Research in Your Backyard: Japan
Contribution of PhRMA and EFPIA Member Companies to Japanese Society & Economy
Through Clinical Trials of Innovative Medicines

November 2016

1

Contents

Introduction: Who We Are

3

Pharmaceutical Industry and Society

5

Collaborating on Clinical Trials

7

R&D Spending, Trends, and Results

14

Summary: For Japanese society and patients20

2

Introduction: Who We Are
We are devoted to advancing public policies that support innovative medical research,yield progress for patients today, and provide hope for the treatments and cures of tomorrow

PhRMA Japan represents U.S. based

EFPIA Japan represents R&D-based European

pharmaceutical companies. Our

pharmaceutical companies. We focus on patient

activities vary from promoting healthcare

needs in Japan, engage in discussions with key

system reform to providing medical

stakeholders regarding public health, and work

information to patients.

to improve the R&D environment forpharmaceutical companies.

MissionMission

PhRMA Japan’s mission
is to promote the healthof patients and contributeto the healthier lives ofall people

EFPIA Japan’s mission isto enhance the health ofJapanese patients byintroducing innovative
drugs and vaccines3

PhRMA and EFPIA member companies

PhRMA

EFPIA

AbbVie GK

Actelion Pharmaceuticals Japan Ltd.

Janssen Pharmaceutical K.K.

Amgen Astellas BioPharma K.K.

AstraZeneca K.K.

LEO Pharma K.K.

Biogen Japan Ltd.

Bayer Yakuhin, Ltd

Lundbeck Japan K. K.

Bristol-Myers Squibb K.K.

Bracco-Eisai Co., Ltd.

Merck Serono Co.,Ltd.

Celgene K.K.

Chugai Pharmaceutical Co., Ltd.

Mylan EPD G.K.

Eli Lilly Japan K.K.

CSL Behring K.K.

Nihon Servier Co.,Ltd.

Janssen Pharmaceutical K.K.

Ferring Pharmaceuticals Co., Ltd.

Nippon Boehringer Ingelheim Co ., Ltd.

MSD K.K.

Galderma (Japan) K.K.

Novartis Pharma K.K.

Mundipharma K.K.

GE Healthcare Japan Corporation

Novo Nordisk Pharma Ltd.

Pfizer Japan Inc.

GlaxoSmithKline K.K.

Sanofi K.K.

Guerbet Japan K.K.

Shire Japan K.K.

Ipsen Pharma SAS

UCB Japan Co. Ltd.

4

Pharmaceutical Industry and Society

5Pharmaceutical companies contribute to society andthe economy in multiple ways
Pharmaceutical companies collaborate with local clinics and hospitals to develop new drugs.

This in turn provides economic stimulus and leads to innovative new medicines with better efficacy and safety profiles.

Drug
Development

Basic
Research

Economic
Stimulation

Creating
Jobs

Pharmaceutical Industry and Society

Increasing
Productivity

Clinical
TrialsInnovative Drugs to
Promote Healthier andLonger Lives
BetterEfficacy

Improved
Safety6Collaborating on Clinical Trials

7

Discovering and developing new medicines is a long,complex, and costly process
Developing innovative medicines takes an average of 10-15 years and 2.6B USD. Less than 12% of the candidate
medicines that make it into phase I clinical trials are approved. Many promising compounds failafter pharmaceutical companies have spent substantial amounts of money on testing and clinical trials
Drug
Discovery

Clinical
TrialsPreclinicalRegulatory
Review

PostMarketing
Surveillance

Apply for new drug approval

Apply to conduct clinical trial

PRE-DISCOVERYPHASE1
3-6 YEARS

Scale-up
to MFG.

PHASE2
6-7 YEARSPHASE3
0.5-2 YEARS…

Source: Cost of Developing a New Drug, Tufts Center for the Study of Drug Development, Tufts School of Medicine. November 2014.
Collaborating on Clinical Trials

8What is a Clinical Trial?
Computer simulations and animal testing are not enough to determine the efficacy and safety of new drugs for people.
Clinical trials are conducted in five phases with the aim of clarifying the impact of experimental drugs on humans.

