World Biological Drugs Market 2013-2023

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World Biological Drugs Market 2013-2023

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Contents

1.1 World Biological Drugs Market Review

1.2 Summary of Report Contents

1.3 Research and Analysis Methods

2.1 Biologics Market Projections for 2013-2023

2.2 The Importance of Biological Drugs to the Global Pharmaceutical Market

2.2.1 Defining ‘Biological’

2.2.2 Biological Drugs Constituted 15% of the Global Pharmaceutical Market in 2012

2.2.2.1 The Leading Biological Products and How they Rank Overall

2.2.2.2 Why are Biologics the Most Lucrative Pharmaceutical Products in the Global Market

Overall?

2.2.3 The Biosimilars Revolution: Coming Soon?

2.2.3.1 Biosimilars Represented Just Over 1% of the Biologics Market in 2012

2.2.3.2 An Important Decade for Biosimilars

2.2.4 Autoimmune Diseases, Cancer and Diabetes Treatments Make Up 73% of the Biologics

Market

2.2.4.1 Other Therapeutic Areas within the Biologics Market

2.2.4.2 How the Biologics Market’s Therapeutic Focus Differs from the Broader Pharmaceutical

Market

2.2.5 Roche Still Leads the Biologics Market

2.3 Overview of the Four Submarkets, 2013-2023

2.3.1 Superior Pipeline Will Drive Increased Market Share for MAbs Submarket

2.4 Protein Therapeutics Submarket: Scientific and Historical Background

2.4.1 Proteins Have Been Used Medicinally Since the 19th Century

1. Executive Summary

2. Biological Drugs Market: Clinical and Commercial Overview, 2013-2023

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Contents 2.4.2 Recombinant DNA Technology

2.4.3 Biotechs and Biotechnology

2.4.4 Insulin: The First Protein Therapeutic

2.4.5 Approval of Recombinant Hormones

2.4.6 Discovery of Plasma and Clotting Proteins

2.4.7 Interferons Approved in 1990s

2.4.8 Other Protein Therapeutics

2.5 MAbs Submarket: Scientific and Historical Background

2.5.1 Natural Antibodies: Key to the Immune System

2.5.2 From Serum Therapy to Monoclonal Antibodies (MAbs)

2.5.3 Humanising the MAb

2.5.4 MAbs for Autoimmune Indications

2.5.5 MAbs for Cancer Indications

2.5.6 MAbs for Other Therapeutic Area Indications

2.5.7 MAbs for All? The Technology Comes Off Patent

2.5.8 Next-Generation Technologies

2.6 Fusion Proteins Submarket: Scientific and Historical Background

2.6.1 Differentiating Fusion Proteins

2.7 Cellular and Regenerative Medicines Submarket: Scientific and Historical Background

2.7.1 Tissue Engineering

2.7.2 Cellular Therapies

2.7.3 Gene Therapy

2.8 Marginal Cases

2.8.1 The Vaccines Market

2.8.1 The Vaccines Market

3.1 Protein Therapeutics Submarket Projections for 2013-2023

3.2 Protein Therapeutics Submarket: Breakdown by Segment, 2013-2023

3.2.1 Insulins Segment: Set to Grow Rapidly to 2023

3.2.1.1 Novo Nordisk, Sanofi and Eli Lilly Dominate the Insulins Segment

3. Protein Therapeutics Submarket 2013-2023

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Contents 3.2.1.2 Duration of Action the Major Differentiator for Insulins

3.2.1.3 Tresiba: A Game-Changer for the Segment?

3.2.1.4 Pegylated Insulins, Ultra-Concentrated Insulins, and Insulin Tablets: Insulin Pipeline for

the Big Three

3.2.1.5 Biosimilars and Other Insulins in Development

3.2.1.6 Diabetes Prevalence the Major Driver for Insulins

3.2.1.7 Market Forecast for Insulins Segment, 2013-2023

3.2.2 Other Recombinant Hormones: Set for Biosimilar Competition

3.2.2.1 Revenues for Erythropoietins Continue to Fall in 2012

3.2.2.2 Biosimilars, Safety Concerns and Other Restraints for Erythropoietins

3.2.2.3 G-CSF: How Long Can Amgen and Kyowa Continue to Dominate?

3.2.2.4 Biosimilar Filgrastim and Pegfilgrastim to Reach All the Major Regional Markets

3.2.2.5 Somatropin: Another Well-Established Recombinant Hormone

3.2.2.6 Biosimilar and Safety Challenges to Growth Hormones

3.2.2.7 Pipeline for Other Recombinant Hormones

3.2.2.8 Drivers and Restraints for Other Recombinant Hormones

3.2.2.9 Market Forecast for Other Recombinant Hormones Segment, 2013-2023

3.2.3 Plasma and Recombinant Coagulating Factors: A Growth Opportunity

3.2.3.1 Types of Recombinant Factor

3.2.3.2 Key Clotting Factor Deficiency Diseases

3.2.3.3 Six Companies Dominate the Segment

3.2.3.4 Other Companies Targeting this Segment: Biogen Idec Leads the Pack

3.2.3.5 Extended Duration of Action to be a Differentiator

3.2.3.6 Limited Opportunities for Biosimilar Challenges

3.2.3.7 Other Pipeline Developments

3.2.3.8 Drivers and Restraints for Plasma and Recombinant Coagulating Factors, 2013

3.2.3.9 Market Forecast for Plasma and Recombinant Coagulating Factors Segment, 2013-2023

3.2.4 Interferons: Two Decades as Key Antiviral and MS Therapeutics

3.2.4.1 Leading Interferon Brands in 2012

3.2.4.2 Interferons Remain Part of Hepatitis Standard of Care Despite Severe Limitations

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Contents 3.2.4.3 How Will Interferons Compete Against the Pipeline Protease and Polymerase Inhibitors?

3.2.4.4 Aubagio, Tecfidera and Lemtrada to Reduce Interferons’ Hold on the MS Therapeutic

Area

3.2.4.5 Biosimilar First-Generation Interferons Widely Available in Emerging Markets

3.2.4.6 Can the Pipeline Rejuvenate the Interferons Segment?

3.2.4.7 Drivers and Restraints for the Interferons Segment, 2013

3.2.4.8 Market Forecast for Interferons Segment, 2013-2023

3.2.5 Other Protein Therapeutics: Enzyme Replacement A Key Area

3.2.5.1 Pipeline for Other Protein Therapeutics

3.2.5.2 Market Forecast for Other Protein Therapeutics Segment, 2013-2023

3.3 Leading Products in the Protein Therapeutics Submarket, 2013-2023

3.3.1 Changing Market Shares, 2013-2023

3.3.2 Lantus (Sanofi), 2013-2023

3.3.2.1 Tresiba’s Cardiovascular Concerns Mean Lantus Will Stay In Front

3.3.2.2 Market Forecast for Lantus, 2013-2023

3.3.3 Neulasta/Neupogen (Amgen), 2013-2023

3.3.3.1 Biosimilars the Main Concern for Amgen

3.3.3.2 Market Forecast for Neulasta/Neupogen, 2013-2023

3.3.4 Epogen (Amgen), 2013-2023

3.3.4.1 Amgen’s Defence of Epogen’s Market Share

3.3.4.2 Market Forecast for Epogen, 2013-2023

3.3.5 Avonex (Biogen Idec), 2013-2023

3.3.5.1 How Will Avonex Fare in the Changing MS Therapeutic Area?

3.3.5.2 Market Forecast for Avonex, 2013-2023

3.3.6 NovoRapid (Novo Nordisk), 2013-2023

3.3.6.1 Competition in the Short-Acting Insulin Analogues Market

3.3.6.2 Market Forecast for NovoRapid, 2013-2023

3.3.7 Other Products, 2013-2023

3.3.7.1 Major Future Approvals in this Submarket

3.3.7.2 Market Forecast for Other Products, 2013-2023

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Contents 3.4 Leading Products in Development in the Protein Therapeutics Submarket, 2013

