Understanding the Pharmaceutical Commercialization Lifecycle

Bringing a new drug to market means navigating one of the most complex lifecycles in any industry. Pharmaceutical commercialization is a high-stakes race against time, data gaps, and market dynamics.

Drug approval is just the beginning. For commercialization teams, the real challenge is translating clinical success into market impact. Success belongs to teams that plan early, launch deliberately, and stay flexible long after approval.

In this article, we provide a guide to the strategic priorities that matter most every step of the way.

How Is Pharmaceutical Commercialization Changing?

Research by McKinsey on 86 $300+ million drug launches underscores the importance of a carefully planned and executed commercialization strategy:

• 40% of newly launched drugs fail to meet their 2-year sales forecast.
• 100% of the sample drugs were delayed from the original timeline: 45% due to internal manufacturer delays, 40% due to regulatory holdups, and a further 15% due to supply chain issues.
  
• In 50 out of the 86 disrupted launches, companies lowered their sales expectations by more than 25%.

An executive survey from Deloitte suggests that pharmaceutical leaders recognize the need for an elevated commercialization strategy: 56% of respondents said the entire commercial function needed to change significantly or transform fully, while a full 89% said at least one subfunction required change.

Recent years have brought both administrative shifts and mounting pricing pressure. During the first Trump administration, several policies aimed to streamline the drug approval process and reduce regulatory bottlenecks, modestly improving commercialization timelines. However, many layers of bureaucracy remain in place.

Under the current administration, proposals to reduce U.S. drug prices through international reference pricing have gained traction. This shift could have important implications for launch strategy. Manufacturers may delay or avoid launching in lower-priced international markets to protect U.S. price benchmarks, prompting a reassessment of market prioritization for new therapies.

Strategic Priorities to Successfully Navigate the Pharmaceutical Commercialization Lifecycle

Each phase of the commercialization lifecycle requires its own strategic focus. In the sections that follow, we outline the priorities, challenges, and practices that help teams drive performance across the full lifecycle of a pharmaceutical product.

Drug Development and Regulatory Approval

The development of a new pharmaceutical product typically begins with the identification of an unmet clinical need (often a rare condition with limited treatment options) and a viable path to reimbursement. Advancing a new therapy requires not only scientific promise but also a clear opportunity to recoup the investment through an addressable patient population and sustainable pricing.

Although commercial strategy intensifies in later stages, preclinical development is an important preliminary stage for the commercialization lifecycle. Early planning in areas such as market access, manufacturing scalability, and regulatory pathway selection should guide the trajectory of development from the outset.

Preclinical Development

Preclinical development focuses on identifying, refining, and evaluating promising drug candidates before they can be tested in humans. This stage includes laboratory studies and animal testing to assess basic pharmacology, toxicity, and other safety markers. 

Before transitioning into human studies, companies must submit an Investigational New Drug (IND) application to the FDA. This submission outlines preclinical findings, chemical and manufacturing data, and the proposed design for early clinical trials. Approval of the IND allows the sponsor to begin formal clinical testing in human subjects.

Clinical Development

Clinical development involves the systematic evaluation of the drug in human populations across multiple trial phases designed to assess safety, dosage, efficacy, and potential adverse effects. Each phase serves a distinct purpose:

• Phase I: Involves 20 to 100 healthy volunteers or patients and typically lasts several months. The focus is on identifying safe dosage ranges and evaluating pharmacokinetics.
• Phase II: Includes several hundred patients with the targeted condition and may run up to two years. This phase examines the drug’s therapeutic efficacy and short-term side effects.
• Phase III: Enrolls several hundred to several thousand patients and may extend over multiple years. These studies confirm clinical effectiveness, monitor adverse reactions, and generate the data required for regulatory submission.

If the results from Phase III trials demonstrate sufficient safety and efficacy, the sponsor can submit a New Drug Application (NDA) to the FDA. The NDA compiles all findings from preclinical and clinical development, as well as detailed information about manufacturing processes, quality control protocols, stability data, packaging standards, and environmental impact assessments.

During the NDA review process, the FDA evaluates whether the submitted evidence supports approval for the drug’s intended use. The agency also works with the sponsor to finalize prescribing information and product labeling. Standard reviews are typically completed in about 10 months, although drugs granted priority review may receive a decision within six months.

