Competitor Analysis: Therapeutic Proteins - Biosimilars, Biobetters & Biosuperiors -





Published: May 2013 Pages: 301

The new Competitive Intelligence Report Therapeutic Proteins – Biosimilars, Biobetters & Biosuperiors of May 2013 provides a competitor analysis in the product portfolios and development pipelines of ten major classes of therapeutic proteins and their biosimilar and biobetter/biosuperior versions in regulated and less regulated markets:


 

  • Erythropoietin (EPO) & Erythropoiesis Stimulating Agents (ESA) 
  • G-CSF & GM-CSF  
  • Thrombopoietin & Thrombopoiesis Stimulating Agents  
  • Interferon  
  • Insulin  
  • Coagulation Factors  
  • Human Growth Hormone (hGH)  
  • FSH, hCG and LH: Therapeutic Proteins for Assisted Reproductive Technology (ART)  
  • Thrombolytics & Fibrinolytics  
  • Enzyme Replacement Therapies 


Territories covered are the major pharmaceutical markets North America, Europe and Japan, as well as South Korea, India, China and other countries in Latin America, Africa and Australasia.


With more than US$ 50 bln in sales, therapeutic proteins represent a major category of pharmaceutical products with established therapeutic value and high economic attractiveness. As more and more of the branded products are running out of patent protection and regulatory agencies are providing better guidance, development of biosimilar versions as well as of improved next generation versions are a highly attractive goal for pharmaceutical and biotechnology as well as technology focused companies.


This report includes a compilation of current active projects in research and development of biosimilar and novel biobetter/biosuperior therapeutic proteins as well as non-protein based competitor products and an overview of approved products in regulated and less regulated markets. Competitor projects are listed in a tabular format providing Information on:


 

  • Drug Codes,  
  • Target / Mechanism of Action,  
  • Class of Compound,  
  • Company,  
  • Product Category,  
  • Indication,  
  • R&D Stage and  
  • additional comments with a hyperlink leading to the source of information. 


About Competitor Analysis Series:


The Competitor Analysis Series delivers NO-FRILLS, but concise information about the pipeline of R&D projects for targets, diseases, technologies and companies at low prices. The information is provided in a tabular format and fully referenced.
 

 


 


 


 

1) Erythropoiesis Stimulating Agents (ESA) 

First generation epoetins in regulated markets 

Second generation epoetins in regulated markets 

Epoetin biosimilars in regulated markets 

Darbepoetin biosimilars in regulated markets 

Next generation biologic Eythropoiesis Stimulating Agents (ESA) in regulated markets 

Next generation small molecule Erythropoiesis Stimulating Agents 

First generation EPO in less regulated markets (Latin America; Africa; Asia; RoW) 

Darbepoietin biosimilars in less regulated markets 

Next generation biologic ESAs in less regulated markets 

2) G-CSF and GM-CSF 

 

2012 Sales of Branded G-CSF Products in Regulated Markets 

1st Generation Branded G-CSF Products in Regulated Markets 

Biosimilar 1st Generation G-CSF Products in Regulated Markets 

Next Generation Branded G-CSF Products in Regulated Markets 

Biosimilar Next Generation G-CSF Products in Regulated Markets 

1st Generation G-CSF Products in Non-Regulated Markets:  India 

1st Generation G-CSF Products in Non-Regulated Markets: China & Taiwan 

1st Generation G-CSF Products in Non-Regulated Markets – Korea 

1st Generation G-CSF Products in Non-Regulated Markets – Latin America 

1st Generation G-CSF Products in Non-Regulated Markets: Other Territories 

Next Generation G-CSF Products in Non-Regulated Markets 

1st and Next Generation GM-CSF Products in Regulated Markets 

1st and Next Generation GM-CSF Products in Non-Regulated Markets 

3 ) Thrombopoiesis-Stimulating Agents (TPO; IL-11) 

 

Thrombopoietin  receptor  (TPO-R) activators 

Interleukin-11 (IL-11) receptor activators 

Small molecule TPO-R Agonists 

Corporate TPO/IL-11 Receptor Agonist Product Portfolios and R&D Pipelines 

4 ) Interferon 

 

a)         INTERFERON alpha 

 

Interferon alpha sales 2012 of branded products in regulated markets 

1st generation Interferon alpha-2a in regulated markets 

1st generation Interferon alpha-2a in non-regulated markets 

Next generation Interferon alpha-2a in regulated markets 

Next generation Interferon alpha-2a in non-regulated markets and biosimilars 

1st generation Interferon alpha-2b in regulated markets 

1st generation Interferon alpha-2b in non-regulated markets and biosimilars 

Next generation Interferon alpha-2b in regulated markets 

Next generation Interferon alpha-2b in non-regulated markets and biosimilars 

Other Interferon alpha sub-types 

Interferon alpha with not specified sub-type – 1/2 

Purified natural human interferon alpha 

b)         Consensus INTERFERONs 

 

c)         INTERFERON beta 

 