Phase 0First-in-human trial with a small number of healthy adults (10 to 15)
to gather data on what the drug does to the body and what the body
does to the drug

Phase 1

Trial to test a drug with a small number of healthy adults (20 to 80) to
test safety, determine a safe dosage range and identify side effects

Phase 2First trial using actual patients (100 to 300) to test efficacy of a new
drug and further evaluate its safety

Phase 3

Trial with an increased number of patients (1,000 to 3,000) in order toconfirm its effectiveness, monitor side effects, and to compare it toexisting treatments

Phase 4After a new drug has been approved, Post Marketing Surveillance ofactual usage is conducted to confirm that the drug acts as expected

Source: PhRMA

Collaborating on Clinical Trials

9What are Therapeutic Areas?
Therapeutic areas are general categories of illnesses, including the examples below
Therapeutic Area

ExampleAllergy

Allergic rhinitis, Asthma, Atopic dermatitis, etc.

Infectious disease

Influenza, Hepatitis C/B, Herpes, etc.

Hematology

Anemia, Hemophilia, etc.

Respiratory disease

COPD, Bronchiectasis, etc.

Oncology

Gastric cancer, Lung cancer, Breast cancer, etc.

Cardiology

Heart failure, Brain ischemia, Hypertension, etc.

Gastroenterology

Gastric ulcer, Reflux esophagitis, etc.

CNS

Alzheimer’s disease, Depression, Epilepsy, etc.

Urology

Nocturia, Lupus nephritis, etc.

Dermatology

Acne, etc.

Ophthalmology

Age-related macular degeneration, Uveitis, etc.

Immunology

Rheumatoid arthritis, Crohn’s disease, Psoriasis, etc.

Musculoskeletal disease

Osteoporosis, Lower back pain, etc.

Endocrine metabolic disease

Diabetes mellitus, Hypercholesterolemia, Hyperphosphatemia, etc.

Rare disease

Gaucher disease, Myelofibrosis, Behcet’s disease, etc.

Collaborating on Clinical Trials

10Collaborating with Japanese institutions in conducting and supporting clinical trials
Conducting clinical trials involves collaboration between pharmaceutical companies and other institutions in Japan,such as hospitals, local clinics, and contract research organizations (CRO).
CLINICHOSPITALPEER REVIEWEDJOURNALDATA

SMOPATIENTSDATAPHARMACEUTICALCOMPANIES

Pharmaceutical Companies
Decide to conduct clinical trials
and request support from CRO

Collaborating on Clinical Trials

CRO
Support pharmaceutical companies
with the coordination of clinical trials

REGULATORYAGENCYCRO

Hospitals / Clinics
Conduct trials performed byphysicians and trained researchprofessionals

SMO(Site Management Organizations)

Provide additional support to hospitals
and clinics during trials

11

Partnering with local Japanese medical institutions to conduct clinical trials
expands the benefit of clinical trials to the hosting area
Conducting clinical trials for new drug development contributes to local Japanese economies

and improves the quality of life for people in Japan

Providing advanced
treatment

Medical facilities conducting clinical trials are able to provide
advanced medical treatments to their patients in these locales

Contributing tolocal economy

The spending on clinical trials in Japan goes to hospitals and clinics
nationwide and supports local economies

Creating jobs

Related stakeholders (local medical facilities and pharmaceuticalcompanies) employ local staff to support clinical trials

Collaborating on Clinical Trials

12

PhRMA and EFPIA member companies conducted 825 clinical trials in 2015
to deliver innovative medicines to patients in Japan

825(+21% since 2013)

CLINICAL TRIALS*

18,09516+(+55% since 2013)

SITES**

THERAPEUTIC AREAS
Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

101 ～ 200

Endocrine Metabolic Disease

Respiratory Disease

31 ～ 100

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others# of clinical trial conducted
201 ～Source: www.clinicaltrials.gov (2015 data)*Figures do not include post marketing surveillance **Individual sites participating in multiple trials are counted multiple times

Collaborating on Clinical Trials

13

PhRMA and EFPIA member companies conduct many clinical trials
across all prefectures of Japan
Prefecture not specified

