The Global Protein Therapeutics Market: Market Dynamics and Pipeline Analysis

Published by: Arrowhead Publishers

Published: Dec. 7, 2006 - 349 Pages

Table of Contents

1 Methodology, Executive Summary and Overview

1.1 Report Objectives

1.2 Research Methodology

1.3 Executive Summary

1.3.1 An Introduction to Protein Therapeutics

1.3.2 Therapeutic Applications

Table 1.1 Key Therapeutic Applications by Protein Class

1.3.3 Market Size

1.3.4 Leading Product Classes

Table 1.2 Leading Product Classes in Protein Therapeutics

Graph 1.1 Market Share of Product Classes in Protein Therapeutics

1.3.5 Leading Products

Table 1.3 Leading Products in the Protein Therapeutics Market

Graph 1.2 Percentage Change in the 2005-2010 Sales of Protein Therapeutics by Class

Graph 1.3 Leading 10 Products in the Protein Therapeutics Market by 2005 Sales

1.3.6 Market Share by Company

Table 1.4 Leading 20 Companies in Protein Therapeutics by 2005 Sales

Graph 1.4 Protein Therapeutics Market Share by Leading Companies

1.3.7 Innovation/R&D Trends

2 Challenges and Issues Facing the Therapeutic Protein Market

2.1 Pricing

2.2 Drug Delivery

2.2.1 Parenteral Delivery: Still the Leading Delivery Route for Therapeutic Proteins

Table 2.1 Main Types of Drug Delivery by Injection (Parenteral Administration)

Table 2.2 Advantages of Injectable Drug Delivery Systems Case Study: Sustainable Release Injectable Technology

