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PHARMA REPORT

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Biologics Market Trends and Forecasts to 2027

Biologics Market Trends and Forecasts to 2027

Evaluation of Therapeutic Segments Including Monoclonal Antibodies, Insulin, Fusion Proteins, Interferons and Gene Therapies; Prediction of Leading National Markets (US, Japan, EU5 and BRIC); Investigation of Top Products Including Humira, Remicade, Lantus and Enbrel; and Assessment of R&D Including Sirukumab and NurOwn

Product code: PHA0260

  • Publication date: 28/11/2017
  • Number of Pages: 300
  1. Report Details
  2. Table of Contents
  3. Companies Listed

Report Details

• Do you need definitive Biologics market data?
• Succinct Biologics market analysis?
• Technological insight?
• Actionable business recommendations?
 
Read on to discover how this definitive report can transform your own research and save you time.

Biologics form a vital part of the treatment portfolio for many serious chronic disorders, including cancer, diabetes, hepatitis and autoimmune diseases such as rheumatoid arthritis. This highly lucrative market is set to experience revenue growth to 2027, but will have to adapt to many new challenges along the way. Those challenges include patent expiries on many leading biological drugs, the emergence of biosimilars and cost-restricting measures in the face of limited national healthcare budgets.

Report highlights

• 155 quantitative tables, charts, and graphs across 300 pages

• Analysis of key Biologics in the Market
• Lantus
• NovoLog/NovoRapid
• Humalog
• Avonex
• Rebif
• Humira
• Remicade
• Tysabri
• Herceptin
• Kadcyla
• Perjeta
• Enbrel
• Eylea
• OsteoCel Plus
• Trinity Evolution and Trinity Elite
• Apligraf
• Dermagraft
• IMLYGIC

• Global Biologics market outlook and analysis from to 2027

• Global Biologics submarket forecasts and analysis from to 2027
• Protein therapeutics, with sub-forecasting for insulin, other recombinant hormones, plasma and recombinant coagulating factors, interferons, enzyme replacement and other agents
• Monoclonal antibodies (mAbs)
• Fusion proteins
• Regenerative medicine, with sub-forecasting for stem cell treatment, tissue engineering and gene therapy
• Vaccines

Biologics Market Trends and Forecasts to 2027

• Regional Biologics market forecasts to 2027
• US forecast to 2027
• EU5 forecast to 2027
• Germany forecast to 2027
• UK forecast to 2027
• France forecast to 2027
• Italy forecast to 2027
• Spain forecast to 2027
• Japan forecast to 2027
• BRIC forecast to 2027
• Brazil forecast to 2027
• Russia forecast to 2027
• India forecast to 2027
• China forecast to 2027

Key questions answered
• What does the future hold for the Pharmaceutical industry with regards to Biologics?
• Where should you target your business strategy?
• Which applications should you focus upon?
• Which disruptive technologies should you invest in?
• Which companies should you form strategic alliances with?
• Which company is likely to success and why?
• What business models should you adopt?
• What industry trends should you be aware of?

Target audience
• Leading Pharmaceutical companies
• Suppliers
• Contractors
• Technologists
• R&D staff
• Consultants
• Analysts
• CEO’s
• CIO’s
• COO’s
• Business development managers
• Investors
• Governments
• Agencies
• Banks

Visiongain is a trading partner with the US Federal Government
CCR Ref number: KD4R6

Table of Contents

1. Report Overview
1.1 Biologics Overview
1.2 Why you Should Read this Report
1.3 How this Report Delivers
1.4 Main Questions Answered by this Report
1.5 Who is this Report for?
1.6 Research and Analysis Methods
1.7 Frequently Asked Questions (FAQ)
1.8 Some Associated Reports
1.9 About Visiongain

2. Introduction to the Biologics Market and Key Concepts
2.1 Biologics: Large and Complex Products
2.2 A Brief History of Biological Drug Development
2.3 Why are Biologics the Most Lucrative Products in the Global Pharmaceutical Market?
2.4 What are Biosimilars?
2.4.1 Brief History of Biosimilars
2.4.2 What are Interchangeable Biological Products and how do They Differ from Biosimilars?
2.4.3 Why Many Nations Oppose Automatic Substitution of Reference Biologics with Biosimilars
2.5 Marginal Cases
2.6 Vaccines Market

3. The Global Biologics Market to 2027
3.1 The Global Biologics Market Forecast, to 2027
3.2 What Factors Will Drive Growth in the Biologics Market?
3.3 Ageing Population and the Rise of Chronic Disease
3.4 Eight of the Top Ten Best-Selling Drugs in 2015 were Biologics
3.5 Biologics Constitute 19% of the Global Pharmaceutical Market - Further Launches Will Drive Market
3.6 Biosimilars - Both an Opportunity and a Threat
3.7 What Factors Will Restrain Growth in the Biologics Market?
3.8 High Costs in the Face of Declining National Healthcare Budgets
3.9 In Some Areas, Clinical Efficacy is not Superior Enough to Justify the Price Gap
3.10 Over $67bn worth of Biologic Patents due to Expire by 2020
3.11 Administration is Often not as Convenient
3.12 Biologics Market: Submarket Forecasts to 2027

