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Refractory Angina (RA)
Market Insights, Epidemiology, and Market
Forecast— 2030
2020
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Healthcare
Market
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Key Insights
The Report contains:
`
Insightful Reviews
on Market Drivers &
Market Barriers
Strategic analysis of
Treatment options &
Emerging Therapies
Research
Analysis
Pipeline
Valuation
Market
Analysis
Epidemiology
Forecast
Market size by
therapies
Pipeline analysis across different
stages of development (Phase III and
Phase II), different emerging trends
and comparative analysis of pipeline
products with detailed clinical
profiles, key cross-competition,
launch date along with product
development activities
Detailed historical and forecasted
market covering the United
States, EU5 and Japan countries
from 2017 to 2030
Overview of pathophysiology,
various diagnostic approaches and
treatment algorithm including
detailed chapters for marketed
products and emerging therapies
Historical as well as forecasted
epidemiology in the 7MM covering
the United States, EU5 (Germany,
France, Italy, Spain, and the United
Kingdom) and Japan from 2017 to
2030
Detailed Market size by therapies, covering the
United States, EU5 (Germany, France, Italy, Spain,
and the United Kingdom), and Japan from 2017 to
2030
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The report provides an understanding of the
epidemiology and changing market dynamics of
Refractory Angina (RA) in the seven major
pharmaceutical markets for the period 2017–2030
Report Introduction
DelveInsight’s “Refractory Angina (RA)-
Market Insights, Epidemiology and
Market Forecast—2030” report
provides an overview of the disease
and market size of RA for the seven
major pharmaceutical markets, i.e.,
the United States, EU5 (Germany,
France, Italy, Spain, and the United
Kingdom), and Japan. This report
covers the various treatment practices,
and RA forecasted epidemiology from
2020 to 2030, segmented by the seven
major markets.
Key Strengths
❖ 11-Year Forecast
❖ 7MM Coverage
❖ Epidemiology Segmentation
❖ Drugs Uptake
❖ Highly Analyzed Market
❖ Key Cross Competition
❖ Market Size by Country
❖ Market Size by Therapy
Key Assessments
❖ Current Treatment Practices
❖ Unmet Needs
❖ Emerging Drug Profiles
❖ Market Attractiveness
❖ Market Drivers and Barriers
✓ The report covers the descriptive overview of Refractory Angina (RA),
explaining its causes and risk factors, pathophysiology, diagnosis and
currently available therapies.
✓ Comprehensive insight has been provided into the epidemiology of
the Refractory Angina (RA) and its treatment in the 7MM.
✓ Additionally, an all-inclusive account of both the current and
emerging therapies for Refractory Angina (RA) is provided, along with
the assessment of new therapies, which will have an impact on the
current treatment landscape.
✓ A detailed review of historical and forecasted Refractory Angina (RA)
market is included in the report, covering drug outreach in the 7MM.
✓ The report provides an edge while developing business strategies, by
understanding trends shaping and driving the global Refractory
Angina (RA) market.
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Epidemiology Insights
• As per Delveinsight’s estimates, the total prevalent cases of Refractory Angina in 7 major markets ranges
from 29,17,196 in 2017.
• According to the Delveinsight’s analysts, the United States accounted for most prevalent cases of RA in
7MM with 19,05,602 cases in 2017.
• Among EU5 countries, Germany accounted for most number of prevalent cases of RA with 5,13,896 cases
in 2017.
• Japan accounted for 27,432 cases in 2017 which are expected to grow during the study period (2017–
2030).
Refractory Angina—Epidemiology by Gender
Refractory Angina (RA) is a chronic condition where pain remain persistent for the duration of less than or equal
to 3 months, characterized by angina. Angina is a type of chest pain caused by reduced blood flow to the heart.
Angina has two types, chronic or stable angina and unstable angina. Around 10–15% of patients of Chronic Angina
meet the measures of RA. The clinical load of RA is growing rapidly due to an ageing population and improved
Coronary Artery Disease (CAD).
Symptoms of RA are chest pain, shortness of breath, and easy fatigability. RA also shows neurological,
psychogenic and mitochondrial dysfunctions in addition to tissue ischemia which are responsible for an insistent
cardiac pain. These symptoms causes poor self-perceived health status, high incidence of depression, and burden
to the health care system due to significant resource utilization.
Patients with RA are a heterogeneous group that remain significantly limited by persistent debilitating chest
discomfort despite optimal conventional therapy.
.
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Diagnosed Population of NORDA in the 7MM (2017–2030)
Epidemiology Parameters- 7MM
1
Total Diagnosed Population of Coronary Artery Disease
and Refractory Angina in the 7MM (2017–2030)
Age Specific Prevalent Cases of RS
Gender-specific Prevalent Population of Refractory Angina in the 7MM
(2017–2030)
2
Sub-type Specific Prevalence of Refractory Angina in the7MM
(2017–2030)
3
• RA is classified on the basis of grading
the pain. Among these sub-types, Class
III contributes the major patient share
of RA followed by Class IV angina.
• Higher Prevalence of Refractory
Angina is observed among males as
compared to females in 7MM.
4
Market Share 2017 [Indicative]
United States EU-5 Japan
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Graphical Representation of Refractory Angina (RA)—Epidemiology
Total Prevalent Cases of RA in the 7MM (2017–2030)
Total Gender-specific Prevalent Cases of RA in the United States (2017–2030)
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
PopulationinNumber(N)
Year
7MM Total Prevalent Patient Population of Refractory Angina
United States Germany France Italy Spain United Kingdom Japan
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
PopulationinNumber(N)
Year
Gender Specific prevalence of RA
Male Female
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Market Outlook for RA
Refractory Angina (RA) is a chronic disease characterized by the presence of persistent angina and patients
with RA defined as being ‘no option’ since they are not considered amenable for conventional
revascularization treatment for reasons related to diffuse coronary lesions, unsuitability to chronic total
occlusion mechanical revascularization, or frailty from the presence of severe comorbidities.
In spite of continuous developments in Coronary Artery Disease (CAD) management, particularly in the
aged population, the number of patients suffering from RA is correlated to the healthcare expenses.
Currently, there are several methods to treat this disease, which involves pharmacological treatments
approaches, coronary sinus reducer, etc. Several non-invasive methods are also available to treat this
disease, like External Enhanced Counter Pulsation (EECP), extracorporeal shockwave therapy (ESWT),
neuromodulation, etc. Pragmatic rehabilitation is also an important approach to promote patients to
manage their own chest pain.
There is no significant pharmacologic approved therapy to improve quality of life in patients of RA, but a
significant amount of evidence exists in the literature that supports the use of pharmacologic treatment in
the stable Angina. Beta-blockers and Calcium Channel Antagonists like Nicorandil (K-ATP - channel opener),
Market Size of RA in the 7MM is
expected to grow during the study
period (2017–2030)
The lack of approved therapies, specifically
for the treatment of RA remains the primary
unmet need of the disease
Owing to the launch of upcoming
therapies, the market size shall
increase significantly during forecast
period (2020–2030)
Several pharmacological, noninvasive, and invasive therapeutic
techniques are under investigation, with the aim of improving
care for this challenging indication.
Safety and tolerability of current anti-
anginal agents is not good, so the
primary focus is on improving quality
of life for patients with refractory
angina
Market Insight
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Ivabradine (If current inhibitor), Trimetazidine (Reversible 3-ketoacyl-thiolase inhibitor), Ranolazine,
Fasudil/hydroxyfasudil (Rho-kinase inhibitor) are few mainstay medical treatment for angina. Furthermore,
the European Society of Cardiology guidelines now consider ivabradine, nicorandil, or ranolazine with long-
acting nitrates as a second-line therapy for patients with persistent angina, according to heart rate, blood
pressure, and tolerance.
Ivabradine helps to reduce the number of angina attacks in patients with chronic stable angina by blocking
If channels, which regulate the intrinsic chronotropic characteristics of the sinoatrial node. It may be useful
in patients with refractory angina who do not tolerate high doses of β-blockers, or when calcium-channel
blockers are contraindicated. Nicorandil is a nicotinamide ester which contains nitrate like moiety, which
helps in vasodilation of coronary arteries and also promotes the opening of the mitochondrial ATP-sensitive
potassium channels (KATP), known to mimic ischemic preconditioning. This drug has shown
cardioprotective effect among patients of Chronic Stable Angina.
Additionally, Trimetazidine is a metabolic agent that increases glucose oxidation by blocking the
mitochondrial long-chain 3-ketoacylCoA thiolase. This is an important enzyme for the β-oxidation of fatty
acids. Trimetazidine might enhance the energy efficiency of ischemic myocytes by inhibiting the βoxidation
of fatty acid. This drug is also recommended as a second-line therapy, but its use is less well established.
Another therapy, Ranolazine, affects ion channels in cardiomyocytes via inhibition of late sodium currents.
