Emergent Therapeutic Capabilities of RX Food

According to the U.S. Food and Drug Administration (FDA), Rx Food or Medical Food is a carefully prepared and processed product intended for a patient's partial or exclusive feeding. Rx food is designed to fulfill the specific nutritional needs of a disease or condition. It is used under medical supervision for the dietary treatment of that particular disease or condition.

The ingredients used in this kind of food are usually dominated by high protein, Omega 3 fatty acids, chelated zinc, isoflavone, and Vitamins and Minerals. Rx Food products are subject to available food and safety labeling requirements under the 1988 Orphan Drug Act in the USA. In Europe, it falls under "foods for special medical purposes" (FSMP).

The FDA classifies Rx Food into four categories: Nutritionally complete formulas, Nutritionally incomplete formulas, Formulas for metabolic disorders, and Oral rehydration products. The market for Rx food has been pushed by the rise in diabetic cases and a significant increase in individuals suffering from depression and ADHD. In addition, over 11 million people die from cardiovascular disease each year due to poor diet. The rise in health consciousness amongst consumers has considerably increased the demand for Rx food products.

Critical Factors Shaping the R.X. Food Industry

A) Adequate nutritional support has been a critical component for those in acute/ critical care or belonging to the group of chronically ill patients. Further, the demand for clinical nutrition has constantly been picking up pace with patients suffering from various disorders. As a result, companies are robustly investing in innovation centers that aim to introduce locally manufactured products to support the aiding group. For example, Nestle Health Sciences announced its plans to invest in a product innovation center in Taizhou, Jiangsu province of China, to tap into opportunities in the clinical nutrition sector. 

B) Oncology Patients groups have had been at higher risk of malnutrition. As per multiple studies, malnutrition is a considerable financial drain on healthcare systems, as it affects nearly 70% of hospitalized patients across the world. The cost burdens are due to frequent hospital visits, extended hospital stays, and a higher risk of developing complications. Moreover, companies such as Stern-Life have been acquiring proficiency to produce medical foods to prevent malnutrition.

C) A growing field of medical science has started to advocate "food medicine programs and interventions," which focus on providing medically tailored meals, ensuring that vulnerable populations have access to fresh, healthy foods. Increasing evidence has demonstrated that individuals living in low-income and underserved communities are disproportionately impacted by diet-related disease and chronic health conditions. Further, re-alignment of other ancillaries such as nutrition and food education, transportation, cooking materials, and resources such as financial support from various governing bodies can allow the overall medical foods market to grow.

D) Growing government advocation about unhealthy foods leading to higher diseases has made people aware of the dire consequences their diet can have on them. Further, unhealthy diets are a core reason for nearly 85% of the U.S. healthcare costs, which runs in trillions. Moreover, various start-ups are coming together to bring forward multiple market offerings that are unique.

Effect of Covid-19 on the Rx Food Market

Covid-19 has induced various psychological changes concerning health and food consumption. For example, a joint online Survey by the University of Denmark, the University of Florida, and the University of Granada show that in the initial stages of Covid-19, around 20% of the European population suffered from cardiac problems related to obesity due to the increased consumption of processed foods. Moreover, Nutrient-rich foods are particularly affected by COVID-related shocks, which exacerbates these shocks' impact on malnutrition.

However, the study also shows that the consumption trends changed to healthy dietary behaviors further down the line. Another survey by IQVIA Inc. shows that Patients with COVID-19 were almost 170% more likely to receive a new diabetes diagnosis. WHO also reported a 25% increase in Anxiety and Depression during Lockdown. This has significantly driven the market for RxFood products such as L-methyl folate and Metanx.

Common Medical Food and Their Uses:

MEDICAL FOOD	MANUFACTURER	USES
Axona (Caprylic Triglyceride)	Accera	A powder formula marketed for the dietary management of Alzheimer's disease. Axona has medium-chain triglyceride found in coconut oil.
BCAD1	Mead Johnson	An iron-fortified infant formula and medical food powder that's free of the branched-chain amino acids isoleucine and valine for infants and toddlers with maple Syrup urine disease dietary management.
Calcilo XD	Abbott Nutrition	A powdered formula for the nutrition support of infants with hypercalcemia.
Cabzero	Nestle Health Science	Ready-to-use emulsions of long-chain triglycerides for use in conditions requiring a source of LCTs.
Enterade	Entrinsic Health Solutions	Liquid formula for the dietary management of gastrointestinal dysfunction benefits individuals suffering from occasional diarrhea, cramping, dehydration, nausea, and malnutrition.
Ketonex-2	Abbott Nutrition	A powdered formula for the nutrition support of children and adults with maple syrup urine disease.
Limbrel	Primus Pharmaceuticals	A capsule marketed for osteoarthritis.
Foltx	Pamlab	It is a tablet containing 2.5 mg folic acid, 25mg pyridoxine, and 2mg cyanocobalamin and is used to treat cardiovascular disease.
GlutarAde	Nutricia	A drink mix formulated for the dietary management of glutaric aciduria Type 1
Hominex-2	Abbott Nutrition	A powdered formula for the nutritional support of adults and children with Vitamin B-Nonresponsive homocystinuria.
Low Protein Portabella Spinach Ravioli	Campbrooke Therapeutics	The company offers over 100 low-protein foods.
Propimex 1	Abbott Nutrition	A powdered formula for the nutrition support of infants and toddlers with propionic or methylmalonic academia.
Propimex 2	Abbott Nutrition	A powdered formula for the nutrition support of children and adults with propionic or methylmalonic academia.
Renastart	Nestle Health Science	A high-energy powdered formula with low levels of protein, calcium, chloride, potassium, phosphorus, and vitamin A, containing whey protein, amino acids, carbohydrate, fat vitamins, and minerals.
Tylactin RESTORE	Campbrooke Therapeutics	A powdered drink that contains a formulation of glycomacropetide and essential amino acids for use in patients with tyrosinemia types I, II, and III.
Vayarin	Vaya Pharma	A capsule for the dietary management of ADHD. It contains phosphatidylserine and Omega 3s.
Vayacog	Vaya Pharma	A capsule for the dietary management of complex lipid imbalances in early memory impairment. It contains phosphatidylserine and Omega 3s.

Source: Company Website & IndustryARC Analysis

Product Type Analysis:

• Pills - Rx food pills are specially processed and formulated for patients who require a specific dietary plan for a particular disease. The food pills usually contain vitamin & mineral dietary supplements. These days Rx food producers are also producing pills that can be directly administered via a tube.
• Powder – Powdered Rx foods are one of the more preferred forms as they are usually manufactured in a variety of flavors and are also easy to administer. A lot of dietary supplements in powder form are also considered Rx food due to the similarity in the ingredients used.
• Liquid - Rx food in Liquid form is extensively used for old age patient care. As per WHO, by 2050, the proportion of the world's population over 60 years will nearly double from 12% to 22%. The increasing population of old age patients has driven the demand for Liquid type medical foods.
• Others – Rx foods are being manufactured in several forms in order to cater to the demand of the large variety of patients the industry serves. Some nontraditional types of Rx foods include chewable bars, wafers, and even high-protein Rx Pasta.

Therapeutic Application Analysis:

• Diabetic Neuropathy – Diabetic Neuropathy can cause severe nerve damage if not dealt with at an early stage. However, a study by the American Diabetes Association reveals that the usage of prescription Rx Food containing L-methyl folate, methylcobalamin, and pyridoxal 5’-phosphate, significantly improved the level of neuropathic symptoms in patients.
• Nutritional Deficiency – Nutritional deficiencies have been linked to a variety of issues, including eyesight loss, scurvy, and beriberi, to name a few. Rx foods containing the specific lacking elements can aid in the treatment of the condition.
• ADHD – ADHD (Attention-deficit/hyperactivity disorder) is usually diagnosed during childhood and can turn into a severe mental illness if not treated properly. Rx food with high omega-3 content is usually used to deal with the illness.
• Alzheimer's disease – As of now, there are three Rx foods that claim to have benefits for Alzheimer's disease (A.D.) and memory impairment: Axona, Souvenaid, and CerefolinNAC. The National Institutes of Health (NIH) has determined that Axona can give patients an alternate energy source to glucose in the form of the ketone body -hydroxybutyrate.
• Irritable bowel syndrome (IBS) – IBS is a relatively common intestinal disorder, an accumulation of a group of symptoms together, including repeated pain in the abdomen and changes in bowel movements. With Rx foods' increasing research and development, IBS patients can now use cultured milk products enriched with proprietary strains of probiotic organisms to treat the disease. Additionally, prescribed food intake would revolve around consuming more fiber, avoiding gluten, or following a special diet known as low FODMAP diet. The population of people suffering worldwide stands for nearly 10-15%. Additionally, IBS affects between 25-45 million people in the U.S. across ages and sexes.
• Ulcerative colitis - Ulcerative colitis is an inflammatory bowel disease that causes inflammation in the digestive tract. Patients suffering from this are usually prescribed Low Fat Yoghurt, white rice, and even medicinal pasta noodles in some instances. Within the U.S. around 1 million people suffer from such a disease, with an annual incidence closing up to 14.2 per 100,000 people.
• Depression – A recent randomized controlled trial (RCT) revealed that the Rx Food Adjunctive L-methyl folate is a safe and tolerable treatment for patients with major depressive disorder. Moreover, around 2.5 million people in the U.S. have severe depression, a 1.24% increase from last year's dataset. In the bottom-ranked states, up to 19% of youth ages 12-17 experienced major depression. Additionally, the prevalence topped 14.5% who identified themselves under "more than one race".
• Others – Medical foods have been shown to be effective for treating various other diseases, including metabolic disorders, pulmonary diseases, and even cardiac problems.

