Global Biosimilars Market Report, 2015-2025 - Taj Pharma, The biosimilar market is projected to be worth USD 32 billion worldwide by 2025

Characterised by increased utility in chronic diseases and capital intensive manufacturing, the global biopharmaceutical market is expanding robustly. As the demand for biologics is increasing continuously, manufacturers are on the lookout for novel strategies that will help them attain maximum returns on investment.Derived from biological elements, biologic medications have transformed the treatment paradigm of life threatening, debilitating diseases. However, such drugs come at staggering prices in the market. Hence, cheaper biological products have become an economic and healthcare requisite.

The Global Biosimilars Market, 2015 - 2025' report provides an extensive study of the rapidly growing biosimilars market. With the blockbuster biologics losing patent protection and biotechnology industry striving to minimize costs, biosimilars are being viewed as viable substitutes to the highly expensive biological medications. The study presents an in-depth review of the developments in established markets and emerging regions, with respect to the market landscape, global and local players, regulatory scenario and emerging opportunities. It provides a detailed analysis of the worldwide pipeline of biosimilars on key parameters such as product categories, indications, biosimilar targets and status of development.

The study presents a comprehensive view of key product classes into which biosimilars can be categorized; these include monoclonal antibodies (mAbs), insulin, interferons, G-CSF/ GM-CSF, erythropoietins and others. We have highlighted some of the important aspects specific to these product categories including regulatory guidelines, development challenges, marketed / pipeline biosimilars, sales data (where available) and information on patent expiry of the reference products.

The report assesses some of the key drivers that have governed the evolution of biosimilars market over the past several years along with an elaborate discussion on the future trends that will shape the market in the coming years. One of the focus areas of this study is to estimate size of the future opportunity in the biosimilars market over the next decade, segmented on the basis of geographical clusters and product categories.

The study also provides information on some of the most recent activities in this market; amongst others, these include growing collaborations, investment activity and technological advancements. In addition to some of the well-known benefits and a promising outlook, the study also highlights considerable challenges currently prevalent in the market. Examples of such challenges include manufacturing complexities, heterogeneous regulatory framework, and associated safety and efficacy issues. Nevertheless, these challenges are paving the way for new strategies and technological improvements, which will indeed be advantageous in the long run.

The report provides market forecasts for the time period 2020 and 2025. The research, analysis and insights presented in this report is backed by a deep understanding of key insights gathered both from secondary and primary research.

Example Highlights:

- The market is driven by the presence of a growing pipeline; during our research, we identified over 600 biosimilar products across various product categories covering mAbs, insulin, interferons amongst others.
- Specifically, mAb biosimilars being developed for multiple diseases form a sizeable proportion of the preclinical/clinical development pipeline. In our pipeline, we reviewed around 200 mAb biosimilars. Neupogen, Enbrel and Humira, owing to their staggering revenues, are examples of some of the most popular target reference products.
- The emerging pharmaceutical markets of Asia, Latin America and Eastern Europe, with benefits such as lower labour costs, access to regional / domestic markets and, most importantly, relaxed regulatory requirements serve as attractive destinations for biosimilars research and commercialisation. This geographical cluster currently dominates the market with respect to the number of approved products.
- In order to exploit the advantages of combined resources and use licensed assets, stakeholders have announced numerous collaborations in the recent past. During our research, we identified around 70 partnerships which have taken place in the biosimilar market over the last few years.
- Looking at the ongoing focus, the market is well positioned to achieve a robust growth in the coming decade as the number of patent expiries grows and the legal and regulatory squabbles are sorted out; based on a very comprehensive analysis, we have projected the market to be worth USD 32 billion worldwide by 2025.
- Although emerging markets have been on a fast track in the recent past, the desired market uptake in the US and Europe will drive the market to attain its peak potential.

Key Topics Covered:

1. Preface

2. Executive Summary

3. Introduction

4. Biosimilars: Developed Markets

5. Biosimilars: Emerging Markets

6. Global Market Overview

7. Market Dynamics

8. Monoclonal Antibody Biosimilars

9. Insulin Biosimilars

10. Biosimilar Interferons

11. Other Leading Biosimilar Markets

12. Recent Developments

13. Outsourcing of Biosimilars

14. Market Forecast

15. Conclusion

16. Interview Transcripts

17. Appendix 1: Tabulated Data

18. Appendix 2: List of Companies and Organisations

- 3S Bio Inc.
- Abbott
- AbZ Pharma
- Accord Healthcare Ltd.
- Actavis
- Aequus BioPharma
- AET Biotech
- Agila Biotech
- Alvartis Pharma
- Alvogen
- Amega Biotech
- Amgen
- Anhui Anke Biotechnology (Group) Co., Ltd
- Anika Therapeutics
- ANMAT (Argentina)
- Apotex
- Aprogen Inc.
- AryoGen
- ASKA Pharmaceutical Co. Ltd.
- Aspen Pharmacare Australia
- Avesthagen
- Axicorp GmbH
- AXXO GmbH
- Barr Pharmaceuticals
- Baxter International
- Bayer Healthcare
- Beacon Pharmaceuticals Ltd.
- Beijing Four Rings Bio-Pharmaceutical
- Beijing ShuangLu Pharmaceutical Co., Ltd.
- Bharat Serums
- Binex
- Bio Process
- Bio Profarma SA
- Bio Sidus SA
- Biocad
- BioCeuticalsArzneimittel AG
- BioCND Inc.
- Biocon
- Biogaran
- Biogen Idec
- BioGenomics
- BioMarin
- Bionovis
- Biosano Laboratories
- Biotechpharma
- Bioton
- Bioviz
- BioXpress Therapeutics
- BlauFarmaceutica
- Blue Stream Laboratories
- BMS
- Boehringer Ingelheim
- Boston Oncology, LLC
- Cadila Pharmaceuticals
- Cangene
- Catalent
- CCL Pharmaceuticals
- CCM Duopharma Biotech Bhd
- Cell Therapeutics
- Cellectis
- Celltrion
- Celon
- Central Drugs Standard Control Organisation
- Chandra Bhagat Pharma
- Charles River Laboratories
- Chemical Company of Malaysia Berhad
- China Food and Drug Administration
- CHMP
- Chong Kun Dang Pharma
- Chugai Pharmaceuticals
- CIMAB
- Cinnagen
- Cipla
- CJ Healthcare
- Claris Lifesciences
- Clinigene International Pvt. Ltd.
- CMC Biologics
- Cobra Biologics
- COFEPRIS
- CoGenesys
- Coherus Biosciences
- Cook Pharmica
- Covance
- CP Guojian Pharmaceutical Co. Ltd
- CTI BioPharma
- Curaxys
- Dabur
- Daewoong Pharmaceutical Co. Ltd.
- Daiichi Sankyo
- Dong A Pharma
- Dongbao Enterprise Group Ltd.
- Dr. Reddy's Laboratories
- Dragon Pharmaceuticals Inc.
- Egis Pharmaceuticals
- Eli Lilly
- Elpen Pharmaceutical
- Emcure Pharmaceuticals
- Emergent Biosolutions
- Epirus Biopharmaceuticals
- Eurofins Central Global Laboratory
- Farmabion del Ecuador C.A
- Farmasa
- Finox Biotech
- Fiocruz
- Fosun Pharmaceutical
- Fougera Pharmaceuticals
- Fountain Biopharma Inc.
- Frontage Laboratories, Inc.
- Fuji Pharma
- Fujifilm Kyowa Kirin Biologics
- Fuso Pharmaceutical Industries
- Gambro
- Gan& Lee
- Gedeon Richter
- Gene Techno Science
- Genentech
- Generium
- GeneScience Pharmaceuticals
- Genexine
- Genhelix
- GenorBiopharma
- GlaxoSmithKline
- Goodwin Biotechnology
- Halozyme Therapeutics
- Handok Inc.
- Hangzhou Jiuyuan Gene Engineering Co., Ltd.
- Hanwha Chemicals
- Harvest Moon Pharmaceuticals
- HEC Pharm
- Henlius Biopharmaceuticals
- Hetero Drugs
- Hexal
- Hikma Pharmaceuticals
- Hindustan Antibiotics Limited
- Hospira
- Hualida Biotech
- HygeneBiopharm Co. Ltd.
- iBio Inc.
- IDDI
- IDEC Pharmaceuticals
- Inbiopro
- INC Research, LLC
- Incepta Pharmaceuticals Ltd.
- Inno Bio Ventures Sdn Bhd.
- Innogene
- Innovent Biologics
- Insmed
