Download - The US Pharmaceutical Market_Doug Long
The US Pharmaceutical Market: What’s In?, What’s Out? and What’s Ahead?,
BY: Doug Long, VP Industry Relations
Presented to NCPDPPresented to NCPDP
May 18, 2011
2011 Strategic management presentation
All reproduction rights, quotations, broadcasting,publications reserved. No part of this publication may bereproduced or transmitted in any form or by any means,electronic or mechanical, including photocopy, recording, orany information storage and retrieval system, withoute p ess itten onsent of IMS HEALTHexpress written consent of IMS HEALTH.
The global pharmaceutical market performance declined in 2010 declined in 2010
Global Pharma Historical Market Dynamics & Current Environment
Global Sales and Market GrowthPharma market challenges
• The US/top 5 Europe/Japan no longer the main growth drivers
• The economic crisis impact has been different across pharmaceutical markets
• Biotechnology, a big growth area, affected by lack of investment fundsaffected by lack of investment funds
• New product launches are not replacing revenues lost to generic competition, especially in primary care
The most att acti e a eas fo g o th • The most attractive areas for growth are in emerging, generics and specialty markets
Source: IMS Health, MIDAS, Dec 2010
Top 10 markets sales and growth Audited markets in 2010Audited markets in 2010
2010
CountrySales, US $
Billions% Market
Share% Growth,
Constant US $CAGR
2006-2010
10 Key Markets 614.9 100 3.9 5.0
United States 310 7 50 5 3 3 4 6United States 310.7 50.5 3.3 4.6
Japan 85.8 13.9 0.4 2.4
Germany 40.0 6.5 3.0 3.6
France 38.9 6.3 0.9 2.738 6 3 0
China 32.8 5.3 21.9 23.9
Italy 25.2 4.1 2.2 3.7
Spain 22.0 3.6 2.6 6.6
Canada 21.6 3.5 2.6 6.4
United Kingdom 20.3 3.3 3.8 4.2
Brazil 17.5 2.9 20.1 13.5
Source: IMS Health, MIDAS, Dec 2010
In both specialist and primary care we have winners and losers
Primary care driven
and losers
Specialist driven
Global RankSalesUS$bn
%MarketShare
%Growth
Top 10 208.2 45.6% 4.2%
Global RankSalesUS$bn
%MarketShare
%Growth
Top 10 185.4 56.8% 7.7%
55 3 16 9% 7 4%Lipid regulators 36.4 8.0% 3.7%
Respiratory agents 28.9 6.3% 7.8%
Anti-ulcerants 28.4 6.2% -5.6%
Angiotensin II antag 26 6 5 8% 7 6%
Oncologics 55.3 16.9% 7.4%
Antipsychotics 24.9 7.6% 9.2%
Autoimmune agents 20.1 6.1% 15.3%
Antidiabetics 15.8 4.8% 12.7%Angiotensin II antag. 26.6 5.8% 7.6%
Antidepressants 20.0 4.4% 2.5%
Antidiabetics, oral 17.5 3.8% 11.9%
Platelet aggr. inhib. 15.2 3.3% 3.8%
Antidiabetics
HIV antivirals 15.1 4.6% 14.4%
Anti-epileptics 12.4 3.8% -11.2%
Narcotic analgesics 11.9 3.7% 7.8%
Vitamins & minerals 12.7 2.8% 6.8%
Cephalosporins & combs. 11.3 2.5% 7.3%
Non-narcotic analgesics 11.1 2.4% 2.5%
Erythropoietins 10.7 3.3% -1.2%
Hospital solutions 9.5 2.9% 7.9%
MS therapies 9.5 2.9% 12.6%
Source: IMS Health, MIDAS, MAT Sep 2010
The generics market reaches $107.5bn; generics growth is four times higher than overall growthgrowth is four times higher than overall growth
Source: IMS Health, MIDAS, Market Segmentation, MAT Dec 2010, Rx only. *Market Segmentation universe
After strong growth recovery in 2009; 2010 sales growth slows to 2 3% and 1 0% TRX growth
Dollars GrowthTRx Growth
growth slows to 2.3% and 1.0% TRX growth
8
9
10
$300
$310
4
4.5
54
5
6
7
$280
$290
CH
AN
GE
S$ B
N .
2.5
3
3.5
GE
.
e B
N
.
