Therapeutic Proteins - Proteins that are engineered in the laboratory for pharmaceutical use are known as therapeutic proteins.

	Therapeutic Proteins
	Table of Contents 1. Executive Summary 2. Introduction 2.1 What are Therapeutic Proteins? 2.2 What is the Market for Therapeutic Proteins and how will it Alter in the Future? 2.3 Aims, Scope and Format of this Report 3. Unmet Needs and Key Issues Affecting the Therapeutic Protein Market 3.1 Drug Delivery Challenges 3.1.1 The Majority of Therapeutic Proteins Can Only be Administered Parenterally 3.1.2 Pulmonary Delivery: A Viable Alternative to Injections 3.1.2.1 What is the Main Challenge in Pulmonary Delivery? 3.1.2.2 Are There any Problems with Bioavailability? 3.1.2.3 Does the Formulation of the Protein Affect its Delivery? 3.1.2.4 Syntonix are Developing Pulmonary Technology that does not Require Deep-Lung Delivery 3.1.2.5 Does Pulmonary Drug Delivery Have a Future? 3.1.3 Nasal Delivery Enables Pulsed-Release Dosing, Which Aids Protein Effectiveness 3.1.3.1 What Types of Nasal Drug Delivery Systems are in Development? 3.1.3.2 The ChiSys(tm) Nasal Delivery System 3.1.4 Oral Delivery: In Development by Altus 3.1.5 Microneedles for Transdermal Delivery of Vaccines 3.1.6 Are There Methods for Increasing the Half-Life of a Protein? 3.1.6.1 Polymeric Delivery Ensures Proteins Remain Active for Longer 3.1.6.2 Polymer-Protein Conjugation 3.1.7 Can Advances in Protein Drug Delivery Result in Drugs for Treatment of CNS Disorders? 3.2 Manufacturing Capacity Shortfall 3.2.1 Why is There a Shortfall in Manufacturing Capacity for Therapeutic Proteins? 3.2.1.1 Make Vs. Buy in the 1980s 3.2.1.2 CMO Manufacturing Capacity was Adequate for the Supply of Clinical Materials Only 3.2.1.3 Late-Stage Products have absorbed CMO Clinical Manufacturing Capacity 3.2.2 How is the Manufacturing Capacity Shortfall Being Overcome? 3.2.3 Does The Future for Therapeutic Protein Manufacturing Lie with Transgenics? 3.3 The Cost of Therapeutic Proteins 3.3.1 The Top Ten Therapeutic Proteins Each Cost at Least $10K Per Patient Per Year 3.3.2 What Do the Most Costly of the Top Ten Therapeutic Proteins Have in Common? 3.3.3 Yeast-Based Systems May Bring Down the Cost of Therapeutic Proteins in the Future 3.4 Biogeneric Competition: A Real or Limited Threat? 3.4.1 How are Approval Pathways Limiting the Development of Biogenerics? 3.4.2 Will the Benefits of Biogenerics be as Great as Anticipated? 3.4.3 What About the High Cost of Market Entry? 3.4.4 What About Manufacturing Capacity Problems? 3.4.5 What Class of Therapeutic Protein is the Chief Target for Biogenerics? 3.4.6 How Imminent is the Threat from Biogeneric Competition? 3.5 Drivers and Restraints of the Therapeutic Protein Market 4. An Overview of the Global Therapeutic Proteins Market, 2003-2004 4.1 The Therapeutic Proteins Market Increased by Almost 20% in 2003, Gaining Six New Products and Four Blockbusters 4.2 Four of the Six Newcomers are Monoclonal Antibodies 4.2.1 Pegasys is the Best-Selling Newcomer to the Therapeutic Protein, and Global Pharma Market 4.2.2 Humira is the Best-Selling New Monoclonal Antibody on the Market 4.2.3 Fabrazyme Made $81m in Eight Months 4.2.4 Amevive Was Approved for Sale in Canada in 2004 4.2.5 Herceptin is Now Enjoying Success in Japan 4.2.6 Xolair: Sales of $170m Expected in its First Full Year on the Market 4.2.7 Newcomers will be Market Drivers in 2004 with a Triple-Digit Increase in Sales 4.3 The Therapeutic Protein Market Contained 11 Blockbuster Products 