4. Protein Therapeutics Submarket to 2027
4.1 Largest and Most Diverse Submarket
4.2 Proteins have been used Medicinally since the 19th Century
4.2.1 Recombinant DNA Technology - The Major Breakthrough in the use of Protein Drugs
4.3 Protein Therapeutics Submarket Forecast to 2027
4.4 Insulin Submarket to 2027
4.4.1 The First Protein Therapeutic
4.4.2 430 Million People Expected to be Diagnosed with Diabetes by 2030
4.4.3 The Status of the Market in 2016: Novo Nordisk, Sanofi and Eli Lilly Dominate
4.4.4 Insulin Submarket Forecast to 2027
4.4.5 Lantus: The Market Leading Drug by Far
4.4.5.1 Lantus Revenue Forecast to 2027
4.4.6 NovoLog/NovoRapid Revenue Forecast to 2027
4.4.7 Humalog Revenue Forecast to 2027
4.4.8 New Approvals and Pipeline
4.4.8.1 Tresiba (Novo Nordisk)
4.4.8.2 BIOD-123 (Biodel)
4.5 Biosimilar Insulin
4.5.1 Approved Insulin Biosimilars
4.5.2 Abasaglar/Basaglar/Insulin Glargine BS - The First Insulin Biosimilars to be Approved in Developed Markets. Delayed in the US
4.6 Other Recombinant Hormones: Erythropoietins, G-CSF and Human Growth Hormone
4.6.1 Erythropoietin
4.6.2 First-Generation Therapies Launched in the 1980s
4.6.2.1 Aranesp: Slowly Growing
4.6.2.2 Epogen: Increases in Selling Price are No Longer Enough to Ward off Decline
4.6.2.3 Procrit/Eprex: In Decline Since 2013
4.6.2.4 NeoRecormon and Mircera (Roche) Provides Competition for Market Leader Amgen
4.6.2.5 Safety Concerns for Erythropoietin-Stimulating Agents is Leading to Decreased Demand
4.6.2.6 The Challenge from Oral Therapies is Coming
4.6.2.7 Treating Anaemia in Patients with CKD - The Leading Use of EPO Therapies
4.6.2.8 Many Biosimilar Epoetins Approved Around the World
4.6.3 G-CSF
4.6.4 G-CSF: Discovered 1983. Recombinant Forms Available Since 1991
4.6.4.1 Amgen Leads the Market
4.6.4.2 Neupogen and Neulasta Revenues, and the Onpro Kit
4.6.4.3 Teva Aiming to Challenge Amgen’s Dominance
4.6.4.4 Facing Much Biosimilar Competition Around the World
4.6.5 Human Growth Hormone
4.6.5.1 Human Growth Hormone: First Extracted in 1958
4.6.5.2 Novo Nordisk Dominates Market
4.6.5.3 Novo Nordisk Aiming to Retain Dominance Through FlexPro Device and NN8640 Somatropin Candidate
4.6.5.4 Multiple Biosimilars Available - Omnitrope is Market Leader
4.6.5.5 Biosimilar Growth Hormones in Asia
4.6.6 Other Recombinant Hormones Submarket Forecast to 2027
4.7 Plasma and Recombinant Coagulating Factors
4.7.1 Discovery of Plasma and Clotting Proteins
4.7.2 Types of Recombinant Factor
4.7.3 Clotting Factor Deficiency Diseases
4.7.4 Baxter/Baxalta: Entered the Bleeding Disorders Market in 1992, Markets Various Leading Products
4.7.4.1 Baxter: New Product Launches Include Rixubis and Obizur
4.7.5 Novo Nordisk: Committed to Remaining a Leading Company in the Bleeding Disorders Market
4.7.5.1 Novo Nordisk: Has filed for Approval for N9-GP and NovoEight is Doing Well
4.7.6 Bayer: Markets Kogenate, Kogenate FS, and has Received FDA Approval for Kovaltry
4.7.7 Limited Opportunities for Biosimilar Challenge
4.7.8 Plasma and Recombinant Coagulating Factors Submarket Forecast to 2027
4.8 Interferons
4.8.1 Interferons: Key Antiviral and MS Therapies Since the 1990s
4.8.2 Interferons for Treating Hepatitis: Its Influence is Decreasing
4.8.3 Competition from Oral Protease and Polymerase Inhibitors
4.8.3.1 Oral Therapies are Expensive
4.8.4 Avonex: The Leading Interferon Therapy
4.8.4.1 Avonex Revenue Forecast to 2027
4.8.5 Rebif: Merck Attempting to Differentiate Rebif from Other Interferon Therapies
4.8.5.1 Rebif Revenue Forecast to 2027
4.8.6 Betaseron
4.8.7 Plegridy: New Therapy with High Potential
4.8.8 Biosimilar Interferons: None Approved in Developed Markets, but Many Available in Emerging Nations
4.8.9 Interferon Submarket Forecast to 2027
4.9 Enzyme Replacement and Other Protein Therapies Submarket
4.9.1 Cerezyme: Genzyme’s Leading Enzyme Replacement Therapy
4.9.2 Myozyme and Lumizyme
4.9.3 Fabrazyme and Aldurazyme
4.9.4 Botulinum Toxin Brands Include Botox, Dysport and Xeomin
4.9.5 Other Protein Therapeutics Pipeline
4.9.5.1 Anthera Buys Sollpura from Eli Lilly, Phase 3 Results Expected Q4 2016
4.9.5.2 Multikine (CEL-SCI)
4.9.5.3 Vonapantiase (Proteon Therapeutics)
4.9.6 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast to 2027

