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Wachstumsmarkt Healthcare Industrie - Gewinner und Verlierer

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Dr. Frank Wartenberg, President Central Europe QuintilesIMS, berichtet über den Wachstumsmarkt Healthcare Industrie.

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Wachstumsmarkt Healthcare Industrie - Gewinner und Verlierer

  1. 1. Copyright © 2016 QuintilesIMS. All rights reserved. Wachstumsmarkt Healthcare Industrie Gewinner und Verlierer Dr. Frank Wartenberg President Central Europe QuintilesIMS
  2. 2. 1 Source: IMS Market Prognosis March 2016; at ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; Sept 2015 forecasts used for all countries outside of top 52 Der Gesundheitsmarkt wächst bis 2020 4-7% jährlich © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Developed Markets CAGR 2016-2020 US 6%-9% Japan (-1)%-2% Germany 3%-6% UK* 4%-7% Italy 2%-5% France (-2)%-1% Spain 2%-5% Canada 3%-6% Developed 4%-7% Pharmerging Markets CAGR 2016-20 LCUS$ China 5%-8% Brazil 7%-10% India 10%-13% Russia 6%-9% Turkey 12%-15% Mexico 2%-5% Pharmerging LCUS$ 6%-9% Pharmerging US$ 4%-7% Global Sales and Market Growth At par with region CAGR Lower than region CAGR Higher than region CAGR *Subject to clawback 0% 2% 4% 6% 8% 10% 12% 0 200 400 600 800 1.000 1.200 1.400 1.600 2015 2016 2017 2018 2019 2020 Growth Sales(BnLCUS$) Global sales Developed growth Pharmerging growth
  3. 3. 2 Die Top-8 tragen rund zwei Drittel zum Wachstum bei © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) 41% 55% 8% 8% 4% 1%19% 13% 8% 8% 8% 9% 11% 6% Rest of World Pharmerging T3 & T4 BRI China Japan EU5 Canada US 44% 2% 13% 6% 11% 6% 7% 12% Region Contribution to Global Growth 2020 Region Market Share 2011 - 2015 2016 - 2020 BRI Pharmerging T3 & T4 China Japan EU5 Canada US RoW AbsolutegrowthcontributioninLCUS$ Source: IMS Market Prognosis March 2016; at ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; Sept 2015 forecasts used for all countries outside of top 52
  4. 4. 3 Deutschland wächst im Vergleich zu anderen europäischen Ländern stark © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Top 25 Europe Growth dynamic EU RestEU5 2011-2015 Europe CAGR 2.8% 2016-2020 Europe CAGR 2- 5% Source: IMS Health Market Prognosis, May 2016, at ex-manufacturer price levels, excluding rebates and discounts. Contains Audited + Unaudited data. Bubble Size indicates 2014 US$ Sales; Europe excludes Russia 1 0 -1 3 10 6 14 5 2 3210-1 98765-2-5-6 4 4 Sweden Netherlands Belgium Switzerland Poland Finland Denmark RomaniaPortugal Greece Historical Growth % (CAGR 2011-15) Turkey Spain Italy England Hungary France Germany Austria PrognosedGrowth%(CAGR2016-20) Slovenia Croatia Bulgaria Slovakia Norway IrelandCzech Republic
  5. 5. 4 Hauptwachstumstreiber in Europa bis 2020 sind die Spezialtherapeutika Anteil absolutes Wachstum 2015-2020 & 2020 Umsatz nach Region © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) 93% 7% Traditional 2020 Sales Specialty 2020 Sales 93% 7% Traditional Growth 2015-20 Specialty Growth 2015-20 66% 34% 64% 36% 94% 6% 93% 7% 60% 40% 24% 76% 82% 18% 79% 21% LATAM LC$ 20Mrd Growth North America LC$ 152Mrd Growth Europe LC$ 42Mrd Growth AFME LC$ 21Mrd Growth Asia LC$ 88Mrd Growth Source: IMS Health Market Prognosis September 2015; at ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; IHII analysis
  6. 6. 5 Onkologie und Autoimmun-Krankheiten werden die führenden Therapiegebiete gemessen am Umsatz © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Oncology Autoimmune Viral Hepatitis Immunosuppressants HIV Antivirals Immunostimulants Interferons Erythropoietins Macular Degeneration *Sales in 2020 CAGR 2016-2020 9-12% 11-14% 7-10% 11-14% 1-4% 2-5% 1-4% 0-3% 6-9% $100-120Bn $55-65Bn $45-55Bn $20-30Bn $20-30Bn $15-18Bn $7-9Bn $7-9Bn $6-8Bn *Sales represented in constant US dollars. Leading Specialty Therapy Areas Source: IMS Health, IMS Therapy Prognosis, September 2015; IMS Institute for Healthcare Informatics, October 2015 Note: Leading traditional therapy areas shown for 8 developed countries and 6 pharmerging countries.