4.4 The Top Three Therapeutic Proteins Sold Over $8bn in 2003 and Held a 23% Market Share 4.4.1 Procrit/Eprex - The Number One Therapeutic Protein Struggles at the Top 4.4.2 Epogen is the Second Best-Selling Therapeutic Protein 4.4.3 Intron A and Peg-Intron 4.5 Aranesp, Neulasta and Enbrel are the Most Successful Therapeutic Proteins in Terms of Growth 4.5.1 Aranesp is the Fastest-Growing Therapeutic Protein 4.5.1.1 Head-to-Head Studies Show Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Once a Week 4.5.1.2 Sales of Aranesp Will Top $2.3 Billion in 2004 4.5.2 Neulasta - Amgen's Neutropenia Superstar 4.5.3 Enbrel Completes a Hat Trick for Amgen as the Third Fastest-Growing Therapeutic Protein on the Market 4.5.3.1 Enbrel Has a Number of New Indications 4.5.3.2 Side-Effects of Competitor Medications May Prove Advantageous for Enbrel 4.6 The Intron A Family and Genotropin were the Least Successful Therapeutic Proteins in Terms of Growth 4.7 The Leading Classes of Therapeutic Proteins are Erythropoietins, Monoclonal Antibodies and Interferons 4.7.1 Erythropoietins Lead with a More-Than Quarter Share of the Market 4.7.2 The Monoclonal Antibody Class Contained More Products than Any Other Class of Therapeutic Protein 4.7.3 Interferons Sold $5.5 Billion in 2003 but are Set for Huge Losses in 2004 4.8 Blood Modifiers, Multiple Sclerosis and Anti-Arthritic Drugs are the Leading Therapeutic Categories for Therapeutic Proteins 4.8.1 Blood Modifiers Dominate Due to Erythropoietins 4.8.2 Multiple Sclerosis Drugs Hold on to Their Market Share 4.8.3 Anti-Arthritic Drugs are Third Best-Selling and Fastest-Growing Therapeutic Category 4.9 Only Two Therapeutic Categories Saw Negative Growth in 2003 4.10 Amgen Dominates the Market with Almost $8 Billion in Sales 4.10.1 Who are Amgen? 4.10.2 All of Amgen's Therapeutic Proteins are Blockbusters.... And Other Facts 4.11 Johnson and Johnson: The Second Most-Successful Company in the Market is Losing its Grip 4.12 Roche are the Number Three in the Market with Drugs For a Variety of Indications 4.13 Wyeth: One of the Fastest-Growing Companies with all Products Experiencing Double-Digit Growth 5. The Market for Erythropoietins 5.1 What is Erythropoietin? 5.2 What are the Different Types of Erythropoietins on the Market and What are they Worth? 5.3 Procrit/Eprex' Sales will Recover 5.4 Epogen - The Class Progenitor 5.5 Aranesp - The New EPO on the Block 5.6 NeoRecormon Will Be Unaffected by Patent Expiry 5.7 Epogin and Espo 5.8 The Erythropoietin Pipeline 5.8.1 Cera will Replace NeoRecormon as Roche's Leading Erythropoietin 5.8.2 Dynepo is Ready to be Marketed in the EU but Still Awaits FDA Approval 5.8.3 Roche Have Another Erythropoietin in Early-Stage Development 5.9 The Erythropoietin Class will be Worth Over $17bn by 2010 6. The Market for Monoclonal Antibodies 6.1 What are Monoclonal Antibodies? 6.2 What are the Problems Associated with Monoclonal Antibodies as Therapeutic Agents? 6.3 What Monoclonal Antibodies are on the Market and what are they Worth? 6.4 What Types of Monoclonal Antibodies are There and What Conditions do They Treat? 6.4.1 Murine 6.4.2 Chimeric Antibodies 6.4.3 Humanised Antibodies (CDR-Grafted) 6.4.4 Human Antibodies 6.4.5 Receptor-Antibody Fusion Protein 6.4.6 Chimeric Monoclonal Antibodies Dominate the Market 6.4.7 Monoclonal Antibodies Have Eight Main Indications, of Which Arthritis is the Best Selling 6.4.8 Why do Arthritis Medications Dominate? 