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Liver Disease Treatments: The Global Market

  • June 2015
  • -
  • BCC Research
  • -
  • 141 pages

Use this report to:
Learn about liver disease drug markets by various types and applications.
Receive information regarding different liver disease drugs in response to an increasing need for new and innovative drug treatments.
Analyze the regulatory environment, technologies, and market projections for liver treatment.
Learn about the application issues, including the latest trends and developments, in each liver disease drug category.

Highlights
The global liver disease therapeutics market totaled nearly $24.5 billion in 2014 and is projected to approach $33.8 billion by 2019, registering a compound annual growth rate
(CAGR) of 6.7% through 2019.
The U.S. as a segment totaled nearly $9.1 billion in 2014 and should total $11.9 billion by 2019, with a CAGR of 5.6% for the period 2014-2019.
Rest of the world as a segment reached nearly $7.7 billion in 2014 and should reach $11.4 billion by 2019, with a CAGR of 8.1% between 2014 and 2019.
CAGR of 8.1% between 2014 and 2019.

INTRODUCTION

STUDY OBJECTIVES
BCC Research’s goal in conducting this study is to provide an overview of the current and future characteristics of the global market for liver disease drugs. The key
objective is to present a comprehensive analysis of the current liver disease drug market and its future direction by utilizing new methods for preventing globally
widespread disease.
This report explores present and future strategies within the liver disease drug market, including market sizes, market leaders, market overview, and various other market
factors. The current state of the market, its setbacks, its innovations, and its future needs are also discussed.
A detailed analysis of the liver disease drug market and the industry structure has been conducted. This includes the different categories of liver disease drugs and the
various types of liver disease broken down by market share belonging to leading manufacturers and/or suppliers. Revenues for each disease type are broken down by
region. Sales figures are estimated for the five-year period from 2014 through 2019.
The strategies and the prospects of the current market are also discussed. Companies that manufacture and sell new and innovative liver disease-related drugs are also
profiled.

REASON FOR DOING THIS STUDY
This study was conducted to provide detailed information regarding different liver disease drugs in response to an increasing need for new and innovative drug
treatments. This industry is experiencing growth, as new product lines have been launched (e.g., Protease inhibitors for the treatment of hepatitis). The study looks at
most of the different drug types and different liver diseases, and cites the research and development for almost all new drugs and applications. The changes in market
behavior demonstrate the need to focus on this segment. Additionally, the study discusses the treatment options provided by these drugs to end-users.

INTENDED AUDIENCE
This study examines the areas of growth in the liver disease drug market from the point of view of both manufacturers and users. This study will be of interest largely to
the pharmaceutical and biopharmaceutical industries, clinics, hospitals, and research institutes.

SCOPE OF THE STUDY
The scope of this study encompasses liver disease drug markets by various types. BCC Research analyzes each market by category with its applications in different regions of
the world. It also analyzes the regulatory environment, technology and market projections. Application issues include the latest trends and developments in each liver
disease drug category.

METHODOLOGY
Both primary and secondary research methodologies were used in preparing this study. BCC Research conducted a comprehensive literature search, which included technical
newsletters and journals, as well as many other sources. Projections were based on estimates such as the current number of end-users, potential end-users, mergers and
acquisitions and market trends.

INFORMATION SOURCES
Many companies within the industry were surveyed to obtain market data, including manufacturers, end-users of drug delivery systems, members of the pharmaceutical
and biotechnical industries and research institutes. Data were gathered from various industry sources. BCC Research spoke with officials within the industry and also
consulted newsletters, company literature, product literature, technical articles, journals, indexes, and abstracts. Exhaustive investigations of databases by key
terminology were completed. In addition, data were compiled from current financial, trade and government sources.



