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Japan Biosimilar- Active Players In Quest of a Specialty & Niche BS space

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Filgrastim BS and Lantus BS Approval- Encouraging uptake and a lesson to fast track JP approval based on Ex-Japan data!
Remicade biosimilar NK A slow start does not pull back NK in starting PhIII for Herceptin BS in Japan

Active companies in Biosimilar Space: Local Japanese Generic Giants- Opening door for Biosimilars in Japan? - Will go for All or Niche in BS space???- Opportunities beyond 2020?

Encouraging Uptake of Filgrastim BS and Lantus BS in 2015 in Japan is indicative of Japan being a key important market after the EU for growth of Biosimilar players in the next five years. Less stringent regulatory environment vs. US for approval, increasing healthcare burden and strong foothold of the marketers have played key roles in this early uptake which is at par to one of the best generic small molecule penetration in Japan in a short time (Filgrastim BS-volume share~45% in two years, Lantus BS- ~9% in 2 months vs. Lipitor generics ~50% volume share).

In contrast, there is a very slow uptake of Remicade Biosimilar post one year launch (~1% volume share). Biosimilars remains to be the key weapon to curb increasing healthcare cost in Japan & there is a forward pressure on Chuikyo (Central social Insurance Medical Council) by Zaimu-sho (Ministry of Finance- Japan) to increase use of biosimilars. We see that Abenomics measures and government involvement in biosimilar use would lead to the same type of progress for complex mAb Biosimilars in the coming times in Japan

The launch of Sandoz EU approved dosage form of Filgrastim BS in Japan, and Lantus BS based mainly on foreign studies (only one PhIII study involved JP patients from the eight studies submitted for approval) along with Celltrion-NK Remicade biosimilar in 2014/2015 in the Japan pharma market demonstrated more flexibility for EU- Ex-Japan data by JP regulatory authorities for a biosimilar approval and a less stringent path vs. US for BS approval.

Biosimilar of Complex mAb structure is an opportunity of cumulative market size of 300b in the next three years in Japan. It will open doors for first oncology biosimilar mAb in Japan after Remicade BS launch in 2014, while in next 7 years it is cumulative 600b market opportunity for biosimilar players.

While analyzing the launched biosimilar penetration since 2009 launch in Japan (Growth hormone, Erythropoietin, G-CSF), use of the product in DPC hospitals, simple protein moiety and product reimbursement under high cost medical care benefit programme of NHI/JP government are the key JP specific factors which decide uptake timeline and penetration of each biosimilar in Japan.
Since the last five years, most of the companies have some alliance in place for biosimilars, with most of the Japanese companies undertaking pacts with South Korean companies to ride on their back of biosimilar mAb expertise. There is a trend of doing product specific alliance by most of the JP companies active in BS space and to go step by step on this high risk/high return opportunities. Overall, in the Japan market, each opportunity has a different competitive landscape for itself, and some companies are looking for niche opportunities in biosimilar space as per their specialty therapy area- like ophthalmology BS (Lucentis), Enzyme therapy BS (JCR)