3.4.1 Recombinant Factor XIII (Novo Nordisk)

3.4.2 NN7008 (Novo Nordisk)

3.4.3 Liprotamase (Eli Lilly)

3.4.4 IDegLira (Novo Nordisk)

3.4.5 LY2605541(Eli Lilly / Boehringer Ingelheim)

3.4.6 LY2963016 (Eli Lilly / Boehringer Ingelheim)

3.4.7 FIAsp (Novo Nordisk)

3.4.8 Somatropin (LG Life Sciences)

3.4.9 Natpara (NPS Pharmaceuticals)

3.4.10 Recombinant von Willebrand Factor (Baxter)

3.4.11 IB1001 (Inspiration Biopharmaceuticals)



3.4.14 Recombinant Factor VIII Fc (Biogen Idec)

3.4.15 Recombinant Factor IX Fc (Biogen Idec)

3.4.16 BAY 94-9027 (Bayer)

3.4.17 Human Recombinant Factor VIII (Octapharma)

3.4.18 OBI-1 (Inspiration Biopharmaceuticals)

3.4.19 BIIB017 (Biogen Idec)

3.4.20 Alferon N Injection (HemispherX Biopharma)

3.4.21 PEG-interferon Lambda (Bristol-Myers Squibb)

3.4.22 NU-100 (Nuron Biotech)

3.4.23 Multikine (CEL-SCI)

3.4.24 Talactoferrin Alpha (Agennix)

3.4.25 Desmoteplase (Lundbeck)

3.4.26 Mycobacterium Cell Wall-DNA complex (Bioniche Therapeutics)

4.1 Monoclonal Antibodies Submarket Projections for 2013-2023

4. Monoclonal Antibodies Submarket 2013-2023

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Contents 4.2 Monoclonal Antibodies Submarket: Breakdown by Segment, 2013-2023

4.2.1 Autoimmune MAbs: Leading Segment of Biologics Market in 2012

4.2.1.1 Humira and Remicade Dominate Autoimmune MAbs Segment

4.2.1.2 TNF Blockers Represent 79% of All Revenues in the Autoimmune Segment

4.2.1.3Johnson & Johnson Leads the Autoimmune Segment with 41% Market Share

4.2.1.4 The Autoimmune MAbs Pipeline

4.2.1.5 Asthma and Lupus Next Behind RA as R&D Focus for Autoimmune MAbs

4.2.1.6 Competition for the Autoimmune MAbs

4.2.1.7 Drivers and Restraints for Autoimmune MAbs, 2013

4.2.1.8 Market Forecast for Autoimmune MAbs Segment, 2013-2023

4.2.2 Oncology MAbs: Focus for Next-Generation Antibody Innovation

4.2.2.1 Roche’s Three Major Products Dominate the Segment

4.2.2.2 Perjeta and Kadcyla Will Cement the Importance of HER2 as Key Molecular Target

4.2.2.3 Eight Approved MAbs Target Haematological Cancers

4.2.2.4 Bristol-Myers Squibb Rank Second in Oncology Segment

4.2.2.5 Next-Generation Formats Bolster Extensive Oncology Pipeline

4.2.2.6 Solid Tumours are the Major Challenge for Oncology MAbs

4.2.2.7 Drivers and Restraints for Oncology MAbs, 2013

4.2.2.8 Market Forecast for Oncology MAbs Segment, 2013-2023

4.2.3 Other Therapeutic Areas MAbs: New Breakthroughs to Come?

4.2.3.1 Lucentis Continues to Dominate this Segment

4.2.3.2 Pipeline Targets Several New Therapeutic Areas

4.2.3.3 Anti-PCSK9 MAbs to Combine with Statins?

4.2.3.4 After Bapineuzumab: New Hope for Alzheimer’s MAbs

4.2.3.5 Building on Lucentis: MAbs for Ophthalmic Indications

4.2.3.6 Anti-Infective MAbs: The New Antibiotics?

4.2.3.7 Drivers and Restraints for Other Therapeutic Areas MAbs, 2013

4.2.3.8 Market Forecast for Other Therapeutic Areas MAbs Segment, 2013-2023

4.3 Leading Products in the MAbs Submarket, 2013-2023

4.3.1 Changing Market Shares, 2013-2023

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Contents 4.3.2 Humira (AbbVie), 2013-2023

4.3.2.1 Approved for Ulcerative Colitis, but will Oral RA Treatments Threaten Humira?

4.3.2.2 Market Forecast for Humira, 2013-2023

4.3.3 Remicade (Johnson & Johnson), 2013-2023

4.3.3.1 Can Remicade Survive the Biosimilar Challenge from Korea?

4.3.3.2 Market Forecast for Remicade, 2013-2023

4.3.4 Rituxan (Roche), 2013-2023

4.3.4.1 Battle for the CD20 Market: Rituxan vs The Rest

4.3.4.2 Market Forecast for Rituxan, 2013-2023

4.3.5 Herceptin (Roche), 2013-2023

4.3.5.1 The First Major PLM Strategy in the MAb Submarket: Herceptin, Perjeta and Kadcyla

4.3.5.2 Market Forecast for Herceptin, 2013-2023

4.3.6 Avastin (Roche), 2013-2023

4.3.6.1 Is Avastin Reaching its Limits?

4.3.6.2 Market Forecast for Avastin, 2013-2023

4.3.7 Other MAb Products, 2013-2023

4.3.7.1 Forecast for Other MAb Products, 2013-2023

4.4 Leading Products in Development in the MAbs Submarket, 2013

4.4.1 CNTO-136 (Johnson & Johnson)

4.4.2 Daclizumab (AbbVie/Biogen Idec)

4.4.3 Epratuzumab (UCB/ Immunomedics)

4.4.4 Ocrelizumab (Biogen Idec/ Roche)

4.4.5 Sarilumab (Sanofi)

4.4.6 Secukinumab (Novartis)

4.4.7 Tabalumab (Eli Lilly)

4.4.8 Ixekizumab (Eli Lilly)

4.4.9 Tanezumab (Pfizer)

4.4.10 Mepolizumab (GlaxoSmithKline)

4.4.11 Reslizumab (Cephalon)

4.4.12 Lebrikiuzmab (Genentech)

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Contents 4.4.13 Tildrakizumab (Merck)

4.4.14 ch14.18 (United Therapeutics)