5.1%2.1%
2
3
4
$260
$270
% C
Sale
s US
1
1.5
2
% C
HAN
G
TRx V
olu
me
0
1
$250
$260
2006 2007 2008 2009 20100
0.5
32006 2007 2008 2009 2010
1.0%2.3%
Source: IMS Health, National Sales Perspectives, Dec 2010 Source: IMS Health, National Prescription Audit, Dec 2010
US market growth in 2010 was 2.3%
20$350
15$250
$300
GE
BN
5
10
$100
$150
$200
% C
HAN
G
ALE
S U
S$B
0
5
$0
$50
$100
SA
Source: IMS Health, National Sales Perspectives, Dec 2010
US prescription growth is 1.0% for 2010
105.0
US Growth Rate
7
8
9
10
4.0
5.0
E B
N
3
4
5
6
2.0
3.0
TR
X P
PG
TR
X V
OLU
ME
0
1
2
3
1.0
T
-10.0
Source: IMS Health, National Prescription Audit Plus, Dec 2010
The largest segments of the US market had b l k t th tbelow market growth rates
Sales Growth (2010)
Total market: +2.3%
Brands: -0.7%Branded generics: Generics: Brands: 0.7% generics: +4.5% +21.7%
Traditional Pharma: 1.9% Specialty: 4.0%
Small molecules: 0.5% Biologics: 6.6%
Retail: 2.0% Institutional: 3.0%
$0 $50 $100 $150 $200 $250 $300
Sales $BN
Retail: 2.0% Institutional: 3.0%
Source: IMS Health, National Sales Perspectives, Dec 2010
US Pharmaceutical Market: 2010
Brand prescription growth continues to decline in 20102010
Unbranded generics
Absolute growth of prescriptions
200
250
Unbranded genericsBrandsBranded generics
0
50
100
150
TR
xs
MN
200
-150
-100
-50AC
T
-200
2006 2007 2008 2009 2010
Source: IMS Health, National Prescription Audit, Dec 2010
Growth remains low for both segments, but growth rates converge in latest periodsrates converge in latest periods
16% US
MAT Nov 2010
% M k t
10%
12%
14%
$
Primary care driven
Specialist driven
Primary care driven
56%
% Market share US$
4%
6%
8%
GRO
WTH
US$ Specialist
driven44%
% Absolute h US$
2%
0%
2%
%
2006 2007 2008 2009 MAT Nov 2010
% G
Primary care driven
Specialist
21%
change US$
-4%
-2% 2010 Specialist driven
79%
Source: IMS Health, National Sales Perspectives, Nov 2010
Sales and TRx share brands and generics
Branded Generics Disaggregated
100%%Dollars %Total prescriptions dispensed
14.6% 15.6% 16.2% 16.8% 17.8% 19.9%
57.7% 61.2% 65 3%70%
80%
90%
100%
AR
E
85.4% 84.4% 83.8% 83.2% 82.2% 80.1%
65.3%69.6% 72.2% 75.4%
40%
50%
60%
MA
RK
ET
SH
A
42.3% 38.8% 34.7% 30.4% 27.8% 24.6%
0%
10%
20%
30%
% M
0%
2005 2006 2007 2008 2009 YTD Nov 2010
2005 2006 2007 2008 2009 2010
Brands GenericsSource: IMS Health, National Sales Perspectives, Nov 2010, Branded generics disaggregated,Source: IMS Health, National
Prescription Audit, Branded generics disaggregated, Dec 2010
US is impacted by continued patent expiries, and historically low contribution from new productshistorically low contribution from new products
US market growth: 2009=5.2%; 2010=2.3%
• Protected brands “list" price growth
• Increasing generic volume and less price
• Protected brands volume decline
• Slow uptake of recently launched products
i ideflation• H1N1/CCF• Fewer safety events
• Patent expiries• Greater substitution of
generics
• Demographic factors• Approvals of innovative
therapies
Source: IMS Health, Market Prognosis, IMS Consulting, Sep 2009
The economic crises impact all stakeholdersTh d f h i l i h f i !The danger for pharma is losing share of voice!