The mechanism of action of ranolazine is debated but it is believed to partially inhibit the fatty acid
oxidation. Ranolazine has never been tested in a specific trial of patients with refractory angina but safety
is well established for RA patients as well as Acute Coronary Syndrome. The US guidelines consider
ranolazine useful only when prescribed as a substitute for β-blockers for relief of symptoms in patients
where the initial treatment with β-blockers was ineffective.
Fasudil and hydroxyfasudil is a Rho kinase inhibitor, which reduces calcium sensitization of vascular smooth
muscle to maintain coronary vasodilatation and prevent vasospasm. Fasudil and hydoexyfasudil currently
available in Japan for the prevention of central nervous system vasospasm associated with subarachnoid
hemorrhage. Potentially useful for vasospastic angina.
Talking about the noninvasive therapies, these are also recommended for the treatment of RA. Enhanced
external counter pulsation (EECP), has been approved by the United States Food and Drug Administration
(FDA) for the management of refractory angina (Class IIb). EECP involves attachment of three sets of
pneumatic cuffs around patient’s legs at the calf and lower and upper thigh, which inflate during diastole to
augment coronary blood flow and deflate in systole to decrease afterload and increase venous return. The
inflation of the cuffs produces a retrograde flow of blood in the aorta which helps in diastolic augmentation
of blood flow. This also increases the relapse of which leads to an improved coronary perfusion pressure
during diastole. EECP session involves 35 one hour session. In the year 2000, EECP has been proven to be
a safe therapy by the International EECP Patient Registry (IEPR).
Extracorporeal shockwave therapy (ESWT) is used to deliver high-amplitude acoustic pressure pulses to
apply focal mechanical stress. In response to this acoustic field, naturally occurring microbubbles inside and
outside of cells oscillate and collapse. These waves also promote in situ expression of chemo-attractants
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(stromal cell-derived factor 1, Vascular Endothelial Growth Factor (VEGF), and nitric oxide). ESWT is a
noninvasive modality that seems to be safe and warrants further study to determine the optimal dose and
protocol as well as its efficacy in patients with refractory angina.
In Neuromodulation pain, signal is interrupted via chemically, mechanically, or electrically in the
transmission pathway from the periphery to the brain. Spinal-cord modulation, subcutaneous electrical
nerve stimulation, cardiac sympathectomy, and transmyocardial laser revascularization are the type of
neuromodulatory methods useful for the patients with cardiac pain.
Moreover, Cardiac cell-based therapy has emerged as a novel therapeutic option for patients dealing with
untreatable RA. According to some experimental studies, cell therapy can improve myocardial perfusion
and contractile function. Cell therapy also promotes neovascularization.
A number of drugs and therapies are suggested as first and the second line of treatment, however, not all
of the above-mentioned treatments were formally suggested for RA. Development of RA-specific clinical
guidelines is needed. Current medical therapy has several shortcomings which include lack of proof of a
direct impact of anti-ischemic therapy on clinical outcomes in the context of RA. Recent efforts have been
directed toward the discovery of novel therapies. The market is expected to experience growth in the
coming years as there are few drugs lined up and are expected to launch during the forecast period [2020–
2030].
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Graphical Representation of Refractory Angina (RA)–Market Size
Total Market Size of RA in the 7MM (2017–2030)
Market Size of RA in the United States (2017–2030)
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
MarketSizeinUSD,Million
Year
Total Market Size of RA in 7MM
United States Germany France Italy Spain United Kingdom Japan
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
SalesInUSD,Million
Year
Total Market of RA
US
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Emerging Therapy Analysis
The dynamics of Refractory Angina market is anticipated to change in the coming years owing to the
expected launch of emerging therapies during the forecast period of 2020–2030, as there is no
pharmacologic treatment available to treat RA patients specifically. Several companies across the globe are
thoroughly working toward the development of new treatment and devices which are expected to change
the current market scenario for RA.
Several emerging pharmacotherapies for RA in different stages of clinical development are Ad5FGF-4
(Angionetics/Huapont Life Sciences), CLBS14 (Caladrius Biosciences), and several others.
Ad5FGF-4 (Angionetics/Huapont Life Sciences) is angiogenic gene therapy cardiac biologic product. It is a
precision medicine, recombinant angiogenic gene therapy product designed to stimulate the formation of
functional coronary collateral vessels in patients with refractory angina due to myocardial ischemia,
resulting in increased myocardial perfusion and improved patient outcomes. This product utilizes a
serotype 5 adenovirus (Ad5) to deliver the FGF-4 transgene into heart cells.
The US FDA has granted fast track designation to this product for the Phase III clinical investigation as a
one-time treatment for improving exercise tolerance in patients who have angina that is refractory to
standard medical therapy, and not amenable to conventional revascularization procedures.
Another drug, CLBS14 by Caladrius Biosciences, is also in development for the treatment of no-option
refractory disabling angina (NORDA). Based on the clinical evidence from the completed studies that a
single administration of CLBS14 reduces mortality, improves angina, and increases exercise capacity in
patients with otherwise untreatable angina, this product received regenerative medicine advanced therapy
designation (RMAT) designation from the US FDA. Furthermore, the company is working closely with the
US FDA, and have finalized the design of a confirmatory Phase III trial which, in combination with previously
filed Phase I, II and III data, will be considered for the registration of CLBS14.
In August 2019, Caladrius Biosciences and Cognate BioServices entered into a manufacturing agreement
for the production of CLBS14. Under the terms of the agreement, Cognate manufacture CLBS14 for
Caladrius’ Phase III confirmatory pivotal clinical trial in subjects with NORDA. Under this agreement, the
company has acquired the rights to data and regulatory filings for a CD34+ cell therapy program for RA that
had been advanced to Phase III by a previous sponsor.
In addition to aforementioned therapies in development, other therapies like IMB-101 (Imbria
Pharmaceuticals), XC001 (XyloCor Therapeutics) and others are in the initial stages of development. While,
some of these companies have recently shifted their focus toward this therapeutic area, yet others have
completed the late stage of development. As few drugs are currently in the pipeline and in their late
development stages, the market will surely experience growth in the upcoming years.
Drug Uptake
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Market Size of Refractory Angina (RA) by Therapies in the United States (2017–2030)
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030
SalesinUSD,Million
Year
US Drug-level Revenue ($M)
Beta-blockers Calcium antagonists
Short or Long acting nitrates Lipid-lowering agents
ACE inhibitors Ivabradine
Ranolazine Nicorandil
Trimetazidine IMB-1018972
CLBS-14 (Auto-CD34+ cells) Generx/ Alferminogene tadenovec (Ad5FGF-4)
AdVEGFXC1 (XC001)
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Conjoint Analysis
Scores 50% 20% 30%
Weighted
ScoreParameters Efficacy
Safety RoA and
Treatment
Drug A 3 XX 4 XX
Drug B 5 XX 5 XX
Drug C 7 XX 3 XX
Drug D XX XX XX XX
KOL Views
The predominant treatment for
patients suffering from RA is
XXXX therapy
Even though management of
patients happen by off-label
therapies, novel drug development
is an ongoing opportunity for
patients of this disease group.
XXXX therapy has provided much-
needed relief to the management of
patients, but many prescribers and
patients are awaiting the approval
of upcoming therapies
KOL A, USA
KOL C, Germany
KOL B, Japan
Legend SafetyEfficacy RoA and Treatment
High
Medium
Low
High
Medium
Low
High
Medium
Low
The objective of updating DelveInsight coverage is to ensure that it represents the most up-to-date vision of the
industry possible. The DelveInsight is a fully integrated solution for comprehensive intelligence on various
pharmaceutical products, both in the market and in the pipeline, across the globe.
