Coagulation Factors 2011 – Who Does Meet the Market Needs? A Pipeline Assessment, Market Survey and Corporate Benchmark Analysis

Date: October 22, 2011
Pages: 162
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US$ 3,258.00
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Publisher: La Merie Publishing
Report type: Strategic Report
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ID: C1CA5412630EN
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Coagulation Factors 2011 – Who Does Meet the Market Needs? A Pipeline Assessment, Market Survey and Corporate Benchmark Analysis
Product description

The report “Coagulation Factors 2011 – who does meet the market needs?

A Pipeline Assessment, Market Survey and Corporate Benchmark Analysis” provides a description, evaluation and assessment of the recombinant coagulation factor R&D pipelines as of October 2011. The authors analyze and assess the target pipeline for each of the coagulation factors for haemophilia and work out the target profiles of development projects. A market research study was conducted to challenge industry’s target profiles and evaluate the sensitivity for pricing.

The report is built upon primary and secondary search for information and use of a proprietary database and news portal. A market survey was conducted among haematologists from haemophilia care centers. In house analysts with experience in biopharmaceutical R&D and business development authored the report and analysed and assessed the findings.

Global sales of the five major recombinant products of coagulation factors VIII, IX and VIIa in 2010 were US$ 6.2 bln (with $ conversion rate October 19, 2010). The first Marketing Authorization Application for a novel recombinant coagulation factor has been submitted in the European Union and further novel wild-type and long-acting recombinant coagulation factors VIII, IX and VII are in advanced clinical stages with potential regulatory approvals within the next 2 to 4 years. Given the progress of the pipeline, a concentration process of players has started. First clinical data are available and will guide further definition of R&D in this field.

Scope of the report
  • R&D pipeline overview;
  • profiles of most promising coagulation factors in the pipeline
  • pipeline analysis for each coagulation factor
  • evaluation and assessment of protein engineering and drug delivery technologies
  • overview and analysis of marketed coagulation factors;
  • market research study with haematologists from haemophilia care centers
  • corporate product portfolios and R&D pipelines;
  • benchmark of competitors regarding achievement of product target profiles
Benefits from the report
  • Understand your position in a highly competitive environment
  • Learn what haematologists think about your product target profiles
  • Understand the market needs
  • Know pricing sensitivities for your haemophilia products
  • Learn from your competitors
  • Challenge your strategy with a view from outside the organization

ABBREVIATIONS

1 EXECUTIVE SUMMARY

2 OVERVIEW

3 COAGULATION FACTOR MARKETS

3.1 Recombinant Factor VIIIa Market
3.2 Recombinant Factor IXa Market
3.3 Recombinant Factor VIIa Market
3.4 Total Market Size of Recombinant Coagulation Factors for Hemophilia
3.5 Recombinant Thrombin Market
3.6 Total Market Sizes and Market Shares of Rec. Coagulation Factors
3.7 Plasma-Derived Coagulation Factors

4 PIPELINE CHANGES SINCE SEPTEMBER 2010

4.1 Alnylam Pharmaceuticals
4.2 Amsterdam Molecular Therapeutics
4.3 Baxter
4.4. Bayer Healthcare Pharmaceuticals
4.5 Biogen Idec
4.6 Catalyst Biosciences
4.7 CSL
4.8 Green Cross
4.9 Grifols (Talecris Biotherapeutics)
4.10 Ipsen & Inspiration Biopharmaceuticals
4.11 LFB (GTC Biotherapeutics)
4.12 Novo Nordisk
4.13 Octapharma
4.15 Pharmstandard
4.16 Pfizer (Wyeth)
4.17 ProFibrix
4.18 Prolor Biotech
4.19 PTC Therapeutics
4.20 ReGenRx Biosciences

5 TARGET PIPELINE ANALYSIS

5.1 Factor VIII
5.2 Factor IX
5.3 Factor VII
5.4 Alternative Procoagulants & Adjuncts
5.5 Factor XIII
5.6 von Willebrand Factor (vWF)
5.7 Fibrinogen & Thrombin

