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Generic League - Market Analysis and Forecasts, 2007-2012, 2017 & 2022

Published by: Visiongain

Published: Feb. 27, 2008 - 320 Pages


Table of Contents


1. Executive Summary


2. An Overview of The Leading Generics Producers in 2007

2.1 Generics Medicines Experience Significant Growth in 2006

2.2 Teva Records Largest Sales of Generic Pharmaceuticals Globally in 2006


3 The World Generics Market

3.1 The World Generics Market to Grow by over 12% Per Annum to 2010

3.2 Top 20 Companies To Lose Leading Products To Generic Competition

3.3 Price is the Principal Competing Factor in the Generics Market

3.4 Countries with Lowest Branded Drug Prices have the Highest Generic Growth

3.5 Patent Expiration is the Major Driver in All Generic Markets

3.6 The US Has The Largest Generics Market

3.7 The UK has the Highest Generic Penetration by Value in All European Markets

3.8 Japan An Isolated Case in the Generic Market



4. The US and European Regulation of Generic Drugs

4.1 Generic Pharmaceuticals in the US Market

4.2.1 The Hatch-Waxman Title I,

4.2.1.1 US Congress First To Market 180-Day Exclusivity Period Incentive

4.2.1.2 Bioequivalence An FDA Requirement

4.3 The Hatch-Waxman Act Title II has Promoted Innovation in the Branded Pharmaceutical Industry

4.4 The Hatch-Waxman Act Drives Influx Of Generic Pharmacuticals Significantly

4.5 Marked Difference In European Generics Patents Laws In Comparison With The US

4.6 European Generic Drug Development: Variation Between European Countries

4.7 EU Benefits From Long Data Exclusivity Protecting Patents

4.8 Additional EU Patent Protection is Afforded by Supplementary Protection Certificates

4.9 Compulsory Licensing Allows Generic Manufacture Before Patent Expiry

4.10 The WHO and Compulsory Licenses

4.11 Compulsory Licenses and the TRIPs Agreement

4.12 The Benefit of Being the First Generic to Market

4.12 The Advatages of First-to-Market Generics

4.13 Biogenerics A Continuously Expanding Market

4.14 Bioequivalence A Growing Concern For The Biogenerics Industry

4.15 US Biogenerics Regulatory Framework Awaits The Implementation of New Bills

4.16 European Drug Regulation Framework

4.17 European Medicines Agency (EMEA) Amends Its Biogeneric Regulation


5 TEVA Pharmaceutical Industries

5.1 Teva is Listed on Various Stock Exchanges, Including NASDAQ

5.2 Teva Achieved Sales of $8.4bn in 2006

5.2.1 Most of Teva's Sales are In North America

5.2.2 Most of Teva's Sales Are Generated by the Pharmaceuticals Division

5.2.3 Vision and Core Values in Teva

5.3 Human Pharmaceuticals Division

5.3.1 Teva Produces Generic Drugs in All Major Therapeutic Categories

5.3.2 Teva Markets and Develops Innovative Drugs for Specialised Markets

5.3.3 The Pharmaceuticals Division Contributes 90% of Teva's Revenues

5.3.4 Copaxone (glatiramer acetate)

5.3.5 Azilect (rasagiline)

5.4 Active Pharmaceutical Ingredients (API) Division

5.5 Teva USA

5.6 Veterinary Products

5.7 Key Acquisitions by Teva

5.7.1 Acquisition of Ivax Corporation in January 2006

5.7.2 Sicor became a wholly owned subsidiary of Teva in January 2004

5.7.3 Acquisition of Novopharm

5.8 A Brief History of Teva

5.8.1 Formation of the Company at the Start of the Twentieth Century

5.8.2 Growth During the WWII and the Establishment of the State of Israel during 1940s & 50s

5.8.3 Consolidation During the 1960s & 70s Establishment of Teva Pharmaceutical Industries Ltd

5.8.4 Further Acquisitions and Dominance During the 1980s

5.8.5 1990s: Expanding Presence Worldwide

5.9 Teva Benefited from an Ambitious Strategy of Acquisition

5.10 Teva Had Over 150 Products Awaiting FDA Approval at the End of 2006

