Japan Korea Bio Austrade Japan Presentation 2009

8/3/2019 Japan Korea Bio Austrade Japan Presentation 2009

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Japan : Pharma/Biopharma Market Overview

Roger Moore

Special Advisor to Austrade Japan Health/Biotechnology

July 2009


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Biotechnology Market Overview

Second largest market after USA: A$ 38 billion (2008)

Number of bioventures: 577 (2007)*9

Biopharmaceuticals market: A$ 8 billion *2

Bio share of total pharma growth 200408: 24%

A$ 1 = JPY 75


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Pharmaceutical Market - Overview

Second largest market after USA

ethical pharmaceuticals: A$ 110 billion (2008) *3

Japan share of global market: 9.1% (2008) *4

Largest share of Asia Pacific market: 67.3% (2007) *2

Drug spend per capita - the worlds highest: approx US$ 540 (2008) *5

High number of prescriptions per patient

Strong patented drugs market


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Top 15 Pharmaceutical Companies by Sales *6

Top 15 Companies by Consolidated Net Sales

CompanyFY 2007

(A$ Million)Growth 06-07

(%)

1 Takeda 18,331 5.3

2 Astellas 12,968 5.6

3 Otsuka 12,380 8.7

4 Daiichi Sankyo 11,735 -5.3

5 Eisai 9,790 8.9

6 Pfizer 5,815 5.1

7 Mitsubishi Tanabe 5,459 1.1

8 Chugai 4,597 5.7

9 Novartis 3,540 6.7

10 Dainippon Sumitomo 3,520 1.1

11 Taisho 3,329 3.1

12 GlaxoSmithKline 2,923 9.4

13 Shionogi 2,857 7.3

14 Banyu 2,588 0.5

15 Astra Zeneca 2,488 9.5

Total / Average Top 15 102,319 4.8

FY2007: Apr/06 Mar/07 FY 2006: Apr/05 - Mar/06 (Japanese FY)


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Top 10 Japanese Pharmaceuticals Overseas Sales *6

Top 10 Companies Overseas Sales% of Total Sales and Growth

CompanyFY 07(%)

FY 06(%)

Growth06-07

(%)1 Eisai 61.9 60.9 1.02

2 Takeda 50.5 49.3 1.02

3 Astellas 50.3 48.9 1.03

4 Daiichi Sankyo 40.8 38.4 1.06

5 Otsuka 38.5 36.0 1.07

6 Kyowa Hakko 19.2 18.1 1.06

7 Shionogi 17.6 13.0 1.35

8 Santen 14.3 13.3 1.08

9 Toyama Chemical 13.9 3.3 4.21

10 Dainippon Sumitomo 9.3 8.4 1.11

Average Top 10 31.6 29.0 1.4018.933,792Total / Average Top 10

11.2198Santen10

11.8327Dainippon Sumitomo9

60.4369Mitsubishi Tanabe8

44.5502Shionogi7

17.21,003Kyowa Hakko6

16.34,767Otsuka5

0.54,782Daiichi Sankyo4

10.76,061Eisai3

8.86,528Astellas2

7.99,256Takeda1

Growth06-07 (%)

FY 07(A$ Million)

Company

Top 10 Companies by Overseas Sales


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Japanese Pharmaceutical Companies - R&D Spending *6

Top 10 Companies by R&D Spending

CompanyFY 2007

(A$ Million)Growth

2006-2007 (%)% of Sales

1 Takeda 3,677 42.7 20.1

2 Eisai 3,005 108.2 30.7

3 Daiichi Sankyo 2,180 -4.2 18.6

4 Astellas 1,792 -19.9 13.8

5 Otsuka 1,357 -3.3 11.0

6 Mitsubishi Tanabe 964 -4.5 17.7

7 Chugai 723 -0.7 15.7

8 Dainippon Sumitomo 631 15.7 18.0

9 Shionogi 536 7.6 18.8

10 Ono 519 10.2 26.7

Total/Average Top 10 15,385 15.18 19.11


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Key Pharma Franchises (Sales & Growth) *7

High growth: Oncologics (+9%), CNS (+5.7%)

Major growth drivers:

