Sie sind auf Seite 1von 72

The US Pharmaceutical Market: Trends, Issues, & Outlook

BY: Doug Long, VP Industry Relations Presented to NCPO January 7, 2011

2011 Strategic management presentation

All reproduction rights, quotations, broadcasting, publications reserved. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, without express written consent of IMS HEALTH.

2010 YTD November sales growth slows to 2.3% and 1.1% TRX growth
$350 $300 $250

Dollars Growth

10 9 8

TRx US TRx growth

SALES US$BN

% CHANGE

$200 $150 $100 $50 $0


2005 2006 2007 2008

5 4 3 2

2.1%
2 2

2.3% 1
0
2009 YTD Nov 2010
0 2005 2006 2007 2008 2009 YTD Nov 2010

1.1%
0

Source: IMS Health, National Sales Perspectives, Nov 2010

Source: IMS Health, National Prescription Audit Plus, Nov 2010

% CHANGE

5.1%

TRX VOLUME BN

7 6

US market growth in MAT Oct 2010 was 3.2%; 2.4% in YTD 2010
$350 $300

20

SALES US$BN

$200 $150 $100 $50 $0

10

Source: IMS Health, National Sales Perspectives, Oct 2010

% CHANGE

$250

15

OTC dollar sales showing 2% sustained growth over time


Highest growth of 4.9% achieved in 2007
$23 $22 15.0

SALES US$BN

$21

$20

5.0

$19 0.0 $18

$17

(5.0)

2008

2006

2007

2009

2005

Source: IRI Infoscan Total US FDMx Latest 52 weeks ending July 11, 2010

Lat 52 Wks

% GROWTH US$

10.0

US prescription growth at 1.5% for MAT Sep 2010

US
5.0 4.0 3.0 2.0 1.0 0.0

Growth Rate
10 9 8 7 6 5 4 3 2 1 0 -1

TRX VOLUME BN

Source: IMS Health, National Prescription Audit Plus, Sep 2010

19 96 19 97 19 98 19 99 20 00 20 01 20 02 20 03 20 04 20 05 20 06 20 07 20 08 M AT 20 09 Se p 20 10

TRX PPG

Absolute TRx growth

200 180
AC TRx MN

Increm ental prescription growth 162

160 140 120 100 80 60 40 20 0

100 80 40 45 39

2006

2007

2008

2009

MAT Nov 2010

YTD Nov 2010

Source: IMS Health, National Prescription Audit, Nov 2010

Branded Generics Disaggregated

Brands are declining in script volume


% Growth US$ Jan 2010 to Sep 2010 % Growth TRx Jan 2010 to Sep 2010

20% % GROWTH 15% 10% 5% 0% -5% YTD Sep 2010 2.3% -0.1%

16.7%
% GROWTH

10% 5.9% 5% 1.0% 0% -5% -10% -10.5% -15% YTD Sep 2010

Total market
Source: IMS Health, National Sales Perspectives, Branded generics disaggregated, Sep 2010

Brands

Generics
Source: IMS Health, National Prescription Audit, Branded generics disaggregated, Sep 2010

Brand growth declines to -0.2% in MAT Nov 2010

Twelve months ending Nov 2010 % Growth US$


25% 20%
% GROWTH

22.1%

15% 10% 5% 0% -5%


Total Market Generic Biologic Molecules Brand Primary Care Driven Atcs Oncologics

5.4% 2.8% 1.0% -0.2% MAT Nov 2010

5.2%

6.7% 3.8%

Branded Generic Specialist Driven Atcs

Source: IMS Health, National Sales Perspectives, Nov 2010

Growth remains low for both segments, but growth rates converge in latest periods
MAT Nov 2010
16% 14%

US Prim ary care driven Specialist driven

% Market share US$ Primary care driven Specialist driven 56% 44%

% GROWTH US$

12% 10% 8% 6% 4% 2% 0% -2% -4% 2006 2007 2008 2009 MAT Nov 2010

% Absolute change US$ Primary care driven Specialist driven 21%

79%

Source: IMS Health, National Sales Perspectives, Nov 2010

US is impacted by continued patent expiries, and historically low contribution from new products
US market growth: 2009 5.2%;

Protected brands list" price growth Increasing generic volume and less price deflation H1N1/CCF Fewer safety events Demographic factors Approvals of innovative therapies
Source: IMS Health, Market Prognosis, IMS Consulting, Sep 2009

Protected brands volume decline Slow uptake of recently launched products Patent expiries Greater substitution of generics

Protected brand volume growth has declined to negative levels in 2010


Growth by Segment
Protected Brands - Volume Existing LOE New Generics Protected Brands - Pricing New LOE Safety New Brands Old Generics Net Growth

10.0 8.0 6.0 AC US$BN 4.0 2.0 0.0 -2.0 -4.0 -6.0
Dec-08 Dec-06 Dec-07 Dec-09 Jun-08 Jun-06 Jun-07 Jun-09 Mar-08 Mar-06 Mar-07 Mar-09 Sep-08 Sep-06 Sep-07 Sep-09 Mar-10 Jun-10

-8.0

Quarter Ending
Source: IMS Health, National Sales Perspectives, June 2010

Cough, cold, and flu has contributed negative growth in 2010


Growth by Segment
CONTRIBUTION TO GROWTH US$BN
All Other Therapies C ough, C old & Flu

6.0 5.0 4.0 3.0 2.0 1.0 0.0 -1.0

0.48 0.48 0.24 0.02 0.39 0.11

-0.04 -0.21 -0.40

-0.32

Dec-08

Dec-06

Dec-07

Dec-09

Dec-05

Jun-08

Jun-06

Jun-07

Jun-09

Mar-08

Mar-06

Mar-07

Mar-09

Sep-08

Sep-06

Sep-09

Mar-10

Mar-05

Jun-10

Jun-05

-2.0

-0.32 -0.32 -0.36 -0.58-0.49 -0.36 -0.03 -0.91-0.93-0.79 -0.26 -0.12

Source: IMS Health, National Sales Perspectives, Sep 2010

Sep-10

Sep-05

PATIENT VISITS BN 1.450 1.656 Jun05 1.563 Jun04 1.641 Jun06 1.676 Sep05 1.550 1.650 1.750 1.500 1.600 1.700 1.800

