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Regional prevalent diseases in Asia:
Where do the key market opportunities lie?
Phacilitate’s 1st Asian Cell & Gene Therapy Forum Singapore, 2011
1
Which diseases can and are being targeted with cell & gene therapies in Asia?
September 21, 2011
Dr. Milind Sabnis, MD, MBA
Principal Consultant
Healthcare, Asia Pacific
Agenda
• Introduction
• Global trends & impact on health care in Asia
• Key Diseases in Asia
• Gene therapy
2
• Gene therapy
• Cell therapy
• Summary
GLOBAL TRENDS & IMPACT ON HEALTH CARE IN ASIA
3
GLOBAL TRENDS & IMPACT ON HEALTH CARE IN ASIA
Percent of world GDP – Last 500 yearsChina, India, Japan, Latin America, Western Europe and United States
21%11%
Share of World GDP in
2005
15%27%
Share of World GDP in
2035
4
21%11%
6%
15%27%
15%
Source: Frost & Sullivan
Growing middle class is changing the mix in demand for healthcare services
• Creation of “healthcare elite”: those that can, will spend money out of pocket for elective procedures, executive and personalized levels of care.
5
Source: Frost & Sullivan
Changing demographics leads to changing disease patterns and health risks
6
Source: Frost & Sullivan
Aging population will account for around 20% of the world population in 2050
7
Source: Frost & Sullivan
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
50.0
100.0
150.0
200.0
250.0
300.0
350.0
400.0
Pe
rce
nta
ge o
f A
ged
65
an
d A
bo
ve t
o
Tota
l Po
pu
lati
on
(%
)
Po
pu
lati
on
(M
illio
n)
By 2020, two-third of the Asia-pacific population over 65 years will have at least one chronic disease
Healthcare Industry: Population Aged 65 and Above, (Asia Pacific), 2009-2020
The Burden of Disease in elderly, Asia Pacific
8
0.0%
2.0%
-
50.0
2010 2015 2020
Pe
rce
nta
ge o
f A
ged
65
an
d A
bo
ve t
o
Tota
l Po
pu
lati
on
(%
)
Year
Aged 65 and Above (Million)
Percentage of Aged 65 and Above to Total Population (%)
� In 2010, 7.6% (241.7 million) of the Asia Pacific population was aged 65 and above.
� By 2020, this will be more than 9.7% (333.95)
� 65.2% of those aged 65+ have one chronic condition
Source: WHO, Frost & SullivanSource: Frost & Sullivan
Asia Pacific Healthcare Expenditure is growing
Healthcare Expenditure and Growth Rate by Country (2010 & 2015)
428.50
259.80
99.7058.22 58.02 58.00 36.50
571.20
561.90
139.50111.60 78.90
95.10 49.905.0
16.3
6.8
13.8
6.0
9.9
6.2
2.0
4.0
6.0
8.0
10.0
12.0
14.0
16.0
18.0
100.0
200.0
300.0
400.0
500.0
600.0
700.0
He
alt
hca
re E
xpe
nd
itu
re (
$ B
illi
on
)
Healthcare Expen diture by
Country
(CAGR %
)
9
Note: All figures are rounded; the base year is 2010.
� Japan has the highest healthcare expenditure in 2010 and 2015, with 5% CAGR between 2010-2015China has the second highest healthcare expenditure planned.
� Among other Asia Pacific countries, China has the highest healthcare expenditure growth of CAGR of16.3% followed by India, with CAGR of 13.8% and SEA 9.9%
� The value of Asia Pacific healthcare expenditure is estimated at around $ 1080 billion in 2011.
58.22 58.02 58.00 36.50
-
2.0
0.0
Japan China ANZ India South
Korea
SEA* Others
He
alt
hca
re E
xpe
nd
itu
re (
$ B
illi
on
)
2010 2015 Healthcare Expenditure CAGR (%)
* SEA – South East Asia – Includes Singapore, Malaysia, Thailand, Indonesia and Philippines
Healthcare Expen diture by
Source: Frost & Sullivan
Faster healthcare per-capita growth compared to per-capita income is unsustainable; healthcare needs innovative solutions
Healthcare Spending Per Capita (2007, 2050)
In most countries worldwide, per capita In most countries worldwide, per capita
healthcare spending is rising faster than per healthcare spending is rising faster than per
capita income which is unsustainable capita income which is unsustainable
If current trends hold If current trends hold -- by 2050, healthcare by 2050, healthcare
spending will double, claiming 20spending will double, claiming 20--30% of 30% of
GDP for some economies GDP for some economies
Innovative therapies such as gene therapy and cell therapy will help treat various currently untreatable diseases
10
Due to rising costs of healthcare, future Due to rising costs of healthcare, future
spending will move away from spending will move away from
treatment treatment
Healthcare Spending by Type of Activity
Source: Frost & Sullivan.
