Japan Biosimilars Market 2016-2019 - Cumulative Market Size of ¥300b in the Next Three Years

01 Feb, 2016, 11:10 ET from Research and Markets

DUBLIN, Feb. 1, 2016 /PRNewswire/ --

Research and Markets (http://www.researchandmarkets.com/research/frtt84/japan_biosimilar) has announced the addition of the "Japan Biosimilar - Active Players In Quest of a Specialty & Niche BS Space" report to their offering.

The encouraging uptake of Filgrastim BS and Lantus BS in 2015 in Japan is indicative of Japan being one of the key markets, after the EU, for the 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.

In contrast, there is a very slow uptake of Remicade Biosimilar, one year on from its initial launch (-1% volume share). Biosimilars are still seen as the key weapon to curbing soaring healthcare costs in Japan & there is pressure on Chuikyo (Central social Insurance Medical Council) by Zaimu-sho (Ministry of Finance- Japan) to increase the use of biosimilars. We see that Abenomics measures and government involvement in biosimilars use would lead to the same type of progress for complex mAb Biosimilars in the coming years 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.

Biosimilars of Complex mAb structure are expected to grow to a cumulative market size of ¥300b in the next three years in Japan. It will open doors for the first oncology biosimilar mAb in Japan after Remicade BS launch in 2014, while over the next 7 years it is anticipated to be worth a cumulative ¥600b.

While analyzing biosimilar penetration since its 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.

In 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 the back of biosimilar mAb expertise. There is a trend of seeking out product specific alliances by most of the JP companies active in the BS space and to go step by step on these high risk/high return opportunities. Overall, in Japan's 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).

This report attempts to analyze trends and requirements 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 also attempts to analyze in detail the 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 collaborations in the biosimilar space.

Key Topics Covered:

1. Executive Summary - Biosimilars (BS) - One of the key weapons for Government to curb healthcare cost in Japan - Uptake of Filgrastim and Lantus BS in Japan - Better than Small molecule generics - Key reasons - A slow start of Remicade BS NK - Will it change in near term or take time? - - Abenomics initiatives to Promote BS use - How will it change the current scenario? - - BS use must to curb healthcare cost - A forward Pressure on Chukiyo? - Japan early than US in approving mAb biosimilar - at What Price? - Upcoming next opportunities in biosimilar space in Japan beyond key Onco/RA drugs and Post 2020 - Licensing activities in biosimilar space in Japan - - Current Status of pipeline of Each Active company in the BS space: - What is in and what is left? - Are some still in the dilemma of entering the BS space? - Most of the companies have cherry picked couple of biologics from the full basket - Launch timeline and Our view on Each potential key opportunity in Biosimilar space in Japan based on - - Regulatory/Development investment - JP dosage strength of originator vs. US dosage strength of Originator - - JP Market size and Reimbursement/NHI Price of Originator - - Expected no. of players in the biosimilar space in Japan, Innovator strategy in Japan, Re-examination period expiry - - Key challenges for each biosimilar opportunity in Japan - Niche BS opportunities in Japan - Factors driving biosimilar penetration in Japan - Government incentives to prescribe BS is key. - - JP specific factor - Use in DPC hospitals - Reimbursement under high cost medical care Government benefit programme. - Price difference for small molecule generic use vs. biologic - how big role it will play for biosimilar penetration? - - Therapy Specific Factor - - Acute vs. Chronic/ Pediatric vs. Adult - Support therapy vs. treatment therapy Physician experience of using class of therapy drugs

2. Launched Biosimilars In Japan:

2.1 Filgrastim (Gran) BS:

Filgrastim biosimilar Japan - Neutropenia Market dynamics, Intensified Competition in Filgrastim Biosimilar Space?

- Launch of Pegfilgrastim by KHK in Japan - How will it impact market dynamics for Filgrastim biosimilar?

Dosage Strength: Comparison of each available BS vs. GRAN (Originator) - Does one need the photocopy of a JP originator product to get approval - A Myth?

What type of Bridging study was done by Sandoz for JP approval of its Ex-Japan approved Filgrastim BS?

- Insight From The Clinical Studies Submitted For Regulatory Approval Of Gran Bs

- - Dosage strength comparison of Filgrastim BS vs. GRAN BS -

- - Regulatory studies submitted for Made in Japan vs. Made for Japan GRAN BS

- Teva/NK's GRAN BS

- Fuji Pharma/Mochida GRAN BS

- Sandoz/Sawai GRAN BS

- NHI reimbursement pricing - Trends for GRAN biosimilar

- % price cut to Originator - Impact on NHI reimbursement price to biosimilar

- For Sandoz, Late entry did not result in any NHI reimbursement price disadvantage? -Implications

- - bserved Impact Post two years of Launch in Crowded Filgrastim BS market

- Estimated volume share vs. Gran - Same as the best-selling generic small molecule penetration in Japan

- Impact of Made & Tested in Japan vs. Imported by Japan on Filgrastim BS market share dynamics post two years of launch

- G-Lasta launch and uptake impact on Filgrastim BS market

2.2 Remicade Biosimilar:

Slow Uptake Post One Year In Market But Switch Data And Expected Government Incentives For Bs Use Will Change Picture In Next Two-Three Years

- Findings from JP approval of First complex mAb - Remicade biosimilar in Japan

- - Extrapolation of Indication expansion - possible or not? What studies needed/submitted?