Source: IMS Health, National Disease and Therapeutic Index, Nov 2010

TOTAL PATIENT VISIT IN US

Patient visits remain below peaks in 2006

ROLLING MAT

1.671 Dec 06 1.653 Jun07

1.607 Jun08 1,616 Aug09

Jun-03 Aug-03 Oct-03 Dec-03 Feb-04 Apr-04 Jun-04 Aug-04 Oct-04 Dec-04 Feb-05 Apr-05 Jun-05 Aug-05 Oct-05 Dec-05 Feb-06 Apr-06 Jun-06 Aug-06 Oct-06 Dec-06 Feb-07 Apr-07 Jun-07 Aug-07 Oct-07 Dec-07 Feb-08 Apr-08 Jun-08 Aug-08 Oct-08 Dec-08 Feb-09 Apr-09 Jun-09 Aug-09 Oct-09 Dec-09 Feb-10 Apr-10 Jun-10 Aug-10 Oct-10

1,529 Nov10

Patient visit trends remain negative with -4.7% growth in MAT Nov 2010

6% 4% ROLLING MAT GROWTH 2% 0% -2% -4% -6% -8% -10%


Jul-08 Jul-09 Mar-08 Mar-09 Nov-08 Nov-09

Patient Visit Growth

Mar-10

Jan-08

Jan-09

Jan-10

Jul-10

May-08

May-09

May-10

ROLLING MAT

Source: IMS Health, National Disease and Therapeutic Index, Nov 2010, Confidence Interval shown (+/-3.9%)

Nov-10

Sep-08

Sep-09

Sep-10

Patient visit growth trends vary among classes; antipsychotic recovering and DPP-IV continue growth
15% 10% ROLLING MAT GROWTH 5% 0% -5% -10% -15%
Nov-08 Mar-09 May-09 Jan-09 Sep-08

Patient Visit Growth Statins PPI Anti-Psychotics Res Fixed Dose Comb DPP-IV Antiplatelets

Jul-09

Nov-09

Jul-10

May-10

ROLLING MAT

Source: IMS Health, National Disease and Therapeutic Index, Nov 2010

Nov-10

Sep-09

Mar-10

Jan-10

Sep-10

The economic crises impact all stakeholders


The danger for pharma is losing share of voice!
Stakeholders
1 Patients

Likely reactions
Significant increase in price sensitivity Down-trading to cheaper drugs or generics Deferral of treatment Reduced spend on promotion Rationalisation of product lines Mergers/acquisitions Cash-flow and credit issues Reduced inventories to minimise financial exposure Increase in distribution costs Consolidation among local distributors Changed prescribing practices Increase generic / therapeutic substitution Shifting costs to patients Increased focus on evidence and value Formulary control intensifies

Manufacturers

Distributors

Healthcare Providers

Payers

The declines in consumer sentiment in the US were not matched by TRx declines or claims
Market Indicators Indexed to January 2007
120 110 100 INDEX 90 80 70 60 50 40
Jan-07 Feb-07 Mar-07 Apr-07 May-07 Jun-07 Jul-07 Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 Jan-08 Feb-08 Mar-08 Apr-08 May-08 Jun-08 Jul-08 Aug-08 Sep-08 Oct-08 Nov-08 Dec-08 Jan-09 Feb-09 Mar-09 Apr-09 May-09 Jun-09 Jul-09 Aug-09 Sep-09 Oct-09 Nov-09 Dec-09 Jan-10 Feb-10 Mar-10 Apr-10

Index of Consumer Sentiment Car Sales Index of Employment TRX

Data for the last month of reported claims remains volatile until late reporting physician s claims are added
Source: IMS Health, National Prescription Audit, Jun 2010, LifeLink Apr 2010; Reuters / University of Michigan Surveys of Consumers, Jul 2010; Bureau of Labor Statistics, Jul 2010; Car sales from Bureau of Economic Analysis, National Economic Accounts, Last Revised on Aug 2010

Prescriptions grow 1.1% in MAT Nov 2010

MAT Nov 2010 Channels Retail Chain/Mass Independents Mail service Food stores Non retail channels LTC Total TRxs mn 3,645 2,171 749 236 489 318 318 3,964 % Market Share 92.0 54.8 18.9 6.0 12.3 8.0 8.0 100.0 % Growth 1.1 2.3 -0.9 -0.8 0.2 1.0 1.0 1.1

Source: IMS Health, National Prescription Audit, Nov 2010

US market grows 2.3% in YTD Nov 2010

YTD Nov 2010 Channels Retail Chain/Mass Mail service Independents Food stores Institutional Clinics Hospitals Long-term care Home health care HMO Others Total
Source: IMS Health, National Sales Perspectives, Nov 2010

US$bn 198.5 97.6 47.3 34.2 19.2 79.2 32.8 29.0 13.3 2.2 1.0 0.9 277.6

% Market Share 71.5 35.2 17.1 12.3 6.9 28.5 11.8 10.4 4.8 0.8 0.4 0.3 100.0

% Growth 2.0 2.6 2.1 1.3 0.2 2.9 4.2 0.7 6.2 -0.2 -3.9 -1.7 2.3

Drug accounts for 58% of total OTC sales volume and grew at 2.2% in latest 52 weeks period
Last 52 Wks Channels FDMx Drug Food Massx Sales US$bn $22.1 $12.9 $6.8 $2.4 % Market Share 100.0 58.2 30.9 10.9 % Growth 2.2 2.2 1.2 5.2

Source: IRI Infoscan Total US FDMx Latest 52 weeks ending July 11, 2010

$95bn at risk to generic competition in the US by 2014


Value of products at risk 2004-2014
Const US$bn 35 30 CONSTANT US$BN 25 % of Prior Year's Sales 12%

