Home > Back to Publisher > Report Information

Biogenerics

Global Industry Analysts
July 1, 2006
187 Pages - SKU: GJOB1364935

Abstract Table of Contents Related Reports

Countries covered: Global

This report analyzes the worldwide markets for Biogenerics in US$ Million. The report provides separate comprehensive analytics for the US, Europe, and Rest of World. Annual forecasts are provided for each region for the period of 2007 through 2013. The report profiles 42 companies including many key and niche players worldwide such as Biocon Limited, BioPartners, BioGeneriX AG, Cangene Corporation, Cipla Ltd., Dr. Reddy's Laboratories, GeneMedix, LG Life Sciences, Pliva d.d., Ranbaxy Laboratories Limited, Sandoz International GmbH, Stada Arzneimittel, Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA, and Wockhardt Limited.

Please note: Reports are sold as single-site single-user licenses. The delivery time for hard copies is between 3-5 business days, as each hard copy is custom printed for the organization ordering it. Electronic versions require 24-48 hours as each copy is customized to the client with digital controls and custom watermarks. The Publisher uses digital controls protecting against copying and printing is restricted to one full copy to be used at the same location. Adobe Acrobat Reader 7.0 is required to view the report. Upon ordering an electronic version, the Publisher will provide a link to download the purchased report.

Titles available via "online download" are not affected by this and are still delivered to your personal library immediately.

Prior to fulfillment of an order, the client will be required to sign a document detailing the purchase terms for a publication from this publisher.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

II. EXECUTIVE SUMMARY

1. Market Overview

Biogenerics Spell Opportunities

Patent Expiration of Biotech Medicines Paves Way for New Generation Biogenerics

Patent Expiration of Major Biotechnology Products before 2007

Market Structure

Potential Key Competitors in the Biogenerics Space

Entry Barriers for Biogenerics

Comparison of Entry Barriers for Biogenerics in Select Global Markets

Is Commercialization of Biogenerics Possible?

Will Biopharmaceutical Market Witness Intense Competition from Generic Firms?

Branded Vs Generics Drugs - The Debate Continues

Growth Impediments

Heavy Investment

Shortage of Manufacturing Capacity

Lack of Clear Regulatory Mechanism

Overview of Select Markets

United States

Biogenerics to Exhibit Slow Start

Europe

Australia

India - Emerging Player in the Biogeneric Market

2. Trends and Issues

US FDA Under Pressure

Entry Barriers Limit Competition in Biogenerics Market

Bend the Rule or Not - Authorities in Dilemma

Biogenerics Market Gains Support from Other Institutions

Generic Drug Producers Adopt “Evergreening” Concept

Biogenerics Need to Conform to the Production Norms of Original Products

3. Drug Approval Process in US and Europe

Bioequivalence Tests - Mandatory Requirement for Generics

Approval Process in the US

Hatch Waxman Act and FDA Approval Process

ANDA Review Process

Generic Exclusivity

30-Month Stay Period

180-Days Exclusivity Period7

Time Period for Generic Approval

Approval Process in Europe

Generic Companies Face Strict Regulations for Approval

Data Exclusivity

4. Product Overview

What are Biogenerics?

Biogenerics - Generic Version of Biopharmaceuticals

Biopharmaceuticals

Biogenerics Versus Conventional Generics

Manufacturing Process of Biogenerics - A Debatable Issue

5. Recent Industry Activity

Teva Acquires IVAX Corporation

Biopartners Bags EU Marketing Approval for Valtropin

Sandoz Bags EC Marketing Approval for Omnitrope

Omnitrope Receives US FDA Approval

Biocon Limited Partners with Vaccinex Inc

Novartis Pockets Hexal AG

Mayne’s Pharma Division Collaborates with Pliva

Clinigene Initiates Clinical Trials on Biocon’s EGFR Monoclonal Antibody

Barr Laboratories Signs Agreement with Pliva for Developing G-CSF

Pliva Croatia Bags Approval for Biogeneric EPO

Teva Pharmaceutical Industries Acquires SICOR

Biocon Launches Bio-Insulin

Cipla in Strategic Alliance with Dongbao Pharmaceutical Company Ltd

Crucell N.V. Signs a Licensing Agreement with Gene Medicine Japan Inc

6. Focus on Select Players

Biocon Limited (India)