In this report, we attempt to analyze trend/requirement of regulatory approval of biosimilars based on Ex-Japan clinical trial data, Factors responsible for each key launched biosimilar penetration (Made in Japan vs. Tested by Japan), and the future competitive landscape in the biosimilars space in Japan. We also attempt to analyze detail BS market of EPO, Filgrastim/Pegfilgrastim/ Insulin/Lantus apart from other key complex Mab Biosimilar opportunities and list out niche opportunities in biosimilar space in Japan. It details all major consolidation activities done by JP/Foreign companies in biosimilar space in the last five years and crisp summary on strategies of each key player (~21 JP local companies, multinational companies), their interest & focus for future collaboration in biosimilar space.
Summary Table 1: Originator JP Dosage strength, Launch timeline and our view on each Potential biosimilar opportunity, Key players, and Key challenges
Table 2: Other Key JP Specific opportunities in Complex Mab biosimilar area
Table 3: Opening Opportunities in Biosimilar Space in Japan
Table 4: Japanese Companies in the Biosimilar Space
Table 5: Local vs. Overseas Clinical Studies Submitted for JP approval by each BS player
Table 6: Mochida- Filgrastim BS studies submitted for Approval
Table 7: Nippon Kayaku- Filgrastim BS studies submitted for Approval
Table 8: Sandoz- JP Filgrastim BS same as US dosage strength- Studies submitted for JP approval
Table 9: NHI REIMBURSEMENT pricing trend of GRAN, FILGRASTM BS and G-LASTA
Table 10: FILGRASTIM BS Competitive landscape Market strategy of each player
Table 11: Sales Trend of Filgrastim BS/GRAN/G-LASTA
Table 12: Clinical development of Remicade biosimilar Clinical studies data submitted for JP approval
Table 13: Clinical Data Comparison of CT-P13 vs. INX in RA
Table 14: Lantus, Lantus XR and Insulin Glargine BS- Dosage Strength/NHI Price
Table 15: Lantus BS Estimated Volume share in Japan/EU market post Launch
Table 16: Clinical studies submitted for Lantus BS approval in Japan
Table 17: Other Key Biosimilar Opportunities in Insulin area in Japan
Table 18: Launched biosimilar in Japan- Uptake Varies per Therapy Area
Table 19: Anemia Market- Market share and sales of Erythropoietin
Table 20: Niche opportunities other than complex mAb
Table 21: RA Biologics sales Trend Japan 2010-2014
Table 22: Other Niche Opportunities in Onco/Autoimmune therapy area
Table 23: Japan IP landscape of Key biosimilars focusing on autoimmune Disease
Table 24: Japan competitive landscape of key biosimilars focusing on autoimmune disease
Table 25: Japan IP landscape of key biosimilars focusing on oncology disease
Table 26: Japan competitive landscape of key biosimilars focusing on oncology disease
Table 27: Co-pay Slabs in Japan
Table 28: Revised Pricing of key biologics in Japan
Table 29: JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners. Now thrives in Regenerative Medicine
Table 30: Meiji Seika Pharma (MSP) Trastuzumab Race- May not be the first one
Table 31: Fuji Film - Kyowa Kirin Biologics (FF-KKH) - Looking beyond Domestic Opportunities, First step in that direction by FKB238 JV with Astrazeneca
Table 32: Nichi-Iko - Aspiring to Capture Overseas Markets As Well, Plans to file Remicade BS in US in 2018
Table 33: Mochida: Now Equipped with Full Basket for Being a Top Biosimilar Player in Japan
Table 34: Nipro Pharma: Not Much Development Following First Success
Yoshindo: A Three Step Approach to Build a Bio Company
Nippon Kayaku - Pioneering New Age Of Biosimilars by First launching Remicade BS in Japan- A slow start but situation will change soon
Table 35: Mitsubishi Tanabe: Late Entrant But With Many Strengths
Table 36: Sawai: Intends to Establish Sales team in Biosimilar Field in next few years
Table 37: Towa: May Venture in the Biosimilar Space in near term
Table 38: Daiichi Sankyo - Premium Generics Business. Will Prioritize Biosimilars- Ph III for Enbrel BS started in 2014
Table 39: UMN Pharma - Transforming Vaccines Heritage into New Generation Biologics but No major progress in recent past
Table 40: Kissei: Focus to be a Niche Player in BS space
Table 41: TaKyowa Hakko Kirin: Gearing up for Bigger Pie- AZN JV is the first step
Table 42: Aska Pharmaceuticals - Barriers to Gain from Partners Pipeline
Table 43: Toyobo Biologics - Eying Biosimilars CMO Business
Table 44: Gene Techno Science- JP Rising star in biosimilar and biobetter space
Table 45: Fuji Pharma- Dynamic Specialty Pharma Focusing on Biosimilars
Itochu Chemical Frontier- A trading house with New role in Biosimilar value chain
MGC Pharma- A Bio-pharmaceutical CMO


List Of Tables

Chart 1 : Neutropenia Market Dynamics Change in Last One Year
Chart 2: Japan Neutropenia Market Market share of each key
player
Chart 3: Volume share trends of GRAN and Filgrastim BS
Chart 4: Japan Anemia market- Trends of Market share of each player
Chart 5: Japan Anemia market 12 month cumulative market share
Partners. Now thrives in Regenerative Medicine

