A lot of our focus in previous blogs has been on how to best negotiate regulatory hurdles to get your product approved as quickly and cheaply as possible, and how to differentiate your product from the marketed products.
And as we have previously blogged, to get a successful return on investment (ROI) for your product, it is essential to establish early in the process:
- Is there an unmet need for the product?
- Which attributes will the product need to access the market?
- Will providers and patients be receptive to the product?
- Will payers reimburse the product at a reasonable price?
- What is the potential revenue opportunity over time?
This initial market assessment is especially important for 505(b)(2) developers who need to balance the rapid development program characteristic of 505(b)(2) approvals with data collection that payers and providers will need to displace existing therapies.
Easier said than done? Given the number of products that fail to reach their potential, this step can prove elusive to many, or may be performed too late in product development.
So What Does a Potential Sponsor Need to Know?
A detailed knowledge of the therapeutic area, of other pipeline and approved products in the space, and access to Key Opinion Leaders (KOLs) and payers is essential to determining how your product will fit into the market. While larger companies with robust R&D and marketing departments have access to some of this data for several selected therapeutic areas, mid-tier and smaller companies struggle to gain detailed insights into more than one therapeutic area. Companies of all sizes often lack the expertise to fully explore the opportunities and challenges that a 505(b)(2) product will face in the market and which product attributes will need to demonstrated to access the market.
Camargo’s Market Assessment Offering
As true believers in gaining as much knowledge about a product and its market as early as possible, Camargo has been providing Market Assessment services for our clients for years. Out of a need to reduce product failures through early intervention, and due to increasing demand from Sponsors, we have recently expanded this service into a more comprehensive offering.
As part of the Camargo Market Assessment, our team of regulatory scientists and commercial specialists perform a full evaluation of the therapeutic area and target population. Our team utilizes public and proprietary sources to build a thorough understanding of the epidemiology, current standards of care, treatment patterns, and patient journey to determine the unmet need and therapeutic options at each step. A market and regulatory evaluation is undertaken to assess the approved and pipeline products and how the proposed product would compete. Input from key opinion leaders is sought to validate key market dynamics and gather initial feedback on the proposed product concept.
Finally, a Product Concept Summary, similar to a preliminary Target Product Profile (TPP), and an evaluation of the current reimbursement landscape for the product based on payer reaction to the TPP is provided. Followers of our blog won’t be surprised to learn that the TPP is included as part of our Market Assessment offering. As we have previously mentioned (here and here), the TPP is a critical planning and strategy document that should accompany any development program from the start. The Product Concept evaluation contains a Strengths, Weaknesses, Opportunities, and Threats (SWOT) assessment, and a commercial opportunity estimate.
The real benefit of the Market Assessment is that the results of our evaluations are concise, delivered in plain English, and presented to all appropriate management and board members. The key findings are clearly explained without the need for a lengthy report full of jargon. We believe being thorough, clear, and concise is the best way to get the important messages across.
When Should the Market Assessment be Performed?
Ideally, the market assessment should be performed as early as possible in a product’s development. This will ensure that the development program is designed not just for regulatory approval, but to maximize uptake by payers and providers. That’s why Camargo offers the Market Assessment as a highly recommended add-on to our regulatory Strategic Assessment and Pre-IND meeting preparation services.
Camargo welcomes the opportunity to evaluate the market for your product. Let our experience in market opportunities and key success factors guide your product development decisions. Contact us to discuss how we can help.
Angela Drew, PhD, Product Ideation Consultant, Camargo Pharmaceutical Services
Jennie Orr, Vice President of Product Strategy, Camargo Pharmaceutical Services