BioPartners (Switzerland)

BioGeneriX AG (Germany)

Cangene Corporation (Canada)

Cipla Ltd. (India)

Dr. Reddy's Laboratories (India)

GeneMedix (UK)

LG Life Sciences (Korea)

Pliva d.d. (Croatia)

Ranbaxy Laboratories Limited (India)

Sandoz International GmbH (Germany), a Unit of Novartis

Stada Arzneimittel (Germany)

Teva Pharmaceutical Industries Ltd. (Israel)

Teva Pharmaceuticals USA (USA)

Wockhardt Limited (India)

7. Global Market Perspective

Table 1: Worldwide Market for Biogenerics - Market Projections for US, Europe and Rest of World with Annual Sales Figures in US$ Million for Years 2007 through 2013 (includes corresponding Graph/Chart)

Table 2: Worldwide 6-Year Perspective for Biogenerics - Percentage Breakdown of Dollar Sales for US, Europe and Rest of World for Years 2007, 2010 & 2013 (includes corresponding Graph/Chart)

III. COMPETITION

1. Anhui Anke Bio Tech (China)

2. Barr Laboratories, Inc. (USA)

3. Bharat Biotech International Limited (India)

4. Biocon India Limited (India) Table 3: Annual Sales Analysis: 2004-2005 (In INR million) Clinigene (India)

5. Biogenerics GmbH (Germany)

6. Biogenerics Pharma (USA)

7. BiogeneriX AG (Germany)

8. Biopartners (Switzerland)

9. Cangene Corporation (Canada)

Table 4: Nine Months Sales Analysis: 2005-2006 (Nine Months Ended, April) (In Can$ million)

Table 5: Nine Months Sales Analysis by Quarter: 2005- 2006 (Nine Months Ended, April) (In Can$ million)

Table 6: Annual Sales Analysis: 2003-2005 (In Can$ million)

Table 7: Annual Sales Analysis by Geographic Region: 2004-2005 (In Can$ million)

10. CIGB (Cuba)

11. Cipla Ltd. (India)

Table 8: Annual Sales Analysis: 2003-2005 (In INR billion)

Table 9: Annual Sales Analysis by Quarter: 2004-2005 (In INR billion)

12. Crucell NV (The Netherlands)

Table 10: First Quarter Sales Analysis: 2005-2006 (In € million)

Table 11: Annual Sales Analysis: 2004-2005 (In € million)

Table 12: Annual Sales Analysis by Geographic Region: 2004-2005 (In € million)

13. Dr. Reddy's Laboratories Ltd. (India)

Table 13: Annual Sales Analysis: 2004-2006 (In INR billion)

Table 14: Annual Sales Analysis by Segment: 2004-2005 (In INR billion)

Table 15: Annual Sales Analysis by Geographic Region: 2004-2005 (In INR billion)

14. Dragon Pharmaceuticals, Inc. (USA)

15. Eli Lilly And Company (USA)

Table 16: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 17: First Quarter Sales Analysis by Segment: 2005-2006 (In US$ million)

Table 18: First Quarter Sales Analysis by Product: 2005-2006 (In US$ million)

Table 19: Annual Sales Analysis: 2003-2005 (In US$ Billion)

Table 20: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 21: Annual Sales Analysis by Product: 2004-2005 (In US$ million)

Table 22: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

16. Ferring Pharmaceuticals (USA)

17. Gene Medicine Japan, Inc. (Japan)

18. GeneMedix PLC (UK)

19. Inno Biologics Sdn. Bhd. (Malaysia)

20. Insight Biopharmaceuticals Ltd. (Israel)

21. Intas Pharmaceuticals Ltd. (India)

22. LG Life Sciences (Korea)

23. Mayne Pharma PLC (UK)

24. Merck KGAA (Germany)

Table 23: Annual Sales Analysis: 2003-2005 (In € million)

Table 24: Annual Sales Analysis by Segment: 2004-2005 (In € million)

25. Microbix Biosystems, Inc. (Canada)

Table 25: Half Yearly Sales Analysis: 2005-2006 (H1) (In US$ million)

Table 26: Annual Sales Analysis: 2004-2005 (In US$ million)

Table 27: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

26. Migenix, Inc. (Canada)

Table 28: Annual Sales Analysis: 2003-2005 (In US$ million)