5.11 Promising First Quarter Results for 2007

5.12 Copaxone - Teva's First Innovative Drug to Receive FDA Approval

5.12 Copaxone - Teva's First Innovative Drug to Receive FDA Approval

5.12.1 Steady Revenue Increase Expected for Teva's Flagship Product

5.12.1.1 Copaxone A Unique Immunomodulator Therapy For The Treatment of Relapsing-Remitting Multiple Sclerosis.

5.12.2 Copaxone Faces Present and Future Competitive Challenges in the Market

5.12.3 Copaxone Was Originally Licensed from the Weizmann Institute of Science

5.12.4 Copaxone is the Subject of Promising Clinical Studies

5.12.5 Lifecycle Management of Copaxone: Teva Makes Good Use of Collaborations

5.13 Azilect - Teva's Recently Launched Innovative Product

5.13 1 Azilect is Currently In a Period of High Early Growth

5.13.2 Azilect is a Potent Agent for Early and Advanced Parkinson's Disease

5.13.3 Azilect Benefits from Convenient Dosing

5.13 4 Azilect is Co-Marketed in Europe by Lundbeck and Teva

5.13.5 Co-Development of Azilect with Eisai

5.13.6 Phase IV Post-Marketing Study to Investigate Risk of Melanoma

5.13.7 Azilect May Have Potential in the Early Treatment of Parkinson's

5.13.8 Competition for Azilect

5.13.9 Azilect Has Performed Well in Clinical Studies

5.14 Teva Has a Diverse Generics Portfolio

5.14.1 Revenues from Generics Spread Over Many Products

5.14.2 Teva Receives First US Approval For Generic Uniretic Tablets

5.14.3 Teva Receives Approval For Generic Dostinex Tablets

5.15.4 Teva Announced Approval of Alprazolam ER Tablets

5.14.5 Teva Announced Its Launch of Generic Wellbutrin XL Tablets Through Agreement With Anchen And IMPAX

5.14.6 Teva Announced Tentative Approval Of Sumatriptan Succinate Tablets

5.14.7 Teva Receives Approval for Generic Focalin Tablets

5.14.8 Teva Announced Agreement with Pfizer Regarding Idarubicin, Azithromycin, And Epirubicin

5.14.9 Launch of Generic Zoloft by Teva

5.14.10 Final Approval of Venlafaxine HCL Tablets

5.14.11 Final Approval of Meloxicam Tablets

5.14.12 Tentative Approval of Generic Lotrel

5.14.13 Approval of Generic Zocor

5.14.14 Teva Received First FDA Approval for Generic Proscar Tablets

5.14.15 Tentative Approval of Losartan Potassium & Hydrochlorothiazide Tablets

5.14.16 Tentative Approval for Generic Cozaar Tablets

5.14.17 Tentative Approval of Simvastatin Tablets

5.14.18 Approval of Generic Lexapro Tablets

5.15 The Integration of Ivax's Operations Greatly Increased Teva's Strengths in Respiratory Drugs

15.16 Teva Pharmaceutical Market Forecast 2008-2013 & 2023

5.17 Pipeline Developments in Teva

5.17 1 Teva is Conducting R&D in Important Therapeutic Areas

5.17.2 Teva's Investment in R&D Has Been Rising in Recent Years

5.17.3 As a Leading Generic Producer Teva Has Progressed into Innovative Research & Development

5.18 Teva Has a Very Strong Generics Pipeline in Addition to Innovative Developments

5.18.1 R&D Focussed on Multiple Sclerosis, Autoimmune Diseases, Neurology and Oncology

5.18.2 Teva R&D is Concentrated in Four Divisions

5.19 Antineoplastics/Immunomodulating Agents

5.19.1 Stemex Cell Therapy

5.19.2 HMN 214

5.19.3 EDRATIDE (TV 4710)

5.19.4 SAIK-MS

5.19.5 LMB 9

5.19.6 Cervene (TP 38)

5.20 Central Nervous System Agents

5.20.1 Citicoline (IP 302)

5.20.2 Cladribine (NSC 105014F)

5.20.3 Fampridine-SR

5.20.4 Ladostigil

5.20.5 Valrocemide

5.21 Genitourinary System/Sex Hormones

5.22 Respiratory System Agents

5.22.1 Respicort

5.22.2 Other Agents in Development

5.23 Licensing Deal With Vaccinex for Monoclonal Antibody

5.24 Teva Collaborates on Protalix's Recombinant Plant Cell Expression Technology

5.25 Teva And Procognia (Israel) Ltd. Sign an Exclusive Collaboration Agreement for the Development of Biopharmaceuticals


