明確ではありませんが、BlopressのAGが先日上市され、それに対してジェネリック医薬品企業が対抗の動きを見せるなど、徐々に日本でもAGの普及の道が開けつつあります。革新的企業の場合、腫瘍に次いで、再生医療や希用薬が研究開発 (R&D) 活動の中心的分野となっています。

当レポートでは、日本のバイオ医薬品市場について詳細に調査し、主要企業13社 (先発薬/ジェネリック医薬品の専業企業および兼業企業を含む) のパイプライン製品や成長促進要因、戦略展開情報 (AG、バイオシミラー、海外進出など) といった情報を取りまとめてお届けいたします。


  • アステラス製薬:Xtandi (前立腺がん向け) やIsavuconazoleが米国で認証を取得し、次のイノベーション (Roxadustat、CMVワクチン、ASP8273) のための足がかりを得る
  • 中外製薬:乳がんのフランチャイズ/フランチャイジー
  • 第一三共:エドキシバンの承認や、RanbaxyのSun Pharmaへの譲渡に伴う業績向上
  • 大日本住友製薬:Latudaの成長が、再生医療・細胞療法での技術革新を進めるための鍵となる
  • エーザイ:研究開発 (R&D) の成功だけに望みを置く
  • 協和発酵キリン:PoteligeoとIO Therapyの組み合わせ治験が、今後の進路につながる
  • Meiji Seika ファルマ:成長促進のための、中枢神経系 (CNS) 部門の強化とGX融合政策
  • 田辺三菱製薬:海外事業の将来的な強化
  • 塩野義製薬:TivicayとTriumeq - 次のイノベーションへのステップ
  • シンバイオ製薬:Treakisymの適用範囲拡大に注目が集まる
  • 武田薬品工業:新製品 (Entyvio、Takecab、Brintellix) の上市は、次の成長サイクルへの手がかりとなるのか?


  • 日本ケミファ:新薬価に左右されない体制が優位性につながる
  • 沢井製薬:困難な時期への対応
  • 東和薬品:薬価改定に伴う経営困難
Product Code: 4481

The new pricing system adopted in Japan from April -2014 (Annexure 1) is a game changer initiative. It pains most of the companies - whether generic or innovator. The most of the companies are revalidating their domestic (and thus overseas) strategies to adopt with new regulations. For the innovators - testing Authorized Generics (AGs) phenomenon for protecting their long-listed sales against generic could be one of new choice in Japan. The format and regulations for AG's are still not clear in Japan, however with the largest Japanese product Blopress AG's launched recently and generic companies in queue to compete with their generic versions will make the things lucid for the fate of AG's in Japan.

For most of the generic companies focusing on reducing manufacturing costs, and for many of them to venture in biosimilars space as a new growth avenue would be focus. The trends suggest that Japanese companies may need to set up or alliance with companies overseas for manufacturing. In this note of Outlook-15, we look deeper into these trends to anticipate likely near term changes of Japanese pharma industry.

In innovation space, after Oncology, regenerative medicine and Orphan disease are the areas where Japanese innovator companies are focusing its R & D efforts. While from late stage pipeline/new launch, Edoxaban, Lenvatinib, Entyvio, Brintellix, and Ixazomib are the few important NCEs, uptake of which will decide Japanese Innovator growth in Global market. In this report- We analyzed pipeline, strategies and key growth drivers of 13 major Japanese biopharma companies (Pure play innovators/ Innovators+ Generics/Pure play generics) and detailed our view on these growth drivers along with their interest for inlicensing external innovation from the globe for increasing R&D productivity. 2015 -Year to Watch out for Authorized Generics (AGs), Biosimilars and Overseas Strategic Initiatives

Company Analysis:

Astellas - Xtandi uptake in Pre-chemo PC, Isavuconazole US approval & Uptake will provide cushion to Next batch of innovation (Roxadustat, CMV vaccine, ASP8273)!