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Table of Content to View
1:Key Insights
2:Executive Summary of Refractory Angina
3:SWOT Analysis for Refractory Angina
4:Refractory Angina (RA) Market Overview at a Glance
4.1:Market Share (%) Distribution of Refractory Angina (RA) in 2017
4.2:Market Share (%) Distribution of Refractory Angina (RA) in 2030
5:Disease Background and Overview
5.1:Introduction
5.2:Types
5.3:Symptoms
5.4:Etiology
5.5:Risk Factors
5.6:Pathophysiology
5.7:Diagnosis
6:Epidemiology and Patient Population
6.1:Key Findings
6.2:7MM Total Prevalent Patient Population of Refractory Angina [RA]
7:Epidemiology Assumptions and Rationale - 7MM
8:Country Wise-Epidemiology of Refractory Angina (RA)
8.1:The United States
8.1.1:Total Diagnosed Population of CAD and RA in the United States
8.1.2:Sub-type Specific Prevalence of RA in the United States
8.1.3:Gender specific Prevalence of RA in the United States
8.1.4:Diagnosed Population of NORDA in the US
8.2:Germany
8.2.1:Total Diagnosed Population of CAD and RA in Germany
8.2.2:Sub-type Specific Prevalence of RA in Germany
8.2.3:Gender specific Prevalence of RA in Germany
8.2.4:Diagnosed Population of NORDA in Germany
8.3:France
8.3.1:Total Diagnosed Population of CAD and RA in France
8.3.2:Sub-type Specific Prevalence of RA in France
8.3.3:Gender specific Prevalence of RA in France
8.3.4:Diagnosed Population of NORDA in France
8.4:Italy
8.4.1:Total Diagnosed Population of CAD and RA in Italy
8.4.2:Sub-type Specific Prevalence of RA in Italy
8.4.3:Gender specific Prevalence of RA in Italy
8.4.4:Diagnosed Population of NORDA in Italy
8.5:Spain
8.5.1:Total Diagnosed Population of CAD and RA in Spain
8.5.2:Sub-type Specific Prevalence of RA in Spain
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8.5.3:Gender specific Prevalence of RA in Spain
8.5.4:Diagnosed Population of NORDA in Spain
8.6:The United Kingdom
8.6.1:Total Diagnosed Population of CAD and RA in the UK
8.6.2:Sub-type Specific Prevalence of RA in the UK
8.6.3:Gender specific Prevalence of RA in the United Kingdom
8.6.4:Diagnosed Population of NORDA in the United Kingdom
8.7:Japan
8.7.1:Total Diagnosed Population of CAD and RA in Japan
8.7.2:Sub-type Specific Prevalence of RA in Japan
8.7.3:Gender specific Prevalence of RA in Japan
8.7.4:Diagnosed Population of NORDA in Japan
9:Treatment
9.1:Pharmacological Therapies
9.2:Noninvasive Antianginal therapies
9.3:Invasive Antianginal therapies
9.4:Treatment Guidelines
9.4.1:European Society of Cardiology (ESC) Guidelines for Refractory Angina Patients
9.4.2:National Institute for Health and Clinical Excellence (NICE) guidelines: Chest pain of recent onset
9.4.3:Canadian Cardiovascular Society (CCS) Guidelines
10:Unmet Needs
11:Case Studies
11.1:A Case of Refractory Angina
11.2:A Case Report of Refractory Angina
12:Organizations related with Refractory Angina
13:Emerging Therapies
13.1:IMB-101: Imbria Pharmaceuticals
13.1.1:Other Developmental Activities
13.1.2:Clinical Development
13.1.3:Safety and Efficacy
13.2:Auto CD34+ Cells: Caladrius Biosciences, Inc.
13.2.1:Other Developmental Activities
13.2.2:Clinical Development
13.2.3:Safety and Efficacy
13.3:Generx: Angionetics Inc.
13.3.1:Other Developmental Activities
13.3.2:Clinical Development
13.3.3:Safety and Efficacy
13.4:XC001: XyloCor Therapeutics, Inc.
13.4.1:Other Developmental Activities
13.4.2:Clinical Development
14:Refractory Angina (RA): 7 Major Market Analysis
14.1:Key Findings
14.2:Total Market Size of RA in 7MM
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14.3:Market Outlook: 7MM
15:United States
15.1:Total Market size of RA
15.2:RA Market Size by Therapies
16:EU5 Countries
16.1:Germany
16.1.1:Total Market size of RA
16.1.2:RA Market Size by Therapies
16.2:France
16.2.1:Total Market size of RA
16.2.2:RA Market Size by Therapies
16.3:Italy
16.3.1:Total Market size of RA
16.3.2:RA Market Size by Therapies
16.4:Spain
16.4.1:Total Market size of RA
16.4.2:RA Market Size by Therapies
16.5:United Kingdom
16.5.1:Total Market size of RA
16.5.2:RA Market Size by Therapies
17:Japan
17.1:Total Market size of RA
17.2:RA Market Size by Therapies
18:Market Drivers
19:Market Barriers
20:Appendix
20.1:Bibliography
20.2:Report Methodology
21:DelveInsight Capabilities
22:Disclaimer
23:About DelveInsight
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*The table of contents is not exhaustive; will be provided in the final report
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List of Tables
Table 1: Summary of Refractory Angina (RA) Market, Epidemiology, and Key Events (2017–2030) 4
Table 2: Difference between Stable and Unstable Angina 18
Table 3: Probability of Coronary Artery Diseases and Associated Diagnostic Strategies 23
Table 4: Total Prevalent Patient Population of RA in 7MM (2017–2030) 28
Table 5: Diagnosed Population of CAD and RA in the United States (2017–2030) 32
Table 6: Sub-type Specific Prevalence of RA in the United States (2017–2030) 33
Table 7: Gender specific Prevalence of RA in the United States (2017–2030) 34
Table 8: Diagnosed Population of NORDA in the US (2017–2030) 35
Table 9: Total Prevalent Population of RA in Germany (2017–2030) 36
Table 10: Sub-type Specific Prevalence of RA in Germany (2017–2030) 37
Table 11: Gender specific Prevalence of RA in Germany (2017–2030) 38
Table 12: Diagnosed Population of NORDA in Germany (2017–2030) 39
Table 13: Diagnosed Population of CAD and RA in France (2017–2030) 40
Table 14: Sub-type Specific Prevalence of RA in France (2017–2030) 41
Table 15: Gender specific Prevalence of RA in France (2017–2030) 42
Table 16: Diagnosed Population of NORDA in France (2017–2030) 43
Table 17: Diagnosed Population of CAD and RA in Italy (2017–2030) 44
Table 18: Sub-type Specific Prevalence of RA in Italy (2017–2030) 45
Table 19: Gender specific Prevalence of RA in Italy (2017–2030) 46
Table 20: Diagnosed Population of NORDA in Italy (2017–2030) 47
Table 21: Diagnosed Population of CAD and RA in Spain (2017–2030) 48
Table 22: Sub-type Specific Prevalence of RA in Italy (2017–2030) 49
Table 23: Gender specific Prevalence of RA in Spain (2017–2030) 50
Table 24: Diagnosed Population of NORDA in Spain (2017–2030) 51
Table 25: Diagnosed Population of CAD and RA in the UK (2017–2030) 52
Table 26: Sub-type Specific Prevalence of RA in the UK (2017–2030) 53
Table 27: Gender specific Prevalence of RA in the United Kingdom (2017–2030) 54
Table 28: Diagnosed Population of NORDA in the UK (2017–2030) 55
Table 29: Diagnosed Population of CAD and RA in Japan (2017–2030) 56
Table 30: Sub-type Specific Prevalence of RA in Japan (2017–2030) 57
Table 31: Gender specific Prevalence of RA in Japan (2017–2030) 58
Table 32: Diagnosed Population of NORDA in Japan (2017–2030) 59
Table 33: Grading of Angina Pectoris 78
Table 34: Organizations contributing toward Refractory Angina 86
Table 35: IMB-101, Clinical Trial Description, 2020 89
Table 36: Auto CD34+ cells, Clinical Trial Description, 2020 91
Table 37: Generx, Clinical Trial Description, 2020 96
Table 38: XC001, Clinical Trial Description, 2020 100
Table 39: 7 Major Market Size of RA in USD Million (2017–2030) 102
Table 40: The US Market size of RA in USD Million (2017–2030) 107
Table 41: The US market size of RA by Therapies in USD Million (2017–2030) 108
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Table 42: Germany Market size of RA in USD Million (2017–2030) 109
Table 43: Germany market size of RA by Therapies in USD Million (2017–2030) 110
Table 44: France Market size of RA in USD Million (2017–2030) 111
Table 45: France market size of RA by Therapies in USD Million (2017–2030) 112
Table 46: Italy Market size of RA in USD Million (2017–2030) 113
Table 47: Italy market size of RA by Therapies in USD Million (2017–2030) 114
Table 48: Spain Market size of RA in USD Million (2017–2030) 115
Table 49: Spain market size of RA by Therapies in USD Million (2017–2030) 116
Table 50: The UK Market size of RA in USD Million (2017–2030) 117
Table 51: The UK market size of RA by Therapies in USD Million (2017–2030) 118
Table 52: Japan Market size of RA in USD Million (2017–2030) 119
Table 53: Japan market size of RA by Therapies in USD Million (2017–2030) 120
*The list of tables is not exhaustive; will be provided in the final report
D e l v e I n s i g h t | P a g e | 18
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List of Figures
Figure 1: SWOT Analysis
Figure 2: Normal and Plaque Buildup Artery
Figure 3: Pictorial Representation of Different Types of Angina
Figure 4: Few of the causes of Chest Pain
Figure 5: Mechanisms and Pathways involved in Cardiac Chest Pain
Figure 6: The Heart-Brain Axis Model of Angina Physiopathology and Related Therapeutic Targets
Figure 7: Diagnosis of Chest Pain Symptoms according to Anginal Symptoms
Figure 8: Diagnostic Interventions
Figure 9: Definite Diagnosis
Figure 10: Total Prevalent Patient Population of RA in 7MM (2017–2030)
Figure 11: Diagnosed Population of CAD and RA in the United States (2017–2030)
Figure 12: Sub-type Specific Prevalence of RA in the United States (2017–2030)
Figure 13: Gender specific Prevalence of RA in the United States (2017–2030)
Figure 14: Diagnosed Population of NORDA in the US (2017–2030)
Figure 15: Diagnosed Population of CAD and RA in Germany (2017–2030)
Figure 16: Sub-type Specific Prevalence of RA in Germany (2017–2030)
Figure 17: Gender specific Prevalence of RA in Germany (2017–2030)
Figure 18: Diagnosed Population of NORDA in Germany (2017–2030)
Figure 19: Diagnosed Population of CAD and RA in France (2017–2030)
Figure 20: Sub-type Specific Prevalence of RA in France (2017–2030)
Figure 21: Gender specific Prevalence of RA in France (2017–2030)
Figure 22: Diagnosed Population of NORDA in France (2017–2030)
Figure 23: Diagnosed Population of CAD and RA in Italy (2017–2030)
Figure 24: Sub-type Specific Prevalence of RA in Italy (2017–2030)