6 Novartis' Sandoz

6.1 Sandoz is a Leading Supplier of Generics Internationally

6.1.1 Sandoz Has A Wide Product Range An Important Core Competencies

6.1.2 Sandoz Finally Benefits from Landmark Regulatory Decision Concerning Omnitrope

6.1.3 Sandoz

6.2 Novartis' Sandoz Generics Division

6.2.1 Background: Novartis Re-branded Its Generics Companies as Sandoz

6.3 Sandoz Has A Complex History From Establishment in 1886 to Present

6.4 Sandoz Has a Broad Product Range, Much of it Due to Acquisition of Generics Companies

6.5 Retail Generics Produces Finished Dosage Generic Forms

6.6 Sandoz Products: Retail Generics

6.7 Sandoz Products: Contract Biopharmaceuticals

6.8 Sandoz Products: Active Pharmaceutical Ingredients (API)

6.9 Sandoz Products: Product Intermediates

6.10 Sandoz Achieved Impressive Growth in 2006

6.11 Sandoz Will Achieve Strong Growth from 2008-2023

6.12 Sandoz Has Consolidated Its Market Position Through Acquisitions

6.12.1 Sandoz Acquisition Post-Unification: Sabex

6.12.2 Sandoz Acquisitions Post-Unification: Durascan

6.12.3 Novartis Bought Hexal and Eon in $7bn Deal

6.13 Sandoz Receives Landmark US and European Regulatory Approval for Omnitrope in 2006

6.13.1 Sandoz is Committed to The Emerging Field of Biosimilars - Generic Versions of Biopharmaceuticals

6.13.2 Sandoz Filed Lawsuit Against FDA Ruling on Omnitrope

6.13.3 Omnitrope Finally Received US and EU Approval in Early 2006

6.13.4 Omnitrope is a Ground-Breaking Product in the Generics Sector - With Far Reaching Implications for the Market

6.14 Sandoz Invests in Low Cost Production

6.15 The Outlook 2008-2023- Being Part of Novartis Will Confer a Significant Competitive Advantage upon Sandoz

6.15.1 Generics Market is Increasingly Competitive

6.15.2 Sandoz Generic Segment Forecast 2008-2013 & 2023

6.15.3 A Co-ordinated Strategy by Novartis Benefits Sandoz Greatly

6.15.4 Sandoz Will Continue to Gain Prominence in the World Generics Market


7. Merck KGaA

7.1 Merck KGaA is a Leading International Producer of Generic Pharmaceuticals

7.1.1 Merck - The Oldest Pharmaceutical Company in the World

7.1.2 The Structure of the Merck KGaA

7.1.3 The Generics Division Generates the Second Largest Sales in Merck's Pharmaceuticals Business Sector

7.1.4 Recent Developments in Merck Generics - Expansion of Core Business

7.2 Merck Generics Worldwide: the Merck KGaA group of companies

7.2.1 Alphapharm - Australia

7.2.2 Genpharm - Canada

7.2.3 Merck South Africa

7.2.4 Generics UK Limited

7.2.5 Dey Incorporated

7.2.6 Other Merck Companies Worldwide

7.3 Merck Generics Financials, 2006

7.3.1 Merck Has Two Types of Generics Markets

7.3.2 Generics Division Experiences The Highest Operating Results

7.3.3 France Sees Generic Expansion

7.3.3.1 Merck KGaA’s Spanish Market Experiences 47% Rise is Sales in 2006

7.3.4 Merck KGaA Sales Declines in UK and Germany

7.3.5 Integration of Dey as the Basis for Strategic Reorientation

7.3.6 Sales Rise in The US and Canada

7.3.7 Japan Experiences Sustained Revenue Growth

7.4 Merck KGaA Generics Segment Forecast, 2008-2013 & 2023

7.5 Merck Set to See Sustainable Generic Revenues Through Innovation of Product Life Cycle.

7.6 Major Developments in Merck Generics

7.6.1 Innovative Products for High-Growth Indications

7.6.2 Acquisition of NM Pharma from Pfizer

7.6.3 Litigation and Other Claims Against Subsidiaries Resolved

7.6.4 Merck To Leverage Its Position In Generic Respiratory Medicines

7.7 Merck's Strategic Acquisition of Serono Will Drive Revenues in the Long-Term



8. Ratiopharm

8.1 Ratiopharm Is a Pioneer In Generics Pharmaceuticals

8.2 RatioPharm Generics Segment

8.3 International Sales Drives RatioPharm's Revenue

8.4 Ratiopharm Leading Generics Sale

8.4.1 Ratiopharm Regional Sales

8.4.2 The US and Canadian Market

8.4.3 Sales Distribution in Africa, Asia and Australian Markets, 2006

8.4.3 Brazil Dominates Latin American Market

8.5 Ratiopharm Generic Segment Forecast 2008-2013 & 2023

8.6 Research And Development

8.6.1 Ratiopharm Commences Biogeneric Projects

8.6.1.1 Ratiopharm Enters Agreement With BioGeneriX and Neose

8.6.1.2 Ratiopharm and Neose's pegylated GCSF in Phase I Studies

8.7 Litigation and Agreements

8.7.1 Ratiopharm Successfully Challenges Patent Protecting AstraZeneca's Nexium (esomeprazole)

8.7.2 Court Rules Against Ratiopharm’s Lipitor Challenge

8.8 Mergers and Acquisition

8.8.1 Ratiopharm Acquires Magnafarma

8.8.2 Ratiopharm Other Key Acquisitions



9 Watson Pharmaceuticals

9.1 History and Background to Watson Pharmaceuticals

9.2 Watson's Generics Operations - A Large Product Portfolio Combined with A Strong Pipeline

9.3 Watson's Strategy - The Development of Technologically Challenging and High Demand Products

9.4 Watson Business Strategy

9.5 Watson R&D Expenditure Expands

9.6 Watson's Generic Product Range Accounts for Over Two Thirds of Net Sales

9.7 Watson's Branded Products Profit Margins decline in 2006

9.8 Merger Between Watson and Andrx Drives Sales of Generic Products

9.9 Watson Generics Segment Forecast, 2008-2013 & 2023

9.10 Watson New Generic Product Launches

9.11 Watson Puerto Rico Site to Close as Cost Saving Strategy

