Time and Cost
to Develop a
New GM TraitRESULTS APRIL 2022

Cost and Time Required forthe Discovery, Development
and Authorisation of a New
Plant Biotechnology-Derived
A Study on Behalf of Crop Life International

Genetic TraitApril 2022

Contents
01

Executive Summary

302

Introduction

6

03

Study Definitions

904

Glossary of Terms

1205

Study Scope

14

Methods

16

Study Results

17Part 1: Cost of a New Plant

18

06

Biotechnology-Derived Genetic Trait

2

Part 2: Time by Activity Stage (Non-Consecutive)

19

Part 3: Time by Activity Stage (Consecutive)

21

07

Discussion

23

08

Key Results of the Study

29

09

Survey Response Variance31

10

Appendix 1: Study Plan

33

11

Appendix 2: Questionnaire38

12Disclaimer

43

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April 2022

Executive
Summary01

April 2022

Executive
Summary

Rationale• To provide an up-to-date view on the cost and duration of
the discovery, development and authorisation of a new plantbiotechnology-derived trait that has received cultivation approvalin at least two countries and import approvals from at least fivecountries.
• The data to be collected was intended to demonstrate the current
situation according to three main categories:• Cost of each part of the discovery, development andauthorisation process.
• Time involved to complete each part of the process needed tocommercialise a biotechnology-derived genetic trait.
• Total consecutive time required to bring a biotechnology-derived
genetic trait from discovery to commercialisation (including
authorisations).
• The aim of the study was to focus on a single novel trait andexclude the time and cost to develop and gain authorisation forstacked genetic traits containing multiple genetic events.

Method• The data was collected via a questionnaire.
• The companies taking part were:• Bayer Crop Science• Corteva Agriscience• Syngenta• BASF Agricultural Solutions• Responses were anonymised and compiled, with data averaged to
produce a mean value for each activity stage.

4

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Executive
Summary
Continued

Findings• The cost of discovery, development and authorisation of a new plantbiotechnology-derived genetic trait commercialised in the period from2017 to 2022 is $115.0 million.
• The discovery phase of the process accounted for 6.6% of total costs
and 13.3% of the non-consecutive total time.
• The genetic event construction and testing phase represented 55.8% of
total costs and 35.6% of the non-consecutive total time.
• The regulatory phase, the longest duration of the overall process,accounted for 37.6% of total costs and 51.1% of the non-consecutive
total time.
• The mean duration to bring a genetic trait to the point ofcommercialisation in 2017–2022 was 16.5 years. However, this study
did not assess the time required to develop stacked trait varieties, which
commonly represent commercial seed product offerings.
• As indicated by a comparison with the previous study, the cost of
discovery, development and authorisation of a new plant biotechnologyderived genetic trait has declined from $136 million in the 2008–2012
period to the current value of $115 million, whilst the time required tocomplete the process has increased from 13.1 years to 16.5 years.

5

Trait R&D Study

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Introduction

02

The first instance of abiotechnology-derived genetic
trait in commercial agriculture
was in 1995. Since then, thenumber of GM traits used incrops has increased significantly,
which in turn has increased thelevel of technification, as well as
the number of crop species andgeographic spread.

April 2022

Introduction

The first instance of a biotechnology-derived genetic trait in commercial
agriculture was in 1995. Since then, the number of GM traits used incrops has increased significantly, which in turn has increased the levelof technification, as well as the number of crop species and geographic
spread. In 2020, 21 countries cultivated GM crops in a commerciallysignificant volume, totalling an estimated 198.4 million hectares (including
non-traded seed). Despite the relative confinement of GM crop cultivation
to a select number of countries, it is generally accepted that before GM
crop varieties are commercialised for cultivation, crop varieties containing
these traits must gain import approval from countries that import such
crop commodities.

GM Crop-Cultivating Countries of Commercial Significance in 2020

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As a result of a round of mergers and acquisitions, the number ofmultinational seed companies holding CropLife International membershipand involved in research and development of GM traits has declined fromsix to four since 2017.

