Fabry Disease Market 2024: Industry Size, Company Share And Distribution Share Data And Analysis
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About
Fabry Disease Market
GlobalData estimates the 2014
sales for the Fabry disease market at approximately $682m across the
7MM. The US contributed the majority of these sales, generating an
estimated $295m. By the end of the forecast period in 2024, Fabry
disease sales are expected to grow to $1.25 billion at a Compound
Annual Growth Rate (CAGR) of 6.3% over the 10-year period. The
majority of sales in the 7MM in 2024 will come from the US, which
will represent 44.2% of the market. GlobalData expects an increase in
the number of newly diagnosed cases of Fabry disease, and
consequently in the number of treatable Fabry patients, as a result
of increasing awareness of Fabry disease among physicians. ERT is now
well established in the treatment of Fabry disease; however, there
still remains concern about its efficacy, tissue penetrance, and
intravenous administration. As a result, alternative approaches are
being investigated to advance new treatments for Fabry disease, which
focus on three main areas of research: chaperone therapies, substrate
reduction therapies (SRTs), and combinations of their use with ERT.
Highlights
Key Questions Answered
- At present, patient registries
demonstrate a long delay between onset of initial symptoms and a
diagnosis, which can span between 10 to 20 years. This is due the
condition being very rare, the lack of awareness of the disease among
physicians, and the diverse range of symptoms that a patient may have
when initially presenting with the disease. What are the main unmet
needs in this market? Will the drugs under development fulfil the
unmet needs in this market?
- Since the approval of Fabrazyme
and Replagal in the EU in 2001, no other drugs have been approved for
the treatment of Fabry disease. Will the pipeline drugs in
development change the treatment landscape for Fabry disease and
attain high sales revenues during 2014-2024?
- Key opinion leaders interviewed
by GlobalData believe the biggest opportunity lies with combination
therapies, to improve drug delivery and increase drugs efficacy,. How
will these changes impact the growth of the future market?
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Key Findings
- One of the main drivers for the
Fabry disease market growth will be an increase in the number of
newly diagnosed cases of Fabry disease, and consequently in the
number of treatable Fabry patients, as a result of increasing
awareness of Fabry disease among physicians.
- The first pharmacological
chaperone for the treatment of Fabry disease, Amicus Therapeutics
migalastat, will launch in the US and 5EU (France, Germany, Italy,
Spain, and UK) in 2017, followed by its launch in Japan in 2020.
Migalastat patient share is not only expected to be captured from
existing patients receiving enzyme replacement therapy (ERT), but
also treatment-nave patients who have not previously been considered
suitable for ERT.
- There is a lack of suitable
treatments available for young children with Fabry disease. ERT
requires intravenous infusions every two weeks; hence, until orally
available treatment options become available, such as Amicus
migalastat, it is expected that expansion of the Fabry disease market
to include younger children will not occur.
Scope
- Overview of Fabry disease,
including epidemiology, etiology, pathophysiology, symptoms,
diagnosis, and treatment guidelines.
- Annualized Fabry disease
therapeutics market revenue, annual cost of therapy and treatment
usage pattern data from from 2014 and forecast for ten years to 2024.
- Key topics covered include
strategic competitor assessment, market characterization, unmet
needs, clinical trial mapping and implications for the Fabry disease
therapeutics market.
- Pipeline analysis: comprehensive
data split across different phases, emerging novel trends under
development, and detailed analysis of late-stage pipeline drugs.
- Analysis of the current and
future market competition in the global Fabry disease therapeutics
market. Insightful review of the key industry drivers, restraints and
challenges. Each trend is independently researched to provide
qualitative analysis of its implications.
Reasons to buy
- Develop and design your
in-licensing and out-licensing strategies through a review of
pipeline products and technologies, and by identifying the companies
with the most robust pipeline. Additionally a list of acquisition
targets included in the pipeline product company list.
- Develop business strategies by
understanding the trends shaping and driving the Fabry disease
therapeutics market.
- Drive revenues by understanding
the key trends, innovative products and technologies, market
segments, and companies likely to impact the Fabry disease
therapeutics market in future.
- Formulate effective sales and
marketing strategies by understanding the competitive landscape and
by analysing the performance of various competitors.
- Identify emerging players with
potentially strong product portfolios and create effective
counter-strategies to gain a competitive advantage.
- Track drug sales in the 7MM
Fabry disease therapeutics market from 2014-2024.
- Organize your sales and
marketing efforts by identifying the market categories and segments
that present maximum opportunities for consolidations, investments
and strategic partnerships.
Table of Contents
1 Table of Contents 8
1.1 List of Tables 12
1.2 List of Figures 13
2 Introduction 14
2.1 Catalyst 14
2.2 Related Reports 14
3 Disease Overview 15
3.1 Etiology and Pathophysiology
15
3.1.1 Etiology 15
3.1.2 Pathophysiology 15
3.2 Symptoms 18
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4 Epidemiology 19
4.1 Disease Background 19
4.2 Risk Factors and
Comorbidities/Manifestations 20
4.3 Global Trends 20
4.3.1 US 20
4.3.2 5EU 20
4.3.3 Japan 21
4.4 Forecast Methodology 21
4.4.1 Sources Used 22
4.4.2 Sources Not Used 23
4.4.3 Forecast Assumptions and
Methods - Diagnosed Prevalent Cases 24
4.5 Epidemiological Forecast for
Fabry Disease (2014-2024) 26
4.5.1 Diagnosed Prevalent Cases of
Fabry Disease 26
4.5.2 Age-Specific Diagnosed
Prevalent Cases of Fabry Disease 27
4.5.3 Sex-Specific Diagnosed
Prevalent Cases of Fabry Disease 29
4.6 Discussion 31
4.6.1 Epidemiological Forecast
Insight 31
4.6.2 Limitations of the Analysis
32
4.6.3 Strengths of the Analysis 32
5 Current Treatment Options 34
5.1 Overview 34
5.2 Product Profiles 40
5.2.1 Fabrazyme (Agalsidase Beta)
40
5.2.2 Replagal (Agalsidase Alfa)
50
6 Unmet Needs Assessment and
Opportunity Analysis 57
6.1 Overview 57
6.2 Earlier Fabry Disease
Diagnosis 57
6.2.1 Unmet Need 57
6.2.2 Gap Analysis 59
6.2.3 Opportunity 61
6.3 Fabry Disease Treatments with
Improved Efficacy 62
6.3.1 Unmet Need 62
6.3.2 Gap Analysis 64
6.3.3 Opportunity 65
6.4 Lower Cost of Fabry Treatments
66
6.4.1 Unmet Need 66
6.4.2 Gap Analysis 67
6.4.3 Opportunity 69
6.5 Widespread Availability of
Home-Based Infusion to Improve Compliance 69
6.5.1 Unmet Need 69
6.5.2 Gap Analysis 70
6.5.3 Opportunity 72
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