Stakeholders Likely reactions
Patients1•Significant increase in price sensitivity•‘Down-trading’ to cheaper drugs or generics•Deferral of treatment
2•Reduced spend on promotion •Rationalisation of product lines• Mergers/acquisitions
•Cash flow and credit issues
Manufacturers
3
•Cash-flow and credit issues•Reduced inventories to minimise financial exposure•Increase in distribution costs•Consolidation among local distributors
Distributors
4•Changed prescribing practices •Increase generic / therapeutic substitutionHealthcare Providers
5 Payers•Shifting costs to patients•Increased focus on evidence and value5 Payers Increased focus on evidence and value•Formulary control intensifies
Patient visit trends remain negative with -4.7% growth in MAT Nov 2010growth in MAT Nov 2010
2%
4%
6%
WTH
Patient Visit Growth
-4%
-2%
0%
ING
MAT
GRO
W
10%
-8%
-6%RO
LLI
-10%
Jan-0
8
Mar-
08
May-0
8
Jul-
08
Sep-0
8
Nov-0
8
Jan-0
9
Mar-
09
May-0
9
Jul-
09
Sep-0
9
Nov-0
9
Jan-1
0
Mar-
10
May-1
0
Jul-
10
Sep-1
0
Nov-1
0
ROLLING MAT
Source: IMS Health, National Disease and Therapeutic Index, Nov 2010, Confidence Interval shown (+/-3.9%)
The declines in consumer sentiment in the US were not matched by TRx declines or claimsnot matched by TRx declines or claims
Market Indicators Indexed to January 2007
100
110
120
70
80
90
IND
EX
40
50
60
7 7 7 7 7 7 7 7 7 7 7 7 8 8 8 8 8 8 8 8 8 8 8 8 9 9 9 9 9 9 9 9 9 9 9 9 0 0 0 0 0 0 0 0 0
Index of Consumer Sentiment
Index of Employment
Monthly Claims
TRX
Jan-0
7Fe
b-0
7M
ar-0
7Apr-
07
May
-07
Jun-0
7Ju
l-07
Aug-0
7Sep
-07
Oct
-07
Nov
-07
Dec
-07
Jan-0
8Fe
b-0
8M
ar-0
8Apr-
08
May
-08
Jun-0
8Ju
l-08
Aug-0
8Sep
-08
Oct
-08
Nov
-08
Dec
-08
Jan-0
9Fe
b-0
9M
ar-0
9Apr-
09
May
-09
Jun-0
9Ju
l-09
Aug-0
9Sep
-09
Oct
-09
Nov
-09
Dec
-09
Jan-1
0Fe
b-1
0M
ar-1
0Apr-
10
May
-10
Jun-1
0Ju
l-10
Aug-1
0Sep
-10
Source: IMS Health, National Prescription Audit, Sep2010, LifeLink Sep2010; Reuters / University of Michigan Surveys of
Data for the last month of reported claims remains volatile until late reporting physician’s claims are added
Consumers, Sep 2010; Bureau of Labor Statistics, Sep 2010; Car sales from Bureau of Economic Analysis, National Economic Accounts, Last Revised in Dec 2010
US market grows 2.3% in 2010
Channels US$bn% Market
% Growth
2010
Channels US$bn Share
% Growth
Retail 167.3 54.4 2.0
Chain/Mass 108.1 35.2 2.6
Independents 37.9 12.3 1.3
Food stores 21.3 6.9 0.5
Mail Service 52.6 17.1 2.1
Institutional 87.6 28.5 3.0
Clinics 36 2 11 8 4 2Clinics 36.2 11.8 4.2
Hospitals 31.9 10.4 0.6
Long-term care 14.8 4.8 6.4
Home health care 2.5 0.8 -0.6
HMO 1.1 0.4 0.4
Others 1.0 0.3 -1.2
Total 307.5 100.0 2.3
Source: IMS Health, National Sales Perspectives, Dec 2010
The US market prescriptions grew at 1.0%, driven by chainsby chains
2010
Channels TRxs mn% Market
Share% Growth
Retail 3,646 92.0% 1.2
Chain/Mass 2,173 54.8% 2.1
2010
Chain/Mass 2,173 54.8% 2.1
Independents 748 18.9% -0.8
Food stores 490 12.4% 0.5
Mail Service 235 5.9% -1.0
Non retail channels 319 8.0% 0.9
LTC 319 8.0% 0.9
Total 3,965 100.0 1.0
Source: IMS Health, National Prescription Audit, Dec 2010
Absolute growth of leading therapy classes
DollarsAC
US$mn Total Rx dispensed
