by Tommaso Salanitri, MD

Business analysis in Pharma industry, either during the early phases of drug development phase or close to the launch, represents a relevant preparatory part – especially for the preparation of Business Plan – in which Medical Affairs is a main contributor, because of deep knowledge of the disease state, epidemiological data, competitors, link with external experts, deep understanding of unmet medical and patients needs and other topics, below described.

To achieve the objective, the priority that all relevant functions – cross-functional working is vital for the  success – as Medical Affairs, Marketing & Sales, Market Access & Corporate Affairs, Business Operations, Regulatory and Finance – as “high performing cross-functional team” – provide their contributions and insights for a deep understanding of the market scenario, highlight and assess any threats or opportunity.

Market Research is one of the critical component for assessing a deep situation analysis and represents an import tool for analyzing and understanding the market scenario, either in early phase of development, or in pre-launch time, or during post-launch.

The reasons to carry out market research in a business are mainly  to answer questions, gain insight, get confirmation, generate ideas, develop understanding of current market scenarios and discover unmet needs.

As markets in which the products compete become bigger, more complex and more crowded, the decisions that companies have to take, have greater consequences than ever before, therefore, in order to increase the probability of making the right decisions, market research can be used so that decisions are made from a position of knowledge and insight, as opposed to assumptions and guess work.

Appropriate market research will provide the data from which insights can be obtained and hence increase the chance that the correct decisions are made and are an excellent tool to gain insight into market and customers and hence, to create a solid competitive advantage.

Some topic to consider and that need to be asked at each stage, with different sub-questions for each topic, should include, at least:

  • Defining the problem and research objectives
  • Developing the research plan and methodology
  • Implementing the plan and collecting and analyzing data
  • Interpreting and reporting the findings

The several business questions that arise throughout the examined period, can be answered by the data collected through qualitative and quantitative research.

The decision of which type of research to use will also be a “trade-off” between the available budget, the level of accuracy required to sufficiently answer the business question and any potential time constraints. The insight that can be gained from market research, as anticipated, can positively impact on the product launch performances due to the competitive advantage gained in the marketplace, but also impact in the early phase of drug development, as during the pivotal trials protocol development, as well as in the post-launch activities, especially regarding the LCM of a product and also the competitors projects and activities.

Before starting a business analysis to understand the market, is crucial to have in mind, at least, the following:

  • Market definition
  • Market segmentation
  • Competitors
  • Environment
  • Customer analysis and adoption pathway

In a business analysis the most relevant input should be driven by SWOT analysis and Critical Success Factors (CSF).

In the SWOT, the segment evaluation will provide a measure of the attractiveness of the segments evaluated.

During the business or situation analysis of the market, an important activity to consider, should be the Environmental Analysis, that generally include a “two stage” process:

  • PEST analysis (Political, Economic, Social and Technological), for identifying the factors which will have the greatest impact on the product/brand over the plan period
  • Assessment of  Implications of the identified factors

CSF are those aspects of a strategy that must be achieved to successfully meet objectives and to secure competitive advantage.

Patient Journey is a formal term for indicating the sequence of care events, which a patient follows from the point of entry into the system, triggered by illness, until the patient is discharged from hospital to home, or due to worsening or death. In a typical patient journey, is important to identify – as example – and address:

  • Patient population (according epidemiological data and/or available disease registries)
  • Seeking treatment
  • Consulting physicians
  • Approaches to physicians and therapies
  • Diagnosis
  • Treatment
  • Barriers and bottlenecks (for diagnosis, treatment, access to therapy)
  • Brand differentiation

In the patient journey several info should be obtained as, patient flow, percentage of patients remained at each step, which are major influence factors, which obstacles and constraints.

