Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars

Date: July 22, 2011
Pages: 252
Price:
US$ 2,265.00
Publisher: Espicom Business Intelligence
Report type: Strategic Report
Delivery: E-mail Delivery (PDF)
ID: HF3B222BC01EN
Leaflet:

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Hospital Injectable Drugs: Future Prospects for Generics & Biosimilars
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.
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)
  Mode of Action
  Approvals
  Lifecycle Development
  Competition within the Marketplace
  Patents
  Market Outlook
Alimta (pemetrexed)
  Mode of Action
  Approvals
  Lifecycle Development
  Competition within the Marketplace
  Patents
  Generic Company Activity
  Market Outlook
Velcade (bortezomib)
  Mode of Action
  Approvals
  Lifecycle Development
  Competition within the Marketplace
  Patents
  Generic Company Activity
  Market Outlook
MONOCLONAL ANTIBODIES
Rituxan/MabThera (rituximab)
  Mode of Action
  Approvals
  Lifecycle Development
  Competition within the Marketplace
  Patents
  Biosimilar Activity
  Market Outlook
Herceptin (trastuzumab)
  Mode of Action
  Approvals
  Lifecycle Development
  Competition within the Marketplace
    Breast Cancer
    Gastric Cancer
  Patents
  Biosimilar Activity
  Market Outlook
Avastin (bevacizumab)
  Mode of Action
  Approvals
  Lifecycle Development
  Competition within the Marketplace
  Patents
  Biosimilar Potential
  Market Outlook
Erbitux (cetuximab)
  Mode of Action
  Approvals
  Lifecycle Development
  Competition within the Marketplace
  Patents
  Biosimilar Activity
  Market Outlook
SUPPORTIVE THERAPIES
  G-CSF
Neupogen (filgrastim)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Patents
  Biosimilar Activity
    EU
    US
  Market Outlook
Neulasta (pegfilgrastim)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Patents
  Biosimilar Activity
  Market Outlook

HAEMATOLOGY

ERYTHROPOIETIN
  Epogen/Eprex (epoetin alfa)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Patents
    Biosimilar Epoetin
      EU
      US
    Market Outlook
  Aranesp (darbepoetin alfa)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Biosimilar Development
    Market Outlook
  NeoRecormon (epoetin beta)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Market Outlook
  Mircera (methoxy polyethylene glycol-epoetin beta)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Market Outlook
THROMBOSIS
  Lovenox/Clexane (enoxaparin)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Patents
    Generic Company Activity
      Momenta & Sandoz file enoxaparin suit against Teva
    Market Outlook

IMMUNOLOGY

MULTIPLE SCLEROSIS
  Copaxone (glatiramer acetate)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Generic Company Activity
      Sandoz and Momenta
      Mylan and Natco Pharma
    Market Outlook
  Avonex (interferon beta-1a)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Market Outlook
  Rebif (interferon beta-1a)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Market Outlook
  Betaferon/Betaseron & Extavia (interferon beta-1b)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Market Outlook
  Tysabri (natalizumab)
    Mode of Action
    Approvals
    Lifecycle Development
    Competition within the Marketplace
    Patents
    Market Outlook
RHEUMATOID ARTHRITIS
  Enbrel (etanercept)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Patents
    Biosimilar Activity
      Merck & Co
      Avesthagen
      Protalix BioTherapeutics
      Simcere
    Market Outlook
  Humira (adalimumab)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Patents
    Biosimilar Activity
    Market Outlook
  Remicade (infliximab)
    Mode of Action
    Approvals
    Competition within the Marketplace
    Patents
    Biosimilar Activity
    Market Outlook

INFECTION

Merrem/Meropen (meropenem)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Generic Approvals
  Market Outlook
Zosyn/Tazocin (piperacillin+tazobactam)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Patents
  Generic Approvals
  Market Outlook
Primaxin (imipenem+cilastatin sodium)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Generic Approvals
  Market Outlook
Cubicin (daptomycin)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Patents
  Generic Company Activity
  Market Outlook
Tygacil (tygecycline)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Patents
  Generic Company Activity
  Market Outlook
Synagis (palivizumab)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Patents
  Market Outlook
PegIntron (peginterferon alfa-2b)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Patents
  Biosimilar Activity
  Market Outlook
Pegasys (pegylated-40K interferon alfa-2a)
  Mode of Action
  Approvals
  Competition within the Marketplace
  Patents
  Biosimilar Activity
  Market Outlook

