a comprehensive evaluation of the u.s. rheumatic diseases therapeutics market
TRANSCRIPT
A Comprehensive Evaluation of the U.S.
Rheumatic Diseases Therapeutics Market:
Psoriatic Arthritis, Ankylosing Spondylitis, and
Rheumatoid Arthritis Pharmacotherapeutics
Markets
Three Related Complex Diseases with Distinct Unmet Needs
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Contents
Section
The United States Rheumatic Diseases Therapeutics Market—Sample Slides
• Executive Summary
• Market Overview—Segmentation
• Percent Sales Breakdown by Disease
• Percent Sales Breakdown by Therapy—2011 and 2017
United States Market for Psoriatic Arthritis Pharmacotherapy—Sample Slides
• Market Drivers for PsA Pharmacotherapy
• Patient Forecast Discussion
United States Market for Ankylosing Spondylitis Pharmacotherapy—Sample Slides
• Treatment Algorithm
• Patient Forecast—TNF Inhibitor Segment
United States Market for Rheumatoid Arthritis Pharmacotherapeutics—Sample Slides
• Total Rheumatoid Arthritis Pharmacotherapeutics Market—Patient Flow Dynamics
• Rheumatoid Arthritis Pharmacotherapeutics Market—Competitive Landscape
Next Steps
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The United States Rheumatic Diseases Therapeutics
Market—Sample Slides
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Executive Summary—Rheumatic Diseases
• The market for add-on therapeutics for rheumatoid arthritis (RA), psoriatic arthritis
(PsA), and ankylosing spondylitis (AS) collectively earned revenue of approximately
$8,995.8 million in 2011.
• The majority of revenue, 86.1 percent, was from sales for the treatment of RA.
• The tumor necrosis factor (TNF) inhibitors Enbrel, Humira, and Remicade dominate the
market, as first-line standard therapies and combined sales accounted for
approximately 81.0 percent of the revenue in 2011.
• This market share is expected to decline during the forecast period as other biologics
and novel oral therapies gain traction.
• Although overall disease prevalence is not expected to change significantly, the eligible
patient population is expected to grow due to anticipated changes in clinical practice.
• There is a high, unmet need for cost-effective alternatives to biologics and for
alternative mechanisms for TNF refractory patients, particularly for PsA and AS
patients.
Source: Frost & Sullivan analysis.
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Executive Summary—CEO’s Perspective
2The market is dominated by three
entrenched biologic products.
3The high cost of biologics limits patient
access and leaves a large portion of
the market untapped.
4Changes in clinical practice trends such
as earlier diagnosis and earlier initiation
of treatment could expand the market.
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In light of the availability of several safe
and effective therapies, the bar for
approval of new therapies has been
raised significantly.
1Rheumatic diseases are highly
complex disorders; pharmacological
management is inherently challenging.
Source: Frost & Sullivan analysis.
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RA AS
Rheumatic Diseases Therapeutics Market
Rheumatic Diseases Therapeutics Market: Market Segmentation, U.S., 2011
PsA Others¹
Source: Frost & Sullivan analysis.
Market Overview—Segmentation
¹Other noteworthy rheumatic diseases not covered in this research service include
lupus, psoriasis, gout, osteoarthritis, juvenile idiopathic arthritis, fibromyalgia, and scleroderma.
² None currently approved for rheumatic diseases.
*Not covered in this research service.
Analgesics and
NSAIDsCorticosteroids DMARDs TNF Inhibitors
Celocoxib Prednisone
Cortisone
Methylprednisolone
Methotrexate (MTX)
Hydroxychloroquine
(HCQ)
Sulfasalazine
Leflunomide (LEF)
Anti-IL-6
Novel Oral
DMARDs
Acetaminophen
Ibuprofen
JAK inhibitor²
SYK inhibitor²
Background Standard of Care Therapies* Add-on Therapies
Acetylsalicylic acid
Naproxen
Non-TNF
Biologics
Anti-CD20
Anti-IL-12/23
T cell modulator
Anti-IL-17²
PDE4 inhibitor²
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Percent Sales Breakdown by Disease
Note: All figures are rounded. The base year is 2011. Source: Frost & Sullivan analysis.
