Report: Biosimilars (2009

1. INTRODUCTION

1.1. KEY TAKE AWAYS
1.2. REPORT DESCRIPTION
1.3. SCOPE OF THE REPORT
1.4. STAKEHOLDERS

2. SUMMARY

2.1. GLOSSARY

3. MARKET OVERVIEW

3.1. ISSUES RELATED WITH BIOSIMILAR
3.2. DEFINING THE GLOBAL BIOSIMILAR MARKET
3.3. DRIVING FACTOR ANALYSIS
- 3.3.1. DEMAND-SIDE DRIVERS
- 3.3.2. SUPPLY-SIDE DRIVERS
- 3.3.3. RESTRAINTS & OPPORTUNITIES
- 3.3.4. KEY COMPETITIVE POINTS
3.4. POTENTIAL MATRIX FOR GLOBAL BIOSIMILAR PRODUCTS
3.5. POTENTIAL MATRIX FOR GLOBAL BIOSIMILAR APPLICATIONS
3.6. BIOSIMILAR MARKET DYNAMICS
3.7. COMPARISON OF BIOSIMILAR AND GENERIC DRUGS
3.8. PRICING OF BIOSIMILAR DRUG
3.9. SUPPLY SIDE STAKEHOLDERS
- 3.9.1. Innovator drug manufacturers
- 3.9.1. rug device manufacturers & next-generation innovators
3.10.BIOSIMILAR PRODUCTS GEOGRAPHICAL TREN0D
3.11.CYCLE OF INNOVATION AND COMPETITION

4. BIOSIMILAR PRODUCTS SUMMARY

4.1. RECOMBINANT NON-GLYCOSYLATED PROTEIN
- 4.1.1. DRIVERS
- 4.1.2. INSULIN
  - 4.1.2.1. Drivers & Opportunities
    - 4.1.2.1.1. Increasing demand from huge patient-base
    - 4.1.2.1.2. Improvements in drug delivery method
- 4.1.3. RECOMBINANT HUMAN GROWTH HORMONE
- 4.1.4. LEPIRUDIN
- 4.1.5. NTERLEUKIN - 2 (IL-2)
- 4.1.6. INTERFERONS
  - 4.1.6.1. Interferon Alfa
  - 4.1.6.2. Interferon beta-1a
  - 4.1.6.3. Interferon gamma
- 4.1.7. GRANULOCYTE COLONY-STIMULATING FACTOR (G-CSF)
- 4.1.8. INTERLEUKIN-11
- 4.1.9. ANAKINRA
4.2. RECOMBINANT GLYCOSYLATED PROTEINS
- 4.2.1. DRIVERS & RESTRAINTS
  - 4.2.1.1. Applications in many therapeutic indications
  - 4.2.1.2. Segment covers major drug categories
  - 4.2.1.3. Requires high degree of clinical and manufacturing expertise
- 4.2.2. ERYTHROPOIETIN (EPO)
- 4.2.3. FOLLITROPIN
- 4.2.4. HYROTROPIN
- 4.2.5. UROKINASE
- 4.2.6. GLUCOCEREBROSIDASE
- 4.2.7. BECAPLERMIN
- 4.2.8. GRANULOCYTE-MACROPHAGE-CSF (GM-CSF)
- 4.2.9 RECOMBINANT HUMAN DNASE (RHDNASE)
- 4.2.10.FACTOR VIIA
- 4.2.11.FACTOR VIII
- 4.2.12.FACTOR IX
- 4.2.13.ACTIVATED PROTEIN C
- 4.2.14.TISSUE PLASMINOGEN ACTIVATOR
- 4.2.15.MONOCLONAL ANTIBODIES
  - 4.2.15.1. Chimaeric Antibodies
  - 4.2.15.2. Humanized / CDR-grafted / Reshaped antibodies
  - 4.2.15.3. Human antibodies and fusion protein
4.3. PEPTIDES
- 4.3.1. DRIVERS
  - 4.3.1.1. Development of synthetic and biological peptide libraries
  - 4.3.1.2. Fewer side effects and maximum therapeutic index
- 4.3.2. RESTRAINTS & OPPORTUNITIES
  - 4.3.2.1. Short half-life of peptide molecules
  - 4.3.2.2. Costly manufacturing and purification process
  - 4.3.2.3. Approval of drug candidates in Phase II & III
- 4.3.3. OCTREOTIDE
- 4.3.4. DESMOPRESSIN
- 4.3.5. CYCLOSPORINE
- 4.3.6. CALCITONIN
- 4.3.7. EPTIFIBATIDE
- 4.3.8. LH-RH (LEUPROLIDE)
- 4.3.9. NESIRITIDE
- 4.3.10.TERIPARATIDE
- 4.3.11.BIVALIRUDIN
- 4.3.12.ENFUVIRTIDE
- 4.3.13.GLUCAGON