$95bn
% OF PRIOR YEAR'S SALES 10%

25
20

25 19

8% 6% 4%

19
15 10

16 14 10 8 10

15 10

5 0 2004

2% 0%

2005

2006

2007

2008

2009

2010

2011

2012

2013

2014

Source: IMS Health, MIDAS, Market Segmentation, Jun 2010

22

$95bn at risk to generic competition in the US by 2014


Value of products at risk 2010-2014
Const US$bn 35 30 CONSTANT US$BN 25 20 % of Prior Year's Sales 12%

$95bn
% OF PRIOR YEAR'S SALES 10%

LOE date changes since March 2010 forecast Lovenox LOE date from future unknown to 6/2010 ($2.6b) Strattera from 5/2015 to 8/2010 ($510m) - patent invalidated Aug 2010 for lack of enablement/utility Alimta from 9/2011 to 7/2016 ($930m)- patent term extension granted

24.8

25.4 19.2

8% 6% 4%

15 10 5 0

15.2 10.3

2% 0% 2010 2011 2012 2013 2014

Source: IMS Health, MIDAS, Market Segmentation, Jun 2010

23

$95bn at risk to generic competition in the US by 2014


Value of products at risk 2010-2014
ALL OTHERS OXYCONTIN LOVENOX LIPITOR CYMBALTA Total LOE sales

35 ADVAIR DISKUS SEROQUEL 30 CONSTANT US$BN 25 20 15 10 5 0 2010 2011

NEXIUM SINGULAIR ZYPREXA

PLAVIX ACTOS LEXAPRO

LOE date changes since March 2010 forecast Lovenox LOE date from future unknown to 6/2010 ($2.6b) Strattera from 5/2015 to 8/2010 ($510m) - patent invalidated Aug 2010 for lack of enablement/utility Alimta from 9/2011 to 7/2016 ($930m)- patent term extension granted

24.8 2.7 4.6 15.2 2.6 5.7 7.1

25.4 2.7 3.4 3.8 4.2 10.3 3.0 19.2 2.9 6.1

2012

2013

2014

Source: IMS Health, MIDAS, Market Segmentation, Jun 2010

24

Long term LOE exposure

Value of products at risk 2004-2020


35 30 CONSTANT US$BN 25 20 15 10 5 0
2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
Source: IMS Health, MIDAS, Market Segmentation, Jun 2010

Biologics protection expiries Small molecule protection expiries

4 1 25 1 16 1 10 2 19 3 15 1 10 25 11

19

9 6 13 8 8 12 2 12 2 4 1 5

1 14 10 8

Key Biologics and U.S. Patent Expiries


Brand Name
NEUPOGEN ENBREL EPOGEN/PROCRIT LANTUS COPAXONE HERCEPTIN NEULASTA AVONEX REBIF HUMIRA RITUXAN ARANESP AVASTIN LUCENTIS REMICADE

Molecule
FILGRASTIM ETANERCEPT EPOETIN ALFA INSULIN GLARGINE GLATIRAMER ACETATE TRASTUZUMAB PEGFILGRASTIM INTERFERON BETA-1A INTERFERON BETA-1A ADALIMUMAB RITUXIMAB DARBEPOETIN ALFA BEVACIZUMAB RANIBIZUMAB INFLIXIMAB

Year Launched
1997 1989 1989 2001 1997 1998 2002 1996 2002 2002 1997 2001 2004 2006 1989

Patent Expiry Year U.S. Sales (US$b)


2009 2012 2014 2014 2014 2014 2015 2015 2015 2016 2016 2016 2017 2019 2021 $0.9 $3.1 $4.7 $2.7 $1.8 $1.4 $2.9 $1.3 $0.9 $2.6 $2.5 $1.3 $2.9 $1.2 $3.1

Source: IMS Health, MIDAS MAT Jun 2010

Branded Generics Disaggregated

Generic Share continues to grow


% Dollars
12.5% 13.6% 13.9% 14.2% 14.7% 16.6%

100% % MARKET SHARE 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 2005
87.5%

% Total prescriptions dispensed

56.0%

59.7%

63.5%

67.7%

70.4%

73.6%

86.4%

86.1%

85.8%

85.3%

83.4%

44.0%

40.3%

36.5%

32.3%

29.6%

26.4%

2006

2007

2008

2009

YTD Sep 2010

2005

2006

2007

2008

2009

YTD S ep 2010

Brands

Generics

Source: IMS Health, National Sales Perspectives, Sep 2010, National Prescription Audit, Sep 2010, Branded generics disaggregated

Branded Generics Disaggregated

Brands Contribution to growth is declining


% Contribution to growth US$
2006

MAT Sep 2010

26%

Brands 32%

Brands 74%

Generics 68%

AC = +$23bn

AC = +$10bn

Source: IMS Health, National Sales Perspectives, Branded generics disaggregated, Sep 2010

Average cost of treatment for major therapy areas has declined significantly in recent years
Across 9 therapy areas that now account for over 25% of total sales, an average 38% reduction in the daily cost of therapy has occurred within 12 months The impact of loss of exclusivity of a major product affects the average cost for the total therapy area Over the past seven years, generics share of total scripts has increased from 51% to 74%
The market available for direct generic substitution has increased from 61% of total scripts to 81% The percentage of scripts dispensed as generic when one is available ( generic efficiency rate ), has increased from 84% to 92%

Most major molecules that have lost exclusivity now have over 10 generic competitors Price competition within the generic market is intense and contributing to the decline in average therapy costs

% CHANGE IN COST PER DAY (12 MTHS POST EVENT) (WHOLESALE)

-50%

-80%

-70%

-60%

-40%

-30%

-20%

-10%

An tin

0%

au se an t 5H t3 An ta go ni st e er ag Av

Bi s ph os ph on a te s

Pr ot on Pu m p In hi b

Li p id Re gu la to rs Al ph aBe t a Bl oc ke r ss -b ar bi tu ra Ca te lc

An t N on id

Source: IMS Health, National Sales Perspectives, National Prescription Audit, Dec 2009
ep re an ts , iu O m th e Bl o An rs ck tim An er s ig ra tiep ile ne pt ic s

An average 38% reduction in the daily cost of therapy has occurred in many major classes with recent expiries

Lipid regulators
Lipid Regulators
3.00

Zocor generic COST PER DAY ($)


