IMARC Group, one of the world’s leading research and advisory firms, has recently launched one of the most comprehensive studies on the US biosimilar market. The study entitled “Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US (2011-2020)” provides an analytical and statistical insight into the US biosimilar market. The study, that has been undertaken using desk-based as well as qualitative primary research, provides and draws upon analysis of six aspects of the US biosimilar market.
Key Aspects Analyzed:
Evaluating the Current Market Landscape of Biosimilars:
• Identification of currently marketed biosimilars and their historical performance;
• Identifying the reasons for the slow uptake of currently marketed biosimilars;
• Analyzing historical data to formulate conclusions on the future growth and market trends of biosimilars.
Evaluating the Extent of Price, Sales and Volume Erosions Caused by Biosimilars:
• Analyzing historical time series data on price, volume and sales erosion in the US & Europe;
• Analyzing previous models and assumptions on price and volume erosion caused by biosimilars;
• Evaluating and comparing price and volume erosion created by biosimilars vis-a-vis by small molecule generics;
• Evaluating and comparing price, volume and sales erosion by biosimilars across various biological classes.
Evaluating the Market Potential of Biosimilars Across Various Molecules:
Molecules Covered: Somatropin (Genotropin/Humatrope/Other HGH), Epoetin Alfa (Epogen/Eprex), Filgrastim (Neupogen), Pegfilgrastim (Neulasta), Insulin Lispro (Humalog), Insulin Glargine (Lantus), Insulin Detemir (Levemir), Interferon Beta-1A (Avonex), Interferon Beta-1A (Rebif), Interferon Beta-1B (Betaferon), Bevacizumab (Avastin), Trastuzumab (Herceptin), Rituximab (Mabthera/Rituxan), Cetuximab (Erbitux), Etanercept (Enbrel), Infliximab (Remicade), Adalimumab (Humira), Ranibizumab (Lucentis), Omalizumab (Xolair) and Natalizumab (Tysabri).
Focus of the Analysis for Each Molecule:
• Historical background and overview;
• Historical brand sales;
• Patent position;
• Competing products;
• Biosimilars in pipeline;
• Brand and biosimilar sales forecasts.
Evaluating the Sales of Biosimilars across Various Indications:
Indications Covered: Immunology & Inflammation, Diabetes, Oncology, Blood Disorders and Growth Deficiency
Focus of the Analysis for Each Indication:
• Historical brand sales;
• Brand and biosimilar sales forecasts;
• Indication wise breakup of molecules.
Evaluating the Biosimilar Competitive Landscape:
• Identifying branded biological manufacturers that expect the highest amount of erosion from biosimilars;
• Identifying biosimilar manufacturers and their pipelines.
Understanding the Current Legislation on Biosimilars:
• An insight into the Biologics Price Competition and Innovation Act;
• An insight into the key biosimilar issues that still remain unaddressed;
• Interchangeability and Substitutability;
• Data Exclusivity;
• Statutory provisions for dealing with patent litigations.
Key Questions Answered in this Report:
• What is the current landscape of biosimilars in the US?
• How is the market for biosimilars different from small molecule generics?
• How are biosimilars belonging to different biological classes different from one another?
• What will be the volume and price erosion of different biosimilars post patent expiry?
• What is the patent position of various biological brands in the US?
• What are the expected launch dates of various biosimilars?
• How fast will biosimilars be accepted among physicians and consumers?
• What are the most popular indications for which biosimilars will be prescribed?
• Which companies carry the maximum risk from biosimilar entry?
• Which companies represent the frontrunners in the biosimilar race?