Table 2.3 Key Companies in the Needleless Drug Technology Market

2.2.2 Pulmonary Delivery

2.2.3 Oral Delivery

2.3 Manufacturing Capacity Case Study: Immunex (Amgen) and Their Enbrel Shortage Case Study: Genentech

2.3.1 New Methods of Protein Manufacture

Table 2.4 Companies Involved in the Field of Transgenic Protein Technology

2.3.1.1 Transgenic Animal Production

Table 2.5 Main Methods of Creating Transgenic Animals

2.3.1.2 Protein Pharming

Table 2.6 Advantages of Avian Transgenic Technology in Protein Manufacture

2.3.1.3 Transgenic Plant Production

Table 2.7 Pros and Cons of Transgenic Plants

2.4 The Biogeneric Threat

2.4.1 Loss of Patent Protection

2.4.2 High Manufacturing Costs

2.4.3 Lack of Adequate Legislation Case Study: Biogenerics - Novartis and Omnitrope

2.4.4 Restrictive Cost of Biotech Generics

2.4.5 Biogeneric Landscape

3 Erythropoietins

3.1 Overview of Class

3.2 How Do Erythropoietins Work?

Table 3.1 Advantages and Disadvantage of Erythropoietin Therapy

3.3 Therapeutic Applications for Erythropoietins

3.3.1 Anemia

3.3.1.1 Cancer Related Anemia

3.3.1.2 Renal Anemia

3.4 Currently Marketed Products in the Class

3.4.1 Procrit/Eprex (epoetin alfa)

3.4.2 Epogen (epoetin alfa)

3.4.3 Aranesp (darbepoetin alfa)

3.4.4 NeoRecormon/Epogin (epoetin beta)

3.4.5 Espo (epoetin alfa)

3.4.6 Clinical Comparisons Between Marketed Erythropoietins

3.5 Market Analysis

3.5.1 Commercial Market Size

Table 3.2 Global Sales of Erythropoietins 1999-2005

Table 3.3 US Sales of Erythropoietins 1999-2005

Table 3.4 Non-US Sales of Erythropoietins 1999-2005

Graph 3.1 Sales of Erythropoietin Products 1999-2005, US & Rest of World

Graph 3.2 Percentage Growth of Erythropoietin Products, 2004-2005

3.5.2 Market Share by Country/Region

Graph 3.3 Market Share Erythropoietin Products, US vs Rest of World 2005

Graph 3.4 Market Share Erythropoietin Products, US vs Rest of World 2004

3.5.3 Market Share, by Product Sales

Graph 3.5 Market Share, Erythropoietin Products 2005

Graph 3.6 Market Share, Erythropoietin Products 2004

3.5.4 Market Share by Company

Graph 3.7 Company Market Share, Erythropoietin Products 2005

Graph 3.8 Company Market Share, Erythropoietin Products 2004

3.6 Key Emerging Erythropoietin Therapies

3.6.1 Dynepo

3.6.2 Mircera

3.7 Market Outlook

3.7.1 Drivers

3.7.2 Restraints

3.7.3 Financial Forecast

Table 3.5 Erythropoietin Financial Forecast 2005-2011

4 Interferons

4.1 Overview of Class

4.2 Therapeutic Uses for Interferons

4.2.1 Multiple Sclerosis

Table 4.1 Major Types of MS

4.2.2 Hepatitis

4.2.3 Leukemia

Table 4.2 Major Types of Leukemia

Table 4.3 Types of Leukemia Treatments

4.3 Classes of Interferons

4.3.1 Beta Interferons

Table 4.4 Leading MS Therapy Delivery Routes and Dosage

4.3.1.1 Avonex (interferon beta-1a)

4.3.1.2 Rebif (interferon beta-1a)

4.3.1.3 Betaferon/Betaseron (interferon beta-1b)

4.3.2 Alpha Interferons

4.3.2.1 Intron A (interferon alpha-2b)

4.3.2.2 PEG Intron (peg interferon alpha-2b)

4.3.2.3 Rebetron (interferon alpha-2b + ribavirin)

4.3.2.4 Roferon-A (interferon alpha-2a)

4.3.2.5 Alferon N (interferon alpha-n3)

4.3.2.6 Pegasys (pegylated interferon alpha-2a)

4.3.2.7 Infergen (interferon alfacon-1)

4.3.3 Gamma interferons

4.3.3.1 Actimmune

4.4 Market Analysis

4.4.1 Commercial Market Size

Graph 4.1 2005 Sales of Leading MS Therapies

Table 4.5 Global Sales of Beta Interferons 2000-2005

Table 4.6 US Sales of Beta Interferons 2000-2005

Table 4.7 Non-US Sales of Beta Interferons 2000-2005

Table 4.8 Global Sales of Alpha Interferons 2000-2005

Table 4.9 Global Sales of Gamma Interferons 2000-2005

4.4.2 Market Share by Country/Region

Graph 4.2 Country/Region Market Share Beta Interferons 2005

4.4.3 Market Share by Product Sales

Graph 4.3 Market Share Beta Interferons 2005

Graph 4.4 Market Share Alpha Interferons 2005

4.4.4 Market Share by Company

Graph 4.5 Company Market Share, Beta Interferons 2005

Graph 4.6 Company Market Share Alpha Interferons 2005

4.5 R&D Trends in the Interferon Class

4.5.1 Albuferon-Alpha

4.5.2 Tauferon

