Article updated June 2023.
The pharmaceutical lifecycle broadly includes three stages: development, commercialization, and generic competition. From initial development to the eventual loss of market exclusivity, a pharmaceutical product’s lifecycle can span several decades.
The development phase alone of a novel drug can take 10 to 15 years and cost billions of dollars. How are companies using pharmaceutical life cycle management strategies to maximize exclusivity, gain a competitive edge, and improve patient outcomes?
Drug manufacturers deploy various strategies to maximize the product’s value and maintain market dominance before its patent expires. Today, we’ll review the normal pharma product life cycle and then offer essential pharmaceutical lifecycle management strategies you can deploy at each of the three major stages to improve your pharmaceutical innovation.
What does the pharmaceutical lifecycle look like?
Every new drug product will follow its unique path toward the commercialization process. However, most novel drugs will go through three stages:
- Development (early)
- Commercialization (middle)
- Generic competition (late)
Let’s break down each of these three lifecycle periods and the strategies for success.
Better insights management across the entire product development process.
New drug development
Also known as drug discovery, this initial process seeks new medicines to treat and cure ailments and diseases. The underlying goal is to identify new compounds that could have the desired palliative effect on the human body and establish the compound’s quality, safety, and efficacy for treating patients.
According to researchers, precious few new drugs survive this daunting process: “Of 5,000 compounds that enter pre-clinical testing, only five, on average, are tested in human trials, and only one of these five receives approval for therapeutic use.”
As mentioned, this incremental process typically takes more than a decade to finish and will cost more than a billion dollars. That’s because you must successfully pass through the various stages and series of actions, which include:
Stage 1: Early drug discovery – Researchers seek to identify genes connected to diseases or ailments, identify and authenticate proteins that cause the disease, and identify new compounds to prevent or assuage the disease. This consists of several pre-clinical steps, including:
- Target identification and validation
- High throughput screening
- Hit identification and discovery
- Assay development and screening
- Lead optimization and generation
Stage 2: Pre-clinical phase – Once the target substances have been identified, researchers can start pre-clinical testing. Typically, these are performed on animals to identify lead candidates, develop the best drug scale-up procedures, find the optimal formulation, and initiate human trials.
Stage 3: Clinical phases – After animal tests have concluded, the pharmaceutical company will file an Investigational New Drug Application (INDA2). If approved, a new drug must pass through three phases of clinical trials:
- Phase 1: A small group of healthy subjects (20 to 80) tests the tolerance and safety of the drug candidate. It answers questions like: is it safe, what is the ideal dosage, and how does the substance interact with the body?
- Phase 2: In the next stage, larger groups (100 to 500 adult patients) begin to test the effectiveness, tolerability, and dosage.
- Phase 3: In the final phase, doctors test the drug on groups of thousands of patients to determine whether it is safe and effective.
- Stage 4: Regulatory approval – Having all the essential documents for clinical trials is important. Otherwise, it’s difficult to reach this stage. The few drugs that emerge from the unscathed clinical trials will submit their data and research to governing authorities for analysis. The company files a New Drug Application (NDA) covering all pre-clinical and clinical trial data. If the FDA approves the application, the company will begin post-market monitoring to further confirm the safety and efficacy of the new drug—especially compared to alternative treatments.
Strategies for pharmaceutical development
Seeing as only one in 5,000 compounds will ever make its way to market; small pharmaceutical companies must go above and beyond to position themselves for success. Today, patient-centricity lies at the heart of such efforts. To that end, HHS and the FDA recommended that companies deploy the following strategies for a patient-first focus:
- Collect comprehensive and representative input – Pharma company teams must gather accurate patient insights from all relevant stakeholders to ensure that individuals are heard and considered for quality assurance.
- Discover what matters to patients – Here, the patient experience matters deeply. Pharmaceutical companies must understand what matters to patients to design the most effective, accommodating, and applicable clinical trials possible.
- Identify the insights that matter – With so much feedback, it can be challenging to sift through all of the data to find the insights that can be applied to create a successful market strategy.