Avastin (bevacizumab, Chugai, 04/2008) Nexavar (sorafenib, Bayer, 04/2008)

Tarceva (erlotinib, Chugai, 12/2007) Velcade (bortezomib, Janssen, 12/2006)

Erbitux (cetuximab, Merck Serono, 09/2008) Sutent (sunitinib, Pfizer, 06/2008)

J-Zoloft (sertraline, Pfizer, 07/2006) Abilify (aripiprazole, Otsuka, 06/2006)

Lonasen (blonanserin, Dainippon Sumitomo, 04/2008)


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Top 10 Pharmaceutical Companies By Key Therapy Areas*7


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Japanese Pharma - M&A and International Collaboration

Major M&As & Collaboration in 2008:

- Takeda - Millennium Pharmaceuticals (US$ 8.8 billion)

- Takeda Amgen Japan (13 molecules development and commercialisation)

- Daiichi Sankyo - Ranbaxy (US$ 4.6 billion); U3 Pharma AG (US$ 235 million)- Eisai MGI Pharma (US$ 3.9 billion)

- Shionogi Sciele (US$ 1.1 billion)

Pharma in-licensing from bioventure companies (preclinical to registration, by No of items)*8

(Origin of Bioventure)

US Europe Japan

US 136 141 57

Europe 59 85 21Canada 14 9 6

Australia 4 7 5

Japan 1 2 7

Other 9 3 3


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Challenges for all Companies

Launch lag / PMDA capacity

Environment for clinical studies ICH - GCP

Expand MRA with EU/US to the quality & non-clinical areas ofpharmaceuticals

Pricing reform more reward for innovation

Continual progress on IP protection


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Why be in Japan

10% of global pharma market

NHI system universal access for 127 million

Ageing population / increase in chronic diseases

Strong patented market / respect for innovation

High wish to prescribe & receive medicines

Japanese big pharma strong & global ambitions

Japanese middle size pharma weak R&D pipelines

Strong growth in biotech products


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Austrade Japan Team:

Aiko NishideBDM, Austrade Osaka, [email protected]

Airi SakaguchiBDM, Austrade Tokyo, [email protected])

Health/Bio/Wellbeing Industry Team, AustradeBrisbane Janelle CaseySydney Rika Sasaki
mailto:[email protected]:[email protected]:[email protected]:[email protected]


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Sources

*1 Biotechnology 2009, Nikkei BP

*2 2008 Japan Pharmaceutical Market Review, IMS Japan K.K.

*3 2008 Pharma Delegates Market Summary, Copyright 2009 IMS Japan K.K., JSTR 2008 Dec MAT

Reprinted with permission

*4 2008 Pharma Delegates Market Summary, Copyright 2009 IMS Health. All rights reserved.

MIDAS Quantum 2008 Sept MAT, Reprinted with permission

*5 Japan Self-Medication Industry (JSMI), IMS Japan, BMI

*6 Monthly Medical Information eXPress Medical Rankings 2008, Elsevier Japan

*7 IMS Japan Monthly Market Insights 2009 June Edition, IMS Japan K.K.

*8 Pharmaprojects (Jan 2009)

*9 Japan Bioindustry Association


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Growth Opportunity Areas

Oncology

Diabetes

Hyperlipidemia, Hypertension, Artherosclerosis

CNS


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Introduction of the PPSR would attract pharmaceutical companies moreto the Japan market; consequently, patients would be able to access

many useful drugs without lag

Introduction of the PPSR

Sales

(volume x price)

Price protectedspecial rule

Currentpricing rule

Generic launch

Pharmaceutical companies couldrecoup investment quicker

Japan market becomes moreattractive and less risky

Sales image after introduction of the PPSR*1

Pharmaceutical companies could re-invest on development of noveldrugs needed for Japan, whichwould have not been embarkedthus far, at the same time of globaldevelopment

As a result, patients would accessmany useful drugs w/o lag from the

global launch*1 The price protected special rule (PPSR): Yakka Iji Tokurei

Year after launch

(Source: Pharmaceutical Research and Manufacturers of America)

Japan Korea Bio Austrade Japan Presentation 2009

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