global trends 2025 - the american chamber of commerce in … · 2018-06-06 · 3 ® 2018 iqvia...

Copyright © 2017 IQVIA. All rights reserved.

Tomasz Kluszczynski

Global Trends 2025

1® 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

2

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%


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

5

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

6

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

7IQVIA - Biosimilar Market Trends and Country Archetypes

Adoption of Biosimilars is high, though differs significantly by market, by molecule and by TA

Biosimilar Shares of Molecule Treatment Day(MTH Dec 2017; in %)*

Source: IQVIA MIDAS.

EU

5

Hig

h

pe

ne

tra

tio

n

EU

High

uptake

Low

uptake

Country infliximab insulin glargine etanercept rituximab

UK 88.0% 5.3% 66.7% 66.9%

France 40.5% 6.7% 8.2% 18.8%

Germany 48.9% 7.5% 43.8% 43.4%

Italy 60.9% 15.5% 22.5% 14.5%

Spain 45.7% 8.1% 7.8% 10.4%

Finland 100.0% 3.3% - -

Norway 100.0% 3.4% 87.0% 40.0%

Poland 100.0% 26.2% 50.0% -

Denmark 100.0% 6.2% 100.0% -

Czech 50.0% 13.1% 0.0%* 0.0%*

Slovakia 25.0% 37.7% - -

Japan 4.8% 36.4% - -

Canada 3.4% 2.7% 4.8% -

US 2.9% 15.5% - -

Source: IQVIA; European Thought Leadership; MIDAS MTH December 2017; *Uptake represented within 6 months of launch, GPE (VIAL SC RET) FME (AMPOULES S.C.)

excluded from Insulin calculations, FPE (VIAL SC) FPB (VIAL DRY) excluded from etanercept calculations,FNA (PRE-FILL SYRNG) excluded from rituximab calculations

IQVIA - Biosimilar Market Trends and Country Archetypes

Infliximab example shows dependence of Biosimilar uptake on Regulations (compulsory switch in DK) and existence of Tenders (DK and PL)

Infliximab Biosimilar Market Share in Standard Units(MTH; in %)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

M24M20M16M12M8M4M0

France

Germany

Ireland

Italy Portugal

Poland

Czech Republic Finland

DenmarkCroatia

Sweden

UKSpain

Sta

nd

ard

Un

its

(in

%)


• Six months post launch, infliximab accomplished an almost 100% market share in Denmark; Yet, in France, share values remained below

10% in the same period of time

Denmark: Tender and

Compulsory Switch Poland: Tender Market

IQVIA - Biosimilar Market Trends and Country Archetypes

However, etanercept example reveals uptake differentiation independent of national regulations but dependent on TA specificity

Etanercept Biosimilar Market Share in Treatment Days(MTH Oct 2017; in %)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

M11 M12 M13 M14M0 M19 M20M3M2M1 M16 M17M15 M18M4 M5 M6 M7 M8 M9 M10

Spain

ItalyCzech

FranceNorway

Poland

Ireland

Belgium

Austria

Romania

CroatiaDenmarkUK

SwedenGermany

Tre

atm

en

t D

ays

(in

%)

• Within the first six months post launch, Denmark and Norway have shown the most successful uptake with a +60% market share

• However, in Spain and Ireland market shares have remained low between 0.3-1.4%


Poland: Uptake significantly

slower than Infliximab

10

Innovation & Competitive Dynamics

• Specialty & Targeted Therapies

• Rise of Disruptive Approaches (Cell & Gene)

• Biosimilars 2nd Wave

• Value Added Generics

PharmaCo’s landscape 2018 onwards…

® 2018 IQVIA Commercial – Pharma Trends 2018

Evolving Commercial Model

• Commercial Organization of the Future

• Multichannel: Orchestrated Customer

Engagement

• Intense Patient Focus

Digital Opportunities

• Health Apps

• Digitally Enabled Devices

• Digital Biomarkers

The Regulatory Challenge

• Payer & Policy Maker Influence on Budgets

• New HTA initiatives

• Rise of sophisticated MEAs

• Data Protection (GDPR)

11











Engagement



• Health Apps








12

New wave of innovation is apparent through an explosion of approvals for NMEs in the last few years…

EMA NME (new molecular entity) approvals by therapy area

0

15

30

4541

29

2013

15

2012 20152014

Num

ber

of

pro

ducts

14

2011

5

Musculo-Skeletal

Dermatology

Genito-Urinary

Cardiovascular

Alimentary

Nervous system

Respiratory

Anti-Infectives

Blood

Antineoplastic

Source: IQVIA HTA Accelerator

13

• ~60% of NMEs in 2015 were

priced at a discount to price

comparator, vs. ~20% in 2012

• Oncology products account for

the highest proportion of list

price premiums in 2015 NME

cohort

… however all players are experiencing growing price pressure from payers as they try to contain budgets

Comparative price premiums of EMA New Molecule Entities (NMEs)

0%

20%

40%

60%

80%

100%

20152014201320122011

-5 ~ 5%

-6 ~ -20%6 ~ 20% -36 ~ -99%

-21 ~ -35%21 ~ 35%

36 ~ 99%

>100%

Source: IQVIA HTA Accelerator

14

Similarly, Orphan Drug approvals surge in Europe…

10

18

20

14

7

11

54

10

6

0

5

10

15

20

2017*20162015201420132008 2012201120102009

Orphan drugs in Europe with European Market

Authorisation by approval year (2001-16) – 135 in total

Source: European Medicines Agency October 2017; *to Oct 2017 only

• 146 medicines were reviewed by

the EMA for orphan designation

since 2001-2016.

