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It takes a lot of money, time, and risk to create a new medicine and get it to market. Research and development (R&D) expenditures for a new drug range from an estimated $314 million to $2.8 billion, and the process can take up to ten years. There is no assurance that a product will be successful in the long run, despite the fact that a lot of time and money were spent developing it and getting it approved for distribution.
Drug manufacturers need a well-thought-out pharmaceutical commercialization strategy to help them break into the market, improve patient access and education, get the supply chain ready, guide marketing efforts, and increase sales in today’s competitive industry. But what does the perfect commercialization strategy for pharmaceuticals look like?
In this article, we will talk about a proper strategy for assuring the commercial success of a brand-new pharmaceutical.
How is a New Medicine Developed?
A persistent medical issue requiring a proper solution is usually the genesis for developing a new pharmaceutical treatment. Once the problem has been recognized, there are normally three major steps taken before the product is ready for release, which are-
Research and Discovery
According to the ‘International Journal of Innovation, Management, and Technology,’ there are three stages to research and discovery- locating disease-associated genes, identifying and authenticating proteins that cause disease, and locating new molecules that prevent disease. Once the framework is built, including clinical trials and case studies, a pharmaceutical company can produce real medicine using promising molecules uncovered in this early-stage testing.
Development
Preclinical and clinical testing are integral parts of the pharmaceutical development process. Preclinical testing, or testing the new drug on animals, is required before an Investigational New Drug Application (INDA2) can be filed and human trials can begin. If fast-tracked, the clinical trial process consists of three phases:
Phase One
Over the course of several months, 20–100 test subjects are used to determine the safest and most effective dosage.
Phase Two
The drug’s efficacy and negative effects are studied in as many as 200 patients with the disease or condition for as long as 24 months.
Phase Three
Up to 48 months are used to establish efficacy and monitor potential adverse responses in hundreds to thousands of people with the disease or condition.
With the right insight management platform in place, you can better understand the market, connect and cooperate with HCPs, payers, and patients, and use data-driven insights to advance your strategy across the entire clinical testing process.
FDA Drug Evaluation
Following the completion of Phase 3, the company will submit a New Drug Application (NDA) that will include everything from the trial’s preclinical phases through its current Phase 3 results. If the FDA agrees that the drug is safe and effective for its intended use based on the data provided, they will begin working with the application to generate prescribing instructions via the labeling procedure.
After making it through these hoops, a new medicine is ready for sale.
What is Commercialization?
Commercialization and product lifecycle management are the final steps in the drug development process. This step often occurs after clinical trials have concluded.
The term “commercialization” often refers to the steps businesses take to develop and implement profitable means of mass producing and distributing a product. It includes all the promotional and sales tactics a pharmaceutical firm might employ to boost demand for its product. Potential focus areas include product launch preparation, operational readiness, and payer influence.
If you want to attract people to use your new medical product, you need a plan for getting the word out to doctors, nurses, and patients. Only by having a thorough understanding of your managed-market clients is this possible in the healthcare industry. Both governmental and private organizations have significant impacts on healthcare providers’ and patients’ drug selections through their roles in drug reimbursement and access.
However, that’s only the beginning. A pharmaceutical business faces numerous challenges on the road to market entry, including regulatory oversight, market volatility, and technical and commercial hazards.
Scheduling the Commercialization of Pharmaceuticals
Generally, the pharmaceutical industry has two distinct phases: pre-launch and post-launch, though this may vary depending on the drug manufacturer.
Pre-Launch
Getting into the market should be your top priority right now. After receiving FDA approval, producers must plan their branding and marketing by determining the product’s competitive advantages.
During this phase, which might last up to two years, numerous parties’ viewpoints will need to work together. A company must tailor its marketing efforts to diverse audiences, such as healthcare professionals and patients.
Pre-launch initiatives, such as early engagement with customers to co-develop the product value proposition (aligning R&D and Commercial) while gathering insights to support the commercialization and access strategy, need to have a better customer focus. Identifying the three or four fundamental questions that characterize each drug launch is also crucial.
In order to increase the chances that your newly launched drug will be well-received by the general public, consider finding the answers to the following questions as you prepare for its launch:
- Who is the target audience for your product?
- Who or what will be in charge of distributing the product?
- Is the product intended for self-use or site-of-care administration?
- How do you fulfill the regulatory compliance requirements?
- How much information is needed to achieve market transparency?
- How do you ensure that the product has the right price and is affordable?
You’ll need the right partnerships and technological investments to succeed after launch, and answering these questions can help you do just that.
Post-Launch
Spreading the word once a product has been released is essential. The work that started with patient support programs requires constant marketing and education efforts for both providers and patients. And they work far better for pharmaceutical companies that have assembled a cross-functional team consisting of essential stakeholders.
The use of digital tools has become increasingly important in this area. In order to make the most informed judgments possible, most pharmaceutical firms are shifting toward a digital-first strategy for launching new drugs.
Launch events are, therefore, once again on the agenda. The field reps you meet and work with during a well-organized event can give you invaluable feedback on improving your messaging.
So, how will you know whether your new release was a success? Among the key performance indicators you should keep an eye on are:
Key Performance Indicators (KPIs) for Launching
They measure the interest surrounding the new product by analyzing things like:
- Coverage in News
- Generated Leads
- Traffics on websites
- Views on pages
Product Adoption KPIs
These indicators reveal whether or not the new medicine is satisfying consumer demands. Those things are:
- Use by Customers
- Retention of Users
- Product Trials
- Both internal and external qualitative feedback
Market KPIs
These metrics assess the launch’s effect on market share and revenue. For that purpose, here are some examples of KPIs:
- Revenue
- Demand and supply in the market
- Market share
- Competitive Success Rate
You can track and evaluate your campaign’s initial success across multiple dimensions with the help of an insight management tool.
Challenges Associated with Commercialization of Pharmaceuticals
Three issues, in particular, have the potential to derail the introduction of new medicine, while there are many others.
Misguided Communications
It is crucial to have open lines of communication in both the pre-launch and post-launch phases. However, many projects fail because they don’t have the communication cadence—the clear, constant messaging—required to inspire people to take action, educate them, and encourage them to become loyal to the product.
Missing USPs and value propositions
A lack of patient and stakeholder engagement frequently leads to marketing surrounding a new medicine launch that fails to appropriately represent the treatment’s most essential value propositions. Simply put, it is essential to involve patients, physicians, and other key stakeholders in medication development at every stage so that:
- The nature of their illness
- How do they react to messaging?
- Obstacles they usually face
Developers can more easily involve patients in every step of the commercialization process if they prioritize stakeholder involvement, especially with the aid of insight management systems.
Failure to properly evaluate competitors
Researching the market and your competitors will help you develop a solid commercialization plan. You can improve your own method by studying theirs, both for what worked and what didn’t. However, many pharmaceutical firms have not yet adopted tools that can reliably monitor their rivals’ actions.
Final Words
It is important to develop a proper commercialization strategy for a new pharmaceutical product in order to ensure its success and make sure that patients are benefiting from the new drug. After successfully completing the development process of a new medicine, it is essential for a pharmaceutical company to go through the phases of pre-launch and post-launch stages of the drug so that it can do well in the market and make sure to sustain itself despite consistent competition from other pharmaceutical companies. With a proper commercialization strategy in place, a drug is more likely to sustain itself in the market and achieve more sales and customer usage to ensure high revenue for the company.