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What's Next in Biopharmaceuticals? (mAbs, rDNA, Interferons, and Other Upcoming Biologic Drugs) 2011-2015

Kalorama Information
May 1, 2011
150 Pages - SKU: KLI6329805

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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?

Find out in Kalorama Information's report, What's Next in Biologics?, which 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 focuses on those biologics that are used in conjunction with, or as a replacement to, traditional pharmaceutical treatments. 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.

The following topics are among the qualitative analysis found in this report:

The Role Government Incentives Will Play in the Future Biotech Market
Pharmaceutical Regulatory Exclusivity
Biosimilars: Where They Stand and What We Can Expect
The Largest Areas of Research for Biopharmaceuticals
Improvements in the Next Generation of Biologics
The Impact of Aging Populations on Biotechnology Market Development
Health Care Reform: What it Means
Recent Mergers, Acquisitions, and Collaborations
Contributors to R&D Success
Targeted Cancer Therapy
Genome Sequencing for Personalized Healthcare
The Role of Contract Research Organizations

In the traditional pharmaceutical market, the pipeline is struggling to produce strong therapies and the growing number of drugs losing patent protection will more than offset revenues generated from new developments. For now, the biotechnology market is spared the impact of this setback as the path to generic or biosimilar development is more involved and the number of biotechnology drugs facing generic competition remains limited. Many companies are capitalizing on this trend, and among those discussed in the report include the following:

Abbott Laboratories
Amgen
Biogen Idec
Johnson & Johnson
Merck & Co.
Merck Serono
Novo Nordisk
Pfizer
Roche/Genentech
Sanofi-Aventis/Genzyme

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For Kalorama's take on the healthcare news of the week, based on our analysis of healthcare markets, follow Kalorama Information's Key Point Blog at http://kaloramakeypoint.blogspot.com/

Additional Information

A full biologics pipeline will lead to continued growth in the biopharmaceutical market, according to Kalorama Information. The healthcare market research firm expects annual growth of 7.1% through 2015, given the nearly 200 products in late-stage development. According to their latest report, What's Next in Biologics (mAbs, rDNA, Interferons, and Other Biologics) 2011-2015, the top five biopharmaceutical companies continue to dominate this market landscape.

A majority of the 200 biologics currently in the development pipeline are aimed at the treatment of cancers, followed by cardiovascular diseases and autoimmune and hormone disorders. According to the report, monoclonal antibodies account for the largest share of the innovation with nearly thirty new antibody compounds in development. Multiple companies expecting to profit from the products currently in late-stage development, each of which can cost $1-2 billion to develop, are driving the market's growth through 2015, when Kalorama expects it to reach just under $150 billion.

"The Phase III pipelines are heavy in this area and that will keep growth up," said Bruce Carlson, publisher of Kalorama Information. "The beneficiaries will be a number of companies, though especially the top five. Although a number of smaller companies are operating in this market, difficulties remain in overcoming the high cost of development."

The report details several companies, but indicates that the biologics market is still dominated by the top five pharmaceutical companies--Amgen, GlaxoSmithKline, Novartis, Pfizer and Roche--which combined hold over a quarter of the late-stage products.

"The big players have a steady flow of new products and extensions coming through the pipeline, with over 100 projects in development," added Carlson. "The strongest pipeline is still held by Roche's Genetech."

Kalorama Information's What's Next in Biologics (mAbs, rDNA, Interferons, and Other Biologics) 2011-2015 looks at the market for non-vaccine biological drugs and the companies that compete in the market. The report discusses the biopharmaceutical pipeline for major companies and provides market size estimates and forecasts for monoclonal antibodies, recombinant hormones and proteins, interferons and other biologics.

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

What's Next in Biopharmaceuticals? (mAbs, rDNA, Interferons, and Other Upcoming Biologic Drugs) 2011-2015

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