5. Monoclonal Antibodies Submarket to 2027
5.1 Monoclonal Antibodies Submarket: Scientific and Historical Background
5.1.1 Natural Antibodies: Key to the Immune System
5.1.2 From Serum Therapy to Monoclonal Antibodies
5.1.3 Humanising the mAb
5.1.4 MAbs have found Success in Treating Autoimmune Disorders, Cancers and Others Diseases - Great Potential for the Future
5.1.5 MAbs for All? Technologies Come Off Patent
5.2 Three out of the Top Five Best-Selling Drugs are mAbs
5.3 Autoimmune mAbs
5.3.1 Past Approvals
5.3.2 Humira - The World’s Best-Selling Prescription Drug
5.3.2.1 AbbVie Plans to Drive Growth Through New Indications
5.3.2.2 Positive Opinion from CHMP for Treatment of Non-Infectious Uveitis
5.3.2.3 Recently Approved for Hidradenitis Suppurativa in the US, Europe, and Japan
5.3.2.4 Biosimilar Adalimumab: Patents Protect Humira in Developed Markets for Now
5.3.2.5 Humira Revenue Forecast to 2027
5.3.3 Remicade: Second Only to Humira
5.3.4 2016 Revenue for J&J and Merck
5.3.4.1 Has Defended Revenues well but now Has to Deal with Biosimilar Competition
5.3.4.2 Patent Dance in US
5.3.4.3 Biosimilar Infliximab: Multiple Launches
5.3.4.4 Remicade Revenue Forecast to 2027
5.3.5 Stelara: Blockbuster Status Well Established
5.3.5.1 Stelara Revenues 2014-2016
5.3.5.2 Orphan Drug Designation for paediatric Crohn’s Disease
5.3.6 Simponi and Simponi Aria: Another Blockbuster mAb for J&J and Merck & Co.
5.3.6.1 2015 and 2014 Revenue Breakdown
5.3.7 Tysabri: Blockbuster Drug’s High Efficacy Offsets its Risks
5.3.7.1 Tysabri: Revenues 2012-2016
5.3.7.2 Tysabri Revenue Forecast to 2027
5.3.8 Xolair: New Indication, and Revenue Breakdown
5.3.9 Actemra/RoActemra: Strong Growth in All Regions
5.3.10 Cimzia: Blockbuster Which has been Used by Over 90,000 Patients
5.3.11 Autoimmune mAbs Pipeline: RA is the Main Target
5.3.11.1 Sarilumab (REGN88/SAR153191) by Regeneron and Sanofi: BLA Accepted for Review and Decision Expected by November 2016
5.3.11.2 Sirukumab (CNTO-136) by J&J and GSK: Multiple Phase 3 Studies Around the World
5.3.11.3 Clazakizumab: Developed by Alder Biopharmaceuticals and BMS but now Licensed to Vitaeris
5.3.11.4 Tregalizumab (BT-061) by Biotest: AbbVie Backs out After Poor Results
5.3.11.5 Mavrilimumab by AstraZeneca: Approaching Phase 3
5.3.11.6 Zinbryta (daclizumab high-yield process) by Biogen and AbbVie: Positive Opinion from CHMP
5.3.11.7 Lebrikizumab by Roche: Undergoing Phase 3 After Positive Phase 2b Results
5.3.11.8 Sifalimumab (MEDI-545) by AstraZeneca: Hasn’t Made the Cut for Phase 3
5.3.11.9 Anifrolumab by AstraZeneca
5.4 Oncology mAbs
5.4.1 Past Approvals
5.4.2 Rising Incidence of Cancer Will Drive Demand
5.4.3 Rituxan: The World’s Leading Anti-Cancer mAb
5.4.4 Biosimilar Rituximab: Two Candidates Await Approval in Europe
5.4.5 Gazyva: Roche’s Successor to Rituxan, Will Help to Retain Revenues in Face of Biosimilar Competition
5.4.5.1 Approval for Follicular Lymphoma and Being Investigated for Other Indications
5.4.6 Avastin: Growing under CER, Through New Indications
5.4.6.1 Controversy over Off-Label Avastin use: Roche is Backed up by Incidents in India, and Opinion of EFPIA
5.4.6.2 Biosimilar Bevacizumab: Late Patent Expiry is a Blessing for Roche, Although Various Biosimilars in Development
5.4.7 Herceptin: Breast Cancer Blockbuster
5.4.7.1 Pricing Challenges in Emerging Markets, and 2016 Revenues
5.4.7.2 Roche Builds Franchise of Anti-HER2 mAbs Around Herceptin
5.4.7.3 Herceptin Revenue Forecast to 2027
5.4.7.4 Biosimilar Trastuzumab
5.4.8 Kadcyla
5.4.8.1 Mixed Results from Different Clinical Trials
5.4.8.2 Kadcyla Sales Forecast to 2027
5.4.9 Perjeta
5.4.9.1 Positive Results from Different Clinical Trials
5.4.9.2 Perjeta Revenue Forecast to 2027
5.4.10 Yervoy: Bristol-Myers Squibb’s Leading Anti-Cancer mAb, KeepsHigh Revenues, but with Decline over 2015
5.4.11 Opdivo: Big Potential for Bristol-Myer Squibb’s PD-1 Inhibitor
5.4.11.1 Good News and Bad News for NSCLC from CheckMate Trials
5.4.11.2 Cyramza (Eli Lilly): Approved in Three Additional Indications Since its First Approval in April 2014
5.4.12 Oncology mAbs: New Approvals and Pipeline
5.4.12.1 Empliciti (Elotuzumab) by Bristol-Myers Squibb and AbbVie): Recently Approved
5.4.12.2 Avelumab: Pfizer and Merck KGaA Team Up to Develop Their Own Anti-PD mAb
5.4.12.3 Unituxin (United Therapeutics) Receives FDA Approval March 2015
5.4.12.4 SAR3419 (coltuximab ravtansine) (anti-CD19, Sanofi)
5.5 Monoclonal Antibodies Submarket Forecast to 2027

