2018 global trends & local dynamics - lynx2market.com · biologic pipeline: non-traditional...

Copyright © 2017 IQVIA. All rights reserved.

Tomasz Kluszczynski

Principal and Head of Biopharma

2018 Global Trends

& Local Dynamics

3

Global Overview

4® 2018 IQVIA Commercial – Pharma Trends 2018

Higher than region CAGR

On par with region CAGR

Lower than region CAGR

-4%

-2%

0%

2%

4%

6%

8%

10%

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4

1.6

2016 2017 2018 2019 2020 2021

Global sales (2016-21), Trillions of constant USD

EU5

US

Pharmerging

Japan

CAGR 2016-21

Developed 2-5%

US 2-5%

Japan (-2)-1%

Germany 2-5%

UK* 2-5%

France 1-4%

Italy 2-5%

Spain 2-5%

Canada 2-5%

Pharmerging 6-9%

Pharmerging US$ 5-8%

China 6-9%

Brazil 6-9%

India 9-12%

Russia 6-9%

Turkey 11-14%

Mexico 3-6%G

row

th

The pharmaceutical market grows to $1.4 trillion by 2021,with a CAGR of 3-6%

Notes: *Subject to PPRS rebate; Ex-manufacturer price levels, not including rebates and discounts. Contains Audited + Unaudited data; Growth

considered on par if the there is overlap between country and region CAGR ranges Source: IQVIA, IMS Market Prognosis September 2017


Global biologics sales and trends (Bn of LCUS$, 2011-2017)

Biologics continue to significantly outgrow the overall market,mainly driven by the US

Biologics –

2017 Share of sales

Biologics –

Share of 5 yr growth

-2%

0%

2%

4%

6%

8%

10%

12%

14%250

200

150

100

50

0

Gro

wth

Sa

les

(B

nL

CU

S$

)

201620152014201320122011

Global Pharma growth

Small molecule growth

Biologics growth

Biologics Sales

11%7%

6%

17%59%

9%

8%4%

11%

68%

RoWPharmergingJapanEU5US

Source: IQVIA; European Thought Leadership; MIDAS MAT Q4 2017; IQVIA Market

Prognosis March 2017; Share of growth in LC$. Brazil and Mexico non-retail included


Biologic pipeline: non-traditional biologic indications (from Pre-Clin to Reg)

Novel Biologics are now covering indications typically treated by small molecules

10

11

12

12

12

13

17

27

30

32

34

45

0 5 10 15 20 25 30 35 40 45

No. of pipeline candidates

for indication

COPD

Malaria

Stroke

Osteoarthritis

Pain

Osteoporosis

Heart failure

Allergy

Parkinson’s

HIV

Asthma

Alzheimer’s

Common Factors

• Dominated by small molecules and highly generic

• High patient population

• Aim to treat severe subsections of these indications

• High cost per patient cause payer concern

• Mixed experience with pioneer biologics (Xolair in

respiratory, Praluent & Repatha in hyperlipidemia)

• Biologic specific challenges such as patient

targeting & referral, infrastructure and administration

Source: IQVIA; European Thought Leadership; R&D Focus April 2017; Thought Leadership analysis

7

Global Biosimilar sales and trends (Bn of LCUS$, 2011-2016)

Recent Biosimilars upsurge is mostly due to high uptake in the EU5 and the EU as a whole…

Biosimilars –

2016 Share of sales

Biosimilars –

Share of 5 yr growth

0%

10%

20%

30%

40%

50%

60%

70%

80%

0.0

1.5

2.0

1.0

0.5

Gro

wth

Sa

les

(B

nL

CU

S$

)

201620152014201320122011

Global Pharma growth

Biologics growth

Biosimilar growth

Biosimilar sales

25%

2%

62%7%

4%

62%

5%

26%

6%1%

RoWPharmergingJapanEU5US

Source: IQVIA; European Thought Leadership; MIDAS MAT Q4 2016; IQVIA Market Prognosis March 2017; Share of growth in LC$. Brazil and Mexico non-retail

included® 2018 IQVIA Commercial – Pharma Trends 2018

8

Europe Top 10 biologics sales by region (US$ MAT Q3 2017)

