Accelerator Driven Production of Medical Isotopes

World Market Usage and Industrial Production

Presentation at The Cockcroft Institute 8th and 9th Dec 2011

Dewi M. Lewis CERN, and AIPES

Radioisotope Markets Approx World Market 99Mo 6000 Ci/wk at 6 day Ref >150 M$US Assumes no generators, kits etc 18F as FDG around 2x106/yr ~400 MUS Assumes supply of radiopharmaceutical grade FDG 60Co as Low Spec Ac (LSA) ~120 MUS Assumes selling price of isotope only

Radionuclides for labelling

99mTc 18F 123I

Nuclear Medicine Imaging

SPECT PET

Nuclear Medicine Imaging Procedures

NUCLEAR MEDICINE PROCEDURES

USA 2008 TOTAL 17.3 million

9%

54%

15%

7%

4%

3%

2%

2%

2%

2%

PET All

SPECT cardiac

SPECT bone

SPECT liver

SPECT respiratory

SPECT thyroid

SPECT reanl

SPECT infection

SPECT tumour location

SPECT other

NUCLEAR MEDICINE PROCEDURES

USA 2008

0

5

10

15

20

1

Mill

ions

per

year

Total procedures

Total Tc-99m

TOTAL PET procedures

Total Other radionuclides

Tc-99m PROCEDURES

Tc-99m Cardiolite

Tc-99m MyoView

Tc-99m bone

Tc-99m others

Global markets M$ US

1.E+00

1.E+01

1.E+02

1.E+03

1.E+04

1.E+05

1.E+06

1.E+07

Total h

ealth

care

phar

mac

eutic

als

med

ical diagn

ostic

s an

d de

vice

s

diag

nostic im

aging

nuclea

r med

icine

Rad

ioph

arm

aceu

ticals

Tc-99

m b

ased

age

nts

Mo-

99 G

ener

ator

s

Mo-

99 cos

tsB

$ U

S

22% 1% 0.1% 0.004%

NUCLEAR MEDICINE PROCEDURES

USA 2008 TOTAL 17.3 million

9%

54%

15%

7%

4%

3%

2%

2%

2%

2%

PET All

SPECT cardiac

SPECT bone

SPECT liver

SPECT respiratory

SPECT thyroid

SPECT reanl

SPECT infection

SPECT tumour location

SPECT other

Market Models 2009 USA Imaging Procedures World Consumption of 99mTc

PET

Other nuclides

Tc-99m

Cardiology

Tc-99m Bone

Tc-99m Other

procedures

Structure of the 99Mo Industry

Research Reactor

Operators

Suppliers of Radiopharmaceutical

grade 99Mo

Manufacturers of 99mTc/99Mo Generators

Supplier Dynamics of 99Mo Industry

Australia OPAL ANSTO

STRUCTURAL INDUSTRY ISSUES FOR 99Mo

1. HEU to LEU conversion requirement

2. Cost recovery problem for irradiations

3. General re-imbursement

4. Additional European reactor capacity – EU

5. Incentives to invest in R&D

Future Trends for SPECT imaging

1. Large infrastructure of SPECT cameras

2. Forecast increasing demand

3. Increasing use of SPECT/CT cameras

4. Emergence of new detectors with CZT

NUCLEAR MEDECINE CAMERAS IN EUROPE

2009

Courtesy of EANM survey

0

1000

2000

3000

4000

SPECT SPECT/CT PET PET/CT

Scanner Placements in Europe market estimates

Courtesy of the Petten future Project Group, Holland

Applications of Accelerators

Accelerators for medical isotope production

Energy (MeV)

Industry Vendors Cyclotrons for SPECT radioisotope production

FDG Procedure Volume

0

150

300

450

600

2002 2003 2004 2005 2006 2007 2008

Total Examinations

25+% per year

0

125

250

375

500

2002 2003 2004 2005 2006 2007 2008

PET PET/CT

15+% per year

PET Scanners Installed

0

300

600

900

1200

1500

2002 2003 2004 2005 2006 2007 2008

Avg procedures per scanner

European PET Imaging Industry

0

40

80

120

160

2002 2003 2004 2005 2006 2007 2008

COMPANY INSTITUTION

PET Cyclotrons Installed

9+% per year

PET Cyclotron Installed Base

• Historically, commercial supply were taken from existing cyclotrons in partnership with a host institution

• Number of PET commercial suppliers have relocated away from hospitals or universities to focus on production

Europe Cyclotron coverage

= 2 hour drive times Academic

Commercial

63

74

Academic Commercial

European PET Cyclotron Market 2009

WORLD CYCLOTRONS IN 2009

0

50

100

150

200

250

300

GE Siemens IBA ACSI

Data supplied by Dave Schlyer, Brookhaven

PET Cyclotron Technology

TargetsAndBeamLineStart.JPGTargetsAndBeamLineStart.JPG

Cyclotron Targets

Manufacturing of PET agents Automated PET synthesis - FastLAb - GMP

•Reproducibilty & robustness,

•Ease of use & safety,

•Flexible & multi tracers

•GMP compliant processes

RadioPharmaceutical Industry SPECT Isotope Production

Company No of Cyclotrons

Europe USA Japan Total

Amersham 5 5 4 14

Tyco/Mallinckrodt 2 3 5

Dupont 6 6

MDS/Nordion 1 2 3

Schering/CIS 2 2

Daiichii 2 2

Theragenics 14 14

Total 46

COMPANY NO OF

CYCLOTRONS

Europe North America Japan Total World

General Electric 3 4 4 11

Covidien 2 3 5

Lantheus 5 5

BEST 1 1

Nordion 2 2

IBA 2 2

FujiFilm 2 2

Theragenics 10 10

TOTALS 8 24 6 38

CYCLOTRON PRODUCTION

TYPICAL INDUSTRIAL CYCLOTRON LAYOUT

KIPROS 120 - 123I Production system Side View (left and right)

Courtesy of Hermann Schweikert, Zyklotron AG

Radiochemistry, Hot cells, Finishing ops, GMP

DISTRIBUTION Canadian national strategy for 99mTc

Stable Isotope Enrichment Some Issues

1. 235U enrichment - the HEU problem

2. 18O enrichment - increasing use for 18F

3. 100Mo production - quantities/quality for 99mTc

4. Metal elements - 201Tl, 68Zn, 112Cd etc

CURRENT METHODS OF ISOTOPE ENRICHMENT Gaseous Diffusion Electromagnetic Separation

Centrifuge Methods Laser separation

General Conclusions

Mature industry Advantages for cross disciplinary scientific approaches Longitudinal integration of technology needed Opportunities remain - accelerator lab collaborations Probable requirement for constructing demonstrators No strategic involvement by UK government Increased funding now available by the EU Scope remains for scientific innovation

Industry Trends

1. Development of PET imaging with 18F

2. Global crisis of 99Mo Production for SPECT imaging a) Potential use of cyclotrons for 99mTc b) alternative accelerator-driven methods

3. Increasing use of 123I for SPECT imaging

4. Development of very small cyclotrons

THANK YOU