Nutritional Deficiency as a percentage of U.S. Population (2020*)

(Source –National Library of Medicine and IndustryARC Analysis)

Distribution Channel Analysis:

• Offline Channels – a survey by the NIH shows that offline purchase is the preferred method for purchasing Rx Food. Around 34% of the participants purchased from pharmacies, while 18% purchased from hospitals and clinics.
• Online channel – The onset of Covid 19 has seen the popularity of online purchases skyrocket, and it is no exception with the Rx food market. The online-channel are further picking up pace due to the influx of new mobile applications developed by reliable retailers. For example, online pharmacy applications such as Netmeds and Now Rx have raised nearly $35 million and $7 million to increase their operations across the Indian region. Moreover, wider internet penetration allows for robust usage of the online channel.

Rx Food's Capabilities Are Being Investigated in Depth:

In 2017, The ASPEN Value Project conducted a study to explore the impact of Rx food, particularly concerning specific conditions, on health care costs and utilization. In 2019, the Healthcare Nutrition Council and the American Society of Nephrology (ASN) held an Rx Medical Foods Workshop. Participants in the workshop focused on issues such as the statutory term unique nutritional requirements, the regulatory term modification of a particular diet, the function of clinical guidelines, the imperative necessity of medical foods being used under medical supervision, and the distinction of foods for special dietary use from medical foods. The workshop also helps discussions related to product innovation and future research. For example, intractable epilepsy, diabetes, end-stage renal disease, and inflammatory bowel disease were all discussed as real-life instances.

The global population is predominantly unhealthy due to the drastic lifestyle change and consequently suffers from high rates of heart disease. As per the World Health Organization, more than 30% of the worldwide population suffers from cardiovascular disease. Furthermore, a study by the Centers for Disease Control and Prevention (CDC) shows that almost 40% of the worldwide population suffers from obesity. As a result, many people live with some form of the disease, which can be cured with the help of Rx Food. The workshop also concluded that more than 60% of the transitioning patients are administered Rx food orally.

Food as Medicine has a Real Financial Impact:

Source: Geisinger Health Plan

Practical Usage of Rx Foods for Specific Disease Types

A study by ANS shows that several patients in the hospitals meet only about 55% of their prescribed calorie needs and 60% of their specified protein needs. Rx Foods have been monumental in treating various diseases because they can target specific nutritional requirements required to address the condition. For example, according to a study conducted by Johns Hopkins University, keeping a rigorous Rx food diet with epileptic patients has been beneficial to epilepsy management, particularly in children.

Another Harvard Medical School study found that Diabetic Specific Rx food diets resulted in patients spending less time in the hospital and saving about $2500. Additionally, a survey by ANS shows that the diet of around 60% of End-stage renal disease(ESRD) patients lacked Vitamin K, and almost 50% of them lacked carbohydrates. Therefore, the primary Rx food products used for ESRD are Renal-friendly ONSs.

Entry of new players driving the growth of the Rx Food market:

The Rx Food industry is highly regulated, with numerous labeling regulations. Although key businesses such as Nestlé, Abbott, and Nutricia dominate the market, organizations such as Targeted Medical Pharma and Dutch Medical Food have increased their presence. The arrival of Netherlands-based Dutch Medical Food on the scene coincides with increased demand for medical foods and a consumer shift toward healthier choices. The company has introduced a new line of liquid-based Rx food products for the treatment of gastrointestinal disorders that can be utilized in a clinical or at-home scenario.

