What's Next in Biologics? (mAbs, rDNA, Interferons, and Other Biologics) 2011-2015

April 2011 | 150 pages | ID: WD681D7CD0EEN
Kalorama Information

Abstracts

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The future of the pharmaceutical market will be determined by biologics - drugs produced by natural organisms or recombinant techniques consisting of proteins and other products derived from living organisms for the treatment or management of diseases or injuries. What are the products that lead the market now and what can we expect to see in the coming years?

This Kalorama Information report, What's Next in Biologics? represents our latest research into the market for non-vaccine biological drugs and the companies who compete in the market. The following are among the data points in this report:

• Biopharmaceutical Pipeline for Significant Companies
• Market Size of Biopharmaceuticals
• Monoclonal Antibodies (mAbs), Recombinant Hormones and Proteins (rDNA)
• Interferons and
• Other Biologics
• Biopharmaceutical Market Forecast to 2015
• Products in Development: New Compound vs. Additional Indications
• Competitor Market Shares for Biopharmaceuticals
• Autoimmune, Cancer, Cardiovascular and Hormone Treatments Market Sizes and Competitor Shares
• Drug Development Cost Progression
• Leading Biotech Therapies by 2010 Revenues
• Population and Healthcare Spending Trends
• Select Biotechnology Drugs Approved for Marketing

The biologics industry encompasses a wide range of products including monoclonal antibodies, blood products, vaccines, and some diagnostics and devices. For the purpose of this study, Kalorama Information has focuses on those biologics that are used in conjunction with or as a replacement to traditional pharmaceutical treatment. For example, treatments for cancer, growth disorders, autoimmune diseases and blood disorders. This study excludes products such as vaccines—including prophylactic vaccines—which are covered in-depth in separate Kalorama studies.

Contents

CHAPTER ONE: EXECUTIVE SUMMARY

Introduction

Scope and Methodology

Biopharmaceutical Market Overview

Issues and Trends Affecting Market

Leading Companies

CHAPTER TWO: INTRODUCTION

Overview of Biopharmaceutical

General Biotech Terms

Expanded Options in Treating Diseases

Disease Descriptions

Autoimmune Diseases

Cardiovascular and Blood Disorders

Cancer

Hormone Disorders

Infectious Diseases

Neurological Disorders

Research & Development Overview

CHAPTER THREE: BIOLOGIC PRODUCTS ON THE MARKET

Product Segments

Monoclonal Antibodies

Recombinant Hormones and Proteins

Gene Therapy

Interferons/Interleukins

Cell Therapy

Antisense Therapy

Growth Factors

Current Products

CHAPTER FOUR: BIOPHARMACEUTICAL PIPELINES

Overview

Biopharmaceutical Development Outlook

Company R&D Profiles

Abbott

Amgen

Biogen Idec

Bristol-Myers Squibb

Eli Lilly

GlaxoSmithKline

Merck KGaA

Novartis

Novo Nordisk

Pfizer

Roche

CHAPTER FIVE: ISSUES AND TRENDS

Overview of the Industry

The Next Generation of Biologics

Technology for Drug Adherence, Targeted Delivery and Monitoring

Government Incentives for Biologic Development

Biopharmaceutical and Biosimilar Drug Development

Clinical Trial Costs

Orphan Drugs

Pharmaceutical Regulatory Exclusivity

Pediatric Extensions

Biopharmaceutical Industry—Biosimilar (Biogeneric) Development and Exclusivity

Aging Population

Healthcare Expenditures Growth

Health Care Reform's Impact on Biopharmaceutical Companies

Mergers, Acquisitions, and Collaborations

Contributors To R&D Success

R&D Spending

Cancer Drugs in Development 2011

The Impact of Targeted Therapy in Oncology

Genome Sequencing for Personalized Healthcare

The Role of Contract Research Organizations

Global Expansion

CHAPTER SIX: MARKET SUMMARY

Market Overview

Biopharmaceutical Product Analysis

Market Forecast

Geographical Analysis

Competitor Analysis

Company Analysis by Therapeutic Segment

CHAPTER SEVEN: COMPANY PROFILES

Introduction

Abbott Laboratories, Inc

Amgen, Inc.

Biogen Idec

Johnson & Johnson

Merck & Co., Inc.

Merck Serono

Novo Nordisk

Pfizer

Roche/Genentech

Sanofi-Aventis/Genzyme

TABLE OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1 Global Biopharmaceutical Treatments (non-vaccine)Market, 2008-2015 Compound Annual Growth Rate

Figure 1-1 Global Biopharmaceutical Treatments (non-vaccine)Market, 2008-2015

CHAPTER TWO: INTRODUCTION

Table 2-1 World Cancer Incidence by Selected Types of Cancer, 2010 and 2020, all races, both sexes

Table 2-2 Total Cancer Incidence by Sex and Country, 2010 Estimates

Table 2-3 Phases of Clinical Drug Development in the United States

CHAPTER THREE: PRODUCT OVERVIEW

Table 3-1 Monoclonal Antibody Source Identifiers

Figure 3-1 Biopharmaceutical Approvals by Year Range (FDA)

