The Trillion Dollar Market for Medicines: Characteristics ... · The Trillion Dollar Market for...

The Trillion Dollar Market for Medicines: Characteristics, Dynamics and Outlook

Johns Hopkins Bloomberg School of Public Health Center for Drug Safety and Effectiveness Safety, Value and Innovation Seminar

Murray Aitken Executive Director www.theimsinstitute.org [email protected]

February 24, 2014

http://www.theimsinstitute.org/

Contents

• About the IMS Institute

• Methodology and measures

• Global spending on medicines

• Mix of branded and generic medicines

• Transformations in disease treatment

• Implications and discussion

Safety Value and Innovation Seminar JHU 022414 2

About the IMS Institute

Unbiased Information

Academic Research

Public Policy Support

3 Safety Value and Innovation Seminar JHU 022414

During 2013 we published six major reports

Teva Public Health Discussion 013014 4

Methodology

• Forecasts of spending on medicines globally are based on proprietary analysis performed by IMS Health and published as IMS Market Prognosis reports for 42 countries, 11 regions, and globally

• Methodology for each country forecast combines: − Collection of historical data by sector as captured by IMS audits, estimates of

unaudited market sectors, and 5 most significant macroeconomic indicators based on historical correlation

− Quantitative projection of baseline based on historical trends and macroeconomic indicator forecasts provided by the Economist Intelligence Unit

− Identification, evaluation and quantification of specific events that are used to refine the baseline based on IMS expertise and insight within each country

• Evented 5-year forecasts are produced for retail and hospital, price and volume, as well as total market

• Additional proprietary analysis of the IMS Market Prognosis reports is performed by the IMS Institute to generate additional analytics and insights, some of which are incorporated in the IMS Institute report


Notes on measures

• Market sizes are measured in U.S. $, converted at Q2 2013 average exchange rates

• All growth rates are measured in constant dollars (local currency growth)

• “Spending” refers to the amounts paid to pharmaceutical companies for medicines, not the cost incurred by the end-user or payer


Total global spending on medicines will reach about $1.2Tn in 2017, an increase of $205-235Bn from 2012

Global spending and growth, 2008-2017

2007 2008-2012 2012 2013-2017 2017

$731Bn

$234Bn

$965Bn

$205-235Bn

$1,170-1,200 Bn

Source: IMS Health Market Prognosis, September 2012

7 Safety Value and Innovation Seminar JHU 022414

Annual spending growth will reach a low point in 2013, followed by increased growth particularly in developed markets


Global Growth, 2008-2017

-10

0

10

20

30

40

50

60

70

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

ABSO

LUTE G

RO

WTH

CO

NST $

USBN

Developed Pharmerging Rest of World

2008-12 Growth $217Bn

2013-17 Growth $230 -260Bn


Medicine spending per capita and growth rates are starkly different between high income countries and those with income under $25,000 per capita


Per capita Gross National Income 2012 (GNI) vs. Forecast Pharma Spend

India

China

Mexico

Turkey

Russia

Brazil

S. Korea

Spain

UK Italy

Japan

France

Canada

USA Germany

-5%

0%

5%

10%

15%

20%

0 10 20 30 40 50 60

PHARM

A F

ORECAST G

RO

WTH

(CAG

R 2

013-1

7)

GNI (US$ THOUSANDS PER CAPITA)

Pharma Spend per Capita

Source: World Bank, 2012; IMS Health Market Prognosis, September 2013

$100

$500

$1,000

Interferons

ADHD

Antivirals excluding HIV

Antidepressants

Antiulcerants

Antipsychotics

Immunosuppressents

Anti-Epileptics

Cholesterol

Antibiotics

Dermatology

HIV Antivirals

Immunostimulants

Hypertension

Other CNS Drugs

Asthma/COPD

Pain

Anti-TNFs

Diabetes

Oncology

Immunostimulants

Erectile Dysfunction

Heparins

Antipsychotics

Antiplatelet

Antidepressants

Allergy

Immunosuppressents

Antivirals excluding HIV

Anti-Epileptics

Asthma/COPD

Cholesterol

Antiulcerants

Dermatology

Diabetes

Hypertension

Oncology

Antibiotics

Other CNS Drugs

Pain

Spending levels in 2017 on medicine for specific disease areas will differ significantly between developed and pharmerging markets