6. Fusion Proteins Submarket to 2027
6.1 Scientific and Historical Background
6.2 Differentiating Fusion Proteins
6.3 Enbrel: The First FP to be Approved, in 1998
6.3.1 Gradually Approved for Additional Indications
6.3.2 The Leading Fusion Protein
6.3.3 Enbrel Granted Extended Patent Protection in the US, Patent has Expired in EU
6.3.4 Multiple Biosimilars Available in Emerging Markets
6.3.5 Enbrel Revenue Forecast to 2027
6.4 Eylea: Blockbuster FP Treatment for Wet AMD
6.4.1 Eylea Revenue Forecast to 2027
6.5 Orencia: Grows Blockbuster Revenues for Second Year in a Row
6.6 Nplate: Generates Half a Billion in Revenues for Amgen
6.7 Eloctate: Approved June 2014, Fulfils Unmet Need in the Haemophilia Community
6.8 Nulojix: Bristol-Myers Squibb’s Therapy for Preventing Organ Rejection
6.9 Arcalyst by Regeneron Pharmaceuticals: For Very Rare Conditions
6.10 Fusion Proteins Pipeline
6.10.1 Trebananib (Amgen)
6.10.2 Sotatercept by Acceleron Pharma and Celgene Corporation - Currently Undergoing Eight Clinical Trials
6.10.3 Blisibimod (Anthera Pharmaceuticals) for the Treatment of Various Autoimmune Diseases, in Late Stage Development
6.11 Fusion Protein Submarket Forecast to 2027

7. Regenerative Medicines Submarket to 2027
7.1 Regenerative Medicines Market Breakdown
7.2 Regenerative Medicines Submarket Forecast, to 2027
7.3 Stem Cell Therapies Submarket, to 2027
7.3.1 Stem Cells: Scientific Breakdown
7.3.2 Stem Cell Therapies Submarket Breakdown
7.3.3 Haematopoietic Stem Cell Transplantation: Over 95,000 Carried out in 2016
7.3.3.1 From Procedures to Products: Cord Blood Stem Cell Approvals
7.3.4 Osteocel Plus: The Leading Stem Cell Orthobiologic
7.3.4.1 Osteocel Plus Revenue Forecast to 2027
7.3.5 Trinity Evolution and Trinity Elite
7.3.5.1 Trinity Evolution and Trinity Elite Revenue Forecast to 2027
7.3.6 MSC-100-IV (Previously Known as Prochymal): World’s First Approved Stem Cell Drug Outside of South Korea
7.3.6.1 An Important Role to Play in the Future of HSCT, and also Wins Approval in Japan through Partner
7.3.7 CARTISTEM (MEDIPOST): The World’s First Allogeneic Stem Cell Drug
7.3.8 Hearticellgram-AMI (PharmaCell B.V.): One of the First Approved Cardiovascular Stem Cell Treatments in the World
7.3.9 Stem Cell Therapies Pipeline
7.3.9.1 Cx601 by TiGenix: Marketing Authorisation Application has been Submitted to EMA
7.3.9.2 CardiAMP (BioCardia) for Heart Failure: Undergoing Phase 3 Trial and has Received Grant from MSCRF
7.3.9.3 NurOwn (BrainStorm Cell Therapeutics): Neurotrophic Factor -Releasing Stem Cells for ALS in Phase 2 and Due to end Soon
7.3.9.4 Agenmestencel-T (Apceth): Phase 1/2 Due to end Soon
7.3.10 Stem Cell Therapies Submarket Forecast to 2027
7.4 Tissue Engineering Therapies Submarket to 2027
7.4.1 Tissue Engineering – In Vitro Manipulation for Therapeutic Purposes
7.4.2 Current Status of the Market
7.4.3 Apligraf: The Leading Product
7.4.3.1 Apligraf Revenue Forecast to 2027
7.4.4 Dermagraft: Organogenesis Further Strengthens Position Through this 2014 Acquisition
7.4.4.1 Dermagraft Revenue Forecast to 2027
7.4.5 ReCell
7.4.6 MySkin and CyroSkin
7.4.7 Tissue Engineering Therapies Pipeline
7.4.7.1 NeoCart by Histogenics: Undergoing Phase 3 Trial for Knee Cartilage Repair
7.4.7.2 Extracorporeal Bio-Artificial Liver Therapy by Vital Therapies
7.4.7.3 StrataGraft by Stratatech Corporation Demonstrates Positive Top-Line Results
7.4.8 Tissue Engineering Therapies Submarket Forecast to 2027
7.5 Gene Therapies Submarket to 2027
7.5.1 Gene Therapy: Historical and Scientific Background
7.5.2 Harnessing Infectivity: Viral Vectors in Gene Therapy
7.5.3 Approved Gene Therapy Products
7.5.3.1 Gendicine: The World’s First Commercial Gene Therapy Product
7.5.3.2 Oncorine: First Oncolytic Viral Therapy
7.5.3.3 Neovasculgen: Russia’s First Gene Therapy
7.5.3.4 Neovasculgen: Drop in Revenues in 2015, but HSCI Predicts Notable Increases as Product is Added to VED List
7.5.3.5 Glybera: The First Gene Therapy for Western Markets, Although Has Abandoned Hope of Receiving FDA-Approval
7.5.4 IMLYGIC
7.5.4.1 IMLYGIC: Clinical Trials and Development Efforts
7.5.4.2 IMLYGIC: Revenue Forecast to 2027
7.5.5 Gene Therapies Pipeline
7.5.5.1 AAV2-hRPE65v2 (Spark Therapeutics): Undergoing Phase 3 Trial
7.5.5.2 AdV-tk/ProstAtak (Advantagene): Phase 3
7.5.5.3 Collategene (beperminogene perplasmid, AMG0001) - (AnGes MG/Vical)
7.5.6 Gene Therapy Submarket Forecast to 2027