Key Recent Company M&A Events
M&A EventYear

Syngenta acquired by ChemChina

2017

DuPont and Dow merge to form Corteva

2017

Bayer acquired Monsanto

2018

BASF acquired the majority of Bayer’s former seed business2018

This study was conducted in order to establish the average cost andduration of the process associated with the discovery, development
and authorisation of a new biotechnology-derived genetic trait thathas gained cultivation approval in two countries or more, as well as
gaining import approval in at least five countries. Although the majority
of commercial products contain stacked traits (i.e. contain one or morebiotechnology-derived genetic traits combined through conventional
breeding), the aim of the study was to focus on a single novel trait, as
this eliminates any costs related to the combining of traits.

8

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Study
Definitions

03

The discovery, development andauthorisation of biotechnologyderived genetic traits is a complex
and time-consuming process.
Overall, it can be separated into
three development stages, which
can be further broken down into
activity stages.

April 2022

Study
Definitions

The discovery, development and authorisation of biotechnology-derived
genetic traits is a complex and time-consuming process. Overall, it canbe separated into three development stages, which can be further broken
down into activity stages.
The first stage is the discovery and identification of candidate genes that
confer the desired trait, such as herbicide tolerance or insect resistance.
Candidate genes can be sourced from a range of organisms orsynthetically generated through modification. The identification and initial
testing to demonstrate the biological activity of a candidate genetic trait
occurs in the discovery phase. Only candidate genes that show sufficientbiological activity are selected for further development.

Genetic Trait Development and Activity Stages
Development Stage

Activity Stages
Early Discovery

Discovery
Late Discovery
Construct Optimisation
Commercial Event Production
Genetic Event Construction and Testing& Selection
Introgression, Breeding & Wide-Area Testing
Regulatory Science

Regulatory
Registration & Regulatory Affairs

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Candidate genetic traits that progress beyond the discovery phase into

Study
Definitions
Continued

the genetic event construction and testing phase are typically combinedwith different promoter sequence in order to generate the most suitable
genetic construct. Optimised genetic constructs are then incorporated
into a specific crop for evaluation in greenhouse and field conditions.
Based on the performance of these genetic constructs, the candidates
with the most commercial potential are selected for introgression into
the developing company’s elite germplasm. The resulting crop variety isthen further evaluated under field conditions to confirm the biological
performance and commercial potential of the genetic trait.
The final stage of the process is the regulatory phase. Developing
companies are required to submit applications to the authorities incountries where crop varieties utilising the genetic trait are intended to
be cultivated, as well as in major importing countries where harvested
produce, or items derived from the crop, are to be imported for foodand/or feed uses. In addition, intellectual property submissions will be
undertaken to patent the genetic trait and commercially protect theinvention for a period of time.

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Glossary of
Terms

04

April 2022

Glossary of Terms
Term

Definition
The genetic sequence created to facilitate the production

Constructof specific gene products once inserted in a cell containing,at the minimum, a promoter, a gene of interest, and aterminator

Gene expression
Genetic event

Genetic sequences

The generation of functional gene products from DNA/genes
The insertion of a particular transgene into a specific location
on a chromosome
Typically, a structure comprising DNA organised into a geneor genes

GenomeSum of the total genetic material within a cellHybridProgeny generated by crossing two different inbred lines
The utilisation of conventional breeding methods toIntrogression

incorporate a genetic event into a commercial crop variety or
inbred line

Promoterand rate of transcription) of another genetic sequence

Research & Development

The complete process of bringing a new product from

(R&D)

discovery to the point of commercialisation

Selectable marker

Stacked trait

Trait

13

A genetic sequence used to control the expression (timing

A gene that is introduced into a cell, along with the gene ofinterest, to aid selection
The combination of two traits, typically between herbicide
tolerance and insect resistanceA distinguishing characteristic or quality conveyed by a genesequence

Trait R&D Study

April 2022

Study
Scope

05

The primary aim of this study is
to continue previous analysis andprovide an up-to-date view on thecost and duration of the discovery,
development and authorisation ofa new plant biotechnologyderived
trait that has received cultivation
approval in at least two countries
and import approvals from at least
five countries.

