Mental health is gaining attention due to its impact on consumers, caregivers, and government healthcare budgets and expenses. Informed and empowered consumers demand a safer and effective solution in every walk of life, and mental health is no exception. Gut-Brain Axis (GBA), as a platform, has the potential to deliver natural & scientific solutions with clinical benefits comparable to Rx medicines.
This article canvases current ecosystem and potential opportunities for industry players to leverage. It also highlights implementation challenges with probable solutions to harness the true potential of this emerging science.
Capitalizing on Mental Health Issues
Mental wellbeing is not limited to the prevention and treatment of major disorders, such as depression, bipolar disorder, dementia, schizophrenia, and anxiety, etc. It includes effective management of emotional and psychological health. Good sleep, lack of stress, and positive mood are all essential components of mental wellness. Mental health is a growing concern and is considered a top priority for various health policies and corporate social initiatives.
- About 18% of Americans are having one or more forms of mental illness as per the State of Mental Health in America (SMHA), 2019 report. One in five adults with mental illness have an unmet need; 12.2% of adults with a mental illness in the US remain uninsured; the ratio of the mental health workforce to individuals is quite low (1:180 in Massachusetts to 1:1180 in Alabama).
- As per the WHO report for Europe in 2016, 27% of the adult population in Iceland, Norway, and Switzerland had at least one mental disorder. The count of psychiatrists to 100,000 population is low even in EU (EU15 – 12.9, countries joining the EU since 2004 – 8.9, countries in south-eastern Europe – 8, and CIS countries – 5.6).
People with mental illness are mainly dependent either on Rx medicines, counseling, or both at times. Moreover, treatment and management options are not easily accessible due to high costs, lack of time and sufficient skilled professional, and social stigma associated with mental health.
For common ailments, the consumer has a choice of OTC products, but for mental health, there are very few approved OTC products in the market. Available medications have their own challenges, including dependency, withdrawal symptoms, and lingering effect.
New scientific explorations have uncovered that gut bacteria play a pivotal role in brain development, behavior, and mood (in humans). “Gut-Brain Axis (GBA)” showcases the silver lining for individuals who seek mental wellbeing with ease of access and no dependency on medications. Initial research suggests that certain species of gut bacteria can interact with the nervous system to affect stress responses and vice-versa. There is scope for over-the-counter products to utilize GBA science to manage mental wellness with lateral benefits of ease of access, natural positioning, and low-to-no risk of dependency or withdrawal.
GBA-enabled products will aid consumers to embrace mental wellness by elevating mood and treating anxiety, stress, depression, and sleep disorders, as a preventive measure and avoid deterioration of the mental condition. It can make consumers less dependent on Rx treatment that eventually burdens the pocket of ones who are uninsured. Easy & direct consumer access will lower the burden on government healthcare spending; already undersized mental health workforce can be channelized to patients in dire need. GBA factually can deliver a lucrative opportunity for the consumer, government, and the healthcare industry, thereby allowing players in the healthcare domain to collaborate and operate to improve mental health and overall wellbeing of individuals suffering from mental disorders.
Behind the Scene – Basis of Science
In recent years, animal studies have suggested a strong link between ‘gut-brain-microbiota’ and behavioral disorders and various moods. However, more evidence through human studies is required to confirm this link. The primary investigation has led to the discovery of Psychobiotics (live microbes that provide mental benefits when ingested).
The relationship between the gut and the brain is synchronized at hormonal, immunological, and neural levels through a two-way signaling.
Key components involved in gut-brain axis communication are:
- Short-chain Fatty Acids (SCFA) such as propionate, butyrate, and acetate are bacterial metabolites that have widespread health benefits and impact the brain in many ways.
- Neurotransmitters (NT) include serotonin, acetylcholine, norepinephrine, gamma amino butyric acid, cortisol, etc.
- The intrinsic nervous system is part of the Autonomic Nervous System (ANS). It is a neuron network that governs the function of the gastrointestinal tract. There are multiple ways in which microbiota interacts with the central nervous system; the intrinsic nervous system is a communicator for this relay. Communication channels vary as per different conditions. Vagus nerve stimulation and modulation of the intestinal barrier are among the key mechanisms identified.
