Therapeutic Proteins
Proteins that are engineered in the laboratory for pharmaceutical use are known as therapeutic proteins. The majority of biopharmaceuticals marketed to date are recombinant therapeutic protein drugs. But how much potential does this market have? Will the shortfall in manufacturing capacity dampen its growth? Will the high cost of these drugs ever be reduced? And how imminent is the threat from biogeneric competition? These and many other questions will be answered in this comprehensive 230-page report on the market for therapeutic proteins.
In 2003, the market for therapeutic proteins grew by almost 19% to $37 billion, and is predicted to achieve sales of over $90 billion by 2010. Future growth however depends largely on the industry overcoming a number of hurdles, including drug delivery challenges and cost issues.
Today therapeutic proteins are used to relieve patients suffering from many conditions, including:
- Various cancers (Monoclonal antibodies, Interferons)
- Heart attacks, strokes, cystic fibrosis, Gaucher's disease (Enzymes, Blood factors)
- Diabetes (Insulin)
- Anaemia (Erythropoietin)
- Haemophilia (Blood clotting factors)
The leading therapeutic protein treatments in 2003 were:
- Johnson & Johnson's anaemia treatment Procrit
- Amgen's anaemia treatment Epogen
- Schering-Plough's hepatitis treatments Intron A and Peg-Intron
The leading classes of therapeutic proteins in 2003 were:
- Erythropoietins
- Monoclonal antibodies
- Interferons
While the top companies on the market were:
- Amgen
- Johnson & Johnson
- Roche
WHY YOU MUST BUY THIS REPORT?
With over 80 graphs and figures, plus almost 60 tables, this report represents a key tool for companies wishing to enter into or expand in the therapeutic protein market. The reader will be left with a clear idea of:
- The challenges faced by the therapeutic protein market, and how these are being overcome
The current and future market leaders in terms of brand, class, category and company, covering the period 2003-2010 - Therapeutic targets currently being developed in the field and who is responsible for this development
- The competition that companies will face during the forecast period from current and pipeline products.
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?
- 3.2.1 Why is There a Shortfall in Manufacturing Capacity for Therapeutic Proteins?
- 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
- 3.1 Drug Delivery Challenges
- 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 Antibodie
- 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 Month
- 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 Indication
- 4.5.3.2 Side-Effects of Competitor Medications May Prove Advantageous for Enbrel
- 4.5.1 Aranesp is the Fastest-Growing Therapeutic Protein
- 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 Blod 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
- 7.6.2 Amarillo Biosciences are Developing an Oral Interferon for Hepatitis C
- 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
- 10.1 The Market for Blood Factors
- 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 201012. Conclusion: The Market will Continue its Double-Digit Growth for the Foreseeable Future
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