April 2022

Study Scope

Rationale
The primary aim of this study is to continue previous analysis and provide
an up-to-date view on the cost and duration of the discovery, development
and authorisation of a new plant biotechnologyderived trait that hasreceived cultivation approval in at least two countries and import approvals
from at least five countries. The data to be collected was intended todemonstrate the current situation according to three main categories:• Cost of each part of the discovery, development and authorisation
process.
• Time involved to complete each part of the process needed tocommercialise a biotechnology-derived genetic trait.
• Total consecutive time required to bring a biotechnology-derived
genetic trait from discovery to commercialisation (including
authorisations).
The aim of the study was to focus on a single novel trait and exclude thetime and cost to develop and gain authorisation for stacked genetic traits
containing multiple genetic events.

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April 2022

Study Scope

Methods

continued

The study was conducted in line with the protocol attached in Appendix
1. The data was collected via a questionnaire, as found in Appendix
2, which was sent to the following CropLife International member
companies:• Bayer Crop Science• Corteva Agriscience• Syngenta• BASF Agricultural Solutions
The companies taking part in this study have all been involved in the
recent round of mergers and acquisitions that have occurred since 2017,
and, as such, they have attempted to provide as accurate information as
possible based on the data they have available.
Once completed and submitted to AgbioInvestor, each response wasanonymised and compiled. All data was then averaged to produce amean value for each activity stage; however, there was a reasonable
degree of variance across the responses, which is described later in thisreport. Where the analysis required that companies submit data for morethan one crop, for example, in Part 1 of the study, data was averaged
before being compiled. In the case where data was incomplete or lacked
a response, mean values were calculated on a pro rata basis.

16

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Study
Results

06

The primary aim of this study is
to continue previous analysis andprovide an up-to-date view on thecost and duration of the discovery,
development and authorisation ofa new plant biotechnologyderived
trait that has received cultivation
approval in at least two countries
and import approvals from at least
five countries.

April 2022

Study Results

Part 1: Cost of New Plant
Biotechnology-Derived Genetic Trait
CropLife International members were surveyed to establish theaverage cost of the discovery, development and authorisation of anew plant biotechnology-derived genetic trait that was introduced orscheduled for introduction between 2017 and 2022.
All companies surveyed have provided a response; however, due
to the impact of recent mergers and acquisitions, only one of thesecompanies is comparable to pre-2017. However, the companies haveattempted to provide as accurate information as possible based on
the data they have available.
In the case where a company has provided incomplete data for an
activity stage, mean values were calculated for the activity stage on a
pro rata basis, according to the number of responses received.

Cost of a New Plant Biotechnology-Derived Genetic Trait 2017–2022 ($ m.)18

Activity Stage

Cost ($ m.)

Number of Responses

Early Discovery

2.8

3Late Discovery

4.8

3Construct Optimisation

13.4

4

Commercial Event Production & Selection

21.8

4

Introgression, Breeding & Wide-Area Testing

29

4

Regulatory Science

32.9

4

Registration & Regulatory Affairs

10.3

4

Total

115

N/A

Trait R&D Study

April 2022

Analysis of the company responses shows that mean cost associatedStudy Results
Continued

with the discovery, development and authorisation of a new plantbiotechnology-derived genetic trait introduced between 2017 and 2022 is$115.0 million.
The analysis also shows that the largest mean cost was associated withregulatory science at $32.9 million (28.6% of total costs), followed byintrogression, breeding and wide-area testing with a mean cost of $29.0
million (25.2%).
When summing these activity stages into groups of discovery(early and late discovery), genetic event construction and testing(construct optimisation, commercial event production and selection,and introgression, breeding and wide-area testing), and regulatory(regulatory science and registration and regulatory affairs), genetic event
construction and testing form the bulk of overall costs at $64.2 million,
followed by regulatory at $43.2 million and discovery at $7.6 million.

19

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Study Results

Part 2: Time by Activity Stage (Non-Consecutive)

Continued

The second part of the study was undertaken to determine the time
involved to complete each activity stage in the discovery, development
and authorisation of a new plant biotechnology-derived genetic trait thatwas introduced or scheduled for introduction between 2017 and 2022.
As previously stated, due to the impact of recent mergers andacquisitions, companies have attempted to provide as accurate
information as possible based on the data they have available.
The mean results are shown in the table below:

Duration for a Genetic Trait Commercialised Between 2017 and 2022 (Months)

20

Activity Stage

Duration (Months)

