The Global Use of Medicines 2022 - OUTLOOK TO 2026 - IQVIA
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The Global Use of Medicines 2022 O U T L O O K TO 2 0 2 6 JANUARY 2022 Copyright © 2020 IQVIA. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States and various other countries.
Agenda
▪ Welcome and introductions
Murray Aitken, Executive Director, IQVIA Institute for Human Data Science
▪ Global outlook and drivers
Michael Kleinrock, Research Director, IQVIA Institute for Human Data Science
▪ Regional Highlights
• U.S.
• Europe
• China
• Japan
• Latin America
▪ Audience questions and moderated discussion
Murray Aitken
▪ Closing
1Today’s panelists
Alan Thomas
Sarah Rickwood Director, Strategic
VP, Thought Leadership Planning
and Marketing Japan
EMEA Howard Chen
Hannah Law Head of
VP, Thought Leadership Management
and Marketing Consulting
U.S. China
Sydney Clark
VP, Consulting Services
LATAM
2
2Global outlook and drivers
3Key Points
1. Global spending on COVID-19 vaccines is modeled to be $250Bn through 2026, though cost and volume
estimates vary, and overall medicine spending is expected to exceed the pre-pandemic outlook by $133Bn
to 2026 and grow 3-6% CAGR through 2026, reaching about $1.8 trillion in total market size.
2. Overall volume is projected to grow 1.5% in days of therapy through 2026, driven by pharmerging growth
of 2.0% CAGR, while low-income countries are expected to grow at just 0.6% CAGR.
3. Slowing growth across key geographies is expected as health systems absorb pandemic costs and
manage spending from the continuing historically high numbers of new medicines.
4. The two leading global therapy areas — oncology and immunology — are forecast to grow 9–12% and 6–
9% CAGR, respectively, through 2026.
5. Treatments for autoimmune disorders are forecast to reach $178 billion globally by 2026, driven by steadily
increasing numbers of treated patients and new products, and offset after 2023 due to biosimilars.
6. New therapies contribute to rapid acceleration of neurology markets, including novel migraine therapies,
potential treatments for rare diseases, and the potential for therapies for Alzheimer’s and Parkinson’s.
7. The outlook for next-generation biotherapeutics includes significantly uncertain clinical and commercial
prospects for cell, gene and RNA therapies, which will grow to $20 billion in spending by 2026.
4Global spending, including COVID-19 vaccines and therapeutics,
to exceed pre-pandemic outlook by $133Bn to 2026
Changes in the historical and projected global medicine pending model due to COVID-19, 2019–
2026, US$Bn
1,900
Spending outlook change
1,800
Incremental spend for COVID-19 vaccines & therapeutics 41 due to COVID:
Current outlook excluding COVID vaccines
1,700
Pre-COVID-19 outlook
39 $133Bn, 2020–2026
39
1,600
48
42
=
1,764 COVID-19 vaccine spending:
1,500
97 1,689
1,400
3 1,615 $251Bn
1,489 1,550
1,300
1,424 ($185–$295Bn)
1,297 1,340
1,200
2019 2020 2021 2022 2023 2024 2025 2026 +
3E+11
Cumulative difference, US$ Billion 251 COVID-19 therapeutics:
217 $58 Billion ($48-69Bn)
185
2.5E+11
2E+11
155 133
121 105 114 123
84 88
+
1.5E+11
1E+11
58 35 44 50 58
5E+10
3 16 26
0
COVID-19 disruption impact:
-$175Bn 2020–2026
-5E+10
-28 -25 -41
-60
-1E+11
-85 -175
-115
-1.5E+11
-2E+11
-145
2019 2020 2021 2022 2023 2024 2025 2026
Cumulative difference in non-COVID spending from pre-COVID-19 levels Cumulative Covid-19 vaccine spending
Cumulative COVID-19 therapeutics Total cumulative difference from pre-COVID-19 levels
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science.
5Global market growth will return to pre-pandemic projections by
2025 despite year-to-year fluctuations
Comparison of current outlook to pre-COVID outlook
Constant dollar growth forecast (invoice) Key events in the outlook
12%
1 2020: -2.1% (~$27Bn)
10% Incremental COVID-19-related
usage for treatments and vaccines 2 2021: +1.1% above pre-Covid-19
growth; +2.9% above 2020 growth
8% 3 Post-pandemic excluding vaccine and therapeutics
economic/budget
pressures 3 2021: +8% higher growth including
6% vaccines and therapeutics compared
5 to spending without them
4% Demand
2 4 2022: Significant decline in required
impact
spending for COVID-19 vaccines as
Post- much of the world is inoculated to
2%
during 1 pandemic Vaccine spending some degree
pandemic volume 4 declines with shift to
rebound boosters 5 Expected budget pressures will
0% emerge from longer-term pressures
2019 2020 2021 2022 2023 2024 2025 2026 of sustained pandemic
Pre-COVID-19 outlook
Current outlook excluding COVID-19 vaccines & therapeutics
Current outlook including incremental spend on COVID-19 vaccines & therapeutics
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science.