Spending by Therapy area in 2017

Top 20 Classes, 71% Others, 29% Top 20 Classes, 45% Others, 55%

Developed Markets Pharmerging Markets* Sales in 2017 (LC$)

$74-84Bn

$34-39Bn

$32-37Bn

$31-36Bn

$31-36Bn

$26-31Bn

$23-26Bn

$22-25Bn

$22-25Bn

$22-25Bn

$18-21Bn

$16-19Bn

$15-18Bn

$15-18Bn

$13-16Bn

$12-14Bn

$10-12Bn

$8-10Bn

$7-9Bn

$6-8Bn

$22-25Bn

$20-23Bn

$18-21Bn

$17-20Bn

$14-17Bn

$10-12Bn

$10-12Bn

$9-11Bn

$6-8Bn

$3-5Bn

$3-5Bn

$3-5Bn

$3-5Bn

$3-5Bn

$3-5Bn

$3-5Bn

$2-3Bn

$1-2Bn

$1-2Bn

$1-2Bn

Sales in 2017 (LC$)

Source: IMS Health Thought Leadership, September 2013

A growing share of all medicines are biologic, with biosimilars and non-original biologic (NOB) products now taking a small share of the total market


The biologics market

2002 2007 2012 2017

Biologics share of total pharmaceutical market:

15% 18% 19-20% 11%

NOBs

Biosimilars

Global biologics size

1.0%

0.4% 0.5% 0.3%

$46Bn $106Bn $169Bn

1.0%

0.4% 0.3%

2-5%

Share of biologics:

$205-235Bn


0.5%

The U.S., EU5, Japan and China account for just under 70% of total global medicine spending


Geographic distribution of medicine spending

31%

13%

9%

15%

33%

$1,170 – 1,200BN

34%

15% 12%

8%

31%

Spending

2012 2017

US EU5 Japan China ROW

$965BN

16% 3%

6%

34%

41%

$230-260BN

Growth

2013-17


Base case forecast for the U.S. is for 1-4% CAGR


U.S. Spending and Growth, 2008-2017

-4%

-2%

0%

2%

4%

6%

8%

10%

0

50

100

150

200

250

300

350

400

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

GRO

WTH

CO

NST U

S$ S

PEN

DIN

G U

S$BN

Sales Growth

2013-17 CAGR, 1-4% Forecast


Alternative scenarios for the U.S. focus on the implementation of healthcare reform


Scenario Healthcare Reform Implementation

Implications for Medicine Spending

Scenario 1: Reforms lead to expanded access and performance-based healthcare system

• Almost full enrollment of the currently uninsured according to original government estimate

• Rapid movement toward performance-cased system and organization of healthcare delivery

• Increased demand for medicines resulting from increased enrollment, screening, removal of caps, and management of existing conditions

• Cost-effective medicines with clinical value being used more extensively

• Continued premium places on innovative medicines with strong clinical profile

• Total spending on medicines in 2017: $420-460Bn

Scenario 2: Slow pace of change but some expansion in access and incremental changes to payment system

• Initial enrollment of currently uninsured 1/3 of target level, though improvement over time

• Payment system remains largely fee-for-service

• Uncertainty of political support slows or stalls reform implementation

• Modest incremental demand for medicines and primarily for generics

• Incremental pressure by payers and employers limit price increases to current levels at most

• Positioning of competitive medicines primarily based on price

• Newly launched medicines see slow uptake and limited commercial returns


Scenario 3: Implementation leads to major unintended consequences and change

• Exchanges fail to enroll “young invincibles” and insurance model fails

• Employers move large number of employees to private exchanges

• Significant decline in healthcare utilization for prevention and treatment of chronic illness

• Decline in medicine demand volume • Major reduction in formulary access for

insurance plans or major cost reductions from manufacturers

• Limited acceptance of new medicines with price premium


The base-case scenario for the Top 5 European markets is for spending growth to be flat through 2017


Top 5 Europe Spending and Growth, 2008-2017

-2%

0%

2%

4%

6%

8%

10%

0

20

40

60

80

100

120

140

160

180

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

GRO

WTH

CO

NST U

S$ S

PEN

DIN

G U

S$BN

Sales Growth

Forecast

2013-17 CAGR, 0-3%


The economic crisis has had a direct impact on the number of launched products and their uptake


NCEs launched vs. market share achieved

Austria

Belgium

Bulgaria

Czech Rep.