Number of Responses

Early Discovery

25.5

4

Late Discovery

27.7

4

Construct Optimisation

28.6

4

Commercial Event Production & Selection

35.3

4

Introgression, Breeding & Wide-Area Testing

78.6

4

Regulatory Science

112.2

4

Registration & Regulatory Affairs

92.4

4

Total

400.1

N/A

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Study Results

Part 3: Time by Activity Stage (Consecutive)

Continued

Part 2 of the study shows the non-consecutive time, where activity stages
may overlap and run nonconsecutively; however, this does not reflect theactual duration of the overall process.
This final part of the study was intended to establish the mean actual
time involved in the discovery, development and authorisation of a newplant biotechnology-derived genetic trait commercialised in the period
from 2017 to 2022. The mean of the responses received from eachcompany is shown in the following table.

Mean Duration to Bring a Genetic Trait to the Point of Commercialisation in 2017–2022
Maize

Soybean

CottonAll Crops*

Months

239.5

199.5

156.0

198.3

Years

20.0

16.6

13.0

16.5

*Based on crops provided incompany responses

Analysis of survey responses shows that the mean time required tobring a new plant biotechnologyderived genetic trait to the point ofcommercialisation was 16.5 years. However, there was considerable
variation between the company responses and crop types. At thecrop level, responses varied from 11.6 years to 24.0 years. Based on
this analysis, cotton biotechnology-derived genetic traits took, on
average, 13.0 years to be brought from early discovery to the point ofcommercialisation, compared to a lengthier process for soybean (16.6
years) and maize (20.0 years).

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Number of Years to Bring a Genetic Trait to the Point of Commercialisation in
2017–2022 Vs Year of Commencement for Individual Crop Responses
35

NUMBER OF YEARS

30
25
20
15
10
5
0
1985

1990

1995

2000
Year of Project Commencement

2005
2010

2015

The data in the graph above differs from that contained in the previous

Study Results
Continued

table, as this data refers not to mean values but to anonymised
individual crop responses. The Y axis shows the number of years taken tocomplete the discovery, development and authorisation of a new plantbiotechnologyderived genetic trait commercialised in the period from2017 to 2022, while the X axis shows the year of project commencement.
The graph clearly shows that projects initiated post-2000 are taking lesstime to reach the point of commercialisation compared to those initiatedin the 1990’s. In addition, projects initiated in the 1990’s in this study
took longer to complete compared to those initiated in the same time
period in the study conducted in 2011, as a result of a significantly longer
regulatory phase.

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Discussion

07

This study was conducted toestablish the average cost andduration of the process associatedwith the discovery, development
and authorisation of a new
biotechnology-derived genetic
trait that has gained approval in
two countries or more, as well as
gaining import approval in at least
five countries.

April 2022

Discussion

This study was conducted to establish the average cost and durationof the process associated with the discovery, development andauthorisation of a new biotechnology-derived genetic trait that has
gained approval in two countries or more, as well as gaining importapproval in at least five countries.
The companies taking part in this study account for the majority of thecommercialised GM traits used in agriculture today. These companies
were provided with a questionnaire, the responses to which wereanonymised, and the mean values established.
The results of the study indicate that the cost of bringing a new
biotechnology-derived genetic trait to the point of commercialisation
between 2017 and 2022 was on average $115 million. In comparison to
the previous CropLife International study that estimated the same costs,
the analysis shows that the average cost has fallen from $136 million in
the 2008–2012 period to the current value of $115 million, indicating a
cost reduction of 15.4%.

Cost to Bring a Genetic Trait to the Point of Commercialisation by Period of Introduction
160

NUMBER OF YEARS

140
120
100
80
60

$136 m.

$115 m.

2008 - 20122017 - 2022

40
20
0

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Within this, the majority of costs in the 2017–2022 period were directed

Discussion
Continued

at genetic event construction and testing (construct optimisation,commercial event production and selection, and introgression,
breeding and wide-area testing) at $64.2 million, representing 55.8%
of total costs. Following this, regulatory activities (regulatory scienceand registration and regulatory affairs) required an average of $43.2
million, 37.6% of total costs, with the remaining $7.6 million (6.6% of
total costs) directed at discovery (early and late discovery).
The proportion of R&D expenditure between development categories
has changed from that indicated in the previous study. While genetic
event construction and testing have broadly remained comparable
at 55.8% of total costs, the proportion required to fulfil regulatory
activities has increased significantly to 37.6% of total costs; this higher
proportional spend has come at the expense of expenditure in the
discovery phase, which has fallen from 22.8% of total costs in 2008–2012 to just 6.6% in 2017–2022.