5. BIOSIMILAR SERVICE MARKET SUMMARY

5.1. CONTRACT RESEARCH AND MANUFACTURING SERVICES
- 5.1.1. DRIVERS
  - 5.1.1.1. Outsourcing non-core activities to low cost destinations
  - 5.1.1.2. Time consuming nature of drug manufacturing
- 5.1.2. RESTRAINTS & OPPORTUNITIES
  - 5.1.2.1. Long inception period
  - 5.1.2.2. Low returns
  - 5.1.2.3. Emergence of biosimilars
5.2. CLINICAL TRIALS
- 5.2.1. DRIVERS & RESTRAINTS
  - 5.3.2.1. Extensive information about new drug candidate
  - 5.3.2.2. Central role in drug development
- 5.2.2. High cost
- 5.2.3 PHASE I
- 5.2.4. PHASE II
- 5.2.5. PHASE III

6. BIOSIMILAR APPLICATION MARKET SUMMARY

6.1. DRIVERS
- 6.1.1. Prevalence of incurable diseases
- 6.1.2. xpanding patient population
- 6.1.3. Developed technology
- 6.1.4. Increased life expectancy
6.2. RESTRAINTS
- 6.2.1. Failure of clinical research
- 6.2.2. Adverse effects of therapies
6.3. ONCOLOGY
- 6.3.1. DRIVERS
  - 6.3.1.1. Unraveling of the genetics behind cancer
  - 6.3.1.2. Significance and variants
  - 6.3.1.3. Availability of new treatments
  - 6.3.1.4. Increase in the ageing population
- 6.3.2. RESTRAINTS & OPPORTUNITIES
  - 6.3.2.1. Lack of early stage diagnostic
  - 6.3.2.2. Unawareness and lack of penetration of therapeutics
  - 6.3.2.3. Large product pipeline
- 6.3.3. LUNG CANCER
- 6.3.4. COLORECTAL CANCER
- 6.3.5 BREAST CANCER
- 6.3.6. CERVICAL CANCER
- 6.3.7. LEUKEMIA
  - 6.3.7.1. Drivers
    - 6.3.7.1.1. Huge market potential
    - 6.3.7.1.2. Rising awareness
  - 6.3.7.2. PROSTATE CANCER
6.4. INFECTIOUS DISEASES
- 6.4.1. HIV/AIDS
  - 6.4.1.1. Drivers
    - 6.4.1.1.1. Continual research to increase market size
    - 6.4.1.1.2. Biological drugs increase life expectancy
    - 6.4.1.1.3. Less expensive than biological drugs
    - 6.4.1.1.4. Lack of awareness and access among low income population
- 6.4.2. HEPATITIS B
- 6.4.3. EPATITIS C
6.5. CHRONIC AND AUTOIMMUNE DISEASES
- 6.5.1. DIABETES
  - 6.5.1.1. Drivers
    - 6.5.1.1.1. Awareness & early diagnosis prevents disease development
    - 6.5.1.1.2. Changing approach of patients towards medication
- 6.5.2. NEUTROPENIA
- 6.5.3. MULTIPLE SCLEROSIS
  - 6.5.3.1. Drivers
    - 6.5.3.1.1. Rising awareness
    - 6.5.3.1.2. Increases the life expectancy
    - 6.5.3.1.3. Inhibitors and opportunities
- 6.5.4. CYSTIC FIBROSIS
- 6.5.5. RHEUMATOID ARTHRITIS (RA)
  - 6.5.5.1. Drivers
    - 6.5.5.1.1. Large patient population
    - 6.5.5.1.2. Need for continued treatment
  - 6.5.5.2. Restraints
- 6.5.6. ACROMEGALY
  - 6.5.6.1. Driver
    - 6.5.6.1.1. Risk of getting other diseases
    - 6.5.6.1.2. Worldwide prevalence of the disease
- 6.5.7. LEPROSY
6.6. HEMATOLOGY
- 6.6.1. DRIVERS
  - 6.6.1.1. Prevalence of blood-related disorders
  - 6.6.1.2. Availability of cheaper treatment alternatives
  - 6.6.1.3. Early start of medication and longer treatment time
- 6.6.2. CHEMOTHERAPY INDUCED ANEMIA
  - 6.6.2.1. Drivers
    - 6.6.2.1.1. Chemotherapy has become the preferred treatment
    - 6.6.2.1.2. Availability of new treatment alternatives
    - 6.6.2.1.3. Early and easy diagnostics drives the market
  - 6.6.2.2. Restraints and Opportunities
- 6.6.3. HEMOPHILIA
- 6.5.4. PULMONARY EMBOLISM
  - 6.6.4.1. Drivers
    - 6.6.4.1.1. Availability of large number of diagnosis tools
    - 6.6.4.1.2. Need for immediate medication
6.7. GROWTH HORMONE DEFICIENCY (GHD)
- 6.7.1. DRIVERS
  - 6.7.1.1. Natural deficiency of GH and destruction of normal pituitary gland
  - 6.7.1.2. Need for body mass management
  - 6.7.1.3. Changes in the body composition
6.8. OTHER DISEASES
- 6.8.1. GAUCHER DISEASE
- 6.8.2. OSTEOPOROSIS
- 6.8.3. FERTILITY DISORDERS (INFERTILITY)
- 6.8.4. SKIN ULCER
- 6.8.5. HYPOGLYCEMIA
- 6.8.6. NOCTURNAL ENURESIS
- 6.8.7. CONGESTIVE HEART FAILURE (CHF)
- 6.8.8. SYSTEMIC SEPSIS
- 6.8.9. OTHERS