ACTRxs mnUS$mn TRxs mn
Antipsychotics,oth 1520.7 Anti-depressants 7.7
Analogs of human insulin 1205.9 Seizure disorders 7.3
Analeptics 971.1 Codeine & comb 6.4
Anti-platelets,oral 650.8 Vitamin D 6.2
Antiarth,biol resp mod 637.9 Lipid regulators 5.9
Alzheimer-type dementia 598.9 Analeptics 4.4
HIV antiviral combination 550.9 Calcium blockers 4.2
GI anti-inflam 518.3 Biguanides 4.1
Neurological disorders 505.1 Benzodiazepines 3.3
Codeine & comb 466.2 Mus relx,non-surg 2.7
Source: IMS Health, National Sales Perspectives, Nov 2010, National Prescription Audit, Nov 2010
Relative growth of leading therapy classes
Dollars%
GrowthTotal Rx dispensed
%GrowthGrowth Growth
HIV integrase inhib 58 Vitamin D 47
Biguanides 40 Antinauseant 5HT3 antag 35
Pneumococcal 38 Dpp-4 Inhib 16
fMiscellaneous,oth 32 Specific antagonists 15
Antineoplastics,misc,oth 31 Antihyperlipidemic agt 12
Neurological disorders 30 Analeptics 10
Newer gen psycother agt 29 H2 antagonists 8
Hormones,androgens 28 Analogs of human insulin 8
Ophth preps,oth 26 Ophth corticoids 8
Ophth anti-inflam,oth 24 Alpha-beta blocker 7
Source: IMS Health, National Sales Perspectives, Nov 2010, National Prescription Audit, Nov 2010
Absolute declines of leading therapy areas
DollarsAC
US$mn Total Rx dispensed
ACTRxs mnUS$mn TRxs mn
Ace inhibitors -242.0 Proton pump inhib -1.6
Calcium blockers -261.6 Narc cgh/anthst -1.8
Quinolones, systemic -269.2 Angiotensin II antagonists -1.8
Immunosup/transplant age -419.3 Glitazones -1.9
Platinum coordination -471.6 Quinolones, systemic -2.2
Anti-migraine -500.6 Macrolides & related -2.3
Herpes Antivirals -527.7 Synth narc,analg -2.4
UT benign prostate -806.5 O/C estrogen/progestogen -2.4
Seizure disorders -1663.0 Beta blockers -2.4
Proton pump inhib -2257.2 Osteoclast Inhibitors -4.1
Source: IMS Health, National Sales Perspectives, Nov 2010, National Prescription Audit, Nov 2010
Fastest growing products-Absolute growth
DollarsAC
US$mnTotal Rx Dispensed
ACTRxsmnUS$mn TRxsmn
venlafaxine hcl er (tev) 877 metoprolol succin (wts) 9.8
Prevnar 13® (Pfz) 732 amlodipine besy (lu.) 9.2
Crestor® (Azn) 694 simvastatin (lu.) 8.9
Copaxone® (Tvn) 559 hycd/apap (qlt) 8.2
enoxaparin sod (sdz) 540 gabapentin (am9) 7.6
Abilify® (Ots) 535 lisinopril/hctz (lu.) 6.3
Plavix® (Bsa) 534 omeprazole (rx) (myn) 6 2Plavix® (Bsa) 534 omeprazole (rx) (myn) 6.2
budesonide (tev) 508 azithromycin (tev) 5.9
Humira® (Abt) 405 albuterol (myn) 5.8
Atripla® (Bmg) 368 prednisone (w-w) 5.7
Source: IMS Health, National Sales Perspectives, Jan 2011, National Prescription Audit, Jan 2011
Relative growth of leading products
Dollars%
GrowthTotal Rx Dispensed
%GrowthGrowth Growth
valacyclovir hcl (rby) >999 amlodipine besy (lu.) >999
venlafaxine hcl er (tev) >999 albuterol (myn) >999
Prevnar 13® (Pfz) >999 valacyclovir hcl (rby) >999
enoxaparin sod (sdz) >999 amlodipine besy (gmk) >999
amphetamin salt er (glb) 682 metoprolol succin (wts) 908
pantoprazole sod (spi) 342 gabapentin (am9) 665
ti h l ( d)budesonide (tev) 235 paroxetine hcl (zyd) 275
Renvela® (Gzy) 144 furosemide (rby) 253
Trilipix® (Abt) 144 alendronate sod (wts) 239
oxaliplatin (t+p) 135 ranitidine hcl (gmk) 193oxaliplatin (t+p) 135 (g ) 193