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Total Costs Attributed to Each Development Category ($ m.)
Development Category

2008-2012%2017-2022%

Discovery

31.0

22.8

7.6

6.6

Genetic Event Construction and Testing

69.9

51.4

64.2

55.8

Regulatory

35.1

25.8

43.2

37.6

Total

136.0

100.0

115.0

100.0

The study was also designed to show the time associated with bringing a

Discussion
Continued

new biotechnology-derived genetic trait to the point of commercialisation.
Analysis of the submitted data shows that the nonconsecutive timerequired to complete the process was approximately 400.1 months forgenetic traits brought to the point of commercialisation in 2017–2022.
This is significantly longer than the 234.1 months described for the
genetic traits brought to the point of commercialisation in 2008–2012.
When summing activity stages into development categories, it is clearthat the greatest proportion of time spent is in the regulatory phase witha total of 204.5 months, representing 51.1% of the total time required
to complete the R&D process. An average of 142.4 months (35.6%) was
required to complete the genetic event construction and testing phase,with the remaining 53.2 months (13.3%) spent on the discovery phase.

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April 2022

Non-Consecutive Time Attributed to Each Development Category (months)
Development Category

2008-2012%2017-2022%

Discovery

53.9

23.0

53.2

13.3

Genetic Event Construction and Testing

94.2

40.2

142.4

35.6

Regulatory

86.0

36.7

204.5

51.1

Total

234.1

100.0

400.1

100.0

In comparison to the previous study, it is evident that the duration

Discussion
Continuedof the regulatory phase for genetic traits reaching the point ofcommercialisation in the 2017–2022 period has increased significantly,
approaching the duration of the entire R&D process for genetic traits
reaching the point of commercialisation in the 2008–2012 period.
As with total costs, the non-consecutive duration of the genetic event
construction and testing phase remained the closest to the previous
study values at 35.6% of the time. The time spent in the discovery
phase, meanwhile, has decreased from 23.0% in 2008–2012 to just
13.3% in 2017–2022.
While the summed duration of the non-consecutive activity stages
does not accurately describe the total duration of the R&D process, it isindicative of the duration from project commencement to completion,and it is included to show the duration of each incremental activity stage.
Companies were also asked to quantify the total duration of the R&D
process in bringing a new biotechnology-derived genetic trait to the pointof commercialisation. These responses were averaged to establish themean duration of 16.5 years for a genetic trait commercialised between
2017 and 2022.

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Mean Duration to Bring a Genetic Trait to the Point of Commercialisation
by Crop and Period of Introduction (Years)
Crop

2008-20122017-2022% Change

Maize

12.0

20.0

66.3

Soybean

16.3

16.6

1.8

Cotton

12.7

13.0

2.4

Canola

11.7

N/A

N/A

All Crops

13.1

16.5

26.0

All Crops Excluding Canola

13.7

16.5

20.7

The table above compares the mean duration to bring a genetic trait to

Discussion
Continued

the point of commercialisation by crop, for the periods 2008–2012 and2017–2022. At the “all crop” level, the analysis shows that the mean
duration has increased by 26.0%, with the greatest increase in duration
for maize (+66.3%), followed by cotton (+2.4%) and soybean (+1.8%).
Responses in the latest survey did not include any for canola; whenexcluding canola responses from the previous study, the mean duration
for all crops rose by 20.7%.
It is evident from the analysis of the submitted data showing the nonconsecutive time required to complete the R&D process that the primaryreason for the sharp rise in overall duration is the greatly increased periodrequired to complete the regulatory process. However, a secondary
contributing factor is the large rise in the time required to complete theintrogression, breeding and wide-area testing activity stage.

