The Market for Bioengineered Protein Drugs

Published by: BCC Research

Published: Jan. 30, 2007 - 132 Pages

Table of Contents

INTRODUCTION

STUDY OBJECTIVES

SCOPE AND CONTENT

METHODOLOGY AND SOURCES

AUDIENCE FOR THIS REPORT

ANALYST CREDENTIALS

RELATED BCC PUBLICATIONS

BCC ONLINE SERVICES

DISCLAIMER

EXECUTIVE SUMMARY

Summary Table:

WORLDWIDE MARKET FOR PROTEIN DRUGS, THROUGH 2011 ($ BILLION)

Summary Figure:

WORLDWIDE SALES FORECAST FOR PROTEIN DRUGS, 2006 AND 2011 ($ BILLIONS)

OVERVIEW

THE MAKING OF A PROTEIN

ADVANTAGES OF PROTEIN-BASED DRUGS

DRAWBACKS TO PROTEIN-BASED DRUGS

DRUG DELIVERY

Aerosol

Table 1 COMPANIES INVOLVED IN DEVELOPMENT OF PULMONARY DELIVERY SYSTEMS

Oral Administration

Implanted Drug Delivery

Smart Materials

Sustained Delivery

Injection/I.V.

DRUG DISCOVERY-DEVELOPMENT OF PROTEIN BASED DRUGS

PROTEIN IMMUNOGENICITY

PROTEOMICS

PROTEIN CHIPS

SYNTHETIC BIOLOGY

Directed Evolution

SOURCES

RECOMBINANT PROTEIN THERAPEUTICS

Table 2 TOP TEN RECOMBINANT THERAPEUTIC PROTEINS AND THEIR GLOBAL SALES, 2001-2005 ($ MILLIONS)

HARVESTED PROTEINS

Human

Animal

Plant

Microbial

TYPES OF PROTEIN BASED DRUGS

Replacement proteins

Antibodies

Peptides versus whole proteins

INDUSTRY BACKGROUND

THE PHARMACEUTICAL INDUSTRY

Table 3 GLOBAL PHARMACEUTICAL SALES, 1998-2005 ($ BILLIONS)

Table 4 LEADING PRODUCTS BY GLOBAL PHARMACEUTICAL SALES, 2005 ($ BILLIONS)

THE FDA

GENERICS MARKET

Table 5 TOP PROTEIN DRUGS TO GO OFF PATENT, 2006-2010

Table 6 U.S. GENERIC DRUG MARKET SHARE (DISPENSED PRESCRIPTIONS) (%)

TECHNOLOGICAL ADVANCES OF NOTE

REAL TIME MONITORING OF PROTEIN PRODUCTION

PROTEIN FOLDING

PROTEIN PHOSPHORYLATION

FDA APPROVAL PROCESS

Table 7 COSTS OF EACH STAGE OF FDA APPROVAL PROCESS ($ MILLIONS)

DEPENDENT INDUSTRIES: RESEARCH TOOLS

AUTOMATION

Expression

CELL CULTURE

Table 8 COMPANIES INVOLVED IN PROVIDING CELL CULTURE REAGENTS, EQUIPMENT AND CELL LINES, 2003-2005 ($ MILLION)

Table 9 PRIVATE COMPANIES SELLING CELL CULTURE REAGENTS AND EQUIPMENT

PROTEIN ASSAY KITS AND EQUIPMENT

Table 10 MARKET SHARES OF COMPANIES SELLING PROTEIN ASSAY KITS AND EQUIPMENT (%)

Protein Refolding

PROTEIN ARRAYS

Table 11 MARKET SHARE OF COMPANIES SELLING PROTEIN ARRAYS

MICROWELL PLATES

Table 12 COMPANIES INVOLVED IN PRODUCTION OF MICROWELL PLATES

IMAGING

Fluorescence

Table 13 SALES OF COMPANIES OFFERING BIOLOGICAL STAINS, DYES AND OTHER IMAGING REAGENTS, 2003-2006 ($ MILLION)