KEY DISEASES IN ASIA
11
KEY DISEASES IN ASIA
More DALY are lost due to cardiovascular diseases in Asia than in the rest of the world
Total DALYs (000s, all ages) lost due to cardiovascular disease in the Asia Pacific, 2005
12
DALY=Daily adjusted life years; Cardiovascular diseases excludes rheumatic heart disease
• Globally, CVDs are the No.1 cause of mortality (~ 29% of all deaths)
• 82% of CVD deaths take place in low- and middle-income countries
• ~17.1 million deaths in 2004, expected to reach ~23.6 million by 2030
• The largest increase in number of deaths will occur in the South-East Asia Region
•Source: Health in Asia and the Pacific. Priority noncommunicable diseases and conditions. 2011. 287-332. Frost & Sullivan.
Lung, Stomach, and Liver cancers are the top three male cancers in Asia Pacific
13
CancerAll
cancersLung Stomach Liver Colorectal Esophagus Prostate Bladder Leukemia
Lip, oral cavity
Non-Hodgkin
lymphoma
Incidence 3241249 604629 484411 416589 283596 247060 133212 101776 95941 91327 75866
Mortality 2353611 523899 342163 376006 144980 204919 59669 44316 76962 54518 50707
• Globally, ~ 7.6 million total cancer deaths (around 13% of all deaths) in 2008
• Deaths from cancer worldwide are projected to reach over 11 million by 2030
Source: GLOBOCAN 2008: Cancer incidence, mortality and prevalence worldwide; Frost &Sullivan.
Breast, Cervix/uterus, and Lung cancers are the top three female cancers in Asia Pacific
14
CancerAll
cancersBreast
Cervix uteri
Lung Stomach Colorectal LiverCorpus uteri
Esophagus Ovary Leukemia
Incidence 2851110 528927 312990 268434 243154 225688 167851 131178 124507 102408 76111
Mortality 1718721 193497 159894 229778 188427 122034 157719 35044 103313 60142 60298
Source: GLOBOCAN 2008: Cancer incidence, mortality and prevalence worldwide; Frost &Sullivan.
• Lung cancer is the top cancer killer both in males & females in Asia
• More than 30% of cancer deaths can be prevented
Prevalence of diabetes is expected to continue to rise in Asia pacific and globally
Prevalence of diabetes (million) in Asia-pacificDiabetes
• 346 million people worldwide have
diabetes
• ~157 million people suffer from
diabetes in Asia Pacific
15
• More than 80% of diabetes deaths
occur in low- and middle-income
countries
• Globally, ~ 3.4 million people died from consequences of high blood sugar in 2004
• WHO projects that diabetes deaths worldwide will double between 2005 and 2030
Source: Frost & Sullivan.
GENE THERAPY
16
GENE THERAPY
Gene therapy
Genetic Disorders
Severe Combined Immune Deficiency (ADA-SCID)
Chronic Granulomatous Disorder (CGD)
Hemophilia
Other genetic disorders*
Cancer
Two-thirds of all current gene therapy trials are for various cancer indications
17
Acquired Diseases Neurodegenerative Diseases
Other acquired diseases**
*Congenital blindness, lysosomal storage disease and muscular dystrophy, etc** Viral infections (e.g. influenza, HIV, hepatitis), heart disease and diabetes, etcSource: Frost & Sullivan.
