Biosimilar Drug Revenues Will Reach $2,445m Worldwide in 2013, Predicts New visiongain Report

LONDON, May 7, 2013 /PRNewswire/ --

A new report by visiongain predicts the world market for biosimilar drugs will be worth $2,445m in 2013, growing by more than 20% from 2012. In 2013 it will account for around 2% of the overall biologics (biological drugs) market. That study forecasts rapid growth to 2023 for the global biosimilars market. The launch of more biosimilars worldwide, but particularly in the US and EU, will drive that sales growth. These predictions and other forecasts appear in Biosimilars and Follow-On Biologics: World Market 2013-2023, published in April 2013.

Fastest growth will be in the biosimilar monoclonal antibodies and insulin submarkets. Two companies - Celltrion and Hospira - submitted biosimilar antibody approval applications to the European Medicines Agency (EMA) in 2012. Those products will be launched in the EU in 2014, visiongain predicts. From 2014, many companies will try to launch monoclonal antibody biosimilars, with most targeting Roche's Rituxan (rituximab) and Herceptin (trastuzumab), and Remicade (infliximab, J&J/Merck & Co./Mitsubishi Tanabe) for competition.  By 2023, biosimilar monoclonal antibodies (mAbs) and insulin products will account for 57% of the global biosimilars market, the study also predicts.

Visiongain forecasts steady growth to 2023 for other segments of the biosimilars market. Biosimilar erythropoietins and filgrastim products are already available in the EU, Japan and other developed markets and achieve limited revenues compared with their reference biologics. The launch of these biosimilars in the US will drive growth from 2014, as will the launch worldwide of second generation filgrastim (pegfilgrastim) and epoetin alpha (darbepoetin alpha) biosimilars. The biosimilar human growth hormone submarket will be the slowest-growing of the leading market sectors. Sandoz's growth hormone biosimilar, Omnitrope (somatropin) was the first biosimilar launched in many major markets, from 2004 onwards. That drug has achieved limited market penetration, though.

Richard Lang, a pharmaceutical market analyst for visiongain, said: "Many companies are interested in entering the biosimilars market. These drugs offer a simpler way to launch biopharmaceuticals, compared with developing novel biologics. Big pharma companies, such as Pfizer, Merck & Co. and Boehringer Ingelheim, have invested in this area in recent years. Many of these companies are focusing on biosimilar monoclonal antibody development - those three companies have clinical-stage candidates in that sector.

"Not all biosimilar development programmes will be successful, though. Biologics and biosimilars are large, complex molecules requiring long and expensive development and manufacturing. The recent release of development guidelines by regulatory agencies in markets worldwide will increase the success rate of biosimilar development. However, commercialising biosimilars is as challenging as developing them. Companies will need to brand and market their biosimilars in a similar way to novel drugs, engaging key stakeholders such as doctors, healthcare payers and patients, to achieve high market penetration."

Visiongain's new report forecasts the world biosimilars market to 2023, as well as providing forecasts for its seven leading segments:

• Monoclonal antibodies (mAbs)
• Insulins - with sub forecasts for human insulin, fast-acting and long-acting analogues
• Interferons - with sub forecasts for alpha and beta interferon
• Erythropoietin (EPO)
• Filgrastim
• Somatropin
• Follicle stimulating hormone (FSH).

That study also forecasts leading national markets for biosimilars. In 2012 emerging markets accounted for the majority of global biosimilar revenues. Biosimilars were first launched in these markets more than two decades ago. Hundreds of biosimilars are marketed in China, which was the leading national market in 2012. There, as in other leading emerging countries, such as India, the market is fragmented, with few companies achieving revenue over $10m. Growth in developed markets will be much faster than in emerging markets between 2013 and 2023. In 2012 the US, EU and Japan accounted for just 20% of the global biosimilars market. Patent expiries for blockbuster biologics between 2013 and 2017 will drive growth in those national markets.