4.4.15 Inotuzumab Ozogamicin (Pfizer)

4.4.16 Elotuzumab (Bristol-Myers Squibb)

4.4.17 Farletuzumab (Eisai)

4.4.18 Ganitumab (Amgen)

4.4.19 MABp1 (Xbiotech)

4.4.20 GA101 (Roche)

4.4.21 Mogamalizumab (Kyowa Hakko Kirin)

4.4.22 Necitumumab (Eli Lilly)

4.4.23 Nivolumab (Bristol-Myers Squibb)

4.4.24 Onartuzumab (Roche)

4.4.25 Ramucirumab (Eli Lilly)

4.4.26 Girentuximab (Wilex)

4.4.27 AMG145 (Amgen)

4.4.28 SAR 236553 (Sanofi/ Regeneron)

4.4.29 Gevokizumab (XOMA)

4.4.30 Teplizumab (MacroGenics)

4.4.31 Anthraximmune Globulin (Cangene)

4.4.32 Actoxumab (Merck)

4.4.33 Romosozumab (Amgen)

4.4.34 Solanezumab (Eli Lilly)

5.1 Fusion Proteins Submarket Projections for 2013-2023

5.2 Leading Products in the Fusion Proteins Submarket, 2013-2023

5.2.1 New Approvals to Drive Submarket Growth to 2023

5.2.2 Enbrel (Amgen): Leading Fusion Protein, 2013

5.2.2.1 Biosimilar Enbrel Competitors on Hold?

5. Fusion Proteins Submarket 2013-2023

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Contents 5.2.2.2 Market Forecast for Enbrel, 2013-2023

5.2.2.3 Can Orencia Differentiate Itself in the RA Market?

5.2.3 Eylea (Regeneron): Breaking Into the AMD Market in 2012

5.2.3.1 Scope for Expansion with Eylea

5.2.3.2 Market Forecast for Eylea, 2013-2023

5.2.4 Other Fusion Proteins, 2013-2023

5.3 Leading Products in Development in the Fusion Proteins Submarket, 2013

5.3.1 Albiglutide (GlaxoSmithKline)

5.3.2 Dulaglutide (Eli Lilly)

5.3.2.1 Could the Fifth in Class Become the Best in Class?

5.3.3 Atacicept (Merck KGaA/ZymoGenetics)

5.3.4 AMG 386 (Amgen)

6.1 Cellular and Regenerative Medicines Submarket Projections for 2013-2023

6.2 Cellular and Regenerative Medicines Submarket: Breakdown by Segment, 2013-2023

6.2.1 Tissue Engineered Products: Prospects Beyond Wound Repair?

6.2.1.1 Apligraf Leads the Tissue Engineered Products Segment in 2013

6.2.1.2 Apligraf Competes with Dermagraft in Diabetic Foot Ulcers Therapeutic Area

6.2.1.3 Other Potential Applications for Tissue Engineering

6.2.1.4 Drivers and Restraints for the Tissue Engineered Products Segment, 2013

6.2.1.5 Market Forecast for Tissue Engineered Products Segment, 2013

6.2.2 Cellular Therapies Segment, 2013-2023

6.2.2.1 Approvals in Canada and South Korea Bolster Stem Cell Field

6.2.2.2 The Big Stem Cell Breakthrough I: The New Wave of MSC Treatments

6.2.2.3 The Big Stem Cell Breakthrough 2: Regenerating Organs

6.2.2.4 Chondrocytes for Cartilage Repair

6.2.2.5 Drivers and Restraints for Cellular Therapies, 2013

6.2.2.6 Market Forecast for Cellular Therapies, 2013-2023

6. Cellular and Regenerative Medicines Submarket, 2013-2023

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Contents 6.2.3 Gene Therapy: Has the Time Come at Last for This Technology?

6.2.3.1 Existing Gene Therapy Products: Asian Approvals

6.2.3.2 Glybera Brings Gene Therapy to Europe

6.2.3.3 Significant Pipeline for Gene Therapies

6.2.3.4 Drivers and Restraints for Gene Therapy, 2013

6.2.3.5 Market Forecast for Gene Therapy, 2013-2023

6.3 Leading Products in Development in the Cellular and Regenerative Medicines Submarket,

2013

6.3.1 CAIS (Depuy Mitek)

6.3.2 Neocart (Histogenics Corporation)

6.3.3 Ixmyelocel-T (Aastrom Biosciences)

6.3.4 "Off-the-shelf" Mesenchymal Precursors (Mesoblast)

6.3.4.1 Gamida Cell Competing for this Market Opportunity

6.3.5 Prochymal (Osiris Therapeutics)

6.3.6 Auto-CD34+ Cells (Baxter)

6.3.6.1 NeoStem vs Baxter

6.3.7 Cx601 (Tigenix)

6.3.8 Talminogene Laherparepvec (Amgen)

6.3.9 Generx (Cardium Therapeutics)

7.1 The US Remained the Largest Market in 2012

7.2 Overview of Market Change, 2013-2023

7.3 Breakdown by Region, 2013-2023

7.3.1 US, 2013-2023

7.3.1.1 US Health Spending Nears $3 Trillion

7.3.1.2 Value-Based Pricing in the US

7.3.1.3 US Regulation of Biologics

7.3.1.4 Biologics Price Competition and Innovation Act

7.3.1.5 Market Forecast for the US, 2013-2023

7. Leading National Markets for Biological Drugs 2013-2023

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Contents 7.3.2 EU5, 2013-2023

7.3.2.1 European Leadership on Biosimilars

7.3.2.2 Other Biosimilar Regulations

7.3.2.3 Market Forecast for EU5, 2013-2023

7.3.2.4 Breakdown of the EU5, 2013-2023

7.3.3 Japan, 2013-2023

7.3.3.1 Sandoz and JCR Pioneering Japanese Biosimilars

7.3.3.2 Market Forecast for Japan, 2013-2023

7.3.4 BRIC Nations, 2013-2023

7.3.4.1 Market Forecast for the BRIC Nations, 2013-2023

7.3.4.2 Brazil: Government to Take the Lead in Biologics Manufacture?

7.3.4.3 Russia: Targeting Domestic Biomanufacturing Capacity

7.3.4.4 India: Will the Generics Hub Become the Biosimilars Leader?

7.3.4.5 China: The Major Market Opportunity

7.3.4.6 Breakdown of the BRIC Nations, 2013-2023

8.1 Strengths: An Established and Successful Market

8.2 Weaknesses: Has the Advance of Biopharmaceuticals Reached its Limits?

8.3 Opportunities: Time for a New Phase in the Biologics Revolution

8.4 Threats: Where Will the Innovations Needed to Keep the Market Moving Come From?

8.5 Social Factors: How Much do Physicians and Patients Want the New Biologics?

8.6 Technological Developments: Crucial to the Market

8.7 Economic Pressures: A Constant Theme in the Biologics Market

8.8 Political Issues: Governments Shaping the Regulatory Future of the Market

9.1 Overview of the Biotech Industry in 2013: Interview with Ronald A. Rader, President of

Biotechnology Information Institute

9.1.1 Steady Growth, but a Dearth of New Blockbusters

8. Qualitative Industry Analysis: Drivers and Restraints, 2013

9. Research Interviews

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Contents 9.1.2 The Price of Biological Drugs