6The use of medicines particularly in pharmerging markets grew in
2020 despite the pandemic but will normalize beginning in 2021
Historical and projected use of medicine by segment, 2011–2026, Defined Daily Doses (DDD) in
Billions
Forecast
5-Year
5-Year CAGRs
3,782 CAGRs 3,877 3,965 3,971 3,944
5-Year 3,773
4,000
3,628 3,665 191 192 192 191 1.5%
CAGRs 3,469 204 2.9% 189
3,297 204 185 0.6%
-2.8%
3,500
3,109 3,177 4.2% 195
2,998 194
3,000 2,881 213 214 1.8%
225
2,590 2,683 218
198 2,452 2,458 2,442
196 2,236 2,215 2,295 2,378
2,500
6.5% 2,010 2,128 4.6% 2.0%
1,885
1,724 1,769
1,502 1,585
2,000
1,294 1,374
1,500
1,000
500
1,100 1,111 1,162 1,188 1,172 1,194 1.6% 1,218 1,264 1,297 1,343 1,265 1.2% 1,289 1,308 1,321 1,321 1,311
0.7%
-
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Lower income Pharmerging Developed
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science.
7The global medicine market — using invoice price levels — is
expected to grow at 3–6% CAGR through 2026 to about $1.8Tn
Global medicine market size and growth 2011–2026, const US$Bn
Forecast
5-Year
2,000
5-Year 1,750– CAGRs
1,800 CAGRs 1,780 Overall
5-Year Overall 3-6%
1,600 3-6%
CAGRs 1,424 5.1%
1,400 Overall 0.1%
6.5%
1,200 1,112
1,000 4.8%
813 11.4% 7.8% 5-8%
800
600
400 5.3% 4.3% 2-5%
200
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Developed Pharmerging Lower income
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
8
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science.Strong growth in pharmerging markets and new brands in
developed markets will lift global spending through 2026
Spending and growth drivers 2016–2026 const US$Bn
Forecast
1,750–
1,780
2016 2021 2026
Spending Spending Spending
10 Developed 10 Developed
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science
9New brand spending in developed markets projected to be similar
to the last 5 years but a smaller share of spending
Ten developed countries new brand spending
Total 2012−16 = $177Bn Total 2017−21 = $161Bn Total 2022−26 = $196Bn
60 12%
New brands % of total brand spending
New brand spending const US$Bn
50 Forecast 10%
40 8%
30 6%
20 4%
10 2%
17 15 34 55 57 38 35 36 26 26 31 40 42 41 42
0 0%
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Global
79 Average launches projected at 54–63/year
NAS 36 42 56 46 39 48 59 51 79 (290–315 launches within 5-years)
Launches
(77-81)*
New brand spending New brands share of brand spending
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 10The impact of exclusivity losses will increase to $188Bn over
the next 5 with a large increase in the impact of biosimilars
Developed markets impact of brand losses of exclusivity 2017–2026, US$Bn
Forecast
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
0
-1.4 -3.7 -5.5 -5.2 -6.4
-23.4 -9.7 -11.6
-5
-20.5 -14.8 -13.8
-10
-21.9 -10.5 -25.5
-9.4 -23.0
-15
-24.3
-28.8 -24.8
-20
-15.7
-19.1
-14.9
-25
-24.7 -24.3
-30
-27.4
-35
-31.9
-35.9
-37.9
-40
-38.6
-45
-43.7
-50
$25Bn $86Bn $70Bn $118Bn
$111Bn $188Bn
Biologic Small $ Total brand loss due to LOE
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science
11Global savings from biosimilars will have a significant impact on
country medicine spending through 2026
Global savings from biosimilars 2021-2026
5-year savings scenarios
120
$215Bn base case ($165–270Bn Range)
100
80
60
40
20
0
2021 2022 2023 2024 2025 2026
Savings high-low range Savings
Source: IQVIA Market Prognosis, Sep 2020; IQVIA Institute, Mar 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 12Oncology and neurology lead growth while immunology slows
due to biosimilars
Top 20 therapy areas in 2026 in terms of global spending with forecast 5-year CAGRs, const $US
5-Year CAGR
2022–2026 Const US$
2026 Spending
Oncologics 306 9-12%
Immunology 178 6-9%
Antidiabetics 173 6-9%
Neurology 151 3-6%
Anticoagulants 87 8-11%
Cardiovascular 87 4-7%
Respiratory 71 5-8%
Pain 70 6-9%
HIV antivirals 45 3-6%
Antibacterials 41 2-5%
GI products 37 4-7%
Ophthalmology 26 3-6%
Vaccines ex COVID 26 -1-2%
Dermatologics 25 8-11%
Lipid regulators 23 5-8%
Hospital solutions 22
2-5%
Anti-ulcerants 20
1-4%
Blood coagulation 19
5-8%
Trad chinese med 16
-1-2%
Cough cold, incl flu antivirals 5
-1-2%
Source: IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 13Global oncology spending to exceed $300 billion by 2026,
with growth slowing to 10% from biosimilar savings
