Strategizing New Drug Development Pathways

Project Title: Strategizing New Drug Development Pathways

Client:  Top 30 Global Pharmaceutical Company

Description:

Our Client was a potential new entrant in the therapeutics market for Non-Hodgkin’s Lymphoma. VOI was given the task of conducting strategic analysis and providing a competitive landscape for optimal product development.

VOI executed a complete assessment using primary and secondary market research tools. We developed market forecasts and financial models to estimate efficient product development. Some of the major findings of the study were identification of market drivers, market gaps, treatment algorithms, assessment of revenues, pricing strategies and potential marketing expenses.

Results:

Our Client adopted the product development pathway suggested by VOI to effectively direct their resources in the identified market segment.

 

Project Title: Rx-to-OTC Switch Strategic Analysis

Client:  Worldwide leader in supplying drug delivery systems.

Description:

Our Client was facing the challenge of impending patent expiration and therefore sought the expertise of VOI Consulting to identify potential implications and hurdles of Rx-to-OTC transition. VOI was needed to conduct extensive market analysis of the OTC segment specific to their product.

VOI started its examination using secondary market research activities and developed a broad competitive analysis. We also assessed various regulatory and economic hurdles associated with Rx-to-OTC switch. Based on these studies VOI formulated a number of probable scenarios. Forecast models were developed for each scenario, which were flexible to accommodate changes in future market trends and regulations.

Results:

 

Project Title: Post-Exclusivity Strategic Analysis

Client: Top 10 Biopharmaceutical Company

Description:

Like any product losing exclusivity, our Client’s drug faces an imminent challenging post-exclusivity environment. VOI was approached to develop a comprehensive strategy for maximizing the drug’s profits and hence successfully tackle the changing commercial market of the drug. In phase I of the project VOI conducted analytical market studies. A variety of strategic options were explored to understand their potential to maximize drug’s post-exclusivity sales potential. High-level strategic recommendations were made based on the outcome of this analysis. In phase II, these options were fully developed into an executable strategic plan. A risk-modeling forecasting approach was employed to fully identify the costs and benefits of each approach as well as their probabilities of success.

Results: 

Strategy developed by VOI is in execution by the Client.

 

Project Title: Strategic Planning to Sustain Profits against Generic Competition

Client: Renowned pharmaceutical company

Description:

Our Client faced an imminent threat from generic competition and wished to explore and ultimately pursue options for preserving the product’s revenue and profit streams in this commercially challenging environment. VOI segmented the project into two phases. Phase I involved identifying, developing and exploring a number of strategic alternatives with detailed cost/benefit framework, analysis of competitive intent and procedures/lead-time, using VOI’s proprietary market data services. Forecasts models including associated unit volume, market uptake, and share data, along with analysis of key assumptions, upside/downside risks, and probability of success were provided to the Client. Based on the results of phase I data, phase II was initiated which involved implementing strategy with detailed study of launch planning, preparation and execution to gain the first mover advantage in generic market.

Results:

Our Client successfully implemented the launch strategy.

 

Project Title: Therapeutic Opportunity Analysis / Licensing Review

Client: R&D-based Biopharmaceutical Firm

Description:

VOI reviewed the Congestive Heart Failure (CHF) market for a biotech firm that was deciding whether to follow its normal practice of licensing to a major company or to keep the new product in-house as a means of establishing itself as a full-service company with marketing and other capabilities.

We thoroughly evaluated the potential for this product based on its probability of approval and likelihood of commercial success.

Note: Although this project was specific to the CHF market, we have conducted numerous similar studies for virtually all major and minor therapeutic categories.

Results:

Based on our work, our Client decided that this product faced too many regulatory and commercial risks to justify a major change in company direction and decided to license the product. Our work served as the basis for product valuation in the licensing negotiations.

 

Project Title: Major Market Entry Assessment for Generic Drug Portfolio

Client: Top 20 U.S. Generic Manufacturer

Description:

VOI was hired by a generic drug company to explore options for their product portfolio in Western Europe and Japan. Our Client had not yet ventured into ex-U.S. regions and needed to understand these markets at both a structural and product-specific level.

For the structural component of our analysis, we assessed regulatory frameworks, approval procedures, generic pricing and reimbursement policies, penetration rates for branded and unbranded generics and customer characteristics. For the product-specific component, we looked at sales, volume and pricing trends at both the category (ATC-3 / 4) and compound levels, competitive presence, intellectual property status of original drugs and brand versus generic share figures.

Based on this analysis, VOI recommended a mix of products to launch in each country so as to maximize the commercial potential of our Client's portfolio.

Results:

Our Client is in the process of filing approval applications based on our recommended mix of products and countries.

 

Project Title: Post-patent Brand Defense Strategy, Injectable Oncology Market

Client: Leading specialty pharmaceutical company

Description:

For the first time in the company’s history, our Client was facing a loss of US patent protection on one of their key brands. VOI was brought in to help assess options and develop a strategy that would maximize profits on the franchise in the pre- and post-patent environment. Among the multitude of strategies considered were: launch of an authorized generic,  various pricing scenarios and potential lifecycle management options.

Strategy development required in-depth analysis of likely generic entrants and their capabilities, Medicare Part B and private payer reimbursement issues, influence of major customers including group purchasing organizations (GPOs) and the incentive structure of various parties in the decision-making chain. Using this research and analogous case histories, VOI developed a five year financial model incorporating top-line forecasts, the cost of executing each option and a timeline of important milestones.

In addition to evaluating external factors within the customer and competitive set, we  worked with the Client to determine whether, based on the Client company’s overall direction and capabilities, the recommended strategies were best handled in-house or by an outside partner.

Results:

Our Client is moving forward with one of the recommended strategies and expects to realize several hundred million dollars in revenue over the forecast period that would not have been realized in a typical post-patent environment.

 

Project Title: Global Biosimilar Strategic Opportunity Assessment

Client: Top 10 Generic Drug Manufacturer

Description:

Our Client needed to evaluate a number of strategic options regarding possible entry into the biosimilar category. VOI performed a thorough analysis of clinical, manufacturing, intellectual property and marketing issues in both advanced (e.g. US, EU, Canada) and emerging (e.g. India, China, Latin America) markets. The developing legislative and regulatory frameworks in these markets were explored in-depth. In countries such as the U.S., where governing regulations are not yet in place, the implications of various scenarios (e.g. different lengths of data exclusivity, clinical trial requirements) were explored.

Based on current market activity and probability-based (Monte Carlo) forecasts of future activity, we evaluated the commercial opportunity for the category as a whole and for selected biosimilar products. Factors considered in this phase included pricing / reimbursement, demand and penetration rates. Analyses of competitive actions, capital requirements, timing and potential partnership opportunities were also conducted. The final product included a net present value forecast of the biosimilar opportunity.

Results:

The results of our analysis were used as the basis for recommendations on both market entry and a make or buy path forward. Our Client is currently evaluating our findings.

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