Winning Necessary Resources for a Successful Product Launch

To support new product launch investment decision making at pharmaceutical and biotechnology companies, Best Practices, LLC undertook this research, which benchmarks the total investment for launch activities during the four budget years leading up to launch. This report will support brand and marketing leaders in developing optimal total resourcing plans and fund allocations for their new brands based on Peak-Year Sales Forecast, Market Archetype, Product Type, and Physician Type. The report also highlights the top success factors for effective product launches in the current healthcare environment.

Brand and marketing leaders can refer to this report to develop competitive launch and pre-launch activity budgets to ensure successful U.S. market entry for their new products.

Study Snapshot

Best Practices, LLC engaged 48 marketing and commercial leaders from 38 leading pharmaceutical, biotech, and life sciences companies through a benchmarking survey instrument, capturing resourcing efforts from 51 product launches. More than 80% of the benchmark participants serve at the director level and above.

Key topics covered in this report include:

• Industry investments for new pharmaceutical product launch from 3 years prior to launch, through launch year
• Budget allocation to 12 key marketing, education and market access activities during and prior to launch
• Investment timing for conducting 50+ activities
• FTE allocated to key launch activities
• Anticipated budget & activity trends
• Top three success factors

• Early investment (Year – 3 & Year – 2) is less than 1/4th of total spend for all 4 years. Resource needs make their largest leap going into Year – 1, while Launch year investment growth is driven by new commercial demands.
  
  
• In terms of the launch activities, Market Research is an early investment focus for benchmark participants, trailing off as launch approaches. Medical Affairs, Physician Education, and Agency Fees are staples across the launch timeline.
  
  
• Many approaches exist to segmenting market types. The Asset Development process focuses on existing Therapeutic Area knowledge, Market Size and Competitiveness. Best-in-class market planners develop their strategies, tactics, budgets and programs to reflect their specific market-entry archetype.

Sr. No.	Topic	Slide No.
I.	Research Objectives & Methodology	pp. 3
II.	Universe of Learning	pp. 4
III.	Executive Summary	pp. 5-14
IV.	Launch Investment Benchmarks	pp. 15-25
	Total Product Launch Investment By Year	pp. 16-25
V.	Launch Activities	pp. 26-38
VI.	Launch Staffing Benchmarks	pp. 39-44
VII.	The Influence of Market Archetypes on Launch Resourcing	pp. 45-67
VIII.	Launch Activities Timing	pp. 68-80
IX.	Benchmark Profile	pp. 81-85
X.	APPENDIX 1: Total Launch Investment Benchmarks	pp. 86-116
XI.	APPENDIX 2: Launch Investment Benchmarks Across Launch Activities	pp. 117-143
XII.	APPENDIX 3: Launch Staffing Benchmarks	pp. 144-166
XIII.	About Best Practices, LLC	pp. 167

• Optimal launch resource planning feeds forward to maximize the uptake curve
• Year-over-year growth in total launch spending
• Using peak year sales forecast (PYSF) multiplier to build baseline expectations of commercial and medical launch resource plan
• Key diagnostic questions to be asked when greatly exceeding or falling short of investment benchmarks for yearly spend/$1M in PYSF
• Guarding against underserving critical areas and optimizing the launch approach
• Proportional distribution of activity investment by year
• Product position relative to market potential and competition
• Best-in-class resourcing reflecting archetype factors

• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch (Includes all resources invested in promotional, educational & market-access activities. Excludes only clinical trial costs.)
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Year-to-year growth in spending
• Total U.S. investment for the product in the three years prior to the U.S. product launch and the launch year – by PYSF
• Using PYSF multiplier to gauge the product’s total commercial and medical investment by year
• Key diagnostic questions to be asked when greatly exceeding or falling short of investment benchmarks for yearly spend/$1M in PYSF
• Total year – 3 investment distribution by PYSF
• Total year – 2 investment distribution by PYSF
• Total year – 1 investment distribution by PYSF
• Total launch year investment distribution by PYSF