Estonia

Finland France

Germany

Greece

Hungary

Ireland

Italy

Latvia Lithuania

Luxembourg

Netherlands

Norway

Poland

Portugal

Romania

Slovakia

Slovenia Spain Sweden

SUI

UK

France

Germany

Italy

Spain

UK

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

3.5%

4.0%

4.5%

5.0%

5.5%

6.0%

10 20 30 40 50 60 70 80 90

NCE M

ARKET S

HARE O

F TO

TALR

X M

ARKET

NUMBER OF NCEs (2008-12) LAUNCHED

2008-2012

2003-2007

Countries with low # NCEs and strong penetration

Countries with high # NCEs and low penetration

Countries with low # NCEs and low penetration

EUR average n46 Countries with high # NCEs and strong penetration

Source: IMS Health MIDAS, September 2013

EUR average 2.3%

The base-case scenario for Japan’s spending growth is for a slight acceleration through 2017


Japan spending and growth, 2008-2017

0%

2%

4%

6%

8%

10%

0

20

40

60

80

100

120

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

GRO

WTH

CO

NST U

S$

SPE

ND

ING

US$BN

Sales Growth

Source: IMS Market Prognosis, September 2013

Forecast

2013-17 CAGR, 2-5%

Alternative scenarios for Japan’s efforts to dramatically increase the use of generic medicines


Generics volume share of the unprotected market by country in 2003, 2008 and 2013

20%

30%

40%

50%

60%

70%

80%

90%

100%

2003 2008 2013

Source: IMS Health MIDAS, September 2013

0%

5%

10%

15%

20%

25%

30%

35%

40%

0

20

40

60

80

100

120

140

160

180

200

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

GRO

WTH

CO

NST U

S$

SPE

ND

ING

US$BN

Sales Growth

The base-case scenario for China’s spending growth is a slowing trend and stability through 2017


China spending and growth, 2008-2017


Forecast

2013-17 CAGR, 14-17%

Alternative scenarios for the 2017 outlook are driven by the depth of reform implementation in the next 5 years


Scenario Reform implementation depth 2017 Implications for Medicine and Spending Growth

Scenario 1: Rapid rise of private insurance

• The rise of private insurance (30-50% uptake in urban areas) will fund >70% of cost for innovative drugs for critical diseases.

• Substantial increases in private hospitals will provide both higher quality healthcare and access to innovative drugs.

• The update of the NRDL in 2014 will increase the coverage of international drugs with price cuts expected to be <15%.

• The EDL usage ratio, which means more local generics in Tier 2 and 3 hospitals, will remain limited.

• Single reimbursement price based on generic pricing will not be implemented.

• CGMP guidelines widely implemented leading to an improvement in the quality of local generics.

• Quality generics will enjoy strong representation in primary care institutions and lower tier cities, while international off patent drugs will retain a price premium and will be widely used in large hospitals and big cities.

• The rise of private insurance will fund on patent branded products prior to their inclusion on the state reimbursement list (which may take years and be a relatively low level of access).

• The rise of private insurance together with a faster regulatory system will result in an expanded on-patent branded market for international companies.

Scenario 2: Moderate change in medicine reimbursement

• Some private insurance (30% uptake or less) will fund 50% of the innovative drugs cost for critical diseases.

• There will be some increase in the number of private hospitals to provide higher quality healthcare but access to new innovative products will be contained.

• The NRDL list will be updated in 2014 but with some delays in implementation and price cuts >15%.

• The actual usage ratio of EDL will increase to be closer to governments targets.

• Single reimbursement price based on generic pricing will be implemented in some provinces.

• CGMP guidelines will be implemented to a lesser degree

• Some private insurance (30% uptake or less) will fund 50% of the innovative drugs cost for critical diseases.

• There will be some increase in the number of private hospitals to provide higher quality healthcare but access to new innovative products will be contained.

• The NRDL list will be updated in 2014 but with some delays in implementation and price cuts >15%.