It’s also important to understand and address, in a pre-launch and post-launch period, any barrier, as “lack of gain access to treatment”, that could briefly simplified as mainly:

  1. Clinician lack of Knowledge of product
  2. Clinician limited experience & confidence
  3. Clinician not “allowed to use”

In the first case, levers of growth should be, as example, pre-launch strategy, Med Ed activities, congresses data spread, publications, relationship management, any other “awareness” activity linked with the company, disease management or product data; in the second case, an example of lever for growth should be represented by latest “expert opinion” or any other “consensus paper”, local trials (including investigators initiated studies), peer usage; in the third case, also in this case, as a simple example, some lever of growth could be represented by the inclusion into hospital formularies or national/central guidelines and recommendations to follow.

In a patient journey, the customers (i.e.: physician/patients/pharmacist) analysis are important stakeholders to consider, to understand which are their needs, constraints, treatment approaches (physicians) and considerations (patients).

Other assessment will be focused mainly on the market characteristic, trend and size.

Medical Affairs function must be able to provide main contribution and added-value, for obtaining and addressing the above topics, working in a cross-functional way with other function, as an “integrated team”, and in many cases of the above statements and examples, Medical Affairs has to “lead” the generation of the insights, advices and gained recommendations, through KOLs and other stakeholders by  building and maintaining professional relationships, and managing experts with a “peer-to-peer” approach.

In fact, as per the above, Medical Affairs team has the direct contact with the most important external stakeholders (KOLs, Investigators and Scientific Societies firstly, but also with other relevant stakeholders, as Patients Association Groups, Payors, Health Economists and Pharmacologists) and through MSLs team, all these activities, can be more direct, capillary and specific.

Addressing all the needed info to be collected with the right stakeholder, is highly important and it needs time. For this reason, collecting info by Medical Affairs has never to be a “spot” activity, but, on the contrary, has to be a well planned in advance – at least some months – activity, with an adequate and detailed plan of external meetings, F2F, congress attendance (to reach as many experts as possible all at once), clinical site visits together with CRAs or other Clinical Research personnel, to discuss with investigators and experts in a specific therapeutic areas, the “market disease environment”, also planning and leading Advisory Boards for obtaining medical insights and for investigating unmet needs and global uncharted market potential/access opportunities.

Other topics to deeply investigate and to be included in a SWOT analysis are:

  • Clinical trials status of competitors and patent expirations;
  • Publications of competitive trials (deep analysis of these can provide valuable and differentiating strategic info);
  • Documenting business rules, ensuring global data is in line with domestic data parameters
  • Stay current on global pharma business and identify any factors that may impact business, present and future including M&A, new technologies, global markets, politics and approaches;
  • Presence of “disease local registries”, in addition to any eventual Regional one, managed by Scientific Societies, Healthcare Agency or Patients Association Groups for using these as a relevant source for patients information and related treatments, starting from Standard of Care (SoC).

Of course, all of the above, must be completed by a full knowledge of “disease area”, main competitors and products phases of LCM, extensive knowledge of MoA of the marketed products, including development pipelines, as well; in addition to that, another relevant accountability to consider for Medical Affairs, is the deep knowledge of therapeutic algorithms, main guidelines and recommendations, local restrictions at country/regional level.

At each level of Medical Affairs organization, from Medical in the field (MSLs) and office-based (Medical Advisors and Medical Managers) to Medical Affairs Director/Medical Director, all Medical team should be able to provide a highly relevant contribution, according the shared and highlighted topics.

In conclusion, for completing a business analysis and having a deep market scenario picture, is important to consider, at least the following:

  • Understand the market: reviewing global market understanding from a local perspective; considering information on actual markets and future pipelines perspective, raising additional, relevant local knowledge and identifying and prioritize brand implications.
  • Identify any potential opportunities: reviewing global guidelines and opportunities to ensure alignment and identify any deviation from these; develop a SWOT for the product/brand, highlighting any critical implication from patient understanding and from the market.
  • Build patient understanding: assessing and defining the “patient journey”, evaluating global patient populations (with info provided by Global teams) with local insight and information obtained, to define potential local patient segments.

The more detailed and accurate info are obtained, the more specific and valuable work will provide a direction and an assessment of business analysis, providing a valuable business and market scenario.