Global oncology spending and growth
350 Forecast 20%
306 18% 2022–2026 Key Metrics
300
278
16%
% Spending growth constant US$
Spending constant US$Bn
252 +63% total
250 14% spending growth
229
208 (9–12% CAGR)
12%
200 187
170
10%
151
150 +$119Bn
128 8%
110
98 6%
100 86
75
60 66
4% ~+100 new
50
2% oncology drugs
0 0%
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Spending Growth
Source: IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 14Immunology spending growth to slow to 6-9% through 2026 from
biosimilar impact as volume growth continues at 12% annually
Global immunology Spending and Growth
200 Forecast 25%
180 2022–2026 Key Metrics
178
Global spending constant US$Bn
160 168 20%
158
140 149 +12% per year
141
volume growth
120 127 15%
% Growth
100 108 +50 Billion
94 +39%
80 10%
80 (6-9% CAGR)
60 69
58
40 49 5% Average cost
40 per day
20 32
28 -$7 to $27
0 0%
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Spending Growth DDD growth
Source: IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 15The outlook for next-generation biotherapeutics includes
significantly uncertain clinical and commercial successes
Cell, gene and RNA therapeutics
60
50
Global spending constant US$Bn
40
30
20
First therapies were launched
in 2010 but had less than $1Bn
10 total spending until 2018
0
2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Range of Scenarios Base case
Source: Company Financials; IQVIA Institute Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 16New therapies in rare neurological disorders, Alzheimer’s, and
migraine are expected to drive spending growth in neurology
Leading CNS disorders global market growth dynamics
25%
Alzheimer's
Migraine
Global % CAGR const US$ 2021–2026
20%
15%
10% All other central
Antipsychotics nervous system
Anxiety
5% Anti-epileptics
Opioid dependence
Parkinson's
Alcohol dependence
0% Antidepressants
ADHD
Multiple sclerosis Neurology
Mental Health
-5%
-15% -10% -5% 0% 5% 10% 15% 20% 25% 30%
Global % CAGR const US$ 2016–2021
Source: IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 17The Global Use of Medicines 2022 U . S . M AR K E T O V E RV I E W JANUARY 2022 Copyright © 2020 IQVIA. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States and various other countries.
The U.S. market, on a net price basis, is forecast to grow 0–3% CAGR
over the next 5 years, down from 3.5% CAGR for the past 5 years
U.S. Medicine Spending and Growth at invoice-level and estimated net 2011–2026
Forecast
699
700
674
5-Year 5-Year 648 5-Year
625
CAGRs CAGRs 605 CAGRs
600 580
545
Invoice 521 Invoice Invoice
493
500
456 CAGR 465 CAGR CAGR
437 7.0% 4.9% 2-5%
400
384
327 332 Net 28% Net 35% Net 39%
317 below below below
300
invoice invoice invoice
397 406 416 424
200
363 363 380 390
318 331 Net CAGR 331 344 Net CAGR Net CAGR
262 255 286 4.8% 3.5% 0-3%
100
253
0
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Net sales Invoice to net difference
Source: IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science
19Spending in the U.S. is expected to increase by $119Bn through
2026 driven by new and existing brands
Spending and growth drivers in US 2016–2026 Const US$Bn
Forecast
2016 2021 2026
Spending Spending Spending
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science
20New brand spending in the U.S. is projected to be higher than the
last five years but a smaller share of spending
U.S. New brand spending
Forecast
Total 2012−16 = $112Bn
New brand spending US$Bn
40 12%
New brands % of total brand spending
Total 2022−26 = $114
35 Total 2017−21 = $93Bn 10%
30
8%
25
20 6%
15
4%
10
2%
5
9 8 25 35 34 22 18 22 15 15 18 23 25 24 24
0 0%
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
US NAS 60 Average launches projected at 50–55/year
29 37 46 49 27 42 58 51 55
Launches (58-62)* (250–275 launches within 5-years)
New brand spending New brands share of brand spending
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science
21The U.S. is an increasingly complex environment
Market dynamics to watch
1 Perpetual uncertainty of
healthcare reform 2 Payer control in
commercial 3 COVID accelerates
new models of care
✓ Healthcare reform + Part D re- ✓ Expanding payer control ✓ New sites, new models pick up
design impact of loss care
✓ Formulary exclusions
✓ Growth and controversy in 340B ✓ Rising awareness and evidence
✓ Net price pressure in of disparity in access
immunology and other specialty
