Section. The Future of Pharma Outsourcing. June, Syndicated Publication

Transcription

1 The Future of Pharma Outsourcing Section Syndicated Publication June,

2 About the Author Life Science Strategy Group, LLC (LSSG) syndicated report authors draw upon extensive business, consulting and life science experience and backgrounds. Jon Meyer, MSc, MBA Mr. Meyer is a Founder and Principal Consultant with the Life Science Strategy Group, LLC (LSSG). With more than a decade of contract research services consulting experience, Mr. Meyer leads LSSG s contract research services consulting division which serves the leading global contract research organizations (CROs) across all phases of preclinical and clinical development including: Pre-clinical safety pharmacology, drug metabolism & bioanalytical services Non-clinical/GLP toxicology services Clinical development services (Phase I, II, III) Pre & post-approval services (Phase IIIb and IV) Clinical trial supply chain management and technologies (IVRS, IWRS, EDC) Chemistry, manufacturing and controls (CMC) services Large molecule & vaccines services Mr. Meyer has managed consulting engagements in a variety of commercialization and market research areas including strategic planning, opportunity assessments, pricing and reimbursement analyses, forecasting, competitive benchmarking, positioning and messaging strategy and clinical trial benchmarking and analysis. Prior to LSSG, Mr. Meyer was a Director in the Life Sciences Division at Navigant Consulting, Inc. and conducted preclinical drug development in the department of inflammatory disease at Roche Bioscience. Mr. Meyer holds Masters Degrees in Biomedical Science and Business Administration. Jon Meyer, MSc, MBA Founder & Principal Life Science Strategy Group, LLC 325 Sharon Park Drive, Suite 737 Menlo Park, CA jmeyer@lifesciencestrategy.com Tel: , Ext 82 Source: Life Science Strategy Group, LLC Life Science Strategy Group, LLC

3 Table of Contents I. Study Methodology and Respondent Demographics Page 4 II. Pharma / CRO Market Trends Page 6 III. Use of CROs Page 16 IV. Past and Future Service Delivery Page 35 V. Conclusions Page 42 VI. About LSSG and The OutsourcePharma Advisory Board Page 45 Source: Life Science Strategy Group, LLC 3

4 Study Methodology Methodology The primary research for this report was fielded during April and May, Study participants (100) work for biopharmaceutical companies in North America and Europe. All study participants draw from The OutsourcePharma Advisory Board ( and were prescreened by LSSG to ensure a high level of involvement and/or key decision-making authority for selecting an outsourcing partner for clinical development/trials. All data analysis and reporting was performed by LSSG. Respondent Location Company Size Western Europe 26% North America 74% Small Pharma 24% Midsized Pharma 23% Large Pharma 53% N=100 N=100 Source: Life Science Strategy Group, LLC 4

5 Pharma / CRO Market Trends TREND IMPACT Pharma under increasing Pharma leveraging. Shift in focus Clinical market.. Preferred Provider Lists.. Fewer, bigger. Greater use of.. Pharma passing. Large CROs gaining Mid-size CROs Niche Providers.. Niche providers need Source: Life Science Strategy Group, LLC; The OutsourcePharma Advisory Board 5

6 Outsourcing Penetration Large Pharma % Total Work Outsourced Phase I Phase II Phase III Phase IV In 2-3 In 5-10 In 2-3 In 5-10 In 2-3 In 5-10 In 2-3 In 5-10 N=53 Outsourcing penetration is expected... 6

7 Outsourcing Penetration Large Pharma Drivers for Change: More internal X and fewer Y Focus on We are moving more projects into xxx and there is more need for CRO services to support the project load. -NA, Large Pharma Need for. Greater flexibility offered through Increase in X, Y and Z at CRO We are cutting xxx by using fewer xxxx and outsourcing xxxx studies and other functional work. The move is driven by xxx and yyyyyy. -WE, Large Pharma 7

8 Offshoring Penetration Large Pharma 22% % Total Work Offshored Phase I Phase II Phase III Phase IV 19% Today In 2-3 Today In 2-3 Today In 2-3 Today In 2-3 N=53 Large Pharma clinical development offshoring should see YYY over the next 2-3 years. 8