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Key Resultsof the Study08

April 2022

Key Results of
the Study• The cost of discovery, development and authorisation of a new plantbiotechnology-derived genetic trait commercialised in the period from2017 to 2022 is $115.0 million.
• The discovery phase of the process accounted for 6.6% of total costs
and 13.3% of the non-consecutive total time.
• The genetic event construction and testing phase represented 55.8% of
total costs and 35.6% of the non-consecutive total time.
• The regulatory phase, the longest duration of the overall process,accounted for 37.6% of total costs and 51.1% of the non-consecutive
total time.
• The mean duration to bring a genetic trait to the point ofcommercialisation in 2017–2022 was 16.5 years. However, this study
did not assess the time required to develop stacked trait varieties, which
commonly represent commercial seed product offerings.
• As indicated by a comparison with the previous study, the cost of
discovery, development and authorisation of a new plant biotechnologyderived genetic trait has declined from $136 million in the 2008–2012
period to the current value of $115 million, whilst the time required tocomplete the process has increased from 13.1 years to 16.5 years.

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April 2022

SurveyRepsonse
Variance09

April 2022

SurveyResponse
Variance

As described in Methods, participating companies were surveyed toestablish a mean cost for the discovery, development and authorisationof a new plant biotechnology-derived genetic trait that was introduced orscheduled for introduction between 2017 and 2022.

Cost to Bring a Genetic Trait to the Point of Commercialisation 2017–2022 ($ m.)

160

Mean = 115

140

STDEV = 40.2

120
100
80
60
40
20
0

The graph above shows the mean cost to bring a genetic trait to the pointof commercialisation between 2017 and 2022, compared to the standard
deviation of responses. The graph highlights the variation in the survey
responses; however, this is not unexpected, as each company may havea different commercial strategy that ultimately dictates R&D expenditure
and/or difference in crop focus, thus leading to significant differences in
the cost of genetic trait development.

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Appendix 1:
Study Plan

10

All information provided byrespondents will be anonymised,with all data in the final publishedreport being mean values.

April 2022

Company
Information

All information provided by respondents will be anonymised, with all datain the final published report being mean values.
Please provide the name of the company and the currency used in
responses to the questionnaire. Any non-US dollar currencies will be
converted to US dollars using average yearly exchange rates.

Company Name
Currency Used

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Summary

10

The primary aim of this study is
to continue previous analysis andprovide an up-to-date view on
the cost and duration associatedwith the discovery, development
and authorisation of a new plantbiotechnology-derived trait thathas received cultivation approvalin at least two countries andimport approvals from at least fivecountries.

April 2022

Summary

The primary aim of this study is to continue previous analysis andprovide an up-to-date view on the cost and duration associated with thediscovery, development and authorisation of a new plant biotechnologyderived trait that has received cultivation approval in at least two
countries and import approvals from at least five countries.
The leading R&D-focused seed companies are being asked to participate
in a black box study by providing data via a questionnaire. The
questionnaire is separated into three sections: Cost, Time by Activity
Stage (non-consecutive) and Time by Activity Stage (consecutive).
Part 1: Cost – shows the level of expenditure in each of the activity stages.
Part 2: Time by Activity Stage (Non-Consecutive) – describes theincremental length of time required to complete each individual activity
stage, measured in months. As activity stages may occur simultaneously,
the sum total of time spent in each activity stage may be in excess of thetotal linear time.
Part 3: Time by Activity Stage (Consecutive) – describes the total(actual) length of time required to successfully bring a biotechnologyderived trait from discovery to commercialisation, measured in years andby crop.

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Summary
Continued

LaunchPrelunch

Early Development

Proof of Concept

Discovery

Advanced Development

Example of How Activity Stages May Be Segmented by Year

R&D
PhasesYears
for R&D

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Activity
Stages

Early Discovery
Late Discovery
Construct Optimisation
Commerical Event Production & Selection
Introgression, Breeding * Wide-Area Testing
Regulatory Science
Registration & Regulatory Affairs

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Appendix 2:
Questionnaire11

The data in this section will be
used to illustrate the level of
expenditure at each activity
stage as well as the total spenton bringing a biotechnologyderived trait from discovery tocommercialisation.

