The World Market for Orphan Drugs (Markets for Oncology, Hematology, Neurology, Endocrine, Metabolic and Other Drugs)

Jun 13, 2013
400 Pages - Pub ID: KLI5061933
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In recent years, there has been a substantial increase in the number of drugs available to treat rare ("orphan") diseases. This comprehensive report, The World Market for Orphan Drugs, looks at this trend and provides estimates for the market opportunity in the U.S., Europe, Japan and globally. With over 400 pages of market analysis and over 120 figures and tables, the report provides in-depth coverage of key competitors and important trends and challenges for makers of orphan drug treatments.

Osteoporosis, arthritis, Alzheimer’s, and Parkinson’s are major factors affecting quality of life. Mortality from cancer, diabetes, liver and kidney diseases has been slow to change, offering significant areas for research breakthroughs. Cancer, poorly served by traditional chemotherapies, is a major opportunity for biotech firms because the investment compared to return can be favorable: the field has high priority with regulatory authorities who are willing to give it fast track status on the basis of smaller (and therefore cheaper) clinical trials (a few extra months of survival could be enough to win FDA approval); the clinical community is highly concentrated; and the market size is often larger than the approved indication because of a high off-label use (for other cancers). Infectious diseases, the third most common cause of death in many geographic regions, highlight the pressing need for new therapies with novel mechanisms of action to avoid growing issues affecting this industry including a top area of concern—drug resistance.

This report provides estimates for the world market for orphan drugs, as well as the E.U. and Japan markets. Given the size of the U.S. opportunity, the report offers in-depth market data for the U.S. market. Several segments are discussed, including:
  • Oncology
  • Hematology
  • Musculoskeletal
  • Neurology
  • Endocrine
  • Metabolic
  • Others
These segments are the most common areas of development and success for orphan drug developers/marketers which required providing detailed information about these orphan drug market segments.

In the U.S., a drug may be designated an orphan drug if the disease or condition for which it is indicated, affects less than 200,000 Americans. Orphan medicinal products in the E.U. member states are intended for the diagnosis, prevention or treatment of life-threatening or very serious conditions that affect not more than 5 in 10,000 persons. In Japan an orphan drug may be designated for a patient population of less than 50,000 and provide for an unmet medical need. Other countries have similar designations. These three regional markets for drugs are examined in separate sections of the report.

Analysis of The “Pure” Orphan Drug Market

Some publicized estimates of orphan drug markets include brand revenue that is not truly related to the orphan status of the drug. In this unique research effort, Kalorama Information separates strictly orphan revenue from total brand revenue where necessary to provide a true picture of the pure orphan drug market opportunity. The world orphan drug market is difficult to determine due to the variances in orphan drug status and requirements by country. Products may be available as an orphan drug on one country and be a traditional marketing approval for another country. In addition, some products gain orphan status, are granted approval and then removed from the orphan drug database at the request of the developer. There are a number of factors involved, including reimbursement by country, regulation by country, disease status by country and general development by country.

For this market research report, market numbers discussed in this report are focused on the global market in brief with in-depth market coverage of the U.S. market. Additionally, there is select coverage for the European Union and Japanese market. All sales are displayed at the manufacturers’ level in U.S. dollars.

This report includes orphan drugs. In cases where sales are generated by indications for both orphan indications and non-orphan indications, we have attempted to extract just the orphan portion of sales. The base year is 2012, with forecasts provided for each year through 2017. The market was generated using estimates of individual product sales and compared with market data from a combination of other methods including disease prevalence trends, population trends, pricing trends, government regulations and reimbursements. Both primary and secondary sources were consulted in developing market estimates.

Demographics, Costs, Regulation and Other Trends Examined

The list of trends and factors affecting the orphan drug market remain lengthy. The orphan drug market is affected by both trends that affect the pharmaceutical industry as a whole and trends that specifically affect the orphan drug market:
  • Orphan drug pricing
  • Aging of the population
  • Increasing life expectancy
  • Trends in birth rates
  • Cost effectiveness
  • Regulatory environments
  • Orphan drug incentives
  • Population demographics
  • Product availability by country/region
Due to the wide variety of products to receive orphan designations, there are numerous developers with products in this area. Some of the developers that have received an orphan designation have followed through to receive a full product approval but others may not gain additional approvals.

