What Are the Major Steps in Launching a New Pharmaceutical Product?
Many factors go into launching a new pharmaceutical product. The process of gaining approval and the commercialization of a new pharmaceutical product is deeply complex and can take many years of careful planning, coordination, and execution across multiple stages. At Magnolia Market Access, we work closely with our pharmaceutical and biotechnology clients to ensure success throughout each step.
Drug Discovery and Approval
Beginning with drug discovery, a pharmaceutical company’s researchers are sifting through many possibilities for a molecule to identify 1 and begin the product life cycle. This can take 3-6 years and involves testing thousands of compounds to find just a few promising candidates to pursue for further development.
Preclinical development is the next stage that includes in vitro and in vivo studies to evaluate safety and efficacy. The primary objective is to gather enough data to support human testing. This stage usually takes about 1-3 years. Clinical trials, focused on evaluating the safety and efficacy of a product through phases 1-3 (small to large trials), can take an additional 6-7 years.
The pharmaceutical product can then be submitted for regulatory review, which is where the company submits a New Drug Application (NDA) to regulatory agencies like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) (in the European Union [EU]) for approval. This includes all data from the preclinical stage and clinical studies and can typically take about 6-12 months.
Pharmaceutical Product Launch and Commercialization
When a product has been approved, the company can begin large-scale manufacturing and pharmaceutical commercialization tactics. This next stage includes landscape assessments, market access, and payer pricing strategies. After appropriate strategies are developed, the company can focus on distribution planning to ensure timely access to their therapy. Pricing and reimbursement of a product depends on the comparable value through market research, and direct negotiations with payers can be initiated.
A product then goes through marketing and sales preparation to build a branding strategy and sales force for launch. This includes creating the messaging framework and developing payer, provider, and patient field resources. Finally, a product goes through launch execution with the full sales force deployment, marketing campaign rollout, and product distribution to pharmacies and hospitals. Payer teams call on health plans and health systems, while sales and medical affairs teams directly engage healthcare professionals to communicate a product’s impact.
Post-Launch Marketing and Monitoring
This stage includes ensuring a product’s adverse effects are tracked and appropriately reported through ongoing phase 4 clinical trials. Real-world evidence (RWE) is also collected and analyzed to gauge the impact of a product on clinical and economic outcomes. By capturing RWE, pharmaceutical companies can continue to tailor key messaging to address unmet needs and population-specific challenges. RWE informs market access to impactfully articulate value to payers and providers. This can be done through leveraging electronic health records, claims data, drug registries, or patient-reported outcomes.
Navigating Product Launches and Beyond
The healthcare landscape continues to evolve, and new policies can affect drug launch initiatives. Pharmaceutical companies will need to continue to find new solutions as they explore strategies, from drug discovery to post-launch marketing and enhanced product positioning. For further questions on new drug launch capabilities, please contact us at Magnolia Market Access.