• As of 2016:

• 90 are approved Orphans

• 45 have been withdrawn

• 11 were refused designation

• 91% (82) of approved Orphan

drugs in 2016 have sales in Europe

in MIDAS

15Source: IQVIA HTA Accelerator

… but restricted or negative outcomes are becoming more common in orphan drug assessments

* Positive = full access as per label; Restricted = access but with label restrictions; negative = no access granted

** In DE, Positive = “minor” or “major additional benefit” rating, Restricted = “non-quantifiable additional benefit”

rating, no negative ratings due to OD law mandating that drugs with OD designation automatically receive an

“additional benefit” rating

Orphan Designated Drug HTA Outcomes

(2013-2016)

22% 29% 27% 24%

43%31%

22%

14%

43%

89%72%

29%42%

78%62%

100%

57%

11%0%

20%

40%

60%

80%

100%

2013-

2016

2006-

2012

2013-

2016

6%

2006-

2012

2013-

2016

2013-

2016

2006-

2012

2006-

2012

Restrictive outcome Negative outcomePositive outcome

n = 18 50 14 56 5 32 9 28

16

EBPs are in the driving seat of extreme innovation, with over 220 highly promising breakthrough therapies

Source: Pharmaprojects, Datamonitor Healthcare, Regenerative Medicine Landscape, Pharma Trends / Regenerative Medicine July 2017

Active medicine therapy developers in the pipeline, preclinical to pre-registration

0

2

4

6

8

10

12

14

16

18

20

22

Novart

is

Celp

rogen

iCell

Gene T

hera

peutics

RE

GE

NX

BIO

Sorr

ento

Thera

peutics

Kite P

harm

a

Juno T

hera

peutics

Zio

pharm

Oncolo

gy

Cellu

lar

Bio

medic

ine

Intr

exon

Geneth

on

NantK

west

Takeda

Sanofi

AG

TC

Editas

Oxfo

rd B

ioM

edic

a

Note: The figure shows companies with 10 or more pipeline products. The company list includes counts as both an originator and licensee

Num

be

r o

f p

rod

ucts

in d

eve

lop

ment

17

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

Immuno-Oncology and Cell & Gene therapies are at the forefront of the new wave of technologies

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

18

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

Immuno-Oncology’s remarkable clinical profile offers unique opportunity through 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

19

Cell & Gene therapies, on the other hand, offer unique value across large number of under- or un-treated diseases

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

20

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


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

22

The value from this shift is also being captured by the Third Sector (Value Added Medicines)

Precision medicine, adaptive clinical

trials, conditional market access,

sophisticated real world data

measurement, and analysis

New Chemical

EntitiesSmall Molecule

Generics

The Third Sector

Route of Administration

Indication extension

Reformulation

CombinationPatent protection

Better outcomes

Better patient experience

More Effective

Greater convenience

Improved compliance

FeaturesPossesses a brand plus at least one other of these features

BenefitsDelivers an advantage to patients, payers or provider on at

least one of these benefits

Safety

Nanotechnology

23

Third Sector products fall on a spectrum of innovation

Source: IQVIA European Thought Leadership

Low innovation High innovation

• Lower price premium

• Lower barrier to entry

• Lower R&D cost

• Higher price premium

• Higher barrier to entry

• Higher R&D cost

Lower level innovation

• Combination

• Formulation

• Dermal patches

Incremental innovation

• Inhalers

• Auto-injectors

Novel delivery technologies

• Nanoparticles

• Microchips

• Minipumps

24











Engagement



• Health Apps









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,using variety of novel mechanisms…

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

26

Collaborative purchasing is gaining momentum; though few initiatives have succeeded thus far

Joint purchasing agreement focused on Orphan drugs

• Pioneered by Netherlands and Belgium

• Joined by Luxembourg and Austria

• Ireland announced it would join

Bulgaria and Romania have entered an agreement to jointly

negotiate pricing and availability

Greece, Portugal, Spain and Italy have called for greater collaboration within the EU to

drive down prices

Sweden increasing joint purchasing of high cost drugs across

county councils

EU commission exploring EU wide pharmaceutical price control

measures, centred around collaboration and price transparency

Dutch insurers introducing joint hospital purchasing schemes for

biologics

Italy restricting confidential pricing agreements

27

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

28

Multiple types of Innovative Agreements (or MEAs) are possible…

INCA Presentation November 2017

Contracting Description

Clinical

Outcomes dependant Reimbursement dependent on demonstrated outcome/ performance (aka Risk share agreements)