ION CHANNELS

Table 14 COMPANIES INVOLVED IN ION CHANNELS AND PATCH CLAMPING SYSTEMS

Designer Cells

X-ray Crystallography

Spectroscopy

PURIFICATION/ SEPARATION

Separation

Spectroscopy

Flow Cytometry

Table 15 COMPANIES INVOLVED IN FLOW CYTOMETRY TECHNOLOGY

Western Blots

BIOINFORMATICS

PROTEIN DATABASES

EFFECT OF PATENTING/TRADE SECRETS OF RESEARCH TOOLS

PROTEIN DRUGS

PROTEIN DRUGS

Table 16 TOP SELLING PROTEIN DRUGS WORLDWIDE, 2002-2005 ($ MILLION)

Table 17 GLOBAL MARKET FORECAST FOR TYPES OF PROTEIN DRUGS, THROUGH 2011 ($ MILLIONS)

Figure 1 GLOBAL MARKET FORECAST FOR TYPES OF PROTEIN DRUGS 2006 AND 2011 ($ MILLIONS)

PROTEIN DRUGS (CONTINUED)

REPLACEMENT PROTEINS

Table 18 GLOBAL MARKET FORECAST OF REPLACEMENT PROTEINS, THROUGH 2011 ($ MILLION)

Figure 2 GLOBAL MARKET FORECAST OF REPLACEMENT PROTEINS, 2006 AND 2011 ($ MILLION)

HORMONE REPLACEMENT

GROWTH HORMONE

OTHER RECOMBINANT REPLACEMENT PROTEINS

THERAPEUTIC ENZYMES

Table 19 WORLDWIDE SALES OF THERAPEUTIC ENZYMES, 2003-2011 ($ MILLION)

RECOMBINANT PROTEIN DRUGS

Table 20 WORLDWIDE SALES OF RECOMBINANT/BIOENGINEERED PROTEIN DRUGS, 2003-2005 ($ MILLION)

GROWTH FACTORS

Table 21 GLOBAL MARKET SALES GROWTH FACTORS, 2003-2011 ($ MILLION)

Figure 3 GLOBAL MARKET SALES GROWTH FACTORS, BY MANUFACTURER, 2006 AND 2011 ($ MILLION)

Table 22 WORLDWIDE SALES GROWTH FACTOR INHIBITORS, 2003-2005 ($ MILLIONS)

PEPTIDE DRUGS

CURRENTLY MARKETED PEPTIDE DRUGS

Fuzeon

Integrilin

Cubicin

Prialt

NON-NATURAL AMINO ACIDS

PEPTIDE DRUGS IN DEVELOPMENT

Oxytocin Analogs

Icatibant

Neurovax

HURDLES TO PEPTIDE DRUG DEVELOPMENT

COAGULANTS

Table 23 WORLDWIDE SALES OF COAGULANTS, THROUGH 2011 ($ MILLION)

HORMONES

Table 24 WORLDWIDE SALES OF HORMONES, THROUGH 2011 ($ MILLION)

ESTROGEN ANALOGS

Raloxifene

Premarin

Gonal-F

GONADAL STEROIDS

Tibolone

HORMONE REPLACEMENT THERAPY (HRT)

THYROID AND PARATHYROID DERIVED HORMONES

Parathyroid Hormone (Teriparatide)

MONOCLONAL ANTIBODIES

Table 25 CURRENTLY APPROVED THERAPEUTIC MONOCLONAL ANTIBODIES, UNITED STATES

Table 26 WORLDWIDE SALES OF MONOCLONAL ANTIBODIES USED AS THERAPEUTICS, 2003-2005 ($ MILLION)

DENOSUMAB

MORPHOTEK

Table 27 GLOBAL MARKET SALES OF MONOCLONAL ANTIBODIES USED AS THERAPEUTICS, 2003-2011 ($ MILLION)

Figure 4 GLOBAL MARKET SALES OF MONOCLONAL ANTIBODIES USED AS THERAPEUTICS, 2006 AND 2011 ($ MILLION)

VACCINES

ROTAVIRUS

HEAT SHOCK PROTEINS

DISEASES

DIABETES

INSULIN DELIVERY SYSTEMS

Inhaled-Exubera

Inhaler-Nektar Therapeutic

Alternatives to insulin

Byetta (Eli Lilly/Amylin)

