Biosimilars (2009 - 2014)

Published by: MarketsandMarkets

Published: Sep. 24, 2009 - 189 Pages

Table of Contents

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-2 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 56

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 GEOGRAPHY2007 - 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 75

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 GEOGRAPHY2007 - 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

Abstract

• Biosimilars product market

• Biosimilars service market

• Biosimilars applications market

• Biosimilars technology market

• We provide the longest market segmentation chain in this industry- not many reports provide market breakdown upto level 5.
• Each report is about 250 pages with 100+ market data tables, 40 competitive company profiles, analysis of 300 patents and a minimum of 50 micro markets, which are collectively exhaustive and mutually exclusive.
• No single report by any other publisher provides market data for all the segments viz products, services, applications, ingredients, technology, and stakeholders in a single report for all the four geographies - US, Europe, APAC, ROW (Rest of the World).
• We provide 10% customization. Normally it is seen that clients do not find specific market intelligence that they are looking for. Our customization will ensure that you necessarily get the market intelligence you are looking for and we get a loyal customer.
• 15 pages of high level analysis including benchmarking strategies, best practices and the market’s cash cows (BCG matrix). We conduct detailed market positioning, product positioning and competitive positioning. Entry strategies, gaps and opportunities are identified for all the stakeholders.
• Comprehensive market analysis for the following sectors: Pharmaceuticals, medical devices, biotechnology, semiconductor and electronics, energy and power supplies, food and beverages, chemicals, advanced materials, industrial automation, and telecom and it. we also analyze retailers and super-retailers, technology providers, and research and development (R&D) companies.

• Which are the high-growth segments/cash cows and how is the market segmented in terms of applications, products, services, ingredients, technologies, and stakeholders?
• What are market estimates and forecasts; which markets are doing well and which are not?
• Where are the gaps and opportunities; what is driving the market?
• Which are the key playing fields? Which are the winning edge imperatives?
• How is the competitive outlook; who are the main players in each of the segments; what are the key selling products; what are their strategic directives, operational strengths and product pipelines? Who is doing what?

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