Hokkaido

147

325

Hokkaido

Tottori
Shimane
Okayama
Hiroshima
Yamaguchi

43
56
188
183
100

Osaka
Hyogo
Kyoto
Shiga
Nara
Wakayama

438
324
191
61
67
66

ToyamaIshikawa
Fukui

76
130
65

Aomori
Iwate
Miyagi
Akita
Yamagata
Fukushima

Hokuriku

Kinki

TohokuKanto Koshinetsu

Chugoku
KyushuFukuoka
Saga
Nagasaki
Kumamoto
Oita
MiyazakiKagoshima
Okinawa

67
93
215
57
53
86

Tokai
415
75
112
166
93
59
128
86

Aichi
Gifu
Shizuoka
Mie

Shikoku
Tokushima
Kagawa
Ehime
Kochi

79
107
174
78

390
103
241
100

Tokyo
Kanagawa
Saitama
Chiba
IbarakiTochigi
Gunma
Yamanashi
NaganoNiigata

611
359
237
346
173
119
148
58
123
124

Source: www.clinicaltrials.gov (2015 data)

Collaborating on Clinical Trials

14

R&D Spending, Trends, and Results

15

PhRMA and EFPIA member companies contribute a significant shareof the research and development spending in Japan

2014 Clinical Trial Related
Spending in Japan Total*

2014 Clinical Trial Related
Spending in Japan: PhRMA and EFPIA Subtotal**

204B JPY

79B JPY

Source: JPMA data based on company disclosures for fiscal year 2014
* 72 JPMA companies ** 19 PhRMA and EFPIA member companies participating in JPMA
Note: The figures refer only to clinical research related spending during fiscal year 2014 disclosed by JPMA member companies

R&D Spending, Trends, and Results

16Reducing the “drug lag*”
PhRMA and EFPIA member companies are planning simultaneous international drug submissions**
which will allow Japanese patients to be in the first wave of access to innovative medicines

17%

Simultaneous international submissions plannedby PhRMA / EFPIA member companies

4%

Completed simultaneous international submissions

45%

Planned simultaneous international submissions
Simultaneous international submissions is under consideration

34%
Simultaneous international submissions is not planned or not
feasible

Source: PhRMA and EFPIA Japan joint research of 28 member companies (clinical trials conducted between April 2015 and March 2016)“Drug lag” refers to the delay to approve a new drug in Japan such as cases where approval is delayed compared to other countries, such as the U.S. and Europe
Conducting more global simultaneous clinical trials shortens the drug lag**Simultaneous international submission refers to the submission of a new drug application (NDA) at the similar timing (within 3 months, in this study) as other countries, such as the U.S. and Europe
R&D Spending, Trends, and Results

17

Bringing innovation to Japanese patients
PhRMA and EFPIA member companies obtained approvalfor 185 new drugs* in Japan over the last 9 years

Number of New Drugs Approved in Japan
50
37

22
21

33

39

40

43

39

42

27

(57%)

20
(61%)

18
(67%)

20
(51%)

22
(55%)

16
(37%)

19
(49%)

26
(52%)

23
(55%)

2007

2008

2009

2010

2011

2012

2013

2014

2015

Japan Total
PhRMA and EFPIA Member Companies
Source: PMDA website*New drugs refer to New Molecular Entities only approved between April 2007 and March 2016 (Other approvals, such as new indications, are excluded)
Besides the approvals obtained by PhRMA and EFPIA member companies, other approvals include products licensed from global companies

R&D Spending, Trends, and Results

18

Continuing investment in Japan to treat more conditions
PhRMA and EFPIA member companies obtained approvalfor 373 new indications* in Japan over the last 9 years
Number of New Indications Approved in Japan
102

97

88

92

97

76

76

36
(59%)

38
(50%)

35
(46%)

55
(54%)

41
(42%)

41
(47%)

48
(52%)

46
(47%)

2008

2009

2010

2011

2012

2013

2014

2015

63

61

33
(52%)
2007

Japan Total
PhRMA and EFPIA Member Companies
Source: PMDA website*New indications refer to New Molecular Entities approved between April 2007 and March 2016, as well as new indications approved for existing drugs
Besides the approvals obtained by PhRMA and EFPIA member companies, other approvals include products licensed from global companies

