A Comprehensive Evaluation of the U.S. Rheumatic Diseases Therapeutics Market

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A Comprehensive Evaluation of the U.S. Rheumatic Diseases Therapeutics Market

  1. 1. 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
  2. 2. ContentsSection 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 2
  3. 3. The United States Rheumatic Diseases Therapeutics Market—Sample Slides 3
  4. 4. 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.NAF0-52 4
  5. 5. Executive Summary—CEO’s Perspective Rheumatic diseases are highly 1 complex disorders; pharmacological management is inherently challenging. The market is dominated by three 2 entrenched biologic products. The high cost of biologics limits patient 3 access and leaves a large portion of the market untapped. Changes in clinical practice trends such 4 as earlier diagnosis and earlier initiation of treatment could expand the market. In light of the availability of several safe and effective therapies, the bar for 5 approval of new therapies has been raised significantly. Source: Frost & Sullivan analysis.NAF0-52 5
  6. 6. Market Overview—Segmentation Rheumatic Diseases Therapeutics Market: Market Segmentation, U.S., 2011 Rheumatic Diseases Therapeutics Market RA PsA AS Others¹ Background Standard of Care Therapies* Add-on Therapies Analgesics and Non-TNF Novel Oral Corticosteroids DMARDs TNF Inhibitors NSAIDs Biologics DMARDs Celocoxib Prednisone Methotrexate (MTX) Anti-IL-6 JAK inhibitor² Acetaminophen Methylprednisolone Hydroxychloroquine Anti-CD20 SYK inhibitor² (HCQ) Acetylsalicylic acid Cortisone Anti-IL-12/23 PDE4 inhibitor² Sulfasalazine Ibuprofen T cell modulator Leflunomide (LEF) Anti-IL-17² Naproxen¹Other noteworthy rheumatic diseases not covered in this research service includelupus, psoriasis, gout, osteoarthritis, juvenile idiopathic arthritis, fibromyalgia, and scleroderma.² None currently approved for rheumatic diseases.*Not covered in this research service. Source: Frost & Sullivan analysis. NAF0-52 6
  7. 7. Percent Sales Breakdown by Disease Percent Sales Breakdown by Disease Total Rheumatic Diseases Therapeutics Market: U.S., 2011 PsA 8.4% RA 86.1% AS 5.5% Note: All figures are rounded. The base year is 2011. Source: Frost & Sullivan analysis.NAF0-52 7
  8. 8. Percent Sales Breakdown by Therapy—2011 and 2017 Percent Sales Breakdown by Therapy Percent Sales Breakdown by Therapy Rheumatic Diseases Therapeutics Rheumatic Diseases Therapeutics Market: U.S., 2011 Market: U.S., 2017 TNF Inhibitors 86.1% Non-TNF Biologics Non-TNF 15.5% TNF Biologics Inhibitors 13.9% 80.9% Novel Oral DMARDs 3.6%Novel Oral DMARDs = 0.0% Note: All figures are rounded. The base year is 2011. Source: Frost & Sullivan analysis.NAF0-52 8
  9. 9. United States Market for Psoriatic Arthritis Pharmacotherapy—Sample Slides 9
  10. 10. Market Drivers for PsA PharmacotherapyNew Evidence of Beneficial Effect On Disease Progression in PsA Will BenefitRegulatory, 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.NB3A-52 10
  11. 11. Market Drivers for PsA Pharmacotherapy (continued) The Increasing Trend Toward Personalized Medicine Will Drive Innovation (continued):Selected Biomarkers With Current or Potential Clinical Utility in Psoriatic Arthritis; United States, 2011 Biomarker Description Potential Clinical Use Predicting risk of developing PsA for patients HLA-C2*06 allele Genetic biomarker 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 Composite score Assessment of disease severity Activity Index (CPDAI) Source: Frost & Sullivan analysis. NB3A-52 11