4.5.3 Interferon gamma-1b

4.5.4 Neoferon

4.5.5 Low-Dose Oral Interferon Alpha

4.6 Market Outlook

4.6.1 Drivers

4.6.2 Restraints

4.6.3 Financial Forecasts

4.6.3.1 Beta Interferon Financial Forecast

Table 4.10 Forecast Sales of Avonex

Table 4.11 Forecast Sales of Betaseron

Table 4.12 Forecast Sales of Rebif

4.6.3.2 Alpha Interferon Financial Forecast

Table 4.13 Forecast Sales of PEG-Intron

Table 4.14 Forecast Sales of Intron

Table 4.15 Forecast Sales of Pegasys

4.6.3.3 Gamma Interferon Financial Forecast

Table 4.16 Forecast Sales of Actimmune

5 Insulins

5.1 Overview of Class

5.2 How Does Insulin Work?

5.3 Therapeutic Applications

5.3.1 Diabetes

Table 5.1 Other Types of Diabetes

Table 5.2 Treatment of Types II Diabetes

5.4 Epidemiology

Table 5.3 Estimated Number of People with Diabetes

5.5 Key Products in Diabetes Treatment

Table 5.4 Types of Insulin

5.5.1 Rapid-acting

5.5.1.1 NovoRapid/Novolog (insulin aspart)

5.5.1.2 Humalog (insulin lispro)

5.5.1.3 Apidra (insulin glulisine)

5.5.1.4 NovoMix (insulin aspart mix)

5.5.2 Exubera (inhaled insulin)

5.5.3 Short-acting (regular) and intermediate-acting

5.5.3.1 Novolin (insulin)

5.5.3.2 Insuman

5.5.3.3 Humulin (insulin)

5.5.4 Long-acting

5.5.4.1 Lantus (glargine insulin)

5.5.5 Levemir (insulin determir)

Table 5.5 Relationship of A1C to Average Whole Blood and Plasma Glucose Levels

5.5.6 Iletin (insulin)

5.6 New Delivery of Insulin Stimulating Sales

Table 5.6 Patch Insulin

Table 5.7 Oral Spray Insulin

Table 5.8 Pulmonary Insulin

5.7 R&D Trends

5.7.1 NN304 (insulin detemir)

5.7.2 AERx insulin Diabetes Management System (iDMS)

5.7.3 AIR (inhaled insulin)

5.7.4 MannKind (inhaled insulin)

5.7.5 NN344

5.7.6 NN5401

5.8 Market Analysis

5.8.1 Commercial Market Size

5.8.2 Market Share by Insulin Class

Graph 5.1 Insulin Sales Segmentation by Drug Class

5.8.3 Market Share by Country/Region

Graph 5.2 Insulin Market by Country/Region

Graph 5.3 Humulin Sales by Geographical Region (2005)

Graph 5.4 Humalog Sales by Geographical Region (2005)

5.8.4 Market Share by Product Sales

Table 5.9 Insulin Product Sales (US$mn)

Graph 5.5 Insulin Market Share by Product (2005)

5.8.5 Market Share by Company

Graph 5.6 Insulin Market Share by Company

5.9 Market Outlook

Table 5.10 Forecast Insulin Product Sales

Graph 5.7 Product Sales Percentage Change 2005-2010*

5.9.1 Financial Forecast

Table 5.11 Financial Forecast for the Insulin Market

Graph 5.8 Forecast Growth of the Insulin Market (2005-2010)

5.9.2 Drivers

5.9.3 Restraints

6 Monoclonal Antibodies

6.1 Overview of Class

6.2 How do Monoclonal Antibodies Work?

6.3 Therapeutic Applications for Monoclonal Antibodies

Table 6.1 Monoclonal Antibody Therapies on the Market 2006

6.3.1 Cancer

Table 6.2 Types of Cancer

6.3.1.1 Rituxan (rituxumab)

6.3.1.2 Erbitux (cetuximab)

6.3.1.3 Herceptin (trastuzumab)

6.3.1.4 Avastin (bevacizumab)

6.3.1.5 Bexxar (tositumomab)

6.3.1.6 Mylotarg (gemtuzumab ozogamicin)

6.3.1.7 Zevalin (ibritumomab tiuxetan)

6.3.2 Autoimmune/Inflammatory Diseases

6.3.2.1 Rheumatoid Arthritis

6.3.2.1.1 Remicade (infliximab)

6.3.2.1.2 Humira (adalimumab)

6.3.2.2 Multiple Sclerosis

6.3.2.2.1 Tysabri (natalizumab)

6.3.2.3 Crohn’s Disease

6.3.2.3.1 Remicade

6.3.2.4 Psoriasis

6.3.2.4.1 Raptiva (efalizumab)

6.3.2.5 Asthma

6.3.2.5.1 Xolair

6.3.3 Age-Related Macular Degeneration (AMD)

6.3.3.1 Lucentis (ranibizumab)

6.3.4 Transplant Rejection

Table 6.3 Types of Transplant Rejection

Table 6.4 Antibodies Used to Prevent Transplant Rejection

6.3.4.1 Simulect (basiliximab)

6.3.4.2 Orthoclone OKT-3 (muromonab CD3)

6.3.5 Other Conditions

6.3.5.1 Percutaneous coronary intervention (PCI)

6.3.5.1.1 ReoPro (abciximab)

6.3.5.2 Lower Respiratory Tract Disease

6.3.5.2.1 Synagis (palivizumab)

6.4 Market Analysis

6.4.1 Commercial Market Size

Table 6.5 Leading Monoclonal Antibody Products, by Sales 2000-2005

Graph 6.1 Leading Monoclonal Antibody Products by 2005 Sales

6.4.2 Segmentation by Therapeutic Category

Graph 6.2 Monoclonal Antibody Market by Therapeutic Category (2005)