9.12 Watson Agreements

9.12.1 Agreement with GSK to Market Generic Zyban

9.12.2 Agreement with Proctor & Gamble to Distribute Generic Macrobid

9.12.3 Watson Terminates its Contract Sales Force Agreement With Ventiv Health

9.12.4 Litigation Proceedings - Possible Adverse Effects on Company Finances

9.13 Watson Alliances and Collaborations

9.14 Watson’s Branded Pharmaceutical Will Contribute Significantly To Year-on-Year Sales Growth


10 Actavis

10.1 Actavis Leading European Generic Company

10.2 Actavis Products Portfolio And Strategic Business Markets

10.3 Actavis Market Segmentation Market Segmentation

10.3.1. Actavis North American Markets Generates Highest Revenue

10.3.2 Actavis CEEA Markets Performance

10.3.3 Actavis WEMEA Markets

10.3.3.1 Actavis Sales in The UK Grows By 6%

10.3.3.2 Actavis Sales in Germany Declines

10.3.3.3 Actavis Experiences Sales Declines in The Netherlands

10.3.3.4 Actavis Scandanavian Market Grows

10.4 Actavis Third-Party Markets

10.5 Actavis Generics Segment Forecast, 2008-2013 & 2023

10.6 Actavis’ Pipeline - Strong Product Development and Investment in Manufacturing

10.6 1 Actavis’ ANDA Filings Increases Significantly In Both US And EU

10.6 2 Actavis Expands IP Project India and Iceland

10.6 3 Actavis And Colotech Investigates Cancer Chemoprevention Medicines

10.7 Mergers, Acquisitions and Agreements

10.7.1 Actavis Subsidiaries Expands

10.7.2 Actavis Acquires Alpharma

10.7.3 Actavis Establishes Global Hospital Business Unit (GHBU)

10.7.4 Actavis To Expand In-licensing Deals

10.8 Actavis Is Strongly Positioned To Maintain Status As a Leading Generics Supplier


11. Barr Pharmaceuticals Inc

11.1 Barr Has Developed A Strong Range of Therapeutic Core Competencies

11.2 Barr's Strengthens Portfolio Through Acquisition of Pliva

11.3 Barr Experiences Revenue Decline After Transition Period (July1-December 31)

11.4 Barr Products: Specialisation in Oral Contraception and HIV/AIDS

11.5 Barr Leading Products

11.6 Barr Key Financials

11.6.1 Barr Generics Revenue

11.6.2 Barr DDAVP (Desmopressin Acetate) 180 Days Marketing Exclusivity

11.6.3 Barr Exclusive Provider of Diadanosine Delayed-Release Capsules.

11.6.4 Court Denies Aventis Motion Against Barr's Generic Allegra

11.6.5 Barr Completes Isotrenioin Strength

11.6.6 Barr Completes Claravis (Isotrenioin) Strength

11.6.7 Barr Launches Leflunomide and Clonazepam Orally Disintegrating Tablets

11.7. Other Significant Barr Generic Launches

11.7.1 Barr’s Aranelle Generic Version of Watson’s Tri-Norinyl

11.7.2 Barr’s Kelnor Generic Version of Pfizer's Demulen

11.7.3 FDA Approves Barr’s Anagrelide Hydrochloride, Generic Version of Shire’s Agrylin

11.7.4 Barr's Duramed Expands Products With Shire's Adderall IR

11.7.5 Duramed To Market Seqsonique Extended-Cycle Oral Contraceptive In Leading Markets

11.7.6 Barr Markets Generic Glucophage (metformin hydrochloride) For Diabetes

11.7.7 Barr Investment In DTC Will Drive Products Growth

11.8 Pending Generic Patent Challenges

11.9 Barr Generics Segment Forecast, 2008-2013 & 2023

11.10. Proprietary Product Sales

11.10.1 Barr’s ParaGard IU - A Non-Hormonal Contraceptive Proprietary Franchise

11.10.2 Barr Doubles Women's Health Sales Force

11.10.3 Duramed’s Plan B OTC/Rx Emergency Contraceptive Receives Marketing Approval

11.10.4 Duramed’s Proprietary Drugs Portfolio Boosted By Pliva Acquisition

11.11 Barr Invests Significantly in R&D of Generic And Proprietary Products

11.11.1 Pliva Acquisition Strenghtens Barr R&D Pipeline Significantly

11.12 Barr's Alliances

11.13 Litigations Facing Barr


12 Stada Healthcare

12.1 Stada A Leading European Generics Pharmaceutical Company

12.2 Stada Key Competencies

12.3 Stada Regional Sales

12.4 Stada US Markets Revenue Declines

12.4.1 Stada Sales Reaches Newer Heights In The EU Market

12.4.2 Stada’s Key EU Markets Contributes Significantly To Yearly Sales

12.5 Stada Generics Division

12.5.1 Omeprazole - Stada’s Leading Product

12.6 Stada Branded Products

12.6.1 Stada’s Proprietary Products Sales Growth Exceeds 20% In 2006

12.7 Stada Generics Segment Forecast, 2008-2013 & 2023

12.8 Stada Product Developments

12.9 Mergers, Acquisitions and Disposals

12.9.1 Stada Acquires Significantly In 2007

12.10 Stada Initiates Biosimilar Projects

12.10.1 Stada And Bioceuticals Arzneitmittel’s Biosimilar Pipeline.

12.10.2 Stada Erythropoietin-Zeta (Epo-zeta)Receives Positive Opinion From EMEA


13. Mylan Laboratories

13.1 Mylan Was Originally a Packaging Company

13.2 Mylan Leading Therapeutic Classes

13.3 Mylan Records Highest Sale in US Market

13.3.1 Mylan Product Sales Grows In the EU Market

13.4 Mylan's Pharmaceuticals Product Porfolio Expands Significantly

13.5 Mylan's Recent Financial Results

13.6 Mylan New Product Lauches To Drive Revenue Growth

13.6.1 Mylan launched Amlodipine Besylate

13.6.2 Mylan's Oxybutynin ER Tablets

13.6.3 Mylan's Propranol hydrochloride ER capsules

13.6.4 Mylan's Other Major Launches

13.6.5 Mylan Generics Segment Forecast, 2008-2013 & 2023

13.7 Mylan Increases R&D Expenditure

13.7.1 Mylan Has A Strong Pipeline And Increased R&D Spending