Most gene therapy phase 3 trials are for cancer and cardiovascular diseases indications
Most Advanced Gene Therapy Products, March 2010
Product Name Constructs Company Indication Development Stage
Gendecine (genkaxin) Ad5p53Si Bono / Benda Pharmaceutical
Head & Neck Cancer
Marketed (China); 2003
Glybera (alipogen tiparvovec) AAV-mLPLAmsterdam Molecular
TherapeuticsLPL Deficiency MAA Filed with EMA
Collategene (beperminogen pHGF AnGes /Daiichi Sankyo
Peripheral Vascular BLA Submitted in Japan
18
Collategene (beperminogen perplasmid)
pHGF AnGes /Daiichi SankyoPeripheral Vascular
DiseaseBLA Submitted in Japan
(2008) Phase 3 (U.S. / EU)
Allovectin-7 (velimogene aliplasmid)
Immunotherapy Vical / AnGesMetastatic Melanoma
Phase 3
TK-DLI (TBI-0301)HVS-TK
transfected HSCMolMed / Takara Bio Leukemia Phase 3
Generx (alferminogene tadenovec)
Ad5FGF-4 CardiumCoronary Artery
DiseasePhase 3
riferminogene pecaplasmid NV1FGF1 Sanofi - AventisCritical Limb
IschemiaPhase 3
LPL=lipoprotein lipase Source: http://www.cardiumthx.com/pdf/Most-advanced-gene-therapy-products.pdf;;accessed: June 2011.
• The first gene therapy to be marketed was in China
Another Adenovirus (Replication-competent adenovirus) was commercialized in China in 2005
Japan has a strong pipeline for gene therapy products in late stages of development
Nu
mb
er
of
cli
nic
al tr
ials
c
Gene therapy clinical trials in Japan by stage of development
19
*ASO/Buerger's Disease. c=Lung cancer (NSCC)(5); Esophageal cancer(1); prostate cancer(1); breast cancer(1); leukemia(1); glioma(1); melanoma(1). d=Prostate
cancer. e=Renal carcinoma. f=ADA Deficiency. SCID=Severe combined immunodeficiency. ADA=Adenosine deaminase . ASO=atherosclerosis obliterans
Source: Kim S, Peng Z, Kaneda Y. Current Status of Gene Therapy in Asia. The American Society of Gene Therapy. 2008;16:237–243. Frost & Sullivan.
Nu
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ials
Target diseases
e
d
f
Currently in Asia, Japan has the most gene therapy products that have completed phase 2 clinical trials/
entered phase 3; majority of these products are for cancer treatment
China approved the world first gene therapy for cancer treatment
Nu
mb
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cli
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ials
Gene therapy clinical trials in China by stage of development
20
Nu
mb
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of
cli
nic
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ials
Target diseases
a
b
a=Ischemic disease b=AIDS(1); Hepatitis B(1)Source: Kim S, Peng Z, Kaneda Y. Current Status of Gene Therapy in Asia. The American Society of Gene Therapy. 2008;16:237–243. Frost & Sullivan.
• World’s 1st approved gene therapy product (2003) gendicine (recombinant human p53 adenovirus)
• Chinese Government's 863 Program: In 2007, ~$52.0 million was allotted to projects in 11 priority
biotechnology areas, including gene therapy and cell therapy for major diseases
Korea has a few gene therapy products in early stage of development
Nu
mb
er
of
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ials
Gene therapy clinical trials in Korea by stage of development
g
j
h
l
21
Source: Kim S, Peng Z, Kaneda Y. Current Status of Gene Therapy in Asia. The American Society of Gene Therapy. 2008;16:237–243. Frost & Sullivan.
b=AIDS(1); g=Prostate cancer. h=melenoma (1); melanoma, breast cancer,head-and-neck cancer (1). i=liver cancer. j=Ischemic limb disease. k=coronary artery
disease. l=Chronic granulomatous disease. m=osteoarthritis.
Nu
mb
er
of
cli
nic
al tr
ials
Target diseases
j
i bk m
l
Currently, Korea has 3 products in phase 2 funded mainly by small sized venture companies;
pharmaceutical companies are still hesitant about getting involved in gene therapy
CELL THERAPY
22
CELL THERAPY
Cell Therapy
Hemophilia A,B: blood transfusion
Leukemia, Lymphoma: bone marrow transfer
Thalassemias
Most common cell therapies are targeted toward blood disorders
23
SCID
Others*
*Skin, Eye, orthopedics, cerebral palsy, diabetes, etc ; eg. skin regeneration and healing (Apligraf®), diabetic foot ulcers
(Dermagraft®, skin substitute), nasolabial fold wrinkles (LaVív),cerebral palsy (umbilical cord blood transplantation), etc
• Most cell therapies are for treating hemophilia, leukemia, lymphoma, thalassemias
• Both approved and experimental stem cell products are used in Asia to treat multiple disorders
Source: Frost & Sullivan.