7. BIOSIMILAR TECHNOLOGY SUMMARY

7.1. MONOCLONAL ANTIBODIES (MAB) TECHNOLOGY
- 7.1.1. DRIVERS
  - 7.1.1.1. Broad range of therapeutic, diagnostic, and research applications
  - 7.1.1.2. Low cost of development
  - 7.1.1.3. Higher success rate
- 7.1.2. TOP PLAYER ANALYSIS
7.2. RECOMBINANT DNA TECHNOLOGY (RDNA TECHNOLOGY)
- 7.2.1. DRIVERS
  - 7.2.1.1. Human therapeutics application
  - 7.2.1.2. Agricultural genetic engineering application
  - 7.2.1.3. Increase in demand of biopharmaceutical products
- 7.2.2. RESTRAINTS & OPPORTUNITIES
  - 7.2.2.1. High Cost
  - 7.2.2.2. Risk of failure
  - 7.2.2.3. Role in production of edible vaccines
7.3. CHROMATOGRAPHY
- 7.3.1. DRIVERS & OPPORTUNITIES
  - 7.3.1.1. High resolution refinement
  - 7.3.1.2. Efficacy of end product
  - 7.3.1.3. Wide applications
  - 7.3.1.4. Emergence of biosimilars
- 7.3.2. TOP PLAYER ANALYSIS
- 7.3.3. LIQUID CHROMATOGRAPHY (LC)
- 7.3.4. GAS CHROMATOGRAPHY (GC)
7.4. PROTEIN SEQUENCING
- 7.4.1. DRIVERS
  - 7.4.1.1. Applications in life saving drug development
  - 7.4.1.2. Applications in protein classification
  - 7.4.1.3. Use in diagnosis
7.5. NUCLEAR MAGNETIC RESONANCE (NMR) TECHNOLOGY
- 7.5.1. DRIVERS
  - 7.5.1.1. Leading technology for 3-D structure
  - 7.5.1.2. Eliminates risk of x-radiation
  - 7.5.1.3. Application in drug delivery system
7.6. ELECTROPHORESIS
- 7.6.1. DRIVERS
  - 7.6.1.1. Genomic application
  - 7.6.1.2. Most reliable technique
  - 7.6.1.3. Separation Efficacy
- 7.6.2. RESTRAINTS & OPPORTUNITIES
  - 7.6.2.1. High sample runtime
- 7.6.3. GEL ELECTROPHORESIS
- 7.6.4. CAPILLARY ELECTROPHORESIS
7.7. MASS SPECTROMETRY
- 7.7.1. DRIVERS
  - 7.7.1.1. Simple Quantification of Protein Structures
  - 7.7.1.2. Supporting Element for Growing Technologies:
  - 7.7.1.3. Gaining Popularity of Hybrid Mass Spectrometry Instruments
- 7.7.2. RESTRAINTS
  - 7.7.2.1. Fails to Analyze Small Quantities of Proteins
  - 7.7.2.2. Manual Interruption Necessary, Increasing the Error Rate
7.8. WESTERN BLOTTING
- 7.8.1. DRIVERS
  - 7.8.1.1. Application in molecular biology disciplines
  - 7.8.1.2. Application in diagnosis of diseases
  - 7.8.1.3. High efficacy at low cost
7.9. BIOASSAY
- 7.9.1. DRIVERS
  - 7.9.1.1. Central role in new drug development
  - 7.9.1.2. Monitoring environmental pollutants
  - 7.9.1.3. Cost benefits and error reduction
  - 7.9.1.4. Shrinking pipelines of new drug candidates
  - 7.9.1.5. Increasing price pressures in the U.S. and Europe
- 7.9.2. RESTRAINTS
  - 7.9.2.1. Accuracy of experiment not guaranteed
  - 7.9.2.2. Time-consuming, laborious, and organism-specific activity
- 7.9.3. TECHNIQUES IN BIOASSAY
  - 7.9.3.1. Six Point Assay
  - 7.9.3.2. Multiple Point Assays
  - 7.9.3.3. Interpolation Method
  - 7.9.3.4. Bracketing Method
  - 7.9.3.5. Matching Bioassays

8. GEOGRAPHIC ANALYSIS

8.1. AMERICAN BIOSIMILAR MARKET
- 8.1.1. Large patient base and high Medicare expenditure
- 8.1.2. Largest Biopharmaceutical market
8.2. EUROPEAN BIOSIMILAR MARKET
8.3. ASIAN BIOSIMILAR MARKET
8.4. ROW BIOSIMILAR MARKET

9. REGULATORY GUIDELINES

9.1. AMERICA
- 9.1.1. CANADA
- 9.1.2. U.S.
9.2. ASIA
- 9.2.1. JAPAN
- 9.2.2. HINA
- 9.2.3. NDIA
- 9.2.4. UROPE
- 9.2.5. ROW

