Biosimilar/Follow-on Monoclonal Antibodies: The Next Big Thing for Generic Manufacturers

With the patents of all major monoclonal antibodies set to expire during 2015 - 2020, Biosimilar (or Follow-on) Monoclonal Antibodies are expected to represent the next big thing for generic manufacturers.
Bookmark and Share
Noida, India ( November 1, 2011 - The commercial success achieved by monoclonal antibodies in the last five years cannot be matched by any other drug class. During 2005-2010, the market for monoclonal antibodies in the US grew at an impressive CAGR of 18% and its market size zoomed to US$ 19 billion. However, with the patents of most of these drugs set to expire during 2015 - 2020, biosimilar (or follow-on) monoclonal antibodies are expected to grab the opportunity and become the next big thing for generic manufacturers.

A study undertaken by IMARC Group, one of the world's leading research and advisory firms, reveals that by 2015, Rituximab (Rituxan/MabThera) will be the first biosimilar monoclonal antibody to emerge on the scene. This will be followed by the launch of eight other biosimilar molecules, one by one, by 2020. The series of launches, however, may not immediately give sleepless nights to the branded antibody manufacturers. The study results, which are based on a robust long range forecast for each brand and its biosimilar monoclonal antibody, suggest that due to their more complex molecular structure and higher regulatory requirements, the price and volume erosion of monoclonal antibodies will be at a slower pace than other biological classes such as ESAs and Insulin. However, due to the humongous market size as well as their potential to be great money savers for payers and providers, sales of these drugs are likely to pickup in the medium and long term. After their launch in 2015, the market size of biosimilar/follow-on monoclonal antibodies is expected to cross the billion dollar threshold by 2019, and grow exponentially since then.

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

To buy the complete report or to get a free sample:
Call: +91-120-425-6531 (Asia),
To know more please visit:


Tag Words: biosimilar industry, biosimilar market
Categories: Medical

Press Release Contact
Address Sector 10, Noida, UP, India


Phone +91-120-4256531

Link To This Press Release:

Create Press Release
Press Release Options
About This Press Release
If you have any questions about this press release, please contact the listed publisher. Please do not contact prHWY as we cannot help you with your inquiry.