Role of Rx Food in the treatment of diabetes:

The worldwide population of diabetic patients rose from around 100 million in 1980 to over 500 million in 2021. The International Diabetes Federation (IDF) study shows that the figure will grow over 10% within 2030 and by almost 25% within 2045. Moreover, an increasing number of adults have an increased chance of developing type 2 diabetes. A study by ANS reveals that hospitals and medical centers are turning to Rx food, specifically formulated for diabetes, to cut down healthcare costs.

A study by the Harvard Medical School also shows that Type 2 Diabetes can be managed with a diabetes-specific formula containing high cereal fiber and magnesium. These formulae have been proven to be more effective than standard formulae for controlling postprandial glucose, glycated hemoglobin, and insulin response.

Figure: Worldwide Diabetic Patients Trend, 1980-2050:

Source –WHO, IDF, and IndustryARC Analysis

The Raging Issue of Insurance Coverage for Rx Food:

Insurance Coverage for R.X. Food is a complex topic as it varies from region to region. According to the Academy of Nutrition and Dietetics research, insurance coverage is a significant challenge for patients who require Rx food because the amount and products covered are unpredictable. As of now, there are no federal laws that necessitate the coverage of Rx food. However, some trends show that Insurance companies are more likely to cover medical foods for inborn errors of metabolism over-diagnoses such as sleep disorders or ADHD. The research also reveals that the costs of Rx food are usually on the higher side and may cost anywhere between $3500 to upwards of $25,000.

Another survey by Crohn's & Colitis Foundation shows that almost 10% of patients reported a lack of liquid or oral nutrition coverage. The issue has further spread to pharmacists who are finding it increasingly difficult to deal with the oblivious outlook of insurers and the patients who are incognizant of their insurance policies. Furthermore, major manufacturers such as Nestlé and Abbott typically provide support programs that teach parents how to advocate for their children and gain insurance coverage. Nonprofit groups like the Oley Foundation also donate supplies and specific formulas to children and families who require specialized enteral supplies for Rx Foods.

The U.S. Health Insurance Coverage from 2017-to 2021 across all ages (%)

Source –National Center for Health Statistics, and IndustryARC Analysis

Key Facts and Figures

• Dominant Markets: A report by the NIH shows that The United States of America, Europe (Germany, France, United Kingdom, and the Netherlands dominated the E.U.), and Japan held the most amount of share in the R.X. Food market, accounting for 33%, 28%, and 20% respectively. Because of the high prices of the items, Rx Food trends indicate a higher acceptance rate in developed countries than in underdeveloped countries.
• Market Size: The Global Rx Food Market is estimated to be $ 22,412.1 million in 2021 and is estimated to grow at a CAGR of 6.1% during the forecast period (2022-2027).
• Market Share: The Market share is held by a few key companies such as Abbott Laboratories, Nestlé Health Science, Danone S.A, and Vaya Pharma. This is due to the extensive R&D investments made by the key players.
• Dairy Products Dominate: A study by the NIH shows that dairy products, especially fermented milk, are the most popular form of ingredient for the Formulation of Rx Food. The study also shows that Yoghurt accounted for the largest share of sales among these products, with around 35%.

Conclusion

The Formulation and production of Rx food products are complex because, on the one hand, they must maintain their medicinal effects in food matrices until the end of the product shelf life. On the other hand, sensory characteristics such as flavor, texture, and appearance must be acceptable and pleasant following customer demands. However, with the advancement of medical and health science, Rx food is being developed for several therapeutic areas, such as malabsorption caused by Crohn's disease, ulcerative colitis, gastroesophageal reflux disease, and chronic intestinal disease pseudo-obstruction, insomnia, ADHD, or inherited diseases of amino acids and organic acids.

A variety of research is being carried out not only by Manufacturers but also by regional health bodies to understand the impact of medical foods on patients across several therapeutic areas. While dietary management is essential, many people miscalculate and do not follow the prescribed diets, leaving out important nutrients. Rx Food helps with this cause, and with new research being conducted, it can serve more patients with particular dietary requirements.

Due to the increase in health consciousness among consumers, there is a promising prospect for the market of Rx food due to its usual low costs and high consumer preference as compared to medicines. However, different challenges in terms of medical effects and sensory qualities may arise during Formulation, processing, and storage. Furthermore, problems related to the high prices of some products and issues related to insurance coverage need to be sorted out in order for the market to reach its full potential.

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