6 MARKET RESEARCH: SURVEY ON NOVEL COAGULATION FACTORS

6.1 Methodology
6.2 Results: Profile of Participant, Center and Usage of Factors
6.3 Results:Valuation of Characteristics of New Hemophilia Products
6.4 Results: Decisive Characterstics to Switch to New Hemophilia Products
6.5 Results: Price Sensitivity of Characteristics of New Products
6.6 Results: Factors Influencing Decision to Switch to New Products
6.7 Results: Role of Plasma-Derived Coagulation Factors
6.8 Assessment of Survey Results

7 CORPORATE BENCHMARK ANALYSIS

7.1 Time to Market
7.2 Immunogenicity
7.3 Administration Frequency
7.4 Pricing: Me Toos and Biosimilars
7.5 Non-Intravenous Administration
7.6 Safety Features of Drug Substance and Drug Product
7.7 Novel Procoagulants and Adjuvants

8 REFERENCES

9 TABLES IN THE TEXT

Table 1 Sales of Advate/Recombinate
Table 2 Sales of Kogenate (FS)
Table 3 Sales of Helixate
Table 4 Sales of Refacto (AF) / Xyntha
Table 5 2010 Sales of Recombinant Factor VIIIa Products
Table 6 Growth of the Recombinant Factor VIIIa Market
Table 7 Sales of BeneFIX
Table 8 Sales of NovoSeven
Table 9 Total Market Size of Rec Coagulation Factors in Hemophilia
Table 10 CAGR of the Rec Coagulation Factor Market in Hemophilia
Table 11 Sales of Recothrom
Table 12 Market Shares of Individual Rec Coagulation Factors
Table 13 Sales of Thrombin-JMI Product Family
Table 14 Sales of Koate DVI
Table 15 Sales of Grifols’ pdFVIII Products
Table 16 2010 Sales of Selected Systemic pd Coagulation Factors
Table 17 2010 Sales of Selected Topical pd Coagulation Factors
Table 18 Baxter’s Coagulation Factors Pipeline
Table 19 BAX 326: Clinical Studies
Table 20 BAX 111: Clinical Studies
Table 21 Baxter’s Strategic Goals in Hemophilia
Table 22 Bayer’s Coagulation Factors Pipeline
Table 23 BAY 81-8973: Clinical Studies
Table 24 Bayer’s Strategic Goals in Hemophilia
Table 25 Biogen Idec’s Coagulation Factor Pipeline
Table 26 rFIXFc Clinical Studies
Table 27 rFVIIFc Clinical Studies
Table 28 Biogen Idec’s Strategic Goals in Hemophilia
Table 29 Catalyst Biosciences’ Coagulation Factor Pipeline
Table 30 Catalyst Biosciences Strategic Goals in Hemophilia
Table 31 CSL’s Recombinant Coagulation Factor Pipeline
Table 32 CSL’s Strategic Goals in Hemophilia
Table 33 Green Cross’ Pipeline of Coagulation Factors in Hemophilia
Table 34 Green Cross’s Strategic Goals in Hemophilia
Table 35 Grifols’ Pipeline of Rec. Coagulation Factors in Hemophilia
Table 36 Grifols’ Strategic Goals in Hemophilia
Table 37 Ipsen and Inspiration’s Coagulation Factor Pipeline
Table 38 Ipsen and Inspiration’s Strategic Goals in Hemophilia
Table 39 LFB’s Pipeline of Recombinant Coagulation Factors
Table 40 Novo Nordisk’s Pipeline of Coagulation Factors
Table 41 Turoctocog alfa: Clinical Studies
Table 42 NN7128: Clinical Studies
Table 43 Novo Nordisk’s Strategic Goals in Hemophilia
Table 44 Octapharma’s Recombinant Coagulation Factor Pipeline
Table 45 Human-cl rFVIII: Clinical Studies
Table 46 Octapharma’s Strategic Goals in Hemophilia
Table 47 Pharmstandard’s Coagulation Factor Pipeline
Table 48 Pfizer’s Coagulation Factor Pipeline
Table 49 Pfizer’s Strategic Goals in Hemophilia
Table 50 ProFibrix’ Pipeline of Coagulation Factors
Table 51 ProFibrix’ Strategic Goals with Coagulation Factors.
Table 52 PROLOR Biotech’s Coagulation Factor Pipeline
Table 53 Product Characteristics of improved rhu F. VIII products
Table 54 Overview of rFVIII Pipeline
Table 55 Features of Novel Wild-Type rFVIII Molecules in R&D
Table 56 Pharmacokinetics of Long-Acting rFVIII Molecules
Table 57 Features of Novel Long-Acting rFVIII Molecules in R&D
Table 58 Overview of rFIX Pipeline
Table 59 Pharmacokinetics of Long-Acting rFIX Molecules
Table 60 Features of Novel Long-Acting rFIX Molecules in R&D
Table 61 Overview of rFVII Pipeline
Table 62 Features of Novel WT or Short-Acting rFVII Molecules
Table 63 Pharmacokinetics of Long-Acting rFVII Molecules
Table 64 Features of Novel Long-Acting rFVII Molecules in R&D
Table 65 Rating of characteristics of future hemophilia producs
Table 66 Summary of Ranking of Product Characteristics
Table 67 Benchmarking for Novel F.VIII Molecules
Table 68 Benchmarking for Novel F. IX Molecules
Table 69 Benchmarking for Novel F. VII Molecules
Table 70 Benchmarking for Novel Procoagulants & Adjuvants
Table 71 Potential First Approvals in EU or USA