- Gather, store, and analyze clinical outcome assessment (COA) data – COAs should be woven into decision-making to ensure a patient-centric approach to drug development.
An insights management platform closes the insight gaps detrimental to the new drug development regulatory process. This technology can identify, engage, and analyze input from medical affairs, clinical, commercial, internal, and payer groups worldwide to help you answer your most pressing questions.
With technologies like natural language processing and sentiment analysis, you can fine-tune your trial processes, identify new target markets, strengthen relationships with key opinion leaders (KOLs), and prevent costly mistakes or delays that so often occur because of the insights gap.
Also known as the market exclusivity period, this stage covers the years between the launch of a new drug and the market launch of its first generic. While this period could span as long as 20 years, typically, the R&D phase can take so long that by the time the product is available on the market, its patent has already begun to expire.
The market exclusivity period can be broken down into four sections:
- Introduction to market – Early drug launch is primarily concerned with building stakeholder education and awareness, establishing patient support programs, forming partnerships with KOLs, and marketing the product.
- Growth – As the company begins to grow and make a profit, leaders will seek to maximize market share and turnover.
- Maturity – After a certain point, the growth of a pharmaceutical product is capped. Once maximum growth has been achieved, the focus shifts toward maintaining market share.
- Decline – Eventually, profits and market share decline. In response, the company seeks to consolidate market segments and reduce expenses.
Strategies for commercialization
The commercialization process isn’t easy. Even if a new product makes it this far, success’s not guaranteed. That said, if you deploy the following strategies, you can increase the odds that your product can establish a foothold:
- Practice supply chain management – One of the most important juggling acts involves physically bringing the product to the market without detracting from product quality. Product lifecycle management involves four major facets, including packaging & labeling, inventory management & transportation, product distribution, and product tracking and tracing. Here, practicing demand management and utilizing available technologies can facilitate all aspects of supply chain management.
- Monitor post-launch success – Post-launch success requires constant campaign tweaking and optimization. But, to make the best decisions possible, you’ll need to carefully monitor the relevant KPIs.
- Know and speak to your customer – There are three major reasons why a product development fails to launch: lack of communication, insufficient value propositions, and poor competitor understanding. If you want to capture the largest audience possible, you must purposefully address these common issues.
An insights management platform could provide significant value to your pharma marketing and commercialization efforts, especially when it comes to monitoring your post-launch data, better understanding customers, and improving communication between stakeholders.
The final stage is when the exclusive patent for the pharmaceutical product expires. This is what’s known as the “drug patent cliff.”
At this point, generic competition can enter the market and eat away at a company’s market share and profits. As a result, the drug’s average price drops dramatically, as does the branded drug’s market share.
During the late stage of the pharmaceutical lifecycle, the goal is to minimize market share loss. Strategies you can deploy to accomplish this include:
- Evergreening – By either extending the line of releasing a next-generation version of the drug product, a company seeks to transition existing and would-be clients from the older drug to the newly patented product. Ideally, this is done to prevent loss of exclusivity.
- Pediatric licensing – If the drug was exclusively used for adults, another loss of exclusivity countermeasure would be to expand its usage to children. Doing so could temporarily delay patent expiry.
- Maximizing profits – Many pharmaceutical companies seek to maintain or raise prices before the patent cliff. Then, after the patent has expired, they can mitigate losses by offering patient rebates, vouchers, or adherence programs.
Tech-enabled life cycle management
Developing, launching, and selling a new pharmaceutical product is an incredibly complex, expensive, and time-intensive process. And because the costs are so high and the odds of success so low, performing robust pharmaceutical lifecycle management is imperative.
Fortunately, insights management platforms designed for pharmaceutical companies can support identifying key experts, engaging audiences, and obtaining a 360-degree view of disease communities. This technology empowers teams to perform the data analysis required to make the best strategic decisions possible at each crossroad.
Our blog series discusses how insights management technology supports the drug development process.