The Medical Foods Market
This new Marketdata study examines the little-known but growing $1.3 billion niche healthcare market of medical foods. While medical foods are gaining more widespread acceptance, they remain poorly understood by patients, pharmacists and physicians. Most doctors in the U.S. have not heard of the term 'medical food' and don't know that it is a distinct, FDA-regulated category.
Medical foods are custom made liquid solutions, used enterally, to treat people with Alzheimers, depression, PTSD, osteoporosis, oncology patients, kidney dialysis patients, and infants with NEC/colitis. These products are obtained via pharmacies, by prescription—not retail. They are not regulated like drugs but must meet GRAS standards. The market has huge potential but is hampered by a lack of a trade association, a lack of exposure, and domination by a few large players.
This is a complete analysis of: market nature and definition, history and evolution, the major medical foods products/brands, how manufacturers operate, distribution channels, the role of physicians and pharmacists, market size and structure (2011, 2015, 2020 forecasts), government regulation and FDA actions/guidelines, major end-users and demand factors, potential for use in treating 10 major diseases/conditions, major market trends, functional foods market status, issues and obstacles, and more. Includes 29 in-depth competitor profiles and market outlooks by competitors. Includes 16 tables and charts.
Medical foods are custom made liquid solutions, used enterally, to treat people with Alzheimers, depression, PTSD, osteoporosis, oncology patients, kidney dialysis patients, and infants with NEC/colitis. These products are obtained via pharmacies, by prescription—not retail. They are not regulated like drugs but must meet GRAS standards. The market has huge potential but is hampered by a lack of a trade association, a lack of exposure, and domination by a few large players.
This is a complete analysis of: market nature and definition, history and evolution, the major medical foods products/brands, how manufacturers operate, distribution channels, the role of physicians and pharmacists, market size and structure (2011, 2015, 2020 forecasts), government regulation and FDA actions/guidelines, major end-users and demand factors, potential for use in treating 10 major diseases/conditions, major market trends, functional foods market status, issues and obstacles, and more. Includes 29 in-depth competitor profiles and market outlooks by competitors. Includes 16 tables and charts.
Executive Overview of Major Findings 6-12
Summary of all report chapter highlights. Discussion of medical foods definition, industry structure, what conditions medical foods are used for, major issues & trends affecting the market, end-user demand, market size and 2020 forecasts, outlook by mfrs., distribution channels, major competitors.
Market Nature and Definition: what are medical foods?
Definition of medical foods by the FDA
History and evolution of the products since the 1950s
Diseases and medical conditions targeted
End-users
New Product Development Process – discussion.
Market position in the healthcare space
Reimbursement for Medical Food Prescriptions: private insurance, workmen’s compensation insurance.
Products: The main brands
Descriptions of products and their intended uses:
Axona (Accera)
Limbrel (Primus Pharmaceuticals)
Deplin (Pamlab)
Lofenalac (Mead Johnson Nutrition)
Neurepa
Immunolin
Table: Sample of Medical Foods Currently Sold & Their Targeted Diseases
End-User Markets & Demand Factors 26-38
Summary & discussion of main drivers of demand
Aging of the U.S. population – discussion of prevalence of chronic diseases associated with aging, to 2030 (Parkinsons, diabetes, hypertension, heart disease).
Shift to enteral nutrition.
Demand for customized medicine
PTSD – discussion of, no. of sufferers
Depression discussion of, no. of sufferers
Osteoporosis discussion of, no. of sufferers
Chronic pain discussion of, no. of sufferers
Insomnia discussion of, no. of sufferers
Kidney disease discussion of, no. of sufferers
Necrotizing enterocolitis in low birthweight infants discussion of, no. of sufferers
Alzheimer’s discussion of, no. of sufferers
Obesity discussion of, no. of sufferers
Fibromyalgia discussion of, no. of sufferers.
Tables:
U.S. population projections, by age group: 2015-2050
Population by percentage of the population: 1900 -2060
Estimated Number of Americans With Conditions That Can Be Treated With
Medical Foods: 2015
How Providers of Medical Foods Operate 39-41
Discussion of the manufacturing process, how medical foods get from the mfr. to the retail pharmacists and other healthcare facilities.