RA86.1%
PsA8.4%
AS5.5%
Percent Sales Breakdown by DiseaseTotal Rheumatic Diseases Therapeutics Market: U.S., 2011
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Percent Sales Breakdown by Therapy—2011 and 2017
Note: All figures are rounded. The base year is 2011. Source: Frost & Sullivan analysis.
TNF Inhibitors
86.1%
Non-TNF Biologics
13.9%
Percent Sales Breakdown by TherapyRheumatic Diseases Therapeutics
Market: U.S., 2011
Novel Oral DMARDs = 0.0%
TNF Inhibitors
80.9%
Novel Oral DMARDs
3.6%
Non-TNF Biologics
15.5%
Percent Sales Breakdown by TherapyRheumatic Diseases Therapeutics
Market: U.S., 2017
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United States Market for Psoriatic Arthritis
Pharmacotherapy—Sample Slides
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New Evidence of Beneficial Effect On Disease Progression in PsA Will Benefit
Regulatory, Physician, and Payer Acceptance of Emerging Therapies:
• While traditional DMARDs, such as sulfasalazine or leflunomide, are generally effective for
reducing symptoms of PsA in many patients, none have been shown to inhibit disease
radiographic progression in this indication.
o Once considered a mild disease, there is increasing evidence that in many patients PsA is a
progressive disease and is associated with permanent damage to bone and joints and
disability.
o Structural damage may still be occurring despite perceived control of symptoms by
traditional DMARDs.
o The efficacy of DMARDs on radiographic disease progression in an important consideration
for regulatory approval, payer acceptance, and clinical adoption.
• A solid body of evidence on the beneficial effect of biologic agents such as anti-TNFs on
disease progression is accumulating.
• As with rheumatoid arthritis, there is increasing evidence of the long-term benefit on outcomes
of the early initiation of biologic DMARD therapy.
• New therapies that can raise the bar, slowing disease progression and postponing or
preventing disability in PsA patients, will likely experience rapid market uptake.
Source: Frost & Sullivan analysis.
Market Drivers for PsA Pharmacotherapy
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Source: Frost & Sullivan analysis.
Biomarker Description Potential Clinical Use
HLA-C2*06 allele Genetic biomarkerPredicting risk of developing PsA for patients
with type 1 psoriasis
HLA-complex P5 (HCP5) Genetic biomarker Predicting risk of developing PsA
High-sensitivity CRP (hsCRP) Soluble biomarker Diagnosis
Osteoprotegerin (OPG) Soluble biomarker Diagnosis
MMP-3 Soluble biomarker Diagnosis
C-propeptide of type II collagen Soluble biomarker Diagnosis
Composite Psoriatic Disease
Activity Index (CPDAI)Composite score Assessment of disease severity
Selected Biomarkers With Current or Potential Clinical Utility in Psoriatic Arthritis; United States, 2011
Market Drivers for PsA Pharmacotherapy (continued)
The Increasing Trend Toward Personalized Medicine Will Drive Innovation (continued):
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Patient Forecast Discussion—PsA
• Estimates of the prevalence of PsA vary widely, but approximately 15 to 30 percent of
psoriasis sufferers will develop PsA. Psoriatic arthritis affects approximately 0.4 percent of
the general population.
• The patient population for psoriatic arthritis includes those patients with moderate to
severe disease, who are in need of therapy beyond traditional standard of care. This is
estimated to be approximately 60 percent of psoriatic arthritis patients.
• The annual incidence of psoriatic arthritis is expected to remain relatively constant, with a
gradual increase in prevalence closely tied to the aging of the population.