10.COMPANY PROFILES

10.1. 3SBIO (SHENYANG SUNSHINE PHARMACEUTICAL CO. LTD)
10.2. ANHUI ANKE BIOTECHNOLOGY (GROUP) CO., LTD
10.3. BHARAT BIOTECH
10.4. BIOCLONES (PTY) LTD.
10.5. BIOCON
10.6. BIOGNERIX AG
10.7. BIOPARTNERS
10.8. CANGENE
10.9. CINNAGEN INC.
10.10. CLARIS LIFESCIENCES
10.11. DONG-A PHARMACEUTICAL
10.12. DR. REDDY' S LABORATORIES
10.13. DSM BIOLOGICS
10.14. DYNAVAX TECHNOLOGIES
10.15. EMCURE
10.16. GENESCIENCE PHARMACEUTICALS CO LTD.
10.17. GLENMARK PHARMACEUTICALS
10.18. GTC BIOTHERAPEUTICS LTD.
10.19. HOSPIRA INC.
10.20. INTAS BIOPHARMACEUTILCALS LTD.
10.21. LG LIFE SCIENCES
10.22. MAXYGEN
10.23. MERCK
10.24. MOMENTA
10.25. PANACEA BIOTECH
10.26. PHAGE BIOTECH CORPORATION
10.27. PHARMACLON
10.28. PROLONG PHARMACEUTICALS
10.29. RANBAXY
10.30. RELIANCE GENEMEDIX PLC 1
10.31. SANDOZ (NOVARTIS PHARMACEUTICAL)
10.32. SCIGEN
10.33. SCINOPHARM TAIWAN, LTD.
10.34. SHANTHA BIOTECH
10.35. SHENZHEN NEPTUNUS INTERLONG
10.36. SHREYA LIFE SCIENCES LTD.
10.37. STADA ARZNEIMITTEL AG
10.38. TEVA PHARMACEUTICAL INDUSTRIES LTD.
10.39. VIROPRO INTERNATIONAL INC.
10.40. WOCKHARDT LIMITED

11.PATENT ANALYSIS

11.1. PATENT EXPIRATION IN 2008 AND BEFORE
11.2. PATENT EXPIRATION IN 2009 AND AFTER

APPENDIX

PATENT EXPIRY IN 2008 AND BEFORE
U.S. BIOPHARMACEUTICAL PATENTS
EUROPEAN BIOPHARMACEUTICAL PATENTS
ASIAN BIOPHARMACEUTICAL PATENTS
PATENT EXPIRY IN 2009 AND AFTER
U.S. BIOPHARMACEUTICAL PATENTS
EUROPEAN BIOPHARMACEUTICAL PATENTS
ASIAN BIOPHARMACEUTICAL PATENTS