Source: IMS Health, National Sales Perspectives, Nov 2010, National Prescription Audit, Nov 2010
Fastest declining products-Absolute declines
DollarsAC
US$mnTotal Rx Dispensed
ACTRxs mnUS$mn TRxs mn
Tricor® (Abt) -271 simvastatin (drl) -4.4
Prograf® (Aes) -274 hycd/apap (mkr) -4.4
pantoprazole sod (Pfz) -307 alendronate sod (tev) -4.5p p ( ) ( )
Cellcept® (Roc) -325 simvastatin (aob) -4.6
Arimidex® (Azn) -434 amoxicillin (tev) -4.7
Yaz-28® (Byh) -443 cephalexin (tev) -4.8
Lovenox® (S.A) -550 Lipitor® (Pfz) -6
Effexor Xr® (Pfz) -1311 prednisone (wts) -6.9
Valtrex® (Gsk) -1524 Effexor Xr® (Pfz) -7.1
Flomax® (B.I) -1772 amlodipine besy (myn) -7.1Flomax® (B.I) 1772 amlodipine besy (myn) 7.1
Source: IMS Health, National Sales Perspectives, Jan 2011, National Prescription Audit, Jan 2011
Absolute Growth Vs. Yr. Ago-Companies
Dollars AC US$BN TRx AC TRx mn$
Novartis (incl Sandoz) 2.3 Mylan Labs, Inc. 35.7
Lilly 1.2 Lupin Pharma 33.5
Teva lTeva 1.2 Amneal Inc 30.6
AstraZeneca 0.9 Novartis (incl Sandoz) 24.7
Bristol-Myers Squibb 0.8 Qualitest Products 21.0
Gilead Sciences 0 8 Z d Ph 18 3Gilead Sciences 0.8 Zydus Pharma 18.3
Global Pharma Corp 0.7 Glenmark Pharma 12.4
Novo Nordisk 0.7 Teva 12.4
Otsuka America Ph 0 6 W t W d 11 2Otsuka America Ph 0.6 West Ward 11.2
Mylan Labs, Inc. 0.5 Northstar Rx 10.1
Source: IMS Health, National Sales Perspectives, Sep 2010, National Prescription Audit, Sep 2010
Sales of leading corporations (Top 10)
% Market
MAT Nov 2010
US$mn% Market
Share% Growth
US Industry 306,689 100.0 2.8
1 Pfizer (incl Greenstone) 26,292 8.6 -5.0
2 M k & C 18 838 6 1 4 8
Leading corporations
2 Merck & Co 18,838 6.1 -4.8
3 AstraZeneca 18,401 6.0 2.1
4 Novartis (incl Sandoz) 15,361 5.0 18.7
5 Lilly 14,222 4.6 9.0
6 Roche (incl Genentech) 13,721 4.5 -3.0
7 GlaxoSmithKline 13,655 4.5 -9.2
8 Teva 13,627 4.4 12.9
9 Johnson & Johnson 12,748 4.2 -1.79 Johnson & Johnson 12,748 4.2 1.7
10 Amgen Corporation 12,675 4.1 1.7
Top 10 159,542 52.0 1.0
Source: IMS Health, National Sales Perspectives, Nov 2010
Sales of leading corporations (11-20)
% Market
MAT Nov 2010
US$mn% Market
Share% Growth
11 Abbott 10,824 3.5 2.6
12 Sanofi Aventis 10,464 3.4 -6.4
13 B i t l M S ibb 9 684 3 2 9 3
Leading corporations
13 Bristol-Myers Squibb 9,684 3.2 9.3
14 Boehringer Ingelheim 6,507 2.1 -12.2
15 Takeda 6,014 2.0 -25.6
16 Eisai Corp 4,706 1.5 8.2
17 Forest Lab 4,694 1.5 8.1
18 Mylan Labs, Inc. 4,601 1.5 18.1
19 Gilead Sciences 4,596 1.5 19.9
20 Otsuka America Ph 4,566 1.5 15.30 Otsu a e ca 4,566 5 5 3
Top 20 104,332 73.8 0.8
Source: IMS Health, National Sales Perspectives, Nov 2010
$98 bn at risk to generic competition in the US by 20152015
Value of products at risk 2004-2015
$98 bn
Source: IMS Health, MIDAS, Market Segmentation, Sep 2010
More innovative products will be lost than gained in the next few years if FDA approvals remain at the current levelfew years if FDA approvals remain at the current level
2014(f)2014(f)
2011(f)
2012(f)
2013(f)
2014(f)
2011(f)
2012(f)
2013(f)
2014(f)
2008
2009(f)
2010(f)
( )
2008
2009(f)
2010(f)
( )
2005
2006
2007
2005
2006
2007
0 5 10 15 20 25 30 35 40 45 50
2004
# NCE APPROVALS
05101520253035404550
2004