✓ New opportunity across value
✓ New evidence requirements chain
✓ Patient engagement in high
demand
22Access and costs under pressure as payers and manufacturers
prepare for potential policy changes and new competition
Proposed Part D changes Increase in access restrictions Formulary exclusions
Reform potential a constant Competitive dynamics matter Oncology no longer protected
✓ Removes coverage gap1 ✓ Rising number of blocked products in 20212 ✓ Payers address market competition, open the
door for more patient alternatives
✓ Adds manufacturer liability in initial and ✓ Specialty patients 20% more likely not to fill a
catastrophic phases1 prescription vs 20133
✓ 25% abandonment in specialty for Part D patients4
60
60
100% 55
Number of Formulary Exclusions
90% 21% 50
31% 29%
37% 45
New Patient Starts (% NBRxs)
80% 34
45%
12% 40 37
70%
11% 12% 35
60% 10% 30
50% 11% 25 22
40% 20
16
67% 15
30% 58% 60% 6 26
53%
44% 10
20% 15
5 10
10% 2 4
0
0% 2017 2018 2019 2020 2021
2013 2015 2017 2019 2021
Excluded Products with Branded Preferred Alternatives
Filled Abandoned Rejected Excluded Products with Generics/Biosimilars
Sources: IQVIA LAAD Claims Data, 2021; Published national formularies; 1IQVIA Thought Leadership; 2, 3, 4IQVIA US Market Access Strategy Consulting analysis 23COVID-19 disrupted care, and the status quo, making room for
new players, and new models, to serve and empower patients
DISRUPTION INNOVATION
Raised in 1H2021 for States expand
missed preventive health $15B
8.5M visits, unevenly distributed1
telemed platforms5 38 telehealth coverage7
CAGR through ’27 in Digital Health
missed diagnosis visits in 7.9% $29B
269M 1H20212 home healthcare market6 Funding in ‘21
(2x 2020)8
compound annual growth rate
-8% of oncology diagnosis visits
from 2019 to 20213
Growth in telehealth claims
2,901% compared to 2021 vs 20194
Sources: 1Health Equity in the Time of COVID-19, IQVIA; 2, 3, 4IQVIA Claims Data, 2021; 5https://mercomcapital.com/product/1h-q2-2021-digital-health-healthcare-it-funding-ma-
report/; 6Advancing Health Outcomes Through Home Healthcare, IQVIA; 7 ; 8https://rockhealth.com/insights/2021-year-end-digital-health-funding-seismic-shifts-beneath-the-surface/ 24The Global Use of Medicines 2022 E U R O P E O V E RV I E W JANUARY 2022 Copyright © 2020 IQVIA. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States and various other countries.
Spending in top 5 Europe is expected to increase by $51Bn
through 2026 driven by new brands
Spending and growth drivers in France, Germany, Italy, Spain, and UK 2016–2026 const US$Bn
Forecast
2016 2021 2026
Spending Spending Spending
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 26The impact of exclusivity losses will reach $33 billion over 5
years, with more than half due to the availability of biosimilars
EU4+UK Impact of brand losses of exclusivity 2017–2026, US$Bn
Forecast
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
0
-0.2 -0.3 -0.7
-0.3 -1.7
(1)
-1.7 -1.0 -1.7
-1.1
-3.1 -3.6
(2)
-1.3 -3.9
-2.0 -1.8 -1.8 -2.9 -4.8
(3)
-5.3
(4)
-1.3
-2.3
-3.8
(5)
-4.4 -4.6 -3.2
(6)
-1.7
-6.0
(7)
(8)
-7.0
-7.7 -8.0
(9)
(10)
$4.6Bn $6.7Bn $19.4Bn $13.9Bn
$11.3Bn $33.3Bn
Biologic Small $ Total brand loss due to LOE
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 27Rate of uptake of biosimilars has accelerated as stakeholders
become increasingly comfortable and competition grows
Biosimilar market averaging 40% after 12 months and likely 60% after 24
Europe biosimilar uptake rates Biosimilar market dynamics
(months since launch, Treatment Days) Launch
Dates • Payers extract steep discounts in EU,
100% eg >80% for Humira in Nordics…
Bevacizumab Jul 20
Price • ...but savings have not translated into
80% Adalimumab
Oct 18
impact consistent volume expansion of biologics
Oct 18
Pegfilgrastim • Originators are also evolving their offer…
60% –Re-formulation (eg sub-Q; improved excipient)
Apr 18 can slow erosion, but only for a while
Trastuzumab
–Aggressive price competition to win back tenders
40% Competitor • Biosimilar manuf. are innovating…
Rituximab
Apr 17
strategies –Celltrion launched infliximab sub-Q formulation in
Etanercept
EU – while original Remicade only available as IV
20%
Infliximab
Mar 16 • Even greater budget pressures will drive
0% payers to aggressively seek savings
Oct 13
M0 M6 M12 M18 M24 M30 M36 COVID-19 • Catalyst for changing biosims. dynamics?