Table 29: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

27. Momenta Pharmaceuticals, Inc. (USA)

Table 30: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 31: Annual Sales Analysis: 2003-2005 (In US$ million)

28. Neose Technologies, Inc. (USA)

Table 32: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 33: Annual Sales Analysis: 2003-2005 (In US$ million)

Table 34: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

Table 35: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 36: First Quarter Sales Analysis by Segment: 2005-2006 (In US$ million)

Table 37: Annual Sales Analysis: 2003-2005 (In US$ million)

Table 38: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 39: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

Sandoz International GmbH (Germany)

Sandoz, Inc. (USA)

30. Novo Nordisk A/S (Denmark)

Table 40: Annual Sales Analysis: 2003-2005 (In DKK million)

Table 41: Annual Sales Analysis by Segment: 2004-2005 (In DKK million)

Table 42: Annual Sales Analysis by Geographic Region: 2004-2005 (In DKK million)

31. Pfizer, Inc. (USA)

Table 43: Annual Sales Analysis: 2003-2005 (In US$ billion)

32. Pliva D.D. (Croatia)

Table 44: Annual Sales Analysis: 2003-2005 (In US$ million)

Table 45: Annual Sales Analysis by Segment: 2004-2005 (In US$ million)

Table 46: Annual Sales Analysis by Geographic Region: 2004-2005 (In US$ million)

33. Ranbaxy Laboratories Ltd. (India)

Table 47: First Quarter Sales Analysis: 2004-2005 (In INR billion)

34. Savient Pharmaceuticals, Inc. (USA)

Table 48: First Quarter Sales Analysis: 2005-2006 (In US$ million)

Table 49: Annual Sales Analysis: 2004-2005 (In US$ million)

Table 50: Annual Sales Analysis by Quarter: 2004-2005 (In US$ million)

35. Shantha Biotechnics Limited (India)

36. Shenyang Sunshine Pharmaceutical Co., Ltd. (China)

37. Stada Arzneimittel AG (Germany)

Table 51: Annual Sales Analysis: 2003-2005 (In € million)

Table 52: Annual Sales Analysis by Segment: 2004-2005 (In € million)

Table 53: Annual Sales Analysis by Geographic Region: 2004-2005 (In € million)

38. Teva Pharmaceutical Industries Ltd. (Israel)

Table 54: First Quarter Sales Analysis: 2005-2006 (In US$ billion)

Table 55: Annual Sales Analysis: 2003-2005 (In US$ billion)

Teva Pharmaceuticals (USA)

Sicor, Inc. (USA)

39. Vaccinex, Inc. (USA)

40. Wockhardt Ltd. (India)

Table 56: Annual Sales Analysis: 2003-2005 (In INR billion)

41. Zenotech Laboratories Ltd. (India)

Table 57: Annual Sales Analysis: 2003-2005 (In INR million)

42. Zydus Cadila (India)

Table 58: Annual Sales Analysis: 2004-2005 (In INR million)

More Global Biopharmaceuticals Reports

Global Biosimilars Market Forecast to 2015 by RNCOS
The biosimilars industry has been growing stupendously across the globe for past few years. Increasing healthcare costs and rising aging population are driving the industry, ...

Biosimilars: Current Situation & Future Prospects, Worldwide by JustPharmaReports.com
The engine of the biosimilar sector is the same as with small molecule drugs, patent expiry. On this basis, prospects for biosimilars look good, with ...

World Biological Drugs Market 2012-2022 by Visiongain
Where is the market for biological drugs heading? Visiongain's report shows you potential revenues to 2022, with data, forecasts and discussions. Our new study ...

Global Biosimilars: A return to optimism? by Espicom Healthcare Intelligence
Despite some commentators predicting a muted or near nonexistent market for advanced biosimilars, many companies - and some surprising names - are positioning themselves for ...

Cell Culture: The World Market for Media, Sera and Reagents, 3rd. Edition by Kalorama Information
Several cell culture-derived biopharmaceutical drugs were launched in the US and European markets in 2010. Biopharmaceuticals (recombinant proteins, monoclonal antibody and nucleic acid-based products) represent ...

See all reports like this >>

Biogenerics

Share this report

Other tasks

Research Assistance

Related Markets

Biopharmaceuticals Reports

Free Alert Me service