  • Xtandi- Xtandi's early stage clinical data in HER2 positive, HR+ve, AR +ve Breast cancer and Data from TERRAIN/STRIVE study in early PC will drive Xtandi momentum in 2015, while PhIII data read out of ARN-509 from SPARTAN study is the key near term threat
  • Isavuconazole: Our view on US approval and Uptake
  • Myrbetriq: Myrbetriq uptake in OAB market - a blockbuster potential likely- EB178 (FDC/combo of Solifenacin+ Mirabegron) combination - Next Batch of Innovation
  • Roxadustat- Can change the current treatment paradigm mainly in CKD-NDPatients- AKB-6548 is the key competitor
    • Key advantage over current EPO
    • Biosimilar EPO is not a threat
    • Pipeline HIF inhibitors and clinical data comparison
  • ASP-8273 (Ph 1, Irreversible mutant selective EGFR inhibitor)
  • Evolocumab
  • Table 1: Deals done by Astellas in 2013, 2014
  • Table 2: Pipeline Early stage Androgen Receptor antagonist
  • Table 3: Competitive landscape for Antifungals
  • Table 4: Competitive landscapes for OAB drugs
  • Table 5: Pipeline HIF alpha stabilizer- AKEBIA AKB-6548 is closest competitor
  • Table 6: Competitive landscape- Anti PCSK9 MAB- ALIROCUMAB vs. EVOLOCUMAB
  • Chart: 1, 2 - Current and Future use of anti androgens in treatment of Prostate Cancer Chugai - Alectinib, ACE910 Global Success - Next Growth Driver!

Chugai's - Breast Cancer Franchisee: Breast Cancer Franchise-

  • Perjeta will be the key growth driver for the franchisee-not Kadcyla -
  • In long term, Perjeta + Herceptin + Chemo will be the standard of care vs. currently Herceptin + chemo. Kadcyla will cater 2nd line market, while data from APHINITY trial in 2016 will decide Perjeta + Herceptin use for adjuvant setting in Breast cancer
  • Failure of MARIANNE Study further increases threat of Herceptin biosimilar
    • Chugai's NSCLC franchisee:
  • MPDL3280A (anti-PDL1 mAB, PhIII, NSCLC, Melanoma) - It is in PhIII in Japan and for NSCLC indication- Nivolumab is the closest competitor.
    • April 2014 price cut to Long listed products resulted in sales decline of Suvenyl, Sigmart and Alfarol ....
    • MPDL3280A - Anti PD1 from Roche- competitive landscape and status in Japan
  • Table 1: Deals Done By Chugai Pharma in 2013-2014
  • Table 2: Ongoing Important Clinical Studies of Kadcyla in Late Stage Her 2 Positive Cancers
  • Table 3: Actemra - Ongoing Global Trials

Daiichi Sankyo -Edoxaban uptake + Ranbaxy/Sun Closure will provide Momentum in 2015!

  • Ranbaxy +Sun= Sun = 9% equity stake in New Sun- Exit or hold???-
  • Vision 2017 Revision is expected around FY03/15 results:
  • Edoxaban: A blockbuster potential likely despite restricted US launch and will be 4th Entrant in NOAC market
  • Acquisition of Ambit bioscience
  • Quizaritinib
  • Other Assets from Ambit
  • Other Assets in Pipeline- CL 108 and Etanercept biosimilar
  • JP domestic market - Long listed products sales decline.....
  • Daiichi Sankyo Espha (DSE) - New pricing policy make difficult road ahead
  • Table 1: Edoxaban - Possible Scenario Analysis and Peak Sales Estimate
  • Table 2: % Patients Crcl<95% In Key Pivotal Studies Of Noac In Nvaf
  • Table 3: Launched Noac- Efficacy And Safety Comparision - In Renally Imparied Patients
  • Table 4: Launched Noac- Ww Reported Sales
  • Table 5: Competitive Landscape - Select Late And Mid Stage Drug Targeting Aml
  • Table 6: Select Jak 2/1 Inhibitors: Mid- To Late-Stage Pipeline
  • Annexure 1: 5-Year Business Plan: Numerical Targets For Fy2017
  • Annexure 2: Core Strategies Of 5-Year Business Plan
  • Annexure-3: New Generation Oral Anticoagulants - Market Dynamics

Dainippon Sumitomo Pharma - Latuda growth is the Key to support Regenerative/Cell therapy Innovation!

  • BBI-608 - Post failure in PhIII CRC (Colorectal cancer) study, focus now shifts to PhIII clinical data
    • Pipeline CSC Inhibitors
  • BBI-503- Clinical data from PhI/II study in 2015 will decide its future potential-BBI-503
  • Regenerative medicine/Cell therapy medicine - A long way to go!!!-SB623
  • Other Pipeline candidates:
    • EPI-743
    • AS-3201 (Ranirestat)
    • DSP-1747
    • Dasotraline
  • Table 1: Pipeline Of Drugs Targeting Cancer Stem Cell
  • Table 2: Pipeline Of Boston Biomedical
  • Table 3: Psychiatrists See High Unmet Need
  • Table 4: Latuda Swot Analysis
  • Table 5: Dainippon Sumitomo-Key Pipeline Candidates- Japan
  • Table 6: Dainippon Sumitomo-Key Pipeline Candidates- Us
  • Table 7: Deals Done By Dainippon In 2013-2014
  • Chart 1: Atypical antipsychotics market

Eisai - Success in R&D is the Only Hope!