Glucophage

DIABETIC RETINOPATHY

HEMOPHILIA

ANTI-COAGULANTS

HEART DISEASE

APOA-1

LIPITOR

RAISING HDL

VEGF AS A TREATMENT

Table 28 WORLDWIDE SALES OF PROTEIN DRUGS USED FOR TREATMENT OF CARDIOVASCULAR DISEASE, 2003-2005 ($ MILLION)

NEURODEGENERATIVE DISEASE

Table 29 POSITION IN THE PIPELINE OF BIOTECHNOLOGY THERAPIES TARGETING ALZHEIMER'S DISEASE

Table 29 (CONTINUED)

RESPIRATORY DISEASES

CYSTIC FIBROSIS

EMPHYSEMA

PULMONARY FIBROSIS

INFECTIOUS DISEASE

ANTIBIOTIC RESISTANCE

FUNGAL DISEASES

TWEAK

SKIN DISEASES/ INJURIES

PSORIASIS

LESIONS

WOUND TREATMENT

ARTHRITIS

RHEUMATOID ARTHRITIS

Table 30 WORLDWIDE SALES OF PROTEIN DRUGS FOR ARTHRITIS, 2003-2005 ($ MILLION)

PSORIATIC ARTHRITIS

OSTEOARTHRITIS

CONGENITAL DISEASE

ORPHAN DRUG ACT

CANCER

Table 31 WORLDWIDE SALES BY TYPE OF CANCER DRUGS, THROUGH 2011 ($ MILLION)

INTERFERONS

Interferon -2a (Roferon-A)

Interferon -2b (Intron A)

Interferon -n3 (Alferon N)

Interferon con-1 (Infergen)

Interferon -1a (Avonex)

Interferon -1b (Betaseron)

Interferon -1b (Actimmune)

COMBINATION THERAPY

PEGYLATED INTERFERONS

Table 32 GLOBAL MARKET FORECAST OF INTERFERON, THROUGH 2011 ($ MILLION)

Figure 5 GLOBAL MARKET FORECAST OF INTERFERON, 2006 AND 2011 ($ MILLION)

Cytokines

CANCER VACCINES

Table 33 COMPANIES INVOLVED IN DEVELOPMENT OF CANCER VACCINES BASED ON PROTEIN THERAPEUTICS

COLORECTAL CANCER

Table 34 PROTEIN THERAPEUTICS FOR THE TREATMENT OF COLORECTAL CANCER

ANGIOGENESIS INHIBITORS

Figure 6 CHEMOTHERAPY DRUG TARGETS THAT MAY HAVE ANTIANGIOGENIC EFFECTS

Table 35 STRATEGIES TARGETING ENDOTHELIAL AND NON-ENDOTHELIAL CELLS TO INHIBIT TUMOR ANGIOGENESIS

Table 36 SELECTED BREAST CANCER BIOTECH COMPANIES AND DRUG CANDIDATES IN THE CLINIC ($ MILLION)