… especially as key biologics already lost or are about to lose exclusivity

Half of the top biologics

have lost protection in

Europe, but not all have

biosimilars yet

Biosimilar delay factors:

• Cost

• Complexity in development

• Patent uncertainty

• Regulatory difficulties and

uncertainties

(mainly US)

Biologic sales (Bn)EU Patent

expiry date

Expired

Expired

Expired

2019

Expired

Expired

2021

2026

2022

Expired

Herceptin (Trastuzumab)1.4 0.6

Humira (Adalimumab)2.8 1.2

Lucentis (Ranibizumab)1.1 0.2

Opdivo (Nivolumab)1.0 0.3

Eylea (Aflibercept)1.1 0.4

Lovenox (Enoxaparin sodium)1.2 0.4

1.3

1.2 0.5

Avastin (Bevacizumab)1.3 0.5

Mabthera (Rituximab)

Lantus (Insulin Glargine)0.9 0.4

0.6

Enbrel (Etanercept)

Abasaglar

Rest of EuropeEU5

Benepali, Erelzi

Truxima, Rixathon

Biosimilars

® 2018 IQVIA Commercial – Pharma Trends 2018 Source: IQVIA; European Thought Leadership; MIDAS Q3 2017

Ontruzant*

Amgevita*, Imraldi*, Cyltezo*

*Approved by EMA but not yet launched

9

Share of absolute growth by region (Forecast 2017-2022)

Growth in US and Europe is in specialty medicine,while other geographies grow in traditional indications

® 2018 IQVIA Commercial – Pharma Trends 2018Source: IQVIA Market Prognosis Q3 2017 Note: at ex-manufacturer price levels, not including rebates and discounts. Contains Audited +

Unaudited data; IHII analysis; Turkey included in AFME, Russia in Asia/Aust./NZ

LATAMLC$ 23Bn Growth

North AmericaLC$ 203Bn Growth

EuropeLC$ 36Bn Growth

AFMELC$ 25Bn Growth

Asia/Aust./NZLC$ 86Bn Growth

87%

13%

Specialty Share of Growth 2017-22

Traditional Share of Growth 2017-22

85%

15%

7%

93%

90%

10%

21%

79%

10

Global Trends

11

PharmaCo’s landscape in 2018

® 2018 IQVIA Commercial – Pharma Trends 2018

Innovation & Competitive Dynamics

• Specialty & Targeted Therapies

• Rise of Disruptive Approaches (Cell & Gene)

• Novel Application Technologies

Evolving Commercial Model

• Commercial Organization of the Future

• Orchestrated Customer Engagement

• Intense Patient Focus

Digital Opportunities

• Health Apps

• Digitally Enabled Devices &

Digital Biomarkers

The Regulatory Challenge

• Payer & Policy Maker Influence on Budgets

• Compliance from Molecule to Market

• Data Protection (GDPR)

• Falsified Medicine Initiative

12

Immuno-Oncology PD-1 and PD-L1 Inhibitor Uptake in the United States

Immuno-Oncology represents the next big wave, driven bytheir remarkable clinical profile and rapid indication expansion


0

200

400

600

800

1,000

1,200

1,400

Nov 2

014

Dec 2

014

Jan 2

015

Feb 2

015

Mar

2015

Apr

2015

May 2

015

Jun 2

015

Jul 201

5

Aug 2

015

Sep 2

015

Oct 2015

Nov 2

015

Dec 2

015

Jan 2

016

Feb 2

016

Mar

2016

Apr

2016

May 2

016

Jun 2

016

Jul 201

6

Aug 2

016

Sep 2

016

Oct 2016

Nov 2

016

Dec 2

016

Jan 2

017

Feb 2

017

Mar

2017

Exte

nd

ed

Un

its T

ho

us

an

ds

Non-Squamous NSCLC

BRAF V600 Wild-Type

Melanoma

(combination with

ipilimimab)

pembrolizumab approvals

nivolumab approvals

atezolizumab approvals

avelumab approval

Squamous

NSCLC

Renal Cell

Carcinoma

BRAF V600

Wild-Type

Melanoma

MelanomaNSCLC

PD-L1+

Melanoma

(first line)