13.8 Mergers, Acquisitions and Agreements

13.8.1 Mylan Completes The Acquisition of Matrix Laboratory Outstanding Shares

13.8.2 Mylan And Matrix Acquisition Will Intensify Antiretroviral Research

13.9 Legal Challenges on Products

13.9.1 Omeprazole

13.9.2 Lorazepam and Clorazepate



14. Apotex

14.1 Apotex Privately Owned Canadian Pharmaceutical Firm

14.2 Apotex Geneic Division

14.3 Apotex Experiences Continuous Growth Revenue

14.4 Apotex Regional Segmentation

14.4.1 EU Region Apotex’s Third Largest Market

14.4.2 Apotex’s Sales Growth Expands in Latin And Central American Markets

14.4.3 Apotex‘s Africa, Asia and Australia Generated The Least Sales In 2006

14.5 Apotex Leading Generic Drugs

14.5.1 Sanofi-Aventis And BMS Secure Injunction Against Apotex’s Leading Drug Clopidogrel

14.5.2 Apotex’s Omeprazole Sales Expands By A Significant Margin

14.6 Apotex Generics Segment Forecast, 2008-2013 & 2023

14.7 Apotex Research and Development

14.7.1 Apotex R&D Investment Drives Sales By Over 20%

14.7.2 Apotex R&D Projects Increases Innovative And Biotechnological Products

14.7.3 Apotex Markets Amlodopine Generic Version of Pfizer's Blockbuster Drug Norvasc

14.7.4 Apotex Intensifies Haematology And Skin Replacement Research

14.8 Apotex Second Largest Mergers and Acquisitions

14.8.1 Apotex Acquires Lareq Pharma In Spain

14.9 Apotex Will Compete Strongly With The Top Five Leading Generic Companies


15. Conclusions

15.1 Generics Market Bubble-Patent Expiration $100bn Branded Products

15.2 Major Wave of Patent Expirations To Occur

15.2.1 Patent expirations in 2006

15.2.2 Patent Expirations in 2007

15.2.3 Patent Expirations in 2008

15.2.4 Patent Expirations in 2009

15.2.5 Patent Expirations in 2010

15.2.6 Patent Expirations in 2011

15.3 Generic Drugs Uptake in The US on the Rise

15.4 The UK has the Highest Generic Penetration by Value in All European Markets

15.5 The Expiration of Branded Patents is The Most Important Driver of Growth in The Sector

15.6 Characteristics of Differing Regulatory Systems Affect the Market for Generics

15.7 Biogenerics Are Becoming Increasingly Important

15.8 Teva Leads The Generic Sector

15.9 Consolidation to be Key Factor in Growth of Generic Industry

15.10 Strong Positioning in EU Market Will Be An Influential Factor For High Revenue

15.11 Generics Sector An Expanding Market With Lucrative Opportunities

15.12 Strategic Focus On Geographical Markets Will Be Key To Levarging Technological Innovations

15.13 Growing Presence of Automatic Substitution At Pharmacy Will Drive Generic Growth

15.14 Top Ten Generic Companies Will Experience Strong Revenues During 2008-2023

15.15 Device-Driven Products Holds Significant Revenue Potential For Generic Investors

15.16 Product Life-Cycle Management Will Be Crucial To Generic Revenue Growth



List of Tables

Table 1.1 Top 10 Generic Comapnies, Generics Revenue ($bn) Forecast, 2008-2013,2018 & 2023

Table 2.1 Sales of All Companies: Total Group and Generics Sales,2005-2006

Table 2.2 Sales of All Companies: Total Group Sales,2005-2006

Table 2.3 The Leading Generics Companies: Total Generic Sales Only, 2005-2006

Table 3.1 Major Drugs Losing Patent Expiration in Near-Term

Table 3.2 Branded and Generics Price Differentials in Selected Leading European Countries, 2006

Table 3.3 The Top Ten US Generic Drugs by Revenue ($m) and Units

Table.3.4 Prescription Number (m), 2004 Top 10 Generic Drugs, Dispensed by Prescriptions in the US, 2006

Table 3.5 US Top Ten Generic Drugs as a Function of Combined Branded and Generic Drugs by Prescription Number (m) and Revenues ($m),2006

Table 5.1 Top 20 Leading Pharmaceutical Companies,2006

Table 5.2 Teva Net Sales, Net Income, 2006

Table 5.3 Teva Subsidiaries, 2006

Table 5.4 Sales ($m) by Geographical Area, 2004-2006

Table 5.5 Sales ($m) by Business Division, 2004-2006

Table 5.6 Principal Therapeutic Products Manufactured by Teva, 2007

Table 5.7 Teva Pharmaceuticals: Top Five Therapeutic Classes, 2005-2006

Table 5.8 Pharmaceuticals: Leading International Products, 2005-2006

Table 5.9 Teva Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 5.10 R&D Investment by Teva, 2002-2006

Table 5.11 Summary of R&D Pipeline

Table 6.1 Sandoz Net Sales ($m) and Other Key Financials, 2006

Table 6.2 Sandoz Net Sales (%) by Region, 2006

Table 6.3 Sandoz Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 7.1 Sales of Pharmaceutical and Chemical Division, 2002-2006

Table 7.2 Revenues of Pharmaceutical Businesses, 2002-2006

Table 7.3 Merck KGaA Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 8.1 Revenues of Top Ten Selling Therapeutic Classes,2006

Table 8.2 Revenues of Top Ten Selling Generics, 2006

Table 8.3 Regional Sale Distribution, 2006

Table 8.4 Sales Distribution in Major EU Markets, 2006

Table 8.5 Sales Distribution in Canada and the US, 2006

Table 8.6 Sales Distribution in Africa, Asia and Australian Markets, 2006

Table 8.7 Sales Distribution in Latin and South American Markets, 2006

Table 8.8 Ratiopharm Subsidiaries

Table 8.9 Ratiopharm Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 9.1 Total Revenue including Major Operations, 2006