Table Of Contents

Liver Disease Treatments: The Global Market
ISBN: 1-66-100-5
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2
STUDY OBJECTIVES 2
REASON FOR DOING THIS STUDY 2
INTENDED AUDIENCE 2
SCOPE OF THE STUDY 3
METHODOLOGY 3
INFORMATION SOURCES 3
ANALYST'S CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 3
BCC RESEARCH WEBSITE 4
DISCLAIMER 4
CHAPTER 2 EXECUTIVE SUMMARY 6
SUMMARY TABLE GLOBAL DRUG MARKET TO TREAT LIVER DISEASES BY REGION,
THROUGH 2019 ($ MILLIONS) 7
SUMMARY FIGURE GLOBAL DRUG MARKET TO TREAT LIVER DISEASES BY REGION,
2012-2019 ($ MILLIONS) 8
CHAPTER 3 OVERVIEW 10
THE LIVER 10
DEFINITIONS 10
FUNCTIONS OF LIVER 11
PRODUCTION OF BILE 11
STORAGE OF FATS, CARBOHYDRATES, PROTEINS, VITAMINS, AND MINERALS 11
REGULATION OF NECESSARY SUBSTANCES IN THE BLOOD 12
SYNTHESIS OF COAGULATING PROTEINS 12
REMOVAL OF HARMFUL SUBSTANCES 12
OTHER FUNCTIONS 13
COMMON SYMPTOMS OF LIVER DISEASE 13
FATIGUE 13
JAUNDICE 13
SWOLLEN ABDOMEN 13
EFFECTS OF HORMONAL IMBALANCE 14
STOOL ABNORMALITIES 14
POLYDYPSIA AND POLYURIA 14
HEPATIC ENCEPHALOPATHY 14
SEXUAL DYSFUNCTION 14
NON-SPECIFIC SYMPTOMS OF LIVER DISEASE 15
LIVER DISEASE 15
TABLE 1 CLASSIFICATION OF LIVER DISEASE 15
TOXIC INJURY TO THE LIVER 16
Drug-induced Liver Disease 16
Industrial and Environmental Toxins 16
Alcohol-induced 16
Postoperative Hepatic Dysfunction 17
INFECTIOUS AGENTS AND PARASITES 17
Hepatitis Virus 17
Hepatitis A 17
Hepatitis B 17
Hepatitis C 17
Hepatitis D 18
Hepatitis E 18
Neonatal Hepatitis 18
Bacterial and Other Pathogenic Agents 18
Parasites 19
IMMUNE DISORDERS 19
Autoimmune Hepatitis 19
Primary Biliary Cirrhosis 19
TUMORS 20
Primary Malignant Tumors 20
Metastatic Malignant Tumors 21
Benign Hepatic Tumors 21
Tumor-like Lesions 21
INHERITED LIVER DISEASES 21
Wilson's Disease 21
Alagille Syndrome 22
Hemochromatosis 22
Inborn Errors 23
Alpha-1 Antitrypsin Deficiency 23
Cysts 24
Galactosemia 24
Gilbert's Syndrome 24
Tyrosinemia 25
MISCELLANEOUS DISEASES AND CONDITIONS 25
Non-alcoholic Fatty Liver Disease 25
Biliary Atresia 26
Cirrhosis 27
Hepatic Encephalopathy 27
Variceal Bleeding 28
Fatty Liver Disease 29
Gallstones 30
Reye's Syndrome 30
Sarcoidosis 31
CHAPTER 4 CLASSIFICATION OF THERAPIES BY DISEASE AND PRODUCTS ON THE
MARKET 33
VIRUS-INDUCED LIVER DISEASE AND HEPATITIS 33
VIRAL VACCINES 33
TABLE 2 VACCINES FOR HEPATITIS A PREVENTION 33
TABLE 3 VACCINES FOR HEPATITIS B PREVENTION 33
ANTIVIRAL DRUGS 34
Nucleoside Analogs 34
TABLE 4 NUCLEOSIDE ANALOGS USED TO TREAT HEPATITIS 34
Nucleotide Analogs 34
TABLE 5 NUCLEOTIDE ANALOGS USED TO TREAT HEPATITIS 35
Interferon 35
TABLE 6 INTERFERONS USED TO TREAT HEPATITIS 35
