As biosimilars become the focus of attention, generics companies must
overcome some significant challenges - who will win and what are the products
to watch?
The generic injectables sector exceeds US$11.2 billion and numerous
high-value injectable products will face patent expiry in major markets over
the next decade. This critical new report evaluates the markets, players and
products in detail.
As companies seek new ways to gain a competitive edge in maturing generics
markets, injectables have become increasingly desirable to the major players.
Companies like Teva, Sandoz, Mylan, Hospira and Hikma have all increased their
presence in the injectables sector through acquisitions in the last couple of
years. And interest has not been limited to established generic companies, as
pharmaceutical majors like Pfizer have also become attracted to the generic
injectables market.
High risks, high reward
This is hardly surprising with a global injectables market in the region of
US$120 billion. While the lion' s share remains with the innovative industry
for the time being, the generic injectables sector already exceeds US$11.2
billion and numerous high-value injectable products will face patent expiry in
major markets over the next decade. But, many of the big sellers are
biological products and biosimilar approvals will only be possible for a few
companies. Gaining regulatory approval in developed markets is more complex
for biosimilars. For companies who are able to navigate the approval process,
the sector for biosimilars is inherently different to the traditional generics
market. Market acceptance remains a big challenge and the take-up of
biosimilars in Europe has been relatively slow. Not only will companies need
to convince healthcare providers that biosimilar drugs are as good as the
originator products, they will also have to compete with the originator
companies who are unlikely to exit the market as they may previously have done
when faced with a flood of bioequivalent generics.
Is a biosimilar market inevitable?
The fact remains that the generic drugs sector must either respond vigorously
or rely on a diminishing number of non-biological products. Progress to
developing a biosimilar market to date has been patchy and slow, and few
competitive therapies are beyond early-stage research. But accessing the
fast-growing hospital market will be essential. Health payers, the branded
industry and investment community will all be watching developments closely.
A complete analysis packed with market facts, product forecasts to 2016
and detailed company evaluations
About the author:
The report has been researched and written by Espicom' s Senior Pharmaceuticals
Analyst, Karen Holmes. Karen has over 15 years pharmaceutical and healthcare
market analysis experience. Her recent studies include Injectable Generic
Drugs: Prospects and Opportunities, Emerging Opportunities in Inhalation and
Nasal Spray Generic Drugs, and Ophthalmology Drug Futures.
Table of Contents
Table of Contents
Volume I: Generic & Biosimilar Opportunities
FOREWORD
EXECUTIVE SUMMARY
OVERVIEW
INJECTABLE DRUGS MARKET
European Markets
Biosimilars Approved in the EU
Austria
Belgium
Denmark
France
Germany
Italy
Netherlands
Spain
Sweden
Switzerland
United Kingdom
US Market
MAJOR COMPETITORS
CANCER
HORMONAL THERAPIES
Faslodex (fulvestrant)
Mode of Action
Approvals
Lifecycle Development
Competition within the Marketplace
Patents
Generic Company Activity
Market Outlook
Zoladex (goserelin)
Mode of Action
Approvals
Competition within the Marketplace
Breast Cancer
Prostate Cancer
Patents
Generic Company Activity
Europe
North America
Market Outlook
CHEMOTHERAPY
Eloxatin (oxaliplatin)
Mode of Action
Approvals
Competition within the Marketplace
Patents
Generic Company Activity
The ‘874 Patent Litigation: At Risk Launches and Subsequent Withdrawals’
Europe
Market Outlook
Taxotere (docetaxel)
Mode of Action
Approvals
Competition within the Marketplace
Patents
Generic Company Activity
Europe
US
Market Outlook
Abraxane (paclitaxel protein-bound particles for injectable suspension;
albumin-bound)
Remicade Sales by Company, 2009-2016 (US$ Million)