• New criteria imposed for the diagnosis of PsA as well as increasing disease awareness
may eventually result in an increase in the number of diagnosed patients.
Source: Frost & Sullivan analysis.
0.0
2.0
4.0
6.0
8.0
Patient Type
Pa
tien
ts (
milli
on
)
Comparative Prevalence of Patient TypesUnited States, 2011
Psoriasis
PsA
Moderate-to-SeverePsA
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United States Market for Ankylosing Spondylitis
Pharmacotherapy—Sample Slides
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Treatment Algorithm—AS
Treatment Algorithm
Initial pharmacotherapy for AS is treatment with one of a number of NSAIDs. These
drugs can be quite effective in milder cases for the relief of symptoms; however, they do
not have a significant beneficial effect on disease progression. For patients who have an
inadequate response to NSAIDs, second-line treatment is either a DMARD (typically
sulfasalazine) or a TNF inhibitor. Since there are very few available therapies that have
been shown to slow or halt disease progression, patients typically only need to fail at two
or more NSAIDs before initiation of TNF inhibitor therapy is advised.
Source: American College of Rheumatology and Frost & Sullivan analysis.
NSAIDs or COX-2
inhibitors
DMARD monotherapy
(sulfasalazine)
TNF inhibitor therapy
Failure of at
least 2 NSAIDS
or COX-2
inhibitors
Total Ankylosing Spondylitis Pharmacotherapeutics Market:
Treatment Guidelines for AS Pharmacotherapy; U.S., 2011
ORAS
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AS Patient Forecast—TNF Inhibitor Segment
• Growth in the TNF inhibitor patient population is expected to decline following a peak reached in 2011.
• TNF inhibitors are currently the only therapeutic option for AS patients in need of therapy beyond traditional
NSAIDs. However, not all patients respond to this class, and those that do not are left with no other options.
o While some patients will respond to one TNF inhibitor and not another for reasons not fully understood, the
option for TNF inhibitor refractory patients to try a different mechanism is a key unmet need in the current
market.
• The introduction of promising alternative biologics such as inhibitors of IL-17 as well as novel oral therapies
such as PDE4 inhibitors will be important additions to an otherwise small toolbox for the rheumatologist.
• As such, the TNF inhibitor patient population is expected to begin to decline as rheumatologists increasingly
adopt these alternative therapies.
Source: Frost & Sullivan analysis.
(1.0)
0.0
1.0
2.0
3.0
4.0
5.0
6.0
7.0
8.0
9.0
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
2009 2010 2011 2012 2013 2014 2015 2016 2017
Patients 18,928 19,414 20,855 22,386 24,135 25,955 27,515 28,825 30,157
Growth Rate (0.4) 2.6 7.4 7.3 7.8 7.5 6.0 4.8 4.6
Gro
wth
Ra
te (
%)
Pa
tie
nts
Year
TNF Inhibitor Segment: Patient Forecast,U.S., 2009–2017
CAGR = 6.3%
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United States Market for Rheumatoid Arthritis
Pharmacotherapeutics—Sample Slides
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Total Rheumatoid Arthritis Pharmacotherapeutics
Market—Patient Flow Dynamics
0.0
500,000.0
1,000,000.0
1,500,000.0
2,000,000.0
2,500,000.0
Total Estimated RA Patient Population
Moderate-to-Severe Patients
Patients Failing 1st-line Therapy
Patients Failing 2nd-line Therapy
Pa
tien
tsRheumatoid Arthritis Pharmacotherapeutics Market: Patient Flow
Through Treatment ParadigmUnited States, 2011
• Rheumatoid arthritis affects an estimated one percent of the United States adult population.
• Approximately 60 percent of patients are considered moderate-to-severe and are candidates for first-line
therapy, typically methotrexate .
• Approximately 55 to 60 percent of MTX-treated patients will require add-on therapy, typically a TNF
inhibitor.