9.1.3 Biosimilars to Outnumber Innovator Products

9.1.4 ‘Differentiated Biologics’: Biosimilars vs Bio-Betters

9.1.5 Changing of the Guard: Can New Classes of Biopharmaceuticals Transform the Market?

9.1.6 Big Pharma and the Biotechs

9.1.7 Bundled Payments and Bulked-up Portfolios, and Other Reasons Why Every Major Player

Will Get Involved in Biosimilars

9.1.8 Modular Bioprocessing: The Next Revolution?

9.2 Next-Generation MAbs: Interview with Dr Janice Reichert

9.2.1 On Antibody-Drug Conjugates

9.2.2 On Engineered Improvements to Antibodies

9.2.3 On the Current Scientific Understanding of Antibody Functions

9.2.4 On Bispecific Antibodies

9.2.5 On Antibody Fragments and Market Pricing

9.2.6 On the Overall Prospects for Next-Generation Antibodies

9.3 MAb vs. Fusion Protein in the AMD Market: Interview with Dr Michael Stewart, Mayo Clinic

9.3.1 The Impact of Eylea, 2011-2012

9.3.2 The Comparative Dosing Schedules of Eylea and Lucentis

9.3.3 Patient Transitioning to Eylea: Salvage Switching

9.3.4 Avastin After the CATT Study

9.3.5 Prospects for Eylea in Other Indications and Combinations

9.3.6 Future Possibilities in Wet AMD Treatment

9.4 A Revolution in Regenerative Medicine? Interview with Dr Alan Trounson, President,

California Institute for Regenerative Medicine (CIRM)

9.4.1 Current Stem Cell Clinical Trials

9.4.2 Big Pharma Investment in Stem Cells

9.4.3 Mesenchymal Cells in Clinical Trials

9.4.4 On Definitions of Cell Types and Regulatory Pathways

9.4.5 The Prospects for Stem Cell Cures

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Contents

10.1 The Biologics Market Will Grow in Importance for the Pharmaceuticals Industry

10.2 MAbs and Protein Therapeutics Will Continue to Be the Dominant Submarkets

10.3 Biosimilars Will Transform the Market

10.4 Cost will Remain the Main Challenge

10. Conclusions

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Contents

Table 2.1 World Biological Drugs Market: Total Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 2.2 World Biological Drugs Market: Total Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 2.3 Comparative Biological Molecule Sizes

Table 2.4 Top 10 Biological Drugs: Revenues ($m), Market Share (%), 2012

Table 2.5 Top 10 Drugs in the Global Pharmaceutical Market: Revenues ($m), 2012

Table 2.6 Key Therapeutic Areas in the Biologics Market: Revenues ($m), Market Share (%),

2012

Table 2.7 Leading Companies in the Biologics Market: Revenues ($m), Market Share (%), 2012

Table 2.8 Breakdown by Submarket: Revenues ($m), Market Share (%), 2012

Table 2.9 Breakdown by Submarket: Revenues ($m), AGR (%), CAGR (%), Market Share (%),

2012-2017


Table 2.11 Breakdown by Submarket: Revenues ($m), AGR (%), CAGR (%), Market Share (%),

2018-2023


Table 2.13 Regions of an Antibody

Table 2.14 Natural Antibody Mechanisms of Action

Table 2.15 Potency and Source of Stem Cells

Table 3.1 Protein Therapeutics Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2012-

2017

Table 3.2 Protein Therapeutics Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2018-

2023

Table 3.3 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), Submarket

Share (%), 2012

Table 3.4 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), AGR (%),

CAGR (%) Submarket Share (%), 2012-2017


Share (%), 2017

List of Tables

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Contents Table 3.6 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), AGR (%),

CAGR (%), Submarket Share (%), 2018-2023


Share (%), 2023

Table 3.8 EU and US Patent Expiry Dates for Leading Insulins

Table 3.9 Types of Insulin Product, 2013

Table 3.10 Insulins Pipeline: Selected Products, 2013

Table 3.11 Classes of Diabetes Treatments, 2013

Table 3.12 Insulins Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 3.13 Insulins Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 3.14 EU and US Patent Expiry Dates for Leading Erythropoietins

Table 3.15 Other Recombinant Hormones Pipeline: Selected Products, 2013

Table 3.16 Other Recombinant Hormones Segment: Revenues ($m), AGR (%), CAGR (%), 2012-

2017

Table 3.17 Other Recombinant Hormones Segment: Revenues ($m), AGR (%), CAGR (%), 2018-

2023

Table 3.18 Selected Coagulating Factors Significant in Segment R&D, 2013

Table 3.19 Plasma and Recombinant Coagulating Factors Pipeline: Selected Products, 2013

Table 3.20 Plasma and Recombinant Coagulating Factors Segment: Revenues ($m), AGR (%),

CAGR (%), 2012-2017

Table 3.21 Plasma and Recombinant Coagulating Factors Segment: Revenues ($m), AGR (%),

CAGR (%), 2018-2023

Table 3.22 Leading Interferon Products: Revenues ($m), Market Share (%), 2012

Table 3.23 EU and US Patent Expiry Dates for Leading Interferons

Table 3.24 Interferons Pipeline: Selected Products, 2013

Table 3.25 Interferons Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 3.26 Interferons Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 3.27 Other Protein Therapeutics Pipeline: Selected Products, 2013

Table 3.28 Other Protein Therapeutics Segment: Revenues ($m), AGR (%), CAGR (%), 2012-

2017

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Contents Table 3.29 Other Protein Therapeutics Segment: Revenues ($m), AGR (%), CAGR (%), 2018-

2023

Table 3.30 Leading Protein Therapeutic Products: Revenues ($m), Submarket Share (%), 2012

Table 3.31 Leading Protein Therapeutic Products: Revenues ($m), AGR (%), CAGR (%),

Submarket Share (%), 2012-2017

Table 3.32 Leading Protein Therapeutic Products: Revenues ($m), Market Share (%), 2017

Table 3.33 Leading Protein Therapeutic Products: Revenues ($m), AGR (%), CAGR (%), Market

Share (%), 2018-2023

Table 3.34 Leading Protein Therapeutic Products: Revenues ($m), Market Share (%), 2023

Table 3.35 Lantus: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 3.36 Lantus: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 3.37 Neulasta/Neupogen: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 3.38 Neulasta/Neupogen: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 3.39 Epogen: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 3.40 Epogen: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 3.41 Avonex: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 3.42 Avonex: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 3.43 NovoRapid: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 3.44 NovoRapid: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 3.45 Other Products: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 3.46 Other Products: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 3.47 Protein Therapeutics Late-Stage Pipeline, Selected Products, 2013

Table 4.1 Monoclonal Antibodies Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2012-

2017

Table 4.2 Monoclonal Antibodies Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2018-

2023

Table 4.3 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market

Share (%), 2012

Table 4.4 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), AGR (%),

CAGR (%) Market Share (%), 2012-2017

www.visiongain.com

Contents Table 4.5 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market

Share (%), 2017

Table 4.6 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), AGR (%),

CAGR (%) Market Share (%), 2018-2023

Table 4.7 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market

Share (%), 2023

Table 4.8 Leading Products in Autoimmune MAbs Segment, Revenues ($m), Share of Segment

(%), 2012

Table 4.9 Main Molecular Targets in Autoimmune Segment: Revenues ($m), Market Share (%),

2012

Table 4.10 Level of Antibody Humanisation in Autoimmune Segment: Revenues ($m), Market

Share (%), 2012

Table 4.11 Leading Companies in Autoimmune Segment: Revenues ($m), Market Share (%),