6.4.2.1 Cancer

Table 6.6 Global Sales of Monoclonal Antibodies, Cancer Indications 2003-2005

Graph 6.3 Annual Growth of Global Monoclonal Antibody Market, Cancer Indications 2003-2005

6.4.2.2 Autoimmune/Inflammatory

Table 6.7 Global Sales of Monoclonal Antibodies, Autoimmune/Inflammatory Indications, 1999-2005

Graph 6.4 Annual Growth of Global Monoclonal Antibody Market, Autoimmune/Inflammatory Indications, 1999-2005

6.4.3 Market Share by Country/Region

Table 6.8 Monoclonal Antibody Sales Market Share (2005), by Country/Region

Graph 6.5 Monoclonal Antibody Sales Market Share by Three Key Regions

6.4.4 Key Product Sales

Graph 6.6 Monoclonal Antibody Market Share, by Top Five Products

Table 6.9 Global Sales of Remicade 2000-2005

Table 6.10 Global Sales of Rituxan 2000-2005

Table 6.11 Global Sales of Herceptin 2000-2005

Table 6.12 Global Sales of Humira 2003-2005

Table 6.13 Global Sales of Avastin 2004-2005

6.4.5 Market Share by Company

Graph 6.11 Leaders in the Monoclonal Antibody Therapy Market, 2005 Market Share

6.4.6 Market Outlook

6.4.6.1 Drivers

6.4.6.2 Restraint

6.4.6.3 Financial Forecast

Table 6.14 Financial Forecast for the Monoclonal Antibody Market

6.5 Emerging Monoclonal Antibody Therapies

Table 6.15 Emerging Monoclonal Antibody Therapies

6.5.1 Herceptin (Line Extension)

6.5.2 Cotara (TNT-1)

6.5.3 Rencarex (WX-G250)

6.5.4 Humira

6.5.5 Rituxan

6.5.6 Actemra (tocilizumab)

Table 6.16 Types of ACR Response Criteria

6.5.7 Remicade

6.5.8 Tysabri

6.5.9 Segard

6.5.10 Anti-C5 antibody

6.5.11 Aurograb

7 Blood-Clotting Factors

7.1 Overview of Class

Table 7.1 Overview of Blood-Clotting Factors and Their Function

7.2 How do Blood-Clotting Factors Work?

7.3 Therapeutic Applications for Blood-Clotting Factors

7.3.1 Hemophilia

7.4 Leading Blood-Clotting Factors on the Market

Table 7.2 Leading Blood-Clotting Factors

7.4.1 NovoSeven (recombinant coagulation factor VIIa)

7.4.2 Advate (antihemophilic factor (recombinant), plasma/albumin-free method)

7.4.3 Alphanate

7.4.4 Helixate FS

7.4.5 Hemofil-M (Factor VIII)

7.4.6 Humate-P (antihemophilic factor/von Willebrand factor complex)

7.4.7 Koate HP and Koate DVI (human antihemophilic (human) factor VIII)

7.4.8 Kogenate FS (recombinant factor VIII)

7.4.9 Monarc-M

7.4.10 Monoclate-P

7.4.11 Recombinate

7.4.12 ReFacto (recombinant factor VIII)

7.4.13 AlphaNine SD

7.4.14 Bebulin VH (factor IX complex)

7.4.15 BeneFIX (recombinant factor IX)

7.4.16 Konyne 80

7.4.17 Mononine

7.4.18 Profilnine SD (systemic factor IX)

7.4.19 Proplex T (factor IX complex)

7.5 Market Analysis

7.5.1 Commercial Market Size

7.5.2 Market Share by Country/Region

Graph 7.1 Blood Clotting Market Share by Country/Region

7.5.3 Market Share by Product Sales

Table 7.3 Competing Antihemophilic Factor Brands

Table 7.4 Key Blood Clotting Factors Product Sales (US$mn)