• Approximately 70 percent of patients respond to their initial biologic treatment. However, an estimated 35
to 40 percent do not but will require an alternative biologic therapy, either a different anti-TNF or a non-
TNF biologic.Source: Frost & Sullivan analysis.
Add-on Population
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Rheumatoid Arthritis Pharmacotherapeutics Market—
Competitive Landscape
Marketed
Pre-
registration
Phase 2
Phase 1
Phase 3
Anti-GM-CSF*Interleukin
Inhibitors
TNF Inhibitors
Humira
(Abbott)
Anti-CD20
Kinase
Inhibitors
Other
Other B/T
Cell Targeting
Enbrel
(Amgen)
Remicade
(Johnson & Johnson)
Simponi
(Johnson & Johnson/Merck)
Cimzia
(UCB)
ATN-103
(Pfizer/Ablynx)
Rituxan
(Biogen/Roche)
Arzerra
(GSK)
GSK315234
(GSK)
KB003
(KaloBios)CAM-3001
(Medimmune)
MOR103
(MorphoSys AG)
Kinaret
(Biovitrum)Actemra
(Genentech)
Actemra - SC
(Genentech)
AIN457
(Novartis)
SAR153191
(Sanofi/Regeneron)XOMA-052 (XOMA)
AMG-827 (Amgen)
LY2439821 (Eli Lilly)
BMS-945429 (BMS)
CNTO-136 (Johnson & Johnson)
CDP6038 (UCB)
Tofacitinib
(Pfizer) Fostamatinib
(Rigel/AZ)
LY3009104
(Eli Lilly/Incyte)
GLPG0634
(Galapagos)
VX-509
(Vertex)
Masitinib
(AB Science)
CCX354
(ChemoCentryx)4SC101
(4SC AG)Xtoll
(Cbio)
BG-12
(Biogen
Rabeximod
(OxyPharma)
Apremilast
(Celgene)
LX2931
(Lexicon)
BIIB023
(Biogen)
Orencia
(BMS)
LY2127399
(Eli Lilly)
Otelixizumab
(BTG/GSK)
RG7424
(Roche)
PF-04236921
(Pfizer) JNJ 38518168
(Johnson & Johnson)
CF101
(CanFite)
BMS-582949
(BMS)
Triolex
(Harbor Biosciences)
Source: Frost & Sullivan analysis.*GM-CSF = Granulocyte-macrophage
colony-stimulating factor
Injectable oral
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Next Steps
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Additional Sources of Information on Rheumatic
Diseases from Frost & Sullivan
Source: Frost & Sullivan research.
• United States Market for Rheumatoid Arthritis Pharmacotherapy
• United States Market for Ankylosing Spondylitis Pharmacotherapy
• United States Market for Psoriatic Arthritis Pharmacotherapy
• U.S. Rheumatoid Arthritis Market: Assessment of Biologics and New
Treatments
• Rheumatoid Arthritis Therapeutics in Indonesia
• Rheumatoid Arthritis Therapeutics Market in Australia
• Rheumatoid Arthritis Therapeutics Market in Taiwan
• Rheumatoid Arthritis Therapeutics Market in Malaysia
• Rheumatoid Arthritis Therapeutics Market in South Korea
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Additional Sources of Information on Rheumatic
Diseases (continued)
Source: Frost & Sullivan research.
• Rheumatoid Arthritis Therapeutics Market in Thailand
• Rheumatoid Arthritis Therapeutics Market in India
• Rheumatoid Arthritis Therapeutics Market in Japan
• Rheumatoid Arthritis Therapeutics Market in Philippines
• Rheumatoid Arthritis Therapeutics Market in China
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Learn More—Next Steps
• Talk to an analyst
• Take our DNA Survey
• Arrange a Growth Workshop
• Explore the Growth Excellence Matrix 2.0
• Attend a relevant live or virtual event
• Explore Healthcare Growth Consulting opportunities
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Contact
Britni MyersExecutive
Healthcare Corporate Communications
(210) 477-8481