  • Thyroid cancer
  • Hepatocellular carcinoma
  • Lung Cancer
    • Table 1: Sales outlook for major lung cancer drugs vs. Lenvatinib expectation
  • Halaven - Eisai's Flagship Product After Aricept and Aciphex
    • Table 2: Indications Prospects For Halaven
  • Fycompa to maintain presences into CNS space
  • E2006 is another candidate strengthening base of CNS franchise
  • Annexure 1; EISAI R&D Pipeline (Ph II and III Only)

Kyowa Hakko Kirin - Poteligeo Combination Trial With IO Therapy Will Drive The Story

  • KHK's Potelligent technology
  • Biosimilar JV

Our view on its global late stage pipeline candidates

  • KW-0761
  • KW-6002
  • KRN-23
  • MEDI-563/Benralizumab/KHK4563
  • Archimedes acquisition Strengthen Prostakan Product portfolio + EU presence
  • Newly launched products in Domestic Market (Japan) Poteligeo, Nouriast, Onglyza - Very slow
  • uptake does not allow KHK to withstand pricing pressure /biosimilar competition in domestic
  • market - G-Lasta may change the picture
  • Table 1: Competitive Landscape Of Biologics In Severe Asthma
  • Table 2: Parkinson's disease competitive landscape of recently launched PD Drugs in Japan
  • Table 3: Global Pipeline And Our Comments
  • Table 4: Deals Done By Khk In 2013-2014
  • Table 5: Potelligent Technology

Meiji Seika- : Strengthening CNS Foothold & Gx Fusion Strategy to Drive Growth

  • The core focus on antidepressant market is going to strengthen further:
  • Medreich Acquisition - a bold step to venture into overseas markets
  • Success in Generic business likely to continue
  • Table 1: Pharma contribution on sales
  • Table 2: High Profitability of Pharma Segment
  • Table 3: R & D pipeline
  • Table 4: Meiji Seika overseas R & D activity

Mitsubishi Tanabe - Overseas Efforts to be intensified in Coming Years!

  • Growth drivers vs. long listed exposure
  • Our view on MT's acquisition strategy
  • Remicade: biosimilars are unlikely to generate massive loss in near term
  • Invokana- to play important role in Japan SGLT-2 inhibitor market
    • Invokana US prescription vs. newly launched products in type 2 diabetes space
  • Gilenya: Gilenya sales well on track, no impact of negative data from PPMS
  • Our view on Gilenya growth going forward & upcoming competition
  • Key reasons why Gilenya will continue to Maintain its market share in the new competitive landscape
  • Venture into Vaccine Business to unfold soon
  • Table 1:Clinical data comparison of CT-P13 (Celtrion/NK Remicade biosimilar) vs. INX. In RA (54 week, PLANETRA study) in EU study
  • Table 2: Top Ten Most Expensive Drugs Procured By Tokyo Medical Hospital
  • Table 3: SGLT -2 Inhibitors And Dppiv Players In Japan

Shionogi - Tivicay + Triumeq- Cushion for Shionogi's Next Batch of Innovation!

  • Tivicay- Tivicay (Dolutegravir) best in class profile has already set the stage for Triumeq use in first line setting, and helps Triumeq to take the market share from Atripla/ Stribild, Post 2018, FDC with Truvada is a free call option
    • Pipeline HIV drugs competing with Triumeq- No near term threat- TAF- Stribild has its own disadvantage
  • Shionogi- Late stage pipeline analysis of the global candidates (Table 5)
    • S-297995
    • S-888711 (Lusutrombopag)
  • Shionogi- Early stage pipeline analysis
    • S-222611
    • S-010887
  • Shionogi- Japan- late stage pipeline analysis (Table 7)
    • S-556971
    • S-877489 9
  • Chart 1: Tivicay Prescription Trend vs. Isentress VS. Stribild
  • Chart 3: Current HIV treatment paradigm
  • Table 1: Single Trial Data- Triumeq vs. Atripla
  • Table 2: Dolutegravir - Phiii Trials
  • Table 3: Treatment Of Thrombocytopenia - Recently Approved Drugs + Late Stage Pipeline
  • Table 4: Global Clinical Data Comparison Of Late Stage Oral Tpo Mimetics For Treatment OF Thrombocytopenia Associated With Chronic Liver Disease
  • Table 5: Shionogi- Late Stage Pipeline Analysis Of Global Candidates
  • Table 6: Shionogi- Early Stage Pipeline Analysis - Out Licensing Opportunities
  • Table 7: Shionogi- Early Stage Pipeline Analysis - Out Licensing Opportunities
  • Table 8: Deals Done By Shionogi In 2013-2014

