Phase II/IIII Study Trends and Market Outlook (2016-2020)

PHASE II/III STUDY TRENDS AND MARKET OUTLOOK (2016-2020)

J U N E , 2 0 1 6

P R E V I E W O F

REPORT OVERVIEW

WHAT YOU WILL LEARN

How you can use this report

In much of our research, we make a point to ask respondents for their outlook on market changes or trends they expect to occur regarding a specific topic. To this end, ISR dedicated a research effort to providing a broad view into the industry’s perspectives on the clinical development market. For this report, 112 Phase II/III decision-makers were surveyed to gather their insights into where the Phase II/III market is expected to head over the next four years. This report is designed to assist those interested in the Phase II/III market in not only remaining current with market happenings but in getting a jump on what the market is expected to look like in 2020.

D A T A C O L L E C T I O N I N Q 2 , 2 0 1 6

2 0 - M I N U T E W E B - B A S E D

S U R V E Y

1 1 2 R E S P O N D E N T S F R O M U S , E U R O P E

A N D A S I A

74 PAGES

73 CHARTS AND

GRAPHS

VALUABLE FOR

MAJOR SECTIONS:1. Executive Summary

2. Market Dynamics

3. Provider Perceptions and Selection

4. Trends and Predictions

5. Respondent Demographics and Qualifications

• 4-year examination of the industry’s Phase II/III market dynamics (i.e. study volume, outsourced spend)

• Average dollar value of outsourced Phase II/III studies and how this varies by sponsor size

• Criteria sponsors use to select (and disqualify) clinical service providers

• Current and future use of adaptive trials and risk-based monitoring in Phase II/III trials

• Gain understanding of the key decision-makers within sponsor organizations to develop more targeted communications

• Learn the most desirable characteristics of a Phase II/III service provider

• Discover the expansion into developing markets

FOR PHARMA FOR AGENCIESUse the predictions of your peers to identify in what types of studies your competition is investing resources and understand how your company’s strategy compares to that of the industry.

Utilize this information to ensure your capabilities and capacity are in line with the study types and volume that will be needed in the near future.

Introduction

SMARTER QUESTIONS SMARTER ANSWERS

Full Table of Contents on next page.

MEDICAL DIRECTOR CLINICAL OPERATIONS

OUTSOURCING BUSINESS DEVELOPMENT

PROCUREMENT SERVICE PROVIDER MARKETING

PROJECT MANAGERS RESEARCH & DEVELOPMENT

Introduction


TABLE OF CONTENTS

FOR FULL TABLE OF CONTENTS, PLEASE DOWNLOAD THE FULL PREVIEW AT:

HTTPS://WWW.ISRREPORTS.COM/REPORTS/PHASE-IIIII-STUDY-TRENDS-AND-MARKET-OUTLOOK/

Introduction


Introduction

EXECUTIVE SUMMARY

Phase II/III Study Trends and Market Outlook (2016-2020) 10www.ISRreports.com ©2016

On average, respondents from both large and non-large sponsors expect modest increases by 2020 in the already significant percent of Phase II/III studies that are outsourced� Smaller sponsors outsource more of their clinical work than larger sponsors and foresee this trend continuing in the coming years� Smaller sponsors generally have less internal capability and fewer resources than larger sponsors, thus the increased need for externally sourced capacity�

“What percent of your company’s spend on Phase II/III studies has been outsourced over the last 12 months?”

“What percent of your company’s spend on Phase II/III studies would you estimate will be outsourced in 2020?”

Outsourced proportion of Phase II/III spend

PHASE II/III STUDY TRENDS AND MARKET OUTLOOK (2016-2020) 10

Outsourced proportion of Phase II/III spend On average, respondents from both large and non-large sponsors expect modest increases by 2020 in the already significant percent of Phase II/III studies that are outsourced. Smaller sponsors outsource more of their clinical work than larger sponsors and foresee this trend continuing in the coming years. Smaller sponsors generally have less internal capability and fewer resources than larger sponsors, thus the increased need for external outsourced capacity.



*Respondents unable to estimate have been excluded

88%

73%

83%

67%

0% 100%

Non-large Sponsors (R&D<$500M) (n=32*)

Large Sponsors (R&D$500M+) (n=76*)

20% 40% 60% 80%

Average % of Phase II/III Spend that is Outsourced

Past 12 months

In 2020

*Outliers and respondents unable to estimate have been excluded

© Industry Standard Research

S A M P L E P A G E :

OUTSOURCED PROPORTION OF PHASE II/III SPENDThis report provides both sponsors and service providers with insight into where the Phase II/III market currently is and where it is expected to head over the next four years.