6.4.9 Non-Hodgkin's Lymphoma Drugs Come a Close Second to Arthritis Medications 6.4.10 What is Non-Hodgkin's Lymphoma and how Prevalent is it? 6.5 Remicade is the Best-Selling Monoclonal Antibody 6.5.1 How Safe is Remicade? 6.5.2 Remicade Lacks Patent Protection and Market Exclusivity but Continues to Grow 6.6 Genentech's Rituxan Leads the Way in Treatment for Non-Hodgkin's Lymphoma 6.7 Herceptin is the Third Best Selling MAb on the Market 6.8 What are the Most Promising New MAbs on the Market? 6.8.1 Abbott's Humira is the First in its Class 6.8.2 Bexxar and Zevalin Represent Another New Class of MAbs 6.8.3 Avastin: An Important New Treatment for the Third Most Fatal Cancer in the US 6.8.4 Erbitux will Enjoy Success, but not on the Same Scale as Avastin 6.9 The Monoclonal Antibody Late-Stage Pipeline 6.9.1 Tysabri Could Take a 50% Share of the Multiple Sclerosis Market 6.10 The Monoclonal Antibody Early-Stage Pipeline 6.11 Monoclonal Antibodies Will be Worth Over $26 Billion by 2010 7. The Market for Interferons 7.1 What is an Interferon? 7.2 What Diseases do Interferons Treat? 7.3 What Interferons are on the Top 400 Market and How Much are they Worth? 7.4 The Intron A Family versus Pegasys: Pegasys Looks Set for Victory 7.4.1 What is Pegasys and what makes it Different from Other Hepatitis Treatments? 7.4.2 Pegasys Can Now Also Treat Hepatitis B 7.4.3 Pegasys will be the Market Leader by 2005 7.5 Who Will Win the War to Become the Top-Selling Multiple Sclerosis Treatment? 7.5.1 Market-Leading Avonex will soon Succumb to Competitive Pressure from Rebif 7.5.2 Betaseron will Remain a Best-Seller, But Growth will be Relatively Flat 7.6 The Interferon Pipeline 7.6.1 Nastech Pharma Have a Nasal Interferon Available for Licensing Box 7.1 Who are Nastech Pharmaceuticals? 7.6.2 Amarillo Biosciences are Developing an Oral Interferon for Hepatitis C Box 7.2 Who are Amarillo Biosciences? 7.7 The Market for Interferons will be Worth over $12bn in 2010 8. The Market for Insulin 8.1 What is Insulin? 8.2 How Prevalent is Diabetes? 8.3 What Insulin Treatments are on the Market and What are They Worth? 8.4 Humulin Will Lose its Spot at the Top to Lilly's New and Improved Humalog 8.5 Sanofi-Aventis' Lantus is Rising Fast to the Top of the Insulin Market 8.6 Recently-Approved Insulins: How Will They Perform? 8.6.1 Novo Nordisk Claims New Product Superior to Lantus 8.6.2 Apidra May Benefit from Lantus' Success 8.7 The Insulin Pipeline 8.7.1 Exubera will be the First Non-Injected Insulin on the Market 8.7.2 Novo Nordisk May Launch Their Inhaled Insulin by 2009 8.7.3 Generex Biotech Lead the Race to Market the First Oral Insulin 8.7.4 Will HIM2 be the First Insulin Pill on the Market? 8.8 Lantus will be the Top Selling Insulin in 2010, when the Market will be Worth $9.5bn 9. The Market for Colony Stimulating Factor 9.1 What is Colony Stimulating Factor and What Diseases does it Treat? 9.2 What CSFs are Available and What is the Market Worth? 9.3 Neupogen: Amgen's Orphan Drug for the Treatment of Neutropenia 9.4 Amgen Has Released a New-Improved Form of Neupogen: Neulasta 9.5 Little Competition for Amgen in the Neutropenia Market 9.6 The CSF Pipeline 9.7 The CSF Market will be Worth Over $4.8bn by 2010 10. The Market for Other Classes of Therapeutic Protein 10.1 The Market for Blood Factors 10.1.1 What are Blood Factors and which ones Feature on the Therapeutic Protein Market? 