About the Microbiome

THE MICROBIOME

The human microbiome provides metabolic and synthetic functions essential to the human health, including regulating the immune system and aiding in digestion. It also provides protection against colonization and invasion by potential microbial pathogens. Through a complex network of interacting microbes, the microbiome directly or indirectly affects physiologic and immunologic functions. An imbalance or disruption of this complex ecologic system can lead to “dysbiosis”, which is characterized by a loss of microbial diversity and is now associated with a multitude of chronic diseases and some infections.

MICROBIOME THERAPEUTICS & DYSBIOSIS

Improvement of dysbiosis through microbiome therapeutics is an exciting new frontier for medical innovation. The area of research that is best understood at present is the important role the microbiome plays in preventing recurrent Clostridium difficile infection (CDI). Dysbiosis secondary to antibiotic exposure leads to vulnerability to CDI with recurrent disease occurring in a significant subset of patients. Emerging data also support a key role of dysbiosis in inflammatory bowel disease (IBD) and other intestinal disorders such as irritable bowel syndrome (IBS), coeliac disease, and colon cancer. In fact, the role of the microbiome is now perceived to be so influential to human health that a multitude of other disorders are being explored such as allergy, asthma, metabolic syndrome, cardiovascular disease and liver disease. Finally, recognition of a potential connection of dysbiosis through the gut-brain microbiome axis has led to interest in assessing the potential role of microbiome therapeutics in neurodegenerative diseases like Alzheimer’s and Parkinson’s. Other areas of discovery in microbiome research include women’s health (bacterial vaginosis), oral medicine (dental carries), pulmonary (cystic fibrosis) and dermatology (acne).

MICROBIOME THERAPEUTICS & UNMET MEDICAL NEEDS

The unmet medical needs are substantial. The Centers for Disease Control and Prevention (CDC) estimates that 1.4 million Americans suffer from IBD, yet only a third of them respond to existing therapies. Preliminary data from microbiome therapy suggest that improvement in dysbiosis is associated with a clinical response and remission in patients with ulcerative colitis, a form of chronic IBD. Microbiome therapeutics have the potential to serve as a bridge to stabilize disease flares and delay the need for chronic immunosuppressive therapies. The CDC also recognizes C. difficile as one of the top three urgent bacterial threats in the US affecting more than 450,000 persons/year. Yet one of every four persons relapses after standard of care antibiotics, which do not kill the dormant spores that germinate in the setting of persistent dysbiosis. However, disruption of dysbiosis is associated with resolution of relapsing infection. While studies of the gut microbiome have dominated research and clinical studies, the therapeutic potential of the microbiome in other body sites is also vast. Therefore, coalition efforts will embrace a broad scope of interests.

FDA-approved Microbiome Therapeutics (MT) have vast potential to help treat a wide range of diseases and conditions across gastrointestinal, neurological, immunological, oncological, and other indications. The field has grown exponentially in the past several years including the FDA approval of the first two microbiota-based products.

4.68B

INVESTED IN MT AND DIAGNOSTICS TO DATE ⁵

433.5M

EXPECTED SIZE OF THE
MT MARKET BY 2025 ⁶

220+

MICROBIOME
BIOTECHNOLOGY
COMPANIES ⁷

700

ACTIVE MT PROGRAMS
IN VARIOUS STAGES ⁷

30%

OF PROGRAMS INVOLVE THE APPLICATION OF MT TO FIGHT INFECTIOUS DISEASES ⁷

100+

ONGOING CANCER
APPLICATION PROGRAMS ⁷

ONE-CELLED EUKARYOTE

100

The human microbiome, the complex ecosystem of micro-organisms found on and within the human body, is essential to daily human health.

HUMAN MICROBIOME

1,000

T

ROLE OF MICROBIOME

A disruption of this complex system, often referred to as dysbiosis, is associated with a multitude of chronic diseases and infections.

MICROBES CALL THE HUMAN BODY HOME ¹

DIFFERENT MICROBIAL SPECIES APPROXIMATELY ²

MAJORITY OF MICROBES RESIDE IN THE GUT ³

HELPS REGULATE IMMUNE SYSTEM

AIDS IN
DIGESTION

HELPS PROTECT FROM DISEASE

4

AFFECTS OTHER PHYSIOLOGIC AND IMMUNOLOGIC FUNCTIONS

BACTERIA

FUNGI

PROTIST

MICROBIOME THERAPEUTICS APPLICATIONS

CROHN’S DISEASE

C. DIFFICILE

INFLAMMATORY BOWEL DISEASE

ULCERATIVE COLITIS

URINARY TRACT INFECTIONS

CANCER

ALLERGIC DISEASES

METABOLIC DISEASES

ATOPIC DERMATITIS

LIVER DISEASE COMPLICATIONS

DIABETES

ALZHEIMER’S DISEASE

LEARN MORE

MTIG is a coalition of companies leading the research and development of FDA-approved microbiome therapeutics and microbiome-based products to:

IMPROVE CLINICAL OUTCOMES
& QUALITY OF LIFE

ADDRESS UNMET
MEDICAL NEEDS

REDUCE HEALTH
CARE COSTS

MTIG is committed to working with stakeholders to collaborate with patients, healthcare providers, organizations, policymakers, and others who seek tangible policy and regulatory solutions to issues in the emerging microbiome arena.