9 Comments on Use of CROs Need access X, Y and Z of large CROs We need the X, Y and Z for risk-based monitoring. Y CROs cannot keep up X and Y. The big CROs are getting bigger and I expect to do X and Y as the larger CROs offer more end-to-end synergies across different phases and better Y that will keep me hostage to them. -NA, Large Pharma Use Y to avoid being lost among Large Pharma Our company tends to utilize mid-size CROs so that we are not lost amongst the larger pharma. - NA, Mid-Size Pharma Will use mix X and Y We already have established relationships with large CROs which will continue. Z areas that they cant handle will go to smaller and mid -sized CROs and to FSP providers for monitoring. - WE, Large Pharma 9

10 Relationship Models Small / Mid-Size Pharma % of Trials Today Next 2-3 Next 5-10 Fee-for-Service Functional Service Provider Preferred Provider Strategic Partnership N=47 X and Y will increasingly work with Z as preferred providers and strategic partners. 10

11 Strategic Partnership Utilization Large Pharma Strategic Partnerships with CROs Today 100% Number of Strategic Partnerships % of Respondents 80% 60% 40% 20% N=53 0% Next 2-3 Next 5-10 N=53 Most respondents state the number of strategic partnerships per Large Pharma company will. 11

12 Service Bundling Study Monitoring Study Site Recruiting/ Activation Project Management Study Feasibility Data Management Study Reporting Clinical Trial Technology Biostatistical Analysis Safety Large Pharma N=53 Small/Mid Pharma N=47 % of Respondents X, Y and Z are less frequently bundled by large pharma. 12

13 Niche Services Management Small / Mid-Size Pharma Sponsor Manages Niche Provider (TODAY) Main CRO Manages Niche Provider (TODAY) Sponsor Manages Niche Provider (NEXT 2-3 YRS) Main CRO Manages Niche Provider (NEXT 2-3 YRS) % of Respondents Central Lab X Y Z IVRS A B C N=47 Small / Mid-Size Pharma will also shift management X to Z. 13

14 Change in Oversight of CROs Large Pharma Early Stage (Phase II-IIa) Late Stage (Phase IIb-III) Post Approval (Phase IV) % of Respondents Next 2-3 Next 5-10 Next 2-3 Next 5-10 Next 2-3 Next 5-10 N=53 Large Pharma anticipates X and Y in the future when managing Z. 14

15 About Life Science Strategy Group, LLC Life Science Strategy Group, LLC (LSSG) is a life science consultancy specializing in strategic consulting, market research engagements and syndicated publications across a variety of therapeutic, technology and service markets. Our core leadership team brings more than 30 years of combined experience conducting strategic consulting engagements in the following areas: Pharmaceutical Biotechnology Medical Devices Contract Research Diagnostics Drug Discovery LSSG brings extensive breadth and depth of life science knowledge combined with seasoned consultants specializing in strategic and new product planning and commercialization strategy. We provide actionable and insightful strategic consulting results backed by data-driven market research. Solid, responsive, and dependable. That s why we work with LSSG." VP Business Intelligence, Global Top 5 CRO For more information on the Life Science Strategy Group s consulting and market research services, please contact us at info@lifesciencestrategy.com or call toll free at 1 (800) Life Science Strategy Group, LLC 325 Sharon Park Drive, Suite 737 Menlo Park, CA Confidential & Proprietary 15

16 About The OutsourcePharma Advisory Board The OutsourcePharma Advisory Board ( is the first and only sponsor-driven community that provides an open forum to discuss topics related to pharmaceutical discovery, preclinical and clinical development, registration, post-approval and manufacturing activities and outsourced vendor/cro services. The site also includes detailed Yelp-like reviews on CROs providing services to the biopharmaceutical industry. To learn more visit the website or contact: Jon Meyer, MSc, MBA Founder & Principal Life Science Strategy Group, LLC 325 Sharon Park Drive, Suite 737 Menlo Park, CA Tel: , Ext 82 Source: Life Science Strategy Group, LLC Life Science Strategy Group, LLC