The Higher the Unmet Need, the Lower Your Marketing Costs

The Higher the Unmet Need, the Lower Your Marketing Costs

A few months ago, Sean Walter, Komal Gurnani, and Saumya Mukhopadhyay from ZS Associates published a report on the drivers of commercial launch in the pharmaceutical industry. Unsurprisingly, the unmet need was one of the most critical drivers. The higher the unmet need, the less money was needed for marketing and sales to succeed. Intuitively we all know it. So, why are there so many unsuccessful launches in the industry? According to another big consulting firm, IQVIA, only 4-6% of launches are considered excellent globally.?

One of the main reasons for failure is a vaguely defined unmet need. It means that the unmet need is understood only at a high level because someone in the company experienced it as a clinician or a patient and is very passionate about it. But little effort is put into exploring it deeper, for example, understanding the entire patient journey, stakeholders involved at every step, their decision-making process, and drivers and barriers. Finally, the unmet need is not quantified correctly, which means we are unsure how many patients at each step move into the "right" direction – obtaining the most effective therapy and better outcomes or how much the unmet need costs patients and the healthcare system. This last gap sometimes prevents the new treatment from being reimbursed, as the unmet need may not be a priority for the payers.?

Successful companies start from a thorough analysis of the unmet need based on a patient journey (in case of diseases or conditions) or a user journey (in case of diagnostics or services). At each step, they analyze what happens, why, who makes the decision, and who influences it. In addition, it's crucial to project today's trends into the future. After all, most new pharmaceutical and medical technology products will be launched a few years after being developed and approved for use.

?Patient Journey

The patient journey has very well-defined steps which fit most diseases and conditions. Below you will find a set of questions to answer. The best insights are both qualitative and quantitative.

There are a few diseases where various issues prevent proper treatment almost at every step, like post-partum depression. Despite the availability of screening, diagnostic tools, and effective treatments, only 6% of PPD patients in the US receive proper treatment. So, what's happening? Let's follow typical steps to uncover this complex unmet need.

Epidemiology

About 50% of all post-partum women report some anxiety and depression symptoms, but only 17% have symptoms serious enough to meet the criteria of post-partum depression (PPD). So, it is approximately 500,000 women annually in the United States. The two most common risk factors for PPD include previous major depressive episodes (20x increased risk) and a family history of depression or anxiety (50% of women with PPD). Also, any stress during pregnancy or around birth increases the risk of PPD. The disease is well-known and broadly described in the medical literature.

Screening

Several medical societies, such as the American College of Obstetricians and Gynecologists, the American College of Nurse-Midwives, and the US Preventive Services Task Force, recommend universal screening of pregnant and post-partum women for depression as one component of quality obstetric care. However, most of the time, it still needs to be implemented. Postnatal care focuses on the baby and breastfeeding, expecting women to come forward if they feel unwell.

Emerging science on predictive biomarkers focuses on gene expression, levels of various hormones, cytokines, zinc, vitamin D, and tryptophan metabolites. However, all of them still need to be approved for standard use.

Seeking care

Generally, women in the post-partum period seek less care than women in other periods of life. There are several reasons described in the medical literature, such as

• Stigma. 60% of women indicate stigma or shame when seeking care for anxiety and depression and fear of being labeled mentally ill.
• Poor mental health literacy by women and the public. Most cannot identify PPD symptoms, confusing them with the "baby blues" and believing that it is normal to be depressed after birth.
• Access barriers. Inability to get an appointment due to time constraints, logistics and transportation, lack of childcare, geographic distance, and unavailability of healthcare providers in their area.

Like in many other diseases, ethnic disparities exist in the access to care, resulting in African American and Hispanic women having more difficult access and poorer outcomes than White women.

Emerging evidence indicates that telehealth interventions for women with PPD result in increased accessibility and improved treatment effectiveness.

Evaluation and diagnosis

As a result of these barriers, only 30% of women with PPD are diagnosed. However, the diagnosis of PPD is not difficult. It relies on very sensitive depression scales and well-described symptoms.