Extensive Company Coverage

The report looks extensively at what major pharmaceutical companies and smaller concerns are doing within this drug category. The report provides company market share for both the US and global markets. A variety of companies with both designations and designation/approvals are discussed in this report:
  • Abbott Laboratories
  • AbbVie
  • Actelion
  • Amgen
  • Astellas
  • AstraZeneca
  • Baxter
  • Bayer
  • Bio Products Laboratory
  • Biogen IDEC
  • BioMarin Pharmaceuticals
  • Boehringer-Ingelheim
  • Bristol-Myers Squibb
  • Cangene
  • Celgene
  • CSL Behring
  • Depomed
  • Eisai
  • Eli Lilly & Co.
  • EMD Serono
  • Exelixis
  • Gilead Sciences
  • GlaxoSmithKline
  • ImmunoGen
  • Insmed
  • Johnson & Johnson
  • Luitpold Pharmaceuticals
  • Merck & Co
  • Millennium Pharmaceuticals
  • NBI Pharmaceuticals
  • Novartis
  • Novo Nordisk
  • NPS Pharmaceuticals
  • Pfizer
  • Roche
  • Sanofi
  • Seattle Genetics
  • Shire
  • Sigma-Tau
  • Soligenix
  • Spectrum Pharmaceuticals
  • Swedish Orphan Biovitrum
  • TEVA
  • United Therapeutics
  • Valeant Pharmaceuticals
  • XenoPort
Biological therapies have increasingly become the treatment of choice for many diseases. Several hundred million individuals worldwide have been helped by more than 150 therapies. Many of these areas of treatment have huge numbers of individuals affected each year while other areas are small but growing due to the advancement in treatment, superior therapies, and development incentives--such as those that accompany orphan drug designation/approvals.

Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study Kalorama Information conducted interviews with more than 130 key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with leading orphan drug developers' representatives including marketing directors, division managers, and product representatives, were consulted. Secondary sources such as company literature, databases, investment reports, and business journals were used to complement primary information.
CHAPTER ONE: EXECUTIVE SUMMARY
Introduction
Scope and Methodology
Market Segments
Issues and Trends
World Market Summary
Competitors
CHAPTER TWO: INTRODUCTION
Overview
History of the U.S. Orphan Drug Market
Pharmaceutical Research & Development Overview
Pharmaceutical Industry Important Regulatory Terms
Diseases and Orphan Drug Impact
Disease Descriptions
Blood Disorders
Cancer
Hormone Disorders
Infectious Diseases
The Cost Side of Orphan Drugs
CHAPTER THREE: U.S. ORPHAN DRUGS
Overview
Recent Orphan Drug Designations
Orphan Drug Approvals by Company
Abbott Laboratories
Acorda Therapeutics
Actelion Pharmaceuticals
Aegerion Pharmaceuticals
Alexion Pharmaceuticals
Allergan, Inc.
Amgen
Ariad Pharmaceuticals
Astellas
AstraZeneca
Auxilium Pharmaceuticals, Inc.
Bausch & Lomb
Baxter International
Bayer AG
Biogen IDEC
BioMarin Pharmaceutical, Inc.
Boehringer Ingelheim
Bristol-Myers Squibb
Cangene Corporation
Celgene Corporation
CSL Behring
Eisai Co., Ltd.
Eli Lilly & Company
EMD Serono
Endo Health Solutions, Inc.
(previously Endo Pharmaceuticals, Inc.)
Exelixis, Inc.
Gilead Sciences, Inc.
GlaxoSmithKline
Grifols, S.A.
Hyperion Therapeutics, Inc.
Incyte Corporation
Ipsen, Inc.
Jazz Pharmaceuticals plc
Johnson & Johnson
KV Pharmaceutical Company
Merck & Company
Novartis
Novo Nordisk
NPS Pharmaceuticals
Octapharma USA, Inc.
Onyx Pharmaceuticals, Inc.
Otsuka Pharmaceutical Co., Inc.
Pacira Pharmaceuticals, Inc.
Pfizer, Inc.
Rare Disease Therapeutics, Inc.
Reckitt Benckiser Group plc
Regeneron Pharmaceuticals, Inc.
Roche
Salix Pharmaceuticals, Inc.
Sanofi
Savient Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Shire Plc
Sigma-Tau Pharmaceuticals, Inc.
Spectrum Pharmaceuticals
Takeda Pharmaceutical Company Ltd.
Talon Therapeutics, Inc.
Teva Pharmaceuticals
United Therapeutics Corporation
Valeant Pharmaceuticals International, Inc.
Vertex Pharmaceuticals, Inc.
ViroPharma, Inc.
CHAPTER FOUR: E.U. ORPHAN DRUGS
Overview
Recent Orphan Drug Designations
Select Company Orphan Drug Activities
Actelion Pharmaceuticals
Adienne Pharma & Biotech
Alexion Pharmaceuticals
Amgen
Bayer AG
BioMarin Pharmaceutical, Inc.
Bristol-Myers Squibb
Celgene Corporation
Eisai Co., Ltd.
Gilead Sciences, Inc.
GlaxoSmithKline
Novartis
Orphan Europe S.A.R.L.
Pfizer, Inc.
Sanofi
Shire Plc
Vertex Pharmaceuticals, Inc.
CHAPTER FIVE: JAPAN ORPHAN DRUGS
Overview
Recent Orphan Drug Designations
Select Company Orphan Drug Activities
Actelion Pharmaceuticals
Alexion Pharmaceuticals
Bristol-Myers Squibb
Celgene Corporation
GlaxoSmithKline
Johnson & Johnson
Merck Serono
Mitsubishi Tanabe
Novartis
Pfizer, Inc.
Roche
Sanofi
CHAPTER SIX: COMPETITOR TRENDS AND PRACTICES
Acquisitions and Agreements
U.S. Competitor Market Analysis
Amgen
Roche
Celgene
Novartis
Abbott
Biogen Idec
Bayer
Eli Lilly
Bristol-Myers Squibb
Novo Nordisk
Sanofi
Allergan
Other Companies
CHAPTER SEVEN: ORPHAN DRUG INDUSTRY TRENDS
Introduction
U.S. Regulation Shaping the Orphan Drug Segment
Orphan Drug Act of 1983
Rare Disease Act of 2002
Office of Orphan Products Development
Humanitarian Use Device Program
Positives and Negatives of the Orphan Drug Designation
Orphan Drug Designation in the U.S.
Orphan Drug Designation in the E.U.
Orphan Drug Designation in Japan
Orphan Drug Designation in Canada
Orphan Drug Designation in Australia
Factors Affecting the Health Industry
Aging of the Population
Population Statistics
Global Population Trends
Global Population over 65
U.S. Population Trends
U.S. Population over 65
Global Trends in Life Expectancy
Global Trends in Birth Rates
Global Healthcare Spending Trends
General Economic Trends by Country
U.S. Health Industry Trends