Source: IQVIA EMEA Thought Leadership; IQVIA MIDAS MTH September 2021 28Market access environment in EU4+UK remains challenging and
some countries aim for reforms
Healthcare cost containments as a focus together with improving HTA processes
UK
▪ Faster, more agile NICE assessments
to increase access to innovation Germany
▪ Population Health Agreement ▪ New Coalition focus on Cost
▪ Favourable Biosimilar Launch country Containment (AMNOG)
▪ Call for end of “Orphan Privilege”
France
▪ Discussion Substitution for 26
▪ Improve Patient Access (LFSS) Biosimilar Candidates
▪ Ensure Drug Supply Security
▪ Increase Gx and Bx Usage Italy
Spain ▪ 30% Increase in Funds for Innovative
▪ Streamline HTA system Medicine
▪ Approval of Hospital-developed Cell ▪ AIFA reorganisation
Therapy ▪ Faster Access to Orphan Drugs
▪ Promote wider Gx and Bx Usage
Pan-European HTA by 2025: “a key deliverable of the European Pharmaceutical Strategy and an important building block for a European
Health Union” – Health Commissioner Stella Kyriakides
Source: IQVIA EMEA Thought Leadership; IQVIA HTA Accelerator 29EU proposes harmonised regulation on HTA in a phased
approach, starting with cancer therapies in 2025
Aim to improve medicine availability, ensure efficient resource usage and strengthen HTA quality
Regulation passed Begin to take effect EU HTA covering
European Parliament on all therapy areas
13/12/2021 01/01/2025
2021/22 2025 2028 2030+ Open
HTA Guidance Questions
Phases
Cancer Therapies
• Comparability to national
Orphan Drugs & ATMPs assessments
• Timeline unclear for the
All other Areas start of the national HTAs
▪ EUnetHTA Service ▪ Member states collaborate on the creation of Joint Clinical Assessments (JCA) • Handling of the
Agreement and Joint Scientific Consolations (JSC) manufacturers data at the
Details
▪ Consortium of 12 EU/EEA ▪ Solid scientific basis for pricing and reimbursement decisions that will remain national level
member states at the national level ---------------------------------------
▪ Development of ▪ JCA are not legally binding but member sates need to give “due consideration” EU Methods paper essential
methodologies ahead of to ensure consistency
▪ Maximum transparency of the data submitted by the applicant
EU HTA regulation across member states
Source: IQVIA EMEA Thought Leadership; IQVIA HTA Accelerator 30Healthcare system digital maturity accelerates, but not all
countries develop at the same pace
5 EMEA Digital Health System Maturity Score Impact on Medicines
A country’s overall rating is constructed from 12
Innovation and use
elements* and scored against peers from 1 to 5
• Innovation and insight: Mature countries have
Denmark well developed patient data collection, including
EHR, Genomic data and consistent data standards
4 Sweden
Estonia which can drive RWD collection, speed clinical
development; telemedicine infrastructure speeds
remote trial implementation
Israel
Austria
Belgium • Evaluating medicines use and impact: digitally
3 Lithuania Netherlands Switzerland
mature countries have the infrastructure and
Poland
Kazakhstan Russia UAE
governance to collect and use nation wide data on
Hungary
Ukraine Slovenia
medicines use and outcomes, and to act on that –
Ireland
Turkey
Romania
Latvia enabling, for example, the possibility of evidence
South Africa
Bulgaria
Saudi Arabia based medicines use and population health
2 Albania agreements
India Czechia 5 – Sophisticated at a national scale
Croatia Greece 4 – Regional maturity and scaling
Egypt
3 – Developing rapidly with potential • Rationalising medicines use to drive cost
N. Macedonia
2 – Underdeveloped and challenged savings: Europe has had the lengthiest history of
Morocco Bosnia Serbia
1 – Very little digital progress biosimilar approval and uptake, but uptake is still
1 variable and cost saving impact could be driven
0 10 20 30 40 50 60 70 80 90 faster with better use of data to track progress
GDP per Capita (Thousands of USD, 2020)
Notes: *These 12 elements belong to three groupings. Initiatives: policy, funding, data governance, institutions. Infrastructure: Electronic health records, data standards, omics, interoperability. Implementation: telehealth, AI, information use, virtual studies
Source: IQVIA European Thought Leadership; GDP per capita data obtained from World Bank Open Data; Framework scores are based on interviews and surveys with internal IQVIA experts 31The Global Use of Medicines 2022 C H I N A O V E RV I E W JANUARY 2022 Copyright © 2020 IQVIA. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States and various other countries.
