The process of bringing new medicines to market takes approximately 12 years from discovery to approval, with an average cost of $1.3 billion. [1] As scrutiny over drug prices intensifies and governments introduce pricing controls that may impact pharmaceutical companies’ return on investment, the industry has begun focusing on reducing costs, accelerating time to launch, and expanding sales and market reach to sustain profitability in drug development.
A key part of the challenge is that long-term commercial success can never be guaranteed. In today’s landscape, robust drug commercialization strategies are more essential than ever before.
The drug commercialization process from beginning to end
Regulatory approval: The commercialization process for a medicinal product starts with regulatory approval. Prior to this, a large volume of pre-clinical and clinical data must be compiled and submitted to the regulator, alongside manufacturing information and packaging & labelling proposals. Regulatory agencies such as the European Medicines Agency (EMA) are looking at new marketing authorization applications (MAAs) with increasing scrutiny. From stricter evaluation of clinical trial designs to demands for thorough risk-benefit analysis, expectations for the quality of data and evidence required are continually growing.
Manufacturing: Once a marketing authorization has been granted, production scale-up begins. Small-scale and pilot batch production is sized up to commercial-level manufacturing while maintaining quality, safety, and consistency.
Market access and entry: With a finished product ready to sell, it is now time to start marketing. Market research can start much earlier in the process and is necessary for each market the company plans to launch the asset. What is the disease prevalence in that geography? Where are the competitive threats? It is essential to use real-world insights and detailed health economic analyses to craft product value claims and prices, requiring a deep focus on data as well as engagement with key stakeholders such as patients and physicians.
Mapping out a market access strategy is now essential. Every region has its nuances, and the order in which the pharmaceutical company approaches each country can have a significant impact on pricing outcomes in others due to price indexing. Launching medicines in Europe requires careful identification of the best funding pathways. A local commercialization partner can help companies craft a winning launch strategy.
With a plan in place, submissions to health technology assessment (HTA) agencies can now begin. These bodies are tasked with reviewing the medical, economic, social, and ethical issues related to new treatments and deciding whether the medicine should be made available in their country’s health system.
Following a positive HTA outcome, pricing, and reimbursement negotiations with the country’s payer commence. This is where the pharmaceutical company can leverage its previous work on value messaging, market conditions, and the competitive landscape. Meanwhile, it must also be prepared for a range of payment models. In value-based contracting models, for example, payments terms are directly tied to clinical outcomes. This model is becoming increasingly prevalent as payers seek to reduce healthcare expenditure while improving patient care.
Medical affairs: Early commercial success also depends on an effective medical affairs strategy. Direct relationships with key opinion leaders are instrumental in creating influential advocates for a new medicine, as their expertise and network connections can play a key role in the successful introduction of new medicines within the healthcare system. Medical events such as roundtable discussions, congresses, and symposiums can help to raise awareness of the disease and treatment, with the goal being to ensure the new product is understood by those in a position to recommend or prescribe it.
Sales and marketing: A sales strategy that takes into account relevant sales channels, complex regulatory information, distribution pathways, and tender processes must now be crafted. With this, the pharmaceutical field force is ready to jump into action. This involves a team of medical professionals and sales representatives interacting with local buyers to nurture relationships, promote products, and gather valuable feedback.
Distribution: With market access pathways defined, it is time to start distributing the product to wholesalers. Pharmaceutical companies large and small frequently work with third-party logistics partners in order to outsource warehousing, transportation, and order fulfillment processes to an expert. Looking ahead, the value of these partnerships will continue to grow as medicines increase in complexity, with certain advanced therapy medicinal products (ATMPs) such as cell therapies requiring cryogenic storage in order to preserve their viability.
Post-marketing surveillance: Specific regulations and guidelines for post-marketing surveillance are needed to ensure the ongoing safety, efficacy, and quality of approved medicines. In Europe, EMA’s pharmacovigilance system requires a range of activities for the detection, assessment, and prevention of adverse events. Companies must complete a Risk Management Plan (RMP) that details how risks will be minimized and managed. Should any new risks be identified during post-marketing surveillance, the RMP may need to be revised to reflect the medicine’s updated safety profile.
Post-approval trials (Phase IV studies) are sometimes required to further evaluate a medicine’s safety and optimal use. These may be used to investigate specific rare adverse events that only became apparent after the medicine’s use in a larger population for longer periods of time, or simply to gain a deeper understanding of how the medicine behaves in the general population. In addition, Phase IV trials are sometimes required to evaluate a medicine’s use in children or during pregnancy.
Product lifecycle strategies: As time passes, product lifecycle strategies are essential in ensuring a pharmaceutical product’s long-term competitiveness and profitability. In addition to launching the product in further markets, a range of measures are possible for enhancing the medicine’s value — from developing a new dosage form to switching packaging formats. These strategies can help to differentiate the product from emerging competition, including generics, and secure a secondary patent for the company. The MA holder may also consider conducting further post-approval trials that seek to explore the medicine’s potential in other indications.
Pharma commercialization trends in Europe
A new era of market access and pharma commercialization is around the corner in Europe. Growing adoption of value-based pricing models, which link medicine prices to measurable health outcomes, alongside the increasing use of real-world evidence to assess a medicine’s efficacy in real-world settings. This promises to help regulators make more informed decisions about a medicine’s efficacy outside of controlled clinical trial settings.
When it comes to the HTA process, a significant change is anticipated with the implementation of EU-wide joint HTAs, which are set to begin with oncology and ATMPs in 2025 and will thereafter be applied to all medicines by 2030. The collaborative process aims to reduce duplication of assessments across EU member states, and boost efficiency in the assessment process. However, many industry players are concerned that it could add additional administrative work to an already complex commercialization process.
Meanwhile, the incorporation of sustainability measures and the voice of the patient in the clinical development process are both likely to become key considerations in the European landscape. Increased involvement of the patient voice has already begun shaping market access strategies, encouraging pharmaceutical companies to increase their work with patient advocacy groups in order to factor their viewpoints into decision-making and value messaging development. Beyond traditional clinical outcomes, there is a growing emphasis on understanding the impact of a medicine on a patient’s quality of life.
The role of ESG in market access is still in its early stages. However, with the EU’s commitment to carbon neutrality by 2050, there is a strong likelihood that environmental sustainability will become a key consideration for pharmaceutical companies targeting long-term commercial success. Such measures are already underway in the Nordics. For example, the Swedish Association of the Pharmaceutical Industry is laying the groundwork to develop environmental price premiums in the reimbursement system for certain classes of essential medicines.
Pharma commercialization services
The clinical development process of an innovative medicine is inherently risky, characterized by high costs and high attrition. When a product is successful in achieving regulatory approval, the importance of well-chosen commercialization strategies, competitive pricing, and effective stakeholder engagement cannot be underestimated in ensuring that medicine has the best chances of delivering a return on investment (ROI) for the developer.
Maximizing a new medicine’s market reach is not just about profits — it ensures prescribers understand its benefits, giving patients access to innovative new treatment options. Ensuring better outcomes for patients with unmet needs is our mission at Abacus Medicine Pharma Services, and it’s why we partner with the developers of rare/orphan drugs to provide innovative commercialization solutions that improve access to critical therapies.
Abacus Medicine Pharma Services helps pharmaceutical companies navigate the complexities of EU commercialization with a unique suite of solutions tailored towards the needs of rare disease medicines. From market access strategies to KOL engagement and pharmacovigilance, we leverage our expertise and deep knowledge of the European marketplace to empower our partners, strengthen key stakeholder relationships, and advance patient well-being.