2.50 2.00 1.50 1.00 0.50 0.00
5 Ap r-0 5 Ju l-0 Oc 5 t-0 5 Ja n0 Ap 6 r-0 6 Ju l-0 6 Oc t-0 Ja 6 n0 Ap 7 r-0 7 Ju l-0 Oc 7 t-0 Ja 7 n0 Ap 8 r-0 8 Ju l-0 Oc 8 t-0 8 Ja n0 Ap 9 r-0 9 Ju l-0 9 Oc t-0 9 Ja n -0

Source: IMS Health, National Sales Perspectives, National Prescription Audit, Dec 2009

Lipid regulators (projected)


Lipid Regulators
3.00

COST PER DAY ($)

2.50 2.00 1.50 1.00 0.50 0.00


5 Ju l-0 Ja 5 n06 Ju l-0 Ja 6 n07 Ju l-0 Ja 7 n08 Ju l-0 Ja 8 n09 Ju l-0 Ja 9 n10 Ju l-1 Ja 0 n11 Ju l-1 Ja 1 n12 Ju l-1 Ja 2 n13 Ju l-1 Ja 3 n14 Ju l-1 4 Ja n -0

Lipitor generic

Source: IMS Health, National Sales Perspectives, National Prescription Audit, Dec 2009

The leaky bucket

100 Rxs

50-70% 48-66% go to come out of pharmacy pharmacy

25-30% are taken properly

15-20% are refilled as Rx d

Industry figures derived from IMS data


33

Major therapy class losses are driven by generic entries


Top ten classes accounting for gains & losses in US in YTD June 2010

-1,027 -1,002

Anti-epileptics (generic Topamax, Lamictal) Antiulcerants (generic Prevacid)

$-4.1bn in loss

(new products) Anti-Acne Preps (in-line products) Anti-Alzheimers (in-line products) Anti-Platelets (in-line products) Oncologics (in-line products, new products) ADHD Therapies (in-line products) Autoimmune disease (in-line products) HIV Antivirals (in-line products) Antipsychotics (new products) Respiratory Agents (in-line products) Antidiabetics

-308 -220 -211 -144 -130 -129 -118 -113

Anti-migrane (generic Imitrex) Immunosuppressants (in-line products) Advanced Imaging Agents (in-line products) Fluoro-Quinolones (in-line products) BPH Products (generic Flomax) IMM-Glob Antivirals (in-line products) ACE Inhibitors (generic Altace) Calcium Antagonists (in-line products)

332 359 $10.2bn in 364 383 406 468 582 893 943 972

gains

GAIN OR LOSS US$MN


Source: IMS Health, National Sales Perspectives, Jun 2010

Antacid tablets and mineral supplements grew more than $100mn each in the latest 52 weeks with 1&2 Letter Vitamins and cold/allergy/sinus at nearly $100mn
Last 52 Wks Leading classes by absolute growth Total OTC 1 2 3 4 5 6 7 8 9 10 ANTACID TABLETS MINERAL SUPPLEMENTS 1 & 2 LETTER VITAMINS COLD/ALLERGY/SINUS TABLETS/PACKETS MULTI-VITAMINS EYE/LENS CARE SOLUTIONS WEIGHT CONTROL/NUTRITIONALS LIQ/PWD LIQUID VITAMINS/MINERALS LAXATIVE/STIMULANT LIQ/PWDR/OIL ADULT INCONTINENCE PRODUCTS US$mn $22,141 $1,240 $1,629 $496 $2,635 $877 $971 $932 $185 $354 $712 Absolute sales growth $mn $482 $126 $115 $96 $92 $57 $37 $34 $30 $27 $25

Source: IRI Infoscan Total US FDMx Latest 52 weeks ending July 11, 2010

Private Label had the strongest absolute growth followed by Nature s Bounty
Dollars
Private Label Natures Bounty Nature Made Sensodyne One A Day Olay Claritin Advil Poise Alcon PRIVATE LABEL US NUTRITION PHARMAVITE CORP GLAXOSMITHKLINE BAYER AG PROCTER & GAMBLE MERCK PFIZER KIMBERLY CLARK CORP NESTLE S.A. (SWITZERLAND)

AC US$mn
552 69 35 25 20 18 17 13 12 11

Source: IRI Infoscan Total US FDMx, Latest 52 weeks ending July 11, 2010

Global R&D pipeline compared against previous year


2,721
Number of active products in the pipeline to date = 6,119 1,763 (patterned segment) Specialist Driven Products

1,253
833 958 420

1,516
915 601

444
272 172

185

Pre-clinical 44.5%
% share of active pipeline

Phase I 20.5%

Phase II 24.8%

Phase III 7.3%

Pre-reg/reg 3.0%

103 82

Source: IMS Health, R&D Focus, Jun 2010

Applications on FDA s review calendar in 2H 2010 are unlikely to bring total NCE count above prior year levels
50 45