China’s healthcare reform is shifting the market towards a value-based
innovation focused market
Market Access in China
Regulatory Manufacturing Tendering &
Hospital Listing Prescription Reimbursement
Registration & Supply Distribution
Localization of Volume-Based Digital Healthcare
Policy Initiatives Expedited Approval Tiered Care System NRDL Adjustment
Manufacturing Procurement (VBP) Revolution
Healthcare
Mechanism Diagnosis and Rx Digitalization in the
Encouraged expenditure control
Key Trends Deglobalization normalization and outflow to entire industry
innovation thanks to
price cut of drugs improve efficiency ecology
negotiations
Key Hospital (Provider); Hospital (Provider);
NMPA (Regulator) NMPA (Regulator) NHSA (Payer) NHSA (Payer)
Stakeholders NHC (Regulator) NHC (Regulator)
Impact on
Pharmaceutical
Companies
☺ ☺
Source: IQVIA analysis 33Spending growth in China is expected to accelerate post-COVID, driven
almost entirely by new original medicines
China medicine spending by product type 2011–2026
Forecast
5-Year
205 CAGRs
197
200 189
5-Year 182 3.8%
175
Medicine spending const US$Bn
169 CAGRs
161 158
5-Year 6.1%
10.4%
150 CAGRs 140
134
126 13.0% 13.1%
115
107
95 13.2%
100 0.7%
84 2.4%
68 11.5%
50 -0.6%
14.5% 2.6%
13.9% 10.2% 2.7%
0
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Unbranded products OTC & others Non-original brands Original branded products
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science
34Fueled by favorable policies since 2017, new launches of innovative
medicines have rapidly increased
China Policies to Encourage
Number of innovative drug approved Launch lag between China and Global
Innovation
Drug Innovations
Drug approved in 2016
2019 Drug Administration Law Local
✓ Revision MNC2 55 54
…
10 • Only 4 innovative drugs approved in 2016
Marketing Authorization Holder 12 45
✓ Reform 41 Drug approved in 2019
1
19
Harmonizing with Global
✓ (ICH1, Multi-Country Trials, etc.)
45 42
Review Acceleration, 40
✓ Green path Mechanism
26
…
7
• ~40 innovative drugs approved in 2019
3 • Only 4.6 years launch lag, compared to
✓ CDE3 Capability Building 4
8.4 years launch in 2016
2016 2017 2018 2019 2020
Source: IQVIA database, IQVIA analysis, desk research
1. ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
2. MNC: Multi-National Company; 3. CDE: Center for Drug Evaluation 35Innovative drugs are increasingly gaining NRDL access, however, pressures
on price-cuts to enter is continuing to increase
Jul. 2017 Aug. 2018 Nov. 2019 Dec. 2020 Nov. 2021
NRDL
751 formal review 273 Formal
Negotiation list review list
44 Candidates 18 Candidates 150 Candidates
candidates 22% 162 117
Candidates 43% Candidates
Succussed 36 17 97
Succeed 94% Succeed 65% Succeed 96 67
exclusive drugs 82% Succeed Succeed
59% 57%
MNC: 23 MNC:15 MNC: 50 MNC: 39 MNC: 26
MNC vs Local
(Exclusive drug)
Local: 13 Local: 2 Local: 47 Local: 57 Local: 41
• 13 solid tumor
• 2 hematology products
Onco and RD • 15 oncology drugs • 7 oncology drugs • 14 oncology drugs and 4 blood cancer
• Oncology drugs only
drug listing • 2 rare-disease drugs • 6 rare-disease drugs • 7 rare-disease drugs drugs
status • 4 immunology drugs
• 7 rare-disease drugs
~62%
~40% ~54% ~61%
(66 western drugs)
Price-cut Local products: ~ 31% Local products: ~ 33% Local products: ~ 57% ~62%
Local products: ~ 61%
MNC products:~ 41% MNC products:~ 56% MNC products:~ 62%
MNC products:~ 63%
Source: Desktop research, IQVIA analysis
36Timeframe from approval to NRDL listing have shortened significantly with
increased pressure for price reductions
All NRDL negotiated NRDL negotiated Key takeaways
Western drugs oncology drugs
NRDL
2017 2018 2019 2020
2019
25 out of 52
2020
43 out of 66 4 out of 15 11 out of 17 7 out of 8 11 out of 13
• Newly-launched drugs in recent
(48%) (65%) (27%) (65%) (88%) (85%) years have more reimbursement
# of drugs included in opportunities to be included by
NRDL within 2 years negotiation
after launch
7.3 • Time interval is sharply
shortened between launch and
3.0 NRDL listing than ever, indicating
1.5 1.6 1.6 1.2
Median time (years) products must prepare in advance
between approval and 2019 (52 2020 (66 2017 2018 2019 2020 for entering market
NRDL inclusion Western drugs) Western drugs) Negotiation (15 Negotiation (17 Negotiation (8 Negotiation (13
oncology drugs) oncology drugs) oncology drugs) oncology drugs)
57% 59% • Greater price cut is observed
51% 53%
46% for newly listed innovative
Not
announced
drugs, especially oncology drugs,
% of price cut after yet and the trend is expected to
negotiations1 2019 (52 2020 (66 2017 (15 2018 (17 2019 (8 2020 (13 continue
Western drugs) Western drugs) oncology drugs) oncology drugs) oncology drugs) oncology drugs)
Note: 1. Price cut was calculated by comparing the reimbursement price negotiated against the lowest provincial bid price before negotiation
Source: External Interview; IQVIA analysis 37Volume-Based Procurement (VBP) is the national tendering for off-patent
drugs in China