8. Leading National Markets for Biologics to 2027
8.1 Regional Forecasts for the Global Biologics Market to 2027
8.2 US Biologics Market to 2027
8.2.1 The Major National Market
8.2.2 Value-Based Pricing in the US
8.2.3 Regulation of Biologics in the US
8.2.4 US Biosimilars Market
8.2.4.1 FDA Finalises Biosimilar Guidelines and Biosimilar Naming
8.2.5 US Biologics Market Forecast to 2027
8.3 EU5 Biologics Market to 2027
8.3.1 Current Composition and Future Outlook
8.3.2 European Biosimilar Market
8.3.2.1 History of EMA Guidelines and Updates
8.3.3 EU5 Market Forecast by Nation to 2027
8.4 Japanese Biologics Market to 2027
8.4.1 Current Status of the Japanese Biologics Market
8.4.2 Japanese Biosimilar Market
8.4.3 Japanese Biologics Market Forecast to 2027
8.5 BRIC National Biologic Markets to 2027
8.5.1 BRIC Markets Overview
8.5.2 BRIC Biologic Market Forecast to 2027
8.5.2.1 Unique Challenges Faced by the Biologics Industry have led to Current Composition of the BRIC Biologic Market
8.5.2.2 Future Outlook
8.5.2.3 BRIC Nation Market Shares in the Global Biologics Market will Nearly Double During the Forecast Period
8.5.3 Brazil: Disproportionately High Government Spending on Biologics
8.5.3.1 Brazilian Government Eager to Promote Domestic Biologic and Biosimilar Development
8.5.4 Russia: Another Government Which is Eager to Increase Domestic Biological Drug Development
8.5.5 India: Biologics Market Behind that of Other BRIC Nations, but Biosimilars Submarket Thriving
8.5.5.1 CDSCO Guidelines Released in 2012
8.5.6 China: Expected to the Largest BRIC Market for Biologics by 2020
8.5.6.1 The Largest National Biosimilar Market in the World

9. Qualitative Analysis of the Biologics Market and Industry
9.1 SWOT Analysis of the Global Biologics Market and Industry
9.1.1 Strengths
9.1.2 Opportunities
9.1.3 Weaknesses
9.1.4 Threats
9.2 STEP Analysis of the Global Biologics Market and Industry
9.2.1 Social Factors
9.2.2 Technological Developments
9.2.3 Economic Pressures
9.2.4 Political Issues

10. Conclusions
10.1 Biologics Market to Achieve Steady Growth Throughout the Forecast Period
10.2 Changes in Market Composition: mAbs to Become Leading Submarket
10.3 The Emergence of Biosimilars
10.4 Challenges for the Market