Graph 7.2 Forecast Annual Sales Growth of Key Blood Clotting Factor Products

Graph 7.3 Blood Clotting Market Share by Factor

7.5.4 Market Share by Company

Graph 7.4 Blood Clotting Market Share by Company

7.5.5 Market Outlook

Table 7.5 Forecast Sales of Blood Clotting Factors (US$bn)

Graph 7.5 Forecast Annual Growth of Blood Clotting Factors

7.5.5.1 Drivers

7.5.5.2 Restraints

7.6 Emerging Blood-Clotting Factors

7.6.1 Bayer

7.6.2 Cell Genesys

7.6.3 Avigen

7.6.4 Novo Nordisk

7.6.5 Immune Response Corporation

7.6.6 Targeted Genetics

8 Colony-Stimulating Factors

8.1 Overview of Class

8.2 How Do Colony Stimulating Factors Work?

8.3 Therapeutic Applications for Colony Stimulating Factors

8.3.1 Chemotherapy-Induced Neutropenia

8.4 Key Colony Stimulating Factors

8.4.1 Neupogen (filgrastim)

8.4.2 Neulasta (pegfilgrastim)

8.4.3 Gran (filgrastim)

8.4.4 Leukine (sargramostim)

8.4.5 Neutrogin / Granocyte (lenograstim)

8.5 Market Analysis

8.5.1 Commercial Market Size

8.5.2 Market Share by Country/Region

Graph 8.1 CSF Market by Country/Region

8.5.3 Market Share by Product Sales

Table 8.1 Global Sales of Neupogen 1999-2005

Table 8.2 Global Sales of Neulasta 2002-2005

Graph 8.2 Global Sales of Neupogen and Neulasta 2002-2005

Graph 8.3 Global CSF Market by Product (2005)

8.5.4 Market Share by Company

Graph 8.4 Global CSF Market by Company (2005)

8.6 Market Outlook

8.6.1 Drivers

8.6.2 Restraints

8.6.3 Financial Forecast

Table 8.3 Forecast Sales of Neulasta

Table 8.4 Forecast Sales of Neupogen

Table 8.5 Forecast Sales of Colony Stimulating Factors (US$bn)

Graph 8.5 Forecast Annual Sales Growth of the CSF Market

8.7 Emerging Colony-Stimulating Factors

8.7.1 New Indications for Leukine (sargramostim)

8.7.2 Longer-acting GM-CSFs

8.7.3 PEGylated G-CSFs

8.7.4 Maxy-G34

9 Human Growth Hormones

9.1 Overview of Class

9.2 How Do Growth Hormones Work?

Table 9.1 Effects of Human Growth Hormone

9.3 Therapeutic Applications for Growth Hormones

Table 9.2 Therapeutic Applications for Growth Hormones

9.4 Key Growth Hormones

9.4.1 Genotropin (recombinant somatropin)

Table 9.3 Different Indications for Genotropin

9.4.2 Nutropin/Protropin (recombinant somatropin/somatrem)

9.4.3 Norditropin/Norditropin SimpleXx (recombinant somatropin)

9.4.4 Humatrope (recombinant somatropin)

9.4.5 Geref (sermorelin acetate)

9.4.6 Somatuline (lanreotide)

9.4.7 Saizen (somatropin)

9.4.8 Serostim (recombinant somatropin)

9.4.9 Somavert (pegvisomant)

9.4.10 Sandostatin (octreotride) and Sandostatin LAR (octreotide for injectable suspension)

Table 9.4 GH Suppression during Long-Term Treatment with Immediate Release Sandostatin Injection and Sandostatin LAR Depot

9.5 Expected Launches of Growth Hormones

9.5.1 Valtropin (somatropin)

9.5.2 Omnitrope (somatropin)

9.6 Development Pipeline for Growth Hormones

9.6.1 hGH (SkyePharma)

9.6.2 hGHD-1 (MacroMed)

9.7 Market Analysis

9.7.1 Commercial Market Size

9.7.2 Segmentation by Therapeutic Category

Graph 9.1 HGH Market Segmentation by Therapeutic Application

9.7.3 Market Share by Country/Region

Graph 9.2 HGH Market by Region (2005)