Bladder

Cancer

Melanoma across

BRAF status

(combination with ipilimimab)

Hodgkin

Lymphoma

Head and

Neck Squamous

Cell CarcinomaBladder Cancer

Head and

Neck Squamous

Cell Carcinoma

NSCLC

(first line)

Hodgkin

Lymphoma

Merkel

cell

carcinoma

Source: U.S. FDA, QuintilesIMS, National Sales Perspectives, Feb 2017; QuintilesIMS Institute, Apr 2017

13

Pipeline by Technology Class*

Phase II to Reg

5%

Cell therapy2%

Gene therapy6%

Antibiotic/-bacterial

3%

Other recomb. proteins

5%

Other proteins/peptides

10%

Other/Non specified

13%

55%

Vaccines/antivirals

mAb/mAb

drug conjugated

Cell and gene therapies by phase

Phase II to Reg

43

61Cell therapy

RNAi 19

Antisense/

oligonucleotide

6

Other

gene therapies53

6Exon skipping

Hydrolase

Nucleoside

analogue

20

Oncolytic virus

13

Phase III Registered

Phase II Pre-registration

Advanced therapeutics are increasingly in R&D focus:8% of the pipeline are cell and gene therapies

Source: IQVIA R&D Focus October 2017; Thought Leadership analysis; active phase only

*Not specified excluded (717 products)® 2018 IQVIA Commercial – Pharma Trends 2018 Source: IQVIA R&D Focus October 2017; Thought Leadership analysis

14

CAR T-cells, RNAi and CRISPR gene editing are key therapy approaches of cell and gene therapy

Source: Nature news; IQVIA R&D Focus October 2017; Thought Leadership analysis® 2018 IQVIA Commercial – Pharma Trends 2018

…are modified cells with engineered

receptors, which graft an arbitrary

specificity onto an immune effector cell

Key companies/partners

Novartis, Celgene, Merck, Amgen, Pfizer,

Servier, GSK, Gilea/Kite Pharma, Juno,

Cellectis, Celyad

Key therapy areas

Leukemia, cancer

CAR T-cells

T-cell

modification

…is an efficient and stable process in

which RNA molecules inhibit gene

expression or translation


Alnylam, Sanofi Genzyme, BMS, Quark

Pharmaceuticals, Sylentis

Key therapy areas

Cancer, hepatitis, ophthalmological

disorder

RNAi

(RNA interference/silencing)

DNA mRNA Protein

RNAi

…are techniques which are more

powerful, rapid and less expensive than

any previously invented process


Caribou Biosciences, CRISPR Therap.,

Editas Medicine, Intelia Therap.,

Regeneron, Novartis, Vertex, Bayer, Juno

Key therapy areas

Rare genetic diseases, cancer, HIV, organ

transplants

Gene editing technologies,

including CRISPR

DNANew

mRNA

New

Protein

Guided

new

sequence

Source: IQVIA R&D Focus October 2017; Thought Leadership analysis

15

Cell & gene therapies are developed by specialized companies and large pharma. Oncology and genetic disorders are in focus

