Biosimilar Monoclonal Antibodies Will Signify The Subsequent Huge Factor For Generic Producers

Biosimilar Monoclonal Antibodies Will Represent The Next Big Thing For Generic Manufacturers

The business success achieved by monoclonal antibodies within the final 5 years can’t be matched by every other drug class. Throughout 2005-2010, the marketplace for monoclonal antibodies within the US grew at a formidable CAGR of 18% and its market dimension zoomed to US$ 19 billion. Nevertheless, with the patents of most of those medication set to run out throughout 2015 – 2020, biosimilar (or follow-on) monoclonal antibodies are anticipated to seize the chance and change into the following huge factor for generic producers.
A research undertaken by IMARC Group, one of many world’s main analysis and advisory corporations, reveals that by 2015, Rituximab (Rituxan/MabThera) would be the first biosimilar monoclonal antibody to emerge on the scene. This shall be adopted by the launch of eight different biosimilar molecules, one after the other, by 2020. The collection of launches, nonetheless, could not instantly give sleepless nights to the branded antibody producers. The research outcomes, that are based mostly on a sturdy lengthy vary forecast for every model and its biosimilar monoclonal antibody, recommend that on account of their extra complicated molecular construction and better regulatory necessities, the value and quantity erosion of monoclonal antibodies shall be at a slower tempo than different organic courses akin to ESAs and Insulin. Nevertheless, as a result of humongous market dimension in addition to their potential to be nice cash savers for payers and suppliers, gross sales of those medication are more likely to pickup within the medium and long run. After their launch in 2015, the market dimension of biosimilar/follow-on monoclonal antibodies is anticipated to cross the billion greenback threshold by 2019, and develop exponentially since then.

IMARC’s new report entitled “Biosimilar/Follow-on Biologics Market Report & Forecast: A Focus on the US (2011-2020)” offers an analytical and statistical perception into the US biosimilar market. The research, that has been undertaken utilizing desk-based in addition to qualitative major analysis, offers and attracts upon evaluation of six points of the US biosimilar market.
Key Facets Analyzed:
Evaluating the Present Market Panorama of Biosimilars:

Identification of at the moment marketed biosimilars and their historic efficiency
Figuring out the explanations for the gradual uptake of at the moment marketed biosimilars
Analyzing historic information to formulate conclusions on the longer term progress and market tendencies of biosimilars

Evaluating the Extent of Value, Gross sales and Quantity Erosions Brought on by Biosimilars:

Analyzing historic time collection information on worth, quantity and gross sales erosion within the US & Europe
Analyzing earlier fashions and assumptions on worth and quantity erosion attributable to biosimilars
Evaluating and evaluating worth and quantity erosion created by biosimilars vis-a-vis by small molecule generics
Evaluating and evaluating worth, quantity and gross sales erosion by biosimilars throughout numerous organic courses

Evaluating the Market Potential of Biosimilars Throughout Varied Molecules:
Molecules Lined: Somatropin (Genotropin/Humatrope/Different 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 Evaluation for Every Molecule:

Historic background and overview
Historic model gross sales
Patent place
Competing merchandise
Biosimilars in pipeline
Model and biosimilar gross sales forecasts

Evaluating the Gross sales of Biosimilars throughout Varied Indications:
Indications Lined: Immunology & Irritation, Diabetes, Oncology, Blood Problems and Development Deficiency
Focus of the Evaluation for Every Indication:

Historic model gross sales
Model and biosimilar gross sales forecasts
Indication clever breakup of molecules

Evaluating the Biosimilar Aggressive Panorama:

Figuring out branded organic producers that count on the very best quantity of abrasion from biosimilars
Figuring out biosimilar producers and their pipelines

Understanding the Present Laws on Biosimilars:

An perception into the Biologics Value Competitors and Innovation Act
An perception into the important thing biosimilar points that also stay unaddressed
Interchangeability and Substitutability
Information Exclusivity