Visiongain Report Sales Order Form
Some Associated Reports

Appendix A
About Visiongain

Appendix B
Visiongain report evaluation form

List of Figures
Figure 1.1 Forecasted Submarkets of the Biologics Market
Figure 3.1 Global Biologics Market Forecast: Revenues ($bn), to 2027
Figure 3.2 Submarkets within the Biologics Market Forecast: Revenues ($bn),2016-2027
Figure 4.1 Protein Therapeutics Submarket Forecast: Revenues ($bn), to 2027
Figure 4.2 Diabetes Prevalence in Leading National Markets, 2014
Figure 4.3 Insulin Submarket Forecast: Revenues ($bn), to 2027
Figure 4.4 Lantus Revenue Forecast: Revenues ($bn), to 2027
Figure 4.5 NovoLog/NovoRapid Revenue Forecast: Revenues ($bn) to 2027
Figure 4.6 Humalog Revenue Forecast: Revenues ($bn), to 2027
Figure 4.7 Other Recombinant Hormones Submarket Forecast: Revenues ($bn),to 2027
Figure 4.8 Plasma and Recombinant Coagulating Factors Submarket Forecast: Revenues ($bn), to 2027
Figure 4.9 Avonex Submarket Forecast: Revenues ($bn), to 2027
Figure 4.10 Rebif Revenue Forecast: Revenue ($bn), to 2027
Figure 4.11 Interferon Submarket Forecast: Revenues ($bn), to 2027
Figure 4.12 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast: Revenues ($bn), to 2027
Figure 5.1 Humira Revenue Forecast: Revenue ($bn),to 2027
Figure 5.2 Remicade Revenue Forecast: Revenue ($bn),to 2027
Figure 5.3 Stelara Revenue 2014-2016: Revenue ($bn)
Figure 5.4 Total TysabriRevenues 2012-2016, Revenues ($m)
Figure 5.5 Tysabri Revenue Forecast: Revenue ($m), to 2027
Figure 5.6 Herceptin Revenue Forecast: Revenue ($bn),to 2027
Figure 5.7 Kadcyla Revenue Forecast: Revenue ($m), to 2027
Figure 5.8 Perjeta Revenue Forecast: Revenue ($bn), to 2027
Figure 5.9 Monoclonal Antibodies Submarket Forecast: Revenue ($bn),to 2027
Figure 6.1 Enbrel Revenue Forecast: Revenue ($bn), to 2027
Figure 6.2 Eylea Revenue Forecast: Revenue ($bn), to 2027
Figure 6.3 Fusion Proteins Forecast: Revenue ($bn), to 2027
Figure 7.1 Regenerative Medicines Market Forecast: Revenue ($bn), to 2027
Figure 7.2 Osteocel Plus Revenue Forecast: Revenue ($bn), to 2027
Figure 7.3 Trinity Evolution and Trinity Elite Revenue Forecast: Revenue ($m), to 2027
Figure 7.4 Stem Cell Therapies Market Forecast: Revenue ($bn), to 2027
Figure 7.5 Apligraf Revenue Forecast: Revenue ($m), to 2027
Figure 7.6 Dermagraft Revenue Forecast: Revenue ($m),to 2027
Figure 7.7 Tissue Engineering Therapies Submarket: Revenues ($bn), to 2027
Figure 7.8 IMLYGIC Revenue Forecast: Revenue ($m), to 2027
Figure 7.9 Gene Therapies Market Forecast: Revenue ($bn), to 2027
Figure 8.1 Regional Breakdown of Global Biologics Market: Revenues ($bn), Market Share (%), 2016
Figure 8.2 Regional Breakdown of Global Biologics Market: Revenues ($bn), Market Share (%), 2027
Figure 8.3 Regional Forecasts for Global Biologics Market: Revenues ($bn),to 2027
Figure 8.4 US Biologics Market: Revenues ($bn),to 2027
Figure 8.5 EU5 Market Breakdown: Market Share (%), 2016
Figure 8.6 EU5 Biologics Market: Revenues ($bn), to 2027
Figure 8.7 Japanese Biologics Market: Revenues ($bn), to 2027
Figure 8.8 Biologics Market Breakdown: Revenues ($bn), Market Share (%), 2016
Figure 8.9 BRIC Biologics Market: Revenues ($bn), to 2027
Figure 8.10 Biologics Market Breakdown: Revenues ($bn), Market Share (%), 2027
Figure 9.1 SWOT Analysis of Biologics Market and Industry, to 2027
Figure 9.2 STEP Analysis of Biologics Market and Industry, to 2027
Figure 10.1 Global Biologics Market Forecast: Revenues ($bn), Annual Growth Rate (%), to 2027
Figure 10.2 Breakdown by Submarket: Revenues ($bn), to 2027