9.7.4 Market Share by Product Sales

Table 9.5 Global Sales of Key Growth Hormone Products

9.7.5 Market Share by Company

Graph 9.3 Growth Hormone Market Share by Company

9.8 Market Outlook

Table 9.6 Key Company Involvement in hGH Delivery Technology

Table 9.7 Forecast Sales of Growth Hormones

Graph 9.4 Forecast Annual Growth of Growth Hormones

9.8.1 Drivers

9.8.2 Restraints

9.9 Emerging Human Growth Hormones

9.9.1 Serostim (Serono)

9.9.2 SomatoKine (Insmed Incorporated)

9.9.3 Octreotide (QLT)

9.9.4 ALX1-11 (NPS Pharmaceuticals)

9.9.5 Geref (Serono)

9.9.6 Leptin (Amgen)

10 Interleukins

10.1 Overview of Class

10.2 How Do Interleukins Work?

10.3 Types of Interleukins and Their Functions

Table 10.1 Interleukins, Major Sources and Effects

10.4 Therapeutic Applications for Interleukins

10.4.1 Cancer

10.4.2 Human immunodeficiency virus (HIV)

10.4.3 Transplantation

10.5 Key Interleukin Products on Market

10.5.1 Interleukin-1

10.5.2 Interleukin-2

10.5.2.1 Proleukin (aldesleukin)

10.5.2.2 Ontak (denileukin deftitox)

10.5.2.3 Imunace (celmoleukin)

10.5.3 Interleukin 11

10.5.3.1 Neumega (oprelvekin)

10.6 Market Analysis

10.6.1 Commercial Market Size

10.6.2 Segmentation by Therapeutic Category

Graph 10.1 Interleukin Market Segmentation by Therapeutic Category

10.6.3 Market Share by Country/Region

Graph 10.2 Interleukin Market Segmentation by Country/Region

10.6.4 Market Share by Product Sales

Table 10.2 Global Sales of Key Interleukins

Graph 10.3 Interleukins Market by Product Sales

10.6.5 Market Share by Company

Graph 10.4 Market Share by Company

10.7 Market Outlook

Table 10.3 Forecast Sales of Interleukins (US$mn)