Figure 25: Gender specific Prevalence of RA in Italy (2017–2030)
Figure 26: Diagnosed Population of NORDA in Italy (2017–2030)
Figure 27: Diagnosed Population of CAD and RA in Spain (2017–2030)
Figure 28: Sub-type Specific Prevalence of RA in Spain (2017–2030)
Figure 29: Gender specific Prevalence of RA in Spain (2017–2030)
Figure 30: Diagnosed Population of NORDA in Spain (2017–2030)
Figure 31: Diagnosed Population of CAD and RA in the UK (2017–2030)
Figure 32: Sub-type Specific Prevalence of RA in the UK (2017–2030)
Figure 33: Gender specific Prevalence of RA in the United Kingdom (2017–2030)
Figure 34: Diagnosed Population of NORDA in the UK (2017–2030)
Figure 35: Diagnosed Population of CAD and RA in Japan (2017–2030)
Figure 36: Sub-type Specific Prevalence of RA in Japan (2017–2030)
Figure 37: Gender specific Prevalence of RA in Japan (2017–2030)
Figure 38: Diagnosed Population of NORDA in Japan (2017–2030)
Figure 39: Treatments Addressing Myocardial Perfusion
Figure 40: Treatments Addressing Neural Processing
Figure 41: Treatment Landscape of Refractory Angina
Figure 42: Possible Combinations of Anti-anginal Drugs
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Figure 43: Technique of enhanced external counterpulsation
Figure 44: Possible mechanisms responsible for the clinical benefit associated with EECP therapy
Figure 45: Pictorial Representation of Neuromodulation Targets
Figure 46: Pictorial Representation of Coronary Sinus Reducer
Figure 47: Clinical Assessment of Angina
Figure 48: Clinical assessment and the typicality of anginal pain
Figure 49: Unmet Needs of RA
Figure 50: 7 Major Market Size of RA in USD Million (2017–2030)
Figure 51: Market Size of RA in the United States, USD Millions (2017–2030)
Figure 52: The U.S. market size of RA by therapies in USD Million (2017–2030)
Figure 53: Market Size of RA in Germany, USD Millions (2017–2030)
Figure 54: Germany market size of RA by therapies in USD Million (2017–2030)
Figure 55: Market Size of RA in France, USD Millions (2017–2030)
Figure 56: France market size of RA by therapies in USD Million (2017–2030)
Figure 57: Market Size of RA in Italy, USD Millions (2017–2030)
Figure 58: Italy market size of RA by therapies in USD Million (2017–2030)
Figure 59: Market Size of RA in Spain, USD Millions (2017–2030)
Figure 60: Spain market size of RA by therapies in USD Million (2017–2030)
Figure 61: Market Size of RA in the UK, USD Millions (2017–2030)
Figure 62: The UK market size of RA by therapies in USD Million (2017–2030)
Figure 63: Market Size of RA in Japan, USD Millions (2017–2030)
Figure 64: Japan market size of RA by therapies in USD Million (2017–2030)
Figure 65: Market Drivers
Figure 66:Market Barriers
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*The list of figures is not exhaustive; will be provided in the final report
D e l v e I n s i g h t | P a g e | 20
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Appendix
Report Methodology
Pipeline product share:
- IMB-101
- Generx
- Auto CD34+ cells
Country/Regional
population
Prevalent pool
Diagnosed patient pool
Treated Cases
Focused group patient pool
Treatment eligible or
potential patient pool
Revenue by
therapies
Conversion factors
• ACoT
• Compliance rate
• Market access and
Reimbursement
MARKET SIZE
Prevalence rate
Model Flow
Diagnosis rate
Epidemiology Segmentation Methodology
Sub-segmented by
Gender, diagnosed patients CAD and RA,
NORDA etc.
Current Treatment Therapies:
• Approved Therapies
• Beta-blockers
• Calcium-channel blockers
• Others
• Supportive Therapies
ACoT, compliance rate,
market access and
reimbursement
Treatment rate
Patient pool
Existing market
Uptake / Patient
share
Revenue
estimation
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DelveInsight is a premier source for pharmaceutical and biotechnology sector analysis, delivering exclusive,
trusted commercial insight into industry performance through its proprietary platform. DelveInsight’s
reports are continuously updated and revised. The following research methodology is followed for all
databases and reports.
Coverage
The objective of updating DelveInsight coverage is to ensure that it represents the most up-to-date vision
of the industry possible. The DelveInsight is a fully integrated solution for comprehensive intelligence on
various pharmaceutical products, both in the market and in the pipeline, across the globe.
Research Design
Secondary Research
The secondary research on internal and external sources is being carried out to source qualitative and
quantitative information relating to each market. The secondary research sources that are typically referred
to include, but are not limited to:
• Company websites, annual reports, financial reports, broker reports, investor presentations, and
SEC Filings Industry trade journals and other literature.
• Internal and external proprietary databases.
• National government documents, statistical databases, and market reports.
• News articles, press releases, and web-casts specific to the companies operating in the market.
Primary Research
DelveInsight conducts primary research by interacting with the healthcare professionals, doctors, industry’s
experts, and industry participants and commentators in order to validate its data and analysis. The
discussion provides first-hand information on the market size, market trends, growth trends, competitive
landscape, and future outlook, for example.
• It helps in validating and strengthening the secondary research findings.
• It further develops the Analysis Team’s expertise and market understanding.
• An interactive one-stop, fully integrated business intelligence (BI) platform, catering the need of
the global pharmaceuticals market, across all the value chains.
• The comprehensive integration allows for the seamless comparison of the market dynamics,
helps strategic planning, and decision making to stay competitive in the global pharmaceuticals
industry.
• We help our clients to find answers relevant to business decision-making, including potential
market opportunities, competitor assessments, and business environmental dynamics enhances
companies to plan development, trials or process-based research on their competitor focus.
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Forecast Methodology
DelveInsight Reports are prepared considering different epidemiology and market factors, keeping past
and current trends in focus. Our forecasting models are prepared based on the Hybrid approach, where we
use both top to bottom and bottom to top approaches and analyze different factors and parameters to
forecast the numbers.
We develop a deep understanding by doing systemic literature research for Epidemiological data around
different geographies. We prepare the forecast model based on different data sources, considering past
and current trends from different factors such as improvements in survival and disease therapy, unmet
need, risk of disease by gender and age group, population size, diagnose trends, treatment factors, and
others
Our Market Forecast model consider factors such as unmet medical need, drug competitor factor, patient
compliance, product price, marketed drugs calibration based on actual sales and their impact in different
geographies, emerging drugs and their impact, novel agents analysis based on their results, therapeutic
potential, regulatory success, launch dates, etc., market challenges, drivers and barriers, and other factors.
Our major sources are company annual reports, scientific literature, epidemiology studies conducted by
different agencies, Pub-Med Articles, the country-specific government released population sources, and
others. To keep up with current market trends, we try to take doctors, KOLs, and industry experts’ opinion
through secondary as well as primary research to come up with the actual market size.
Expert Panel Validation
DelveInsight uses a panel of experts to cross verify research and forecast methodologies and drive its
analytical content. The panel comprises of marketing managers, product specialists, international sales
managers from pharmaceutical companies; academics from research universities and consultants from
professional services companies.
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DelveInsight Capabilities
Our Consulting Services collaborate with Biotech & Pharmaceutical companies, Venture Capitalist, R&D
units, and API manufacturers to help them in critical business decisions, building commercial excellence
and growing businesses in an increasingly competitive and challenging environment.
DelveInsight delivers strategic CI Inputs to clients for monitoring competition and staying ahead via our
expertise in gathering industry intelligence, leading to better decision-making.
Our in-depth insights help market research and business development teams of global bio-Pharma
companies in understanding the market, identifying and targeting the untapped opportunities.
DelveInsight’s forecasting through epidemiology- and unit-based methodologies help create flexible and
robust models to accommodate key inputs for effective market forecasting.
DelveInsight’s CI team has supported many global clients by delivering CI projects with high-quality insights,
helping improve their business processes, combining primary and secondary research methods and
validating information to provide un-biased insights.
1
2
3
4
5
6
Our subject matter experts help deliver high-quality insights, supporting clients in key decisions like
prioritizing indications, analyzing clinical trials, and analyzing the patents and publications.
Our in-house conference/congress intelligence experts gather information from various websites of
congresses and analyze the data to map the KOLs attending the congresses, for effective planning and
providing an un-biased analysis.