Table 9.2 Net Revenue In Comparison With Other Operational Losses, 2006

Table 9.3 Generic Segment Sales, 2006

Table 9.4 Revenues of Branded Products Operations, 2006

Table 9.5 R&D and Other Operating Expenditure, 2006

Table 9.6 Watson Nephrology Product Portfolio

Table 9.7 Watson Urology Product Portfolio

Table 9.8 Pain Product Portfolio

Table 9.9 Women's Health Product Portfolio

Table 9.10 Other Specialty Product Portfolio

Table 9.11 Watson Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 10.1 Actavis Total Revenue ($m) and Net Profit ($m), 2006

Table 10.2 Actavis Leading Products in Major Markets, 2006

Table 10.3 Actavis Revenue ($m) in Key Regions, 2006

Table 10.4 Actavis Watson Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 11.1 Barr Total Revenues and Net Earnings, 2003-2006

Table 11.2 Comparison of the six months ended December 31 2006 and December 31, 2005

Table 11.3 Barr Leading Products, 2006

Table 13.4 Total Revenue of Oral Contraceptive, 2004-2006

Table 13.5 Barr Patent Challenges and Valuation

Table 11.6 Barr Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 11.7 Total Revenue of Proprietary Products, 2004-2006

Table 11.8 Total Revenue of Proprietary Products, 2004-2006

Table 12.1 Total Revenue ($m), Net Income ($m) and Operating Profit ($m), 2003-2006

Table 12.2 Stada Core Business Revenues, 2006

Table 12.3 Regional Sales Distribution, 2003-2006

Table 12.4 Stada US Revenue ($m), 2002-2006

Table 12.5 Regional Sales Distribution, 2003-2006

Table 12.6 Revenues in Leading EU Markets, 2006

Table 12.7 Revenue in Five Leading EU Markets, 2006

Table 12.8 Revenue in Other Leading EU Markets, 2006

Table 12.9 Revenue Top Five Leading Generic Products, 2006

Table 12.10 Stada Top Five Branded Products Division Revenue, 2006

Table 12.11 Stada Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 12.12 Stada M&A Operations, 2006

Table 12.13 Stada M&A Operations, 2006

Table 13.1 Total Revenue ($m) and Profit ($m) for Mylan

Table 13.2 Total Revenue ($m) of Mylan Leading Therapeutic Classes

Table 13.3 Mylan's Leading Products, 2006

Table 13.4 Mylan Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 13.5 Mylan's R&D Investment, 2003-2007

Table 14.1 Apotex Revenues, 2004-2007

Table 14.2, Market Share of Apotex Leading Therapeutic Classes, 2006

Table 14.3 Apotex Geographical Revenues, 2006

Table 14.4 Apotex Revenues in US and Canada, 2006

Table 14.5 Apotex Revenues in Key EU Markets, 2006

Table 14.6 Apotex Revenues in Key Latin American Markets, 2006

Table 14.7 Apotex Revenues in Key Central American Markets, 2006

Table 14.8 Apotex Revenues in Key Africa, Asia& Australia Markets, 2006

Table 14.9 Apotex Revenues For Leading Drugs, 2006

Table 14.10 Apotex Revenues For Top Five Drugs, 2006

Table 14.11 Apotex Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Table 15.1 Near-term Patent Expiration ,207-2009


List of Figures

Figure 1.1 Top 10 Generic Comapnies, Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 2.1 Sales 2004-2006 All Companies: Total Group Sales

Figure 2.2 Market Share of Sales of All Companies: Total Group Sales,2006

Figure 2.3 The Leading Generics Companies: Total Generic Sales Only, 2005-2006

Figure 2.4 Market Share of Sales of All Companies: Generic Sales Only, 2006

Figure 3.1 Per Capita Growth Rate for National Health Expenditure Vs Prescription Drugs Over Four Decades

Figure 5.1 Teva Net Sales, 2006

Figure 5.2 Teva Net Income, 2006

Figure 5.3 Sales ($m) by Geographical Area, 2004-2006

Figure 5.4 Sales ($m) by Business Division, 2004-2006

Figure 5.5 Teva Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 5.6 R&D Investment by Teva, 2002-2006

Figure 6.1 Sandoz Net Sales ($m) and Other Key Financials, 2006

Figure 6.2 Sandoz Net Sales (%) by Region, 2006

Figure 6.3 Sandoz Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 7.1 Sales of Pharmaceutical and Chemical Division, 2002-2006

Figure 7.2 Revenues of Pharmaceutical Businesses, 2002-2006

Figure 7.3 Market Share of Merck KGaA Businesses, 2006

Figure 7.4 Regional Revenues of Generic Pharmaceuticals, 2006

Figure 7.5 Regional Market Share of Generic Pharmaceuticals, 2006

Figure 7.6 Merck KGaA Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 8.1 Market Share of Ratiopharm Top Ten Selling Therapeutic Classes,2006

Figure 8.2 Market Share of Ratiopharm Top Ten Selling Generics, 2006

Figure 8.3 Regional Sale Distribution, 2006

Figure 8.4 Sales Distribution in Major EU Markets, 2006

Figure 8.5 Sales Distribution in Canada and the US, 2006

Figure 8.6 Sales Distribution in Africa, Asia and Australian Markets, 2006

Figure 8.7 Market Share Distribution in Latin American Markets, 2006

Figure 8.8 Ratiopharm Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 9.1 Total Revenue Including Major Operations, 2006

