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

2

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

COPYRIGHT © PDA 2020

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1. Introduction – Devices for self-injection


Pen

(Patch)

Injector

Auto-

injector

Syringe

and vial

Cartridge

Pre-filled

syringe

4

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


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


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


140

197

58

107

95

108

265

449

163

104 1132

91

115

173

0 200 400 600 800 1000 1200

Cardiovascular

Central Nervous System

Dermatology

Gastrointestinal

Genetic Disorders

Hematological Disorders

Immunology

Infectious Disease

Metabolic Disorders

Musculoskeletal Disorders

Oncology

Ophthalmology

Respiratory

Others

2261

42

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


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


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

3

01

2

4

2

5

23

2

<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


Source: Ypsomed internal information

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2. Trends – Benefits of the platform approach


• 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


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


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


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)


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


0

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10

20

30

40

50

60

1997

1998

1999

2000

2001

2002

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2004

2005

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2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

Number of OBAs per year in US Cumulative number of OBAs in US

Source: Stisali VBA Tracker, Slides Jan. 2018

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2. Trends – Example 3 The global pandemic of patient non-adherence


63

56

56

51

42

40

39

26

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


Yves Grossenbacher

[email protected]

YPSOMED

Brunnmattstrasse 6

CH-3401 Burgdorf

Switzerland

Documents

Trends in the self-injection device market & next