Competitive Intelligence
Market/BD Assessment
Studies
Forecasting
Primary CI
R&D
Analytics
Conference/Congress
Intelligence
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Disclaimer
All Rights Reserved.
No part of this publication may be reproduced, stored in a retrieval system,
or transmitted in any form by any means, electronic, mechanical,
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publisher, DelveInsight.
The facts of this report were believed to be correct at the time of
publication but cannot be guaranteed. Please note that the findings,
conclusions, and recommendations that DelveInsight delivers will be based
on information gathered in good faith from both primary and secondary
sources, whose accuracy we were not always in a position to guarantee.
As such DelveInsight can accept no liability whatsoever for the actions taken based on any information that
may subsequently prove to be incorrect.
About DelveInsight
DelveInsight is a Business Consultant company and serves as a Knowledge partner across the value chain
of the Pharmaceutical Industry. With the use of proprietary databases and analytical models, DelveInsight
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Refractory angina market insights epidemiology and market forecast - 2030 sample pages

  • 1. Refractory Angina (RA) Market Insights, Epidemiology, and Market Forecast— 2030 2020
  • 2. D e l v e I n s i g h t | P a g e | 1 DelveInsight Copyright Healthcare Market Research Key Insights The Report contains: ` Insightful Reviews on Market Drivers & Market Barriers Strategic analysis of Treatment options & Emerging Therapies Research Analysis Pipeline Valuation Market Analysis Epidemiology Forecast Market size by therapies Pipeline analysis across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities Detailed historical and forecasted market covering the United States, EU5 and Japan countries from 2017 to 2030 Overview of pathophysiology, various diagnostic approaches and treatment algorithm including detailed chapters for marketed products and emerging therapies Historical as well as forecasted epidemiology in the 7MM covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2017 to 2030 Detailed Market size by therapies, covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2017 to 2030
  • 3. D e l v e I n s i g h t | P a g e | 2 DelveInsight Copyright Healthcare Market Research The report provides an understanding of the epidemiology and changing market dynamics of Refractory Angina (RA) in the seven major pharmaceutical markets for the period 2017–2030 Report Introduction DelveInsight’s “Refractory Angina (RA)- Market Insights, Epidemiology and Market Forecast—2030” report provides an overview of the disease and market size of RA for the seven major pharmaceutical markets, i.e., the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This report covers the various treatment practices, and RA forecasted epidemiology from 2020 to 2030, segmented by the seven major markets. Key Strengths ❖ 11-Year Forecast ❖ 7MM Coverage ❖ Epidemiology Segmentation ❖ Drugs Uptake ❖ Highly Analyzed Market ❖ Key Cross Competition ❖ Market Size by Country ❖ Market Size by Therapy Key Assessments ❖ Current Treatment Practices ❖ Unmet Needs ❖ Emerging Drug Profiles ❖ Market Attractiveness ❖ Market Drivers and Barriers ✓ The report covers the descriptive overview of Refractory Angina (RA), explaining its causes and risk factors, pathophysiology, diagnosis and currently available therapies. ✓ Comprehensive insight has been provided into the epidemiology of the Refractory Angina (RA) and its treatment in the 7MM. ✓ Additionally, an all-inclusive account of both the current and emerging therapies for Refractory Angina (RA) is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape. ✓ A detailed review of historical and forecasted Refractory Angina (RA) market is included in the report, covering drug outreach in the 7MM. ✓ The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Refractory Angina (RA) market.
  • 4. D e l v e I n s i g h t | P a g e | 3 DelveInsight Copyright Healthcare Market Research Epidemiology Insights • As per Delveinsight’s estimates, the total prevalent cases of Refractory Angina in 7 major markets ranges from 29,17,196 in 2017. • According to the Delveinsight’s analysts, the United States accounted for most prevalent cases of RA in 7MM with 19,05,602 cases in 2017. • Among EU5 countries, Germany accounted for most number of prevalent cases of RA with 5,13,896 cases in 2017. • Japan accounted for 27,432 cases in 2017 which are expected to grow during the study period (2017– 2030). Refractory Angina—Epidemiology by Gender Refractory Angina (RA) is a chronic condition where pain remain persistent for the duration of less than or equal to 3 months, characterized by angina. Angina is a type of chest pain caused by reduced blood flow to the heart. Angina has two types, chronic or stable angina and unstable angina. Around 10–15% of patients of Chronic Angina meet the measures of RA. The clinical load of RA is growing rapidly due to an ageing population and improved Coronary Artery Disease (CAD). Symptoms of RA are chest pain, shortness of breath, and easy fatigability. RA also shows neurological, psychogenic and mitochondrial dysfunctions in addition to tissue ischemia which are responsible for an insistent cardiac pain. These symptoms causes poor self-perceived health status, high incidence of depression, and burden to the health care system due to significant resource utilization. Patients with RA are a heterogeneous group that remain significantly limited by persistent debilitating chest discomfort despite optimal conventional therapy. .
  • 5. D e l v e I n s i g h t | P a g e | 4 DelveInsight Copyright Healthcare Market Research Diagnosed Population of NORDA in the 7MM (2017–2030) Epidemiology Parameters- 7MM 1 Total Diagnosed Population of Coronary Artery Disease and Refractory Angina in the 7MM (2017–2030) Age Specific Prevalent Cases of RS Gender-specific Prevalent Population of Refractory Angina in the 7MM (2017–2030) 2 Sub-type Specific Prevalence of Refractory Angina in the7MM (2017–2030) 3 • RA is classified on the basis of grading the pain. Among these sub-types, Class III contributes the major patient share of RA followed by Class IV angina. • Higher Prevalence of Refractory Angina is observed among males as compared to females in 7MM. 4 Market Share 2017 [Indicative] United States EU-5 Japan
  • 6. D e l v e I n s i g h t | P a g e | 5 DelveInsight Copyright Healthcare Market Research Graphical Representation of Refractory Angina (RA)—Epidemiology Total Prevalent Cases of RA in the 7MM (2017–2030) Total Gender-specific Prevalent Cases of RA in the United States (2017–2030) 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 PopulationinNumber(N) Year 7MM Total Prevalent Patient Population of Refractory Angina United States Germany France Italy Spain United Kingdom Japan 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 PopulationinNumber(N) Year Gender Specific prevalence of RA Male Female
  • 7. D e l v e I n s i g h t | P a g e | 6 DelveInsight Copyright Healthcare Market Research Market Outlook for RA Refractory Angina (RA) is a chronic disease characterized by the presence of persistent angina and patients with RA defined as being ‘no option’ since they are not considered amenable for conventional revascularization treatment for reasons related to diffuse coronary lesions, unsuitability to chronic total occlusion mechanical revascularization, or frailty from the presence of severe comorbidities. In spite of continuous developments in Coronary Artery Disease (CAD) management, particularly in the aged population, the number of patients suffering from RA is correlated to the healthcare expenses. Currently, there are several methods to treat this disease, which involves pharmacological treatments approaches, coronary sinus reducer, etc. Several non-invasive methods are also available to treat this disease, like External Enhanced Counter Pulsation (EECP), extracorporeal shockwave therapy (ESWT), neuromodulation, etc. Pragmatic rehabilitation is also an important approach to promote patients to manage their own chest pain. There is no significant pharmacologic approved therapy to improve quality of life in patients of RA, but a significant amount of evidence exists in the literature that supports the use of pharmacologic treatment in the stable Angina. Beta-blockers and Calcium Channel Antagonists like Nicorandil (K-ATP - channel opener), Market Size of RA in the 7MM is expected to grow during the study period (2017–2030) The lack of approved therapies, specifically for the treatment of RA remains the primary unmet need of the disease Owing to the launch of upcoming therapies, the market size shall increase significantly during forecast period (2020–2030) Several pharmacological, noninvasive, and invasive therapeutic techniques are under investigation, with the aim of improving care for this challenging indication. Safety and tolerability of current anti- anginal agents is not good, so the primary focus is on improving quality of life for patients with refractory angina Market Insight