FDA ANDA Approvals for Meropenem
UK MHRA Marketing Authorisations for Generic Meropenem
Merrem/Meropen Sales by Company, 2009-2016 (US$ Million)
Zosyn US Patents
FDA ANDA Approvals for Piperacillin+tazobactam
UK MHRA Marketing Authorisations for Generic Piperacillin+tazobactam
Zosyn/Tazocin Sales, 2009-2016 (US$ Million)
UK MHRA Marketing Authorisations for Generic Imipenem+Cilastatin
Primaxin Sales, 2009-2016 (US$ Million)
Cubicin US Patents
Cubicin Sales, 2009-2016 (US$ Million)
Tygacil US Patents
Tygacil Sales, 2009-2016 (US$ Million)
Synagis US Patents
Synagis Sales (US$ Million)
PegIntron US Patents
PegIntron Sales, 2009-2016 (US$ Million)
Pegasys US Patent
Pegasys Sales, 2009-2016 (CHF & US$ Million)
List of Figures
Dispensing of NICE Approved Injectables, 2009 (%)
FDA ANDA Approvals by Company, January 2006-May 2011
FDA ANDA Approvals by Company, January 2009-May 2011
Faslodex Sales, 2007-2016
Zoladex Sales, 2007-2016
Eloxatin Sales, 2007-2016
Taxotere Sales, 2007-2016
Abraxane Sales, 2007-2016
Alimta Sales 2007-2016
Velcade Sales, 2007-2016
Rituxan/MabThera Sales, 2007-2016
Herceptin Sales, 2007-2016
Avastin Sales, 2007-2016
Erbitux Sales, 2007-2016
Neupogen Sales, 2007-2016
Neulasta Sales, 2007-2016
Epogen/Eprex Sales, 2007-2016
Aranesp Sales, 2007-2016
NeoRecormon/Epogin Sales, 2007-2016
Mircera Sales, 2008-2016
Lovenox/Clexane Sales, 2007-2016
Copaxone Sales, 2007-2016
Avonex Sales, 2007-2016
Rebif Sales, 2007-2016
Betaferon/Betaseron & Extavia Sales, 2007-2016
Tysabri Sales, 2007-2016
Enbrel Sales, 2007-2016
Humira Sales, 2007-2016
Remicade Sales, 2007-2016
Merrem/Meropen Sales, 2007-2016
Zosyn/Tazocin Sales, 2007-2016
Primaxin Sales, 2007-2016
Cubicin Sales, 2007-2016
Tygacil Sales, 2007-2016
Synagis Sales, 2007-2016
PegIntron Sales, 2007-2016
Pegasys Sales, 2007-2016
Volume II: Company Profiles
COMPANY PROFILES
ACTAVIS
Company Overview
Manufacturing
Major Developments
EC clears acquisition of control of Actavis by Deutsche Bank
Acquisitions & Agreements
Actavis plans biosimilars entry with help from Biopartners acquisition
US development, supply and marketing agreement with Sagent
Co-development relationship with Bioluz
Litigation
Oxaliplatin patent settlement
Products
AKORN
Company Overview
Major Developments
Agreements
Injectable products agreement with Bioniche
Premix product supply agreement with Fresenius
Divestitures
Akorn-Strides product portfolio sold to Pfizer
Products
Financials
AMERICAN REGENT
Company Overview
Major Developments
Acquisitions
PharmaForce
Temporary suspension of manufacturing and distribution
Products
AMPHASTAR PHARMACEUTICALS
Company Overview
Manufacturing
Products
APOTEX
Company Overview
Manufacturing
Major Developments
Agreements
Cangene acquires US commercialisation rights for HepaGam B
Products
Financials
AUROBINDO PHARMA
Company Overview
Manufacturing
Major Developments
Trident Life Sciences acquisition
Products
Financials
BEDFORD LABORATORIES
Company Overview
Products
CLARIS LIFESCIENCES
Company Overview
Manufacturing
Major Developments
Marketing agreement with Pfizer
Product withdrawals and FDA warning letter
Products
Financials
FRESENIUS KABI
Company Overview
Major Developments
Acquisitions
APP
Dabur
Agreements
APP and Teva enter gemcitabine agreement
Products
Financials
HIKMA PHARMACEUTICALS
Company Overview
Manufacturing
Major Developments
Acquisitions & Agreements
Strategic partnership with Hubei Haosun
Baxter Healthcare' s Injectables Business
Strategic partnership with Unimark Remedies
Biosimilars agreement with Celltrion for MENA
Products
Financials
HOSPIRA
Company Overview
Manufacturing
Major Developments
Acquisitions & Agreements
Javelin Pharma
Orchid Pharma
Biosimilars Agreement with Celltrion
Litigation
Oxaliplatin patent settlement
Precedex (dexmedetomidine) lawsuits
FDA Warning Letter
Products
Biosimilars
Financials
MYLAN
Company Overview
Manufacturing
Major Developments
Bioniche Injectable Business Acquisition
Mylan Withdraws Marketing Application for Docetaxel
Products
Financials
PADDOCK LABORATORIES
Company Overview
Products
SAGENT PHARMACEUTICALS
Company Overview
Major Developments
Sagent Pharmaceuticals announces initial public offering