Figure 9.2 Net Revenue In Comparison With Other Operational Losses, 2006

Figure 9.3 Market Share of Branded Products Vs Generics

Figure 9.4 Watson's R&D Expenditure, 2002-2006

Figure 9.5 Generic Segment Sales, 2006

Figure 9.6 Revenues of Branded Products Operations,2006

Figure 9.7 R&D and Other Operating Expenditure, 2006

Figure 9.8 Watson Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 9.9 Watson ANDA Submission, 2002-2006

Figure 9.10 Watson ANDA Pending Approvals 2002-2006

Figure 10.1 Actavis Total Revenue ($m) and Net Profit ($m), 2006

Figure 10.2 Actavis Regional Market Share Distribution

Figure 10.3 Market Share of Actavis Leading Products in Major Markets, 2006

Figure 10.4 Actavis Revenue ($m) in Key Regions, 2006

Figure 10.5 Actavis Market Share in CEEA Market 2006

Figure 10.6 Actavis Market Share in WEMEA Market, 2006

Figure 10.7 Actavis Third Party Division Market Share Market, 2006

Figure 10.8 Actavis Third Party Division Regional Market Share Market, 2006

Figure 10.9 Actavis Watson Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 11.1 Barr Total Revenues and Net Earnings, 2003-2006

Figure 11.2 Barr Leading Products, 2006

Figure 11.3 Total Revenue of Oral Contraceptive, 2004-2006

Figure 11.4 Barr Generic Products Revenues ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 11.5 Total Revenue of Proprietary Products, 2004-2006

Figure 11.6 Total Revenue of Proprietary Products, 2004-2006

Figure 12.1 Net Income ($m) and Operating Profit ($m), 2003-2006

Figure 12.2 Stada Core Business Revenues, 2006

Figure 12.3 Market Share of Stada Core Business Revenues, 2006

Figure 12.4 Regional Sales Distribution, 2003-2006

Figure 12.5 Market share of Regional Sales Distribution, 2006

Figure 12.6 Stada US Revenue ($m), 2002-2006

Figure 12.7 Stada Market Share in Six Major Regions, 2006

Figure 12.8 Market Share Revenues in Leading EU Markets, 2006

Figure 12.9 Revenue in Five Leading EU Markets, 2006

Figure 12.10 Revenue in Other Leading EU Markets, 2006

Figure 12.11 Stada Generic Division Revenue, 2003-2006

Figure 12.12 Revenue Top Five Generic Products, 2006

Figure 12.13 Stada Branded Products Division Revenue, 2003-2006

Figure 12.14 Market Share of Stada's Top Five Branded Products Division Revenue, 2006

Figure 12.15 Stada Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 12.16 Stada M&A Operations, 2006

Figure 12.17 Stada M&A Disposals Revenue, 2006

Figure 13.1 Mylan Total Revenue ($m) and Profit ($m),2003-2006

Figure 13.2 Total Revenue ($m) of Mylan Leading Therapeutic Classes

Figure 13.3 Market Share Distribution of Mylan's Leading Therapeutic Classes

Figure 13.4 Total Revenue Distribution in Major Geographical markets, 2006

Figure 13.5 Market Share of Mylan's Leading Products, 2006

Figure 13.6 Mylan Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Figure 13.7 Mylan's R&D Investment, 2003-2007

Figure 14.1 Apotex Revenues, 2004-2007

Figure 14.2 Market Share of Apotex Leading Therapeutic Classes, 2006

Figure 14.3 Apotex Geographical Revenues, 2006

Figure 14.4 Market Share of Apotex Revenues in US and Canada, 2006

Figure 14.5 Market Share of Apotex Revenues in Key EU Markets, 2006

Figure 14.6 Market Share of Apotex Revenues in Key Latin American Markets, 2006

Figure 14.7 Apotex Revenues in Key Central American Markets, 2006

Figure 14.8 Market Share of Apotex Revenues in Key Africa, Asia & Australia Markets, 2006

Figure 14.9 Apotex Revenues For Leading Drugs, 2006

Figure 14.10 Apotex Revenues For Top Five Drugs, 2006

Figure 14.11 Apotex Generics Revenue ($bn) Forecast, 2008-2013, 2018 & 2023

Abstract

The generic industry is a fast evolving market; with significant lucrative opportunities. The generic market is structurally set to experience high growth potential. That wave is partly driven by cost-containment in several national healthcare sectors and partly by the need for governments to promote the use of generic products over high-priced originator products without compromising quality.

In 2006, the global generics market attained strong revenues of approximately $65bn, up by 12% in comparison with $58bn in 2005. However, during the same period, the Top Ten leading generic suppliers generated total revenues of $27.9bn, up by a growth rate of 34%. The Top Five Companies within that sector experienced significant revenues, with market growth largely driven by significant commercial activities, key Mergers and Acquisition (M&A) and launch of new product in the leading markets.

In light, of the significant number of proprietary branded pharmaceuticals approaching patent expiration in the near-term, visiongain predicts that the generic market is set to experience further market expansion during the forecast period. Visiongain also predicts that by 2023, the Top Ten leading generic suppliers will experience CAGR of 7%. That significant CAGR, will be driven by generic versions of leading blockbuster drugs presently estimated at $100bn, nearing patent expiration during 2008-2012.