  • 8. D e l v e I n s i g h t | P a g e | 7 DelveInsight Copyright Healthcare Market Research Ivabradine (If current inhibitor), Trimetazidine (Reversible 3-ketoacyl-thiolase inhibitor), Ranolazine, Fasudil/hydroxyfasudil (Rho-kinase inhibitor) are few mainstay medical treatment for angina. Furthermore, the European Society of Cardiology guidelines now consider ivabradine, nicorandil, or ranolazine with long- acting nitrates as a second-line therapy for patients with persistent angina, according to heart rate, blood pressure, and tolerance. Ivabradine helps to reduce the number of angina attacks in patients with chronic stable angina by blocking If channels, which regulate the intrinsic chronotropic characteristics of the sinoatrial node. It may be useful in patients with refractory angina who do not tolerate high doses of β-blockers, or when calcium-channel blockers are contraindicated. Nicorandil is a nicotinamide ester which contains nitrate like moiety, which helps in vasodilation of coronary arteries and also promotes the opening of the mitochondrial ATP-sensitive potassium channels (KATP), known to mimic ischemic preconditioning. This drug has shown cardioprotective effect among patients of Chronic Stable Angina. Additionally, Trimetazidine is a metabolic agent that increases glucose oxidation by blocking the mitochondrial long-chain 3-ketoacylCoA thiolase. This is an important enzyme for the β-oxidation of fatty acids. Trimetazidine might enhance the energy efficiency of ischemic myocytes by inhibiting the βoxidation of fatty acid. This drug is also recommended as a second-line therapy, but its use is less well established. Another therapy, Ranolazine, affects ion channels in cardiomyocytes via inhibition of late sodium currents. The mechanism of action of ranolazine is debated but it is believed to partially inhibit the fatty acid oxidation. Ranolazine has never been tested in a specific trial of patients with refractory angina but safety is well established for RA patients as well as Acute Coronary Syndrome. The US guidelines consider ranolazine useful only when prescribed as a substitute for β-blockers for relief of symptoms in patients where the initial treatment with β-blockers was ineffective. Fasudil and hydroxyfasudil is a Rho kinase inhibitor, which reduces calcium sensitization of vascular smooth muscle to maintain coronary vasodilatation and prevent vasospasm. Fasudil and hydoexyfasudil currently available in Japan for the prevention of central nervous system vasospasm associated with subarachnoid hemorrhage. Potentially useful for vasospastic angina. Talking about the noninvasive therapies, these are also recommended for the treatment of RA. Enhanced external counter pulsation (EECP), has been approved by the United States Food and Drug Administration (FDA) for the management of refractory angina (Class IIb). EECP involves attachment of three sets of pneumatic cuffs around patient’s legs at the calf and lower and upper thigh, which inflate during diastole to augment coronary blood flow and deflate in systole to decrease afterload and increase venous return. The inflation of the cuffs produces a retrograde flow of blood in the aorta which helps in diastolic augmentation of blood flow. This also increases the relapse of which leads to an improved coronary perfusion pressure during diastole. EECP session involves 35 one hour session. In the year 2000, EECP has been proven to be a safe therapy by the International EECP Patient Registry (IEPR). Extracorporeal shockwave therapy (ESWT) is used to deliver high-amplitude acoustic pressure pulses to apply focal mechanical stress. In response to this acoustic field, naturally occurring microbubbles inside and outside of cells oscillate and collapse. These waves also promote in situ expression of chemo-attractants
  • 9. D e l v e I n s i g h t | P a g e | 8 DelveInsight Copyright Healthcare Market Research (stromal cell-derived factor 1, Vascular Endothelial Growth Factor (VEGF), and nitric oxide). ESWT is a noninvasive modality that seems to be safe and warrants further study to determine the optimal dose and protocol as well as its efficacy in patients with refractory angina. In Neuromodulation pain, signal is interrupted via chemically, mechanically, or electrically in the transmission pathway from the periphery to the brain. Spinal-cord modulation, subcutaneous electrical nerve stimulation, cardiac sympathectomy, and transmyocardial laser revascularization are the type of neuromodulatory methods useful for the patients with cardiac pain. Moreover, Cardiac cell-based therapy has emerged as a novel therapeutic option for patients dealing with untreatable RA. According to some experimental studies, cell therapy can improve myocardial perfusion and contractile function. Cell therapy also promotes neovascularization. A number of drugs and therapies are suggested as first and the second line of treatment, however, not all of the above-mentioned treatments were formally suggested for RA. Development of RA-specific clinical guidelines is needed. Current medical therapy has several shortcomings which include lack of proof of a direct impact of anti-ischemic therapy on clinical outcomes in the context of RA. Recent efforts have been directed toward the discovery of novel therapies. The market is expected to experience growth in the coming years as there are few drugs lined up and are expected to launch during the forecast period [2020– 2030].
  • 10. D e l v e I n s i g h t | P a g e | 9 DelveInsight Copyright Healthcare Market Research Graphical Representation of Refractory Angina (RA)–Market Size Total Market Size of RA in the 7MM (2017–2030) Market Size of RA in the United States (2017–2030) 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 MarketSizeinUSD,Million Year Total Market Size of RA in 7MM United States Germany France Italy Spain United Kingdom Japan 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 SalesInUSD,Million Year Total Market of RA US
  • 11. D e l v e I n s i g h t | P a g e | 10 DelveInsight Copyright Healthcare Market Research Emerging Therapy Analysis The dynamics of Refractory Angina market is anticipated to change in the coming years owing to the expected launch of emerging therapies during the forecast period of 2020–2030, as there is no pharmacologic treatment available to treat RA patients specifically. Several companies across the globe are thoroughly working toward the development of new treatment and devices which are expected to change the current market scenario for RA. Several emerging pharmacotherapies for RA in different stages of clinical development are Ad5FGF-4 (Angionetics/Huapont Life Sciences), CLBS14 (Caladrius Biosciences), and several others. Ad5FGF-4 (Angionetics/Huapont Life Sciences) is angiogenic gene therapy cardiac biologic product. It is a precision medicine, recombinant angiogenic gene therapy product designed to stimulate the formation of functional coronary collateral vessels in patients with refractory angina due to myocardial ischemia, resulting in increased myocardial perfusion and improved patient outcomes. This product utilizes a serotype 5 adenovirus (Ad5) to deliver the FGF-4 transgene into heart cells. The US FDA has granted fast track designation to this product for the Phase III clinical investigation as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy, and not amenable to conventional revascularization procedures. Another drug, CLBS14 by Caladrius Biosciences, is also in development for the treatment of no-option refractory disabling angina (NORDA). Based on the clinical evidence from the completed studies that a single administration of CLBS14 reduces mortality, improves angina, and increases exercise capacity in patients with otherwise untreatable angina, this product received regenerative medicine advanced therapy designation (RMAT) designation from the US FDA. Furthermore, the company is working closely with the US FDA, and have finalized the design of a confirmatory Phase III trial which, in combination with previously filed Phase I, II and III data, will be considered for the registration of CLBS14. In August 2019, Caladrius Biosciences and Cognate BioServices entered into a manufacturing agreement for the production of CLBS14. Under the terms of the agreement, Cognate manufacture CLBS14 for Caladrius’ Phase III confirmatory pivotal clinical trial in subjects with NORDA. Under this agreement, the company has acquired the rights to data and regulatory filings for a CD34+ cell therapy program for RA that had been advanced to Phase III by a previous sponsor. In addition to aforementioned therapies in development, other therapies like IMB-101 (Imbria Pharmaceuticals), XC001 (XyloCor Therapeutics) and others are in the initial stages of development. While, some of these companies have recently shifted their focus toward this therapeutic area, yet others have completed the late stage of development. As few drugs are currently in the pipeline and in their late development stages, the market will surely experience growth in the upcoming years. Drug Uptake
  • 12. D e l v e I n s i g h t | P a g e | 11 DelveInsight Copyright Healthcare Market Research Market Size of Refractory Angina (RA) by Therapies in the United States (2017–2030) 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 SalesinUSD,Million Year US Drug-level Revenue ($M) Beta-blockers Calcium antagonists Short or Long acting nitrates Lipid-lowering agents ACE inhibitors Ivabradine Ranolazine Nicorandil Trimetazidine IMB-1018972 CLBS-14 (Auto-CD34+ cells) Generx/ Alferminogene tadenovec (Ad5FGF-4) AdVEGFXC1 (XC001)
  • 13. D e l v e I n s i g h t | P a g e | 12 DelveInsight Copyright Healthcare Market Research Conjoint Analysis Scores 50% 20% 30% Weighted ScoreParameters Efficacy Safety RoA and Treatment Drug A 3 XX 4 XX Drug B 5 XX 5 XX Drug C 7 XX 3 XX Drug D XX XX XX XX KOL Views The predominant treatment for patients suffering from RA is XXXX therapy Even though management of patients happen by off-label therapies, novel drug development is an ongoing opportunity for patients of this disease group. XXXX therapy has provided much- needed relief to the management of patients, but many prescribers and patients are awaiting the approval of upcoming therapies KOL A, USA KOL C, Germany KOL B, Japan Legend SafetyEfficacy RoA and Treatment High Medium Low High Medium Low High Medium Low The objective of updating DelveInsight coverage is to ensure that it represents the most up-to-date vision of the industry possible. The DelveInsight is a fully integrated solution for comprehensive intelligence on various pharmaceutical products, both in the market and in the pipeline, across the globe.