LIST OF TABLES

SUMMARY TABLE GLOBAL BIOSIMILAR MARKET, BY PRODUCTS 2007 - 2014($ THOUSANDS)
TABLE 1. GLOBAL BIOSIMILAR NON-GLYCOSYLATED PROTEIN MARKET, BY PRODUCT 2007 - 2014 ($ THOUSANDS)
TABLE 2. GLOBAL BIOSIMILAR RECOMBINANT NON-GLYCOSYLATED PROTEIN MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 3. MAJOR PLAYERS AND THEIR RESPECTIVE DEVELOPMENTS
TABLE 4. GLOBAL BIOSIMILAR RECOMBINANT INSULIN MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 5. GLOBAL BIOSIMILAR RHGH MARKET, BY GEOGRAPHY 2007 - 2014($ THOUSANDS)
TABLE 6. GLOBAL BIOSIMILAR LEPIRUDIN MARKET, BY GEOGRAPHY 2007 - 2014($ THOUSANDS)
TABLE 7. GLOBAL BIOSIMILAR RECOMBINANT INTERLEUKIN - MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 8. GLOBAL BIOSIMILAR RECOBINANT INTERFERONS MARKET, BY PRODUCT2007 - 2014 ($ THOUSANDS)
TABLE 9. GLOBAL BIOSIMILAR RECOMBINANT INTERFERONS MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 10. GLOBAL BIOSIMILAR RECOMBINANT INTERFERON ALFA MARKET BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 11. GLOBAL BIOSIMILAR RECOMBINANT INTERFERON BETA- 1A MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 12. GLOBAL BIOSIMILAR RECOMBINANT INTERFERON GAMMA MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 13. GLOBAL BIOSIMILAR RECOMBINANT GRANULOCYTE COLONY-STIMULATING FACTOR (G-CSF) MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 14. GLOBAL BIOSIMILAR RECOMBINANT INTERLEUKIN- 11 MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 15. GLOBAL BIOSIMILAR RECOMBINANT ANAKINRA MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 16. GLOBAL BIOSIMILAR GLYCOSYLATED PROTEIN MARKET, BY PRODUCTS2007 - 2014 ($ THOUSANDS)
TABLE 17. GLOBAL BIOSIMILAR GLYCOSYLATED PROTEIN MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 18. MAJOR PLAYERS AND THEIR RESPECTIVE DEVELOPMENTS
TABLE 19. GLOBAL BIOSIMILAR RECOMBINANT EPO MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 20. GLOBAL BIOSIMILAR FOLLITROPIN MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 21. GLOBAL BIOSIMILAR THYROTROPIN MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 22. GLOBAL BIOSIMILAR UROKINASE MARKET, BY GEOGRAPHY 2007 - 2014($ THOUSANDS) 61
TABLE 23. GLOBAL BIOSIMILAR GLUCOCEREBROSIDASE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 24. GLOBAL BIOSIMILAR BECAPLERMIN MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 25. GLOBAL BIOSIMILAR RECOMBINANT GM-CSF MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 26. GLOBAL BIOSIMILAR RHDNASE MARKET, BY GEOGRAPHY 2007 - 2014($ THOUSANDS)
TABLE 27. GLOBAL BIOSIMILAR FACTOR VIIA MARKET, BY GEOGRAPHY 2007 - 2014($ THOUSANDS)