Number of pipeline candidates by Top 10 companies

Phase II to Reg

4

5

5

6

8

9

19

2

1

3

3

4

2

GSK

AGTC

Sanofi

Novartis 5

5

Celgene 5

Kite Pharma

Sangamo

Therapeutics

J&J

Alnylam

Ionis

Cell therapy

Gene therapy

Major therapeutic areas of pipeline products

Phase II to Reg

5%Metabolic disease

Ophthalmology6%

Infectious diseaseHaematology

Genetic disorder

12%8%

8%

Oncology34%

6%CNS

6%Musculoskeltal

4%

Cardiology11%

Other

Source: IQVIA R&D Focus October 2017; Thought Leadership analysis® 2018 IQVIA Commercial – Pharma Trends 2018 Source: IQVIA R&D Focus October 2017; Thought Leadership analysis


They improve safety, convenience and compliance, prolonging the lifecycle of therapies

Innovation increasingly covers novel application technologies

Lucideon’s iCRT

Ceramic Pills

Biotech’s

Microchip

Intarcia’s

Medici Mini-Pump

Otzuka’s Sensor-enabled

Abilify MyCite

Problem: Opioid abuse epidemic

Drug: Opioid painkillers

Innovation: Ceramic pills

Outcome: Abuse deterrent

Problem: Daily injections

Drug: Parathyroid hormone

Innovation: Microchip implant

Outcome: Precise automated dosing

Problem: Daily injections

Drug: Exenatide (GLP-1)

Innovation: Mini-pump implant

Outcome: Convenient dosing

Problem: Non-Compliance

Drug: Schizophrenia drug (Abilify)

Innovation: Drug embedded sensor

Outcome: Adherence tracking

Deters abuse

via

Heating

Dissolving

CrushingExtraction

Chewing

Source: IQVIA European Thought Leadership; Device company websites

17







• Biosimilars 2nd Wave






• Health Apps


Digital Biomarkers







Increasing emphasis on drug cost-value

NHS England Cancer Drugs Fund being included under

NICE QALY assessment

NICE QALY cost-effective threshold being reviewed

Italian and French MoH reviewing current drug

reimbursement systems

Post launch payer led RWE scrutiny

France NOAC re-assessment based in part on own RWE

Italy and France Avastin reimbursement 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 Pharmaceutical Price Regulation Scheme (PPRS) scheme

Payers in Europe are focused on managing therapy cost,partially collaborating cross-border, however, …

Price negotiation collaboration and net price transparency

Netherlands and Belgium announced pilot collaborative price

negotiations for orphan drugs

Greek and Portuguese health ministers

call for increasing payer collaborations

Controlling

Costs

Source: IQVIA Thought Leadership analysis

19

Differences

in admini-

strative

capacity

50 national

and

regional

HTA bodies!

Duplication

of work by

national/

regional HTA

authorities

Differences

in the

procedural

framework

Differences

in national

metho-

dologies

Not

financially

sustain-

able over

time at EU

level

… the HTA landscape on EU level is still extremely complex

PharmaCo’s Goals

• Development and timely updates of

European evidence strategies

• Increased use of HQ level input into HTA

processes, avoiding double work with

and by national/regional HTA authorities

• Alignment of the core factors for HTA

(Comparator, Endpoints, Study Duration &

Population, Healthcare Setting)

• Deep understanding of available RWD

to support RCT outcome and prepare for

pricing negotiations

® 2018 IQVIA Commercial – Pharma Trends 2018 Source: IQVIA Thought Leadership analysis

20

The EUnetHTA initiative is seeking to tackle the challenge of putting joint HTA assessments into real life

Joint Action 1

(2010-2012)

Joint Action 2

(2013-2015)

Joint Action 3

2016 - 2019

• Attempt to lower barriers for collaboration

• Deliver context specific reporting of HTA

results, e.g. new application of the HTA

Core Model

• Establish a sustainable structure for HTA

in the EU

• Bringing collaboration to a higher level

resulting in better understanding

• 15 joint pilot assessments performed

during EUnetHTA JA2 (2012-2015)

• Model for scientific & technical cooperation

• Pilot results need to be put into the “real

life” routine HTA production processes of

the EUnetHTA participating organizations

Coordinator: Health Authority DK Coordinator: Zorginstituut NL (ZIN)

