The Market for Biosimilars Will be a Marathon and Not a Sprint

Noida, India (PressExposure) July 27, 2011 -- 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 marathon and not a sprint. IMARC Group, one of the world's leading research and advisory firms, in its new report entitled "US Biosimilar & Follow-On Biologics Market Report (2011-2020): Problems, Prospects & Projections" finds that with eighteen biopharmaceutical molecules expected to face biosimilar competition during 2011 and 2020, the market for biosimilars in the US is expected to reach values worth US$ 11.4 Billion by 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 significantly vary from one another. The report expects competition between branded biological drugs and their biosimilar counterparts to represent more that of a brand-brand competition than a brand-generic competition. The high costs involved in the development and launch of biosimilars is expected to limit the number of players in this market and create a significantly lower price and volume erosion compared to small molecule generics.

Key Aspects Analyzed:

Understanding the Current Legislations on Biosimilars:

• An Insight into the Biologics Price Competition and Innovation Act

• An insight on the key biosimilar issues that still remain unaddressed

• Interchangeability and Substitutability

• Data Exclusivity

• Provisions for patent litigation

Evaluating the Current Market Landscape for Biosimilars:

• Identification of current marketed biosimilars and their historical performance

• Identifying the reasons for the slow uptake of current marketed biosimilars

• Analyzing historical data to formulate conclusions on the future growth and trends of biosimilars

Evaluating the Extent of Biosimilar Price, Sales and Volume Erosion:

• Analyzing historical time series data on price, volume and sales erosion in the US & Europe

• Analyzing previous models and assumptions on biosimilar price and volume erosion

• Evaluating and comparing biosimilar price and volume erosion with that of small molecule generics

• Evaluating and comparing biosimilar price, volume and sales erosion across various biological classes

Evaluating the Sales and Volume Erosion of Biosimilars across Various Molecules:

Molecules Covered: Somatropin, Epoitin Alfa, Darbepoetin Alfa, Filgrastim, Pegfilgrastim, Insulin Lispro, Insulin Glargin, Insulin Detemir, Interferon Beta-1A, Interferon Beta-1B, Bevacizumab, Trastuzumab, Rituximab, Cetuximab, Ethanercept, Infliximab and Adalimumab

Focus of the Analysis for Each Molecule:

• Historical Background and Overview

• Historical Brand Sales

• Brand and Biosimilar Sales Forecast

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 & Biosimilar Sales Forecast

• Biosimilar Sales Forecast by Molecule

Evaluating the Biosimilar Competitive Landscape:

• Identifying branded biological manufacturers that expect the highest amount of biosimilar erosion

• Identifying biosimilar manufacturers and their current partnerships and pipelines

Table of Contents:

1 Market Definitions & Research Methodology

2 Executive Summary

3 Biosimilar Legislation in the US

3.1 The Biologics Price Competition and Innovation Act: An Insight

3.2 Biosimlar Issues that Still Remain Unaddressed

3.3 Major Issues Impacting the Business Strategies of Biological Companies

3.3.1 Interchangeability & Substitutability

3.3.2 Data Exclusivity

3.3.3 Patent Litigation

4 The US Biosimilar Market Landscape

5 US Biosimilar Market: Current Experience

5.1 The Performance of Growth Hormone Biosimilars Has Been Dismal So Far

5.2 Prescribing Patterns for Omnitrope

5.3 Pediatrics Represent the Prime Customer Base of Growth Hormones

5.4 Omnitrope was Launched with an Inconvenient Delivery Device

5.5 Uptake is Likely to Increase with an Accumulation of a Positive Post-Market Safety Data

6 US Biosimlar Market: How Much Price, Volume & Sales Erosion will Result

6.1 Omnitrope Cannot be Taken as a Benchmark to Gauge the Performance of Other Biosimilars

6.2 The European Uptake of ESA & GCSF Give Us a Very Positive Outlook for the US

6.3 Current & Future Biosimilar Volume Erosion Across Various Biological Classes

6.4 Current & Future Biosimilar Price Erosion Across Various Biological Classes

6.5 Current & Future Biosimilar Sales Erosion Across Various Biological Classes

7 US Biosimilar Market: Current Trends & Forecast by Drug

7.1 Growth Hormones

7.1.1 Somatropin (Genotropin/Humatrope/Other HGH)

7.1.1.1 Drug Overview

7.1.1.2 Current Brand & Biosimilar Sales

7.1.1.3 Brand & Biosimilar Forecasts (2011-2020)

7.2 Erythropoiesis-Stimulating Agents

7.2.1 Epoetin Alfa (Epogen/Eprex)

7.2.1.1 Drug Overview

7.2.1.2 Historical Brand Sales

7.2.1.3 Brand & Biosimilar Forecasts (2011-2020)

7.2.2 Darbepoetin Alfa (Aranesp)

7.2.2.1 Drug Overview

7.2.2.2 Historical Brand Sales

7.2.2.3 Brand & Biosimilar Forecasts (2011-2020)

7.3 Granulocyte Colony Stimulating Factor

7.3.1 Filgrastim (Neupogen)

7.3.1.1 Drug Overview

7.3.1.2 Historical Brand Sales

7.3.1.3 Brand & Biosimilar Forecasts (2011-2020)

7.3.2 Pegfilgrastim (Neulasta)

7.3.2.1 Drug Overview

7.3.2.2 Historical Brand Sales

7.3.2.3 Brand & Biosimilar Forecasts (2011-2020)

7.4 Insulin

7.4.1 Insulin Lispro (Humalog)

7.4.1.1 Drug Overview

7.4.1.2 Historical Brand Sales

7.4.1.3 Brand & Biosimilar Forecasts (2011-2020)

7.4.2 Insulin Glargine (Lantus)

7.4.2.1 Drug Overview

7.4.2.2 Historical Brand Sales

7.4.2.3 Brand & Biosimilar Forecasts (2011-2020)

7.4.3 Insulin Detemir (Levemir)

7.4.3.1 Drug Overview

7.4.3.2 Historical Brand Sales

7.4.3.3 Brand & Biosimilar Forecasts (2011-2020)

7.5 Interferons

7.5.1 Interferon Beta-1A (Avonex)

7.5.1.1 Drug Overview

7.5.1.2 Historical Brand Sales

7.5.1.3 Brand & Biosimilar Forecasts (2011-2020)

7.5.2 Interferon Beta-1A (Rebif)

7.5.2.1 Drug Overview

7.5.2.2 Historical Biosimilar Sales

7.5.2.3 Brand & Biosimilar Forecasts (2011-2020)

7.5.3 Interferon Beta-1B (Betaferon/Betaseron)

7.5.3.1 Drug Overview

7.5.3.2 Historical Biosimilar Sales

7.5.3.3 Brand & Biosimilar Forecasts (2011-2020)

7.6 Oncolgy Monoclonal Antibody

7.6.1 Bevacizumab (Avastin)

7.6.1.1 Drug Overview

7.6.1.2 Historical Brand Sales

7.6.1.3 Brand & Biosimilar Forecasts (2011-2020)

7.6.2 Trastuzumab (Herceptin)

7.6.2.1 Drug Overview

7.6.2.2 Historical Biosimilar Sales

7.6.2.3 Brand & Biosimilar Forecasts (2011-2020)

7.6.3 Rituximab (Rituxan)

7.6.3.1 Drug Overview

7.6.3.2 Historical Biosimilar Sales

7.6.3.3 Brand & Biosimilar Forecasts (2011-2020)

7.6.4 Cetuximab (Erbitux)

7.6.4.1 Drug Overview

7.6.4.2 Historical Brand Sales

7.6.4.3 Brand & Biosimilar Forecasts (2011-2020)

7.7 TNF Alpha

7.7.1 Etanercept (Enbrel)

7.7.1.1 Drug Overview

7.7.1.2 Historical Brand Sales

7.7.1.3 Brand & Biosimilar Forecasts (2011-2020)

7.7.2 Infliximab (Remicade)

7.7.2.1 Drug Overview

7.7.2.2 Historical Brand Sales

7.7.2.3 Brand & Biosimilar Forecasts (2011-2020)

7.7.3 Adalimumab (Humira)

7.7.3.1 Drug Overview

7.7.3.2 Historical Brand Sales

7.7.3.3 Brand & Biosimilar Forecasts (2011-2020)

8 US Biosimilar Market: Current Trends & Forecast by Indication

8.1 Immunology & Inflammation

8.1.1 Current Trends & Forecast

8.1.2 Biosimilar Sales Breakup by Product

8.2 Diabetes

8.2.1 Current Trends & Forecast

8.2.2 Biosimilar Sales Breakup by Product

8.3 Oncology

8.3.1 Current Trends & Forecast

8.3.2 Biosimilar Sales Breakup by Product

8.4 Blood Disorder

8.4.1 Current Trends & Forecast

8.4.2 Biosimilar Sales Breakup by Product

8.5 Growth Deficiency

8.5.1 Current Trends & Forecast

8.5.2 Biosimilar Sales Breakup by Products

9 Competitive Landscape

9.1 Branded Manufacturers: Companies Facing the Highest Amount of Biosimilar Erosion

9.2 Biosimilar Manufacturers: Companies Gaining the Most From Biosimilar Launches

9.3 Key Company Profiles

9.3.1 Teva

9.3.2 Sandoz

9.3.3 Hospira

9.3.4 Stada

9.3.5 Dr Reddy's

To buy the complete report or to get a free sample:

Call: +91-120-425-6531 (Asia), +44-844-774-9660 (Europe), +1-631-791-1145 (America)

email: sales@imarcgroup.com

For more information please visit: http://www.imarcgroup.com

About IMARC

For more than 5 years, the International Market Analysis Research and Consulting Group has been a leading advisor on management strategy and market research worldwide. We partner with clients in all sectors and regions to identify their highest-value opportunities, address their most critical challenges, and transform their businesses.

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Press Release Submitted On: July 27, 2011 at 12:29 am
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