What it Takes to Successfully Launch an Oncology Product in the U.S. Marketplace

Also, organizations often pursue a second indication for the same oncology product in order to not only expand a product's patient base but also to leverage savings on launch investment by using infrastructure and resources from the first indication launch.

Best Practices, LLC undertook benchmarking research to inform oncology launch teams with evidence-based benchmarks around investment, staffing and timing requirements to successfully launch new oncology drugs in the U.S. market.

In particular, the report benchmarks investment levels at each launch stage as well as budget and staffing allocation across critical Medical and Commercial activities for various market-entry situations or market-entry archetypes: portfolios featuring multiple molecules which treat single or multiple indications, and portfolios using single molecules to treat individual cancer types. It also probes key U.S. oncology market-entry trends and success factors and explores the synergy or franchise effects where multiple oncology products and indications create lift through shared infrastructure.

Industries Profiled:
Pharmaceutical; Manufacturing; Biotech; Consumer Products; Diagnostic; Medical Device; Biopharmaceutical; Health Care


Companies Profiled:
Astellas; Bayer; EMD Serono; Lilly; Medivation; Nektar Therapeutics; Novartis; OTSUKA; Pfizer; Regeneron; Tesaro; Amgen

Study Snapshot

This research probes oncology product investment levels for 12 companies and 20 U.S. project launches across pre-launch, launch and post-launch periods to inform U.S. Oncology Launch teams in each of the following key intelligence areas:


I. Peak Year Sales Forecasting

• Overall Investment and Staffing Drivers
• ROI Indicators
• Launch Investment & Staffing

• Allocation to Critical Medical & Commercial Activities by Year
• Allocation to Critical Activities by Year (according to Peak Year Sales Forecast)

• Synergies for Launching New Indications and Changing Indications over Time
• Top Cost Savings and Staffing Savings Areas

Key Findings

• Year -2

  Medical Affairs consume three times as many FTE resources as marketing in Year -2. In fact, Medical Affairs is the largest staffing category in that timeframe. Medical Affairs adds staff starting from Year -3 and drastically increases personnel in Year -1.
  
  

• Year -1

  Market access spending jumps significantly (up to the 4^th highest spend area) during Year -1.
  
  

• Launch Year

  Sales, medical affairs, and managed markets staff all jump up in Launch Year. One year post-launch, sales and managed markets staffing levels peak. Brand-specific marketing FTEs increase steadily, peaking during the Launch Year.

I.	Benchmark Study Background	pgs. 3-8
II.	Key Trends and Market Patterns	pgs. 9-11
III.	Key Findings	pgs. 12-16
IV.	Total Investment & Staffing Benchmarks Segmented by Peak Year Sales Forecast	pgs. 17-21
V.	Staffing and Investment Benchmark Analysis for Launch Activities	pgs. 22-30
VI.	Franchise Leverage or Synergy	pgs. 31-35
VII.	U.S. Oncology Market-Entry Trends & Success Factors	pgs. 36-40
VIII.	Total Benchmark Class Launch Data & Analysis	pgs. 41-74
	Total Launch Investment (Summing Year -3 to +3)	pgs. 42-48
	Launch Investment by Year	pgs. 49-55
	Launch Investment by Activity	pgs. 56-63
	Launch Staffing by Year	pgs. 64-74
IX.	Line Extension Data & Analysis	pgs. 75-134
	1st to 2nd Launch Investment Leverage	pgs. 76-82
	1st to 2nd Launch Staffing Leverage	pgs. 83-87
	1st to 2nd Launch Tactical Comparison	pgs. 88-96
	First Launch Drilldown (Multi-Indication Brands)	pgs. 97-112
	Second Launch Drilldown (Multi-Indication Brands)	pgs. 113-119
	First Launch Drilldown (Recent launches with no 2nd Launch as of 2017)	pgs. 120-134
X.	Single-Indication Brands	pgs. 135-147
XI.	About Best Practices, LLC	pg. 148

• Total spending for each year during product launch
• Total spending for each year during product launch - segmented by product’s pre-launch peak year sales forecast
• Total staffing for each year during product launch
• Total staffing for each year during product launch - segmented by product’s pre-launch peak year sales forecast
  

• Staffing allocation for a single indication by year
• Key FTE growth drivers
• Launch investment allocation (mean) by activity for all years – total benchmark class, lower-PYSF oncology products (PYSF <$750 Million) and high-PYSF oncology products (PYSF $750 Million - $2 Billion)
• FTE allocation (mean) by activity for all years– total benchmark class, lower-PYSF oncology products (PYSF <$750 Million) and high-PYSF oncology products (PYSF $750 Million - $2 Billion)
  

• FTE savings and cost savings via portfolio leverage from first launched indication to second launched indication
• Total spend in USD by year – market entry segmented by first and second indications launched
  