• The actual usage ratio of EDL will increase to be closer to governments targets.

• Single reimbursement price based on generic pricing will be implemented in some provinces.

• CGMP guidelines will be implemented to a lesser degree

CAGR 2013-17: 15-18%

CAGR 2013-17: 14-17%

Alternative scenarios for the 2017 outlook are driven by the depth of reform implementation in the next 5 years


Scenario Reform implementation depth 2017 Implications for Medicine and Spending Growth

Scenario 3: Delays and limited change

• Private insurance will not take off; negligible uptake and funding of new products.

• The NRDL update will be delayed and coverage for innovative products will be limited; The NDRC will implement aggressive price cuts across the board for branded products.

• Despite government efforts to encourage foreign investment in private hospitals, barriers will remain and only a small number of private hospitals will emerge.

• The extensive use of the EDL will result in losses due to tendering of international off-patent brands.

• Single reimbursement price based on generic pricing will be widely implemented.

• CGMP is sparsely implemented to minimal effect.

• China will fail to build a high quality locally sourced off patent segment.

• Private insurance failure will perpetuate the funding gap for innovative agents.

• International off-patent drugs will have a significant drop in usage as the government will only reimburse them at a price equivalent to a local generic.

• The market will remain very difficult for innovative agents, which will have to wait years for a possible NRDL inclusion.

CAGR 2013-17: 12-15%

61%

57%

31%

72%

27%

27%

58%

16%

12%

16%

11%

12%

World

Rest of the world

Pharmerging

Developed

Brand Generic Other

Generics will represent a larger share of the market in volume and value terms


Global spending, 2012 and 2017

2012

52%

52%

26%

67%

36%

31%

63%

21%

12%

17%

11%

12%

2017

$622Bn $650-680Bn

$224Bn $370-400Bn

$120Bn $125-155Bn

$965Bn $1,170-1,200Bn


21.0 22.3 26.9 28.4

50.3

19.1 31.7 28.8

20.3 22.6

-18.5 -15.3 -21.5 -22.6

-43.6 -32.1

-17.2 -26.2 -22.5 -15.9

-60

-40

-20

0

20

40

60

2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

SPE

ND

ING

SU

$BN

Pre-Expiry Spending Lower Brand Spending

Patent expiries on small molecule products will reduce brand spending on developed markets by $113Bn through 2017


Developed Markets Patent Expiry Exposure and Impact

Source: IMS Institute for Healthcare Informatics, September 2013

$149Bn

-$121Bn

$123Bn

-$113Bn

Spending on traditional pharmaceuticals will increase by 5% in developed markets and by 69% in pharmerging markets over the next 5 years


Traditional Spending between 2012 and 2017

$453 $448 $450 $459 $466 $476

$199 $218

$244 $273

$302 $336

0

100

200

300

400

500

2012 2013 2014 2015 2016 2017 2012 2013 2014 2015 2016 2017

SALE

S U

S$M

N

Developed Markets Pharmerging Markets


Spending on specialty pharmaceuticals will increase rapidly in both developed and pharmerging markets


Specialty Spending between 2012 and 2017


$148 $153 $160

$169 $180

$193

$23 $26 $29 $34 $38 $43

0

50

100

150

200

250

2012 2013 2014 2015 2016 2017 2012 2013 2014 2015 2016 2017

SALE

S U

S$M

N

Developed Markets Pharmerging Markets

0

5

10

15

20

25

30

35

40

2005 2006 2007 2008 2009 2010 2011 2012 Average Per Year 2013-

2017 Novel Mechanism Existing Mechanism Orphan

Increasing numbers of innovative new medicines and orphan drugs are expected to be launched


Global Launches of New Molecular Entities

Source: IMS Institute for Healthcare Informatics, October 2013

GLO

BAL

NM

E L

AU

NCH

ES

Treatment will be transformed by new and existing mechanisms


Selected Product Launches 2013-2017

Source: IMS Institute for Healthcare Informatics, September 2013

Disease area Existing mechanisms New Mechanisms

Rheumatoid Arthritis • JAK inhibitor (adelatinib VX-509, baricitinib, fostamatinib)

Cystic Fibrosis • Transmembrane conductance regulator corrector (Lumacaftor, VX-661)