Typical profit margins, mark-ups.
Average wholesale prices
Pharmacist entrepreneurs.
Reimbursement.
On-site point-of-care dispensing, cash & carry programs.
Market Size & Growth, Forecasts 42-46
Estimates by several research companies of the market’s size and growth rates, factors affecting demand, estimated revenues for 2011, 2015, 2016, 2020 Forecast. Estimates by: BioStrategies Group,Technology Catalysts, and
Marketdata.
Global market size estimate.
Outlook for the industry by several manufacturers: obstacles to growth, positive and negative factors.
Functional Food Trends
Discussion of functional foods and nutraceuticals, usage by consumers for
Various conditions, consumer attitudes toward these products.
Distribution Channels & Target Markets 47-53
Summary: discussion of how medical foods are distributed from the manufacturers to pharmacies, physicians and the patient.
Profiles of 3 distributors: Samia, Emerson Ecologics, Xymogen.
Tables: Industry snapshots (Census data: no. of establishments, annual revenue per estab., payroll & sales per employee, etc. 1997, 2002, 2007, 2012 revenues) for:
Retail pharmacies
Mail order pharmacies
Hospitals
Long term care facilities, nursing homes
Primary care MDs & specialist MDs offices
Prescribing nurses
Registered dieticians
Home health care services
Specialized disease clinics
Government Regulation of Medical Foods 54-57
Discussion of FDA regulation and monitoring of medical foods, Orphan Drug
Act of 1984, timeline of key developments and actions
Enforcement: Warning Letters from FDA citing medical food issues, actions against various firms.
Recently issued Medical Food Guidance/Q&A document.
Insurance coverage, lack of it, not covered by Affordable Care Act.
2009 Medical Foods Equity Act – discussion.
Competitor Profiles 58-88
(company headquarters address, company history, products made and in development, specializations, acquisitions, revenues when available for public companies).
Abbott Labs
Actavis PLc (Ireland)
Acasti Pharma (Canada)
Aptalis Pharma
Cambrooke Therapeutics
Centrix Pharmaceuticals=
Entera Health
Entia Biosciences
Fresneius Kabi AG
Ganeden Biotech
Laser Pharmaceuticals
Mead Johnson Nutrition Co.
MetaGenes
Metagenics
Microbiome Therapeutics
NattoPharma ASA (Norway)
Nestle Health Sciences (Pamlab, Accera, Prometheus Labs)
Nutricia North America
NVN Therapeutics
Phytomedics
Pivotal Therapeutics
Primus Pharmaceuticals
Proliant Health & Biologicals
Prismic Pharmaceuticals
Realm Labs LLC
Sigma-Tau Pharmaceuticals
SKIM (Netherlands)
Spherix
Targeted Medical Pharma
Valeant Pharmaceuticals
Vaya Pharma
Reference Directory of Market Information Sources 89-91
Directory of relevant trade associations, reports, experts, published articles, other sources.
Summary of all report chapter highlights. Discussion of medical foods definition, industry structure, what conditions medical foods are used for, major issues & trends affecting the market, end-user demand, market size and 2020 forecasts, outlook by mfrs., distribution channels, major competitors.
Market Nature and Definition: what are medical foods?
Definition of medical foods by the FDA
History and evolution of the products since the 1950s
Diseases and medical conditions targeted
End-users
New Product Development Process – discussion.
Market position in the healthcare space
Reimbursement for Medical Food Prescriptions: private insurance, workmen’s compensation insurance.
Products: The main brands
Descriptions of products and their intended uses:
Axona (Accera)
Limbrel (Primus Pharmaceuticals)
Deplin (Pamlab)
Lofenalac (Mead Johnson Nutrition)
Neurepa
Immunolin
Table: Sample of Medical Foods Currently Sold & Their Targeted Diseases
End-User Markets & Demand Factors 26-38
Summary & discussion of main drivers of demand
Aging of the U.S. population – discussion of prevalence of chronic diseases associated with aging, to 2030 (Parkinsons, diabetes, hypertension, heart disease).