• Spending allocated to different activities during year -3
• Types of oncologists targeted for first and second launches
• Roles (lead, support, no role) played by different teams in setting product strategy
• Structure of brand teams associated with multiple indications/molecules
  

• Total spend in USD for all the oncology products launched (aggregation of year -3 to +3) - by portfolio therapy area, by launch era, by market-entry scenario and by target physician type
• Total spend in USD for the oncology products launched - aggregation of year -3 to +3 for co-promoted products
• Best practices and common pitfalls for developing and promoting Oncology products with a partner company
  

• Total spending for each year during product launch (year -3 to year +3)
• Launch investment level by year - portfolio therapy area, launch era, market-entry scenario and target oncologist type
  

• Investment allocation by activity for year –3, year –2, year –1, launch year, year +1, year +2 and year +3
  

• Staffing allocation by activity for year –3, year –2, year –1, launch year and year +1
• Staffing trend: Number of Medical Affairs/MSLs, Managed Markets FTEs (dedicated to portfolio), Brand-Specific Marketing FTEs, Market Research/Analytics FTEs, Managed Markets FTEs (dedicated to brand) allocated during year –3, year –2, year –1 and launch year
  

• First launch investment allocation for different activities during year -3, year –2, year –1 and launch year
• Second launch investment allocation for different activities during year –1 and launch year
  

• For the first molecule/indication launched, number of staff members allocated to different activities during year -1 and launch year
• For the second molecule / indication launched, number of staff members allocated to different activities during year -1 and launch year
  

• Distribution methods for the first and second launch
• Product market entry type for the first and second launch
• Year in which first project was launched or is expected to launch if not yet on the market
• Pre-launch peak annual revenue projection (in USD) for the first and second projects
• Performance of first and second launches relative to participating company's annual targets during the launch year and three years post launch
• Post-launch peak annual revenue for the first project
• Peak year adjustment for the first launch
• Whether first and second launches were co-promoted with a partner or not?
  

• Number of multiple indications/molecules launched by participating companies
• Structure of the brand team associated with multiple indications/molecules treating the same or multiple types of cancers
• Distribution methods for the first indication/molecule
• Product market entry type for the first indication/molecule
• Types of oncologists targeted for the first indications/molecules
• Year in which first indication/molecule was launched or is expected to launch if not yet on the market
• Pre-launch and post-launch peak annual revenue projection for the first indication/molecule
• Performance of first indication/molecule relative to participating company's annual targets during the launch year and three years post launch
• Peak year adjustment for the first indication/ molecule's life cycle
• Total investment (aggregation of year -3 to year +3) in first indication/molecule
• Amount of first indication/molecule's launch year –3 and year -1 budget allocated to different activities
• Cost savings areas via existing infrastructure and resources from the first indication/molecule that could be utilized for later indication/molecule launches
• During Launch Year - 1, how many
• Staffing allocation during year -1 for the first indication/molecule by activity type
• Top staffing leverage areas from the first indication/molecule that could be utilized for later indication/molecule launches
  

• Distribution methods for the second indication/molecule
• Types of oncologists targeted for the second indication/molecule
• Pre-launch peak annual revenue projection (in USD) for the second indication/molecule
• Post-launch peak annual revenue during the second indication/molecule's life cycle
• Total spend in USD (aggregation of year -3 to year +3) for the second indication/molecule
• Amount of second indication/molecule's launch year –1 and launch year budget allocated to different activities
  

• Multiple indication count for single-molecule brand
• First indication distribution method
• Impact of the distribution methods used for the first indication on subsequent molecule launches, if any
• Product market entry type for the first indication
• Year in which first indication was launched or is expected to launch if not yet on the market
• Pre-launch peak annual revenue projection (in USD) for the first indication/molecule
• Post-launch peak annual revenue during the first indication's life cycle
• Whether first indication was co-promoted with a partner or not?
• Total spend in USD for the first brand indication
• First indication's year -1, launch year and year +3 budget
• First indication's year -1 and year +3 budget allocated to different activities
• Cost savings areas via portfolio leverage for later indications
• Total staffing for launch year and year -1 for the first indication
• Staffing allocation by activity for year -1 for first indication
• Top staffing leverage areas for later-indication launches
  

• Product market entry profile for single-indication brands
• Types of oncologists targeted for the marketed indication/molecule
• Launch year of the single-indication/molecule
• Projected pre-launch peak annual revenue (in USD) for the indication/molecule
• Total estimated spend (in USD) for the single-indication product
• Total estimated spend (in USD) for the single-indication brand by year
• Single-indication brand’s year -3, year -2, year -1 and launch year budget allocated to different activities
• Total staffing for single-indication brand in year -3, year -2, year -1 and launch year
• Staffing allocation for single-indication brand for different activities across years