mo/99mtc market demand and production capacity projection … · 2018-09-26 ·...

[email protected] 2018 99Mo Topical Meeting, Knoxville, 23-26 September 2018 1

Medical Isotope Supply Review: 99Mo/99mTc Market Demand

and Production Capacity Projection 2018-2023

2018 99Mo Topical Meeting, Knoxville 23-26 September 2018

Kevin Charlton

OECD Nuclear Energy Agency

Analyst - Nuclear Development Division


The Nuclear Energy Agency (NEA)

• The NEA is a specialist agency of the Organisation for

Economic Co-operation Development (OECD), the NEA is an

intergovernmental organisation of 33 industrialised countries

based in Paris

• The NEA MISSION - To assist its member countries in

maintaining and further developing, through international

co-operation, the scientific, technological and legal basis

required for a safe, environmentally friendly and economical

use of nuclear energy for peaceful purpose


Medical radioisotopes

• The medical radioisotopes market is global and secure

economically sustainable supply is essential

• they are utilised in a wide range of diagnostic procedures,

heart, brain, kidney, bone and in cancer: between 30-40M

patient doses/year

• medical radioisotopes with their short half-lives 99Mo (66 hours)

and 99mTc (6 hour) can not be stored

• they must be produced near continuously and are the original

“Just-In-Time” (JIT) products, pre-dating the JIT concept

• any disruption to the supply chain can cause immediate

disruption to patient services leading to sub-optimal care


HLG-MR

• The High-Level Group on the Security of Supply of Medical

Radioisotopes (HLG-MR) was established at the request of

NEA member countries, following global supply shortages of 99Mo/99mTc in 2009-2010 that resulted from simultaneous

unplanned outages of ageing research reactors in Canada

and the Netherlands and processing problems in Belgium

2004 2006 2008 2010 2012

Demand and Capacity Trends

Market Capacity

HFR & NRU Outages Market Adjustment


• The 2018 Medical Isotope Supply Review: 99Mo/99mTc Market

Demand and Production Capacity Projection, 2018-2023 the

latest in a series of reports has recently been published:-

• Positive News

• Curium conversion to 100% LEU targets

• positive FDA decision for NorthStar RadioGenix project (non-HEU)

• Negative news

• multiple NTP problems led to “chronic” shortage situation in some

markets for 99Mo/99mTc and some shortages of 131I

• Nordion/GA/MURR project terminated on economic grounds

• some reported reductions in reactor irradiation capacity from LEU

conversion

• more project delays

Demand and Capacity Review 2018-2023


NRU Canada HFR

The Netherlands BR-2

Belgium

OSIRIS France

SAFARI-1 South Africa

OPAL Australia

RA-3 Argentina

LVR-15 Czech Republic

MARIA Poland

Reactor

Global Supply Chain – around 2014

Monrol Turkey

POLATOM Poland

Lantheus U.S.

Generator Manufacturer

NTP South Africa

Mallinckrodt U.S. Mallinckrodt

The Netherlands

ANSTO Australia

IBAM France

GE Great Britain

FUJI & MEDIPHYSICS

Japan

Various Russia

Nordion Canada

ANSTO Australia

Mallinckrodt The Netherlands

NTP South Africa

IRE Belgium

CNEA Argentina

Processor


HFR The Netherlands

BR-2 Belgium


OPAL Australia

RA-3 Argentina


MARIA Poland

ANSTO Australia

Curium The Netherlands

NTP South Africa

IRE Belgium

CNEA Argentina


Monrol Turkey

POLATOM Poland

+

Reactor Processor Generator Manufacturer

Lantheus U.S.

NTP South Africa

Curium U.S. Curium

The Netherlands

ANSTO Australia

Curium France

GE Great Britain

FUJI & MEDIPHYSICS

Japan

NorthStar U.S.

MURR U.S. Various

Russia

AT


HFR The Netherlands

BR-2 Belgium


OPAL Australia

RA-3 Argentina


MARIA Poland

ANSTO Australia


NTP South Africa

IRE Belgium

CNEA Argentina

Monrol Turkey

FRM II Germany


+

POLATOM Poland


Lantheus U.S.

NTP South Africa

Curium U.S. Curium

The Netherlands

ANSTO Australia

Curium France

GE Great Britain

FUJI & MEDIPHYSICS

Japan

MURR U.S.

NorthStar U.S.

+

+

Various Russia

AT


HFR The Netherlands

BR-2 Belgium


OPAL Australia

Argentina


MARIA Poland

ANSTO Australia


NTP South Africa

IRE Belgium

CNEA Argentina

Monrol Turkey

FRM II Germany

Potential New Capacity


+

POLATOM Poland


Lantheus U.S.

NTP South Africa

Curium U.S. Curium

The Netherlands

ANSTO Australia

Curium France

GE Great Britain

FUJI & MEDIPHYSICS

Japan

MURR U.S.

NorthStar U.S.