41 37 16 15 33 11 32 24 13
22 25 22 17 11 21 22 14 11 12

Primary care driven

NUMBER OF NCE APPROVALS

40 35 30 25 20 15 10 5 0

36 30 14 9 20 6 23 18 12 6

Specialist driven

26 7

28 10 20 11

26-28

15

13-15

19

18

9
08 09 YT D

11-13

98

99

00

01

02

03

04

06

07

05

19

19

20

20

20

20

20

20

20

20

20

20

20 10

Source: FDA, IMS Health, Market Insights Team Analysis, Sep 2010

20

10

(f

Expected major 2010-11 NCE launches include 11 products with blockbuster potential
Product Daxas (roflumilast) Menveo (meningitis vaccine) Prevnar 13 (13-valent pneumococcal vaccine) Prolia (denosumab) Provenge (sipuleucel-T) Gilenya (fingolimod) apixaban belatacept Brilinta (ticagrelor) Benlysta (belimumab) ipilimumab telaprevir bapineuzumab dapagliflozin iniparib vorapaxar / TRA Company Forest Novartis Pfizer Amgen Dendreon Novartis BMS BMS AZ GSK, HSG BMS Vertex/J&J Wyeth BMS/AZ SanofiAventis Merck Indication Respiratory (Chronic Obstructive Pulmonary Disease) Vaccines (meningitis) Vaccines (bacterial infection) Osteoporosis Vaccines (prostate cancer) Multiple sclerosis Proteinase inhibitors (thrombosis) Immunosuppressants for organ transplants Platelet aggregation inhibitors (acute coronary syndrome) Autoimmune disease (lupus, RA) Oncology (metastatic melanoma) Viral Hepatitis Products (hepatitis C) Alzheimer s disease Diabetes (type II diabetes, weight mgmt) Oncology (breast cancer) Proteinase inhibitors (acute coronary syndrome) Potential blockbuster Stage Marketed Marketed Marketed Marketed Approved Approved Pre-reg Pre-reg Pre-reg Pre-reg Pre-reg Pre-reg Phase III Phase III Phase III Phase III Launch 2010 2010 2010 2010 2010 2010 2010-11 2010-11 2010-11 2010-11 2011-12 2011-12 2011-12 2011-12 2011-12 2011-12

Source: IMS Health, Market Insights, Sep 2010.

REMS programs and a more active FDA safety program will bring new risk/benefit dynamic
Voluntary AE reporting Other safety data sources
Pre Market Safety Data Large data sets HMD CMS VA Other Electronic Health Records GPRD VA DOD Cigna (?) Drug Use Data IMS Verispan US Prevnar (?) Registries Personal health records Drug specific Disease specific Other surveillance Systems NEISS TESS DAWN

AE Reports

From public, Point-of-Care, Industry, Government

Regulatory decisions

FDA Analysis of Safety Profile

Statistical (SAS, STATA) Clinical Integration of all information

Data communication

Industry driven studies

Source: FDA PDUFA IV Information Technology Plan, DRAFT, Dec 2007

2008 FDA approvals of NCEs took place in a challenging environment


Fewer new product submissions
24 in 2008* vs. 34 in 2007

Delayed or denied market access


36 complete response or not-approvable letters

Fewer me-too products

26 NCE approvals

Restricted market access


21 Risk Evaluation & Mitigation Strategies

Review delays
20% of PDUFA goals missed in 2008* FDA staff shortage
Source: IMS, Market Insights Research. *Jan-Oct 2008.

Debate in the US on healthcare reform was broadly centered on core issues of access, affordability and quality
Providing insurance to the currently uninsured Improving the quality of care that is delivered

Access

Quality

Affordability

Lowering costs of existing activities New sources of funding

Medicare Part D

Retail Rx payment type


Week Ending Total 2008 Total 2009 October 1, 2010

Current Week

YTD Cum

Total RXs
TRx % TRx % TRx % TRx %

3,429,188,979

100.0%

3,531,115,463

100.0%

71,093,924

100.0%

2,680,853,692

100.0%

Cash

322,409,855

9.4%

309,343,038

8.8%

5,413,571

7.6%

212,953,870

7.9%

Medicaid 3rd Party minus Medicare Part D Medicare Part D

274,375,086

8.0%

300,350,761

8.5%

7,055,905

9.9%

256,074,256

9.6%

2,171,927,926

63.3%

2,221,505,378

62.9%

43,298,792

60.9%

1,645,271,680

61.4%

660,476,112

19.3%

699,916,288

19.8%

15,325,656

21.6%

566,553,887

21.1%

Source: IMS Medicare National Tracking Report

Walgreens Year In Review 44

July 2010

The most certain impacts are negative in the short term but more positive or uncertain longer term
Upside Expanded coverage of current uninsured Expanded Medicaid coverage Independent Payment Advisory Board Patient Centered Outcomes Res. Inst. Pilots, demonstration projects Preventive care incentives

Reform of insurance practices IMPACT Closure of donut hole Physician payment sunshine rules Annual fees Medicaid price cut Part D donut hole subsidy 2010

Biosimilar regulatory pathway

Downside

2014 TIMING

2019

The reforms will move tens of millions of people to or from coverage types by 2019
COVERAGE AFTER REFORM
400 NUMBER OF PEOPLE (MILLIONS) 350 300

Impact on 2019 (Mn)


Vs. no-reform Vs. 2010

Exchanges Uninsured

+24 -32

+24 -27 -2 +8 +11 +14

250

Nongroup/Other -5
200 150 100 50 0 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019

Employer Medicaid/CHIP Medicare

-4 +16 0

Source: CMS, CBO Healthcare Reform Reconciliation Bill Analysis, Mar 2010

U.S. forecast to grow under 5% in 2011 as patent expiries and lack of innovation hamper growth
US Sales and Growth, 2001-2011

18.4% 11.8% 9.8% 8.5% 5.4%


350 300

9.1%

4.0%

1.6% 5.5%

3-4%

3-5%
20%

SALES US$BN

250 200

15%

10% 150 100 50 5%

$176
0

$197

$216

$234

$247

$270

$281

$285

$301

$310- $320320 330 0%

2001

2002

2003

2004

2005
Sales

2006

2007
Growth

2008

2009

2010 (f)

2011 (f)

Source: IMS Health, Market Prognosis, Sep 2010

GROWTH CONST US$

Global pharma market expected to exceed $880 bn in 2011 with growth of 5-7%
Global Sales and Growth, 2001-2011

1,000

12.1% 9.1%

9.1% 7.7% 7.3%

7.2%

6.9% 5.8% 7.1%

4-6%

5-7%

15%

SALES US$BN

750 10% 500 5% 250

$395 $431

$497

$556

$601

$646

$715

$781

$812

$840- $880850 890


0%

2001

2002

2003

2004

2005

2006

2007

2008

2009

Total world
Source: IMS Health, Market Prognosis, Sep 2010

Growth

2010 (f)

2011 (f)

GROWTH CONST US$

Longer-term upsides to pharma growth are possible

Growing share of healthcare budget for pharmacotherapy Accelerated uptake of healthcare information technology Increased diagnosis of asymptomatic conditions

Expanded patient access to healthcare

Greater clinical evidence of drug efficacy

Emergence of new therapeutic platforms Aging population and economic development

Improved compliance and persistency rates

49

Thank you Visit www.imshealth.com for more information on IMS Viewpoint Doug Long dlong@us.imshealth.com