- - Details of clinical studies submitted for Remicade biosimilar NK approval

- - PMS studies and label of Remicade BS

- NHI reimbursement price to Remicade biosimilar

- - Role of JP clinical studies

- - Originator NHI Price cut in Next NHI price revision (April-2016)

2.3 Remicade Biosimilar Japan Market Dynamics - Role of PhIII study in respective indications - Only RA study carried out

- Remicade use in hospitals

- - Remicade use in DPC hospitals

- - Remicade biosimilar use may reduce working capital of hospitals to some extent

- Co-pay needed for Remicade treatment in Japan - High cost healthcare reimbursement benefit has a key role to play - Reforms under discussion-April-2016 price revision may change current co-pay benefit dynamics

- Competitive landscape of Remicade biosimilar

- - Nippon Kayaku's entry in RA market

- - Nichi-Iko's late entry

2.4 Lantus Biosimilar - Japan Perspective

- Early uptake of Lly BS Encouraging - Fujifilm Lantus BS - The first Insulin Made in Japan on the way

- Regulatory studies submitted for Lantus BS approval in Japan - Only one Ph 3 study included JP patients, else all studies on Foreign patients submitted for approval.

- NHI reimbursement pricing of Lantus BS in Japan

- Early uptake encouraging and better than EU - Probable reasons?

- Competitive Landscape in Japan

- Change in Market dynamics of Lantus in Japan - DPC use of Lantus.

2.5 Lessons From Other Launched Biogenerics Progress In Japan Since 2009 & Other Potential Niche Bs Opportunities

- Launched biosimilar in Japan - Uptake Varies per Therapy area

- Growth Hormone - Erythropoietin (EPO) - Uptake vs. which opportunity poised best for highest penetration?

- - EPO - Do market forces allow this biosimilar market to grow like EU??

- - Japan - Anemia market Dynamics - Trend of market share of key EPO in 2014

2.6 Autoimmune And Oncology Biosimilars: Jp Specific Opportunity Other Than Key Complex Mab

Autoimmune Biosimilars: Ra Market - Share of Key Ra Mab Differ in Japan vs. WW Market

- Enbrel BS - Next opportunity in RA space after Remicade

- Humira -a limited no of players in Japan? - Probable Reasons

- Actemra and Cimzia - Opportunities beyond 2020 and more attractive?

Patent expiry (Indication wise JP patents, Reexamination period expiry) and Competitive Landscape of Autoimmune biosimilar in Japan - Market dynamics will be different for Remicade/Humira/Enbrel biosimilar despite targeting similar key markets

- - Ncology Biosimilar In Japan - Herceptin Followed By Avastin will be the first in the market

- Herceptin Biosimilar - Cleopatra Success And Marine failure makes it an interesting opportunity - A Next mAb opportunity to watch out for in Japan

- Big Oncology Focused Japanese Pharma Giants - Do they follow AZN type of product specific BS deal - to strengthen their Oncology NCE franchisee?

- Patent expiry (Indication wise JP patents, Reexamination period expiry) and Competitive Landscape of Oncology biosimilar in Japan - Era starts with Expected launch of Herceptin biosimilar in 2016/2017in Japan

- - Ther Niche Opportunities In Autoimmune Therapy Area

3. Regulatory Approval Requirement For Complex Mab Biosimilar In Japan - Japan biosimilar Regulatory Guidelines: Key Take away - JP Requirement: Reference Product, Interchangeability/Substitution, Pharmacovigilance - JP Requirement: PMS for Biosimilar - Somatropin BS - Epoetin Alfa BS - Filgrastim - Remicade - Label for biosimilar in Japan

4. Licensing/Consolidation Activities In Biosimilar Space In Japan

Current Status of pipeline of Each Active Company in BS space:

- What is in and what is left?

- Some are still in a dilemma whether to enter?

- Most of the companies have cherry picked couple of biologics from a full basket

- In place for most of the JP Innovator + GE companies - Local GE companies still under dilemma of entering

- JP specific hurdles and drivers

- - Govt. measures to increase use of generics comes under high cost medical care benefit system - What to expect in next scheduled NHI price revision?

- - DPC hospitals - Changing scenario

5. Companies Covered: - JCR Pharmaceuticals: A Pioneer in Space with Healthy Partners. Now thrives in Regenerative Medicine - Meiji Seika Pharma (MSP) - Trastuzumab Race - May not be the first one - Fuji Film - Kyowa Kirin Biologics (FF-KKH) - Looking beyond Domestic Opportunities, First step in that direction by FKB238 JV with Astrazeneca - Nichi-Iko - Aspiring to Capture Overseas Markets As Well, Plans to file Remicade BS in US in 2018 - Mochida: Now Equipped with Full Basket for Being a Top Biosimilar Player in Japan - 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 - Mitsubishi Tanabe: Late Entrant But With Many Strengths - Sawai: Intends to Establish Sales team in Biosimilar Field in next few years - Towa: May Venture in the Biosimilar Space in near term - Daiichi Sankyo - Premium Generics Business. Will Prioritize Biosimilars - Ph III for Enbrel BS started in 2014 - UMN Pharma - Transforming Vaccines Heritage into New Generation Biologics but No major progress in recent past - Kissei: Focus to be a Niche Player in BS space - Kyowa Hakko Kirin: Gearing up for Bigger Pie - AZN JV is the first step - Aska Pharmaceuticals - Barriers to Gain from Partner's Pipeline - Toyobo Biologics - Eying Biosimilars CMO Business - Gene Techno Science - JP Rising star in biosimilar and biobetter space - 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

For more information visit http://www.researchandmarkets.com/research/frtt84/japan_biosimilar

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