List of Tables
Table 1.1 Currency Exchange Rates: Average Exchange Rate to USD for 2015 and 2016
Table 2.1 First Approvals for Recombinant Protein Therapies, 1982-1993
Table 3.1 Global Biologics Market Forecast: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 3.2 Global Biologics Market Forecast: Revenues ($bn), AGR (%), CAGR (%),2021-2026
Table 3.3 Top Ten Best-Selling Drugs in 2016: Revenue ($bn), Share of Biologics Market (%)
Table 3.4 Patent Status of Selected Leading Biologics
Table 3.5 Submarkets within the Biologics Market, Forecast: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2021
Table 3.6 Submarkets within the Biologics Market, Forecast: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2022-2027
Table 4.1 First Approvals for Recombinant Protein Therapies,1982-1993
Table 4.2 Protein Therapeutics Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 4.3 Protein Therapeutics Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2022-2027
Table 4.4 Diabetes Prevalence in Leading National Markets, 2014
Table 4.5 Insulin Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 4.6 Insulin Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2022-2027
Table 4.7 Lantus Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 4.8 Lantus Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%),2022-2027
Table 4.9 NovoLog/NovoRapid Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 4.10 NovoLog/NovoRapid Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%), 2022-2027
Table 4.11 Humalog Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%),2016-2021
Table 4.12 Humalog Revenue Forecast: Revenues ($bn), AGR (%), CAGR (%),2022-2027
Table 4.13 Selected Insulin Biosimilars which have been Approved and Launched
Table 4.14 Selected EPO Biosimilars Approved in India
Table 4.15 European Biosimilar Approvals: G-CSF
Table 4.16 Selected Filgrastim Biosimilars Approved Worldwide, 2016
Table 4.17 Other Recombinant Hormones Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 4.18 Other Recombinant Hormones Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2022-2027
Table 4.19 Selected Coagulating Factors Significant in Segment
Table 4.20 Plasma and Recombinant Coagulating Factors Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 4.21 Plasma and Recombinant Coagulating Factors Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%),2022-2027
Table 4.22 Selected Approved Branded Interferon Therapies
Table 4.23 Avonex Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 4.23 Avonex Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), to 2027
Table 4.25 Rebif Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2016-2021
Table 4.26 Rebif Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2022-2027
Table 4.27 Selected Interferon Alfa Biosimilars Approved Worldwide, 2016-2017
Table 4.28 Selected Interferon Beta Biosimilars Approved Worldwide,2016-2017
Table 4.29 Interferon Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 4.30 Interferon Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2022-2027
Table 4.31 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 4.32 Enzyme Replacement and Other Protein Therapeutics Submarket Forecast: Revenues ($bn), AGR (%), CAGR (%),2022-2027
Table 5.1 Regions of an Antibody
Table 5.2 Natural Antibody Mechanisms of Action
Table 5.3 Top Five Best-Selling Drugs, 2016: Revenue ($bn)
Table 5.4 Selected Biosimilar Adalimumab Candidates
Table 5.5 Humira Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 5.6 Humira Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2022-2027
Table 5.7 Remicade 2016 Revenue Breakdown: Revenue ($bn), Percentage Change over 2016(%)
Table 5.8 Remicade Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%),2016-2021
Table 5.9 Remicade Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%),2022-2027
Table 5.10 Stelara Revenue 2014-2016:
Table 5.11 Total Tysabri Revenues 2012-2016, Revenues ($bn), AGR (%), CAGR (%)
Table 5.12 Tysabri Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 5.13 Tysabri Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2022-2027
Table 5.14 Xolair Revenue Breakdown (between Roche and Novartis): Revenue ($bn), AGR (%), 2015-2016
Table 5.15 Selected Ongoing Sirukumab (CNTO-136) Clinical Trials, 2016
Table 5.16 Selected Ongoing Lebrikizumab Clinical Trials, 2016
Table 5.17 Selected Ongoing Anifrolumab Clinical Trials, 2016
Table 5.18 Herceptin Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%),2016-2021
Table 5.19 Herceptin Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%),2022-2027
Table 5.20 Kadcyla Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%),2016-2021
Table 5.21 Kadcyla Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%),2022-2027
Table 5.22 Perjeta Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 5.23 Perjeta Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2022-2027
Table 5.24 FDA-Approved Indications for Cyramza
Table 5.25 Monoclonal Antibodies Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 5.26 Monoclonal Antibodies Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2022-2027
Table 6.1 Amgen’s US Patents and Expiry Dates for Enbrel
Table 6.1 Bristol-Myers Squibb’s pipeline developments for Orencia
Table 6.2 Enbrel Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 6.3 Enbrel Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%),2022-2027
Table 6.4 Eylea Revenue Breakdown 201: Regeneron and Bayer
Table 6.5 Eylea Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 6.6 Eylea Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2022-2027
Table 6.7 Fusion Proteins Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 6.8 Fusion Proteins Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2022-2027
Table 7.1 Regenerative Medicines Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 7.2 Regenerative Medicines Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2022-2027
Table 7.3 Potency and Source of Stem Cells
Table 7.4 Osteocel Plus Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 7.5 Osteocel Plus Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%),2022-2027
Table 7.6 Trinity Evolution and Trinity Elite Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2016-2021
Table 7.7 Trinity Evolution and Trinity Elite Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2022-2027
Table 7.8 Stem Cell Therapies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2021
Table 7.9 Stem Cell Therapies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2022-2027
Table 7.10 Apligraf Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2016-2021
Table 7.11 Apligraf Revenue Forecast: Revenue ($m), AGR (%), CAGR (%), 2022-2027
Table 7.12 Dermagraft Revenue Forecast: Revenue ($m), AGR (%), CAGR (%),2016-2021
Table 7.13 Dermagraft Revenue Forecast: Revenue ($m), AGR (%), CAGR (%),2022-2027
Table 7.14 Tissue Engineering Therapies Submarket: Revenues ($bn), AGR (%), CAGR (%), 2016-2021
Table 7.15 Tissue Engineering Therapies Submarket: Revenues ($bn), AGR (%), CAGR (%), 2022-2027
Table 7.16 IMLYGICRevenue Forecast: Revenue ($m), AGR (%), CAGR (%),2016-2021
Table 7.17 IMLYGICRevenue Forecast: Revenue ($m), AGR (%), CAGR (%),
Table 7.18 Gene Therapies Market Forecast: Revenue ($bn), AGR (%), CAGR (%),2016-2021
Table 7.19 Gene Therapies Market Forecast: Revenue ($bn), AGR (%), CAGR (%),2022-2027
Table 8.1 Regional Forecasts for the Global Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2021
Table 8.2 Regional Forecasts for the Global Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Market Share (%), 2022-2027
Table 8.3 US Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Global Market Share(%), 2016-2021
Table 8.4 US Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Global Market Share (%), 2022-2027
Table 8.5 European Biosimilar Approvals, 2006-2017
Table 8.6 EU5 Biologics Market: Revenues ($bn), AGR (%), CAGR (%), EU5 Market Share (%), 2016-2021
Table 8.7 EU5 Biologics Market: Revenues ($bn), AGR (%), CAGR (%), EU5 Market Share (%), 2022-2027
Table 8.8 Japanese Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Global Market Share (%), 2016-2021
Table 8.9 Japanese Biologics Market: Revenues ($bn), AGR (%), CAGR (%), Global Market Share (%), 2022-2027
Table 8.10 BRIC Biologics Market: Revenues ($bn), AGR (%), CAGR (%), BRIC Market Share (%), 2016-2021
Table 8.11 BRIC Biologics Market: Revenues ($bn), AGR (%), CAGR (%), BRIC Market Share (%), 2022-2027