U.S. Healthcare Challenges
Economic Trends in the U.S.
U.S. Health Expenditures by Type
CHAPTER EIGHT: U.S. ORPHAN DRUG MARKET SIZE AND OPPORTUNITY
Overview
Market Size and Forecast
Markets by Product Classification
Oncology
Suppliers Market Share
Hematology
Suppliers Market Share
Musculoskeletal
Suppliers Market Share
Neurology
Suppliers Market Share
Endocrinology
Suppliers Market Share
Metabolic
Suppliers Market Share
Others
Suppliers Market Share
CHAPTER NINE: WORLD MARKET SUMMARY⎯ ORPHAN DRUGS
Overview
Market Distribution: United States and World Markets
CHAPTER TEN: CORPORATE PROFILES
Introduction
Orphan Drug Designations by Company: A U.S. Analysis
Company Profiles
Abbott Laboratories
Company Overview
Performance Review
AbbVie
Company Overview
Performance Review
Actelion
Company Overview
Performance Review
Overview
Performance Review
Astellas
Company Overview
Performance Review
AstraZeneca
Company Overview
Performance Review
Baxter
Company Overview
Performance Review
Bayer
Company Overview
Performance Review
Bio Products Laboratory
Company Overview
Biogen Idec
Company Overview
Performance Review
BioMarin
Company Overview
Performance Review
Boehringer Ingelheim
Company Overview
Performance Review
Bristol-Myers Squibb
Company Overview
Performance Review
Cangene
Company Overview
Performance Review
Celgene
Company Overview
Performance Review
CSL Behring
Company Overview
Performance Review
Depomed
Company Overview
Performance Review
Eisai
Company Overview
Performance Review
Eli Lilly
Company Overview
Performance Review
EMD Serono
Company Overview
Performance Review
Exelixis
Company Overview
Performance Review
Gilead Sciences
Company Overview
Performance Review
GlaxoSmithKline
Company Overview
Performance Review
ImmunoGen
Company Overview
Performance Review
Insmed
Company Overview
Performance Review
Johnson & Johnson
Company Overview
Performance Review
LUITPOLD
Company Overview
Performance Review
Merck & Co
Company Overview
Performance Review
Millennium Pharmaceuticals
Company Overview
Performance Review
NBI Pharmaceuticals
Company Overview
Novartis
Company Overview
Performance Review
Novo Nordisk
Company Overview
Performance Review
NPS Pharmaceuticals
Company Overview
Performance Review
Pfizer
Company Overview
Performance Review
Roche
Company Overview
Performance Review
Sanofi
Company Overview
Performance Review
Seattle Genetics
Company Overview
Performance Review
Shire
Company Overview
Performance Review
Sigma Tau
Company Overview
Performance Review
Soligenix
Company Overview
Performance Review
Spectrum
Company Overview
Performance Review
Swedish Orphan Biovitrum
Company Overview
Performance Review
TEVA
Company Overview
Performance Review
United Therapeutics
Company Overview
Performance Review
Valeant
Company Overview
Performance Review
XenoPort
Company Overview
Performance Review
REGULATORY AUTHORITIES AND ORGANIZATIONS
LIST OF COMPANIES
LIST OF EXHIBITS
CHAPTER ONE: EXECUTIVE SUMMARY
Table 1-1
World Orphan Drug Market 2007-2017
Figure 1-1: World Orphan Drug Market
CHAPTER TWO: INTRODUCTION
Table 2-1
Phases of Clinical Drug Development
Table 2-2
Total Cancer Incidence by Sex and Country
Figure 2-1
Total Cancer Incidence by Sex and Country
Table 2-3
Average Annual Drug Costs to Patients, Selected Drugs
Figure 2-2
Average Annual Drug Costs to Patients, Selected Drugs
CHAPTER THREE: U.S. ORPHAN DRUGS
Table 3-1
Orphan Drug Designations Granted and Approvals by the FDA 1983-2013*
Figure 3-1
Orphan Drug Designations Granted and Approvals by the FDA 1983-2013*
Table 3-2
12-Months Orphan Drug Designations Granted by FDA (May 1, 2012 - May 1, 2013)
Figure -3-2
May 2012 - May 2013 FDA Orphan Drug Designations by Target Classification
Table 3-3
Abbott Laboratories' Orphan Drug Approvals Granted by FDA
Table 3-4
Acorda Therapeutics' Orphan Drug Approvals Granted by FDA
Table 3-5
Actelion Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-6
Aegerion Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-7
Alexion Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-8
Allergan's Orphan Drug Approvals Granted by FDA
Table 3-9
Amgen's Orphan Drug Approvals Granted by FDA