Claris Lifesciences' products withdrawn
Agreements
Exclusive collaboration with Actavis
Products
Financials
SANDOZ
Company Overview
Manufacturing
Major Developments
Acquisitions
Ebewe Pharma injectables business
Litigation
Generic Copaxone litigation
Momenta & Sandoz file enoxaparin suit against Teva
Products
Biosimilars
Rituximab Phase II trial
Marketed biosimilar products
Financials
STRIDES ARCOLAB
Company Overview
Manufacturing
Major Developments
Acquisitions & Agreements
Strides gains controlling stake in Inbiopro
Strides acquires injectable facility in Brazil from Aspen
Strides & Aspen restructure oncology partnership
Pfizer and Strides collaborate on generics
Products
Financials
SUN PHARMA
Company Overview
Manufacturing
Major Developments
Acquisitions & Agreements
Merck & Co. and Sun form emerging markets joint venture
Caraco Laboratories
Litigation
Court ruling stops Sun Pharma' s oxaliplatin sales
Products
Financials
TEVA PHARMACEUTICAL INDUSTRIES
Company Overview
Strategic Review
Manufacturing
Major Developments
Acquisitions
ratiopharm
Litigation
Eli Lilly gains pemetrexed patent victory
Oxaliplatin patent settlement
Products
Biopharmaceuticals and Biosimilars
Financials
WOCKHARDT
Company Overview
Manufacturing
Major Developments
Divestitures
Wockhardt sells its German business
Products
Financials
Appendix I: FDA ANDA Approvals
Appendix II: UK Injectable Generic Approvals
SOURCES
Espicom Sources
Others
List of Tables
Actavis ANDA Approvals for Injectables, 2008-2010
Akorn ANDA Approvals for Injectables
Akorn Financial Results, 2006-2010 (US$ Million)
PharmaForce ANDA Approvals for Injectables, 2002-2011
Luitpold Pharmaceuticals ANDA Approvals for Injectables, 2002-2011
Amphastar: Manufacturing Facilities
Amphastar ANDA Approval
International Medication Systems ANDA Approvals
Apotex: Subsidiaries in Canada
Apotex ANDA Approvals for Injectables, 2002-2011
Cangene Financial Results, 2006-2010 (C$ Million & US$ Million)
Aurobindo ANDA Approvals for Injectables, 2008-2011
Cephazone Pharma ANDA Approvals, 2007-2010
Aurobindo Pharma: Financial Results, 2007-2011
Bedford Laboratories ANDA Approvals, 2002-2011
Claris Lifesciences FDA ANDA Approvals
Claris Lifesciences Financial Results, 2009-2010 (Rs. Million & US$
Million)
APP ANDA Approvals, 2002-2011
Fresenius Kabi Oncology ANDA Approvals, 2009-2011
Fresenius Kabi Financial Results, 2005-2010 (EUR Million & US$ Million)
APP Revenues, 2009-2010 (US$ Million)
Hikma Manufacturing Facilities
Hikma ANDA Approvals for Injectables, 2002-2011
Hikma Financial Results, 2006-2010 (US$ Million)
Hospira: Principal Facilities
Hospira NDA Approvals, 2011 (Jan-Mar)
Hospira ANDA Approvals, 2004-2011
Hospira Financial Results by Region, 2006-2010 (US$ Million)
Mylan: Principal Facilities
Bioniche Pharma ANDA Approvals, 2003-2011
Mylan Financial Results, 2006-2010 (US$ Million)
Paddock Laboratories ANDA Approvals for Injectables
Approved ANDAs Acquired From Spectrum Pharmaceuticals
Sagent Strides ANDA Approvals, 2009-2011
Sagent ANDA Approvals, 2010-2011
Sandoz ANDA Approvals for Injectables, 2005-2011
Ebewe Pharma ANDA Approvals for Injectables, 2007-2009
Sandoz Financial Results, 2006-2010 (US$ Million)
Sagent Strides ANDA Approvals, 2009-2011
Strides Arcolab Financial Results, 2006-2010 (Rs. Million & US$ Million)
Sun Pharma NDA Approval, 2011
Sun Pharma ANDA Approvals for Injectables
Sun Pharma Financial Results, 2006-2010 (Rs. Million & US$ Million)
Teva: Principal Manufacturing Facilities
Teva Parenteral ANDA Approvals, 2002-2009
Teva Pharmaceuticals ANDA Approvals for Injectables, 2006
Pliva ANDA Approvals for Injectables, 2004-2008
Pharmachemie ANDA Approvals for Injectables, 2004-2010
Teva Financial Results, 2006-2010 (US$ Million)
Wockhardt ANDA Approvals for Injectables
Wockhardt Financial Results, 2006-2011
FDA ANDA Approvals for Injectable Drugs, January 2009-May 2011
UK MHRA Injectable Generic Approvals, January 2009-April 2011
Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars published by Espicom Business Intelligence in July 25, 2011. This report consists of 252 Pages and the price starts from US $ 2265.