Statutory provisions for coping with patent litigations
Desk of Contents
1 Market Definitions & Analysis Methodology
2 Government Abstract
Three The US Biosimilar Market Panorama
Four US Biosimilar Market: Present Expertise
4.1 The Efficiency of Development Hormone Biosimilars Has Been Dismal So Far
4.2 Pediatrics Signify the Prime Buyer Base for Development Hormones
4.Three Omnitrope Was Launched with an Inconvenient Supply Gadget
4.Four Prescribing Patterns for Omnitrope
4.5 Uptake is Prone to Enhance with the Accumulation of Put up-Market Security Information
5 US Biosimlar Market: How A lot Value, Quantity & Gross sales Erosion will Consequence
5.1 Omnitrope Can’t be Taken as a Benchmark to Gauge the Efficiency of Different Biosimilars
5.2 The European Uptake of ESA & GCSF Biosimilars Give Us a Very Optimistic Outlook for the US
5.Three Fashions for Biosimilar Quantity Erosion Throughout Varied Organic Lessons
5.Four Fashions for Biosimilar Value Erosion Throughout Varied Organic Lessons
5.5 Fashions for Biosimilar Gross sales Erosion Throughout Varied Organic Lessons
6 US Biosimilar Market: Present Tendencies & Forecast by Drug
6.1 Development Hormones
6.1.1 Somatropin (Genotropin/Humatrope/Different HGH)
6.2 Erythropoiesis Stimulating Brokers
6.2.1 Epoetin Alfa (Epogen/Eprex)
6.Three Granulocyte Colony Stimulating Issue
6.3.1 Filgrastim (Neupogen)
6.3.2 Pegfilgrastim (Neulasta)
6.Four Insulin
6.41. Insulin Lispro (Humalog)
6.4.2 Insulin Glargine (Lantus)
6.4.Three Insulin Detemir (Levemir)
6.5 Interferons
6.5.1 Interferon Beta-1A (Avonex)
6.5.2 Interferon Beta-1A (Rebif)
6.5.Three Interferon Beta-1B (Betaferon/Betaseron)
6.6T NF Alpha & Monoclonal Antibodies (Immunology & Irritation)
6.6.1 Etanercept (Enbrel)
6.6.2 Infliximab (Remicade)
6.6.Three 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.Three Rituximab (Mabthera)
6.7.Four Cetuximab (Erbitux)
7 US Biosimilar Market: Present Tendencies & Forecast by Indication
7.1 Immunology & Irritation
7.1.1 Present Tendencies & Forecast
7.1.2 Biosimilar Gross sales Breakup by Molecule
7.2 Diabetes
7.2.1 Present Tendencies & Forecast
7.2.2 Biosimilar Gross sales Breakup by Molecule
7.Three Oncology
7.3.1 Present Tendencies & Forecast
7.3.2 Biosimilar Gross sales Breakup by Molecule
7.Four Blood Problems
7.4.1 Present Tendencies & Forecast
7.4.2 Biosimilar Gross sales Breakup by Molecule
7.5 Development Deficiency
7.5.1 Present Tendencies & Forecast
7.5.2 Biosimilar Gross sales Breakup by Molecule
Eight Aggressive Panorama
8.1 Branded Producers: Corporations Going through the Highest Quantity of Biosimilar Erosion
8.2 Biosimilar Producers: Corporations Gaining the Most From Biosimilar Launches
9 Biosimilar Laws within the US
9.1 The Biologics Value Competitors and Innovation Act: An Perception
9.2 Biosimilar Points that Nonetheless Stay Unaddressed
9.Three Main Points Impacting the Enterprise Methods of Organic Corporations
9.3.1 Interchangeability & Substitutability
9.3.2 Information Exclusivity
9.3.Three Patent Litigation
10 Key Firm Profiles
10.1 Teva Pharmaceutical Industries Ltd.
10.2 Sandoz, Inc.
10.Three Hospira, Inc.
10.Four STADA Arzneimittel AG
10.5 Dr. Reddy’s Laboratories Ltd.
10.6 Celltrion, Inc.
10.7 Bioexpress Therapeutics SA
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