Effective product selection and partner identification within the Generics and Active Ingredient landscape

As the world pharmaceutical landscape continues to develop, companies involved in both generics finished dose and active pharmaceutical ingredient (API) manufacturing are confronted by a rising number of hurdles across many aspects of their business. Competition is increasing, regulations are tightening and costs are continuing to rise at various stages towards commercialization.  Companies must make strategic decisions faster, and differentiate themselves more clearly from the competition.

Three key challenges form the backbone of a company’s decision-making process:

  • Identifying the correct products
  • Selecting the correct partners
  • Following the correct strategy

There are, of course, many further intricate decisions that need to be made, however, ensuring these main pillars work in conjunction plays a major part in business growth and revenue enhancement. Companies along each step of the industry growth curve must make the correct decisions for their business. This includes fine chemical and API companies, finished dose generic companies, companies involved in complex generics or biosimilars and even those pursuing innovation. Although time is of the essence, it is important that key decisions are still made confidently and on the basis of useful and accurate information.


Building an effective portfolio

When aiming for a revenue-rich portfolio, generic finished-dose companies and API manufacturers must address several key questions in order to increase the likelihood of success, and limit the risk of failure:

  • How can you identify the most suitable products to add to your portfolio?
  • What criteria need to be considered to ensure successful portfolio decisions are made?
  • In which direction should your portfolio be taken (e.g. therapeutic area, dose form, market, technology or competition)?
  • Do further decisions need to be taken around your existing portfolio (should you cull your portfolio, drive down development costs, find cheaper raw material sources, etc)?
  • Do you need to assess potential in or out-licensing opportunities?
  • What is the strategy of your competition and how can you differentiate?
  • How can you be more effective and make these decisions in a timelier manner?

Using a generics finished-dose company as an example, various criteria need to be considered in making portfolio decisions including:

  • Exclusivity loss
  • Market data, product criteria (dose form / therapeutic area)
  • Global availability of active ingredient
  • Manufacturing requirements and costs
  • Forecasted competition

If one factor raises concern, it can often result in its exclusion from the evaluation.

The changes in the market landscape over the last decade have reinforced the concept that companies must limit risk more than ever. Wasted costs and time associated with product failures result in huge financial loss, demonstrating how product identification is one of the most crucial strategic considerations for both generics finished-dose companies and API manufacturers.


Identifying the correct partners

Partner selection is another incredibly important driver of business growth. Identifying suitable marketing partners, external manufacturing partners, and suppliers of raw material are all critical to driving business forward in this industry.  To assure optimal partner selection, companies must ask:

  • Does the partner have suitable local networks and relationships in the target country?
  • Does the partner have experience marketing similar portfolios in terms of dose form or therapeutic area?
  • Does the partner have local manufacturing plants or subsidiaries?
  • Does the partner clearly demonstrate experience working with other partners in relevant regions?
  • Is the company of the appropriate portfolio size for your aspirations?
  • From a supply perspective, does the partner have the ability to supply to regulated markets?
  • Does the partner comply with required regulatory status and inspection requirements?

Building successful partnerships and identifying the correct partner to work with can be an extremely time consuming process as it includes multiple selection criteria and critical questions. A correct partner needs to exhibit the correct attributes to add value and provide the infrastructure that allows a clear path to success. 


How can you ensure that you are not missing any potentially viable partners in the market?

Questions such as “is this the correct partner for my requirements?” or “what business impact could occur depending on this partner selection?” often need to be answered quickly, while ensuring that the selection is based on a depth of knowledge and the anticipated results are economically positive.

Effective product targeting and partner selection are the key ingredients of a successful business strategy. Companies that are able to make these decisions quickly based on validated intelligence are better positioned to thrive and grow in this ever-changing environment.

To learn more about key trends impacting generic finished dose and API manufacturing companies, join CPhI and Clarivate Analytics, formerly the IP & Science business of Thomson Reuters, for a complimentary webinar on December 7, 2016. This exclusive post-CPhI insights session will explore global influences, the current landscape of API manufacturers, their changing experience and capabilities, and how these companies are growing and diversifying while managing competitive pressures. Register now.


How we can help

Clarivate Analytics solutions assist companies within the pharmaceutical sector to make effective business decisions. Newport PremiumTM is the most advanced platform for generic finished dose and API manufacturing product targeting and global business development. Newport PremiumTM helps to quickly identify and evaluate new product development and licensing opportunities by integrating data and building targeted searches to match your exact strategy. It also allows for robust partner selection searches to be carried out, by implementing specific company search criteria and deeply evaluating the results obtained. Click here to get started.