Interferon beta sales 2012 of branded products in regulated markets 

1st generation Interferon beta-1a in regulated markets 

1st generation Interferon beta-1a in non-regulated markets and biosimilars 

1st generation Interferon beta-1b in regulated markets 

1st generation Interferon beta-1b in non-regulated markets and biosimilars 

1st generation Interferon beta with not disclosed sub-type 

Next generation Interferon beta in regulated markets 

Purified natural human interferon beta 

d)         INTERFERON gamma 

 

e)         Other INTERFERONs 

 

5 ) Insulin 

 

2012 Sales of branded recombinant human insulins in regulated markets 

2012 Sales of branded short-acting recombinant human insulin analogs in regulated markets 

2012 Sales of branded long-acting recombinant human insulin analogs in regulated markets 

Rhu insulin (2nd generation) in regulated markets 

Biosimilar rhu insulin (2nd generation) in regulated markets 

Rhu insulin analogs (3rd generation) in regulated markets 

Biosimilar rhu insulin analogs (3rd generation) in regulated markets 

Ultra-long acting rhu insulin formulations and insulin analogs (4th generation) 

Ultra-fast acting rhu insulin formulations and insulin analogs (4th generation) 

Combinations of modern basal and prandial insulin & analogs (4th generation) 

Combinations of insulin & GLP-1 agonist (4th generation) 

Other combinations with insulin  

Oral and Transbuccal Insulins (5th generation) 

Inhaled and transdermal insulin  

Novel approaches for insulin therapy   

Rhu insulin (2nd generation) in non-regulated markets: India 

Rhu insulin (2nd generation) in non-regulated markets: China 

Rhu insulin (2nd generation) in non-regulated markets: Other Territories   

Modern insulin analogs (3rd generation) in non-regulated markets       

6 ) Coagulation Factors 

 

Sales of Recombinant Coagulation Factors for Hemophilia in 2012 

Coagulation Factor VIII 

Coagulation Factor IX 

Coagulation Factor VII 

Coagulation Factors for Willebrand Disease 

Fibrinogen 

Factors XI, X and XIII 

Alternative Procoagulants & Adjuncts 

Human Plasma-Derived Prothrombin Complex Concentrates 

Gene Therapy of Hemophilia 

Topical Human Plasma-Derived Fibrinogen and Thrombin Products 

Topical Plasma-Derived Thrombin Products 

Topical Recombinant Human Factor II (Prothrombin) 

Alternative Topical Hemostats 

7 ) Human Growth Hormone (hGH) 

 

2012 Sales of Branded  Somatropin Products in Regulated Markets 

2012 Sales of Selected Somatropin Products in Non-Regulated Markets 

1st Generation:  Somatropin in Regulated Markets 

1st Generation:  Biosimilar Somatropin in Regulated Markets 

2nd Generation:  Injectable Somatropin in Slow-release Formulation in Regulated Markets 

2nd Generation:  Injectable Long-acting Somatropin in Regulated Markets 

2nd Generation:  Injection-Free Somatropin in Regulated Markets 

1st Generation:  Somatropin Products in Non-Regulated Markets 

2nd Generation:  Injectable Long-Acting Somatropin Products in Non-Regulated Markets 

8 ) FSH, hCG and LH - Assisted Reproductive Technology (ART) 

 

Urinary FSH-Containing Products: Menotropins 

Recombinant Menotropins 

1st Generation Purified Human Urinary FSH 

2nd Generation Recombinant Human FSH 

Biosimilar Recombinant Human FSH 

2nd Generation Rhu FSH in Non-Regulated Markets 

3rd Generation Rhu FSH 

Purified Urinary Human Choriogonadotropin (hCG) 

Recombinant Human Choriogonadotropin (rhCG) 

Recombinant Human Luteinizing Hormone (rhLH) 

hCG Receptor Agonist 

9 ) Thrombolytics & Fibrinolytics 

 

Non-fibrin selective (1st generation) Fibrinolytics 

Fibrin selective wild-type t-PA-based Fibrinolytics 

Fibrin selective engineered t-PA-based Fibrinolytics 

Non-t-PA-based Fibrinolytics 

Plasmin-based Fibrinolytics 

Adjunctive therapy to Fibrinolytics 

Biosimilar Thrombolytics and Fibrinolytics in Non-Regulated Markets 

10) Enzyme Replacement Therapies 

 

Gaucher Disease 

Fabry Disease 

Pompé Disease 

Hunter Disease (MPS II) 

Niemann Pick Diseases 

Mucopolysaccharidosis I (MPS I) 

San Filippo Syndrome (MPS IIIA) 

Morquio Syndrome (MPS IVA) 

Mucopolysaccharidosis VI (MPS VI) 

Tay-Sachs Disease 

Chronic Deficiency of Adenosine Deaminase 

Phenylketonuria / Hyperphenylalaninemia 

Other Enzyme Replacement Therapies 

Exocrine Pancreatic Insufficiency: Porcine-Derived ERT 

Exocrine Pancreatic Insufficiency: Recombinant ERT 

Others