  12. 12. 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. Comparative Prevalence of Patient Types United States, 2011 8.0 Psoriasis Patients (million) 6.0 PsA 4.0 2.0 Moderate-to-Severe PsA 0.0 Source: Frost & Sullivan analysis. Patient TypeNB3A-52 12
  13. 13. United States Market for Ankylosing Spondylitis Pharmacotherapy—Sample Slides 13
  14. 14. 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. Total Ankylosing Spondylitis Pharmacotherapeutics Market: Treatment Guidelines for AS Pharmacotherapy; U.S., 2011 DMARD monotherapy (sulfasalazine) Failure of at NSAIDs or COX-2 least 2 NSAIDS OR AS inhibitors or COX-2 inhibitors TNF inhibitor therapy Source: American College of Rheumatology and Frost & Sullivan analysis.NB3B-52 14
  15. 15. 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. TNF Inhibitor Segment: Patient Forecast, U.S., 2009–2017 CAGR = 6.3% 35,000 9.0 8.0 30,000 7.0 25,000 6.0 Growth Rate (%) 5.0 Patients 20,000 4.0 15,000 3.0 10,000 2.0 1.0 5,000 0.0 0 (1.0) 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 Year Source: Frost & Sullivan analysis.NB3B-52 15
  16. 16. United States Market for Rheumatoid Arthritis Pharmacotherapeutics—Sample Slides 16
  17. 17. Total Rheumatoid Arthritis Pharmacotherapeutics Market—Patient Flow Dynamics Rheumatoid Arthritis Pharmacotherapeutics Market: Patient Flow Through Treatment Paradigm 2,500,000.0 United States, 2011 2,000,000.0 Add-on Population Patients 1,500,000.0 1,000,000.0 500,000.0 0.0 Total Estimated Moderate-to-Severe Patients Failing Patients Failing RA Patient Patients 1st-line Therapy 2nd-line Therapy Population• 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. NB33-52 17
  18. 18. Rheumatoid Arthritis Pharmacotherapeutics Market— Competitive Landscape Phase 1 TNF Inhibitors Anti-CD20 Phase 2 Phase 3 ATN-103 Pre- (Pfizer/Ablynx) Other B/T Arzerra registrationCell Targeting (GSK) Marketed Simponi LY2127399 (Johnson & Johnson/Merck) Kinase RG7424 BMS-582949 (Eli Lilly) Enbrel Inhibitors (Roche) Cimzia (BMS) Rituxan (Amgen) (UCB) LY3009104 (Biogen/Roche) Remicade Otelixizumab Orencia (Eli Lilly/Incyte) (Johnson & Johnson) (BTG/GSK) (BMS) Humira GLPG0634 (Abbott) Tofacitinib (Galapagos) SAR153191 Kinaret (Pfizer) FostamatinibXOMA-052 (XOMA) (Sanofi/Regeneron) (Biovitrum) (Rigel/AZ) Actemra VX-509 AMG-827 (Amgen) AIN457 (Genentech) (Vertex) (Novartis) KB003 LY2439821 (Eli Lilly) CAM-3001 (KaloBios) Actemra - SC (Medimmune) BMS-945429 (BMS) (Genentech) Triolex (Harbor Biosciences) MOR103 CNTO-136 (Johnson & Johnson) Masitinib GSK315234 (MorphoSys AG) (AB Science) LX2931 (GSK) Interleukin CDP6038 (UCB) (Lexicon) CF101 Apremilast (CanFite) Anti-GM-CSF* Inhibitors (Celgene) Rabeximod CCX354 4SC101 (ChemoCentryx) (OxyPharma) BG-12 Xtoll (4SC AG) Injectable oral (Biogen (Cbio) PF-04236921 BIIB023 *GM-CSF = Granulocyte-macrophage (Pfizer) JNJ 38518168 (Biogen) Source: Frost & Sullivan analysis. colony-stimulating factor (Johnson & Johnson) Other NB33-52 18
  19. 19. Next Steps 19
  20. 20. Additional Sources of Information on RheumaticDiseases from Frost & Sullivan• 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 Source: Frost & Sullivan research. 20
  21. 21. Additional Sources of Information on RheumaticDiseases (continued)• 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 Source: Frost & Sullivan research. 21
  22. 22. 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 22
  23. 23. ContactBritni MyersExecutiveHealthcare Corporate Communications (210) 477-8481 britni.myers@frost.com 23

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