# NCE PROTECTION EXPIRIES
Source: FDA, IMS Health, Market Insights Team Analysis, Oct 2009
Global launches of innovative products declining, d i b f i d tdriven by fewer primary care products
NCH
ES
OF
NCE L
AU
NU
MBER O
31Source: IMS Health, New Product Focus, Jan 2011. *Preliminary estimate
Active pipeline continues to grow in each stage of clinical development except Phase I
1600Phase I Phase II
clinical development except Phase IN
E
1 205
1,36812541231
11301062
9901200
1400 Phase III Pre-reg/reg
S I
N P
IPELI
N
1,205
572
11591093
995941
893734648
990933
864807
800
1000
PRO
DU
CTS
363340334290299
274 287284258
142139138131130120200
400
600
OF
ACTIV
E
142139138131130110 102 116 120
0
200
June-02 June-03 June-04 June-05 June-06 June-07 June-08 June-09 June-10
# O
Source: IMS Health, R&D Focus, Jun 2010 and previous year slides
Global R&D pipeline compared against previous yearyear
2,721
Number of active products in the pipeline to date = 6,119
,
1 763
1,2531,516
1,763 (patterned segment) Specialist Driven Products
444
185420
958601
172 103
833915
272
Phase I20.5%
Phase II24.8%
Phase III7.3%
Pre-reg/reg3.0%
Pre-clinical 44.5%
172 82
% share of active pipeline
103
Source: IMS Health, R&D Focus, Jun 2010
Leading franchises in the global R&D pipeline
Phase III, pre-registered, registered1. Cancer (109)2. CNS (51)3. Vaccines (51) 4. Cardiovascular (49)4. Cardiovascular (49)5. Anti-infectives & Antivirals (39)6. Diabetes (33)7. Genito-urinary & Hormones (32)8. Arthritis/Pain (26)8. Arthritis/Pain (26)9. Respiratory (22) 10. Dermatology (16)11. Gastrointestinal (16)12. Metabolic (15)( )13. Blood (12)14. Ophthalmics (11)15. Immune system (7)
Source: IMS Health, R&D Focus, Jun 2010
2008 FDA approvals of NCEs took place in a challenging environmentchallenging environment
Fewer new product submissions24 in 2008* vs. 34 in 2007
Fewer “me-too” productsDelayedor denied Restricted or denied market access36 complete
Restricted market access21 Risk 26 NCE approvals
i d l
36 complete response or not-approvable letters
21 Risk Evaluation & Mitigation Strategies
Review delays20% of PDUFA goals missed in 2008*
FDA staff shortage
Source: IMS, Market Insights Research. *Jan-Oct 2008.
71 “traditional” drugs have REMS programs
Program Complexity
75%
60
70
80
40
50
60
23%
20
30
0% 2% 0% 0%0
10
MG MG + CP CP + ETASU + IS MG + ETASU MG + ETASU + IS MG + CP + ETASU + IS
Source: Center for Healthcare Supply Chain Research
68 “specialty” drugs have REMS programs
Program Complexity
57%
50
60
30
40
AranespEpogen/ProcritNplate
19%
4% 7%9%10
20
NplateSabrilOnsolisZyprexa Relprevv
4%3%
7%9%
0
10
MG MG + CP CP + ETASU + IS MG + ETASU MG + ETASU + IS MG + CP + ETASU + IS
Source: Center for Healthcare Supply Chain Research
REMS programs and a more active FDA safety program will bring new risk/benefit dynamic
Voluntary AE reportingAE ReportsFrom public, Point-of-Care,Other safety data
R l t d i i
program will bring new risk/benefit dynamic
Pre Market Safety Data
FDA Analysis of Safety Profile
Industry, Governmenty
sources Regulatory decisions
Safety Profile• Statistical (SAS, STATA)• Clinical• Integration of all
information
Large data sets• HMD• CMS• VA• Other
Registries
Oth
Electronic HealthRecords• GPRD• VA DOD• Cigna (?)