10.1.2 What is Haemophilia and how Prevalent is it? 10.1.3 NovoSeven is the Top Selling Haemophilia Drug, but not for Long 10.1.4 Kogenate: The Runner-Up to NovoSeven 10.1.5 Benefix: Wyeth's Breakthrough Haemophilia B Treatment 10.1.6 ReFacto: Wyeth's Breakthrough Haemophilia A Treatment 10.1.7 The Blood Factor Pipeline 10.1.8 By 2010 Blood Factors will be Worth in Excess of $2.5bn 10.2 The Market for Therapeutic Vaccines 10.2.1 The Market for Therapeutic Vaccines is Sparse 10.2.2 Why is the Market Experiencing Flat Growth? 10.2.3 The Therapeutic Vaccine Pipeline 10.2.4 Sales of Therapeutic Vaccines will Grow in Double-Digits in the Forecast Period 10.3 The Market for Growth Hormones 10.3.1 What is Growth Hormone and What is the Market Worth? 10.3.2 What is Growth Failure and What Causes it? 10.3.3 Genotropin: Pfizer Under Investigation 10.3.4 Humatrope: Eli Lilly's Growth Hormone 10.3.5 Nutropin, Nutropin Depot and Protropin 10.3.6 The Hormone Market will Experience Flat Growth Between 2004 and 2010 10.4 The Market for Enzymes 10.4.1 What are Enzymes, what Diseases do they Treat and what is the Market Worth? 10.4.2 What is in the Enzyme Pipeline? 10.4.3 All Enzymes on the Market will Enjoy Positive Growth Between 2004 and 2010 10.5 The Market for Enbrel 10.5.1 What is Enbrel and what is it Worth? 10.5.2 Who are Enbrel's Competitors on the Therapeutic Protein Market? 10.5.3 Enbrel will Grow with a CAGR of Almost 16% Between 2004 and 2010 10.6 The Market for Copaxone 10.6.1 What is Copaxone and What is it Worth? 10.6.2 New Indications for Copaxone are in the Pipeline 10.6.3 Who are Copaxone's Competitors on the Therapeutic Protein Market? 10.6.4 Sanofi-Aventis Will Overtake Teva in Sales of Copaxone 11. Forecast Summary for Therapeutic Proteins, to 2010 11.1 Aranesp Will be the Market Leader in 2010 11.2 The Market Leader Will Hold A Smaller Market Share in 2010 than in 2003 11.3 Monoclonal Antibodies will Become the Leading Class of Therapeutic Protein 11.4 Monoclonal Antibodies and Insulin will be the Fastest Growing Classes 11.5 Blood Modifiers will Remain the Top Therapeutic Category 11.6 Amgen will Remain the Market Leaders and Retain Their Market Share 11.7 The Therapeutic Protein Market will Total Over $90bn by 2010 12. Conclusion: The Market will Continue its Double-Digit Growth for the Foreseeable Future LIST OF GRAPHS, TABLES AND FIGURES Graphs Graph 1.1 The Top 20 Therapeutic Proteins by Revenue ($m), 2003 Graph 3.1 Cost of Per Patient ($m) of the Top Ten Therapeutic Proteins, 2003 Graph 4.1 Revenues ($m) for Newcomers to the Therapeutic Protein Market, 2003-2004 Graph 4.2 Revenues ($m) for New Blockbusters on the Market, 2003 Graph 4.3 Revenues ($m) for Blockbuster Therapeutic Proteins, 2003 Graph 4.4 Global Procrit/Eprex Sales ($m), 2001-2004 Graph 4.5 Global Epogen Sales ($m), 2001-2004 Graph 4.6 Global Intron A Family Sales ($m), 2001-2004 Graph 4.7 Top Ten Winners and Losers in the Global Therapeutic Protein Market by Growth Rate (%), 2003 Graph 4.8 Global Aranesp Sales ($m), 2001-2004 Graph 4.9 Global Neulasta Sales ($m), 2002-2004 Graph 4.10 Global Enbrel Sales ($m), 2001-2004 Graph 4.11 Global Sales ($m) of Therapeutic Proteins by Class, 2003 Graph 4.12 Class Winners and Losers in the Therapeutic Protein Market by Growth Rate (%), 2003 Graph 4.13 Copaxone Sales ($m) by Company, 2001-2004 Graph 4.14 Market Shares (%) for Anti-Arthritic Therapeutic Proteins, 2003-2004 Graph 4.15 Winners and Losers in the Therapeutic Protein Market by Growth Rate (%), according to Therapeutic Category, 2003 Graph 4.16 Top Ten Companies in the Therapeutic Protein Market by Revenue ($m), 2003 Graph 4.17 Amgen's Annual R&D Expenditure ($m), 1993-2003 