Essential Guide to the Drug Commercialization Process
Developing a new drug and bringing it to market is cost-, time-, and risk-intensive. According to studies, it’s estimated that launching a new drug can take a decade and cost between $314 million to $2.8 billion in R&D costs. Even after all that work and investment to develop a quality product and get it approved for distribution, there’s still no guarantee that it’ll be a long-term success.
To survive this competitive space, pharmaceutical companies must engage a well-planned drug commercialization strategy that helps them enter the market, enhances patient access and education, prepares the supply chain, informs marketing activities, and drives revenue.
But what does the ideal pharmaceutical drug commercialization process look like?
Let’s review the best strategies for ensuring the success of a new drug product.
How Does a
New Drug Get Made?
The genesis of a new pharmaceutical therapy typically begins with a long-standing medical issue that requires novel treatment. Once that issue has been identified, the development process will typically follow three key stages before they’re ready to hit the market:
2. Development – The pharmaceutical development process encompasses both the preclinical and clinical test stages. Preclinical tests are first conducted on animals, and then an Investigational New Drug Application (INDA2) is filed to enter into the clinical, human testing phase. If granted accelerated approval, clinical testing is divided into three stages:
Phase I:
20 to 100 volunteers are tested for several months to ascertain the optimal safety and dosage.
Phase II:
Several hundred people with the disease or condition are tested for up to 24 months to identify the drug’s efficacy and side effects.
Phase III:
Several hundred to several thousand people with the disease or condition are tested for up to 48 months to determine the efficacy and monitor potential adverse reactions.
For this stage, deploying an insights management platform could significantly enhance the entire clinical testing process by helping you understand the market, connect and collaborate with HCPs, payers, and patients, and leverage data-driven insights to move your strategy forward.
3. FDA drug review – After phase 3 is finished, the company will file a New Drug Application (NDA), including all related information from preclinical data to Phase 3 trial data. If the FDA finds that the data conclusively shows that the drug is safe and effective for intended use, they’ll begin working with the application to develop prescribing information via the labeling process.
Having survived this gauntlet, a new drug is finally ready for commercialization.
What is
Commercialization?
The final stage of drug development is commercialization and product lifecycle management. This process typically begins at the end of clinical tests.
At its essence, commercialization is the process by which companies find commercial methods for producing a product and then bringing that product to the market. It encompasses the various marketing and sales strategies a pharmaceutical company must deploy to make their product a sales success. This may cover a wide array of concerns, ranging from product launch planning, logistical and operational readiness, and payer influence.
As with any new product, to achieve success, you must have a coherent strategy for educating and targeting medical providers, caregivers, and patients. To accomplish this in the medical space, you must be intimately familiar with your managed market customers. This can be public (government) or private (commercial) entities that play an essential role in drug reimbursement and access, while exerting influence over prescriber and patient drug choices.
But that’s just the start.
Along the long journey to launch, a pharmaceutical company will have to wrestle with several industry pressures, including regulatory requirements, industry uncertainty, and technical and commercial risks.
Drug Commercialization
Process Timeline
Although it may vary for each drug maker, the drug development and commercialization process will typically follow a binary process: pre-launch and post-launch.
Pre-Launch
At this stage, your primary task is achieving market access. Having received the green light from the FDA, manufacturers must then consider their branding and messaging strategies by identifying the product’s unique value propositions.
This stage typically takes a year or two and will involve collaboration between an array of perspectives from different stakeholders. Naturally, a brand will need to develop different strategies to reach payers, providers, and patients. According to Deloitte:
Pre-launch activities need to have a stronger customer focus, including early engagement with customers to co-develop the product value proposition (aligning R&D and Commercial) while capturing insights to inform the commercialization and access strategy. Furthermore, a critical success factor is to identify the three to four key questions that make each drug launch unique.
Although it may vary for each drug maker, the drug development and commercialization process will typically follow a binary process: pre-launch and post-launch.
Pre-Launch
Checklist
If you’re gearing up for a product launch, here are some questions you should ask in order to foster public acceptance and adoption:
01
Who is the target population for the product?
02
Who will be the entity responsible for dispensing the product?