Graph 10.5 Forecast Annual Sales Growth of Interleukins

10.7.1 Drivers

10.7.2 Restraints

10.8 Emerging Interleukins

10.8.1 IL-11 - Neumega (oprelvekin)

10.8.2 New Indication for Proleukin (aldesleukin)

10.8.3 Interleukin-12

10.8.4 Cytoryn (IL-2 controlled release injectable depot)

10.8.5 Interleukin-6 (Sigosix)

10.8.6 Interleukin-4

10.8.7 Interleukin-1

10.8.8 Recombinant IL-10

10.8.9 Prestara

11 Plasminogen Activators

11.1 Overview of Class

Table 11.1 Embolism and Its Outcomes

11.2 How Do Plasminogen Activators Work?

Table 11.2 Brand Names of PAs

11.3 Therapeutic Applications for Plasminogen Activators

11.3.1 Heart Attack

11.3.2 Stroke

11.3.3 Pulmonary Embolism

11.4 Key Plasminogen Activators on Market

11.4.1 Activase (alteplase)

11.4.2 Actilyse (alteplase)

11.4.3 Abbokinase (urokinase)

11.4.4 Rapilysin/Retavase (reteplase)

11.4.5 TNKase (tenecteplase)

11.4.6 Metalyse (tenecteplase)

11.4.7 Streptase (streptokinase)

11.5 Market Analysis

11.5.1 Commercial Market Size

11.5.2 Segmentation by Therapeutic Category

Graph 11.1 Plasminogen Activators Market Share by Therapeutic Application

11.5.3 Market Share by Country/Region

Graph 11.2 Plasminogen Activators Market Segmentation by Country/Region

11.5.4 Market Share by Product Sales

Graph 11.3 Plasminogen Activators Market Share by Product Sales

Graph 11.4 Global Sales of Genentech's PAs (US$mn)*

11.5.5 Market Share by Company

Graph 11.5 Plasminogen Activators Market Share by Company

11.6 Market Outlook

Table 11.3 Forecast Sales of Plasminogen Activators

Graph 11.6 Forecast Annual Sales Growth of Plasminogen Activators

11.6.1 Drivers

11.6.2 Restraints

11.7 Emerging Plasminogen Activators

11.7.1 Solinase (pamiteplase)

11.7.2 Alfimeprase

11.7.3 Lanoteplase

12 Reproductive Hormones

12.1 Overview of Class

Table 12.1 Overview of Reproductive Hormones

12.2 How do Reproductive Hormones Work? Figure 12.1 Simplified

Graphic Representation of Normal Gonadal Function

12.3 Therapeutic Applications for Reproductive Hormones

Table 12.2 Reproductive Hormones and Their Therapeutic Applications

12.3.1 Osteoporosis

Table 12.3 FDA-Approved Bisphosphonates for the Treatment of Osteoporosis in Post-Menopausal Women

12.3.2 Cancer

Table 12.4 Incidence and Death Rates of Cancer in the US (Male and Female)

12.3.3 Menopause-Related Conditions

Table 12.5 Hormone Therapy Regimes

12.3.4 Male Sexual Dysfunctions

12.3.5 Infertility

Table 12.6 Medications for the Treatment of Infertility

12.3.6 Contraception

12.4 Leading Reproductive Hormones on the Market

12.4.1 Gonadotropins

12.4.2 Hormone Replacement Therapy

12.4.3 Estrogens and Progestins

Table 12.7 FDA-Approved Estrogens/Hormones for the Treatment of Osteoporosis

12.5 Market Analysis

12.5.1 Commercial Market Size

12.5.2 Segmentation by Therapeutic Category

Graph 12.1 Segmentation of Hormone Replacement Market by Therapeutic Category

12.5.3 Market Share by Country/Region

Graph 12.2 Reproductive Hormones Market Segmentation by Country/Region

12.5.4 Market Share by Product Sales

Table 12.8 Sales of Key Gonadotropins in US (2003-2005)

Graph 12.3 Global Sales of Key Gonadotropins

Table 12.9 Global Sales of Key HRT Products in US$mn (2003-2005)

Graph 12.4 Annual Growth of HRT Product Sales

Table 12.10 Global Sales of Johnson & Johnson's Hormonal Contraceptives in US$mn (2003-2005)

Table 12.11 Global Sales of Schering AG's Hormonal Contraceptives in US$mn (2004-2005)

12.5.5 Market Share by Company

12.6 Market Outlook

Table 12.12 Forecast Sales of Reproductive Hormones

Graph 12.5 Forecast Annual Sales Growth of Reproductive Hormones

12.6.1 Drivers

12.6.2 Restraints

12.7 Emerging Reproductive Hormones

12.7.1 Ophena (ospemifene)

12.7.2 Bazedoxifene

12.7.3 Oporia (lasofoxifeneEmerging Reproductive Hormones)

13 Enzyme Replacement

13.1 Overview of Class

13.2 How does Enzyme Replacement Work?

13.3 Therapeutic Applications for Enzyme Replacement

13.3.1 Lysosomal storage disorders

13.3.2 Fabry Disease

13.3.3 Gaucher Disease

13.3.4 Mucopolysaccharidoses (MPSs)

Table 13.1 Types of Mucopolysaccharidosis

13.3.5 Infantile Pompe Disease (IPD)

13.4 Leading Enzyme Replacement Therapies on the Market

13.4.1 Fabrazyme (agalsidase beta)

13.4.2 Ceredase (alglucerase)

13.4.3 Cerezyme (imiglucerase)

13.4.4 Myozyme (alglucosidase alfa)

13.4.5 Elaprase (idursulfase)

13.4.6 Naglazyme (galsulfase)

13.4.7 Aldurazyme (laronidase)

13.5 Market Analysis

13.5.1 Commercial Market Size

13.5.2 Segmentation by Therapeutic Category

Graph 13.1 ERT Market Segmentation by Therapeutic Category

13.5.3 Market Share by Country/Region

Graph 13.2 ERT Market Segmentation by Country/Region

13.5.4 Market Share by Product Sales

Table 13.2 Global Sales of Key Enzyme Replacement Products

Graph 13.3 Global Sales of Key Enzyme Replacement Products

13.5.5 Market Share by Company

Graph 13.4 ERT Market by Company

Table 13.3 Key Companies Involved in the ERT Market

13.6 Market Outlook

Table 13.4 Forecast Sales of ERT Market (US$bn)