Chart 6: RA biologics Market share

List Of Figures

Summary Table 1: Originator JP Dosage strength, Launch timeline and our view on each Potential biosimilar opportunity, Key players, and Key challenges
Table 2: Other Key JP Specific opportunities in Complex Mab biosimilar area
Table 3: Opening Opportunities in Biosimilar Space in Japan
Table 4: Japanese Companies in the Biosimilar Space
Table 5: Local vs. Overseas Clinical Studies Submitted for JP approval by each BS player
Table 6: Mochida- Filgrastim BS studies submitted for Approval
Table 7: Nippon Kayaku- Filgrastim BS studies submitted for Approval
Table 8: Sandoz- JP Filgrastim BS same as US dosage strength- Studies submitted for JP approval
Table 9: NHI REIMBURSEMENT pricing trend of GRAN, FILGRASTM BS and G-LASTA
Table 10: FILGRASTIM BS Competitive landscape Market strategy of each player
Table 11: Sales Trend of Filgrastim BS/GRAN/G-LASTA
Table 12: Clinical development of Remicade biosimilar Clinical studies data submitted for JP approval
Table 13: Clinical Data Comparison of CT-P13 vs. INX in RA
Table 14: Lantus, Lantus XR and Insulin Glargine BS- Dosage Strength/NHI Price
Table 15: Lantus BS Estimated Volume share in Japan/EU market post Launch
Table 16: Clinical studies submitted for Lantus BS approval in Japan
Table 17: Other Key Biosimilar Opportunities in Insulin area in Japan
Table 18: Launched biosimilar in Japan- Uptake Varies per Therapy Area
Table 19: Anemia Market- Market share and sales of Erythropoietin
Table 20: Niche opportunities other than complex mAb
Table 21: RA Biologics sales Trend Japan 2010-2014
Table 22: Other Niche Opportunities in Onco/Autoimmune therapy area
Table 23: Japan IP landscape of Key biosimilars focusing on autoimmune Disease
Table 24: Japan competitive landscape of key biosimilars focusing on autoimmune disease
Table 25: Japan IP landscape of key biosimilars focusing on oncology disease
Table 26: Japan competitive landscape of key biosimilars focusing on oncology disease
Table 27: Co-pay Slabs in Japan
Table 28: Revised Pricing of key biologics in Japan
Table 29: JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners. Now thrives in Regenerative Medicine
Table 30: Meiji Seika Pharma (MSP) Trastuzumab Race- May not be the first one
Table 31: Fuji Film - Kyowa Kirin Biologics (FF-KKH) - Looking beyond Domestic Opportunities, First step in that direction by FKB238 JV with Astrazeneca
Table 32: Nichi-Iko - Aspiring to Capture Overseas Markets As Well, Plans to file Remicade BS in US in 2018
Table 33: Mochida: Now Equipped with Full Basket for Being a Top Biosimilar Player in Japan
Table 34: Nipro Pharma: Not Much Development Following First Success
Yoshindo: A Three Step Approach to Build a Bio Company
Nippon Kayaku - Pioneering New Age Of Biosimilars by First launching Remicade BS in Japan- A slow start but situation will change soon
Table 35: Mitsubishi Tanabe: Late Entrant But With Many Strengths
Table 36: Sawai: Intends to Establish Sales team in Biosimilar Field in next few years
Table 37: Towa: May Venture in the Biosimilar Space in near term
Table 38: Daiichi Sankyo - Premium Generics Business. Will Prioritize Biosimilars- Ph III for Enbrel BS started in 2014
Table 39: UMN Pharma - Transforming Vaccines Heritage into New Generation Biologics but No major progress in recent past
Table 40: Kissei: Focus to be a Niche Player in BS space
Table 41: TaKyowa Hakko Kirin: Gearing up for Bigger Pie- AZN JV is the first step
Table 42: Aska Pharmaceuticals - Barriers to Gain from Partners Pipeline
Table 43: Toyobo Biologics - Eying Biosimilars CMO Business
Table 44: Gene Techno Science- JP Rising star in biosimilar and biobetter space
Table 45: Fuji Pharma- Dynamic Specialty Pharma Focusing on Biosimilars
Itochu Chemical Frontier- A trading house with New role in Biosimilar value chain
MGC Pharma- A Bio-pharmaceutical CMO


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Reports Details

Published Date : Jan 2016
No. of Pages :101
Country :Japan
Category :Healthcare
Publisher :MP Advisors
Report Delivery By :Email
Report Delivery Time :12 to 24 hours after placing the order.

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