  • 14. D e l v e I n s i g h t | P a g e | 13 DelveInsight Copyright Healthcare Market Research Table of Content to View 1:Key Insights 2:Executive Summary of Refractory Angina 3:SWOT Analysis for Refractory Angina 4:Refractory Angina (RA) Market Overview at a Glance 4.1:Market Share (%) Distribution of Refractory Angina (RA) in 2017 4.2:Market Share (%) Distribution of Refractory Angina (RA) in 2030 5:Disease Background and Overview 5.1:Introduction 5.2:Types 5.3:Symptoms 5.4:Etiology 5.5:Risk Factors 5.6:Pathophysiology 5.7:Diagnosis 6:Epidemiology and Patient Population 6.1:Key Findings 6.2:7MM Total Prevalent Patient Population of Refractory Angina [RA] 7:Epidemiology Assumptions and Rationale - 7MM 8:Country Wise-Epidemiology of Refractory Angina (RA) 8.1:The United States 8.1.1:Total Diagnosed Population of CAD and RA in the United States 8.1.2:Sub-type Specific Prevalence of RA in the United States 8.1.3:Gender specific Prevalence of RA in the United States 8.1.4:Diagnosed Population of NORDA in the US 8.2:Germany 8.2.1:Total Diagnosed Population of CAD and RA in Germany 8.2.2:Sub-type Specific Prevalence of RA in Germany 8.2.3:Gender specific Prevalence of RA in Germany 8.2.4:Diagnosed Population of NORDA in Germany 8.3:France 8.3.1:Total Diagnosed Population of CAD and RA in France 8.3.2:Sub-type Specific Prevalence of RA in France 8.3.3:Gender specific Prevalence of RA in France 8.3.4:Diagnosed Population of NORDA in France 8.4:Italy 8.4.1:Total Diagnosed Population of CAD and RA in Italy 8.4.2:Sub-type Specific Prevalence of RA in Italy 8.4.3:Gender specific Prevalence of RA in Italy 8.4.4:Diagnosed Population of NORDA in Italy 8.5:Spain 8.5.1:Total Diagnosed Population of CAD and RA in Spain 8.5.2:Sub-type Specific Prevalence of RA in Spain 1 3 5 6 6 6 14 14 16 17 17 19 19 23 27 27 28 29 32 32 32 33 34 35 36 36 37 38 39 40 40 41 42 43 44 44 45 46 47 48 48 49
  • 15. D e l v e I n s i g h t | P a g e | 14 DelveInsight Copyright Healthcare Market Research 8.5.3:Gender specific Prevalence of RA in Spain 8.5.4:Diagnosed Population of NORDA in Spain 8.6:The United Kingdom 8.6.1:Total Diagnosed Population of CAD and RA in the UK 8.6.2:Sub-type Specific Prevalence of RA in the UK 8.6.3:Gender specific Prevalence of RA in the United Kingdom 8.6.4:Diagnosed Population of NORDA in the United Kingdom 8.7:Japan 8.7.1:Total Diagnosed Population of CAD and RA in Japan 8.7.2:Sub-type Specific Prevalence of RA in Japan 8.7.3:Gender specific Prevalence of RA in Japan 8.7.4:Diagnosed Population of NORDA in Japan 9:Treatment 9.1:Pharmacological Therapies 9.2:Noninvasive Antianginal therapies 9.3:Invasive Antianginal therapies 9.4:Treatment Guidelines 9.4.1:European Society of Cardiology (ESC) Guidelines for Refractory Angina Patients 9.4.2:National Institute for Health and Clinical Excellence (NICE) guidelines: Chest pain of recent onset 9.4.3:Canadian Cardiovascular Society (CCS) Guidelines 10:Unmet Needs 11:Case Studies 11.1:A Case of Refractory Angina 11.2:A Case Report of Refractory Angina 12:Organizations related with Refractory Angina 13:Emerging Therapies 13.1:IMB-101: Imbria Pharmaceuticals 13.1.1:Other Developmental Activities 13.1.2:Clinical Development 13.1.3:Safety and Efficacy 13.2:Auto CD34+ Cells: Caladrius Biosciences, Inc. 13.2.1:Other Developmental Activities 13.2.2:Clinical Development 13.2.3:Safety and Efficacy 13.3:Generx: Angionetics Inc. 13.3.1:Other Developmental Activities 13.3.2:Clinical Development 13.3.3:Safety and Efficacy 13.4:XC001: XyloCor Therapeutics, Inc. 13.4.1:Other Developmental Activities 13.4.2:Clinical Development 14:Refractory Angina (RA): 7 Major Market Analysis 14.1:Key Findings 14.2:Total Market Size of RA in 7MM 50 51 52 52 53 54 55 56 56 57 58 59 60 62 66 70 74 74 76 78 82 84 84 85 86 88 88 88 88 89 90 90 91 92 94 94 95 98 99 99 99 101 101 102
  • 16. D e l v e I n s i g h t | P a g e | 15 DelveInsight Copyright Healthcare Market Research 14.3:Market Outlook: 7MM 15:United States 15.1:Total Market size of RA 15.2:RA Market Size by Therapies 16:EU5 Countries 16.1:Germany 16.1.1:Total Market size of RA 16.1.2:RA Market Size by Therapies 16.2:France 16.2.1:Total Market size of RA 16.2.2:RA Market Size by Therapies 16.3:Italy 16.3.1:Total Market size of RA 16.3.2:RA Market Size by Therapies 16.4:Spain 16.4.1:Total Market size of RA 16.4.2:RA Market Size by Therapies 16.5:United Kingdom 16.5.1:Total Market size of RA 16.5.2:RA Market Size by Therapies 17:Japan 17.1:Total Market size of RA 17.2:RA Market Size by Therapies 18:Market Drivers 19:Market Barriers 20:Appendix 20.1:Bibliography 20.2:Report Methodology 21:DelveInsight Capabilities 22:Disclaimer 23:About DelveInsight 103 107 107 108 109 109 109 110 111 111 112 113 113 114 115 115 116 117 117 118 119 119 120 121 123 124 124 126 128 129 129 *The table of contents is not exhaustive; will be provided in the final report
  • 17. D e l v e I n s i g h t | P a g e | 16 DelveInsight Copyright Healthcare Market Research List of Tables Table 1: Summary of Refractory Angina (RA) Market, Epidemiology, and Key Events (2017–2030) 4 Table 2: Difference between Stable and Unstable Angina 18 Table 3: Probability of Coronary Artery Diseases and Associated Diagnostic Strategies 23 Table 4: Total Prevalent Patient Population of RA in 7MM (2017–2030) 28 Table 5: Diagnosed Population of CAD and RA in the United States (2017–2030) 32 Table 6: Sub-type Specific Prevalence of RA in the United States (2017–2030) 33 Table 7: Gender specific Prevalence of RA in the United States (2017–2030) 34 Table 8: Diagnosed Population of NORDA in the US (2017–2030) 35 Table 9: Total Prevalent Population of RA in Germany (2017–2030) 36 Table 10: Sub-type Specific Prevalence of RA in Germany (2017–2030) 37 Table 11: Gender specific Prevalence of RA in Germany (2017–2030) 38 Table 12: Diagnosed Population of NORDA in Germany (2017–2030) 39 Table 13: Diagnosed Population of CAD and RA in France (2017–2030) 40 Table 14: Sub-type Specific Prevalence of RA in France (2017–2030) 41 Table 15: Gender specific Prevalence of RA in France (2017–2030) 42 Table 16: Diagnosed Population of NORDA in France (2017–2030) 43 Table 17: Diagnosed Population of CAD and RA in Italy (2017–2030) 44 Table 18: Sub-type Specific Prevalence of RA in Italy (2017–2030) 45 Table 19: Gender specific Prevalence of RA in Italy (2017–2030) 46 Table 20: Diagnosed Population of NORDA in Italy (2017–2030) 47 Table 21: Diagnosed Population of CAD and RA in Spain (2017–2030) 48 Table 22: Sub-type Specific Prevalence of RA in Italy (2017–2030) 49 Table 23: Gender specific Prevalence of RA in Spain (2017–2030) 50 Table 24: Diagnosed Population of NORDA in Spain (2017–2030) 51 Table 25: Diagnosed Population of CAD and RA in the UK (2017–2030) 52 Table 26: Sub-type Specific Prevalence of RA in the UK (2017–2030) 53 Table 27: Gender specific Prevalence of RA in the United Kingdom (2017–2030) 54 Table 28: Diagnosed Population of NORDA in the UK (2017–2030) 55 Table 29: Diagnosed Population of CAD and RA in Japan (2017–2030) 56 Table 30: Sub-type Specific Prevalence of RA in Japan (2017–2030) 57 Table 31: Gender specific Prevalence of RA in Japan (2017–2030) 58 Table 32: Diagnosed Population of NORDA in Japan (2017–2030) 59 Table 33: Grading of Angina Pectoris 78 Table 34: Organizations contributing toward Refractory Angina 86 Table 35: IMB-101, Clinical Trial Description, 2020 89 Table 36: Auto CD34+ cells, Clinical Trial Description, 2020 91 Table 37: Generx, Clinical Trial Description, 2020 96 Table 38: XC001, Clinical Trial Description, 2020 100 Table 39: 7 Major Market Size of RA in USD Million (2017–2030) 102 Table 40: The US Market size of RA in USD Million (2017–2030) 107 Table 41: The US market size of RA by Therapies in USD Million (2017–2030) 108
  • 18. D e l v e I n s i g h t | P a g e | 17 DelveInsight Copyright Healthcare Market Research Table 42: Germany Market size of RA in USD Million (2017–2030) 109 Table 43: Germany market size of RA by Therapies in USD Million (2017–2030) 110 Table 44: France Market size of RA in USD Million (2017–2030) 111 Table 45: France market size of RA by Therapies in USD Million (2017–2030) 112 Table 46: Italy Market size of RA in USD Million (2017–2030) 113 Table 47: Italy market size of RA by Therapies in USD Million (2017–2030) 114 Table 48: Spain Market size of RA in USD Million (2017–2030) 115 Table 49: Spain market size of RA by Therapies in USD Million (2017–2030) 116 Table 50: The UK Market size of RA in USD Million (2017–2030) 117 Table 51: The UK market size of RA by Therapies in USD Million (2017–2030) 118 Table 52: Japan Market size of RA in USD Million (2017–2030) 119 Table 53: Japan market size of RA by Therapies in USD Million (2017–2030) 120 *The list of tables is not exhaustive; will be provided in the final report
