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JP Giants leaning in for becoming a Speciality Global PharmaSakigake 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!

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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.

Japan Pharma Outlook 2016:

JP Giants leaning in for becoming a Speciality Global Pharma
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.
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
Chart 1
Mitsubishi Tanabe
US- Prescription Trend of Gilenya
Chart 2
Mitsubishi Tanabe
US- Prescription Trend of SGLT2 inhibitors
Chart 3
Mitsubishi Tanabe
US- Prescription Trend of SGLT2 inhibitors
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
Figure 1 :Sawai
MEDIUM TO LONG TERM VISION
Figure 2:Sawai
Generic Market Size
Chart 1 :Towa
CONSTANTLY INCREASING CAPEX













List Of Tables

Table 1
Chugai
DEALS DONE BY CHUGAI PHARMA IN 2013-2014-2015
Chugai - Key Milestone Table
Table 1
KHK-Outlook 2016
Competitive landscape of Biologics in Severe Asthma
Table 2
KHK-Outlook 2016
PARKINSONS 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
KEY MILESTONES (4568)
KEY MILESTONES (4151)
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
Table 1:Mitsubishi Tanabe SGLT -2 INHIBITORS AND DPPIV PLAYERS IN JAPAN
Key Milestone : Mitsubishi Tanabe
Table 1: Nippon Kayaku BUSINESS SEGMENTS : SALES BREAK UP
(Million yen)
Table 2
Nippon Kayaku rating Income by Segment
(Million yen)
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 Table 1 : Shionogi SINGLE TRIAL DATA- Triumeq vs. Atripla
Table 2 :Shionogi
Global competitive landscape for Treatment of Thrombocytopenia- Recently approved drugs + Late stage pipeline
Table 3 :Shionogi
Global Clinical data comparison of late stage oral TPO mimetics for treatment of
Thrombocytopenia associated with chronic liver disease
Table 4 :Shionogi
Shionogi- Late stage Pipeline Analysis of Global Candidates
Table 5 :Shionogi
Shionogi- Early stage Pipeline Analysis Out licensing pportunities
Table 6 :Shionogi
Shionogi- Late stage Pipeline Analysis Japan Near term Opportunities
Table 7 :Shionogi
DEALS DONE BY SHIONOGI IN 2013-14-15
KEY MILESTONES (4507)Table 1 :SymBio
SymBio PIPELINE
Table 2 :SymBio
RR / 2ND-LINE HR-MDS SELECT LATE - TO MID - STAGE PIPELINE
KEY MILESTONES (4582)
Table 1 :Sawai
GRADUALLY PROVING WHOLESALER BASE
Table 2 :Sawai
BALANCED PRIMARY CARE PRODUCTS-MIX
Table 3:Sawai BTTER PERFORMANCE BY NEW PRODUCTS
Table 4 :Sawai
VALUE OF RODUCTS GOING OFF PATENT IN NEXT 3 YEARS
Table 5 :Sawai
NEWLY LISTED PRODUCTS IN FY 03/16 (YE March-2016)
Table 1 :Towa
DIRECT SALES ON RISE
Table 2 :Towa
KEY LAUNCHES OF 2015 AND MAJOR LAUNCHES EXPECTED IN THE NEXT TWO YEARS
Table 3 :Towa
STEADY RFORMANCE OF KEY PRODUCTS IN LAST THREE YEARS
SALES b
Annexure 3 :MARKET SURVEY 2015
DIFFERENCE BETWEEN NHI PRICE vs. MARKET PRICE OF GENERICS IN
JAPAN
Table 1 :Nippon Chemiphar NIPPON CHEMIPHAR SALES BREAK UP
Table 2 :Nippon Chemiphar
INNOVATORS WITH SIGNIFICANT PRESENCE IN GENERIC BUSINESS






















List Of Figures

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
Chart 1
Mitsubishi Tanabe
US- Prescription Trend of Gilenya
Chart 2
Mitsubishi Tanabe
US- Prescription Trend of SGLT2 inhibitors
Chart 3
Mitsubishi Tanabe
US- Prescription Trend of SGLT2 inhibitors
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
Figure 1 :Sawai
MEDIUM TO LONG TERM VISION
Figure 2:Sawai
Generic Market Size
Chart 1 :Towa
CONSTANTLY INCREASING CAPEX













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Reports Details

Published Date : Mar 2016
No. of Pages :91
Country :Global
Category :Healthcare
Publisher :MP Advisors
Report Delivery By :Email
Report Delivery Time :12 to 24 hours after placing the order.

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