Branded products Rx growth is sharply negative

% Growth US$ Twelve months ending Sep 2010

% Growth TRx Twelve months ending Sep 2010

25% % GROWTH

10% % GROWTH
20.0%

7.2%

20% 15% 10% 5.7% 5% 0% MAT Sep 2010 3.4% 0.7%

5% 0% -5% -10% -15%

1.5%

-9.3%

-9.3%

MAT Sep 2010

Total market

Brands

Branded generics

Unbranded generics

Source: IMS Health, National Sales Perspectives, Sep 2010

Source: IMS Health, National Prescription Audit, Sep 2010

Sales growth for the top 10 generic companies grow at 21.1%


MAT Sep 2010 Sales of unbranded generics by leading corporations US Industry 1 2 3 4 5 6 7 8 9 10 Teva Mylan Labs, Inc. Sandoz (Novartis) Watson Pharma Greenstone (Pfizer) Par Pharma Hospira Inc Actavis US Global Pharm Corp Boehringer Ingelheim Top 10 US$mn 36,863 7,925 3,789 3,457 2,125 1,470 1,380 1,173 992 980 878 24,169 % Market Share 12.1 21.5 10.3 9.4 5.8 4.0 3.7 3.2 2.7 2.7 2.4 65.6 % Growth 20.0 12.8 10.3 53.0 7.6 -9.5 18.2 20.5 93.4 255.3 23.7 21.1

Source: IMS Health, National Sales Perspectives, Sep 2010

Top 20 generic companies grow at 17.7%

MAT Sep 2010 Sales of unbranded generics by leading corporations 11 12 13 14 15 16 17 18 19 20 Fresenius Kabi Ranbaxy Labs Limit Covidien Lupin Pharma Sun Pharmaceutical Qualitest Products Dr Reddy Inc Taro Pharm Apotex Corp Amneal Inc Top 20 US$mn 800 786 604 540 476 463 460 403 368 368 29,436 % Market Share 2.2 2.1 1.6 1.5 1.3 1.3 1.2 1.1 1.0 1.0 79.9 % Growth 21.0 235.7 -34.3 39.1 283.6 26.1 -47.6 21.1 -62.3 116.1 17.7

Source: IMS Health, National Sales Perspectives, Sep 2010

Sales of leading therapy classes

MAT Sep 2010 Leading classes US Industry 1 2 3 4 5 6 7 8 9 10 Lipid regulators Antipsychotics,oth Proton pump inhib Anti-depressants Angiotensin II antagonists Antineo monoclonal antib Analogs of human insulin Antiarth,biol resp mod Anti-platelets,oral Analeptics Top 10 US$mn 305,670 17,207 15,717 11,842 11,490 8,653 8,348 7,150 6,772 6,506 6,419 100,105 % Market Share 100.0 5.6 5.1 3.9 3.8 2.8 2.7 2.3 2.2 2.1 2.1 32.7 % Growth 3.4 1.5 10.0 -14.5 1.1 6.3 6.7 19.2 10.0 11.5 15.9 4.3

Source: IMS Health, National Sales Perspectives, Sep 2010

Sales of leading therapy classes

MAT Sep 2010 Leading classes 11 12 13 14 15 16 17 18 19 20 Erythropoietins Steroid,inhaled bronch GI anti-inflam Codeine & comb HIV antiviral combination Glitazones Alzheimer-type dementia Anticoag,inj Leukotriene agents Seizure disorders Top 20 US$mn 6,187 5,827 5,266 5,243 5,157 4,708 4,438 4,184 4,064 4,047 149,226 % Market Share 2.0 1.9 1.7 1.7 1.7 1.5 1.5 1.4 1.3 1.3 48.8 % Growth -2.6 10.6 10.9 11.9 13.1 1.7 16.4 6.7 9.5 -37.1 3.6

Source: IMS Health, National Sales Perspectives, Sep 2010

Lipid lowering agents now rank second in Rx volume


1 2 3 4 5 6 7 8 9 10 Anti-depressants Lipid regulators Codeine & comb Ace inhibitors Beta blockers Proton pump inhib Seizure disorders Thyroid hormone,synth Calcium blockers Benzodiazepines Top 10 247 243 204 164 126 118 110 105 95 90 1,503 6.3 6.1 5.2 4.2 3.2 3.0 2.8 2.7 2.4 2.3 38.0 3.0 2.8 2.7 1.3 -2.4 -0.8 6.7 2.6 4.6 3.4 2.3

Source: IMS Health, National Prescription Audit, Sep 2010

Rx growth in the top 20 classes is 1.9%

MAT Sep 2010 Leading therapy class 11 12 13 14 15 16 17 18 19 20 Angiotensin II antagonists Antiarth,plain O/C estrogen/progestogen Macrolides & related Beta agonists Penicillins Biguanides Non-barb,oth Antipsychotics,oth Mus relx,non-surg Top 20 US TRX mn 81 79 79 67 63 61 61 59 53 52 2,158 % Market Share 2.0 2.0 2.0 1.7 1.6 1.5 1.5 1.5 1.3 1.3 54.6 % Growth -3.1 2.5 -3.0 0.8 3.6 -0.3 6.0 1.4 1.8 4.6 1.9

Source: IMS Health, National Prescription Audit, Sep 2010

Leading Absolute Growth Vs. Yr. Ago-Classes


AC US$mn
1423.9 1151.2 881.6 671.4 625.4 614.0 598.1 558.3 557.8 520.5

Dollars
Antipsychotics,oth Analogs of human insulin Analeptics Anti-platelets,oral Alzheimer-type dementia Antiarth,biol resp mod HIV antiviral combination Steroid,inhaled bronch Codeine & comb Antineo monoclonal antib

Total Rx dispensed
Anti-depressants Seizure disorders Lipid regulators Vitamin D Codeine & comb Calcium blockers Analeptics Biguanides Benzodiazepines Thyroid hormone,synth

AC TRxs mn
7.1 6.9 6.6 6.2 5.4 4.2 4.1 3.4 3.0 2.7

Source: IMS Health, National Sales Perspectives, Sep 2010, National Prescription Audit, Sep 2010