Protease Inhibitors 36
TABLE 7 PROTEASE INHIBITORS USED TO TREAT HEPATITIS 36
Immunoglobulins 36
TABLE 8 IMMUNOGLOBULINS USED TO TREAT HEPATITIS 36
LIVER TUMORS AND LIVER CANCER 37
CHEMOTHERAPEUTIC DRUGS 37
TABLE 9 CHEMOTHERAPEUTIC DRUGS USED TO TREAT LIVER CANCER 37
TARGETED THERAPY 38
TABLE 10 TARGETED THERAPY USED TO TREAT LIVER CANCER 38
CONGENITAL LIVER DEFECTS 38
AUTOIMMUNE LIVER DISEASES 38
TABLE 11 DRUGS USED TO TREAT WILSON'S DISEASE 39
CORTICOSTEROIDS 39
TABLE 12 CORTICOSTEROIDS USED TO TREAT AUTOIMMUNE HEPATITIS 39
IMMUNOSUPPRESSIVE AGENTS 40
TABLE 13 IMMUNOSUPPRESSIVE AGENTS USED TO TREAT AUTOIMMUNE HEPATITIS 40
ANTIMETABOLITES 40
TABLE 14 ANTIMETABOLITES USED TO TREAT AUTOIMMUNE HEPATITIS 40
ALCOHOL-INDUCED LIVER DISEASE 40
ANABOLIC STEROIDS 41
TABLE 15 ANABOLIC STEROIDS USED TO TREAT ALCOHOLIC LIVER DISEASE 41
ALCOHOL-ABUSE DRUGS 41
TABLE 16 ALCOHOL-ABUSE DRUGS USED TO TREAT ALCOHOLIC LIVER DISEASE 41
CHRONIC LIVER DISEASE 41
ANTI-REJECTION MEDICATIONS 42
TABLE 17 ANTI-REJECTION MEDICATIONS USED TO TREAT CHRONIC LIVER DISEASE 42
ANTI-INFECTIVES 42
TABLE 18 ANTI-INFECTIVES DRUGS USED TO TREAT CHRONIC LIVER DISEASE 42
ANTIFUNGAL PROPHYLAXIS 43
TABLE 19 ANTIFUNGAL PROPHYLAXIS FOR LIVER TRANSPLANT RECIPIENTS 43
NON-ALCOHOLIC FATTY LIVER DISEASE 43
GALLSTONE-SOLUBILIZING AGENTS 44
TABLE 20 GALLSTONE-SOLUBILIZING AGENTS USED TO TREAT NON-ALCOHOLIC
FATTY LIVER DISEASE 44
OTHER DRUGS 44
TABLE 21 OTHER DRUGS USED TO TREAT NON-ALCOHOLIC FATTY LIVER DISEASE 44
CHAPTER 5 REGULATORY ASPECTS 46
TABLE 22 NEW APPROVALS FOR DRUGS USED TO TREAT LIVER DISEASE,
2008-2013 46
TABLE 23 NUMBER OF NEW APPROVALS FOR DRUGS USED TO TREAT LIVER
DISEASE, 2008-2013 46
FIGURE 1 NUMBER OF NEW APPROVALS FOR DRUGS USED TO TREAT LIVER
DISEASE, 2008-2013 47
TABLE 24 NEW DRUG APPLICATIONS, 2008-2013 47
TABLE 25 RECALLS, 2008-2014 47
CHAPTER 6 PREVALENCE 50
U.S. 50
TABLE 26 U.S. PREVALENCE OF LIVER DISEASE, 2000-2020 (NUMBER) 51
TABLE 27 U.S. HEPATITIS BURDEN, 2013 (NO. OF INFECTIONS) 51
EUROPE 51
REST OF THE WORLD 52
CHAPTER 7 MARKET BY DISEASE TYPE 54
TABLE 28 GLOBAL DRUG MARKET TO TREAT LIVER DISEASES BY DISEASE TYPE,
THROUGH 2019 ($ MILLIONS) 54
FIGURE 2 GLOBAL DRUG MARKET TO TREAT LIVER DISEASES BY DISEASE TYPE,
2012-2019 ($ MILLIONS) 54
HEPATITIS 55
TABLE 29 GLOBAL DRUG MARKET TO TREAT HEPATITIS BY REGION, THROUGH
2019 ($ MILLIONS) 56
FIGURE 3 GLOBAL DRUG MARKET TO TREAT HEPATITIS BY REGION, 2012-2019 ($
MILLIONS) 56
HEPATOCELLULAR CARCINOMA 56
TABLE 30 GLOBAL DRUG MARKET TO TREAT HEPATOCELLULAR CARCINOMA BY
REGION, THROUGH 2019 ($ MILLIONS) 58
FIGURE 4 GLOBAL DRUG MARKET TO TREAT HEPATOCELLULAR CARCINOMA BY