2012

Table 4.12 Autoimmune MAbs Pipeline: Selected Products, 2013

Table 4.13 RA MAbs Pipeline: Selected Products, 2013

Table 4.14 Asthma MAbs Pipeline: Selected Products, 2013

Table 4.15 Lupus MAbs Pipeline: Selected Products, 2013

Table 4.16 MS MAbs Pipeline: Selected Products, 2013

Table 4.17 Psoriasis MAbs Pipeline: Selected Products, 2013

Table 4.18 Other Autoimmune MAbs Pipeline: Selected Products, 2013

Table 4.19 Autoimmune MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 4.20 Autoimmune MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 4.21 Leading Products in Oncology MAbs Segment, Revenues ($m), Share of Segment

(%), 2012

Table 4.22 Main Molecular Targets in Oncology Segment: Revenues ($m), Market Share (%),

2012

Table 4.23 Leading Companies in Oncology Segment: Revenues ($m), Market Share (%), 2012

Table 4.24 Oncology MAbs Pipeline: Selected Products, 2013

Table 4.25 Oncology MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017

www.visiongain.com

Contents Table 4.26 Oncology MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 4.27 Leading Products in Other Therapeutic Areas MAbs Segment, Revenues ($m), Share

of Segment (%), 2012

Table 4.28 Other Therapeutic Areas MAbs Pipeline: Selected Products, 2013

Table 4.29 Cardiovascular MAbs Pipeline: Selected Products, 2013

Table 4.30 Alzheimer’s Disease MAbs Pipeline: Selected Products, 2013

Table 4.31 Ophthalmic MAbs Pipeline: Selected Products, 2013

Table 4.32 Anti-Infectives MAbs Pipeline: Selected Products, 2013

Table 4.33 Other Therapeutic Areas MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2012-

2017

Table 4.34 Other Therapeutic Areas MAbs Segment: Revenues ($m), AGR (%), CAGR (%), 2018-

2023

Table 4.35 Leading MAbs: Revenues ($m), Market Share (%), 2012

Table 4.36 Leading MAbs: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017


Table 4.38 Leading MAbs: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023


Table 4.40 Humira: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017

Table 4.41 Humira: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023

Table 4.42 Remicade: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017

Table 4.43 Remicade: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023

Table 4.44 Rituxan: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017

Table 4.45 Rituxan: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023

Table 4.46 Herceptin: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017

Table 4.47 Herceptin: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023

Table 4.48 Avastin: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017

Table 4.49 Avastin: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023

Table 4.50 Other MAb Products: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%),

2012-2017

www.visiongain.com

Contents Table 4.51 Other MAb Products: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%),

2018-2023

Table 4.52 Selected Late-Stage MAbs Pipeline, 2013

Table 5.1 Fusion Proteins Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 5.2 Fusion Proteins Submarket: Total Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 5.3 Approved Fusion Proteins, 2013

Table 5.4 Leading Products in Fusion Proteins Segment: Revenues ($m), Market Share (%), 2012

Table 5.5 Fusion Proteins Submarket Leading Products: Revenues ($m), AGR (%), CAGR (%),

Market Share (%), 2012-2017


Table 5.7 Fusion Proteins Submarket Leading Products: Revenues ($m), AGR (%), CAGR (%),

Market Share (%), 2018-2023


Table 5.9 Enbrel: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017

Table 5.10 Enbrel: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023

Table 5.11 Orencia: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017

Table 5.12 Orencia: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023

Table 5.13 Eylea: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-2017

Table 5.14 Eylea: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-2023

Table 5.15 Other Fusion Protein Products: Revenues ($m), AGR (%), CAGR (%), Submarket

Share (%), 2012-2017

Table 5.16 Other Fusion Protein Products: Revenues ($m), AGR (%), CAGR (%), Submarket

Share (%), 2018-2023

Table 5.17 Fusion Proteins Pipeline: Selected Products, 2013

Table 6.1 Cellular and Regenerative Medicines Submarket: Total Revenues ($m), AGR (%),

CAGR (%), 2012-2017

Table 6.2 Cellular and Regenerative Medicines Submarket: Total Revenues ($m), AGR (%),

CAGR (%), 2018-2023

Table 6.3 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues

($m), Market Share (%), 2012

www.visiongain.com

Contents Table 6.4 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues

($m), AGR (%), CAGR (%) Market Share (%), 2012-2017




($m), AGR (%), CAGR (%) Market Share (%), 2018-2023



Table 6.8 Tissue Engineered Products Pipeline: Selected Products, 2013

Table 6.9 Tissue Engineered Products Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 6.10 Tissue Engineered Products Segment: Revenues ($m), AGR (%), CAGR (%), 2018-

2023

Table 6.11 Cellular Therapies Pipeline: Selected Products, 2013

Table 6.12 Cellular Therapies Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 6.13 Cellular Therapies Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 6.14 Gene Therapy Pipeline: Selected Products, 2013

Table 6.15 Gene Therapy Segment: Revenues ($m), AGR (%), CAGR (%), 2012-2017

Table 6.16 Gene Therapy Segment: Revenues ($m), AGR (%), CAGR (%), 2018-2023

Table 6.17 Cellular and Other Regenerative Medicines Submarket: Selected Late-Stage Pipeline,

2013

Table 7.1 Regional Breakdown of the Biological Drugs Market, Revenues ($m), Market Shares

(%), 2012

Table 7.2 Regional Breakdown of the Biological Drugs Market: Revenues ($m), AGR (%), CAGR

(%), Market Shares (%), 2012-2017


(%) 2017

Table 7.4 Regional Breakdown of the Biological Drugs Market: Revenues ($m), AGR (%), CAGR

(%), Market Shares (%), 2018-2023


(%), 2023

www.visiongain.com

Contents Table 7.6 US: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017

Table 7.7 US: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023

Table 7.8 EU5: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017

Table 7.9 EU5: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023

Table 7.10 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2012

Table 7.11 National Breakdown of the EU5, Revenues ($m), AGR (%), CAGR (%), Share of

Market (%), 2012-2017

Table 7.12 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2017

Table 7.13 National Breakdown of the EU5, Revenues ($m), AGR (%), CAGR (%), Share of

Market (%), 2018-2023

Table 7.14 National Breakdown of the EU5, Revenues ($m), Share of Market (%) 2023

Table 7.15 Japan: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017

Table 7.16 Japan: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023

Table 7.17 BRIC Nations: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2012-2017

Table 7.18 BRIC Nations: Revenues ($m), AGR (%), CAGR (%), Market Share (%), 2018-2023

Table 7.19 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%) 2012

Table 7.20 National Breakdown of the BRIC Nations, Revenues ($m), AGR (%), CAGR (%), Share

of Market (%), 2012-2017

Table 7.21 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%), 2017

Table 7.22 National Breakdown of the BRIC Nations, Revenues ($m), AGR (%), CAGR (%), Share

of Market (%), 2018-2023

Table 7.23 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%), 2023

Table 8.1 World Biologics Market: Strengths and Weaknesses, 2013

Table 8.2 World Biologics Market: Opportunities and Threats, 2013

Table 8.3 World Biologics Market: STEP Analysis, 2013-2023

www.visiongain.com

Contents

Figure 2.1 World Biological Drugs Market: Total Revenues ($m), 2012-2023

Figure 2.1 World Biological Drugs Market: Total Revenues ($m), 2012-2023

Figure 2.2 Comparative Biological Molecule Sizes

Figure 2.3 Biologics Market as Sector Within the Global Pharmaceuticals Market: Revenues