• Average percent of total launch investment directed to the activity area per year - Market Research/ Analytics (ex-DTC), Medical Affairs/Medical Education, Physician Education/Market Shaping, and Agency Fees - excluding DTC
• Average percent of total launch investment directed to the activity area per year - Health Economics/ Outcomes Research, Managed Markets/ Market Access, Patient Education/ Assistance, and Sales Force Preparation
• Proportional distribution of activity investment by year
• Using PYSF resource levels with activity distributions to guard against underserving critical areas and optimize the launch approach
• Investment allocation distribution by activity category (year – 3, year – 2)
• Investment allocation distribution by activity category (year – 1, launch year)
• Year-over-year percent change of launch activity investment
• Activity funding in a changing market
• Year - 3’s investment focus on the following activity categories - (1) Market Research, (2) Medical Affairs, (3) Physician Education, and (4) HEOR
• Year - 2’s investment focus on the following activity categories - (1) Market Research, (2) Medical Affairs, (3) Agency Fees, and (4) Market Access
• Year - 1’s investment focus on the following activity categories - (1) Physician Education, (2) Medical Affairs, (3) Market Research, and Agency Fees

• Total U.S. staffing investment for pre-launch activities for the product in the three years prior to the U.S. product launch (Includes all resources invested in promotional, educational & market-access activities. Excludes only clinical trial costs.) - Quartile breakout
• Cumulative launch staffing (in full time equivalents) by year
• Utilizing the PYSF staffing-multiplier to build the base of commercial and medical launch staffing plan by year
• FTE allocation by function category (year - 3, year - 2)
• FTE allocation by function category (year-1, launch year)

• Product position relative to market potential & competition
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch (Includes all resources invested in promotional, educational & market-access activities. Excludes only clinical trial costs.) - Differentiated product entering established market (in $M)
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch (Includes all resources invested in promotional, educational & market-access activities. Excludes only clinical trial costs.) - Differentiated product entering established market: Market entry position: Archetypes C&F
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product entering established market: By launch activity category
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product entering established market (launch year - 3 & launch year – 2) – By activity category
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product entering established market (launch year - 1 & launch year) – By activity category
• Total U.S. FTE investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product entering established market (launch year - 3 & launch year – 2) – By activity category
• Total U.S. FTE investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product entering established market (launch year - 1 & launch year) – By activity category
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product in novel treatment area (in $ M)
• Total launch investment for differentiated products in novel treatment areas - Market entry position: Archetypes A & D
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product in novel treatment area: By launch activity category
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product in novel treatment area (launch year - 3 & launch year – 2) – By activity category
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product in novel treatment area (launch year - 1 & launch year) – By activity category
• Total U.S. FTE investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Differentiated product in novel treatment area (launch year - 1 & launch year) – By activity category
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch (Includes all resources invested in promotional, educational & market-access activities. Excludes only clinical trial costs.) - Upstart product entering a crowded market (in $M)
• Total launch investment by product position at market entry - Crowded-market upstart product: Market entry position: Archetypes A & D
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Upstart product entering a crowded market : By launch activity category
• Total U.S. investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Crowded-market upstart product (launch year - 1 & launch year) – By activity category
• Total U.S. FTE investment for pre-launch activities for the product in the three years prior to the U.S. product launch - Crowded-market upstart product (launch year - 1 & launch year) – By activity category

• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Agency fees (excluding DTC)
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Direct-to-consumer expenses
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Health Economics/ Outcomes Research
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Managed Markets/ Market Access
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Market Research/ Analytics (excluding DTC)
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Medical Affairs/Medical Education
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Physician Education/Market Shaping
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Patient Education/ Assistance
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Physician Education/Market Shaping
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Sales Force Preparation
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - All other activities
• Activities that were included in the product's year -3, year -2, year -1 and launch year budgets - Launch Meeting (Kickoff)

• Benchmark participants’ job titles and departments/functions
• Benchmark participants’ product performance relative to their company’s annual targets during the launch year and afterward
• Product distribution method
• Peak annual revenue projection for their product before launch