REGION, 2012-2019 ($ MILLIONS) 58
AUTOIMMUNE LIVER DISEASES 58
TABLE 31 GLOBAL DRUG MARKET TO TREAT AUTOIMMUNE LIVER DISEASES BY
REGION, THROUGH 2019 ($ MILLIONS) 59
FIGURE 5 GLOBAL DRUG MARKET TO TREAT AUTOIMMUNE LIVER DISEASES BY
REGION, 2012-2019 ($ MILLIONS) 59
ALCOHOL-INDUCED LIVER DISEASE 60
TABLE 32 GLOBAL DRUG MARKET TO TREAT ALCOHOL-INDUCED LIVER DISEASES
BY REGION, THROUGH 2019 ($ MILLIONS) 61
FIGURE 6 GLOBAL DRUG MARKET TO TREAT ALCOHOL-INDUCED LIVER DISEASES
BY REGION, 2012-2019 ($ MILLIONS) 61
CHRONIC LIVER DISEASE 61
TABLE 33 GLOBAL DRUG MARKET TO TREAT CHRONIC LIVER DISEASE BY REGION,
THROUGH 2019 ($ MILLIONS) 62
FIGURE 7 GLOBAL DRUG MARKET TO TREAT CHRONIC LIVER DISEASE BY REGION,
2012-2019 ($ MILLIONS) 63
NON-ALCOHOLIC FATTY LIVER DISEASE 63
TABLE 34 GLOBAL DRUG MARKET TO TREAT NON-ALCOHOLIC FATTY LIVER
DISEASE BY REGION, THROUGH 2019 ($ MILLIONS) 64
FIGURE 8 GLOBAL DRUG MARKET TO TREAT NON-ALCOHOLIC FATTY LIVER
DISEASE BY REGION, 20120-2019 ($ MILLIONS) 65
CHAPTER 8 PIPELINE 67
TABLE 35 CLINICAL TRIALS FOR LIVER DISEASES BY PHASE 67
TABLE 36 NUMBER OF CLINICAL TRIALS FOR LIVER DISEASES BY PHASE 71
FIGURE 9 NUMBER OF CLINICAL TRIALS FOR LIVER DISEASES BY PHASE 71
CHAPTER 9 DRUG-INDUCED LIVER DISEASE 74
TABLE 37 DRUGS THAT CAN CAUSE LIVER DISEASE 76
MAJOR DRUGS THAT CAN CAUSE LIVER DISEASE 80
ACETAMINOPHEN (TYLENOL) 80
STATINS 80
NICOTINIC ACID (NIACIN) 80
AMIODARONE (CARDARONE) 80
NITROFURANTOIN 80
AUGMENTIN 80
CHAPTER 10 CURRENT SITUATION AND FUTURE PROSPECTS 82
PREVALENCE AND LIFE EXPECTANCY 82
LACK OF EDUCATION AND LIMITED TREATMENT OPTIONS 82
RESEARCH AND DEVELOPMENT 83
LIVER ORGANIZATIONS 84
CHAPTER 11 PATENT ANALYSIS 87
TABLE 38 NUMBER OF U.S. PATENTS FOR DRUGS USED TO TREAT LIVER DISEASE
BY COMPANY, 2012-NOVEMBER, 2014 87
TABLE 39 LIST OF PATENTS ISSUED, 2012-2014 88
TABLE 40 LIST OF PATENT APPLICATIONS, 2012-2014 109
CHAPTER 12 COMPANY PROFILES 137
ABBOTT LABORATORIES 137
ACHILLION PHARMACEUTICALS 137
ACTAVIS INC. 138
ALKERMES 138
ANTIPODEAN PHARMACEUTICALS 139
BAYER HEALTHCARE PHARMACEUTICALS 139
BIOTEST 140
BRISTOL-MYERS SQUIBB 140
CONATUS PHARMACEUTICALS 141
ELI LILLY 141
GALECTIN THERAPEUTICS 142
GILEAD SCIENCES INC. 142
GLAXOSMITHKLINE 143
GLOBEIMMUNE 143
GRIFOLS INTERNATIONAL 144
INTERCEPT PHARMACEUTICALS 144
ISIS PHARMACEUTICALS 144
KYOWA HAKKO KIRIN 145
MERCK and CO. 145
NOVARTIS 146
OCERA THERAPEUTICS INC. 146
PEREGRINE 147
PFIZER 147
ROCHE 148
ROXANE LABORATORIES 148
SALIX PHARMACEUTICALS 149
SCHERING PLOUGH CORP. 149
TAKEDA PHARMACEUTICAL 150
VALEANT PHARMACEUTICALS 151
VERTEX PHARMACEUTICALS INC. 152
XIAMEN AMOYTOP BIOTECH 152
ZYDUS PHARMACEUTICALS INC. 153