($bn), Market Share (%), 2012

Figure 2.4 Top 10 Biological Drugs: Revenues ($m), Market Share (%), 2012

Figure 2.5 Top 10 Drugs in the Global Pharmaceutical Market: Revenues ($m), 2012

Figure 2.6 Biosimilars as Segment of the Overall Biologics Market: Revenues ($m), Market Share

(%), 2012, 2017, 2023

Figure 2.7 Key Therapeutic Areas in the Biologics Market: Revenues ($m), Market Share (%),

2012

Figure 2.8 Key Therapeutic Areas in the Biologics Market, Compared to Overall Pharmaceutical

Market: Market Share (%), 2012

Figure 2.9 Breakdown by Submarket: Revenues ($m), Market Share (%), 2012



Figure 2.12 Breakdown by Submarket: Revenues ($m), 2012-2023

Figure 2.13 Breakdown by Submarket: Revenues ($m), 2012, 2017, 2023

Figure 3.1 Protein Therapeutics Submarket: Total Revenues ($m), 2012-2023

Figure 3.2 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), Submarket

Share (%), 2012


Share (%), 2017


Share (%), 2023

Figure 3.5 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), 2012-2023

Figure 3.6 Protein Therapeutics Submarket Breakdown by Segment: Revenues ($m), 2012, 2017,

2023

Figure 3.7 Drivers and Restraints in the Insulins Segment, 2013

List of Figures

www.visiongain.com

Contents Figure 3.8 Insulins Segment: Revenues ($m), 2012-2023

Figure 3.9 Drivers and Restraints in the Other Recombinant Hormones Segment, 2013

Figure 3.10 Other Recombinant Hormones Segment: Revenues ($m), 2012-2023

Figure 3.11 Drivers and Restraints in the Plasma and Recombinant Coagulating Factors

Segment, 2013

Figure 3.12 Plasma and Recombinant Coagulating Factors Segment: Revenues ($m), 2012-2023

Figure 3.13 Leading Interferon Products: Revenues ($m), Market Share (%), 2012

Figure 3.14 Drivers and Restraints for the Interferons Segment, 2013

Figure 3.15 Interferons Segment: Revenues ($m), 2012-2023

Figure 3.16 Other Protein Therapeutics Segment: Revenues ($m), 2012-2023

Figure 3.17 Leading Protein Therapeutic Products: Revenues ($m), Submarket Share (%), 2012

Figure 3.18 Leading Protein Therapeutic Products: Revenues ($m), Market Share (%), 2017

Figure 3.19 Leading Protein Therapeutic Products: Revenues ($m), Market Share (%), 2023

Figure 3.20 Leading Protein Therapeutic Products: Revenues ($m), 2012-2023

Figure 3.21 Leading Protein Therapeutic Products: Revenues ($m), 2012, 2017, 2023

Figure 3.22 Drivers and Restraints for Lantus, 2013

Figure 3.23 Lantus: Revenues ($m), 2012-2023

Figure 3.24 Drivers and Restraints for Neulasta/Neupogen, 2013

Figure 3.25 Neulasta/Neupogen: Revenues ($m), 2012-2023

Figure 3.26 Drivers and Restraints for Epogen, 2013

Figure 3.27 Epogen: Revenues ($m), 2012-2023

Figure 3.28 Drivers and Restraints for Avonex, 2013

Figure 3.29 Avonex: Revenues ($m), 2012-2023

Figure 3.30 Drivers and Restraints for NovoRapid, 2013

Figure 3.31 NovoRapid: Revenues ($m), 2012-2023

Figure 3.32 Other Products: Revenues ($m), 2012-2023

Figure 4.1 Monoclonal Antibodies Submarket: Total Revenues ($m), 2012-2023

Figure 4.2 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market

Share (%), 2012

www.visiongain.com

Contents Figure 4.3 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market

Share (%), 2017

Figure 4.4 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), Market

Share (%), 2023

Figure 4.5 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), 2012-

2023

Figure 4.6 Monoclonal Antibodies Submarket Breakdown by Segment: Revenues ($m), 2012,

2017, 2023

Figure 4.7 Leading Products in Autoimmune MAbs Segment, Revenues ($m), Share of Segment

(%), 2012

Figure 4.8 Main Molecular Targets in Autoimmune Segment: Revenues ($m), Market Share (%),

2012

Figure 4.9 Level of Antibody Humanisation in Autoimmune Segment: Revenues ($m), Market

Share (%), 2012

Figure 4.10 Leading Companies in Autoimmune Segment: Revenues ($m), Market Share (%),

2012

Figure 4.11 Drivers and Restraints for Autoimmune MAbs Segment, 2013

Figure 4.12 Autoimmune MAbs Segment: Revenues ($m), 2012-2023

Figure 4.13 Leading Products in Oncology MAbs Segment, Revenues ($m), Share of Segment

(%), 2012

Figure 4.14 Main Molecular Targets in Oncology Segment: Revenues ($m), Market Share (%),

2012

Figure 4.15 Leading Companies in Oncology Segment: Revenues ($m), Market Share (%), 2012

Figure 4.16 Drivers and Restraints for Oncology MAbs Segment, 2013

Figure 4.17 Oncology MAbs Segment: Revenues ($m), 2012-2023

Figure 4.18 Leading Products in Other Therapeutic Areas MAbs Segment, Revenues ($m), Share

of Segment (%), 2012

Figure 4.19 Drivers and Restraints for Other Therapeutic Areas MAbs Segment, 2013

Figure 4.20 Other Therapeutic Areas MAbs Segment: Revenues ($m), 2012-2023

Figure 4.21 Leading MAbs: Revenues ($m), Market Share (%), 2012

www.visiongain.com

Contents Figure 4.22 Leading MAbs: Revenues ($m), Market Share (%), 2017

Figure 4.23 Leading MAbs: Revenues ($m), Market Share (%), 2023

Figure 4.24 Leading MAbs: Revenues ($m), 2012-2023

Figure 4.25 Leading MAbs: Revenues ($m), 2012, 2017, 2023

Figure 4.26 Drivers and Restraints for Humira, 2013

Figure 4.27 Humira: Revenues ($m), 2012-2023

Figure 4.28 Drivers and Restraints for Remicade, 2013

Figure 4.29 Remicade: Revenues ($m), 2012-2023

Figure 4.30 Drivers and Restraints for Rituxan, 2013

Figure 4.31 Rituxan: Revenues ($m), 2012-2023

Figure 4.32 Drivers and Restraints for Herceptin, 2013

Figure 4.33 Herceptin: Revenues ($m), 2012-2023

Figure 4.34 Drivers and Restraints for Avastin, 2013

Figure 4.35 Avastin: Revenues ($m), 2012-2023

Figure 4.36 Other MAb Products: Revenues ($m), 2012-2023

Figure 5.1 Fusion Proteins Submarket: Total Revenues ($m), 2012-2023

Figure 5.2 Leading Products in Fusion Proteins Segment: Revenues ($m), Market Share (%),

2012


2017


2023

Figure 5.5 Leading Products in Fusion Proteins Segment: Revenues ($m), 2012-2023

Figure 5.6 Leading Products in Fusion Proteins Segment: Revenues ($m), 2012, 2017, 2023