10 FIGURES IN THE TEXT

Figure 1 Territory of residency of participants
Figure 2 Number of hemophilia patients in centers of participants
Figure 3 Qualification, function & responsibility of participants
Figure 4 Usage of rec and pd coagulation factors in centers
Figure 5 Valuation of characteristics of future hemophilia producs
Figure 6 Prioritization of characteristics of future hemophilia products
Figure 7 Single characteristics making to switch to new product
Figure 8 Combination of characteristics inducing a switch decision
Figure 9 Sensitivity for pricing of new products – single characteristic
Figure 10 Influence of territory on sensitivity for pricing
Figure 11 Sensitivity for pricing of new products – combined features
Figure 12 Sensitivity for pricing of a “Me Too” / “Biosimilar” product
Figure 13 Attributes for selection of new hemophilia products
Figure 14 Requested data for claim of “less inhibitor formation”
Figure 15 Impact of Aledort meta-analysis on prescribing praxis
Figure 16 Impact of Aledort meta-analysis on long-acting BDD FVIII
Figure 17 Critical half-life value for long-acting Factor VIII
Figure 18 Acceptance of porcine factor VIII
Figure 19 Prescribing frequency of plasma-derived coagulation factors
Figure 20 Reasons to prescribe plasma-derived coagulation factors

11 DRUG CODES DESCRIBED IN THE TEXT

ALN-APC
BAX 111
BAX 326
BAX 499
BAX 513
BAX 817
BAX 855
BAY 81-8973
BAY 86-6150
BAY 94-9027
BIIB029
Coagil VII
CSL627
CSL654
CSL689
GreenGene F
Hemodure Biopump
IB1001
JBT8157
MOD-3012
MOD-5023
NN1731
NN1810
NN1841
NN7008
NN7088
NN7128
NN7129
NN7451
NN7999
OBI-1
PF-05280602
PTC124
scAAV2/8-LP1-hFIXco
Tachosil

12 ADDENDUM

A) Tabulated R&D Pipelines of Coagulation Factors
  Tab I: Rec Factor VIII with Normal Half-Life
  Tab II: Rec Factor VIII with Prolonged Half-Life
  Tab III: Gene Therapy for Hemophilia A
  Tab IV: Rec Factor IX with Normal Half-Life
  Tab V: Rec Factor IX with Prolonged Half-Life
  Tab VI: Gene Therapy for Hemophilia B
  Tab VII: Rec Factor VII with Short or Normal Half-Life
  Tab VIII: Rec Factor VII with Prolonged Half-Life
  Tab IX: Alternative Pro-Coagulants for Hemophilia A and B
  Tab X: Rec Factor XIII
  Tab XI: Rec Von Willebrand Factor
  Tab XII: Rec Fibrinogen
  Tab XIII: Rec Thrombin
B) Online Survey on Coagulation Factors 2011
  Tab XIV: List of Hemophilia Centers/Institutions Contacted in the Survey
  Tab XV: Content Online Survey Before Activation
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Coagulation Factors 2011 – Who Does Meet the Market Needs? A Pipeline Assessment, Market Survey and Corporate Benchmark Analysis
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