- Instituto Vital Brazil
- Intas Pharmaceuticals
- Intertek
- InVentiv Health
- Ipca Laboratories
- IsuAbxis
- Itochu Chemical Frontier Corporation
- Janssen Biotech
- JCR Pharmaceuticals
- Johnson & Johnson
- Julphar
- Kawsar Biotech Company
- Kee Pharma
- Kemwell Biopharma
- Kern Pharma
- Kissei Pharmaceuticals
- KlarvoyantBiogenics
- Kocak Pharma
- Kun Wha Pharmaceutical Company
- La Renon
- LaboratoriosVarifarma
- Landsteiner Laboratories
- LG Lifesciences
- Liomont
- LivzonMabpharm
- Lonza
- Lupin
- Mabion
- mAbxience S.A
- MannKind Corp
- Marvel Life Sciences
- Medicago
- MEDICE Arzneimittel Putter
- Meiji Seika Pharma Co., Ltd.
- Merck & Co
- Merck KGaA
- Merieux Alliance
- MGC Pharma
- Micro Labs
- Minapharm Pharmaceuticals
- Ministry for Health Labour and Welfare (MHLW),Japan
- Ministry of Food and Drug Safety (MFDS), Korea
- Mitsubishi Tanabe Pharma
- MJ BiopharmPvt. Ltd.
- Mochida Pharmaceutical
- Momenta Pharma
- MPI Research
- Mundipharma International Corporation
- Mylan
- Nanogen Biopharmaceuticals
- Napp Pharmaceuticals
- Natco Pharma
- National Health Surveillance Agency (ANVISA)
- National Institute for Health and Clinical Excellence
- NCPC Genentech Biotechnology Co. Ltd.
- Neiss Labs Pvt. Ltd.
- Neogenica Bioscience Ltd
- Neuclone
- Nichi-IkoPharmaceuticals
- Nippon Kayaku
- Novartis
- Novo Nordisk
- NPS Pharmaceuticals
- Oncobiologics
- OrygenBiotecnologia
- Panacea Biotec
- PanGen Biotech
- Paras Biopharmaceuticals
- Parexel
- Patheon
- Pfenex
- Pfizer
- Pharmaceutical Product Development Inc.
- Pharmacia
- PharmaPraxis
- PlantForm Corporation
- Pliva
- PLIVA
- Probiomed
- ProFibrix BV
- Prolong Pharmaceuticals
- Protalix Biotherapeutics
- Qilu Pharmaceutical Co., Ltd.
- Quintiles
- Raichem Lifesciences
- Ranbaxy
- Ratiopharm
- Reliance GeneMedix Plc
- Reliance Life Sciences
- RentschlerBiotechnologie GmbH
- RG Pharmaceutica
- RheinMinapharm
- Richter-Helm BioTec GmbH
- Roche
- RPG Life Sciences
- Salix Pharmaceuticals, Ltd.
- Samarth Life Sciences
- Samsung Bioepis
- Sandoz
- Sanofi Aventis
- Sanwa Kagaku Kenkyusho Co., Ltd.
- Schering-Plough
- Sci Gen Australia
- Sedico
- Serum Institute of India
- SGS Life Science Services
- Shandong KexingBioproducts Co., Ltd
- Shanghai Biomabs Pharmaceuticals Co Ltd
- Shanghai Celgen Bio-Pharmaceutical
- Shanghai CP Guojian Pharmaceutical
- Shanghai Fosun Pharmaceutical
- Shanghai Zhangjiang Biotechnology Limited Company
- Shantha Biotech
- Shreya Life Sciences
- Sicor Biotech
- Simcere Pharmaceutical Group
- South Korea's Ministry of Food and Drug Safety
- Spectrum Pharmaceuticals
- StadaArneimittel AG
- STC Biologics
- Stelis Biopharma
- Strides Arcolab Limited
- Symbiosis
- Synthon Pharmaceuticals
- Taj Pharmaceuticals
- Takeda Pharmaceuticals
- TCI Generics
- Tecpar
- Teva
- The Medicines Company
- Torrent Pharmaceuticals
- Toyota Tshuho Corp.
- TTK Healthcare
- UMN Pharma
- United Biotech
- United Therapeutics Corp
- USFDA
- USV Limited
- VHB Life Sciences Ltd.
- Virchow Biotech
- Viropro
- Warner-Lambert
- Watson Pharmaceuticals
- WHO
- WIL Research
- Wockhardt
- Wyeth
- Xiamen Amyotop Biotech
- Xian Janssen
- Yoshindo
- Zenyaku Kogyo
- Zhejiang Hisun Pharma
- Zhejiang Huahai Pharmaceutical Co. Ltd.
- ZhongshanHygeneBiopharm
- Zuventus Healthcare Ltd.
- ZydusCadila
- Zyphars Pharmaceuticals

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