LIST OF TABLES

SUMMARY TABLE GLOBAL DRUG MARKET TO TREAT LIVER DISEASES BY REGION,
THROUGH 2019 ($ MILLIONS) 7
TABLE 1 CLASSIFICATION OF LIVER DISEASE 15
TABLE 2 VACCINES FOR HEPATITIS A PREVENTION 33
TABLE 3 VACCINES FOR HEPATITIS B PREVENTION 33
TABLE 4 NUCLEOSIDE ANALOGS USED TO TREAT HEPATITIS 34
TABLE 5 NUCLEOTIDE ANALOGS USED TO TREAT HEPATITIS 35
TABLE 6 INTERFERONS USED TO TREAT HEPATITIS 35
TABLE 7 PROTEASE INHIBITORS USED TO TREAT HEPATITIS 36
TABLE 8 IMMUNOGLOBULINS USED TO TREAT HEPATITIS 36
TABLE 9 CHEMOTHERAPEUTIC DRUGS USED TO TREAT LIVER CANCER 37
TABLE 10 TARGETED THERAPY USED TO TREAT LIVER CANCER 38
TABLE 11 DRUGS USED TO TREAT WILSON'S DISEASE 39
TABLE 12 CORTICOSTEROIDS USED TO TREAT AUTOIMMUNE HEPATITIS 39
TABLE 13 IMMUNOSUPPRESSIVE AGENTS USED TO TREAT AUTOIMMUNE HEPATITIS 40
TABLE 14 ANTIMETABOLITES USED TO TREAT AUTOIMMUNE HEPATITIS 40
TABLE 15 ANABOLIC STEROIDS USED TO TREAT ALCOHOLIC LIVER DISEASE 41
TABLE 16 ALCOHOL-ABUSE DRUGS USED TO TREAT ALCOHOLIC LIVER DISEASE 41
TABLE 17 ANTI-REJECTION MEDICATIONS USED TO TREAT CHRONIC LIVER DISEASE 42
TABLE 18 ANTI-INFECTIVES DRUGS USED TO TREAT CHRONIC LIVER DISEASE 42
TABLE 19 ANTIFUNGAL PROPHYLAXIS FOR LIVER TRANSPLANT RECIPIENTS 43
TABLE 20 GALLSTONE-SOLUBILIZING AGENTS USED TO TREAT NON-ALCOHOLIC
FATTY LIVER DISEASE 44
TABLE 21 OTHER DRUGS USED TO TREAT NON-ALCOHOLIC FATTY LIVER DISEASE 44
TABLE 22 NEW APPROVALS FOR DRUGS USED TO TREAT LIVER DISEASE, 2008-2013 46
TABLE 23 NUMBER OF NEW APPROVALS FOR DRUGS USED TO TREAT LIVER DISEASE,
2008-2013 46
TABLE 24 NEW DRUG APPLICATIONS, 2008-2013 47
TABLE 25 RECALLS, 2008-2014 47
TABLE 26 U.S. PREVALENCE OF LIVER DISEASE, 2000-2020 (NUMBER) 51
TABLE 27 U.S. HEPATITIS BURDEN, 2013 (NO. OF INFECTIONS) 51
TABLE 28 GLOBAL DRUG MARKET TO TREAT LIVER DISEASES BY DISEASE TYPE,
THROUGH 2019 ($ MILLIONS) 54
TABLE 29 GLOBAL DRUG MARKET TO TREAT HEPATITIS BY REGION, THROUGH 2019
($ MILLIONS) 56
TABLE 30 GLOBAL DRUG MARKET TO TREAT HEPATOCELLULAR CARCINOMA BY
REGION, THROUGH 2019 ($ MILLIONS) 58
TABLE 31 GLOBAL DRUG MARKET TO TREAT AUTOIMMUNE LIVER DISEASES BY
REGION, THROUGH 2019 ($ MILLIONS) 59
TABLE 32 GLOBAL DRUG MARKET TO TREAT ALCOHOL-INDUCED LIVER DISEASES BY
REGION, THROUGH 2019 ($ MILLIONS) 61
TABLE 33 GLOBAL DRUG MARKET TO TREAT CHRONIC LIVER DISEASE BY REGION,
THROUGH 2019 ($ MILLIONS) 62
TABLE 34 GLOBAL DRUG MARKET TO TREAT NON-ALCOHOLIC FATTY LIVER DISEASE
BY REGION, THROUGH 2019 ($ MILLIONS) 64
TABLE 35 CLINICAL TRIALS FOR LIVER DISEASES BY PHASE 67
TABLE 36 NUMBER OF CLINICAL TRIALS FOR LIVER DISEASES BY PHASE 71
TABLE 37 DRUGS THAT CAN CAUSE LIVER DISEASE 76
TABLE 38 NUMBER OF U.S. PATENTS FOR DRUGS USED TO TREAT LIVER DISEASE BY
COMPANY, 2012-NOVEMBER, 2014 87
TABLE 39 LIST OF PATENTS ISSUED, 2012-2014 88
TABLE 40 LIST OF PATENT APPLICATIONS, 2012-2014 109