FDA has approved only two cellular therapy products
Cell Therapy Products that recently got FDA approvals
Product Name Constructs Company Indication
PROVENGE
(sipuleucel-T)
Only FDA approved
Autologous, cellular,
immunotherapy
(2010)
Dendreon
Treatment of asymptomatic or minimally
symptomatic, metastatic, castrate resistant
(hormone refractory), prostate cancer.
24
(2010)
LaVív
(azfibrocel-T)
Autologous cell therapy
(2011)Fibrocell Science, Inc.
First FDA approved autologous cell therapy for
the treatment of moderate to severe
nasolabial fold wrinkles in adults
• LaViv a recently (2011) approved cell therapy drug is for treating naso-labial fold wrinkles
• Apligraf® (1998) & Dermagraft® (2001) are cell therapies (classified as devices by FDA) for treating
diabetic foot ulcers
• Skin disorders could be the other focus area for cell therapy in Asia
Source: Frost & Sullivan.
Asides approved cell therapies, experimental cell therapies are widely used in Japan and China
25
*In Japan, autologus cell therapy can be regulated as clinical treatment under doctor’s own decision. Hence Japan is thought to be a easy country to run clinical application without regulatory control. In fact, a Korean company is running its trial in Japan; but recently the Korean government committed nearly 100 billion won (S$111.7 million) in stem cell research next year and ensured to reform related regulations to make clinical and licensing procedures easier**VistaStemCell, a company in China, claims to treat (with cell therapy) multiple conditions that include neurological diseases, endocrine diseases, cancer, immune system diseases, others including myocardial infarction, femoral head necrosis, kidney disease, liver disease † 2009: The Chinese Ministry of Health has implemented regulations on the clinical application of stem-cell injections. The new regulations, designate all forms of stem-cell therapy as 'category 3' medical technologies — those deemed "ethically problematic", "high risk" or "still in need of clinical verification". The ministry will take direct responsibility for regulating all category-3 procedures, which include cell & gene therapy. Source: Frost & Sullivan.
†
Hospitals in some countries in Asia with various stem cell therapy facilities
In Asia, most common cell therapies available at hospitals are for the treatment of blood disorders and heart diseases
26
*Cerebral Palsy, Diabetes, Motor neuron disease, Multiple Sclerosis, Parkinson's Disease, rejuvenation therapy
• In some Asian countries, hospitals offer cell therapies in multiple areas
Source: Frost & Sullivan.
In Asia, there are multiple stem cell banks that collects, processes and stores stem cells for potential future use
StemLife Berhad(Malaysia) –SECRETARIAT OF THE APCBBC
BIONET Corporation (Taiwan)
Cordlife Pte Ltd (Singapore) / PT. Cordlife (Indonesia)Banks in: China, Hong Kong.Being extended to India &Indonesia
CryoLIFE (Hong Kong)
27
LIFECORD (Korea) StemCellInstitute Ltd (Japan)
THAI StemLife(Thailand)
StemOneBiologicals(India)
• Multiple private stem cell/cord blood bank exist in Asia
Source: Frost & Sullivan.
Summary
� Asia Pacific shows the highest mortality rate from non-communicable diseases compared with
other regions
� Cardiovascular diseases, cancer, and diabetes are the top 3 non-communicable diseases in Asia
� Two thirds of the gene therapy clinical trials are in cancer; most phase 3 gene therapy trials are in
cancer and cardiovascular diseases
28
� In Asia, most common cell therapies available at hospitals are for the treatment of blood disorders
and heart diseases; skin disorders could be another area of focus
� Asides approved cell therapies, experimental cell therapies are widely used in Japan and China
� Cell therapy and gene therapy has enormous opportunity in Asia because of the large target
population and comparatively relaxed restriction on the use of experimental products
� However, regulators in Asian countries should be cautious to prevent misuse that could bring
disrepute to the use of these innovative therapies that hold immense promise for the future
For additional information
Dr. Milind Sabnis, MD, MBA
Principal ConsultantHealthcare, Asia Pacificmilind.sabnis@frost.com
Donna Jeremiah
Corporate Communications
Asia Pacific
+603 6204 5832
djeremiah@frost.com
29
Jessie Loh
Corporate Communications
Asia Pacific
+65 6890 0942
carrie.low@frost.com
Carrie Low
Corporate Communications
Asia Pacific
+603 6204 5910
carrie.low@frost.com
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