Figure 5.7 Drivers and Restraints for Enbrel, 2013

Figure 5.8 Enbrel: Revenues ($m), 2012-2023

Figure 5.9 Orencia: Revenues ($m), 2012-2023

Figure 5.10 Drivers and Restraints for Eylea, 2013

Figure 5.11 Eylea: Revenues ($m), 2012-2023

Figure 5.12 Other Fusion Protein Products: Revenues ($m), 2012-2023

www.visiongain.com

Contents Figure 6.1 Cellular and Regenerative Medicines Submarket: Total Revenues ($m), 2012-2023

Figure 6.2 Cellular and Regenerative Medicines Submarket Breakdown by Segment: Revenues







($m), 2012-2023


($m), 2012, 2017, 2023

Figure 6.7 Tissue Engineered Products: Drivers and Restraints, 2013

Figure 6.8 Tissue Engineered Products Segment: Revenues ($m), 2012-2023

Figure 6.9 Cellular Therapies: Drivers and Restraints, 2013

Figure 6.10 Cellular Therapies Segment: Revenues ($m), 2012-2023

Figure 6.11 Gene Therapy: Drivers and Restraints, 2013

Figure 6.12 Gene Therapy Segment: Revenues ($m), 2012-2023

Figure 7.1 Regional Breakdown of the Biological Drugs Market, Revenues ($m), Market Shares

(%), 2012


(%), 2017


(%), 2023

Figure 7.4 Regional Breakdown of the Biological Drugs Market: Revenues ($m), 2012-2023

Figure 7.5 Regional Breakdown of the Biological Drugs Market: Revenues ($m), 2012, 2017,

2023

Figure 7.6 Healthcare Spending as Share of GDP (%) for the US, France, Germany, the UK, Spain

and Italy, 2010

Figure 7.7 US: Revenues ($m), 2012-2023

Figure 7.8 EU5: Revenues ($m), 2012-2023

www.visiongain.com

Contents Figure 7.9 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2012

Figure 7.10 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2017

Figure 7.11 National Breakdown of the EU5, Revenues ($m), Share of Market (%), 2023

Figure 7.12 National Breakdown of the EU5, Revenues ($m), 2012-2023

Figure 7.13 National Breakdown of the EU5, Revenues ($m), 2012, 2017, 2023

Figure 7.14 Japan: Revenues ($m), 2012-2023

Figure 7.15 BRIC Nations: Revenues ($m), 2012-2023

Figure 7.16 National Breakdown of the BRIC Nations, Revenues ($m), Share of Market (%),

2012


2017


2023

Figure 7.19 National Breakdown of the BRIC Nations, Revenues, 2012-2023

Figure 7.20 National Breakdown of the BRIC Nations, Revenues, 2012, 2017, 2023

Figure 10.1 World Biologics Market: Revenues ($m), 2012-2017

Figure 10.2 World Biologics Market: Revenues ($m), 2018-2023

Figure 10.3 Breakdown by Submarket: Revenues ($m), 2012-2023

Figure 10.4 Breakdown by Segment: Revenues ($m), 2012-2023

www.visiongain.com

Contents

Abbott Laboratories

3SBio

AbbVie

AbGenomics International

Ablynx

Actavis

Actinium Pharmaceuticals

Advanced Technologies and Regenerative Medicine

Aerovance

AET BioTech

Affimed Therapeutics

Agennix

Agensys

AgonOx

Alcon Labs (subsidiary of Novartis)

Alder Biopharmaceuticals

Alexion

Allergan

Allozyme

Altor BioScience

Altrika

Ambrx

Amgen

Apeiron Biologics

AREVA Med

Argos Therapeutics

Artaeus Therapeutics

Artisan Pharma

AryoGen

Organisations Mentioned in the Report

www.visiongain.com

Contents Asahi Kasei Pharma

Astellas

AstraZeneca

AVEO Oncology

Avesthagen

Avita Medicals

Baxter

Bayer

Beijing Shuanglu Medicine

BioArctic Neuroscience

BioCancell Therapeutics

Biocon

Biogen Idec

BioInvent International

Biolex

Bioniche Therapeutics

Biopartners

BioSante Pharmaceuticals

Biotest

Bioton

Biotechnology Information Institute

BioXpress Therapeutics

Boehringer Ingelheim

Bristol-Myers Squibb

BZL Biologics

California Institute for Regenerative Medicine (CIRM)

Cambridge Antibody Technology

Cangene

Catalyst Biosciences

CCL Pharmaceuticals

www.visiongain.com

Contents Cell Control

CellCoTec

Celldex

Cell Therapeutics

Celltrion

CEL-SCI

Celtic Pharma

Centocor (subsidiary of Johnson & Johnson)

Cephalon (part of Teva Pharmaceutical Industries)

Chiron

Chugai (subsidiary of Roche)

CinnaGen

Circadian Technologies

Clinimmune Labs

Co-Genesys

Compass Biotechnologies

Crucell

CSL Behring

CT Arzneimittel

CureTech

Cytheris

Cytimmune Sciences

CytoDyn

Cytograft Tissue Engineering

Cytovance Biologics

Daiichi Sankyo

Dekkun

Dendreon

Depuy Mitek

Dompé

www.visiongain.com

Contents Dong-A

Dr. Reddy’s Laboratories

Duke University School of Medicine

Eisai

Elan

Eli Lilly

Elusys Therapeutics

EMA (European Medicines Agency)

Emergent BioSolutions

Endo Pharmaceuticals

Esteve

Exsulin

Facet

FDA (Food and Drug Administration, US)

Feron

Fibrocell Science

Fibrogen

Fresenius

Fujifilm Kyowa Kirin Biologics

Fuji Pharma

Functional Genetics

Galaxy Biotech

Gedeon Richter

Genentech

Genesis

GenMab

Genzyme

Getz Pharma

Gilead Sciences

GlaxoSmithKline

www.visiongain.com

Contents Glycotope

Grifols

Halozyme Therapeutics

HanAll Biopharma

Hanmi Pharmaceutical

Helix BioPharma

HemispherX Biopharma

Hexal

Histogenics

Hoechst Marion Roussel

Hospira

Hualida Biotech

Human Genome Sciences

ImClone Systems

Immunocore

ImmunoGen

Immunomedics

InnoMab PTE

Inspiration Biopharmaceuticals

ISTO Technologies

Intarcia Therapeutics

Intas Biopharmaceuticals

InterMune

InterveXion Therapeutics

Ipsen

Janssen Alzheimer Immunotherapy (subsidiary of Johnson & Johnson)

Janssen Biotech (subsidiary of Johnson & Johnson)

Johnson & Johnson

KaloBios Pharmaceuticals

Kaketsuken

www.visiongain.com

Contents Korean Food and Drug Administration

Kyowa Hakko Kirin

Labrys Biologics

LFB

LG Life Sciences

LifeCell

Life Science Pharmaceuticals

Lipoxen

Lpath

Lundbeck

Mabgene

MabVax Therapeutics

MassBiologics

Maxygen

Mayo Clinic

Medarex (subsidiary of Bristol-Myers Squibb)

Medice

MedImmune (subsidiary of AstraZeneca)

Medixion

Medtronic

Menarini

MENTRIK Biotech

Merck & Co.