TABLE 28. GLOBAL BIOSIMILAR FACTOR VIII MARKET, BY GEOGRAPHY 2007 - 2014($ THOUSANDS)
TABLE 29. GLOBAL BIOSIMILAR FACTOR IX MARKET, BY GEOGRAPHY 2007 - 2014($ THOUSANDS)
TABLE 30. GLOBAL BIOSIMILAR ACTIVATED PROTEIN C MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 31. GLOBAL BIOSIMILAR TPA MARKET, BY GEOGRAPHY 2007 - 2014($ THOUSANDS)
TABLE 32. GLOBAL BIOSIMILAR MONOCLONAL ANTIBODIES MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 33. GLOBAL BIOSIMILAR PEPTIDE MARKET, BY PRODUCTS 2007 - 2014($ THOUSANDS)
TABLE 34. GLOBAL BIOSIMILAR PEPTIDE MARKET, BY GEOGRAPHY 2007 - 2014($ THOUSANDS)
TABLE 35. MAJOR PLAYERS AND THEIR RESPECTIVE DEVELOPMENTS
TABLE 36. GLOBAL BIOSIMILAR OCTREOTIDE PEPTIDE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 37. GLOBAL BIOSIMILAR DESMOPRESSIN PEPTIDE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 38. GLOBAL BIOSIMILAR CYCLOSPORINE PEPTIDE MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 39. GLOBAL BIOSIMILAR CALCITONIN PEPTIDE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 40. GLOBAL BIOSIMILAR EPTIFIBATIDE PEPTIDE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 41. GLOBAL BIOSIMILAR LH-RH PEPTIDE MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 42. GLOBAL BIOSIMILAR NESIRITIDE PEPETIDE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 43. GLOBAL BIOSIMILAR TERIPARATIDE PEPTIDE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 44. GLOBAL BIOSIMILAR BIVALIRUDIN PEPTIDE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 45. GLOBAL BIOSIMILAR ENFUVIRTIDE PEPTIDE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 46. GLOBAL BIOSIMILAR GLUCAGON PEPTIDE MARKET, BY GEOGRAPHY2007 - 2014 ($ THOUSANDS)
TABLE 47. MAJOR PLAYERS AND DEVELOPMENTS
TABLE 48. GLOBAL BIOSIMILAR MARKET, BY APPLICATIONS 2007 - 2014($ THOUSANDS)
TABLE 49. GLOBAL BIOSIMILAR ONCOLOGY MARKET, BY TYPES 2007 - 2014($ THOUSANDS)
TABLE 50. GLOBAL BIOSIMILAR INFECTIOUS DISEASES MARKET, BY TYPES 2007 - 2014 ($ THOUSANDS)
TABLE 51. GLOBAL BIOSIMILAR CHRONIC AND AUTOIMMUNE DISEASE MARKET, BY TYPES 2007 - 2014 ($ THOUSANDS)
TABLE 52. GLOBAL BIOSIMILAR HEMATOLOGY MARKET, BY TYPES 2007 - 2014($ THOUSANDS)
TABLE 53. GLOBAL BIOSIMILAR OTHER DISIEASES MARKET, BY TYPES 2007 - 2014($ THOUSANDS)
TABLE 54. MAJOR PLAYERS AND DEVELOPMENTS
TABLE 55. MAJOR PLAYERS AND DEVELOPMENTS
TABLE 56. GLOBAL BIOSIMILAR MARKET, BY GEOGRAPHY 2007 - 2014 ($ THOUSANDS)
TABLE 57. AMERICAN BIOSIMILAR MARKET, BY SEGMENTS 2007 - 2014($ THOUSANDS)
TABLE 58. EUROPEAN BIOSIMILAR MARKET, BY SEGMENTS 2007 - 2014($ THOUSANDS)
TABLE 59. ASIAN BIOSIMILAR MARKET, BY SEGMENTS 2007 - 2014 ($ THOUSANDS)
TABLE 60. ROW BIOSIMILAR MARKET, BY SEGMENTS 2007 - 2014 ($ THOUSANDS)

