1. Get more info on this report!
What's Next in Biologics? (mAbs, rDNA, Interferons, and Other
Biologics) 2011-2015
May 1, 2011
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
o Monoclonal Antibodies (mAbs)
o Recombinant Hormones and Proteins (rDNA)
o Interferons and
o 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

2. 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
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

3. 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.
More Drug Discovery Reports by Kalorama Information
Laboratory Information Systems (LIS / LIMS) Markets by Kalorama Information
Automating instruments in the laboratory has created a demand for similar automation
of information management systems, a need for speeding the turnaround of data and ...
Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, 4th
Edition by Kalorama Information
Kalorama Information's Outsourcing in Drug Discovery offers unparalleled discussion of
the drug discovery outsourcing market. It presents viewpoints from both customers and
suppliers. ...
The Worldwide Market for Anti-Infectives (Antifungals, Antibacterials and Antivirals) by

4. Kalorama Information
The anti-infective market is at a critical juncture. For the past 60 years, antibiotic drugs
have turned bacterial infections into treatable conditions rather than ...
World Veterinary Health Products (Animal Pharmaceuticals, Vaccines, OTC and
Performance Enhancers) by Kalorama Information
The multi-billion veterinary health products market, though smaller in opportunity as
compared with the human health sector, offers significant return on investment,
primarily driven by ...
Clinical Nutrition Products: World Markets, 3rd Edition by Kalorama Information
This Kalorama Information report - Clinical Nutrition - focuses on three primary
segments of essential medical nutrition: Infant Nutrition: (Milk-based, Soy-based,
Special Needs such as ...
TABLE OF 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
o Autoimmune Diseases
o Cardiovascular and Blood Disorders
o Cancer
o Hormone Disorders
o Infectious Diseases
o Neurological Disorders
Research & Development Overview
CHAPTER THREE: BIOLOGIC PRODUCTS ON THE MARKET
Product Segments
o Monoclonal Antibodies
o Recombinant Hormones and Proteins

5. o Gene Therapy
o Interferons/Interleukins
o Cell Therapy
o Antisense Therapy
o Growth Factors
Current Products
CHAPTER FOUR: BIOPHARMACEUTICAL PIPELINES
Overview
Biopharmaceutical Development Outlook
Company R&D Profiles
o Abbott
o Amgen
o Biogen Idec
o Bristol-Myers Squibb
o Eli Lilly
o GlaxoSmithKline
o Merck KGaA
o Novartis
o Novo Nordisk
o Pfizer
o Roche
CHAPTER FIVE: ISSUES AND TRENDS
Overview of the Industry
The Next Generation of Biologics
o 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
o Pediatric Extensions
o Biopharmaceutical Industry—Biosimilar (Biogeneric) Development and
Exclusivity
Aging Population
Healthcare Expenditures Growth
o 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

6. The Role of Contract Research Organizations
Global Expansion
CHAPTER SIX: MARKET SUMMARY
Market Overview
Biopharmaceutical Product Analysis
Market Forecast
Geographical Analysis
Competitor Analysis
o 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)

7. 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)

8. 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

9. Table 6-10 Top Three Competitors for Hormone Biopharmaceutical Treatments,
2010
Figure 6-11 Competitor Market Shares: Hormone Biopharmaceutical Treatments,
2010
Available immediately for Online Download at
http://www.marketresearch.com/product/display.asp?productid=6329805
US: 800.298.5699
UK +44.207.256.3920
Int'l: +1.240.747.3093
Fax: 240.747.3004