Leading Absolute Declines Vs. Yr. Ago-Classes


AC US$mn
-203.6 -231.4 -234.3 -344.1 -397.4 -455.3 -520.3 -637.1 -2012.8 -2384.7

Dollars
Quinolones, systemic Calcium blockers Ace inhibitors Herpes Antivirals UT benign prostate Immunosup/transplant age Platinum coordination Anti-migraine Proton pump inhib Seizure disorders

Total Rx dispensed
Hormones,estrogens Diuretics,comb GI stimulants Glitazones Quinolones, systemic Synth narc,analg O/C estrogen/progestogen Angiotensin II antagonists Beta blockers Osteoclast Inhibitors

AC TRxs mn
-1.3 -1.5 -1.6 -1.8 -2.2 -2.4 -2.4 -2.6 -3.1 -3.7

Source: IMS Health, National Sales Perspectives, Sep 2010, National Prescription Audit, Sep 2010

Sales of leading products

MAT Sep 2010 Products US Industry 1 Lipitor 2 Nexium 3 Plavix 4 Advair Diskus 5 Abilify 6 Seroquel 7 Singulair 8 Crestor 9 Actos 10 Epogen Top 10 US$mn 305,670 7,275 6,328 6,002 4,743 4,423 4,324 3,984 3,605 3,516 3,349 47,548 % Market Share 100.0 2.4 2.1 2.0 1.6 1.4 1.4 1.3 1.2 1.2 1.1 15.6 % Growth 3.4 -4.3 2.0 11.0 3.4 16.2 6.3 9.3 28.8 5.7 6.8 6.7

Source: IMS Health, National Sales Perspectives, Sep 2010

Sales of leading products

MAT Sep 2010 Products 11 Remicade 12 Enbrel 13 Avastin 14 Oxycontin 15 Cymbalta 16 Neulasta 17 Zyprexa 18 Humira 19 Lexapro 20 Rituxan Top 20 US$mn 3,294 3,247 3,152 3,149 3,060 2,994 2,890 2,796 2,765 2,730 77,625 % Market Share 1.1 1.1 1.0 1.0 1.0 1.0 0.9 0.9 0.9 0.9 25.4 % Growth 3.2 1.0 8.4 14.6 12.2 1.2 10.6 14.4 1.0 5.6 6.8

Source: IMS Health, National Sales Perspectives, Sep 2010

Watson s hydrocodone with APAP replaces Lipitor as the most prescribed product
MAT Sep 2010 Leading Products US Industry 1 2 3 4 5 6 7 8 9 10 hycd/apap hycd/apap Lipitor levothyroxine lisinopril Plavix amoxicillin Nexium Singulair simvastatin Top 10 TRxs mn 3,954 58 50 46 41 36 29 29 29 28 28 375 % Market Share 100.0 1.5 1.3 1.2 1.0 0.9 0.7 0.7 0.7 0.7 0.7 9.5 % Growth 1.5 -3.6 -3.9 -13.2 6.0 2.0 -0.7 -17.4 -5.6 -0.1 40.1 -2.1

Source: IMS Health, National Prescription Audit, Sep 2010

Top 20 drugs show positive growth

MAT Sep 2010 Leading Products 11 metoprolol tart 12 simvastatin 13 Lexapro 14 Synthroid 15 azithromycin 16 levothyroxine 17 Crestor 18 metformin hcl 19 Proair Hfa 20 sertraline hcl Top 20 TRxs mn 28 27 26 25 24 24 24 23 23 22 622 % Market Share 0.7 0.7 0.7 0.6 0.6 0.6 0.6 0.6 0.6 0.5 15.7 % Growth 7.0 13.7 -7.6 -2.2 62.3 9.8 14.5 7.7 -3.6 20.3 2.1

Source: IMS Health, National Prescription Audit, Sep 2010

Leading Absolute Growth Vs. Yr. Ago-Products


AC US$mn 807 623 616 596 446 401 400 394 387 386 AC TRxsmn 9.8 9.4 8.1 7.8 7.2 6.8 6.4 6.2 5.8 5.4

Dollars Crestor (Azn) valacyclovir hcl (rby) Abilify (Ots) Plavix (Bsa) Prevnar 13 (Pfz) Oxycontin (Puf) Atripla (Bmg) budesonide (tev) venlafaxine hcl er (tev) Seroquel Xr (Azn)

Total Rx Dispensed metoprolol succin (wts) azithromycin (tev) simvastatin (lu.) cephalexin (lu.) omeprazole (rx) (myn) gabapentin (am9) Atripla (Bmg) pravastatin sod (tev) warfarin sod (tar) omeprazole (rx) (sdz)

Source: IMS Health, National Sales Perspectives, Sep 2010, National Prescription Audit, Sep 2010

Sales of leading corps

MAT Sep 2010 Leading corporations US Industry 1 2 3 4 5 6 7 8 9 10 Pfizer (incl Greenstone / Wyeth) Merck & Co (inc S-P) AstraZeneca Novartis (incl Sandoz) Roche (incl Genentech) Lilly GlaxoSmithKline Teva Amgen Corporation Johnson & Johnson Top 10
Source: IMS Health, National Sales Perspectives, Sep 2010

US$mn 305,715 26,654 19,037 18,584 15,180 14,079 14,062 14,021 13,318 12,633 12,599 160,168

% Market Share 100.0 8.7 6.2 6.1 5.0 4.6 4.6 4.6 4.3 4.1 4.1 52.2

% Growth 3.4 -3.7 -3.1 5.3 17.6 3.0 9.3 -7.3 10.3 1.9 -5.9 1.8

Sales of leading corps

MAT Sep 2010 Leading corporations 11 12 13 14 15 16 17 18 19 20 Abbott Sanofi-Aventis Bristol-Myers Squibb Boehringer Ingelheim Takeda Eisai Corp Forest Lab Gilead Sciences Otsuka America Ph Mylan Labs Top 20 US$mn 10,791 10,411 9,564 6,768 6,259 4,683 4,625 4,488 4,482 4,337 226,576 % Market Share 3.5 3.4 3.1 2.2 2.0 1.5 1.5 1.5 1.5 1.4 73.9 % Growth 2.2 -7.7 9.6 -6.3 -23.3 9.7 8.1 21.4 16.7 12.0 1.5