Prominently, amongst the products with looming patent expirations are drugs such as:
  • Pfizer's Lipitor
  • AstraZeneca's Nexium
  • Bristol Myers Squib's Plavix
  • Pfizer's Norvasc
  • Lilly's Zyprexa
  • Janssen's Risperdal
  • Wyeth's Effexor
In 2007, a total of 14 drugs came of patent in the US market. In 2008, a total of 14 drugs are expected to lose patent protection in the US market. In 2009, five drugs are predicted to becoming off-patent in the US market. On the 24 of March 2010, the world's highest selling drug, Pfizer's Liptor will come off-patent in the US. In the EU market, UCB's Keppra and four other medicines are expected to lose patent protection. In 2011, 10 major drugs in the US market will also become exposed to generic competition. An estimated 11 drugs will experience generic competition in the EU market during the same year. Significant among these drugs will be Lipitor and Zyprexa.

Moreover, the generic market is projected to further expand through the growing uptake of biogeneric/ biosimilar products. In 2006, biological drugs, the products of biotechnology generated total revenues of $40bn. The US market alone, accounted for a significant proportion of total worldwide sales. Presently, in the EU, the growing popularity of these products are gaining newer heights, with managed care organisations (MCOs), healthcare providers and payers amongst others increasingly requesting these medicines as a significant cost-saving strategy. However, by 2010, an estimated 24 biologic drugs will near patent expiration opening up the market for generic possibilities.

Visiongain’s market analysis forecast a-to- be lucrative era during the mid-term of our forecast where we believe, the Top Ten generic suppliers will see strong sales growth leveraged through licensing of new products.

With Top Ten company-by-company forecast focus on regions:

Asia
  • Teva (Asia/ Israel)
Europe
  • Actavis (Finland)
  • Merck KGaA (Germany)
  • Ratiopharm (Germany)
  • Sandoz (Switzerland)
  • Stada (Germany)
North America
  • Apotex (Canada)
  • Barr (US)
  • Mylan (US)
  • Watson (US)
This report includes detailed five-year forecasts over the period 2007-2012, and NOW features 10 and 15-year forecasts to help you understand the medium-term prospects for these markets.

Why You Must Buy This Report:

This report features in-depth primary research, tables, graphs and charts, news, insights, the past and present developments in Market. This report will provide you with the complete understanding of operations of Top Ten companies that has driven their corporate growth in recent times. In addition, the report sheds significant emphasis on key strategies that will drive year-on-year sales growth of their leading products. Despite the lucrative opportunities presented to the leading companies through patent expirations, the visiongain reports analyses the key battles that the leading Top Ten generic companies will face during the same period.

This visiongain report is the single tool to equip you with the latest trends in all regional markets and why all (stakeholders) are opting for cheaper generic medicine, that are equally potent as their originator versions. Visiongain recommends this astute report to the major players in the field as it will arm you with the major legal challenges that leading companies face to date. The report, will also inform you on how the Top Ten generic companies are positioning themselves in facing the rising inherent cost of R&D expenditure especially on difficult-to-manufacture biogeneric/ biosimilars. In addition, the reports present a 360 degrees overview of requirements set by major regulatory authorities for larger evidence of clinical data before any authorisation.

When you buy this report, you will also get an understanding, through our overview; of how present changes in Governmental Pharmaceutical Policies with respect to cost-cutting coupled with major hurdles by that the Top Ten generic suppliers will have to overcome in the growing presence of price erosion /sensitivity in key and emerging markets. The Top Ten Generic League Market Analysis & Forecasts 2007-2023 report is a must buy, because it presents in-depth and unbiased financial analysis for the near-term, medium-term and the long-term, market dynamics.

When you buy the Visiongain 2008 Top Ten Generic League report, you will be buying current and vital information on the vast array of commercial opportunities marked for potential success in the long-term treatment of the generic market.

Unique benefits to you when you order this report:
  • Primary research throughout. You will not find this information anywhere else
  • Report stored in your reading room for ever
  • Full searchable report when you buy the company or corporate editions
  • Copies can be printed off for offline reading
  • Packed with charts, analysis, figures, graphs and tables
What questions does the report answer?
  • Who are the generic market leaders?
  • Which regions dominate the generic market?
  • Which of the Top Ten companies conducted key M&As to bolster product pipeline?
  • Have the M&As been successful in expanding product range?
  • Is the cost of branded medicines justifiable by Big Pharma?
  • How will the Top Ten account for future revenues?
  • Will the Top Ten continue to experience market share expansion?
  • How will the Top Ten overcome the legal battles?
  • Are the legal battles really worth the cost of the generic medicines?
  • What direction is Biogenerics marketing taking?
  • Will the EU regulatory bodies narrow the generic gap between the US?
  • Will the Top Ten themselves be acquired under mounting pressure of strong market competitions?
  • Will the rising cost of R&D, deter the Top Ten from investing?
  • Are the voices of managed care organisations (MCOs), healthcare providers and payers driving down sales of Big Pharm’s blockbusters?
  • Is the EU a “nice-to-operate-in” or a “must-operate-in” market for the Top Ten?
Please Note: Reports are sold based on the user licenses indicated. The Publisher delivers the report in Flash format via the publisher website, allowing viewing and printing capabilities only. Within one to two business days after placing the order, the Publisher will email the client with information on accessing their purchase. Prior to initiating fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher.

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