▪ Volume Based Procurement (VBP) was first introduced in 2018, which kicked off national tendering on off-patent drug
in China. 5 rounds national-wide by far, while this mechanism would become normalized and institutionalized
▪ Led by NHSA, VBP bid winners will have sales guarantee for the committed volume (~70% of total hospital market) at the
VBP
negotiated price with a 2-year contract; while the remaining non-committed market (~30% of total hospital market) is still
free-selection based
▪ Off-patent drugs with ≥ 2 generics 1) approved in China, 2) passed Generics Quality Equivalence Test (GQCE), are
exposed to VBP risk
Key Facts on VBP VBP Mechanisms
▪ Six rounds of national-wide VBP organized by NHSA • Originator and GQCE Gx in same competition group
with direct impact on off-patent originators since 2019 VBP bidding rules • Lowest tender price will be set as bid ceiling price
- Average price cut level >50%, with highest at 99% • Lowest price to win the bid
- Over 200 molecules involved contributing beyond
20% of total China market • Multiple winners to ensure national supply and share the 70%
Impact on winners committed market volume by splitting provinces
▪ VBP price cut levels varies across molecules because of
competitiveness and COGS (Cost of Goods Sold).
• The remaining 30% non-committed market is still free-selection
▪ Chemical drugs face with strong price cut, while
competition is milder in biologics, i.e., all insulins won Impact on non-winner • ~30% price cut enforced on originators after VBP becomes
effective
the bidding with average price cut at 41%
Key findings:
VBP is regarded as China version of patent cliff, as originator will still experience enforced price cut (~30%) even lose-bid.
Early planning on patent and launch strategy in China is crucial to prolong product lifecycle
Source: desk research, IQVIA analysis 38The price drop required vs the lowest pre-VBP price to be stabilizing around
~ 60%, and the average # bidders per molecule continues to increase
4th Round 5th Round
VBP
-52%
-56%
5.0 5.7
Source: desktop research, IQVIA research and analysis, quantitative studies 39The Global Use of Medicines 2022 J APAN O V E RV I E W JANUARY 2022 Copyright © 2020 IQVIA. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States and various other countries.
Japan Universal Healthcare coverage through Healthcare Spend
Snapshot National Health Insurance (NHI) System Share of GDP
Elderly (aged 65 or older) Life Expectancy
10.9%
84.3 #5 Globally
Share of Population 28.8% #1 Globally
#1 Globally (USA: 16.9% #29) 1 (USA: 78.9 yrs #29) 2 Years (USA: 16.8% #1) 4
⚫ Long-Life Medical Care System
Over 8,400 Hospitals 12.98 beds per 1,000 people ⚫ Improved HP Resource Management
#1 Globally (USA: 2.87 beds per 1,000 people) 3 ⚫ Diagnosis Related Groups
⚫ Reduced Polypharmacy
Comprehensive Drug List with ~98% of Approved
⚫ Fixed Co-Payment Structure
Prescription Drugs in Japan on Reimbursement List ⚫ Innovation-Based Pricing
⚫ Conditional Early Approval
⚫ Sakigake (Breakthrough Therapy)
Increased Patient Access to Leading Global Therapies
Designation 36 of top 50 in 2010 increasing to 46 of top 50 in 2021 5
Clinical Trials in Japan 20% in 55% in Japan 34 mths 16 mths in
included in Global Trials 6 2010 2020 Drug Lag 5 in 2010 last 3 Yrs
1: https://data.oecd.org/pop/elderly-population.htm ; 2: https://www.who.int/data/gho/data/indicators/indicator-details/GHO/life-expectancy-at-birth-(years) ; 3: https://www.who.int/data/gho/data/indicators/indicator-
details/GHO/hospital-beds-(per-10-000-population) ; 4: https://stats.oecd.org/Index.aspx?ThemeTreeId=9 ; 5: IQVIA MIDAS Quantum Sept 2021 MAT period ; 6: IQVIA Japan. Japan Thought Leadership analysis of 41
PMDA and other public dataJapan medicine spending is forecast to decline slightly through
2026 as stronger innovation is offset by shift to annual price cuts
Japan medicine spending by product type 2011–2026, constant US$ Billions
Forecast
100
5-Year 5-Year 5-Year
87 88 CAGRs 87 88 CAGRs CAGRs
90
83 86 86 85 84 84 84 83
82 83
80 80 1.8% -0.5% -0.6%
80
70 -0.2% 0.1% 0.8%
60
-5.9% -5.3% 0.4%
50
14.3% 7.8% 0.0%
40
10.0% 4.3% 1.1%
30
-4.8% -7.6% -12.1%
20
10
4.0% 0.1% 0.8%
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Protected brands Long-listed products Generics NHI others Non-NHI products OTC/others
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Japan, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science 42While top-line spend remains flat, continued growth expected in
Japan from existing brands and contribution from new brands
Spending and growth drivers in Japan 2016–2026 Const US$Bn
Forecast
2016 2021 2026
Spending Spending Spending
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science
43The Global Use of Medicines 2022 L AT I N AM E R I C A O V E RV I E W JANUARY 2022 Copyright © 2020 IQVIA. All rights reserved. IQVIA® is a registered trademark of IQVIA Inc. in the United States and various other countries.