NON-SMALL-CELL LUNG CARCINOMA

Table 37 ONGOING FIRST-LINE TRIALS OF PROTEIN THERAPIES FOR NON-SMALL CELL LUNG CANCER

AUTOIMMUNE DISORDERS

MULTIPLE SCLEROSIS

PAIN

AGING

Growth Hormones Used to Help the Elderly

AGE-RELATED MACULAR DEGENERATION

OBESITY

COMPANY PROFILES

MAJOR PLAYERS-GENERAL INFORMATION

Table 38 PROTEIN DRUG COMPANY PROFILES

MERGERS/ ACQUISITIONS 2000-2005

FOCUS ON INVITROGEN

2003

2005

2006

MERCK-SERONO

CORIXA-GLAXO SMITHKLINE

STRATEGIC ALLIANCES 2000-2006

MULTISPAN AND MOLECULAR DEVICES

SANOFI-AVENTIS/PFIZER/NEKTAR THERAPEUTICS

MILLIPORE AND JPT PEPTIDE TECHNOLOGIES

APO2L/TRAIL-GENENTECH AND AMGEN

JUVENILE DIABETES RESEARCH FOUNDATION AND IMMUNE TOLERANCE NETWORK

HELIX BIOPHARMA AND QSV BIOLOGICS

ARADIGM AND NOVO NORDISK

INCYTE GENOMICS AND LEXICON GENETICS

Incyte Co-Promotion of LexVision

Access to LexVision and Lifeseq Gold for Drug Discovery Research

FDA APPROVED DRUGS

Table 39 FDA APPROVED PROTEIN DRUGS, BY COMPANY, JAN 2000-MAY 2006

PATENT LANDSCAPE

TYPES OF PATENTS/MAJOR PATENT PORTFOLIOS

Table 40 PATENT OWNERSHIP, 2000-2006

Table 41 RECENT PATENTS AND PATENT APPLICATIONS FOR PROTEIN THERAPEUTICS, JANUARY 2000-JUNE 2006

Table 41 (CONTINUED)

FUTURE DRIVERS: PATENT EXPIRATIONS

Table 42 PROTEIN THERAPEUTICS LOSING PATENT PROTECTION

FUTURE DRIVERS: RESEARCH INITIATIVES

PHARMASTART

SECRETED PROTEIN DISCOVERY INITIATIVE

LITIGATION

CAMBRIDGE ANTIBODY TECHNOLOGY V. ABBOTT

ELI LILLY V. ARIAD

ELI LILLY & CO V. MASSACHUSETTS INSTITUTE OF TECHNOLOGY AND HARVARD UNIVERSITY

NOVO NORDISK V. PFIZER

BRISTOL-MYERS SQUIBB V. APOTEX

DAIICHI PHARMACEUTICAL CO. V. APOTEX INC

FUTURE DRIVERS: FUNDING

BRISTOL-MYERS SQUIBB (BMS)

EUROPEAN SCIENCE FOUNDATION

NATIONAL CANCER INSTITUTE-PROTEOMICS

CLINICAL TRIAL TRENDS

Abstract

INTRODUCTION

This report updates BCC's report Market for Bioengineered Protein Drugs and reviews the global markets for the different types of protein drugs as well as forecasts for trends and sales through 2011. Important research developments, regulatory trends and other factors influencing demand will be discussed.

Protein drugs, as the name suggests, are pharmaceuticals based on proteins or portions of proteins. Also referred to as biologics, protein drugs have become increasingly important over the past 5 years with the advent of high throughput screening and proteomics combined with the changing (some would say declining) health status of the developed countries, particularly the United States.

Technologies included in this report are: protein therapeutics, proteomics, bioengineered protein drugs, recombinant protein drugs, protein arrays, protein expression and protein purification, and protein chips.

Drugs included in this report are insulin, coagulants, interferons, cytokines, bioengineered antibodies, enzymes, hormones (particularly growth hormones), growth factors, interleukins and angiogenesis inhibitors.

Diseases for which protein drugs are particularly amenable and that will be discussed in this report include: hemophilia, diabetes, cancer, cystic fibrosis, hepatitis, psoriasis and congenital diseases.

SCOPE OF STUDY

This report contains:

• Coverage of proteins that are used for therapeutic purposes, including an analysis of protein-based drugs in clinical trials
• Market trends and five-year forecasts with projections through 2011
• Examination of current technologies underlying the market and details the effects of new technologies on this market
• Profiles of the major companies involved in the production and modification of protein drugs.
• An analysis of the patent landscape in this field and the companies with the greatest breadth in their IP portfolios.

METHODOLOGY AND SOURCES

This report uses a combination of direct and indirect sources. Direct sources include interviews and conversations with scientists, analysts and research consultants. Indirect sources include company news releases, governmental and nongovernmental agencies, scientific journals and the popular press.

Sales were gathered from the most recently available data and represent worldwide sales. In nearly all cases, this involved year-end 2005 sales. If these figures were not available, then the latest available figures were used.

In some cases, data was not available. In these cases estimates were made based on indirect data, such as patient populations, percentages treated with other drugs and average sales prices.

Estimates for future sales growth within individual markets depended upon: patent expirations, percentage of the market penetrated, generic competition, competing drug classes, the introduction of new drugs, demographic growth and shifts, recent study results, and other variables. In each case where a forecast is made, the most important factors are listed.

Sales are presented in millions of dollars, unless otherwise noted.

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