Shift to enteral nutrition.
Demand for customized medicine
PTSD – discussion of, no. of sufferers
Depression discussion of, no. of sufferers
Osteoporosis discussion of, no. of sufferers
Chronic pain discussion of, no. of sufferers
Insomnia discussion of, no. of sufferers
Kidney disease discussion of, no. of sufferers
Necrotizing enterocolitis in low birthweight infants discussion of, no. of sufferers
Alzheimer’s discussion of, no. of sufferers
Obesity discussion of, no. of sufferers
Fibromyalgia discussion of, no. of sufferers.
Tables:
U.S. population projections, by age group: 2015-2050
Population by percentage of the population: 1900 -2060
Estimated Number of Americans With Conditions That Can Be Treated With
Medical Foods: 2015
How Providers of Medical Foods Operate 39-41
Discussion of the manufacturing process, how medical foods get from the mfr. to the retail pharmacists and other healthcare facilities.
Typical profit margins, mark-ups.
Average wholesale prices
Pharmacist entrepreneurs.
Reimbursement.
On-site point-of-care dispensing, cash & carry programs.
Market Size & Growth, Forecasts 42-46
Estimates by several research companies of the market’s size and growth rates, factors affecting demand, estimated revenues for 2011, 2015, 2016, 2020 Forecast. Estimates by: BioStrategies Group,Technology Catalysts, and
Marketdata.
Global market size estimate.
Outlook for the industry by several manufacturers: obstacles to growth, positive and negative factors.
Functional Food Trends
Discussion of functional foods and nutraceuticals, usage by consumers for
Various conditions, consumer attitudes toward these products.
Distribution Channels & Target Markets 47-53
Summary: discussion of how medical foods are distributed from the manufacturers to pharmacies, physicians and the patient.
Profiles of 3 distributors: Samia, Emerson Ecologics, Xymogen.
Tables: Industry snapshots (Census data: no. of establishments, annual revenue per estab., payroll & sales per employee, etc. 1997, 2002, 2007, 2012 revenues) for:
Retail pharmacies
Mail order pharmacies
Hospitals
Long term care facilities, nursing homes
Primary care MDs & specialist MDs offices
Prescribing nurses
Registered dieticians
Home health care services
Specialized disease clinics
Government Regulation of Medical Foods 54-57
Discussion of FDA regulation and monitoring of medical foods, Orphan Drug
Act of 1984, timeline of key developments and actions
Enforcement: Warning Letters from FDA citing medical food issues, actions against various firms.
Recently issued Medical Food Guidance/Q&A document.
Insurance coverage, lack of it, not covered by Affordable Care Act.
2009 Medical Foods Equity Act – discussion.
Competitor Profiles 58-88
(company headquarters address, company history, products made and in development, specializations, acquisitions, revenues when available for public companies).
Abbott Labs
Actavis PLc (Ireland)
Acasti Pharma (Canada)
Aptalis Pharma
Cambrooke Therapeutics
Centrix Pharmaceuticals=
Entera Health
Entia Biosciences
Fresneius Kabi AG
Ganeden Biotech
Laser Pharmaceuticals
Mead Johnson Nutrition Co.
MetaGenes
Metagenics
Microbiome Therapeutics
NattoPharma ASA (Norway)
Nestle Health Sciences (Pamlab, Accera, Prometheus Labs)
Nutricia North America
NVN Therapeutics
Phytomedics
Pivotal Therapeutics
Primus Pharmaceuticals
Proliant Health & Biologicals
Prismic Pharmaceuticals
Realm Labs LLC
Sigma-Tau Pharmaceuticals
SKIM (Netherlands)
Spherix
Targeted Medical Pharma
Valeant Pharmaceuticals
Vaya Pharma
Reference Directory of Market Information Sources 89-91
Directory of relevant trade associations, reports, experts, published articles, other sources.