Ribosome interaction for readthrough of nonsense mutations (NM) in NM cystic fibrosis (Ataluren )

Melanoma • BRAF kinase inhibitor (dabrafenib) • MEK kinase inhibitor (trametinib) • Program cell death MAB (nivolumab, lambrolizumab)

• Oncolytic HSV vector (talimogene laherparepvec)*

Breast cancer • Mab (trastuzumab emtansine) • Cyclin dependent kinase inhibitor (palbociclib)

Ovarian cancer • Folate-targeted drug conjugate (vintafolide) • VEGFR inhibitor (nintedanib)

• PARP inhibitor (olaparib)

Multiple sclerosis • Lipophilic molecule (dimethyl fumarate)

Heart Failure • Human peptide synthetic version (ularitide) • Human relaxin-2 hormone recombinant (serelaxin)

Hepatitis C • NS3/4A proteinase inhibitor (asunaprevir, sofosbuvir, simeprevir)

Malaria • RTS,S Adjuvant System (P. falciparum / P.Vivax circumsporozoite protein)

Some of the diseases with highest global burden have fewer new treatment options from recent or forthcoming launches


Disease DALYs%

IHD 8.2%

Stroke 4.7%

Depression 4.3%

Lung Cancer 3.5%

COPD 3.2%

Musculoskeletal 3.1%

Diabetes 2.8%

Alzheimer’s 2.3%

Anxiety 1.9%

Colorectal 1.8%

Alcohol Abuse 1.8%

LRI 1.7%

Breast Cancer 1.4%

Osteoarthritis 1.3%

Other Circulatory 1.3%

Migraine 1.3%

Asthma 1.2%

Other Neoplasm 1.1%

BPH 1.0%

Stomach Cancer 1.0%

Disease DALYs% Pipeline Launches

IHD 5.2% 183 191

LRI 4.6% 53 73

Stroke 4.2% 41 45

Malaria 3.3% 17 6

COPD 3.1% 48 24

Depression 3.1% 44 58

Other HIV 2.7% 45 33

Tuberculosis 2.0% 53 5

Diabetes 1.9% 120 89

Neonatal Sepsis 1.8% 4 0

Diarrhoea 1.6% 6 6

Lung Cancer 1.3% 141 18

Musculoskeletal 1.2% 7 6

Anxiety 1.1% 11 11

Alcohol Abuse 1.1% 25 9

Meningitis 1.0% 12 21

Asthma 0.9% 67 29

Migraine 0.9% 21 19

Liver Cancer 0.8% 53 4

Other Neurological 0.7% 14 9

Global High Income Countries

Source: IHME Global Burden of Diseases, Injuries, and Risk Factors Study 2010; IMS Health R&D Focus, July 2013

The availability of new medicines varies widely by country and disease


Source: IMS Institute for Healthcare Informatics, October 2013

Total 146 94 59 88 65 70 65 88 63 52 45 42 38 37 % of Total 64% 40% 60% 45% 48% 45% 60% 43% 35% 31% 29% 26% 25% Anti-infectives & Antivirals 16 6 10 7 6 5 3 6 7 3 4 4 1 4 Arthritis/Pain 6 3 3 3 2 3 2 3 2 2 1 1 1 2 Blood 8 6 2 3 3 3 3 5 3 1 2 1 1 Cardiovascular 17 12 8 13 8 11 10 12 8 9 8 5 9 7 CNS 20 13 5 13 10 10 9 12 8 5 5 5 9 5 Dermatology 4 2 2 2 1 2 2 2 1 2 2 1 1 1 Diabetes 5 3 4 3 3 4 3 4 3 3 4 4 4 4 Gastrointestinal 9 4 1 3 2 3 2 4 4 2 1 1 3 GU & Hormones 10 4 3 5 1 5 5 4 1 7 1 Immune System 11 9 3 10 7 8 8 9 6 3 3 5 3 Metabolic 2 1 1 1 2 1 1 1 1 Oncologics 23 19 8 18 16 9 11 19 14 9 8 9 2 6 Ophthalmics 5 4 3 2 1 1 1 2 1 2 3 2 Other 3 1 1 1 1 Respiratory 6 3 4 4 3 4 4 4 3 3 4 3 3 3 Vaccines 1 1 1 1 1 1 1 1 1 1 1 1 1 1

