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IMARC Group Releases the Most Robust Market Forecast on the US Biosimilar/Follow-on Biologics Market

With sales worth US$ 57 Million in 2010, biosimilars are still far from their billion dollar sales potential that most analysts believe they will generate. This market, however, unlike small molecule generics, is expected to be more akin to a marathon than a sprint.
Noida, Uttar pardesh, India ( 25/10/2011

IMARC Group, one of the world’s leading research and advisory firms, in its new report “Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US (2011-2020)” finds that biosimilars in the US will soon represent a multi-billion dollar market as they would be posing stiff competition to as many as twenty biological molecules during 2011-2020.

Findings from the report suggest that the historical performance of Omnitrope cannot be taken as a benchmark to gauge the potential of pipeline biosimilars as market acceptance for each biosimilar class is expected to vary significantly from one another. The report expects that the competition between branded biological drugs and their biosimilar counterparts would be more of a brand-brand competition than a brand-generic competition. The high costs involved in the development and launch of biosimilars are expected to limit the number of players in this market. As a result, erosions in price and volume caused by biosimilars are likely to be lower compared to those created by small molecule generics.

IMARC’s new report 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
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 Insulin
6.41. Insulin Lispro (Humalog)
6.4.2 Insulin Glargine (Lantus)
6.4.3 Insulin Detemir (Levemir)
6.5 Interferons
6.5.1 Interferon Beta-1A (Avonex)
6.5.2 Interferon Beta-1A (Rebif)
6.5.3 Interferon Beta-1B (Betaferon/Betaseron)
6.6T NF Alpha & Monoclonal Antibodies (Immunology & Inflammation)
6.6.1 Etanercept (Enbrel)
6.6.2 Infliximab (Remicade)
6.6.3 Adalimumab (Humira)
6.6. Ranibizumab (Lucentis)
6.6. 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 Diabetes
7.2.1 Current Trends & Forecast
7.2.2 Biosimilar Sales Breakup by Molecule
7.3 Oncology
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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