Additional evidence

dependant

Access linked to generation of additional evidence to address remaining uncertainty e.g. related to

safety and/ or efficacy; often linked to doubts about real world performance or long-term outcomes

Financial

Price volume linkage Price reduced as volume increases beyond a specified threshold

Cost/patient capping Total cost to payer capped at a certain figure

Discounting Discounts/rebates provided directly to payers

Cost spreading Payment of costs spread across a period of time

Free additional devices/

goods Additional services provided to enhance a product’s value proposition (typically linked to

compliance and therefore efficacy and/ or safety), making it easier for payers to price/ give access

to the new product

Relationship building can also be an incentive, typically of non-product related servicesServices

Disease awareness/

education

Patient support

programs

29

Possible types of contracts

PAYER NEEDS

Efficacy certainty Safety certainty Position certaintyManageable

budget impact

Cost

effectiveness

Clinical

Outcomes dependant ✓ ✓ ✓

Additional evidence

dependant ✓ ✓ ✓

Financial

Price volume linkage ✓ ✓

Cost/ patient capping ✓ ✓

Discounting ✓ ✓

Cost spreading ✓

Free additional devices/

goods ✓

Services

Disease awareness/

education ✓

Patient support

programs ✓ ✓ ✓ ✓

But only few Innovative Agreements are perceived as “mutually beneficial”; those that are may not always be “innovative”

INCA Presentation November 2017

Illustrative

30

Clinical Commercial

Regulatory pressure goes way beyond pricing & reimbursement.PharmaCo’s must comply with increasingly complex regulation

Required

across

lifecycle &

value chain…

… with growing

scope & cost

Diverse stakeholdersFrequent Changes

• Therapy innovation

• Data submission and

exchange (E2BR3)

• Product Definitions IDMP

• Data privacy & security

Pre Clinical

Increased volumes

• Trials

• AEs & ADRs

• M&A

• Product approvals

• Emerging markets

Complex sources

• Social Media/Apps

• Patient data

• Devices data

• Activity data (CRM)

• Payer/Provider: Cost

• Patients/HCPs: Outcomes

at low risk

• Others: anti-bribery, fraud,

transparency, …

Requirement: Capabilities, integrated & at scale

• Domain expertise: 100+ functional areas

• Keep current of frequently changing regulations

• Global and local geographic reach

Today’s reality:

• Fragmented, point solutions, built on aged technologies

• Varied organization designs, multiple buyers and budgets

• No vendor with end-to-end solutions across lifecycle & globe

• Large internal spend – 60% insourced


Regulatory

AffairsPharmacovigilance Medical Affairs CommercialManufacturing Other Legal

Source: IQVIA

31

Fully in force 25th May 2018

GDPR replaces current EU data protection laws and means multi-layer compliance complexity for PharmaCo


Member state* laws

A29WP and DPA guidelines

GDPR baseline rules

Anonymous data

Prescriber behavior

Prescriber contact data

CRO investigator

data

Clinical trial patient data

Business contact data

HR dataWeb user

data

Personal data is any identified or identifiable data

Source: IQVIA

32











Engagement



• Health Apps








33

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

34

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%

35

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.

36











Engagement



• Health Apps








37Source: 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


Ab

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GS

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eca

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rck &

Co

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rck K

Ga

A

Novo

No

rdis

k

Te

va

Am

ge

n

Sa

no

fi

Nova

rtis

Gile

ad

-20%

-10%

0%

10%

20%

30%

40%

50%

-10%

0%

10%

20%

Change in SGA % of Sales, 2015-16 SG&A % of Sales, 2016

Source: IQVIA Institute Annual Report analysis; Note that companies will not be “pure” pharma in all cases

SG&A spend as % of sales has been declining for many players, with sales forces in Europe undergoing considerable downsizing

-40%

-35%

-30%

-25%

-20%

-15%

-10%

-5%

0%

-24%

France

-38%

UK

-12%

Germany Other

Europe

-34%

EU5

-27%

Italy

-16%

Spain

-21%

Evolution of FTE number 2011-2016

Changes in SG&A % of sales 2015-16

SG&A % of sales 2016


Reps agree: Change is coming to the customer-facing team…

Access to HCPs is increasingly challenging

60%-85% of respondents believe it has become

significantly more difficult to access doctors over the last

two years, and see this trend continuing

According to reps, the main drivers will be:

• Less time for F2F meetings: 59-78%

• Increasing restrictions on access: 46%-56%

• Improvement of digital communication: 25-38%

(English/French), # new products (German, 24%)

• 57% of reps said that digital channels had a

positive impact on their ability to do the job

• 94% found their iPads useful

• 74% agreed that HCPs (of all types) respond

best to digital channels in conjunction with F2F

Digital channels are generally

viewed positively

Understanding the environment will be at

core of rep development needs

To optimise success, reps say they will need to improve their knowledge of:

• Country healthcare system decision-making and funding environment

• Outcomes data and real world insights for products they promote

• Specialty therapies and diseases

Reps also believe they will need to improve digital and social media skills

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

40

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

Source: IQVIA


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

Source: IQVIA

• 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…


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


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

44











Engagement



• Health Apps








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