Table 3-9 (continued)
Amgen's Orphan Drug Approvals Granted by FDA
Table 3-10
Ariad Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-11
Astellas' Orphan Drug Approvals Granted by FDA
Table 3-12
AstraZeneca's Orphan Drug Approvals Granted by FDA
Table 3-13
MedImmune's Orphan Drug Approvals Granted by FDA
Table 3-14
Auxilium Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-15
Bausch & Lomb's Orphan Drug Approvals Granted by FDA
Table 3-16
Baxter International's Orphan Drug Approvals Granted by FDA
Table 3-17
Bayer's Orphan Drug Approvals Granted by FDA
Table 3-18
Biogen IDEC's Orphan Drug Approvals Granted by FDA
Table 3-19
BioMarin Pharmaceutical's Orphan Drug Approvals Granted by FDA
Table 3-20
Boehringer Ingelheim's Orphan Drug Approvals Granted by FDA
Table 3-21
Bristol-Myers's Orphan Drug Approvals Granted by FDA
Table 3-22
Cangene's Orphan Drug Approvals Granted by FDA
Table 3-23
Celgene Corporation's Orphan Drug Approvals Granted by FDA
Table 3-24
CSL Behring's Orphan Drug Approvals Granted by FDA
Table 3-25
Eisai's Orphan Drug Approvals Granted by FDA
Table 3-26
Eli Lilly's Orphan Drug Approvals Granted by FDA
Table 3-27
EMD Serono's Orphan Drug Approvals Granted by FDA
Table 3-28
Endo Health Solutions' Orphan Drug Approvals Granted by FDA
Table 3-29
Exelixis' Orphan Drug Approvals Granted by FDA
Table 3-30
Gilead Sciences' Orphan Drug Approvals Granted by FDA
Table 3-31
GlaxoSmithKline's Orphan Drug Approvals Granted by FDA
Table 3-32
Grifols' Orphan Drug Approvals Granted by FDA
Table 3-33
Hyperion Therapeutics' Orphan Drug Approvals Granted by FDA
Table 3-34
Incyte Corporation's Orphan Drug Approvals Granted by FDA
Table 3-35
Ipsen's Orphan Drug Approvals Granted by FDA
Table 3-36
Jazz Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-37
Johnson & Johnson Pharmaceutical's Orphan Drug Approvals Granted by FDA
Table 3-38
Alza's Orphan Drug Approvals Granted by FDA
Table 3-39
Janssen's Orphan Drug Approvals Granted by FDA
Table 3-40
KV Pharmaceutical's Orphan Drug Approvals Granted by FDA
Table 3-41
Merck & Co.'s Orphan Drug Approvals Granted by FDA
Table 3-41 (continued)
Merck & Co.'s Orphan Drug Approvals Granted by FDA
Table 3-42
Novartis' Orphan Drug Approvals Granted by FDA
Table 3-43
Alcon's Orphan Drug Approvals Granted by FDA
Table 3-44
Novo Nordisk's Orphan Drug Approvals Granted by FDA
Table 3-45
NPS Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-46
Octapharma's Orphan Drug Approvals Granted by FDA
Table 3-47
Onyx Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-48
Otsuka Pharmaceutical's Orphan Drug Approvals Granted by FDA
Table 3-49
Pacira Pharmaceutical's Orphan Drug Approvals Granted by FDA
Table 3-49
Pfizer's Orphan Drug Approvals Granted by FDA
Table 3-49 (continued)
Pfizer's Orphan Drug Approvals Granted by FDA
Table 3-50
Rare Disease Therapeutics' Orphan Drug Approvals Granted by FDA
Table 3-51
Reckitt Benckiser's Orphan Drug Approvals Granted by FDA
Table 3-52
Regeneron Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-53
Roche's Orphan Drug Approvals Granted by FDA
Table 3-54
Genentech's Orphan Drug Approvals Granted by FDA
Table 3-55
Salix Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-56
Sanofi's Orphan Drug Approvals Granted by FDA
Table 3-57
Genzyme's Orphan Drug Approvals Granted by FDA
Table 3-58
Savient Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-59
Seattle Genetics' Orphan Drug Approvals Granted by FDA
Table 3-60
Shire's Orphan Drug Approvals Granted by FDA
Table 3-61
Sigma Tau's Orphan Drug Approvals Granted by FDA
Table 3-62
Spectrum Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-63
Millennium Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-64
Talon Therapeutics' Orphan Drug Approvals Granted by FDA
Table 3-65
Teva's Orphan Drug Approvals Granted by FDA
Table 3-66
Cephalon's Orphan Drug Approvals Granted by FDA
Table 3-67
United Therapeutics' Orphan Drug Approvals Granted by FDA
Table 3-68
Valeant Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-69
Vertex Pharmaceuticals' Orphan Drug Approvals Granted by FDA
Table 3-70
ViroPharma's Orphan Drug Approvals Granted by FDA
