Trends in the self-injection device market & next ...
Transcript of Trends in the self-injection device market & next ...
Trends in the self-injection device
market & next generation platform
technologies
Yves Grossenbacher, Business Development
Ypsomed Delivery Systems
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Outline
1. Market overview and update2. Trends and recent developments
– Platform products– Large volume autoinjectors– Patch injectors– Smart / connected devices and drivers for digitalization
3. Conclusions
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1. Introduction – Devices for self-injection
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Pen
(Patch)
Injector
Auto-
injector
Syringe
and vial
Cartridge
Pre-filled
syringe
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1. Market – The development of self-injection devices
1980s 1990s 2000s 2010s
Launch of first
reusable pens
Launch of first
disposable pens
Next generation
disposable pens & first
disposable autoinjectors
Next generation
disposable pens and
autoinjectors
OptiPen (Hoechst)
KabiPen (Pfizer)
Novolet (Novo)
OptiSet (Sanofi)SoloSTAR (Sanofi)
Humira (AbbVie)
Novopen (Novo)
Enbrel (Amgen)
FlexPen (Novo) FlexTouch (Novo)
Cosentyx (Novartis)
Hulio (Mylan)
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1. Market – Self-injection device market & potential
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Source: Ypsomed internal information
Notes: 1) cycles (times ~13 injections); 2) Auto-injector intramuscular i.m.
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1. Market – More injectables than orals in the pipeline
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Source: PharmaCircle - T Kararli, K Sedo and J Bossart, Contract Pharma 2016, p 46-48
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1. Market – Injectable drug pipeline More biologics to be launched in the therapy of oncology mainly
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Cardiovascular
Central Nervous System
Dermatology
Gastrointestinal
Genetic Disorders
Hematological Disorders
Immunology
Infectious Disease
Metabolic Disorders
Musculoskeletal Disorders
Oncology
Ophthalmology
Respiratory
Others
2261
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872
Injectable Drug Pipeline
Biologics Innovators Biosimilars Non-Biologics
Ca. 3100 Drugs
Biologics Drug Pipeline Therapy Areas
Source: GlobalData (Jan. 2018)
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1. Market – Patent expiry of important biologics
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Source: IQVIA MIDAS, MAT June 2018; ARK Patent Intelligenc, IQVIA Institute, Dez. 2018
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2. Trends – Broad adoption of platform-based 1mL autoinjectors24 out of 29 US product launches were based on platforms between 2010-2019
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Notes: 5 non-platform based autoinjector launches: Humira® (AbbVie), Simponi® (JnJ), Avonex® (Biogen), Sumatriptan (Dr. Reddy’s), Makena® (AMAG)
Repatha®
Amgen
Trulicity®
Lilly
Praluent®
Regeneron/
Sanofi
Aranesp®
Amgen
Plegridy®
Biogen
Taltz®
Lilly
Emgality®
Eli Lilly
Enbrel®
Amgen/ Pfizer
Otrexup®
Antares
Bydureon®
AstraZeneca
Cosentyx®
Novartis
Zembrace®
Dr. Reddy’s
Benlysta®
GSK
Epipen®
(generic)/
Teva
Vyleesi®
AMAG
Neulasta®
Amgen
Sumatriptan
Sun Pharma
Rebif®
Merck
Tanzeum®
GSK
Orencia®
BMS
Zinbryta®
Biogen
Kevzara®
Regeneron/
Sanofi
Aimovig®
Amgen/
Novartis
Nucala®
GSK
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<2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
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2. Trends – Strategy of Delivery Systems PlatformsLower risks and shorter timeline for combination product project
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Source: Ypsomed internal information
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2. Trends – Benefits of the platform approach
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• Innovate without time-pressure
• Reduce project risks by basing customer projects on
proven technology
• Shorter and more reliable project timelines
• Prototype devices available immediately for handling
studies
• Clinical devices available quickly
• Reduced project costs and shared manufacturing
equipment
• Known and established patent position
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2. Trends – 2.25mL AIs are becoming standard
• Novel less frequent dosing regimens (e.g. Fremanezumab,
Dupilumab, Lanadelumab, Secukinumab etc.) require the
administration of up to 2.0mL
• Larger injection volumes up to 2ml can be injected within a
short time with little to no pain
• Available platform options for higher injection forces
– with stronger traditional springs (e.g SHL Molly 2.25 or
Ypsomed YpsoMate 2.25)
– improved drive mechanisms with constant force