LIST OF FIGURES

SUMMARY FIGURE GLOBAL DRUG MARKET TO TREAT LIVER DISEASES BY REGION,
2012-2019 ($ MILLIONS) 8
FIGURE 1 NUMBER OF NEW APPROVALS FOR DRUGS USED TO TREAT LIVER DISEASE,
2008-2013 47
FIGURE 2 GLOBAL DRUG MARKET TO TREAT LIVER DISEASES BY DISEASE TYPE,
2012-2019 ($ MILLIONS) 54
FIGURE 3 GLOBAL DRUG MARKET TO TREAT HEPATITIS BY REGION, 2012-2019 ($
MILLIONS) 56
FIGURE 4 GLOBAL DRUG MARKET TO TREAT HEPATOCELLULAR CARCINOMA BY
REGION, 2012-2019 ($ MILLIONS) 58
FIGURE 5 GLOBAL DRUG MARKET TO TREAT AUTOIMMUNE LIVER DISEASES BY
REGION, 2012-2019 ($ MILLIONS) 59
FIGURE 6 GLOBAL DRUG MARKET TO TREAT ALCOHOL-INDUCED LIVER DISEASES BY
REGION, 2012-2019 ($ MILLIONS) 61
FIGURE 7 GLOBAL DRUG MARKET TO TREAT CHRONIC LIVER DISEASE BY REGION,
2012-2019 ($ MILLIONS) 63
FIGURE 8 GLOBAL DRUG MARKET TO TREAT NON-ALCOHOLIC FATTY LIVER DISEASE
BY REGION, 20120-2019 ($ MILLIONS) 65
FIGURE 9 NUMBER OF CLINICAL TRIALS FOR LIVER DISEASES BY PHASE 71

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