C L O S E R L O O K

<< Non-large Sponsors outsourced an average of 83% of their Phase II/III spend.

Data available in the full report, which can be found at:

www.ISRreports.com

Introduction

EXECUTIVE SUMMARY


On average, respondents from both large and non-large sponsors expect modest increases by 2020 in the already significant percent of Phase II/III studies that are outsourced� Smaller sponsors outsource more of their clinical work than larger sponsors and foresee this trend continuing in the coming years� Smaller sponsors generally have less internal capability and fewer resources than larger sponsors, thus the increased need for externally sourced capacity�



Outsourced proportion of Phase II/III spend


Outsourced proportion of Phase II/III spend On average, respondents from both large and non-large sponsors expect modest increases by 2020 in the already significant percent of Phase II/III studies that are outsourced. Smaller sponsors outsource more of their clinical work than larger sponsors and foresee this trend continuing in the coming years. Smaller sponsors generally have less internal capability and fewer resources than larger sponsors, thus the increased need for external outsourced capacity.



*Respondents unable to estimate have been excluded

88%

73%

83%

67%

0% 100%

Non-large Sponsors (R&D<$500M) (n=32*)

Large Sponsors (R&D$500M+) (n=76*)

20% 40% 60% 80%

Average % of Phase II/III Spend that is Outsourced

Past 12 months

In 2020

*Outliers and respondents unable to estimate have been excluded


D A T A I N F U L L R E P O R T

D A T A I N F U L L R E P O R T

Introduction


Introduction

EXECUTIVE SUMMARY


Desired provider characteristics

If put in charge of starting up a Phase II/III service provider, almost half of respondents would make sure that their Phase II/III service provider excelled at Therapeutic expertise/experience� Customer service/communication is also considered an important provider attribute�

“If you were in charge of starting up a Phase II/III service provider, what attributes would you make sure your company excelled at? Provide up to three responses.” (n=112)


Desired provider characteristics If put in charge of starting up a Phase II/III service provider, almost half of respondents would make sure that their Phase II/III service provider excelled at Therapeutic expertise/experience. Customer service/communication is also considered an important provider attribute.

“If you were in charge of starting up a Phase II/III service provider, what attributes would you make sure your company excelled at? Provide up to three responses.” (n=112)

Sample verbatim responses - “Therapeutic expertise; both state of the art and well-revered medical monitoring

equipment” - “Good communication with all the involved stakeholders: always involve the company

personnel” - “Right balance of cost and quality”- “Good project managers, staff retention, proven track record”- “Superior customer service/reliability”

3%

4%

6%

7%

8%

9%

12%

13%

13%

17%

18%

25%

34%

35%

38%

47%

0% 20% 40% 60%

Reliability

Flexible

Global/broad reach

Technology focus/expertise

Regulatory knowledge

Track record/reputation

Broad range of services

Innovative

Other

Speed/proactivity

Quality/data quality

Good value/low cost

Patient access/recruitment

Strong project management and staff capabilities

Therapeutic expertise/experience

Customer service/communication

% of Respondents

SAMPLE VERBATIM RESPONSES“Therapeutic expertise; both state of the art and well-revered medical monitoring equipment”

“Good communication with all the involved stakeholders: always involve the company personnel”

“Right balance of cost and quality”

“Good project managers, staff retention, proven track record”

“Superior customer service/reliability”


S A M P L E P A G E :

DESIRED PROVIDER CHARACTERISTICSThis page shows what attributes the respondents would be sure their Phase II/III service provider excelled at if they were in charge of starting their own CRO.

The full data is available in the report, which can be downloaded from www.ISRreports.com.

Introduction


FOR ADDITIONAL SAMPLE PAGES, PLEASE DOWNLOAD THE FULL PREVIEW AT:


Introduction


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Clinical Trial Recruitment &

Retention

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ANALYSTS

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professionals, with nearly 1,500 members worldwide.

BYJOB

LEVEL

Director 46%

Manager 29%

C-level 13%

VP 10%

BYEXPERIENCE

IN YEARS

16-20 years 23%

11-15 years 24%

6-10 years 11%

3-5 years 5%

20+ years 37%

BYCOMPANY

TYPE

Other 6%

Sponsor 78%

CRO 6%

ResearchSite 10%

Phase II/IIII Study Trends and Market Outlook (2016-2020)

Health & Medicine

Transcript of Phase II/IIII Study Trends and Market Outlook (2016-2020)