R&D Spending, Trends, and Results

19Summary: For Japanese society and patients
We are devoted to advancing public policies that support innovative medical research,yield progress for patients today, and provide hope for the treatments and cures of tomorrow

PhRMA and EFPIA member companies’ clinical research stimulates local economies through:- Collaboration with local Japanese clinics and hospitals to develop new drugs- Funding clinical trials to develop innovative new medicines with better efficacy and safety profiles

PhRMA and EFPIA member companies invest heavily in clinical trials across all prefectures Japan:- 825 (+21% since 2013) clinical trials across more than 16 therapeutic areas conducted in 2015
- Rapid increase in clinical trials is the result of the premium for new drug development, introduced by the
Ministry of Health, Labour and Welfare in 2010

PhRMA and EFPIA member companies make continuous efforts and investment in Japan to allow
Japanese patients to be in the first wave of access to innovative medicines:- Spent 79B JPY in the research and development in Japan in 2014
- Contribute around half of the new drug approvals in Japan20

To download an electronic version of this presentation,please go to www.efpia.jp or www.phrma-jp.org, or scan the QR code above21

Appendix - Research Activity Map

22

Prefecture Views

23

Japan825

CLINICAL TRIALS

18,09516+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others24

Aichi390

CLINICAL TRIALS

973

15

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others25

Akita57

CLINICAL TRIALS

116

13

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others26

Aomori67

CLINICAL TRIALS

132

11

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others27

Chiba346

CLINICAL TRIALS

687

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others28

Ehime174

CLINICAL TRIALS

269

14

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others29

Fukui65

CLINICAL TRIALS

115

14+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others30

Fukuoka

415

CLINICAL TRIALS

1,110

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others31

Fukushima

86

CLINICAL TRIALS

204

14

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others

32

Gifu

103

CLINICAL TRIALS

215

15+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others33

Gunma148

CLINICAL TRIALS

291

15+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others34

Hiroshima

183

CLINICAL TRIALS

392

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others35

Hokkaido

325

CLINICAL TRIALS

912

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others36

Hyogo324

CLINICAL TRIALS

765

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others37

Ibaraki173

CLINICAL TRIALS

389

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others38

Ishikawa

130

CLINICAL TRIALS

228

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others39

Iwate93

CLINICAL TRIALS

159

15+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others40

Kagawa107

CLINICAL TRIALS

194

14

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others41

Kagoshima

128

CLINICAL TRIALS

233

14+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others42

Kanagawa

359

CLINICAL TRIALS

1,013

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others43

Kochi78

CLINICAL TRIALS

125

13

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others44

Kumamoto

166

CLINICAL TRIALS

294

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others45

Kyoto191

CLINICAL TRIALS

415

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others

46

Mie

100

CLINICAL TRIALS

202

15+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others47

Miyagi

215

CLINICAL TRIALS

394

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others48

Miyazaki

59

CLINICAL TRIALS

108

14

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others49

Nagano123

CLINICAL TRIALS

260

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others50

Nagasaki

112

CLINICAL TRIALS

227

14

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others

51

Nara

67

CLINICAL TRIALS

131

13

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others52

Niigata

124

CLINICAL TRIALS

218

13

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others

53

Oita

93

CLINICAL TRIALS

169

13

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others54

Okayama

188