Biosimilars and Follow-On Biologics: World Market 2013-2023 adds to visiongain's portfolio of market analysis for leading sectors of the biopharmaceutical industry. Visiongain is a business information provider based in London, UK.

For sample pages and further information concerning the visiongain report the Biosimilars and Follow-On Biologics: World Market 2013-2023 please visit

http://www.visiongain.com/Report/1039/Biosimilars-And-Follow-On-Biologics-World-Market-2013-2023

For an executive summary please contact:
Email: Sara Peerun on  sara.peerun@visiongainglobal.com
Tel: +44-(0)20-7336-6100

Companies Listed

3SBio
AbbVie
Aché
Actavis (formerly Watson Pharmaceuticals)
AET BioTech
Agence nationale de sécurité du médicament et des produits de santé (ANSM) [France]
Agência Nacional de Vigilância Sanitária (ANVISA) [Brazil]
Agila Biotech
Allozyne
Amega Biotech
American Cancer Society
American Diabetes Association
Amgen
Antares Pharma
Apotex
Aprogen
AstraZeneca
Avesthagen
Baxter International
Bayer
Beijing Four Rings Biopharmaceutical
Beijing SL Pharmaceutical
Biocad
Bioceuticals Arzneimittel (part of Stada)
Biocon
Biogen Idec
BioGeneriX (part of Teva)
BioGenomics
Bionovis
Biopartners (part of Bioton)
Biopharmaceuticals and Herbal Medicines Bureau [South Korea]
Biosidus
Biotechnology Industry Organization (BIO)
Bioton
BioXpress Therapeutics
Boehringer Ingelheim
Bristol-Myers Squibb
Cambridge University
Cardiovascular and Renal Drugs Advisory Committee [US]
CCL Pharmaceuticals
Celltrion
Centers for Disease Control and Prevention (CDC) [US]
Centers of Medicare and Medicaid Services (CMS) [US]
Centocor Ortho Biotech (now Janssen Biotech part of J&J)
Central Drugs Standard Control Organisation (CDSCO) [India]
Chiron (part of Novartis)
Chugai Pharmaceutical (part of Roche)
CinnaGen
Cipla
CJ Corporation
Coherus BioSciences
Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris) [Mexico]
Compass Biotechnologies
Congressional Budget Office [US]
CT Arzneimittel (part of Teva)
Daiichi Sankyo
Department of Biotechnology (DBT) [India]
Dong-A Pharmaceutical
Dr. Reddy's Laboratories
Drug Controller General of India (DCGI)
Egis Pharmaceuticals
Eli Lilly
EMA Committee for Medicinal Products for Human Use (CHMP) [EU]
Emcure Pharmaceuticals
EMS
Epirus Biopharmaceuticals
European Medicines Agency (EMA)
EvaluatePharma (now Evaluate)
Finox
Food and Drug Administration (FDA) [US]
Fraunhofer Institute [Germany]
Fresenius Kabi
Fuji Pharma
Fujifilm
Fujifilm Kyowa Kirin Biologics
Fundação Ezequiel Dias (Funed) [Brazil]
Gan & Lee Pharmaceutical
Gedeon Richter
Genentech (part of Roche)
GeneScience Pharmaceuticals (GenSci)
Genexine
Gennova Biopharmaceuticals (part of Emcure Pharmaceuticals)
Genzyme (part of Sanofi)
Getz Pharmaceuticals
Gilead Sciences
GSK
Hangzhou Jiuyuan Gene Engineering
Hanwha Chemical
Haselmeier
Health Canada
Hexal (part of Novartis)
Hikma Pharmaceuticals
Hospira
Hualida Biotech
Hypermarcas
iBio
ImmunoGen
IMS Health
Incepta Pharmaceuticals
Insmed
Instituto Vital Brazil
Intas Biopharmaceuticals
Intellectual Property Appellate Board (IPAB) [India]
InterMune
Isu Abxis
J&J
JCR Pharmaceuticals
Kissei Pharmaceutical
Korea Food and Drug Administration (KFDA)
Kyowa Hakko Kirin