GBA has expanded beyond the scientific research topic and has emerged as a lucrative investment avenue with leading health and wellness players investing and collaborating with start-ups, SMEs, universities, etc. Rigorous and thorough scientific evaluation, ably supported with commercial outlook serves to be the most significant driver for the growth of the GBA category.
Platform to Build Product Types for Overall Mental Health & Wellness
The role of the healthy gut in digestive support and immunity regulation is well-known and increasingly explored at the commercial level. Certain strains are also proven to be beneficial in stress, anxiety, and depression. In a few cases, patients who did not benefit from conventional medication for mental illness has seen positive results via microbiome-based products. Thus, GBA offers possible solutions that can help consumers gain an upper hand in maintaining mental health and wellness.
Diverse product categories can be explored through GBA co-ordination. Moreover, GBA benefits are not limited to probiotic/prebiotic-based products, but it rather explores endless product development opportunities, such as:
- Nutritional products for probiotic strains to feed on and flourish
- Herbal products acting on scientific connection/pathways involving GBA to activate neurotransmitters responsible for mental health & wellness
- Human nutrition products that can assist in creating a conducive gut environment
- Apps (standalone or connected) to track gut health and recommend measures to maintain healthy gut & brain
Currently, only a handful of GBA products have reached the commercial scale primarily due to lack of strong clinical data that is quintessential to support their efficacy and potential in promoting mental health benefits. In 2016, probiotics were proven to ameliorate anxiety-like feelings and uphold a healthy mood balance among people witnessing mild-to-moderate stress.
Probio’Stick was the first probiotic product approved by Canadian Health Authorities based on GBA principle for stress, anxiety, and mood balance. Other brands available in the market include ‘Mood Probiotic,’ ‘ProbioMood,’ and ‘Lacidofil.’ Many of the GBA supplements are positioned for stress, sleep, anxiety, and mood balance; however, products for enhancing cognitive abilities are still unmarked.
Evolving regulatory guidelines, credible scientific developments, and industry collaboration/investments are strong market forces to establish GBA as a potential innovation hotspot for the future. This will unlock multiple business opportunities to position, renovate, and expand the portfolio of GBA products. These opportunities include:
- Differentiated positioning for the existing brand
- Personalized offerings to deliver consumer centricity
- Adjacency exploration (new CHC category of mental health)
- Brand line extension offering care across the mental health continuum
Overcoming the Achilles’ heel of GBA
Today consumers are becoming increasingly aware and seeking natural solutions for improving their health. However, many are still unacquainted with GBA and its health benefits. An ill-informed consumer might struggle to differentiate GBA-enabled products from general probiotic and mental well-being products.
Specific and targeted claims (backed with science) and consumer awareness will help GBA-enabled products to gain wider consumer acceptability.
Current products lack concrete evidence, which make them difficult to comply with regulatory requirements. These products are not evaluated from a treatment standpoint by drug authorities. Consequently, GBA products are positioned as dietary supplements and not as an agent for treating or managing mental disorders. A majority of studies involving GBA and the use of microbiome are preliminary and preclinical, although early research points to positive outcomes. Establishing clinical data in place through robust in-vitro or animal models, along with full-fledged clinical trials, will create a conducive regulatory atmosphere.
Compelling campaigns are most likely to guide the consumer to use GBA products owing to their benefits. However, building loyalty and inducing repeat usage will remain a key challenge in the long-run without robust clinical data or HCP endorsement. Obtaining necessary approvals for a product as a reliable treatment/management option is one of the measures enterprises can harness for long-term sustainability. Resisting/defending against the competition in the supplement category will be another challenge to overcome. Data and proprietary exclusivity could provide an edge to players to sustain in this competitive market.
The eagerness of consumers to explore newer solutions, coupled with increased disposable income of consumers and their willingness to pay for prevention/management options, provides a tremendous opportunity for CHC players to explore this untapped avenue in mental wellness. Well-regulated GBA products will overcome apprehensions about treatment guidelines and bring clarity on indications, which, in turn, will propel GBA to be a viable option for the management of mental health conditions.
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