CLINICAL TRIALS

320

15+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others55

Okinawa

86

CLINICAL TRIALS

146

11

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others56

Osaka438

CLINICAL TRIALS

1,484

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others

57

Saga

75

CLINICAL TRIALS

123

11

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others58

Saitama

237

CLINICAL TRIALS

652

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others59

Shiga61

CLINICAL TRIALS

121

13

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others60

Shimane56

CLINICAL TRIALS

89

13

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others61

Shizuoka

241

CLINICAL TRIALS

490

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others62

Tochigi

119

CLINICAL TRIALS

213

14

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others63

Tokushima

79

CLINICAL TRIALS

128

14

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others64

Tokyo611

CLINICAL TRIALS

2,418

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others65

Tottori

43

CLINICAL TRIALS

73

13+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others66

Toyama76

CLINICAL TRIALS

149

13

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others67

Wakayama

66

CLINICAL TRIALS

114

12

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others68

Yamagata

53

CLINICAL TRIALS

110

12

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others69

Yamaguchi

100

CLINICAL TRIALS

198

13

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others70

Yamanashi

58

CLINICAL TRIALS

98

16+

SITES

THERAPEUTIC AREAS

Prefecture Views

Allergy

Infectious Disease

Cardiology

Musculoskeletal Disease

CNS

Oncology

Dermatology

Ophthalmology

Endocrine Metabolic Disease

Respiratory Disease

Gastroenterology

Urology

Hematology

Rare Diseases

Immunology

Others71

Therapeutic Area Views

72Allergy

29

CLINICAL TRIALS

722
SITES

PHASES
Phase 1
Undefined

4%23%

Phase 44%Phase 2

29

23%

TRIALS

Phase 346%

Therapeutic Area Views

73

Cardiology

57

CLINICAL TRIALS

2,368
SITES

PHASES
Phase 1
Undefined

21%

Phase 47%

2%

Phase 2

16%

57
TRIALS

Phase 3

54%

Therapeutic Area Views

74

CNS

49

CLINICAL TRIALS

714
SITES

PHASES
Phase 4

6%

Phase 110%Phase 249
Phase 3

10%

TRIALS

73%

Therapeutic Area Views

75

Dermatology

7

CLINICAL TRIALS

111
SITES

PHASES
Phase 4Phase 114%

Phase 3

43%

Therapeutic Area Views

14%

7

TRIALS

Phase 229%

76

Endocrine metabolic disease82

CLINICAL TRIALS

3,739
SITES

PHASES
Phase 1
Undefined

3%

Phase 223%

Phase 4

15%

7%

82
TRIALS

Phase 3

53%

Therapeutic Area Views

77Gastroenterology

8

CLINICAL TRIALS

432
SITES

PHASES

Undefined

63%

Therapeutic Area Views

8

Phase 3

38%

TRIALS78

Hematology

36

CLINICAL TRIALS

219
SITES

PHASES
Undefined

11%

Phase 2

36

31%

TRIALS

Phase 358%

Therapeutic Area Views

79Immunology

81

CLINICAL TRIALS

3,163
SITES

PHASES
Undefined
Phase 413%

Phase 13%

Phase 2

21%

3%

81
TRIALS

Phase 3

61%

Therapeutic Area Views

80

Infectious disease34

CLINICAL TRIALS

490
SITES

PHASES
Phase 03% Phase 1
7%Phase 2

Undefined

30%

Phase 4

10%

Therapeutic Area Views

34

7%

TRIALS

Phase 343%

81

Musculoskeletal disease11

CLINICAL TRIALS

213
SITES

PHASES
Phase 49%Phase 2Phase 3

55%

Therapeutic Area Views

11

36%

TRIALS

82

Oncology

331

CLINICAL TRIALS

3,354
SITES

PHASES
Phase 42%

Phase 341%

Undefined

6%

Phase 1

25%

331
TRIALS

Phase 2

27%

Therapeutic Area Views

83

Ophthalmology

18

CLINICAL TRIALS

273
SITES

PHASES
Phase 2

6%

Phase 3
Undefined

44%

18

17%

TRIALS

Phase 433%

Therapeutic Area Views

84

Rare disease*28

CLINICAL TRIALS

587
SITES

* Rare disease includes conditions such as:
Gaucher Disease, Myelofibrosis, and Bahcet’s Disease,which could not be categorized into other therapeutic areas

PHASES
Phase 1

4%

Undefined

21%

28

Phase 2

29%

TRIALS

Phase 346%

Therapeutic Area Views

85Respiratory disease20

CLINICAL TRIALS

1,209
SITES

PHASES
Phase 2

Undefined

20%

20%

Phase 4

5%

20
TRIALS

Phase 3

55%

Therapeutic Area Views

86

Urology

14

CLINICAL TRIALS

365
SITES

PHASES
Undefined

Phase 18%

15%

Phase 4

15%

14
TRIALS

Phase 362%

Therapeutic Area Views

87

Others20

CLINICAL TRIALS

136
SITES

PHASES
Phase 120%

Undefined

35%

20

Phase 2

10%

TRIALS

Phase 415%

Therapeutic Area Views

Phase 320%

88