LIST OF FIGURES

FIGURE 1. MARKET TRANSITION IMPACTING BIOSIMILAR MARKET
FIGURE 2. ISSUES RELATED WITH BIOSIMILAR
FIGURE 3. BIOSIMILAR MARKET DEFINITION
FIGURE 4. DRIVING FACTOR ANALYSIS OF GLOBAL BIOSIMILAR MARKET
FIGURE 5. MARKET POTENTIAL MATRIX FOR GLOBAL BIOSIMILAR PRODUCT MARKET, 2009
FIGURE 6. MARKET POTENTIAL MATRIX FOR GLOBAL BIOSIMILAR APPLICATION MARKET, 2009
FIGURE 7. GLOBAL BIOSIMILAR MARKET DYNAMICS
FIGURE 8. COMPARISON OF BIOSIMILAR AND GENERIC DRUGS
FIGURE 9. PRICING OF BIOSIMILAR DRUG
FIGURE 10. SUPPLY SIDE STAKEHOLDERS
FIGURE 11. BIOSIMILAR PRODUCTS GEOGRAPHICAL TREND
FIGURE 12. CYCLE OF INNOVATION AND COMPETITION
FIGURE 13. BIOSIMILAR PRODUCT MARKET TREND
FIGURE 14. EUROPEAN BIOSIMILAR MARKET DYNAMICS
FIGURE 15. GLOBAL BIOPHARMACEUTICAL PATENTS, BY SEGMENT
FIGURE 16. GLOBAL BIOPHARMACEUTICAL PATENTS, BY GEOGRAPHY
FIGURE 17. U.S. BIOPHARMACEUTICAL PATENTS, BY SEGMENT
FIGURE 18. EUROPE BIOPHARMACEUTICAL PATENTS, BY SEGMENT
FIGURE 19. ASIA BIOPHARMACEUTICAL PATENTS, BY SEGMENT
FIGURE 20. GLOBAL BIOPHARMACEUTICAL PATENTS, BY SEGMENT
FIGURE 21. GLOBAL BIOPHARMACEUTICAL PATENTS, BY GEOGRAPHY
FIGURE 22. U.S. BIOPHARMACEUTICAL PATENTS, BY SEGMENT
FIGURE 23. EUROPE BIOPHARMACEUTICAL PATENTS, BY SEGMENT
FIGURE 24. ASIA BIOPHARMACEUTICAL PATENTS, BY SEGMENT