Symbio Pharmaceuticals: All Eyes Are On Label Expansion Of Treakisym

  • Rigosertib - Catering Niche despite Negative ONTIME data- Ph II data read out by
  • YE2014/1H2015 will decide First line potential
    • In 2nd-line Higher Risk MDS patients (IV Rigosertib)
    • In 1st line lower risk MDS pts (Oral Rigosertib)
    • CLL
    • Front line NHL
    • RR aggressive NHL
    • Upcoming Milestones
  • Chart 1: Symbio- Pipeline
  • Table 1: RR/2nd line HR MDS- Select late-to mid stage pipeline

Takeda -Will the New Launches (Entyvio, Takecab, and Brintellix) Set The Stage For Next Growth Cycle???

  • Key milestones to watch for in 2015 are
  • EU portfolio becoming strong post ENTYVIO and Natura alpha launch - Nycomed's strong GI market presence will boost this franchise
  • Entyvio (Vedolizumab/MLN0002, approved US/EU, vedolizumab, α4β7 integrin inhibitor, Ulcerative colitis / Crohn's disease): Strong uptake confirms differentiated profile- blockbuster potential likely
  • Competition from Pipeline drugs:
  • Brintellix (Vortioxetine) - Cognition data will differentiate Brintellix in genericized depression market-
    • Vortioxetine vs. Currently Available Drugs
  • MLN-9708 (PhIII, Multiple Myeloma) interim PhIII data in RRMM in combination with Revlimid in 2015 will decide its potential in crowded Multiple Myeloma market:
  • Expected competition to Velcade in Second/third line setting and upcoming milestones before patent expiry (2017)
  • Table 1: Deals Done By Takeda In 2013-2014
  • Table 2: Key Late Stage Pipeline Global Candidates- Takeda
  • Table 3: Pipeline Leukocyte Traffic Inhibitor (Integrin Inhibitor)
  • Chart 1: Mln9708 -Trial Design Of Tourmaline-Mm1 - Rrmm
  • Table 4: 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 Mln 0002/Vedolizumab Clinical Trial Program
  • Table 7: Vortioxetine - Major Depressive Disorder
  • Table 8: Vortioxetine - Major Depressive Disorder - Drugs Discontinued In The Recent Past
  • Table 9: Vortioxetine - Major Depressive Disorder - Competitive Landscape
  • Table 10: Data Comparison - Newly Diagnosed Multiple Myeloma (Ndmm)
  • Chart 2: MLN-9708 Trial design
  • Chart 3: Reported adverse events in clinical trials- MLN9708
  • Table 11: Data Comparison - Relapsed And Refractory Multiple Myeloma (Rrmm)
  • Table 12: Data Comparison - Relapsed And Refractory Multiple Myeloma (Rrmm) -


Nippon Chemiphar - Less Vulnerability to New Pricing System is Advantageous!

  • Relatively Modest Margins Profile Compared to Peers
  • Impact of April 14 NHI price revision
  • A balanced portfolio provides flexibility in adopting favorable market strategies:
  • Table 1: Nippon Chemiphar Sales break up
  • Annexure 1- Key Features of New NHI Pricing System

Sawai - Poised Well To Sail Through Tough Times!

  • Gradually improving wholesaler base is advantageous
  • Table 1: Gradually Improving Wholesaler Base

Primary Care Focused Product Mix- Not Highly Profitable yet less Risky

  • Table 2: Balanced Primary Care Products-Mix
  • Table 3: Better Performance by New products
  • Table 4: Value To/Of Products Going Off Patent In Next 5 Years
  • Table 5: Newly Listed Products In 2014
  • Figure 1: Sawai- Medium to long term vision

Towa - Tough Time In Adapting To New Pricing Regulations!

  • Need of decreasing dependence on direct sales channel under changed scenarios:
  • A solid foundation of organic growth is in place through years of constant Capex and R&D investments
  • GP Market Focus is Moving to DP Markets; HP Needs Improvement
  • Japan Generic Industry Outlook
  • Table 1: Direct Sales On Rise
  • Chart 1: Constantly Increasing Capex
  • Table 2: Key Launches Of 2014
  • Table 3: Steady Performance Of Key Products
  • Table 4: GP Market Focus Switching To DP Market
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