Source: IMS Health, National Sales Perspectives, Sep 2010

Teva leads in prescription volume with more than 16% share


MAT Sep 2010 Leading corporations US Industry 1 2 3 4 5 6 7 8 9 10 Teva Mylan Labs, Inc. Novartis (incl Sandoz) Pfizer (incl Greenstone) Watson Pharma Lupin Pharma Qualitest Products Amneal Inc AstraZeneca Covidien Top 10 TRxs mn 3,954 639 368 262 251 232 121 117 90 88 84 2,251 % Market Share 100.0 16.2 9.3 6.6 6.3 5.9 3.1 3.0 2.3 2.2 2.1 56.9 % Growth 1.5 2.0 10.7 10.4 -4.3 -1.0 38.4 21.9 51.5 -5.0 -10.0 6.1

Source: IMS Health, National Prescription Audit, Sep 2010

Prescription growth among the top 20 corporations at 4.1%


MAT Sep 2010 Leading corporations 11 12 13 14 15 16 17 18 19 20 GlaxoSmithKline Merck & Co Boehringer Ingelheim Actavis US Dr Reddy Inc Abbott Lilly Zydus Pharma Forest Lab Bristol-Myers Squibb Top 20 TRxs mn 75 73 69 68 62 61 49 49 44 42 2,844 % Market Share 1.9 1.9 1.7 1.7 1.6 1.5 1.2 1.2 1.1 1.1 71.9 % Growth -5.0 -14.5 -2.3 -6.1 -8.5 -6.5 -1.0 60.7 -5.5 -4.2 4.1

Source: IMS Health, National Prescription Audit, Sep 2010

Leading Absolute Growth Vs. Yr. Ago-Companies

Dollars Novartis (incl Sandoz) Lilly Teva AstraZeneca Bristol-Myers Squibb Gilead Sciences Global Pharma Corp Novo Nordisk Otsuka America Ph Mylan Labs, Inc.

AC US$BN 2.3 1.2 1.2 0.9 0.8 0.8 0.7 0.7 0.6 0.5

TRx Mylan Labs, Inc. Lupin Pharma Amneal Inc Novartis (incl Sandoz) Qualitest Products Zydus Pharma Glenmark Pharma Teva West Ward Northstar Rx

AC TRx mn 35.7 33.5 30.6 24.7 21.0 18.3 12.4 12.4 11.2 10.1

Source: IMS Health, National Sales Perspectives, Sep 2010, National Prescription Audit, Sep 2010

Daily cost of therapy is declining across major therapy areas


Pre 12 months Generic post generic avg price avg price 59.73 25.69 2.01 1.35 3.15 2.84 2.52 2.13 2.45 0.60 1.60 1.03 1.30 0.83 2.33 1.32 1.20 0.67 9.35 6.47 2.35 1.24 2.32 1.20 24 months % % post generic reduction reduction avg price 12 months 24 months 14.93 57.0% 75.0% 0.32 32.7% 84.1% 2.76 9.6% 12.4% 1.86 15.3% 26.2% 0.49 75.5% 80.1% 1.06 35.8% 33.8% 0.82 36.6% 36.8% 1.24 43.5% 46.9% 0.57 44.8% 52.7% 5.82 30.8% 37.7% 1.12 47.0% 52.3% 1.08 48.1% 53.3% Key LOE Brand(s) month Zofran Fosamax Prevacid* Zocor Coreg
Zoloft Effexor

Class Antinauseants Bisphosphonates Proton Pump Inhib Lipid Regulators Alpha-Beta Blocker Antidepressants Non-barbiturate, Others Calcium Blockers Antimigrane Anti-epileptics

Dec-06 Jan-08 Nov-09 Jun-06 Sep-07


Jun-06 Jun-08

Ambien Norvasc Imitrex


Lamictal* Topamax*

Apr-07 Mar-07 Feb-09


Jan-09 Mar-09

Average price calculation: Weight Avg. Cost/Day = Tablet cost X Tabs per Day X Tablets share of class (this calculation is done at the form strength level then summed to Class ) 12 and 24 months post generic: average of the cost per day for available months if it is less than 12 or 24 months after the event *If post generic timeframe has not occurred, post generic pricing (to date) is trended to full 12 or 24 month range
THERAPY DAY AVERAGE COSTS 0310 DRAFT 70 Enter fixed date manually [View>Header and Footer...]

US biologic growth over time

Sales
70

Growth
30

60

25

50 20

US$BN

40 15 30 10 20 5

10

0
MAT Mar 1999 MAT Mar 2000 MAT Mar 2001 MAT Mar 2002 MAT Mar 2003 MAT Mar 2004 MAT Mar 2005 MAT Mar 2006 MAT Mar 2007 MAT Mar 2008 MAT Mar 2009 MAT Mar 2010

Source: IMS Health, MIDAS, MAT Mar 2010, US Biologic market at trade level

US$ SALES GROWTH

US biologic leading classes 1- 10

MAT Jun 2010 Rank US Biologic Market 1 L4B Anti-Tnf Products 2 L1X All Other Antineoplastic 3 A10C Human Insulin+Analogues 4 B3C Erythropoietin Products 5 L3A Immunostim Ag Ex Intfron 6 J7A Pure Vaccines 7 B1B Heparins 8 L3B Interferons 9 J6C Polyval Immuno-Globl I.V 10 B2D Blood Coagulation Top 10 US$MN 65,475.2 9,482.7 8,039.5 7,865.8 6,297.8 5,951.5 3,988.0 3,281.6 3,201.4 1,752.1 1,650.5 51,510.9 % Market Share 100.0 14.5 12.3 12.0 9.6 9.1 6.1 5.0 4.9 2.7 2.5 78.7 % Growth 6.5 9.7 4.5 18.7 -2.4 5.5 -2.8 6.0 10.5 10.2 4.5 6.6

Source: IMS Health, MIDAS, MAT Jun 2010, US Biologic Market at trade level

Das könnte Ihnen auch gefallen