Laboratórios Biosintética (part of Aché)
Landsteiner Scientific
LG Life Sciences
Lonza
Mabion
Marvel Life Sciences
Medice
Medicines and Healthcare Products Regulatory Agency (MHRA) [UK]
MedImmune
Medipolis
Medivir
Merck & Co.
Merck Serono
Minapharm Pharmaceuticals
Ministry of Health [Brazil]
Ministry of Health, Labor and Welfare (MHLW) [Japan]
Mitsubishi Tanabe Pharma
Mochida Pharmaceutical
Momenta Pharmaceuticals
Mycenax Biotech
Mylan
National Health Service (NHS) [UK]
National Institute for Health and Care Excellence (NICE) [UK]
National Institute for the Control of Pharmaceutical and Biological Products [China]
Nichi-Iko Pharmaceutical
Nippon Kayaku
Novartis
Novo Nordisk
Nuron Biotech
Octoplus
Oncobiologics
Oramed Pharmaceuticals
Owen Mumford
Parexel International
Pfenex
Pfizer
Pharmaceutical Research and Manufacturers of America (PhRMA)
Pharmapark (part of Pharmstandard)
PharmaPraxis
Pharmstandard
PlantForm
Pliva (part of Teva)
Polfa Tarchomin
PRA International
Pro Generika [Germany]
Probiomed
Prolor Biotech
Protalix Biotherapeutics
Qilu Pharmaceutical
Quintiles
Ranbaxy Laboratories
ratiopharm (part of Teva)
Reliance GeneMedix (pat of Reliance Life Sciences)
Reliance Life Sciences
Rentschler Biotechnologie
Roche
Samsung
Samsung Bioepis
Samsung BioLogics
Sandoz (part of Novartis)
Sanofi
Schnell Biopharmaceuticals
SciGen (part of Bioton)
Shandong Kexing Bioproducts
Shanghai Celgen Bio-Pharmaceutical
Shanghai CP Guojian Pharmaceutical
Shanghai Fosun Pharmaceutical
Shantha Biotechnics (part of Sanofi)
Sicor Biotech (part of Teva)
Sothema Laboratories
Spectrum Pharmaceuticals
Square Pharmaceuticals
Stada Arzneimittel
State Food and Drug Administration (SFDA) [China]
State's Employees´ Social Security and Social Services Institute (ISSSTE) [Mexico]
Sundiro Pharma
Synthon
Teva Pharmaceutical Industries
Therapeutic Goods Administration (TGA) [Australia]
Tibotec Pharmaceuticals (part of J&J)
Tonghua Dongbao
UCB
União Química
United Laboratories
University of California, Los Angeles (UCLA)
University of Michigan
US Patent and Trademark Office
USV Biologics
Viropro
Walter and Eliza Hall Institute of Medical Research
Wanbang Biopharmaceuticals (part of Shanghai Fosun Pharmaceutical)
Washington Legal Foundation
Wockhardt
Wolters Kluwer
World Economic Forum
World Health Organization (WHO)
Xiamen Amoytop Biotech
Ypsomed
Zenotech Laboratories
Zenyaku Kogyo
Zuventus Healthcare (part of Emcure Pharmaceuticals)
Zydus Cadila

About visiongain

Visiongain is one of the fastest growing and most innovative independent media companies in Europe. Based in London, UK, visiongain produces a host of business-2-business conferences, newsletters, management reports and e-zines focusing on the Energy, Telecoms, Pharmaceutical, Defence, Automotive and Materials sectors.

Visiongain publishes reports produced by its in-house analysts, who are qualified experts in their field. Visiongain has firmly established itself as the first port-of-call for the business professional, who needs independent, high quality, original material to rely and depend on.

Notes for Editors

If you are interested in a more detailed overview of this report, please send an e-mail to sara.peerun@visiongainglobal.com or call her on +44-(0)207-336-6100.