Graph 13.5 Forecast Annual Sales Growth of the ERT Market

13.6.1 Drivers

13.6.2 Restraints

13.7 Emerging Enzyme Replacement Therapies

13.7.1 AGT-180

13.7.2 Phex

13.7.3 ENZAGAL

13.7.4 rhASB

14 Company Profiles

14.1 Abbott Laboratories

14.2 Amgen

14.3 Amylin Pharmaceuticals

14.4 Anika Therapeutics

14.5 ArmaGen Technologies

14.6 Biogen Idec

Table 14.1 Biogen Idec’s Oncology Pipeline

14.7 BioMarin Pharmaceutical

14.8 BioMimetic Therapeutics

14.9 Bolder BioTechnology

14.10 Boston Life Sciences

14.11 Cambrex

14.12 Cambridge Antibody Technology

14.13 Ceregene

14.14 Chiron Corporation

Table 14.2 Chiron’s Oncology Pipeline

14.15 Chugai Pharmaceutical

Table 14.3 Chugai’s Oncology Pipeline

14.16 Coley Pharmaceutical Group

14.17 CuraGen

14.18 Curis Inc

14.19 Dragon Pharmaceuticals

14.20 Enobia

14.21 Enzon

Table 14.4 Enzon Drug Delivery Portfolio, 2006

14.22 Eyetech Pharmaceuticals

14.23 FibroGen

14.24 FzioMed

14.25 GeneMedix

14.26 Genentech

14.27 Genmab

14.28 GenSci Regeneration Sciences

14.29 Genvec

14.30 Genzyme

14.31 Human Genome Sciences

14.32 ImClone Systems

14.33 Insmed

14.34 Janssen-Ortho

14.35 Johnson & Johnson

14.36 Maxygen

14.37 Medarex

Table 14.5 Medarex’s Oncology Pipeline

14.38 MedImmune

14.39 OSI Pharmaceuticals

14.40 PeproTech

14.41 PDL Biopharma

14.42 Protein Polymer Technology

14.43 Raven Biotechnologies

14.44 Regeneron Pharmaceuticals

14.45 Rentschler Biotechnologie

14.46 Roche

14.47 Sangamo Biosciences

14.48 Scil Proteins

14.49 Serono

14.50 Spectrum Pharmaceuticals

14.51 Seattle Genetics

14.52 Stryker Biotech

14.53 Theratechnologies

14.54 Transition Therapeutics

14.55 Vernalis Pharmaceuticals

14.56 Wockhardt

Table 14.7 Wockhardt’s Biopharmaceutical Pipeline

14.57 Wyeth

14.58 Xoma

14.59 ZymoGenetics

Abstract

• erythropoietins (EPO)
• interferons
• interleukins
• insulin
• monoclonal antibodies
• blood-clotting factors
• colony-stimulating factors (CSFs)
• growth hormones
• plasminogen activators
• reproductive hormones
• therapeutic enzymes

• Overview of the protein therapeutics environment, including main therapeutic categories, drug delivery technologies and key players
• In-depth analysis of different classes of protein therapeutics, including key drugs in major therapeutic areas, as well as their advantages and disadvantages
• Comprehensive facts and figures for the protein therapeutics market, including main players and regional break-downs
• Future trends in the protein therapeutics marketplace, shaped by medical and technological advances as well as demographic and epidemiological changes and industry needs
• Outlook for the protein therapeutics market, including manufacturing considerations and research into new methods of protein delivery

• Companies with a need to understand the protein therapeutics market and its place in the modern pharmaceutical industry
• Companies interested in understanding the impact and implications of product placement, lifecycle management and competition in the protein therapeutics marketplace
• Companies interested in understanding future opportunities in the protein therapeutics sector provided by a combination of factors, including changing demographics and financial issues
• Pharma/biotech companies wishing to identify potential protein therapeutics areas for partnerships and collaboration in order to examine a variety of profit maximization strategies

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