Table 3-2 Select Biopharmaceutical Drugs Approved for Marketing

Table 3-2 (continued) Select Biopharmaceutical Drugs Approved for Marketing

Table 3-2 (continued) Select Biopharmaceutical Drugs Approved for Marketing

Table 3-2 (continued) Select Biopharmaceutical Drugs Approved for Marketing

Table 3-2 (continued) Select Biopharmaceutical Drugs Approved for Marketing

CHAPTER FOUR: DEVELOPMENTS

Figure 4-1 Biopharmaceutical Development by General Indication and Development Activity (Phase III through Registration)

Table 4-1 New Developments in Biopharmaceutical, Phase III and Beyond

Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond

Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond

Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond

Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond

Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond

Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond

Table 4-1 (continued) New Developments in Biopharmaceutical, Phase III and Beyond

Figure 4-2 Pipeline Snapshot: Biopharmaceutical Pipelines for New Compounds and Product Extensions by Type

Figure 4-3 Select Company Biopharmaceutical Pipelines by Development Status

Table 4-2 Abbott’s Biopharmaceutical Pipeline

Table 4-3 Amgen’s Biopharmaceutical Pipeline

Table 4-3 (continued) Amgen’s Biopharmaceutical Pipeline

Table 4-4 Biogen Idec’s Biopharmaceutical Pipeline

Table 4-5 Bristol-Myers Squibb’s Late Stage Biopharmaceutical Pipeline

Table 4-6 Eli Lilly’s Biopharmaceutical Pipeline

Table 4-7 GlaxoSmithKline’s Biopharmaceutical Pipeline

Table 4-7 (continued) GlaxoSmithKline’s Biopharmaceutical Pipeline

Table 4-8 Merck KGaA’s Biopharmaceutical Pipeline

Table 4-9 Novartis’ Biopharmaceutical Pipeline

Table 4-10 Novo Nordisk’s Biopharmaceutical Pipeline

Table 4-11 Pfizer’s Biopharmaceutical Pipeline

Table 4-11 (continued) Pfizer’s Biopharmaceutical Pipeline

Table 4-12 Roche’s Biopharmaceutical Pipeline (including Genentech)

Table 4-12 (continued) Roche’s Biopharmaceutical Pipeline (including Genentech)

Table 4-12 (continued) Roche’s Biopharmaceutical Pipeline (including Genentech)

CHAPTER FIVE: ISSUES AND TRENDS

Table 5-1 International Population Trend Age 65+ International Population Trend Age 65+

Table 5-2 United States Population Trend Age 65+ United States Population Trend Age 65+

Table 5-3 Recent Biopharmaceutical Business Mergers and Acquisitions

Table 5-4 Pharmaceutical/Biopharmaceutical R&D Statistics

Table 5-5 Total Industry R&D Spending 2004-2010

Table 5-6 Pharmaceutical and Biopharmaceutical Cancer Drugs in Development 2011 CHAPTER SIX: MARKET SUMMARY

Table 6-1 Global Biopharmaceutical Treatments (non-vaccine)Market, 2008-2015 Compound Annual Growth Rate

Figure 6-1 Global Biopharmaceutical Treatments (non-vaccine)Market, 2008-2015

Table 6-2 Global Biopharmaceutical Treatments (non-vaccine)Market by Product Category

Figure 6-2 Global Biopharmaceutical Treatments (non-vaccine)Market by Product Category

Table 6-3 Leading Biotech Therapies by 2010 Revenues

Table 6-4 Global Biopharmaceutical Treatments (non-vaccine)Market Forecast by Product Category, 2010 and 2015—based on late stage development

Figure 6-3 Global Biopharmaceutical Treatments (non-vaccine)Market Forecast by Product Category, 2010 and 2015—based on late stage development

Table 6-5 Biopharmaceutical Treatments (non-vaccine)Sales by Region, 2008-2010 and Forecast through 2015

Figure 6-4 Biopharmaceutical Treatments (non-vaccine)Sales by Region, 2008-2010 and Forecast through 2015

Figure 6-5 Estimated Biopharmaceutical Treatments (non-vaccine)Sales by Broad Region, 2010

Table 6-6 Competitor Market Shares and Revenues for Biopharmaceutical Therapies, 2010

Figure 6-6 Biopharmaceutical Sales by Company, 2008-2010

Figure 6-7 Competitor Market Shares for Biopharmaceutical Therapies, 2010

Table 6-7 Top Three Competitors for Autoimmune Biopharmaceutical Treatments, 2010

Figure 6-8 Competitor Market Shares: Autoimmune Biopharmaceutical Therapies, 2010

Table 6-8 Top Three Competitors for Cancer Biopharmaceutical Treatments, 2010

Figure 6-9 Competitor Market Shares: Cancer Biopharmaceutical Treatments, 2010

Table 6-9 Top Three Competitors for Cardiovascular/Blood Disorder Biopharmaceutical Treatments, 2010

Figure 6-10 Competitor Market Shares: Cardiovascular/Blood Disorder Biopharmaceutical Treatments, 2010

Table 6-10 Top Three Competitors for Hormone Biopharmaceutical Treatments, 2010

Figure 6-11 Competitor Market Shares: Hormone Biopharmaceutical Treatments, 2010