April 2022

QuestionnairePart 1: Cost
The data in this section will be used to illustrate the level of expenditureat each activity stage as well as the total spent on bringing abiotechnology-derived trait from discovery to commercialisation.
1. The event may be commercialised as a single trait or as part of a
stacked trait product.
2. Provide the compiled total expenditure to cover all costs associatedwith the activities defined in each activity stage.
3. If the compiled expenditure information spans two or more of theactivity stages, please provide the value and indicate the relevant
activity stages represented by the value given.
4. If unable to provide a single value investment estimate, please provide
a range where the total range is no more than 10% of the median of
the range.
5. Provide cost estimates on a fully loaded basis to include as many of
the following as possible:
a. R&D staff
b. General R&D operating costsc. External R&D collaboration, contract and testing costsd. Capital depreciation for the R&D facilities required to execute thework
e. R&D collaboration costs for any activity stages
f. Upfront payments and/or royalties for inward licensed events,
technologies or components specific to the trait
g. Costs to discover and develop promoters and selectable markers
used to generate the events (total if unique to the event or prorata if used for multiple events).

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April 2022

6. For e. and f. above, please allocate the costs to the activity stage(s) in

Questionnaire
Continued

which the comparable inhouse activity would normally take place.
7. Do not include the following costs:
a. Further discovery and development activities to generate backup genes and events represented in this study until the “winner”
reached the marketplaceb. Breeding and development costs for stacks containing the eventc. Costs for biotechnology affairs, government affairs, industry
affairs and public acceptance to enable the commercial launch ofa productd. Direct capital expenditures (capital represented on a depreciatedbasis; see #5d above)e. Commercial seed production costs
f. Amortisation of merger or acquisition costs
g. Post commercial launch development
h. Product monitoring and stewardshipi. Patent and litigation costs
j. Sales and marketing costs
8. Please indicate on the form the fully loaded basis for the costs you arereporting.
9. Provide costs in your local currency. This will be converted during theprocess.

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QuestionnairePart 2: Time by Activity Stage (Non-Consecutive)
The data provided in this section will be used to show how long it takes tocomplete each activity stage in isolation. The questionnaire asks for datafor biotechnology-derived traits commercialised in the five years between
2012 and 2017, as well as a comparable trait commercialised from 2017
to the present day.
Please provide an estimate for the length of time it took to complete eachactivity stage. When responding with data for the time period 2012–2017,
please use the same trait used in Part 1. Please provide duration inmonths.
For traits that have been discovered by another company and are now in†Same genetic event used when
responding in Part 1
Note: any inward licensed or
acquired event, please asterisk

possession either through inward licensing or as a result of acquisition,please complete the questionnaire by estimating when the trait enteredactivity stage 1. Any trait inward licensed or acquired, please asterisk.

Activity Stage

Duration of an event
commercialised

Duration of an event
commercialised

between 2012 & 2017†from 2017–present

1. Early Discovery
2. Late Discovery
3. Construct Optimisation
4. Commercial Event
Production & Selection
5. Introgression, Breeding &Wide-Area Testing
6. Regulatory Science
7. Registration & Regulatory
Affairs

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QuestionnairePart 3: Time by Activity Stage (Consecutive)
The data in this section will be used to show the total time taken to bringa biotechnology-derived trait from discovery to commercialisation.
As a result of the overlapping nature of the activity stages during
the R&D process, the total time taken to bring a trait from discovery
to commercialisation cannot be calculated from the data in Part 2.
Please estimate the total time taken to bring a trait from discovery tocommercialisation in years. For traits still in the research phase that arescheduled to be commercialised no later than 2022, please estimate
future time scales.
For traits that have been discovered by another company and are now inpossession either through inward licensing or as a result of acquisition,

Note: any inward licensed or
acquired event, please asterisk

Trait

Crop

please complete the questionnaire by estimating when the event enteredactivity stage 1. Any event inward licensed or acquired, please asterisk.

Month and Year of Startof Activity Stage 1

Month and Year of Commercialisation

1
2
3
4
5
6
7
8
9
10

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Disclaimer

12April 2022

Disclaimer

The information contained in this document constitutes our best
judgement at the time of publication and is subject to change
without notice.
No part of this document should be considered as advice or arecommendation to investors or potential investors.
Agbioinvestor and its owners, collaborating partners, agents andemployees cannot be held liable for the use of and reliance ofthe opinions, estimates, forecasts, findings or any other data inthis document.

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