Table of Contents
1 Market Definitions & Research Methodology
2 Executive Summary
3 The US Biosimilar Market Landscape
4 US Biosimilar Market: Current Experience
4.1 The Performance of Growth Hormone Biosimilars Has Been Dismal So Far
4.2 Pediatrics Represent the Prime Customer Base for Growth Hormones
4.3 Omnitrope Was Launched with an Inconvenient Delivery Device
4.4 Prescribing Patterns for Omnitrope
4.5 Uptake is Likely to Increase with the Accumulation of Post-Market Safety Data
5 US Biosimlar Market: How Much Price, Volume & Sales Erosion will Result
5.1 Omnitrope Cannot be Taken as a Benchmark to Gauge the Performance of Other Biosimilars
5.2 The European Uptake of ESA & GCSF Biosimilars Give Us a Very Positive Outlook for the US
5.3 Models for Biosimilar Volume Erosion Across Various Biological Classes
5.4 Models for Biosimilar Price Erosion Across Various Biological Classes
5.5 Models for Biosimilar Sales Erosion Across Various Biological Classes
6 US Biosimilar Market: Current Trends & Forecast by Drug
6.1 Growth Hormones
6.1.1 Somatropin (Genotropin/Humatrope/Other HGH)
6.2 Erythropoiesis Stimulating Agents
6.2.1 Epoetin Alfa (Epogen/Eprex)
6.3 Granulocyte Colony Stimulating Factor
6.3.1 Filgrastim (Neupogen)
6.3.2 Pegfilgrastim (Neulasta)
6.4.1 Insulin Lispro (Humalog)
6.4.2 Insulin Glargine (Lantus)
6.4.3 Insulin Detemir (Levemir)
6.5.1 Interferon Beta-1A (Avonex)
6.5.2 Interferon Beta-1A (Rebif)
6.5.3 Interferon Beta-1B (Betaferon/Betaseron)
6.6 TNF Alpha & Monoclonal Antibodies (Immunology & Inflammation)
6.6.1 Etanercept (Enbrel)
6.6.2 Infliximab (Remicade)
6.6.3 Adalimumab (Humira)
6.6.4 Ranibizumab (Lucentis)
6.6.5 Omalizumab (Xolair)
6.6.6 Natalizumab (Tysabri)
6.7 Monoclonal Antibodies (Oncology)
6.7.1 Bevacizumab (Avastin)
6.7.2 Trastuzumab (Herceptin)
6.7.3 Rituximab (Mabthera)
6.7.4 Cetuximab (Erbitux)
7 US Biosimilar Market: Current Trends & Forecast by Indication
7.1 Immunology & Inflammation
7.1.1 Current Trends & Forecast
7.1.2 Biosimilar Sales Breakup by Molecule
7.2.1 Current Trends & Forecast
7.2.2 Biosimilar Sales Breakup by Molecule
7.3.1 Current Trends & Forecast
7.3.2 Biosimilar Sales Breakup by Molecule
7.4 Blood Disorders
7.4.1 Current Trends & Forecast
7.4.2 Biosimilar Sales Breakup by Molecule
7.5 Growth Deficiency
7.5.1 Current Trends & Forecast
7.5.2 Biosimilar Sales Breakup by Molecule
8 Competitive Landscape
8.1 Branded Manufacturers: Companies Facing the Highest Amount of Biosimilar Erosion
8.2 Biosimilar Manufacturers: Companies Gaining the Most From Biosimilar Launches
9 Biosimilar Legislation in the US
9.1 The Biologics Price Competition and Innovation Act: An Insight
9.2 Biosimilar Issues that Still Remain Unaddressed
9.3 Major Issues Impacting the Business Strategies of Biological Companies
9.3.1 Interchangeability & Substitutability
9.3.2 Data Exclusivity
9.3.3 Patent Litigation
10 Key Company Profiles
10.1 Teva Pharmaceutical Industries Ltd.
10.2 Sandoz, Inc.
10.3 Hospira, Inc.
10.4 STADA Arzneimittel AG
10.5 Dr. Reddy's Laboratories Ltd.
10.6 Celltrion, Inc.
10.7 Bioexpress Therapeutics SA
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IMARC Group Asia
Email: apac[.]imarcgroup.com - P: +91-120-425-6531
IMARC Group North America
E: america[.]imarcgroup.com - P: +1-631-791-1145.