Putting HTA collaboration at EU

level into practice

Strengthening practical

application of tools and approaches

Implementing a sustainable

mechanism for HTA cooperation

9 Guidelines

1 Pilot - Rapid Relative Effectiveness

Assessment (REA)

5 Guidelines

6 (Drugs) / 6 (Medical Devices)

Pilot Rapid (REA)

11 Early Dialogues

37 (Drug) / 43 (Medical Devices)

Pilot Rapid (REA)

35 Early Dialogues

® 2018 IQVIA Commercial – Pharma Trends 2018 Source: IQVIA Thought Leadership analysis

21













• Health Apps


Digital Biomarkers






22

A recent study from IQVIA is underlining the increasing importance of digital health

® 2018 IQVIA Commercial – Pharma Trends 2018 Source: IQVIA AppScript Use Categories. IQVIA Institute, Sep 2017

• 318,000 health apps globally available

Plus 200 every day

60/40 wellness vs. healthcare

• 340 consumer wearables

• Top 41 apps account for almost 50% of downloads

55% of top apps use sensor data

• 570 published studies on efficiency

Diabetes, depression & anxiety with strong evidence

• 860 clinical trials worldwide with Digital Health tools

• Estimated $7bn savings in US acute care possible

Diabetes (prevent./therapy), asthma, cardiac & pulmonary rehab.

• Extrapolates to up to $46bn savings across HC systems in US

Selected Study Highlights in Numbers

23

Digital Health is now covering all parts of a patient journey

Monitoring, Advice & Behavior Mgmt.

• Exercise & Fitness

• Diet & Nutrition

• Lifestyle & Stress

• Sleep/Insomnia

• Smoking Cessation

• Alcohol Moderation

= Digital Health Use Categories

Well-being and Prevention

= Patient Journey

Information & Motivation to Act

• General Healthcare Information

• Symptom Checking

• Finding a Clinician

• Managing Clinical and Financial Information

• Social Media

Symptom Onset and Seeking Care

Diagnosis and Treatment Decision

Condition Education & Management

• Self-Monitoring

• Remote Patient Monitoring

• App-Enabled Rehabilitation Program

ConditionMonitoring

Prescription Filling & Compliance

• Prescription Discounts

• Prescription Filling

• Medication Management & Adherence

Treatment

Physician recommends

app-supported disease

management programs,

connected sensors for

remote monitoring, or apps

for any use case across

the patient journey

® 2018 IQVIA Commercial – Pharma Trends 2018 Source: IQVIA AppScript Use Categories. IQVIA Institute, Sep 2017

24

The number of Health Apps doubled in 2 years, with anincreasing focus on health condition management


Number of Digital Health Apps (‘000)

Source: 42 Matters, Jul 2017; Mevvy, Jun 2015; IQVIA AppScript App Database, Jul 2015; IQVIA Institute, Jul 2017

Wellness Management

Health Condition Management

19%

72%

13%

40%

2017

Diet & Nutrition

19%

30%

12%

Lifestyle & Stress

61%

Fitness

2015

18%

Healthcare Providers / Insurance

Disease Specific

Women’s Health & Pregnancy

Medication Reminders & Info

20172015

10%

16%

9%

11%

4%

40%

28%

3%

7%

8%

48%

319

165

67

+148%

201720152013

+93%

25

Besides being part of consumer & patients life, digital solutions are frequently used in clinical trials and Real World studies

Average Enrollment N = 1156 N = 192 N = 3175 N = 99 N = 296

N = 540 Unique Trials


241435

159

357

OtherTelemedicineWeb AppsSensorsMobile

Apps and

Messaging

Number of Clinical Trials including

Digital Health Technologies (by type)Examples of Trials with Digital Health

• Roche: Use of a smartphone and

ACCU-CHEK Connect system application

for patient self-monitoring blood glucose

to determine impact on diabetes-related

distress questionnaires

• Proteus Digital Health: Trials using an

ingestion sensor and a wearable sensor

patch to collect information about patients

taking antiretroviral medications and

tuberculosis medications with feedback

of adherence

Sources: Clinicaltrials.gov, Feb 2017; IQVIA Institute, Jul 2017Notes: Total percent exceeds 100% due to inclusion of multiple digital health types in a single trial; Connected devices connect to an app, EMR or other interface; Mobile apps include use of phones to deliver text messages; Other includes offline computer apps, tablet video or virtual Interaction programs; Web apps are presumed to be mobile accessible.

