Life Sciences

Key Essential Factors for Successful New Drug Commercialization

In early 2017, hundreds of Dr. Smith’s acute pancreatitis patients asked him if there was a prescription drug available to treat their particular condition. His answer, unfortunately, was always no.

As per definition on The National Pancreas Foundation website, Acute pancreatitis is an inflammatory condition of the pancreas that is painful and at times deadly. Despite the great advances in critical care medicine over the past 20 years, the mortality rate of acute pancreatitis has remained at about 10%. Diagnosis of pancreatic problems is often difficult and treatments are therefore delayed because the organ is relatively inaccessible. There are no easy ways to see the pancreas directly without surgery, and available imaging studies are often inadequate. In addition to the acute form, there are hereditary and chronic forms of pancreatitis which can devastate a person over many years. Sufferers often endure pain and malnutrition, and are most likely left with a higher risk of pancreatic cancer.

Later that year, Dr. Smith discussed the need for a drug to treat pancreatitis with a colleague, Dr. Jones, who was a biomedical researcher studying diet and pancreas function at a Medical School. Accordingly, the physician and biomedical scientist team began research on a drug to treat pancreatitis and achieved an early breakthrough in 2018. Drs. Smith and Jones subsequently applied for Phase 1 FDA approval and successfully tested their hypothesis in hundreds of acute pancreatitis patients with encouraging prospects for FDA Phase 2 & 3 approval and product commercialization. Once their drug entered the final homestretch after a long research and development road, Drs. Smith and Jones broadened their focus to consider key factors for their new drug’s commercial success.

Commercialization of a new drug can be a complex process, but can be successfully managed with appropriate market research strategies. An effective market research approach is at the heart of all robust new drug development and commercialization strategies and marks the difference between a complete success and commercial failure. Well-planned market research strategies maximize new product potential by evaluating four key factors:

Patient Population and Physician Valuation

Each year, there are more than 300,000 admissions to the hospital for treatment of acute pancreatitis, and the estimated cost of these admissions is greater than $2 billion. Between 16.5% and 25% of patients who develop acute pancreatitis experience a recurrent episode within the first several years.

Using available data to define the patient population for a new-to-market drug is a key step that influences regulatory, clinical, payer, and commercial decisions. Understanding the target patient population needs and behaviors (including medications that patients may already be taking) can help identify commercial opportunity and risk trade-offs during the early commercialization process. Including physicians in these assessments can also estimate physician perception of the new drug—such as the new product’s superiority to drugs that are already available on the market. Together, these evaluations guide strategic decision-making and scenario planning in the early stages of new drug commercialization.

Sample market insights dashboard from the Lore IO commercial analytics app.

Competitor Activity

Given that competitors’ current products will influence the commercial success of new drugs on the market, systematic assessment of competitor activity is indispensable for successfully staking a claim as a pharmaceutical pioneer. Relevant and accurate analysis of competitor activity data supports robust commercialization strategies, critical business decisions, and influential product development investments. Such analysis helps companies avoid marketing blunders in one of the four “P’s”: product, place, promotion, and price. Launching a higher priced drug in a market where a similar product is already well-promoted at a fraction of the cost can mean commercial disaster. Physicians are unlikely to prescribe and insurance companies are unlikely to reimburse a more expensive drug without significant benefits. Thorough competitor analysis helps to fine tune product and marketing strategy to avoid these potential pitfalls and ensure commercial success.

Drug Pricing and Market Access

Appropriate pricing of a new drug product makes the difference between high and no revenue. Robust comprehensive market forecast analyses are built by correctly segmenting the market (i.e., patients, insurance companies, etc.) and identifying key patient and prescriber targets. By appropriately positioning a new drug to appeal to target populations within the selected market segment, an appropriate price for the new product can also be identified. The pricing of a new drug must be (1) justified by product claims or benefits and (2) mirror the market segment’s willingness to pay for the drug in question. If a drug is not superior to the current in-market solution, a higher price tag is unlikely to be justified. Market forecast analyses can also be used to garner strong financial and commercial evidence to pitch to and attract potential investors and support future strategic commercial partnerships.

Sample payer dashboard from the Lore IO commercial analytics app.

Commercialization Uncertainty

Uncertainty will always be a part of the commercialization process. However, commercialization uncertainty can be minimized with robust and relevant forecasting and market data analytics. Systematic assessments can define value propositions for would-be patients and other paying players such as insurance companies. With a strong forecast, potential market launch risks can be significantly mitigated and support a successful launch.

Data analytics are a key part of developing strategic commercialization plans and avoiding common commercialization pitfalls. Internal company data, when combined with external data sources and advanced analytical models can identify critical insights necessary for effective strategic commercialization decisions.

In the case of Dr. Smith and Dr. Jones, their company bought data from third-party companies to perform market analysis on critical factors including: competitors, healthcare organizations (HCOs), patient claims, and patient demographics. With six months to launch the drug, they hired a Director of Commercial Operations to lead a team in appropriate data analysis and plan an effective marketing strategy. Within 3 months, the commercialization team developed a thorough breakdown of healthcare providers, revenue projections, and market areas based on actual field data. By the 6-month mark, their pancreatitis drug was released on time and became a commercial success.

A successful product launch depends on a robust and fully-integrated commercialization strategy to mitigate potential release risks and capitalize on product opportunities based on market trends. Given the ever-changing nature of market data, companies attempting to bring a drug to market must also stay on top of a dynamic marketplace. Using specialized data analytics and forecasting services can help pharmaceutical companies maximize commercialization potential, speed, and—ultimately—success.

Just like the research that Drs. Smith and Jones did, there are other clinical researches about new medical therapies for treating pancreas disease and related indications.

Hope the pancreatitis patients would have a treatment soon and FDA considers this specialty drug under Fast Track Approval process.

Note: All the names in this blog are fictional. My research on pancreatitis is inspired by the recent emergency hospitalization of my wife Dr. Shalini Saxena around Thanksgiving of 2019 because of severe abdominal pain. Later doctors diagnosed it as pancreatitis pain and transitioned her to a zero-fat diet for 3 weeks. She is doing fine now; pain has stopped but research continues along with low-fat diet for entire family.

This article was originally posted by Janardan Prasad on LinkedIn on January 16, 2020.

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