  7. 7. 6 Spezialtherapeutika sind klassischerweise teure Produkte mit geringem Volumen © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) 100.0% 80.0% 60.0% 40.0% 20.0% 0.0% 2015 $142.4 Bn 61.7% 10.2% 16.8% 11.3% 2010 $146.2 Bn 73.2% 7.8% 11.3% 7.7% EU 5 – Concentration of product sales volume in SU bn US$ All othersProducts 51-100Products 11-50Top 10 products 4.0% 2.0% 0.0% 100.0% 8.0% 98.0% 6.0% 2015 411.1 Bn 94.7% 2.8% 1.9%1.7% 2.2% 95.4% 409.9 Bn 2010 0.6%0.7% EU 5 – Concentration of product sales in bn US$ Source: IMS Health, MIDAS MAT Q4 2015, US$ and SU
  8. 8. 7 Das führt zu einem stärkeren Wachstum im Spezialtherapeutika-Markt als im traditionellen Markt Mehr als die Hälfte der neuen Spezialtherapeutika generieren >150mn Umsatz in den ersten zwei Jahren © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) 0 100 200 300 400 500 Traditional Specialty Productsalestwoyearsafterlaunch (LCUS$mn) Top 20 companies: NME launch performance distribution (Includes NMEs launched 2006-2013) n = 69 n = 75 ½ specialty NME launches achieved over $150 Mn sales within two years of launch½ traditional achieved over $67Mn Median Lower quartile Upper Quartile Source: IMS Health MIDAS Q3 2015
  9. 9. 8 Teure Produkte wie Sovaldi beeinflussen die Entscheidungsträger in ihrer Erstattungspolitik © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Confidential discount with some sick funds prior to the GKV-SpV negotiation oucome, which is ground-breaking German government attempts to set a revenue threshold for the first year of free-pricing at €250m NHS England delayed Sovaldi’s introduction by 4 months; this is unprecedented Agreement to refund the cost of Sovaldi for any patient not cured; this type of agreement is not common in France MSSSI set population maximum expenditure caps for each recent innovative HCV launch separately (€125m/year for Sovaldi) AIFA set up an ad hoc fund of €750m to treat a maximum of 50.000 patients with Sovaldi in 2015
  10. 10. 9 Die Herausforderungen für Market Access in Europa sind zahlreich und die Zukunft ungewiss © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Price negotiation collaboration • NL and BE announced pilot joint price negotiations for orphan drugs • GR and PT health ministers call for increasing payer collaborations • Increased transparency of net price Post launch payer led RWE scrutiny • France NOAC re-assessment based in part on own RWE • Italy and France Avastin reimburse- ment for use in AMD • Infliximab switching NOR-SWITCH Budget caps and pharma payback schemes • Portugal and Italy reviewing payback mechanisms for budget overspend • French HCV spending cap • UK PPRS scheme Increasing emphasis on drug cost-value • NHS Cancer Drugs Fund being taken in under NICE QALY assessment • NICE QALY threshold being reviewed • French and Italian MoH reviewing current drug reimbursement system PMA uncertainty
  11. 11. 10 Launches von teuren Produkten werden zudem verzögert © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) DelayinMonths Top 5 onco drugs (launched 2011-2015), delay from 1st country’s launch, EU5 $107 $213 $57 $124 $37 4 9 2 1 18 8 9 3 20 12 6 5 27 10 16 18 1 10 1 SpainFranceItalyGermanyUK JakaviPerjeta ImbruvicaXtandiZytiga MAT 12/15 sales (Mio) Source: IMS Health, MIDAS December 2015, Rx only. Delay calculated from 1st country’s launch in one of the EU5 markets. Country ranked by months of delay since first launch; drugs ranked by sales in EU5. Imbruvica not launched yet in Spain (the 18 months equal the time between first launch and April ’16)
