Biogenerics

Published by: Global Industry Analysts

Published: Jul. 1, 2006 - 187 Pages

Table of Contents

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)

Abstract

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.

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