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The Penetration of Biosimilars in the US Will Vary Across Different Biological Classes


The volume penetration of biosimilars in the US will strongly depend upon the complexity of
the molecule, the patient pool that it caters and the extent of savings it brings to payers and
providers


IMARC Group, one of the world’s leading life science research and advisory firms, finds that as
a result of their higher molecule complexity, higher cost of manufacturing and lower number
of biosimilar competitors (2-5 in case of biosimilars as against up to 9-10 in small molecule
generics); the average volume penetration of biosimilars will be significantly lower than that
of small molecule generics. The study also expects the volume penetration of different
biological classes to vary from one another depending upon the following factors:


       Biosimilars which are more complex will have a lower penetration compared to those
       that are less complex.
       Volume penetration would also depend upon how lucrative the branded biological drug
       is for biosimilar volume erosion. Drugs that have achieved blockbuster sales and show a
       good potential for future growth represent a good target for biosimilar companies. Payers
       and Providers are also expected to promote biosimilars which enable them to achieve
       substantial cost savings.
       Trends of in-market biosimilars show that penetration rates also depend upon the
       targeted indication and patient pool for biosimilar drugs. Drugs which are targeted
       towards more sensitive patients (i.e. children) are expected to have a lower penetration
       rate as physicians will not prescribe these drugs until they have significant long term
       safety and efficacy data. Similarly, indications where the benefits and side effects of the
       drug are not immediately visible and take a long time to identify (i.e. hormone deficiency)
       will have a lower share than indications where the side effects and benefits are easily
       visible (i.e. Anaemia).
       The penetration of various biosimilars would vary across different countries. The volume
       penetration of small molecule generics in the US has been found to be higher than that
       of major European markets. As a result, we expect biosimilar penetration in the US to be
       higher than major European markets.



imarc©                                                                                          1
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).



imarc©                                                                                          2
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


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


IMARC Group Asia
Email: apac@imarcgroup.com
Phone: +91-120-425-6531

IMARC Group North America

imarc©                                                                                     3
Email: america@imarcgroup.com
Phone: +1-631-791-1145

To know more please visit: http://www.imarcgroup.com/



Key words

Biosimilar market, biosimilar industry, follow-on biologics market, biogenerics market, us biosimilar

market, biosimilar volume penetration rate




imarc©                                                                                             4

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Pr biosimlars volume pentration rate

  • 1. The Penetration of Biosimilars in the US Will Vary Across Different Biological Classes The volume penetration of biosimilars in the US will strongly depend upon the complexity of the molecule, the patient pool that it caters and the extent of savings it brings to payers and providers IMARC Group, one of the world’s leading life science research and advisory firms, finds that as a result of their higher molecule complexity, higher cost of manufacturing and lower number of biosimilar competitors (2-5 in case of biosimilars as against up to 9-10 in small molecule generics); the average volume penetration of biosimilars will be significantly lower than that of small molecule generics. The study also expects the volume penetration of different biological classes to vary from one another depending upon the following factors: Biosimilars which are more complex will have a lower penetration compared to those that are less complex. Volume penetration would also depend upon how lucrative the branded biological drug is for biosimilar volume erosion. Drugs that have achieved blockbuster sales and show a good potential for future growth represent a good target for biosimilar companies. Payers and Providers are also expected to promote biosimilars which enable them to achieve substantial cost savings. Trends of in-market biosimilars show that penetration rates also depend upon the targeted indication and patient pool for biosimilar drugs. Drugs which are targeted towards more sensitive patients (i.e. children) are expected to have a lower penetration rate as physicians will not prescribe these drugs until they have significant long term safety and efficacy data. Similarly, indications where the benefits and side effects of the drug are not immediately visible and take a long time to identify (i.e. hormone deficiency) will have a lower share than indications where the side effects and benefits are easily visible (i.e. Anaemia). The penetration of various biosimilars would vary across different countries. The volume penetration of small molecule generics in the US has been found to be higher than that of major European markets. As a result, we expect biosimilar penetration in the US to be higher than major European markets. imarc© 1
  • 2. 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). imarc© 2
  • 3. 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 To buy the complete report or to get a free sample, please contact: IMARC Group Asia Email: apac@imarcgroup.com Phone: +91-120-425-6531 IMARC Group North America imarc© 3
  • 4. Email: america@imarcgroup.com Phone: +1-631-791-1145 To know more please visit: http://www.imarcgroup.com/ Key words Biosimilar market, biosimilar industry, follow-on biologics market, biogenerics market, us biosimilar market, biosimilar volume penetration rate imarc© 4