LIST OF ACRONYMS AND ABBREVIATIONS

ADR - Adverse Drug Reactions
AIDS - Acquired Immunodeficiency Syndrome
ALL - Acute Lymphoblastic Leukemia
AML - Acute Myelogenous Leukemia
ANDA - Abbreviated New Drug Applications
API - Active Pharmaceutical Ingredients
CAGR - Compound Annual Growth Rate
CBC - Complete Blood Count
CF - Cystic Fibrosis
CHF - Congestive Heart Failure
CHMP - Committee for Medicinal Products for Human Use
CLL - Chronic Lymphocytic Leukemia
CML - Chronic Myelogenous Leukemia
CRAMS - Contract Research And Manufacturing Services
CZE - Capillary Zone Electrophoresis
DI - Diabetes Insipidus
DNA - Deoxyribo Nucleic Acid
EBA - Expanded Bed Absorption
ELISPOT - Enzyme-linked Immunosorbent Spot
EMEA - European Medicines Evaluation Agency
ENF - Enfuvirtide
EPO - Erythropoietin
ERT - Estrogen Replacement Therapy
EU - European Union
FDA - Food and Drugs Administration
GC - Gas Chromatography
GH - Growth Hormone
GHD - Growth Hormone Deficiency
GP - Glycoprotein
HAMA - Human Anti-Mouse Antibody
HCV - Hepatitis C Virus
HD - Hansen' s Disease
hGH - Human Growth Harmone
HIT - Heparin Induced Thrombocytopenia
HIV - Human Immunodeficiency Virus
HPV - Human Papillomavirus
IF - Interferon
IL - Interleukin
IND - Investigational New Drug
IUGR - Intrauterine Growth Retardation
KBA - Kansas Bioscience Authority
LC - Liquid Chromatography
LHRH - Latinizing and Releasing Hormone
LMWH - Low Molecular weight Heparin
MAB - Monoclonal Antibodies
MMF - Mycophenolate Mofetil
MS - Multiple Sclerosis
NDS - New Drug Submission
NE - Nocturnal Enuresis
NHL - Non-Hodgkin' s lymphoma
NMR - Nuclear Magnetic Resonance
NTG - Nitroglycerine
PCI - Percutaneous Coronary Intervention
PE - Pulmonary Embolism
PTCA - Percutaneous Transluminal Coronary Angioplasty
R&D - Research and Development
RA - Rheumatoid Arthritis
RCC - Renal Cell Carcinoma
RFLP - Restriction Fragment Length Polymorphism
RHDNASE - Recombinant Human DNase
RMS - Relapsing Multiple Sclerosis
SBIR - Small Business Innovation Research
SEB - Subsequent Entry Biologics
SLE - Systemic Lupus Erythematosus
THST - Thyroid Hormone Suppression Therapy
tPA - Tissue Plasminogen Activator
TSQ - Triple Stage Quad
WHO - World Health Organization

Biosimilars (2009 - 2014)

Table of Contents

1. INTRODUCTION

2. SUMMARY

3. MARKET OVERVIEW

4. BIOSIMILAR PRODUCTS SUMMARY

5. BIOSIMILAR SERVICE MARKET SUMMARY

6. BIOSIMILAR APPLICATION MARKET SUMMARY

7. BIOSIMILAR TECHNOLOGY SUMMARY

8. GEOGRAPHIC ANALYSIS

9. REGULATORY GUIDELINES

10.COMPANY PROFILES

11.PATENT ANALYSIS

APPENDIX

LIST OF TABLES

LIST OF FIGURES

LIST OF ACRONYMS AND ABBREVIATIONS