  12. 12. 11  The increased competition affects not just the price for the directly comparable product but also the price of the whole product class  The countries with the highest reduction show reduction of 50-70%  Caveat – prices used in the study are list prices. It can be assumed that additional discounts have been agreed in certain situations Biosimilars versprechen eine „günstigere“ Alternative © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Price per treatment day (2014/year before biosimilar entrance) -27 -13 -16 -61 -2 -20 -45 -28 -44 -36 -28 -29 -71 -30 -29 -29 -22 -30 -41 -13 -15 -18 -48 -10 -12 7 -10 -21 -5 UK -8 ES SK IT HU DE EU FR CZ AT Epoetin alfa HGH G-CSF Source: IMS Health (2015): The Impact of Biosimilar Competition
  13. 13. 12 Sandoz konnte durch seine Investments in den Bereich Biosimilars eine führende Rolle einnehmen © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) molecule, Brand (EU market size before biosimilar launch) somatropin, Genotropin ($0.3bn) epoetin alfa, Erypo ($0.7bn) epoetin zeta filgrastim, Neupogen ($0.4bn) infliximab, Remicade ($1.7bn) follitropin alfa, Gonal-F ($0.2bn) 1st EMA approval Sandoz Sandoz Stada Teva Celltrion P/M Teva 2nd EMA approval Medice Pfizer (Hospira) Sandoz Samsung Finox 3rd EMA approval Pfizer (Hospira) 4th EMA approval Apotex 5th EMA approval Accord molecule, Brand (EU market size before biosimilar launch) insulin glargine, Lantus ($1.4bn) entanercept, Enbrel ($2.1bn) pegfilgrastim, Neulasta ($0.6bn) rituximab, Mabthera ($1.8) adalimumab, Humira ($3.3bn) 1st EMA approval Lilly Samsung Stada Celltrion Amgen Unknown company Sandoz Sandoz Sandoz Unknown company Unknown company Approval Order Approval Order Under review by the CHMP/EMA Established generic & biosimilar player Source: EMA website June 2016; submission data from June 2016
  14. 14. 13 In den kommenden Jahren werden Biosimilars primär für onkologische und autoimmun Krankheiten erwartet © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) 12 23 1 23 32 0 5 10 15 20 25 30 35 No.ofbiosimilarsindevelopment PhaseIII Pre-Reg/Reg PhaseII PhaseI Preclinical Biosimilar pipeline by phase 2015 Pre-clinical to registration 5 2 2 3 3 3 3 7 10 25 28 0 5 10 15 20 25 30 Erythropoietins Antidiabetics Sex Hormones Dermatologics Number of biosimilars in development * Multiple Sclerosis Others Growth Hormones Oncologics HGFs Immunosuppr. Autoimmune Biosimilar pipeline by therapy area 2015 Pre-clinical to registration 35 biosimilars in late stage development Source: IMS Health R&D focus Dec 2015; Not exhaustive
  15. 15. 14 Der Uptake von Biosimilars in Nicht-Tender-Ländern ist jedoch nur sehr langsam und gering Marktpenetration EU5: im ersten Jahr 10-24% © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Europe: Infliximab biosimilar market share 0% 20% 40% 60% 80% 100% M0 M2 M4 M6 M8 M10 M12 M14 M16 M18 M20 M22 M24 Infliximabbiosimilaruptake Denmark Poland Norway Italy UK Spain Germany France 98% 94% 86% 24% 23% 20% 10% 15% EU5 Tender system markets Other European countries Source: IMS MIDAS monthly Dec 2015 ; Denmark data from MIDAS Monthly Restricted database; Bulgaria, Latvia excluded because only biosimilar manufacturers present in market
  16. 16. 15 Die Regularien für den Market Access von Biosimilars ändern sich jedoch – zu Gunsten der Biosimilars © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Source: QuintilesIMS Proposed new concrete biosimilar approval guidelines in 2016 Behind in terms of regulation, particularly on clinical requirements and length of regulatory process Established biosimilar legislation and guidance (PMDA) Established biosimilar legislation and guidance aligned to EMA framework. Fully established framework and solid draft guidance for biosimilar Mab. Substitution not allowed Guidance published. Global reference product accepted Regulatory maturity framework Fully established framework Lack of a clear framework Legal pathway established, FDA guidelines published. Pathway now being