Graph 4.18 Company Winners and Losers in the Therapeutic Protein Market by Growth Rate (%), 2003 Graph 5.1 Forecast of Global Procrit/Eprex Sales ($m), 2004-2010 Graph 5.2 Forecast of Global Epogen Sales ($m), 2004-2010 Graph 5.3 Forecast of Global Aranesp Sales ($m), 2004-2010 Graph 5.4 Forecast of Global NeoRecormon Sales ($m), 2004-2010 Graph 5.5 Forecast of Global Epogin Sales ($m), 2004-2010 Graph 5.6 Forecast of Global Espo Sales ($m), 2004-2010 Graph 5.7 The Global Market ($m) for Erythropoietins, 2004 Versus 2010 Graph 5.8 The Global Market ($m) for Erythropoietins, 2010 Graph 5.9 CAGR (%) for the Global Erythropoietins Market, 2004-2010 Graph 5.10 Forecast for the Global Erythropoietins Market ($m), 2004-2010 Graph 6.1 Global Revenues ($m) for MAbs by Class, 2003 Graph 6.2 Global Revenues ($m) for MAbs by Indication, 2003 Graph 6.3 Global Sales ($m) of Remicade by Company, 2004-2010 Graph 6.4 Global Rituxan Sales ($m), 2004-2010 Graph 6.5 Global Herceptin Sales ($m) by Company, 2004-2010 Graph 6.6 Global Humira Sales ($m), 2004-2010 Graph 6.7 Global Zevalin Sales ($m), 2004-2010 Graph 6.8 Global Bexxar Sales ($m), 2004-2010 Graph 6.9 Global Avastin Sales ($m), 2004-2010 Graph 6.10 Global Erbitux Sales ($m), 2004-2010 Graph 6.11 Global Sales ($m) of Selected Monoclonal Antibodies, 2010 Graph 6.12 CAGRs (%) for Selected Monoclonal Antibodies, 2004-2010 Graph 6.13 Total Global Revenue ($bn) for the MAb Market, 2004-2010 Graph 7.1 Global Sales ($m) of the Intron A Family Versus Pegasys, 2004-2010 Graph 7.2 Global Intron A Family Sales ($m), 2004-2010 Graph 7.3 Global Sales ($m) of Interferons for Multiple Sclerosis, 2004-2010 Graph 7.4 Best-Selling Interferons ($m), 2010 Graph 7.5 CAGRs (%) for the Best-Selling Interferons, 2004-2010 Graph 7.6 Total Global Revenues ($bn) for the Interferon Market, 2004-2010 Graph 8.1 Global Humulin and Humalog Sales ($m), 2004-2010 Graph 8.2 Global Lantus Sales ($m), 2004-2010 Graph 8.3 Global Levemir Sales ($m), 2004-2010 Graph 8.4 Global Apidra Sales ($m), 2004-2010 Graph 8.5 Global Exubera Sales ($m), 2005-2010 Graph 8.6 Global Insulin Sales ($m), 2010 Graph 8.7 CAGRs (%) for Insulins, 2004-2010 Graph 8.8 Total Global Revenues for the Insulin Market ($m), 2004-2010 Graph 9.1 The Global CSF Market ($m), 2004-2010 Graph 10.1 Global Revenues ($m) for Blood Factor Brands 2004 Versus 2010 Graph 10.2 The Global Blood Factor Market ($m), 2004 Versus 2010 Graph 10.3 Global Revenue ($m) for Therapeutic Vaccines, 2004 and 2010 Graph 10.4 Global Revenue ($m) for Growth Hormones, 2004 Versus 2010 Graph 10.5 The Global Enzyme Market ($m), 2004 vs. 2010 Graph 10.6 Global Enbrel Revenue ($m) by Company, 2004 vs. 2010 Graph 10.7 Global Sales ($m) for Copaxone Versus Competitor Therapeutic Proteins for MS, 2004-2010 Graph 11.1 Top Ten Therapeutic Proteins Globally by Revenue ($m), 2010 Graph 11.2 Revenue ($m) for Therapeutic Proteins by Class, 2010 Graph 11.3 CAGRs (%) for Classes of Therapeutic Protein, 2003-2010 Graph 11.4 Global Revenues ($m) for Therapeutic Proteins by Therapeutic Category, 2010 Graph 11.5 Top Ten Companies by Revenue ($m) in the Therapeutic Protein Market, 2010 Graph 12.1 Total Revenue ($m) for the Therapeutic Protein Market, 2003-2010 Tables Table 1.1 Top 3 Classes, Therapeutic Categories and Indications for Therapeutic Proteins by Revenue, 2003 Table 2.1 Examples of Diseases that Therapeutic Proteins Treat Table 3.1 Methods of Administration (MoA) for the Top Ten Therapeutic Proteins (2003) Table 3.2 Features of the Top