CHAPTER FOUR: E.U. ORPHAN DRUGS
Table 4-1
Orphan Drug Designations and Approvals Granted by the EMA 2000-2013*
Figure 4-1
Orphan Drug Designations and Approvals Granted by the EMA 2000-2013*
Figure 4-2
Orphan Drugs Approved by EMA by Target Category
Table 4-2
Orphan Drug Designations Granted by EMA (January 1, 2012 - December 31, 2012)
Figure -4-3
2012 European Union Orphan Drug Designations by Target Classification
Table 4-3
Orphan Drug Designations Granted by EMA (2013, January - April)
CHAPTER FIVE: JAPAN ORPHAN DRUGS
Table 5-1
Orphan Drug Designations and Approvals Granted by the MHLW 1993-2012*
Figure 5-1
Orphan Drug Designations and Approvals Granted by the MHLW 1993-2012*
Figure 5-2
Orphan Drugs Approved by MHLW by Target Category
Table 5-2
Orphan Drug Designations Granted by MHLW (January 1, 2012 - November 14, 2012)
Figure 5-3
2012 Ministry of Health, Labour, and Welfare Orphan Drug Designations by Target Classification
CHAPTER SIX: COMPETITOR TRENDS AND PRACTICES
Figure 6-1
Amgen’s Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-2
Roche’s Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-3
Celgene’s Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-4
Novartis’ Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-5
Abbott’s Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-6
Biogen Idec’ Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-7
Bayer’s Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-8
Eli Lilly’s Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-9
Bristol-Myers’ Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-10
Novo Nordisk’s Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-11
Sanofi’s Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Figure 6-12
Allergan’s Orphan Drug Sales as a Percentage of Total Prescription Drug Sales, United States
Table 6-1
Competitor Analysis, U.S. Orphan Drug Market, 2012
Figure 6-13
Competitor Analysis, U.S. Orphan Drug Market, 2012
CHAPTER SEVEN: ORPHAN DRUG INDUSTRY TRENDS
Table 7-1
The Global Population, 1980-2050
Figure 7-1
The Global Population, 1980-2050
Table 7-2
Global Population Trends Age 65+, 2000-2050
Figure 7-2
Global Population Trends Age 65+, 2000-2050
Table 7-3
The U.S. Population, 1980-2050
Figure 7-3
The U.S. Population, 1980-2050
Table 7-4
Percent U.S. Population Over Age 65 by Year, 2000-2050
Figure 7-4
United States Population Trend Age 65+, 2000-2050
Table 7-5
Average Life Expectancy in Years by Country 1980 and 2012
Figure 7-5
Average Life Expectancy in Years by Country 1980 and 2012
Table 7-6
Crude Birth Rate per 1,000 Persons 2000, 2005, 2010, Estimated 2012 and Projected 2020
Figure 7-6
Crude Birth Rate per 1,000 Persons 2000, 2005, 2010, Estimated 2012 and Projected 2020
Table 7-7
Total Healthcare Expenditures as a Percent of GDP by Country 1990, 2000 and 2010209
Figure 7-7
Total Healthcare Expenditures as a Percent of GDP by Country 1990, 2000 and 2010210
Table 7-8
Average Annual Growth of GDP by Country 2007-2011
Table 7-9
National Healthcare Expenditures in the United States 1960-2020
Table 7-10
National Health Expenditure Amounts, by Type of Expenditure: Calendar Years 2015- 2021
CHAPTER EIGHT: U.S. ORPHAN DRUG MARKET SIZE AND OPPORTUNITY
Table 8-1
The U.S. Orphan Drug Market 2007-2017
Figure 8-1: U.S. Orphan Drug Market
Figure 8-2
Distribution of Sales by Product Classification for Approved
U.S. Orphan Drugs, 2012
Table 8-2
The U.S. Market for Orphan Drugs with Oncology Targets 2007-2017
Figure 8-3
The U.S. Market for Orphan Drugs with Oncology Targets 2007-2017
Figure 8-4
Distribution of Sales for Orphan Drugs with Oncology Targets by Supplier, 2012
Table 8-3
The U.S. Market for Orphan Drugs with Hematology Targets 2007-2017
Figure 8-5
The U.S. Market for Orphan Drugs with Hematology Targets 2007-2017
Figure 8-6
Distribution of Sales for Orphan Drugs with Hematology Targets by Supplier, 2012
Table 8-4
The U.S. Market for Orphan Drugs with Musculoskeletal Targets 2007-2017
Figure 8-7
The U.S. Market for Orphan Drugs with Musculoskeletal Targets 2007-2017
Figure 8-8
Distribution of Sales for Orphan Drugs with Musculoskeletal Targets by Supplier, 2012