U.S. Korea Canada UK Spain Italy France Germany Japan China Brazil Russia India Global

Global New Molecular Entities 2007-11 Available to Patients in 2012

China will be the second largest market in 2017 and approaching half the size of the U.S. market


Rank 2007 Index Rank 2012 Index Rank 2017 Index

1 U.S. 100 1 U.S. 100 1 U.S. 100 2 Japan 27 2 Japan 27 2 China 45 3 France 13 3 China 25 3 Japan 29 4 Germany 13 4 Germany 13 4 Brazil 13 5 China 11 5 France 11 5 Germany 13 6 Italy 8 6 Brazil 8 6 France 10 7 UK 7 7 Italy 8 7 Italy 8 8 Spain 7 8 UK 7 8 Russia 7 9 Canada 7 9 Canada 7 9 UK 7 10 Brazil 5 10 Spain 6 10 Canada 7 11 Mexico 4 11 Russia 5 11 India 6 12 Australia 4 12 Australia 4 12 Spain 5 13 South Korea 3 13 India 4 13 Mexico 4

14 Russia 3 14 Mexico 4 14 South Korea 4

15 Turkey 2 15 South Korea 3 15 Australia 4 16 India 2 16 Venezuela 3 16 Turkey 3 17 Netherlands 2 17 Turkey 3 17 Venezuela 2 18 Greece 2 18 Poland 2 18 Argentina 2 19 Poland 2 19 Argentina 2 19 Indonesia 2 20 Belgium 2 20 Belgium 2 20 Poland 2

Change in ranking over prior 5 years

1

1

2 1

1

3

2

1

3

11

1

1

8

4

2

2

4

1

1

2

3

3

3

2

8

2

9

1

1

3

1

1

1

1

2

1

2

1

1

3

1

2

1

1

8

2


Region and leading country spending



US$ billions 2012 2008-2012 CAGR 2017 2013-2017 CAGR

Global 965.4 5.4% 1,170-1,200 3-6% Developed 621.6 2.9% 650-680 1–4% U.S. 328.2 3.0% 350-380 1–4% EU5 148.7 2.4% 140-170 0–3% France 36.7 0.3% 30-40 (-2)–1% Germany 42.1 3.8% 41-51 1-4% Italy 26.2 2.9% 23-33 0-3% Spain 19.9 1.7% 13-23 (-4)-(-1)% UK 23.9 3.4% 20-30 1-4% Japan 111.3 3.0% 90-120 2-5% Canada 22.0 3.1% 20–30 1-4% South Korea 11.3 6.3% 10-20 3-6%

Pharmerging 223.9 15.0% 370-400 10-13% China 81.7 22.3% 160–190 14-17% Tier 2 59.6 15.6% 90–110 10-13% Brazil 28.5 14.6% 38-48 11-14% Russia 17.1 17.7% 23-33 8-11% India 14.0 15.1% 22-32 11-14% Tier 3 82.6 9.4% 100-130 5-8% Rest of World 120.0 4.7% 125-155 2-5%

Implications and discussion

• Medicine spending growth rebounding across developed economies and tapering of “patent dividend” over next five years will bring new dynamics to the medicines marketplace

• Spending growth of 10-13% CAGR across pharmerging countries brings extraordinary stresses to funding and healthcare delivery systems

• Recent and future novel therapies bring new options and dynamics to treatment of multiple therapy areas including diabetes, hepatitis C, melanoma, multiple sclerosis and thrombosis/acute coronary syndrome

• Role and penetration of generic drugs remains very uneven across developed markets even as policy levers are being applied

• Levels of spending on new NCEs are at historically low levels bringing inadequate returns to investment capital

• Visibility of $1 trillion medicine cost is high – but not the context and impact on healthcare systems or patients


The Trillion Dollar Market for Medicines: Characteristics, Dynamics and Outlook

Johns Hopkins Bloomberg School of Public Health Center for Drug Safety and Effectiveness Safety, Value and Innovation Seminar

Murray Aitken Executive Director www.theimsinstitute.org [email protected]

February 24, 2014

http://www.theimsinstitute.org/

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