characteristics (e.g. SHL Rotaject or Ypsomed YpsoMate
2.25 Pro) suitable especially for high viscosities
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2. Trends – ExampleThe first approved and launched 2.25 mL prefilled autoinjectors
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TEVA with
AJOVY®
Sanofi with
DUPIXENT ®
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2. Trends – Wearable injectors making headwaySignificant opportunity for patch-injectors
• More than 3’100 biologics are in development for cancer (>800), orphan indications
(>500), neurology (>400), autoimmune diseases (>300) and others (>500)
• Many (cancer) formulations are moving from i.v. to subq allowing the possibility of
more home treatment:
Lower costs due to reduced HCP intervention
Increased patient acceptance of therapies that are still regarded as HCP domain
• Trend towards even less frequent injections (monthly, quarterly) which require even
larger injection volumes
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2. Trends – Example and features of patch injectors
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Device Description
Ypsomed
YpsoDose
Prefilled, pre-assembled,
electromechanical,
3-10ml
West
SmartDose I
Prefilled, patient
assembled,
electromechanical, 3.5ml
West
SmartDose II
Prefilled, patient
assembled,
electromechanical,
3.5 and 10ml versions
BD
Libertas
Prefilled, pre-assembled,
mechanical,
5ml, 10ml
Device Description
Enable enFuse Patient filled, mechanical,
5, 10, 30, 40, 50ml
Insulet
OmniPod
Patient filled,
Specialised infusion
pump, 2ml
Sorrel
Injector
Prefilled, patient or pre-
assembled,
electromechanical,
various cartridge sizes
Gerresheimer
Patch Pump
Patient filled,
semi-disposable,
electromechanical,
various volumes
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One device for fixed doses of 3-10ml
Injection time typically in range 5-30 minutes
Patch including skin detection
Automated needle insertion and safety
Patch and inject for simple and ergonomic handling
Standardised cartridge compatible with existing
filling processes
Unique electromechanical drive system for a range
of fill volumes and viscosities
2. Trends – YpsoDose features & benefits
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2. Trends – Towards connected devices for self-injections
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Improving patient support and convenience (Example 1)
Trend toward outcome-based payments and need to analyze real-world effectiveness (Example 2)
Improving patient adherence (Example 3)
Market pull
Compact and low-cost processing power and data storage
Sensor miniaturization and energy efficiency
Network benefits of ubiquitous wireless connectivity
Big data analyticsResearch shows: Smart
devices increase adherence
Technology push
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2. Trends – Example 1: Connected autoinjector improving patient support and convenience (1/2)
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2. Trends – Example 1: Connected autoinjector improving patient support and convenience (2/2)
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Transform
w/o
change
Transforms platform autoinjector into
a connected system without
modification
GuidanceSupport patients real-time and step-
by-step
Tracking
Captures date/ time and
result of injection; detects
successful injections and use
errors
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2. Trends – Example 2Outcome-based payments are changing the industry
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Source: Stisali VBA Tracker, Slides Jan. 2018
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2. Trends – Example 3 The global pandemic of patient non-adherence
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Multiple sclerosis
HIV
Rheumatoid…
Type II diabetes
Ulcerative colitis
COPD
Psoriasis
Asthma
Median of overall adherence
month 12, % adherent patients• Non-adherence costs the US healthcare system
$290bn annually
• 50 to 60 percent of patients with chronic illnesses
don’t take medication properly
• 125’000 patient lives are lost in the US due to
non-adherence
• 10 percent of hospitalizations could be avoided
through better adherence
Source: McKinsey (2018)
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4. Conclusions
• Market for self-injection devices for both originator and biosimilar drugs is increasing
significantly
• Significant demand for larger injection volumes for autoinjectors and a new product
class of wearable patch injectors
• There are strong drivers for digitalization and connectivity in the injection and injector
area
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Thank you for your attention
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Yves Grossenbacher
YPSOMED
Brunnmattstrasse 6
CH-3401 Burgdorf
Switzerland