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In Vitro Diagnostics: Development Through Postmarket


Description: Make the most of limited resources by benchmarking IVDs' budgets and staff support for development, marketing, reimbursement and sales.

To achieve commercial success, in vitro diagnostic (IVD) companies must earn the approval of several different groups. Regulators, payer organizations, healthcare providers and laboratory technicians ultimately determine the value of a product -- and how well it will do in the market. For that reason, strategic market-focused product development and effective commercialization are crucial.


Slim margins and tight budgets, however, make it a formidable task to design and promote an IVD with a clear picture of the market. To help teams achieve success in their IVD development and marketing efforts, this report provides high-level data benchmarks in these key areas:

-IVD development investments, timelines and processes
-Marketing organization budgets, structures and staffing
-Reimbursement resource allocations
-Sales force staff headcounts and budgeting
-Postmarket IVD management and monitoring


Sample Content:

(Excerpted from Chapter 2: Diagnostic Product Development)

Duration of Development Stages
It is impossible to present a standard benchmark for the amount of time it takes to develop diagnostics products. While the evolution of some products takes more than 10 years, other IVDs fly through development and hit the market in less than three years.

These large variations are present in the data collected for this study, as shown in Figure 2.4 [data figures appear in complete report, but not online]. Total development time from concept to market launch range from Brand 1’s 15 years to Brand 4’s 14 months. The average development time across surveyed companies is slightly more than four years from concept to launch.

IVD development time depends largely on where companies “jump off” with their new products. While some companies’ products are brand new technologies, other diagnostics are conjugations of existing products and technologies. Usually, developing an entirely new diagnostic requires significantly more time than improving on an existing product line. Engineering, regulatory, and marketing hurdles are all lower for IVD conjugations.


Contents: Charts and Graphics
The list below reveals the key metrics included in In Vitro Diagnostics: Development Through Postmarket. It does not include all of the data within the report -- instead, it lists the main categories and types of data in each chapter.

Chapter 1: Trends in IVD Product Investment
- Total Investment and Development Time
- Marketing Investment and Development Time
- Projected Market Life
- Marketing Investment and Sales Projections
- Product Staffing: Total Headcount
- Introducing the Commercial Team

Chapter 2: Diagnostic Product Development
- R&D and Manufacturing Costs by Timeframe
- Average R&D and Manufacturing Costs by Timeframe
- Product Staffing: R&D Group Headcount
- Duration of Development Stages

Chapter 3: Diagnostic Marketing and Commercialization
- Introducing the Commercial Team
- Marketing Investments by Timeframe: Investments Under $1 Million
- Marketing Investments by Timeframe: Investments of $1 Million or Greater
- Average Marketing Investments by Timeframe
- Brand Competition Levels at Product Launch
- Product Staffing: Commercial Group Headcount
- Budgets and Staff Support for Reimbursement Teams: Pre-Market Period
- Budgets and Staff Support for Reimbursement Teams: First Year on Market
- Budgets and Staff Support for Reimbursement Teams: Second Year on Market
- Reimbursement Staffing and Investments, by Timeframe

Chapter 4: Field Sales and Postmarket Management
- Sales Team Headcounts: In-House and Contract Personnel
- Investments in Field-Based Promotion, by Year on Market
- Investments in Postmarket Monitoring, as a Share of Annual Sales

Chapter 5: Diagnostic Product Profiles
Chapter 5 contains 10 individual IVD brand profiles, which include the following basic elements:

Product Facts
- Product Details: establishes the brand’s therapeutic area and regulatory background
- Product Lifecycle: provides timelines for product development and market life

Development and Commercialization Resources
- Product Budget: Budget levels for marketing and R&D and manufacturing from early development through the second year on the market
- Product Staffing: Staffing headcounts throughout development and the first year on the market

Figure Three: Reimbursement and Sales Resources
- Reimbursement Resources: Budget and staffing levels for reimbursement efforts
- Sales Resources: Budget and staffing levels for sales efforts


Companies Mentioned Aqueous Biomedical Athena Diagnostics BioVeritas GeneExcel Incite World LifeScan Medtronic Millipore Urobiologics TEC Edmonton


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