Market Report Source

Overview

In Vitro Diagnostics explores the challenges faced by diagnostic companies as they bring new IVD products to market. The report provides high-level benchmarking of investments, timelines, structures and processes for diagnostics teams seeking real-world information about their industry.

STRATEGY. Tap into winning practices and insights from several medical device and biotechnology firms. Learn how companies assemble project teams, fund marketing and organize sales forces. Find out how to win deeper budgets and more staffing for your team while building a commercially focused structure and culture.

SUPPORT. Compare real-world structures and budgets for critical tasks at the center of IVD development and marketing. Our report provides support for your ideas and helps you prepare for meetings, presentations and strategy discussions with key executives. Learn how great companies such as Millipore, Medtronic, and LifeScan approach IVD product development and commercialization.

SUCCESS. Our reports are ready to use the moment you get them. Skim chapter introductions and subsections to review critical concepts. Then read case studies, data analyses, and strategic assessments to gather the details you need to refine and evaluate your IVD product management structure and strategy. Throughout the report, extensive metrics and qualitative analyses offer in-depth evidence to support your efforts.

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

In Vitro Diagnostics contains more than 300 metrics and 50 charts and graphics. Included among the metrics are:

• Benchmark profiles of 10 different diagnostic products, including budget and staffing data for development, marketing, sales, reimbursement and postmarket monitoring
• Timelines of different IVD product stages, including concept and prototype development, early-planning and pre-clinical work, clinical studies, and the period encompassing approval, manufacturing and the first two years on the market
• Timing for the assembling of initial commercial teams during product development
• IVD marketing budgets from early development through launch and commercial use
• R&D and manufacturing costs compared to marketing investments and peak annual sales projections
• Investments in postmarket monitoring
• Staff headcounts for commercial teams and R&D and manufacturing groups throughout IVD development and marketing
• Reimbursement budgets and staffing headcounts
• Field sales budgets and sales rep headcounts

Sample Content
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.

Companies Included in Report
Aqueous Biomedical
Athena Diagnostics
BioVeritas
GeneExcel
Incite World
LifeScan
Medtronic
Millipore
Urobiologics
A Project Management Consultant
A Medical Technology Law Firm
An IVD Product Consultant
TEC Edmonton

Table of Contents

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.

Executive Summary
Marketing Investments by Timeframe: Investments Under $1 Million
Marketing Investments by Timeframe: Investments of $1 Million or Greater
Marketing Investment and Sales Projections

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