There are emerging attempts to use Artificial Intelligence (AI), especially Natural Language Processing (NLP), to analyze electronic health records (EHR) for early signs of PPD and suicidal ideation.

Treatment options and brand choice

Only 15.8% of women diagnosed with PPD receive any treatment, and only 6.3% receive adequate treatment, despite the availability of pharmaceuticals and psychotherapy.

Pharmacotherapy options include SSRI and TCA antidepressants, mostly nortriptyline, paroxetine, and sertraline, which are the safest during lactation. However, women who breastfeed are very reluctant to take any pharmaceuticals.?

Psychotherapy (interpersonal or cognitive-behavioral therapy) is more limited as an option due to an inadequate number of therapists and sometimes a lack of insurance coverage. So, this treatment is less accessible than it should be.

A new pharmacologic treatment is available for severe PPD – ZULRESSO, a GABA receptor modulator. It has been recently approved by FDA, only for restricted use in severe PPD. It provides fast symptom relief when given as an IV formulation and administered under doctor’s supervision. However, women cannot breastfeed during the treatment. In addition, it costs $34,000 per treatment course plus childcare costs when a woman travels to the clinic, which creates economic barriers to its use, especially for uninsured women.

Ongoing studies assess new investigational therapies, such as other GABAergic NAS compounds (zuranolone, ganaxolone), psychedelics, probiotic supplementation, and mobile health applications (relational agents using NLP to deliver cognitive and behavioral therapy).

I did not find specific data on fulfillment, administration, and medical adherence. However, considering the barriers described above, it is plausible to assume that not all patients fulfill their prescriptions and that there is a probable delay in obtaining psychotherapy.

Treatment outcomes

Only 3.2% of PPD patients achieve timely remission. The consequences of poorly treated PPD include women's suffering and negative impact on child development and emotional bonding. In addition, 20% of maternal deaths are caused by PPD (~100 annually based on pre-pandemic data).

?What Unmet Need to Target?

Now, all these data must be summarized in a way that helps to decide what exact unmet need to target. The slide below shows one way of visualizing unmet needs along a patient journey and the main barriers. All in all, any of these steps could become a target for the company. The decision depends on the company's capabilities, competitive pressures, market trends, business and pricing models, and the potential of the unmet need. For example, a medical education company may focus on training clinicians in screening and diagnosing PPD, a pharmaceutical company will develop new drugs, and digital app developers prefer to use their skills to build an effective NLP chatbot. In addition, many innovations create value by combining different modalities. For example, a digital app may simultaneously provide education, screening tools, CBT treatment, and medical adherence tracking.

?User Journey

But not all innovative solutions in the life science industry are meant to treat patients. In such cases, a user journey is a better way to analyze the unmet need.

The process is somewhat similar and presented on the slide below. Typically in healthcare, there are four buyers besides the actual user – clinical, economic, technical, and operational. Decisions are made by the team, but the unmet need may be expressed very differently by each of them.

Research Methods

Finally, we must deploy systematic methodologies to collect data. Otherwise, the analysis may lead to incorrect conclusions. The slide below lists the most common data-gathering methods to understand the unmet need, but we should remember that the most insightful is always ethnographic research. It is a qualitative method that requires us to behave like an anthropologist who discovered a new, friendly tribe. She spends much time observing, asking open-ended questions, formulating and testing hypotheses, and in the process, gathering insights that the tribe is not even aware of. Understanding patients, clinicians, payers, and other stakeholders on such a deep level lead to unique, innovative solutions that contribute to the company's success. It is beyond the scope of this article to describe ways of conducting ethnographic research in healthcare. However, if you are interested, I will gladly share my experience.

In summary, patient and user journeys are powerful tools that any life science company should learn to utilize. They help to understand the unmet need on a deep level and in a systematic way, quantify the market potential, and help to establish the product development and go-to-market strategy.

Dr. Kasia Hein-Peters is the Founder of the?SciencePreneur Academy?in Las Vegas, NV. Every business has different challenges and innovation strategies. Dr. Hein-Peters can show you how to create a sustainable growth strategy for your medical product or service, starting with the unmet need. So get on her calendar?here.