Medicine spending — using list price levels — is
expected to grow at 7-10% CAGR through 2026 to over $100bn
Latin America medicine market size and growth 2017–2026, const US$Bn
Forecast
5-Year
120 5-Year CAGRs
CAGRs Overall
104
Overall 8.0%
100
8.3% 3.3%
6.4%
80 8.9%
70
4.1% 10.5%
60 11.8%
52 8.6% 6.9%
1.5%
40
7.8%
9.2%
20
11.7%
2017 2018 2019 2020 2021 2022 2023 2024 2025 2026
Brazil Mexico Argentina Colombia Chile Rest of the Region Total
Source: IQVIA Market Prognosis, Sep 2021; IQVIA Institute, Nov 2021
45
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data Science.Spend growth drivers drug type / channel in LatAm
Spend, funding and growth dynamics by drug type / channel in Latin America
Pharmacy Retail Pharmacy Retail Non Retail
Channel Channel Channel
OTC / Consumer Health Prescription Drugs Prescription Drugs
% of total
drug spend
~20% of total spend ~55% of total spend ~25% of total spend
Drug funding Mostly Out of Pocket Mostly Out of Pocket Mostly Payer Funded
model (limited payer funding) (limited payer funding) (public and private payers)
1. Dermatology 1. Cardiovascular 1. Oncology
Top 5
2. VMS 2. Central Nervous System 2. Antibiotics / fungals
Therapy
3. Analgesics 3. Diabetes 3. Immunology
Areas /
4. Cough & Cold 4. Women’s Health 4. Central Nervous System
Categories
5. Anti-acids 5. Antibiotics / fungals 5. Vaccines
• Post pandemic market • Ageing population • Innovation
accomodation • Lifestyle habits • Post pandemic market
Key Growth
• Economic recovery • Mental health accomodation
drivers
• Prevention • Innovation • Payer dynamics
• Ageing population
46
Source: Source: IQVIA MIDAS and IQVIA LOCAL COUNTRY AUDITS
The Global Use of Medicines 2022: Outlook to 2026. Report by the IQVIA Institute for Human Data ScienceSeveral initiatives aimed at broadening access while reducing cost
• Slow implementation of Insabi
• Move to centralize purchases under UNOPS
• Increased HC spending expected from new left-wing government
• Delays in sanitary registration given
• Slow progress in approving Rare Disease and Cancer legislations, as
frequent changes in the commissioner
well as SIS rollout
• Reduction in times at Cofepris for new
molecules thanks to process optimization and
equivalence agreements with other agencies • Increasing number of therapy areas and molecules
• National drug formulary changed to the under direct control
consolidated “Compendio Nacional” • Potential changes in the INVIMA and IETS roles for
approval, value-based pricing and funding of
medicines
• For new medicines, request of forms for “Anexo • Presidential elections May 2022– healthcare likely to be
5” to gain access to the National formulary a key point in candidate programs
• Consolidation of SERCOP process for
purchases in the public sector • Tax reform may increase tax rates for medicines
• Slow progress in legislating the Organic Health • IP protection remains strong despite recent legislation
Code bill (Article 40 and vaccines IP protection)
• Continued development and growth of private
sector, with potential expanded coverage (e.g.,
• Increased adoption of DRG in hospital setting oncology, vaccines)
• Increased central procurement through CENABAST • Digitalization of public sector through ConnectSUS
• “Ley de Fármacos II” which approved INN* prescription and
labeling changes; price control mechanism still under • Increase use of tenders in public sector
discussion • Creation of “free” medicines list for PAMI patients
• Increased demand driven by Ley Ricarte Soto oncology, HIV, • Widening price differentials between PAMI prices and list prices
vaccines), “Cancer Law” and funding of high cost drugs
• Lack of new innovative medicines included in PAMI
• Delay in AGNET (HTA) implementation; high degree of
Source: IQVIA Analysis
*International Nonproprietary Name rejection (75%) from CONETEC 47Concluding thoughts
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