The Biosimilars Landscape in Japan 2020 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “The Biosimilars Landscape in Japan: 2009-2020 Study” report has been added to ResearchAndMarkets.com’s offering.

Since 2009, 25 biosimilars of 12 originator products are approved in Japan and have yielded mixed performances and attained annual sales of ~32.4b ($300m).

Despite the string of recent biosimilars approvals, healthcare professionals still harbor concerns over the quality of biosimilars.

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. Against this backdrop, multinational companies like Pfizer are setting their sights on this market without local partnership taking advantage of pro-biosimilar environment to capture decent biosimilar market share. 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).

While launched biosimilars now generates ~32b ($300m) sales and its penetration is accelerating, MHLW’s approval of “Biosame” of NESP based on same clinical data as the originator NESP, and current ongoing dialogs to price “Biosame” higher than biosimilars, indicative of Biosame to be the key hurdle in the future for mid-size biosimilar companies in Japan. In the year 2020, MHLW’s stand on Biosame, will be important to decide future of theses mid-size /generic biosimilar developers. Around ~550b opportunity is opening for biosimilar in the next 7 years in Japan due to patent expiry of Wave 2-3 biologics.

This report analyzes 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.

It analyzes BS market of EPO, Filgrastim/Pegfilgrastim/ Insulin/Lantus apart from other key complex Mab Biosimilar opportunities and lists out niche opportunities in biosimilar space in Japan. Details of 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.

Key Topics Covered:

CHAPTER 1: EXECUTIVE SUMMARY

CHAPTER 2: JAPANESE GOVERNMENT AND “CHUIKYO” INITIATIVES TO INCREASE BIOSIMILAR PENETRATION IN JAPAN

CHAPTER 3: LESSONS FROM LAUNCHED BIOGENERIC PROGRESS IN JAPAN SINCE 2009

CHAPTER 4: GROWTH HORMONE MARKET (SOMATROPIN) IN JAPAN

CHAPTER 5: ANEMIA MARKET IN JAPAN

CHAPTER 6: FILGRASTIM (GRAN) BS

CHAPTER 7: REMICADE (INFLIXIMAB) BS

CHAPTER 8: LANTUS (INSULIN GLARGINE) BIOSIMILAR

CHAPTER 9: ENBREL (ETANERCEPT) BIOSIMILAR

CHAPTER 10: ONCOLOGY BIOSMILARS ERA STARTS WITH RITUXAN (RITUXIMAB) BIOSIMILAR

CHAPTER 11: HERCEPTIN (TRASTUZUMAB) BIOSIMILAR

CHAPTER 12: AVASTIN (BEVACIZUMAB) BIOSIMILAR

CHAPTER 13: FABRAZYME (AGALSIDASE BETA) BIOSIMILAR

CHAPTER 14: FORTEO (TERIPARATIDE) BIOSIMILAR

CHAPTER 15: NEXT WAVE OF BIOSIMILAR OPPORTUNITIES IN JAPAN

CHAPTER 16: BIOSIMILAR/BIOPHARMA CMO OPPORTUNITY

CHAPTER 17: REGULATORY APPROVAL REQUIREMENT FOR COMPLEX MAB BIOSIMILAR IN JAPAN

CHAPTER 18: LICENSING/CONSOLIDATION ACTIVITIES IN BIOSIMILAR SPACE IN JAPAN

CHAPTER 19: JAPANESE COMPANIES ACTIVE INTO BIOGENERICS SPACE

Companies Mentioned

• Aska Pharmaceuticals
• Asahi Glass
• Chugai Pharmaceuticals
• Daiichi Sankyo
• Fuji Film Kyowa Kirin Biologics
• Fuji Pharma
• Gene Techno Science
• Itochu Chemical Frontier Corporation
• JCR Pharmaceuticals
• Kissei
• Kyowa Hakko Kirin
• Meiji Seika Pharma (MSP)
• Mochida
• Mitsubishi Tanabe
• MGC Pharma (Cultivec)
• Nichi-Iko
• Nipro Pharma
• Nippon Kayaku
• Sawai
• Towa
• Toyobo Biologics
• Takeda Teva Pharmaceuticals
• UMN Pharma
• Yoshindo
• Sanwa Kagaku
• Amgen
• Chong Kun Dang

For more information about this report visit https://www.researchandmarkets.com/r/y7ydvw

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