26













• Health Apps


Digital Biomarkers






27Source: IQVIA

On the commercial side of pharma, we are in the midst of a paradigm shift

® 2018 IQVIA Commercial – Pharma Trends 2018 Source: QuintilesIMS Thought Leadership Publication 2017: Channel Preference vs. Promotional Reality

Past ParadigmCompetitive advantage driven by:

Promotional scale in primary care

Focus on prescribers

Future ParadigmCompetitive advantage driven by:

Promotional precision in specialty

Targeting prescribers plus KOLs,

access stakeholders & patients

One approach fits manyA tailored approach

for each individual customer

Pharma’s value will be driven by a different commercial model

Promoting the productThat, plus innovative

solutions to differentiate beyond

28

Technology that supports an

orchestrated approach to

customer engagement

PharmaCo’s need to be

Tech & social media savvy

Reps become one of many:

Specialty rep, nurse educators

and support, payer liaison,

KAMs,…

New skills are demanded:

• Remote communication

• Disease insight

• Healthcare system insight

• Team working

• Customer networking

Commercial team is likely

to be smaller but with a

broader mix of functions

Pharma’s future value will be driven by a very different commercial team

Source: IQVIA Thougth Leadership analysis

Pharma’s future

customer facing team

Smaller

Different skills

More techenabled

More diverse roles

1

Source: IQVIA


Orchestrated Customer Engagement (OCE) = Breaking down silos, aligning across channels and using all customer insights

Source: IQVIA

2

• Siloed Engagement

• Fragmented data

• One approach fits many, if not all

• Focus on lagging indicators of success

Today Future

• Engagement aligned across functions

• One source of data, available for advanced analytics

• Individual, or at least tailored customer approach

• A learning system, constantly leveraging leading indicators


Intense Patient Focus starts with helping physicians to identify their patients for a therapy, e.g. in rare diseases…

Source: IQVIA Thought Leadership Survey of CSO “The changing role of the rep” – May 2017 (UK only)

3

Identify patients and analyze their medical history PRIOR to 1st diagnosis of the disease

Medical history prior to 1st diagnosis of disease

Patient 1st diagnosed

with disease

Tests &

Diagnostic

Procedures

Treatment

s

Comorbidities/

Misdiagnoses

Specialist

/ER visitsSymptoms

Demographics

Age+

Patients with

the disease

1

Develop an algorithm to identify unique disease

patterns in patients’ pre-diagnosis medical history

Identify patients in wider universe who are identified

by the algorithm as potentially undiagnosed

Patients identified by the algorithm

2 3


… and might go as far as providing a fully integrated solution to support physicians and patients during therapy

Source: IQVIA Thought Leadership Survey of CSO “The changing role of the rep” – May 2017 (UK only)

3

Web services

Mobile App

Call center support

Online community

Differentiating Services Use of Real World evidence

PatientPhysician

Stakeholder ecosystem

Integrated solutions

Ensure patients and physicians can be identified

and followed through course of therapy

Designing, developing

and deploying nurse &

web services, mobile

App, call center support,

and online community

Build technology solution

and processes to collect

real world evidence across

markets and use it to

improve therapy success

One reference data base

Drug safety &

compliance

Track adverse

events

throughout all

channels to

ensure full

compliance

Nurse Support

32













• Health Apps


Digital Biomarkers






2018 global trends & local dynamics - lynx2market.com · biologic pipeline: non-traditional...

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