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

$2,500.00 – $5,000.00

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SKU: KLI5061933 Categories: Manufacturing & Packaging, Pharmaceuticals Market Research Pages: 400
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Description

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.

Table of Contents

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

 

    Biopharmaceutical Contract Manufacturing Organization (BCMO) Market, 2022
    August 2, 2022
    100 Companies in Contract Pharmaceutical Research – White Paper
    March 27, 2018
    Biopharmaceutical Contract Manufacturing (BCMO) Market – by Type of Service, by Organization and by Region
    November 29, 2017
    Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, Forecasts to 2018, 6th Edition
    April 30, 2014

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