Companies Listed

3SBio
AbbVie
Acceleron Pharma
Accord Healthcare
Aché
Actavis
Advanced BioHealing
Advantagene
Agência Nacional de Vigilância Sanitária (ANVISA)
Alder Biopharmaceuticals
Allergan
Alteogen
Amega Biotech
Amgen
AnGes
Anthera Pharmaceuticals
Apceth
Apotex
Aryogen
Astellas Pharma
AstraZeneca
Avita Medical
Baxalta
Baxter
Bayer
Beijing Four Rings
Beijing SL Pharmaceutical
Benda Pharmaceuticals
Biocad
BioCardia
Biocon
Biodel
Biogen
Bionovis
Biosidus
Biotest
Bioton
BioXpress Therapeutics
Boehringer Ingelheim
BrainStorm Cell Therapeutics
Bristol-Myers Squibb
Cambridge Antibody Technology
CCL Pharmaceuticals
Celgene Corporation
Celltrion
CEL-SCI
Centocor Ortho Biotech
Chugai
CinnaGen
ClinImmune Labs
CSL Behring
CT Arzneimittel
Cystic Fibrosis Foundation Therapeutics Inc
Dako
Dendreon
Dong-A
Dong-A Pharmaceutical
Dr. Reddy's Laboratories
Eli Lilly
EMA
Emcure Pharmaceuticals
EMS
Epirus
FDA
FibroGen
FierceBiotech
Finox Biotech
Fuji Pharma
Galencia
Gan & Lee
Genentech
GenSci
Gilead Sciences
GSK
Hangzhou Jiuyuan Gene Engineering Co.
Hanwha Chemical
Hexal
Hindustan Antibiotic
Histogenics
Hospira
Human Genome Sciences
Human Stem Cells Institute
Hypermarcas
Immunex Corporation
Innovare R&D
Intas Biopharmaceuticals
Ipsen
Janssen
JingYuan Bio
Johnson & Johnson
Kyowa Hakko Kirin
Laboratorios Delta
LG Life Sciences
LifeSouth Community Blood Centers
Medice
MEDICE Arzneimittel Pütter
MEDIPOST
Medtronic
Merck & Co.
Merck KGaA
Merz Pharma
Mitsubishi Tanabe
Mochida Pharmaceutical
Musculoskeletal Transplant Foundation (MTF)
Mylan
Nippion Kayaku
Novartis
Novo Nordisk
NuVasive
Oanda
Organogenes
OrLife Bio
Orthofix
Orygen
Pfizer
Pharmicell
Pharmstandard
Probiomed
Proteon Therapeutics
Qilu Pharmaceutical
Ranbaxy
Ratiopharm
Regeneron Pharmaceuticals
Regenerys
Reliance Life Sciences
Rentschler Biotechnologie.
Roche
Samsung Bioepis
Sandoz
Sanofi
Saudi Food and Drug Authority
Schering-Plough
SciGen
Shandong Kexing Pharma
Shanghai CP Guojian Pharmaceutical
Shanghai Fosun
Shanghai Sunway Biotech
Shantha Biotechnics
Shire
Sicor Biotech
Smith and Nephew
Spark Therapeutics
Stada
Stragen Pharma
Stratatech Corporation
Swiss Re
Teva
Tianjin Hualida Biotechnology
TiGenix
Tonghua Dongbao
UCB
União Química
UniQure
United Therapeutics
Vertex Pharmaceuticals
Vital Therapies Inc.
Wall Street Journal
Wockhardt
Wyeth-Ayerst Laboratories
Xiamen Amoytop Biotech
Zenotech
Zydus Biovation
Zydus Cadila

List of Organizations
Central Drugs Standard Control Organisation
Children’s Oncology Group
China Food and Drug Administration
CHMP
Duke University School of Medicine
European Federation of Pharmaceutical Industries and Associations
Europharm
Massachusetts General Hospital
New York Blood Center
NHS
NICE
SSN Cardinal Glennon Children’s Medical Center
Stanford University
The European Generic medicines Association (EGA)
The European Group for Blood and Marrow Transplantation (EBMT)
Toronto University
UCSF (University of California, San Francisco)
University of Colorado Cord Blood Bank
University of Tokyo
US Center for Disease Prevention and Control (CDC)
Walter and Eliza Hall Institute
World Bank
Yonsei University

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