tested Pathway under development. Access through national and regional tenders Global Biosimilar Landscape Guidance finalized in 2010. Dual pathway with abbreviated non- clinical and clinical data Guidance finalized. No clear clinical criteria for biosimilar approval (case-by-case approach) •Regulatory framework of biosimilars in EMs varies and likely to evolve differently from country to country •Competition of biosimilars vs. NOBs in EMs to be influenced by local policies (e.g. PDPs in Brazil) Approval of a “biosimilar product” requires submission of an “abridged” application to the MOH. Biosimilars have interchangeable status
  17. 17. 16 Auf lange Sicht werden drei Faktoren, den Uptake von Biosimilars beeinflussen © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Market opportunity for biosimilar players Huge financial incentive in pursuing this growing market Payer will Cost Savings (~20-30% vs. Originator) and better patient healthcare management Patients seeking access Affordable Access to breakthrough therapies leading to better health outcomes Source: IMS Health
  18. 18. 17 • Reimbursement systems, set-up of healthcare delivery and physician behavior influence success of new developments (e.g. biosimilars) and innovations • Understanding country specific healthcare environments and consider them in the companies strategy is key to success • Price pressure and market access hurdles will remain crucial for launch success • Companies need a thorough and comprehensive market access and strategic pricing strategy • Oncology products and autoimmune products will be the most important therapy areas • R&D of successful companies target leading therapy areas Der Pharmamarkt boomt – doch wer nimmt am Erfolg teil? Wrap-up © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Therapy Area Market Access Strategy Healthcare environment Source: IMS Health
  19. 19. 18 Please contact me for further information © 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) Dr. Frank Wartenberg President Central Europe frank.wartenberg@quintilesims.com +49 (0) 69 6604-4315 Follow me on Twitter: @FrankWartenberg
  20. 20. 19© 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) © 2016, IMS HEALTH GmbH & Co. OHG Alle Rechte vorbehalten. Die Informationen dürfen weder ganz noch teilweise ohne vorherige ausdrückliche Erlaubnis von IMS HEALTH GmbH & Co. OHG vervielfältigt, gespeichert, weiterverarbeitet und in keiner Weise zugänglich gemacht werden. Die gegebenenfalls im Zusammenhang mit Daten verwendeten Begriffe „Patient, Arzt, Arztpraxis, Verordner oder Apotheke“ bezeichnen keine personenbezogenen, sondern ausschließlich (nach § 3 Abs. 6 Bundesdatenschutzgesetz) anonyme Informationen. IMS stellt durch den Einsatz modernster Technologien und Verfahren sicher, dass seine Dienstleistungen, unabhängig davon wie die Daten untereinander verknüpft werden, den Datenschutzbestimmungen entsprechen.
  21. 21. 20© 2016, QuintilesIMS – Dr. Frank Wartenberg (Twitter: @FrankWartenberg) © 2016, IMS HEALTH GmbH & Co. OHG All rights reserved. The information may not be duplicated, stored, further processed, nor be made accessible in whole or in part to any third party without the prior express written consent of IMS HEALTH. In connection with data/figures used terms, such as „patient, doctor, medical practice, prescriber or pharmacy”, do not designate any personal data but exclusively anonymous information (in accordance with § 3 Abs. 6 “Bundesdatenschutzgesetz” – German Federal Data Protection Act) IMS employs high sophisticated technologies and methods which ensure all its Information Services to meet the applicable data-protection requirements, regardless the way data are combined with one another.

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