Alternative Conventional

+

+

Various Russia

AT


Processor Targets5

Anticipated Mo-

99 production

weeks/year

Expected available

capacity per week (6-

day Ci) by 20236

Expected available

capacity per year (6-

day Ci 99Mo) by 20236

Estimated first

full year of

production

Project status (January

2018)

MURR/NorthStar Natural Mo

target 52 750 39 000 2019 FDA approval Feb 2018

MURR/NorthStar1 Enriched Mo

target 52 +2 250 +117 000 2020 In production scale up

NorthStar Non-fissile 52 3 000 156 000 2021 Accelerator vendor selected,

initiating scale up

Nordion LEU-SGE 52 3 200 166 400 2020 Phase 2 underway

PROJECT CANCELLED

SHINE LEU solution 50 4 000 200 000 2021 Construction Permit Granted

CNEA LEU 48 2 500 120 000 2021 Building start by end 2018

Korea2 LEU 43 400 17 200 2023+ Construction permit in

review by regulatory body

MARIA: Mo-99

20103 LEU 40 300 12 000 2023+ Financing – not yet agreed

Brazil MR LEU 41 1 000 41 400 2023+

Detailed design still to be

contracted. Construction

depends on budget

China Advanced

RR4 LEU 34 1 000 34 000 2023+

Financing decision after

2017 tests

TABLE 4 – January 2018 (Revised April 2018)


2018-2023 Demand and Demand +35% ORC

200000

300000

400000

500000

600000

Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec

2018 2019 2020 2021 2022 2023

6-da

y cu

ries

99M

o E

OP

/6m

onth

per

iod

NEA Demand growth (with no ORC) NEA Demand growth (+ 35% ORC)


2018-2023 Processing Capacity (Fig. 6.2 Projections)

200000

300000

400000

500000

600000

Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec Jan-Jun Jul-Dec

2018 2019 2020 2021 2022 2023

6-da

y cu

ries

99M

o E

OP

/6m

onth

per

iod

NEA Demand growth (with no ORC) NEA Demand growth (+ 35% ORC)

Total processing capacity - All Technologies Current processing capacity

Total processing capacity conventional technology Total processing capacity - All Technologies (2-year delay)


The Effect of Multiple Project Delays

200,000

300,000

400,000

500,000

600,000

700,000

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Axi

s Ti

tle

Scenario B - "Technological Challenges" Projection Creep with Time

NEA Demandgrowth (+ 35% ORC)

Total processingcapacity - Alltechnologies 2015





HLG-MR Status Summary

• Many technical problems have been solved and a range of

alternative production technologies demonstrated

• the first alternative technology is being introduced into the US

market

• Supply stabilised as a result of the actions of existing supply

chain participants and the co-ordination activities of the

Association of Isotope Producers and Equipment Suppliers

(AIPES), but challenges remain

• supply has been stressed since mid-November 2017 due to an

unplanned outages at NTP (South Africa) and disruptions at

other facilities

• the AIPES Emergency Response Team (ERT) convening weekly

• supply shortages of up to 15% of world demand in some weeks


Supply Performance to Gen Manufacturers 1Q 2018

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1 2 3 4 5 6 7 8 9 10 11 12 13

Pro

po

rtio

n o

f G

en

era

tor

Man

ufa

ctu

rers

wit

h

vary

ing

leve

ls o

f sh

ort

age

No Supply

Greater than30% Shortage

Up 30%Shortage

Up 20%Shortage

Up 10%Shortage

No Shortage

Weighted

Average


HLG-MR Status Summary

• Conversion to LEU targets (a market externality determined

by governments) has technical challenges; it is less efficient,

produces more waste and has a higher unit cost

• >70% market conversion to LEU recently achieved

• 3rd Self-Assessment 6-policy principles - slow implementation

• FCR pricing levels have not yet achieved

• paid ORC remains under utilised by the supply chain

• reimbursement levels remain unchanged in many markets

• The market remains economically unsustainable

• risk to secure supply remains

• some risk of delay or cancellation of new investment

• Further work needed to reform healthcare economics


• At the 5th meeting of the 4th mandate (February 2018) of the

HLG-MR, the OECD Health Division (HD) joined a review

session on work programme proposals and the HLG-MR

delegates agreed to support the proposal

• final project amendments were agreed with a smaller HLG-MR

working group

• sufficient Voluntary Contribution pledges have been received to

allow HD to perform the work

• work started – early April 2018

• interim update – mid June 2018

• closed presentation to HLG-MR – 9 October 2018

• open presentation - EANM 2018, Düsseldorf – 17 October 2018

• final report – late 2018

Co-operation with OECD Health Division


EANM 2018 Special Session

Wednesday, October 17, 2018, 08:00-09:30 Hall 6

Session Title: High-level Group of the Security of Supply of

Medical Radioisotopes (HLG-MR) - Open Briefing Session for

Participants and Stakeholders

Summary of the content

The Organisation for Economic Co-operation and Development -

Health Division (OECD-HD) and the Nuclear Energy Agency (NEA)

will present on the findings of recent joint work performed for the

HLG-MR on health economics aspects of the medical isotopes

supply chain (in particular 99Mo/99mTc) that are important in

ensuring a long term economically sustainable market model. The

NEA will also provide a short briefing on proposed future activities

to support the security of supply of medical isotopes.


www.oecd-nea.org

Thank you for your attention

mo/99mtc market demand and production capacity projection … · 2018-09-26 ·...

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