Registries• Personal
health records• Drug specific• Disease
specificData communication
Drug Use Data• IMS• Verispan• US• Prevnar (?)
Other surveillanceSystems• NEISS• TESS• DAWN
Industry driven studies
Source: FDA PDUFA IV Information Technology Plan, DRAFT, Dec 2007
Medicare Part D and Medicaid are growing!
% TRx Dispensed
100
42 49 55 60 65 68 71 73 74 73 72 72
2120191915
75
100
1313
1211
10 11
65 68 71 73 74 73 72 72
66 64 63 63 6150
44 38 33 29 25 21 19 16 14 14 14 12 11 10 9 9 8
10 11 11 11 11 13 14 168 8 8 9 10
0
25
4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9 0
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
Cash Medicaid All Other 3rd Party Medicare Part D
Source: IMS Health: National Prescription Audit (NPA) Plus 7, Xponent PlanTrak
Debate in the US on healthcare reform was broadly centered on core issues of access affordability and centered on core issues of access, affordability and quality
• Providing insurance to the currently uninsured
• Improving the quality of care that is deliveredQualityAuninsured deliveredQualityAccess
• Lowering costs of existing activities
• New sources of funding
Affordability
funding
The most certain impacts are negative in the short term but more positive or uncertain longer termterm but more positive or uncertain longer term
UpsideExpanded coverage of current uninsuredcurrent uninsured
Expanded Medicaid coverageReform of insurance practices
Closure of donut hole
IMP
AC
T
pIndependent Payment Advisory BoardPatient Centered Outcomes Res. Inst.Pilots, demonstration projectsPreventive care incentivesPhysician payment
Medicaid rebate
Annual feesBiosimilar regulatory pathway
sunshine rules
increases
Part D donut hole subsidyDownside
2010 20192014TIMING
The reforms will move tens of millions of people to or from coverage types by 2019
400
from coverage types by 2019
COVERAGE AFTER REFORMImpact on 2019
(Mn)Vs no reform Vs 2010
300
350
400
LLIO
NS)
Exchanges
Unins ed
+24 +24
-32 -27
Vs. no-reform Vs. 2010
200
250
F P
EO
PLE
(M
IL Uninsured
Nongroup/Other
Employer
-32 -27
-5 -2
-4 +8
50
100
150
NU
MBER O
F Employer
Medicaid/CHIP
Medicare
+16 +11
0 +14
0
50
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019
Source: CMS, CBO Healthcare Reform Reconciliation Bill Analysis, Mar 2010
Sales and prescription performance-2011
% Growth of prescription productsTotal market
10% 2007
2008
Total market
5 0%WTH U
2009
2010
MAT Feb 2011
YTD Feb 2011
3.8%3.2%
1.8%
5.0%
2.1%2.3%2.6%
2.0%
4.0%4.6%5%
% G
ROW
1.8%1.1% 1.2%
0%Sales TRx
Source: IMS Health, National Sales Perspectives, Feb 2011 IMS Health, National Prescription Audit, Feb 2011
What’s In?
• Slower market growth
• Generics & Patent Cliff
• Specialty is growing but at a slower pace
• RX to OTC
• Private label OTC
• Chain & Mass, Mail service, Clinics, & LTC
M di id & M di P t D• Medicaid & Medicare Part D
• Cough, Cold and Flu
• Price Increases• Price Increases
• REMS
• Drug ShortagesDrug Shortages
What’s out and what’s ahead???
What’s Out? What’s Ahead?What’s Out?• Brand growth
• Innovation
What’s Ahead?• Government
− Medicaid• Innovation
• R&D
Offi i it
− Medicare Part D
− Health Care reform
− Generic User fees• Office visits
• Elective surgery
− Generic approval backlogs
− More FDA inspections
− AMP
− Biosimilar Pathway
− REMS
− Patent SettlementsPatent Settlements
Thank youVisit www imshealth com for more Visit www.imshealth.com for more
information on IMS’ Viewpoint
Doug Long [email protected]