LIST OF TABLES

Global Sales of Injectable Pharmaceuticals, 2009-2010 (US$ Million)
European Hospital Markets, 2009 (US$ millions)
Sales of Injectable Pharmaceuticals in Western Europe, 2010
Biosimilars Approved in the EU
Austria: Pharmaceuticals at Wholesale Prices, 2005-2009 (EUR Million)
Belgium: Pharmaceutical Market, 2000-2010 (EUR Million)
Denmark: Pharmaceutical Sales at Retail Prices, 2004-2008 (DKK Million)
Denmark: Hospital Pharmaceutical Sales, 2006-2008 (DKK Million)
Leading Injectable Drugs by Sales in Denmark, 2005-2008 (DKK Million)
Pharmaceutical Sales in France, 2005-2009 (EUR Million)
Sales of Hospital-only Drugs in Germany, 2004-2008 (EUR Million)
Top 10 GKV Injectables, 2009
Pharmaceutical Expenditure in Italy by Drug Class, 2006-2009 (EUR Million)
Hospital Sales by Therapeutic Area, 2006 -2009 (EUR Million)
Leading Injectable Drugs in the Italian Hospital Sector, 2009
Pharmaceutical Revenue in the Netherlands, 2003-2008 (EUR Million)
Market Value by Sector and Product Type, 2008
Pharmaceutical Market by Sector, 2005-2009
Pharmaceutical Sales in Sweden by Type, 2004-2008 (SEK Million)
Inpatient Hospital Sales by Therapeutic Group, 2007-2008 (SEK Million)
Leading Injectables in Sweden, 2007-2008 (SEK & US$ Million)
Pharmaceutical Market by Sales Channel, 2005-2009 (CHF Million)
Estimated Cost of Medicines in England, 2009 (£ Million)
Estimated Cost of Injectables Approved by NICE, 2009 (£000s)
Top Ten NICE Approved Hospital Injectables, 2009 (£000s)
US Sales of Injectables, 2010 (US$ Million)
US Patent Expiry for Injectable Drugs
Faslodex US Patents
Faslodex Sales, 2009-2016 (US$ Million)
Zoladex US Patents
Zoladex Sales, 2009-2016 (US$ Million)
Eloxatin US Patents
FDA Approvals for Generic Oxaliplatin
UK MHRA Marketing Authorisations for Generic Oxaliplatin
Eloxatin Sales, 2009-2016 (EUR & US$ Million)
Taxotere US Patents
EU Marketing Authorisations for Generic Docetaxel
UK MHRA Marketing Authorisations for Generic Docetaxel
Taxotere Sales, 2009-2016 (EUR & US$ Million)
Abraxane US Patents
Abraxane Sales, 2009-2016 (US$ Million)
Alimta US Patents
Tentative ANDA Approval for Pemetrexed
Alimta Sales 2009-2016 (US$ Million)
Velcade US Patents
Velcade Sales by Company, 2009-2016 (US$ Million)
Rituxan/MabThera Sales, 2009-2016 (CHF & US$ Million)
Herceptin US Patents
Herceptin Sales, 2009-2016 (CHF & US$ Million)
Avastin Sales, 2009-2016 (CHF & US$ Million)
Erbitux Sales by Company, 2009-2016 (EUR & US$ Million)
Filgrastim US Patents
EU Marketing Authorisations for Biosimilar Filgrastim
Neupogen Sales, 2009-2016 (US$ Million)
Pegfilgrastim Patents
Neulasta Sales, 2009-2016 (US$ Million)
Epogen US Patents
EU Marketing Authorisations for Biosimilar Eprex
Epogen/Eprex Sales, 2009-2016 (US$ Million)
Aranesp US & EU Patents
Aranesp Sales, 2009-2016 (US$ Million)
NeoRecormon/Epogin Sales, 2009-2016 (EUR & US$ Million)
Mircera Sales, 2009-2016 (CHF & US$ Million)
Lovenox US Patents
Lovenox/Clexane Sales, 2009-2016 (EUR & US$ Million)
FDA ANDA Approvals for Mitoxantrone
Copaxone US Patents
Copaxone Sales by Company, 2009-2016 (US$ Million)
Avonex US Patents
Avonex Sales 2009-2016 (US$ Million)
Rebif Sales, 2009-2016 (US$ Million)
Betaferon/Betaseron & Extavia Sales, 2009-2016 (US$ Million)
Tysabri Sales by Company, 2009-2016 (US$ Million)
Enbrel US Patents
Enbrel Sales by Company, 2009-2016 (US$ Million)
Humira US Patents
Humira Sales by Company, 2009-2016 (US$ Million)
Remicade US Patents
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
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