Table 8-5
The U.S. Market for Orphan Drugs with Neurology Targets 2007-2017
Figure 8-9
The U.S. Market for Orphan Drugs with Neurology Targets 2007-2017
Figure 8-10
Distribution of Sales for Orphan Drugs with Neurology Targets by Supplier, 2012
Table 8-6
The U.S. Market for Orphan Drugs with Endocrinology Targets 2007-2017
Figure 8-11
The U.S. Market for Orphan Drugs with Endocrinology Targets 2007-2017
Figure 8-12
Distribution of Sales for Orphan Drugs with Endocrinology Targets by Supplier, 2012
Table 8-7
The U.S. Market for Orphan Drugs with Metabolic Targets 2007-2017
Figure 8-13
The U.S. Market for Orphan Drugs with Metabolic Targets 2007-2017
Figure 8-14
Distribution of Sales for Orphan Drugs with Metabolic Targets by Supplier, 2012
Table 8-8
The U.S. Market for Orphan Drugs with Other Disease Targets 2007-2017
Figure 8-15
The U.S. Market for Orphan Drugs with Other Disease Targets 2007-2017
Figure 8-16
Distribution of Sales for Orphan Drugs with Other Disease Targets by Supplier, 2012252
CHAPTER NINE: WORLD MARKET SUMMARY⎯ ORPHAN DRUGS
Table 9-1
World Orphan Drug Market 2007-2017
Figure 9-1: World Orphan Drug Market .Share By Competitor
Table 9-2
World Orphan Drug Market: Distribution by United States and Rest of World, 2007- 2017
Figure 9-2
World Orphan Drug Market: Distribution by United States and Rest of World, 2007- 2017
Figure 9-3
Orphan Drugs: World Markets by Region, 2012
CORPORATE PROFILES
Figure 10-1
Orphan Drug Designations (FDA) by Company
Figure 10-2
Abbott's Financial Performance, 2010-2012
Figure 10-3
AbbVie's Financial Performance, 2010-2012
Figure 10-3
Actelion's Financial Performance, 2010-2012
Figure 10-4
Amgen's Financial Performance, 2010-2012
Figure 10-5
Astellas' Financial Performance, 2010-2012
Figure 10-6
AstraZeneca's Financial Performance, 2010-2012
Figure 10-7
Baxter's Financial Performance, 2010-2012
Figure 10-7
Bayer's Financial Performance, 2010-2012
Figure 10-8
Biogen's Financial Performance, 2010-2012
Figure 10-9
BioMarin's Financial Performance, 2010-2012
Figure 10-10
Boehringer Ingelheim's Financial Performance, 2010-2012
Figure 10-11
Bristol-Myers Squibb's Financial Performance, 2010-2012
Figure 10-12
Cangene's Financial Performance, 2010-2012
Figure 10-13
Celgene's Financial Performance, 2010-2012
Figure 10-14
CSL Limited's Financial Performance, 2010-2012
Figure 10-15
Depomed's Financial Performance, 2010-2012
Figure 10-16
Eisai Company's Financial Performance, 2010-2012
Figure 10-17
Eli Lilly's Financial Performance, 2010-2012
Figure 10-18
Merck KGaA's Financial Performance, 2010-2012
Figure 10-19
Exelixis' Financial Performance, 2010-2012
Figure 10-20
Gilead's Financial Performance, 2010-2012
Figure 10-21
GlaxoSmithKline's Financial Performance, 2010-2012
Figure 10-22
ImmunoGen's Financial Performance, 2010-2012
Figure 10-23
Insmeds's Financial Performance, 2010-2012
Figure 10-24
Johnson & Johnson's Financial Performance, 2010-2012
Figure 10-25
Daiichi Sankyo's Financial Performance, 2010-2012
Figure 10-26
Merck & Co.'s Financial Performance, 2010-2012
Figure 10-27
Takeda's Financial Performance, 2010-2012
Figure 10-28
Novartis' Financial Performance, 2010-2012
Figure 10-29
Novo Nordisk's Financial Performance, 2010-2012
Figure 10-30
NPS Pharmaceutical's Financial Performance, 2010-2012
Figure 10-31
Pfizer's Financial Performance, 2010-2012
Figure 10-32
Roche's Financial Performance, 2010-2012
Figure 10-33
Sanofi's Financial Performance, 2010-2012
Figure 10-34
Seattle Genetics' Financial Performance, 2010-2012
Figure 10-35
Shire's Financial Performance, 2010-2012
Figure 10-36
Soligenix' Financial Performance, 2010-2012
Figure 10-37
Spectrum's Financial Performance, 2010-2012
Figure 10-38
Swedish Orphan Biovitrum's Financial Performance, 2010-2012
Figure 10-39
TEVA's Financial Performance, 2010-2012
Figure 10-40
United Therapeutics' Financial Performance, 2010-2012
Figure 10-41
Valeant's Financial Performance, 2010-2012
Figure 10-42
XenoPort's Financial Performance, 2010-2012
REGULATORY AUTHORITIES AND ORGANIZATIONS
LIST OF COMPANIES

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