Merck KGaA

Merrimack Pharmaceuticals

Merz Pharma

Michigan University

Micromet (subsidiary of Amgen)

Millennium

Minapharm Pharmaceuticals

www.visiongain.com

Contents Ministry of Health, Labour and Welfare (MHLW, Japan)

Mitsubishi Tanabe

Mochida Pharmaceutical

Morphosys

Myriad

The National Hemophilia Foundation (US)

National Institute of Allergy and Infectious Diseases (US)

National Institute for Health and Clinical Excellence (NICE, UK)

Neogenix Oncology

Neurochem

New York Blood Center

Nippon Kayaku

NovaQuest

Novo Nordisk

Novartis

NPS Pharmaceuticals

Nuron Biotech

NuVasive

Octapharma

OncoMed Pharmaceuticals

Organogenesis

Ortho Pharmaceutical Corporation (subsidiary of Johnson & Johnson)

Otsuka

Pacira Pharmaceuticals

Parexel

PDL BioPharma

Peptech

Peregrine Pharmaceuticals

Pfizer

Pharmstandard

www.visiongain.com

Contents PlantForm

Prana Biotechnology

ProChon Biotech

Progenics Pharmaceuticals

Prolor Biotech

Promedior

Prometheus Laboratories

Proteon Therapeutics

Quest Pharmatech

Quintiles Transnational

Qilu

ratiopharm

Regeneron

Reliance Life Sciences

Repligen

Rentschler Biotechnologie

rEVO Biologics (subsidiary of LFB)

Roche

Sandoz (subsidiary of Novartis)

Sanofi

Santarus

Schering-Plough (subsidiary of Merck & Co.)

SciGen (subsidiary of Bioton)

Seattle Genetics

Selexys Pharmaceuticals

Shantha Biotechnics

Shire Regenerative Medicine

Singapore Eye Research Institute (SERI)

Spectrum

Stada

www.visiongain.com

Contents Stanford University

Stratatech

Stem Cell Therapeutics

Swedish Orphan Biovitrum

Symphogen

Syntonix

TaiMed Biologics

Takeda

Targacept

Targa Therapeutics

TauRx

Tengion

Teva Pharmaceutical Industries

TG Therapeutics

Theraclone Sciences

TiGenix

Tolera Therapeutics

Toronto University

TPG-Axon Capital

TRACON Pharmaceuticals

Transkaryotic Therapies

TransTech

Tufts Center for the Study of Drug Development

UCB

UCSF

United Therapeutics

University of Colorado Cord Blood Bank

University Hospital of Tubingen

University of Tokyo

Vaccinex

www.visiongain.com

Contents Versartis

Vertex Pharmaceuticals

Vidara Therapeutics International

Viropharma

Viventia Biotechnologies

Wake Forest University Baptist Medical Center

Walter and Eliza Hall Institute

Wilex

Wockhardt

Wyeth (subsidiary of Pfizer)

Xbiotech

Xencor

XOMA

Zilip-Pharma

Zimmer

Zydus Cadila

ZymoGenetics

Page 238

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5.2.3.1 Scope for Expansion with Eylea Regeneron have a range of additional indications planned for Eylea. These include oncology, with

aflibercept approved (under the brand name Zaltrap) as a treatment for various cancers in early

2013. Within the retinal diseases market, Regeneron has won approval for Eylea in Central Retinal

Vein Occlusion in the US, and has commenced trials in choroidal neovascularisation of the retina

as a result of pathologic myopia in early 2011, in collaboration with the Singapore Eye Research

Institute (SERI). In all of these new retinal indications, Eylea will have to compete with the more-

established Lucentis, yet the evidence from its sales to date is that it is strongly-placed in this

particular struggle. To date, Eylea has been one of the most successful biopharmaceutical

launches in history. Regeneron apparently fixed an initial price of $1,850 per dose for Eylea,

undercutting Lucentis by about 5%. Market penetration has been more extensive than expected,

with physicians switching patients from Lucentis and off-label Avastin to the newer drug.

Regeneron reported that 90% of the prescribing physicians it monitors had switched patients to

Eylea at one point in 2012. The key areas in which Eylea is differentiated, visiongain believes, are

these: i) it has a slightly better dosing schedule than Lucentis; ii) it is slightly cheaper; iii) it benefits

from reported ill-will towards Lucentis on the part of some ophthalmologists, apparently due to

Roche and Novartis’ reported attempts to protect Lucentis from competition from off-label Avastin.

In section 9.3, visiongain discusses with Dr Michael Stewart some of the factors driving the uptake

of Eylea since its launch. Eylea’s chances in the longer term may depend on its success in

penetrating additional markets and in gaining additional on-label indications. Bayer is a significant

international player, with a dominant position in China particularly.

Figure 5.10 Drivers and Restraints for Eylea, 2013

Drivers

Restraints

Relative to Lucentis, Eylea is reportedly slightly cheaper, shows slightly superior VEGF-binding,

and has a preferable dosing schedule

Strong initial take-up shows physicians are willing to switch patients to Eylea, which may also profit

from ill-will to Lucentis

Expansion opportunities in new markets and indications, including oncology

Lucentis is established in wet AMD and other indications

Avastin represents a far cheaper alternative to

Eylea

Data thus far does not indicate much difference between Eylea and Lucentis in terms of dosing

schedule in practice

Source: visiongain 2013

Page 239

www.visiongain.com


5.2.3.2 Market Forecast for Eylea, 2013-2023 Visiongain anticipates that Eylea will reach sales of over $1.1bn 2013, reaching blockbuster status

with 34% growth from 2012. Its share of the fusion protein submarket will grow from 8% to 12% by

2017, as Eylea reaches double-blockbuster status with a five-year CAGR of 23%. Visiongain

anticipates that widening indications and successful competition against Lucentis will see Eylea

record an 11-year CAGR of 14%, with 2023 revenues of $3.5bn, representing 13% of the fusion

proteins submarket overall. See Table 5.13, Table 5.14 and Figure 5.11.

5.2.4 Other Fusion Proteins, 2013-2023 Amgen’s 2008-approved Nplate (romiplostim), a thrombopoietin receptor agonist indicated for

chronic idiopathic (immune) thrombocytopenic purpura, is the only other product in the submarket

with substantial revenues to date. It recorded sales of $368m in 2012. Other fusion proteins on the

market have low revenues relative to the submarket-leading products; for example, Regeneron’s

first product Arcalyst (rilonacept; approved in cryopyrin-associated periodic syndromes since 2008,

Table 5.13 Eylea: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2012-

2017


Table 5.14 Eylea: Revenues ($m), AGR (%), CAGR (%), Submarket Share (%), 2018-

2023

2012 2013 2014 2015 2016 2017

Revenues ($m) 838 1125 1545 1870 2055 2340

AGR (%) 34 37 21 10 14

CAGR (%, 2012-2017) 23Share of submarket (%) 8 9 11 11 11 12


2018 2019 2020 2021 2022 2023

Revenues ($m) 2410 2525 2790 2975 3230 3460

AGR (%) 3 5 10 7 9 7

CAGR (%, 2018-2023) 8

CAGR (%, 2012-2023) 14Share of submarket (%) 13 12 13 13 13 13

Health & Medicine

World Biological Drugs Market 2013-2023