  • 19. D e l v e I n s i g h t | P a g e | 18 DelveInsight Copyright Healthcare Market Research List of Figures Figure 1: SWOT Analysis Figure 2: Normal and Plaque Buildup Artery Figure 3: Pictorial Representation of Different Types of Angina Figure 4: Few of the causes of Chest Pain Figure 5: Mechanisms and Pathways involved in Cardiac Chest Pain Figure 6: The Heart-Brain Axis Model of Angina Physiopathology and Related Therapeutic Targets Figure 7: Diagnosis of Chest Pain Symptoms according to Anginal Symptoms Figure 8: Diagnostic Interventions Figure 9: Definite Diagnosis Figure 10: Total Prevalent Patient Population of RA in 7MM (2017–2030) Figure 11: Diagnosed Population of CAD and RA in the United States (2017–2030) Figure 12: Sub-type Specific Prevalence of RA in the United States (2017–2030) Figure 13: Gender specific Prevalence of RA in the United States (2017–2030) Figure 14: Diagnosed Population of NORDA in the US (2017–2030) Figure 15: Diagnosed Population of CAD and RA in Germany (2017–2030) Figure 16: Sub-type Specific Prevalence of RA in Germany (2017–2030) Figure 17: Gender specific Prevalence of RA in Germany (2017–2030) Figure 18: Diagnosed Population of NORDA in Germany (2017–2030) Figure 19: Diagnosed Population of CAD and RA in France (2017–2030) Figure 20: Sub-type Specific Prevalence of RA in France (2017–2030) Figure 21: Gender specific Prevalence of RA in France (2017–2030) Figure 22: Diagnosed Population of NORDA in France (2017–2030) Figure 23: Diagnosed Population of CAD and RA in Italy (2017–2030) Figure 24: Sub-type Specific Prevalence of RA in Italy (2017–2030) Figure 25: Gender specific Prevalence of RA in Italy (2017–2030) Figure 26: Diagnosed Population of NORDA in Italy (2017–2030) Figure 27: Diagnosed Population of CAD and RA in Spain (2017–2030) Figure 28: Sub-type Specific Prevalence of RA in Spain (2017–2030) Figure 29: Gender specific Prevalence of RA in Spain (2017–2030) Figure 30: Diagnosed Population of NORDA in Spain (2017–2030) Figure 31: Diagnosed Population of CAD and RA in the UK (2017–2030) Figure 32: Sub-type Specific Prevalence of RA in the UK (2017–2030) Figure 33: Gender specific Prevalence of RA in the United Kingdom (2017–2030) Figure 34: Diagnosed Population of NORDA in the UK (2017–2030) Figure 35: Diagnosed Population of CAD and RA in Japan (2017–2030) Figure 36: Sub-type Specific Prevalence of RA in Japan (2017–2030) Figure 37: Gender specific Prevalence of RA in Japan (2017–2030) Figure 38: Diagnosed Population of NORDA in Japan (2017–2030) Figure 39: Treatments Addressing Myocardial Perfusion Figure 40: Treatments Addressing Neural Processing Figure 41: Treatment Landscape of Refractory Angina Figure 42: Possible Combinations of Anti-anginal Drugs 5 14 16 18 20 22 24 25 26 28 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 61 65
  • 20. D e l v e I n s i g h t | P a g e | 19 DelveInsight Copyright Healthcare Market Research Figure 43: Technique of enhanced external counterpulsation Figure 44: Possible mechanisms responsible for the clinical benefit associated with EECP therapy Figure 45: Pictorial Representation of Neuromodulation Targets Figure 46: Pictorial Representation of Coronary Sinus Reducer Figure 47: Clinical Assessment of Angina Figure 48: Clinical assessment and the typicality of anginal pain Figure 49: Unmet Needs of RA Figure 50: 7 Major Market Size of RA in USD Million (2017–2030) Figure 51: Market Size of RA in the United States, USD Millions (2017–2030) Figure 52: The U.S. market size of RA by therapies in USD Million (2017–2030) Figure 53: Market Size of RA in Germany, USD Millions (2017–2030) Figure 54: Germany market size of RA by therapies in USD Million (2017–2030) Figure 55: Market Size of RA in France, USD Millions (2017–2030) Figure 56: France market size of RA by therapies in USD Million (2017–2030) Figure 57: Market Size of RA in Italy, USD Millions (2017–2030) Figure 58: Italy market size of RA by therapies in USD Million (2017–2030) Figure 59: Market Size of RA in Spain, USD Millions (2017–2030) Figure 60: Spain market size of RA by therapies in USD Million (2017–2030) Figure 61: Market Size of RA in the UK, USD Millions (2017–2030) Figure 62: The UK market size of RA by therapies in USD Million (2017–2030) Figure 63: Market Size of RA in Japan, USD Millions (2017–2030) Figure 64: Japan market size of RA by therapies in USD Million (2017–2030) Figure 65: Market Drivers Figure 66:Market Barriers 66 67 69 72 73 76 82 102 107 108 109 110 111 112 113 114 115 116 117 118 119 120 121 123 *The list of figures is not exhaustive; will be provided in the final report
  • 21. D e l v e I n s i g h t | P a g e | 20 DelveInsight Copyright Healthcare Market Research Appendix Report Methodology Pipeline product share: - IMB-101 - Generx - Auto CD34+ cells Country/Regional population Prevalent pool Diagnosed patient pool Treated Cases Focused group patient pool Treatment eligible or potential patient pool Revenue by therapies Conversion factors • ACoT • Compliance rate • Market access and Reimbursement MARKET SIZE Prevalence rate Model Flow Diagnosis rate Epidemiology Segmentation Methodology Sub-segmented by Gender, diagnosed patients CAD and RA, NORDA etc. Current Treatment Therapies: • Approved Therapies • Beta-blockers • Calcium-channel blockers • Others • Supportive Therapies ACoT, compliance rate, market access and reimbursement Treatment rate Patient pool Existing market Uptake / Patient share Revenue estimation
  • 22. D e l v e I n s i g h t | P a g e | 21 DelveInsight Copyright Healthcare Market Research DelveInsight is a premier source for pharmaceutical and biotechnology sector analysis, delivering exclusive, trusted commercial insight into industry performance through its proprietary platform. DelveInsight’s reports are continuously updated and revised. The following research methodology is followed for all databases and reports. Coverage The objective of updating DelveInsight coverage is to ensure that it represents the most up-to-date vision of the industry possible. The DelveInsight is a fully integrated solution for comprehensive intelligence on various pharmaceutical products, both in the market and in the pipeline, across the globe. Research Design Secondary Research The secondary research on internal and external sources is being carried out to source qualitative and quantitative information relating to each market. The secondary research sources that are typically referred to include, but are not limited to: • Company websites, annual reports, financial reports, broker reports, investor presentations, and SEC Filings Industry trade journals and other literature. • Internal and external proprietary databases. • National government documents, statistical databases, and market reports. • News articles, press releases, and web-casts specific to the companies operating in the market. Primary Research DelveInsight conducts primary research by interacting with the healthcare professionals, doctors, industry’s experts, and industry participants and commentators in order to validate its data and analysis. The discussion provides first-hand information on the market size, market trends, growth trends, competitive landscape, and future outlook, for example. • It helps in validating and strengthening the secondary research findings. • It further develops the Analysis Team’s expertise and market understanding. • An interactive one-stop, fully integrated business intelligence (BI) platform, catering the need of the global pharmaceuticals market, across all the value chains. • The comprehensive integration allows for the seamless comparison of the market dynamics, helps strategic planning, and decision making to stay competitive in the global pharmaceuticals industry. • We help our clients to find answers relevant to business decision-making, including potential market opportunities, competitor assessments, and business environmental dynamics enhances companies to plan development, trials or process-based research on their competitor focus.
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  • 26. D e l v e I n s i g h t | P a g e | 25 DelveInsight Copyright Healthcare Market Research REPORT PRICE Refractory Angina (RA) Market Insights, Epidemiology, and Market Forecast—2030 Site License 2-3 Users License Single User License Corporate License USD 20,850 USD 13,900 USD 10,450 USD 6,950