Market Entry

Once a new drug receives regulatory approval, the focus shifts to preparing for launch. Market entry is not a single moment, but an integrated process that turns a regulatory milestone into a commercial reality. An effective launch creates long-term conditions for sustainable success in a dynamic and demanding marketplace. 

Core objectives during market entry are education, access, and engagement:

1. Payer access is a major priority at this stage. Manufacturers must be ready to demonstrate value through economic models and clinical differentiation. Strategies may include value dossiers, health economics data, and account-level planning to navigate reimbursement hurdles and formulary placement.
2. Medical affairs teams focus on provider education and marketing. This may involve sharing clinical data with opinion leaders, sponsoring continuing medical education, and offering resources that support confident prescribing. These activities help build credibility and lay the groundwork for broader adoption.
3. Internally, launch teams undergo intensive training to ensure consistency and compliance. Field teams must understand the product’s therapeutic profile, be fluent in competitive positioning, and know how to tailor communication across stakeholder types.
4. Marketing execution can scale during this period. These may include scientific publications, digital campaigns, provider-facing materials, and product websites. Each tactic plays a distinct role in building visibility, reinforcing key messages, and supporting pull-through in early adoption.

Lifecycle Management

Once a therapy is on the market, sustained performance depends on ongoing education, access support, and strategic refinement. The work that begins during launch (such as provider training, patient support programs, and engagement campaigns) must continue in more targeted and adaptive forms. 

Companies should monitor prescription trends, market share, and revenue performance against forecasted targets. At the same time, feedback from healthcare professionals, patients, and payers can help understand adoption barriers and unmet needs. This insight helps guide messaging adjustments, resource allocation, and updates to support services.

Data also plays a critical role in validating strategy. Regular performance reviews allow companies to assess the return on promotional efforts and ensure that commercialization investments remain aligned with evolving market dynamics.

Common Challenges to Successful Commercialization

Many promising products underperform due to avoidable breakdowns in planning, communication, and execution.

1. Functional Silos

Lack of alignment across teams is one of the most consistent and costly issues in pharmaceutical commercialization. Medical research, medical affairs, and commercial teams often operate in isolation until late in development. As a result, key commercial considerations (like payer-relevant outcomes, provider education needs, or access-related endpoints) are not integrated into Phase III protocols.

This disconnection can limit a brand’s ability to tell a cohesive value story. For example, medical teams may focus on publishing in high-profile journals but deprioritize secondary endpoints that could support payer negotiations or downstream access strategies. In parallel, communication gaps across pre-launch teams hinder unified messaging and delay strategic alignment, particularly during handoffs between clinical and commercial leadership.

Establishing cross-functional collaboration early is critical. Teams must align on shared goals, ensure feedback loops are in place, and maintain consistent communication from development through launch and beyond.

2. Limited Outcomes Data

In accelerated pathways such as breakthrough designation, development timelines are compressed, which can lead to insufficient planning around outcomes data. Yet for payers, outcomes (especially real-world effectiveness and value) are essential to decision-making. Demonstrating efficacy alone is not enough.

To compete in today’s environment, manufacturers must invest in evidence generation that supports not just regulatory approval but also reimbursement, formulary placement, and long-term value perception. This includes proactive incorporation of health economics and outcomes research (HEOR) data.

3. Lack of Preemptive Payer Engagement

One of the most damaging mistakes in commercialization is waiting too long to engage with payers. Many pharmaceutical companies delay access planning until just before approval, missing a critical window to shape payer perception.

In reality, payer organizations should begin evaluating therapies well before FDA action dates. Companies that wait until approval to make their case are often too late: payers may have already reviewed trial data, consulted independent analyses, and formed preliminary coverage positions.

To avoid this fate, manufacturers should begin payer engagement as early as six months before the PDUFA date (Prescription Drug User Fee Act date, a target date by which the FDA aims to complete its review of a new drug application (NDA) or biologics license application (BLA)).

Refine Your Pharmaceutical Commercialization Strategy

Every stage of the commercialization lifecycle presents unique challenges and distinct opportunities to create value.

Looking to strengthen your commercialization strategy?

Connect with TJP to learn how we help pharmaceutical teams bring therapies to market with clarity, coordination, and confidence.