03
Is the product going to be administered at site of care or is it self-use?
04
How can I satisfy regulatory compliance requirements?
05
What are the data requirements for market transparency?
06
How do we ensure that the product is accessible and affordable?
Finding the proper answers to these questions can help you establish the proper partnerships and technology investments necessary to thrive post-launch.
Post-Launch
After the product is launched, awareness is key.
The work that started with patient support programs must continue with ongoing provider and patient education and marketing campaigns. And these are far more effective for drug companies that are able to assemble a cross-functional team of essential stakeholders.
Today, much of this is centered upon digital methods. Most pharmaceutical companies are moving towards a digital-first approach towards a new drug launch – one that leverages the valuable data-based insights to make the best decisions possible.
That said, launch events are now back on the menu. A well-planned event creates further opportunities to establish and grow relationships with field representatives, who can also provide important insights about your messaging strategies.
Post-Launch
Checklist
So, how can you measure the success of your new launch?
There are several KPIs you should actively monitor, including:
Launch KPIs – These measure the buzz surrounding the new product launch, such as:
Leads generated
News coverage
Website traffic
Page views
Product adoption KPI – These metrics tell you whether the new drug is meeting market needs. They include:
Customer usage
User retention
Product trials
Qualitative feedback
(internal and external)
Market KPIs – These measure the market penetration and sales impact of the launch. To that end, common KPIs include:
Revenue
Market share
Competitive win rate
An insights management platform can help you monitor and gauge your campaign’s launch performance according to many of these variables.
3 Challenges of
Drug Commercialization
While there are dozens of pressing concerns for any new drug launch, three, in particular, could interfere with a successful launch:
1. Misguided communication – Establishing clear lines of communication is vital for pre- and post-launch processes. And yet, many initiatives come up short because they lack the communication cadence—the clear, consistent messaging—necessary to motivate, educate, and foster product commitment.
2. Missing USPs and value propositions – Far too often, the messaging surrounding a new drug launch fails to adequately convey the drug’s most important value props, which is usually the result of poor patient and stakeholder engagement. Put simply, patients, doctors, and other key stakeholders must be engaged throughout all stages of drug development to better understand:
Their
specific condition
How they respond
to messaging
Common challenges
they face
Focusing on stakeholder engagement, especially with the help of insights management technology, makes it easier for developers to engage with patients throughout every stage of the commercialization process.
3. Inability to accurately compare competitors – Competitor and market research can play critical roles in developing a commercialization strategy. You can learn from their success and mistakes to refine your own process. But many pharma companies fail to implement the technologies capable of accurately gauging competitor behavior and activity.
Within3 – Identifying
Actionable Insights
With an Integrated Platform
To sprout from the seed of an idea to the sapling of a product, a new drug product must undergo an arduous commercialization process – a gauntlet that renders 90% of new pharma products a failure.
Achieving success, especially in light of the transition to digital-heavy launches, is no easy feat. You must enlist a cross-functional team of key stakeholders, carefully strategize pre-launch and post-launch activities, and adopt the technologies capable of delivering actionable insights.
That’s where Within3 can tip the scales. We provide the tools you need to streamline and organize a successful launch strategy. Our insights management platform empowers you to take a data-driven approach, partner with thought leaders, and close the insight gap that contributes to the all-too-common messaging disconnect.
Want to see how Within3 can enhance your drug commercialization process? Experience a free demo today.
Sources
JAMA Network. Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018. https://jamanetwork.com/journals/jama/fullarticle/2762311#:~:text=Importance%20The%20mean%20cost%20of,market%2C%20using%20publicly%20available%20data.
IJIMT. Commercialization Process of Biopharmaceuticals Development. http://www.ijimt.org/vol8/743-CBEES.pdf
FDA. Clinical Research.
Deloitte. Pharma Launch Paradigm. https://www2.deloitte.com/content/dam/Deloitte/ch/Documents/life-sciences-health-care/ch-lshc-Pharma-Launch-paradigm.pdf
Science Direct. Why 90% of clinical drug development fails and how to improve it? https://www.sciencedirect.com/science/article/pii/S2211383522000521
