Microbiome Manufacturing Market (3rd Edition)

Microbiome Manufacturing Market (3rd Edition)

Distribution by Type of Product Manufactured (API and FDF), Type of Formulation (Solid, Liquid and Others), Type of Primary Packaging Used (Blister Packs, Glass / Plastic Bottles, Pouches / Sachets and Vials), Scale of Operation (Clinical and Commercial), Company Size (Small, Mid-sized, and Large and Very Large), Key Geographical Regions (North America, Europe, Asia-Pacific, and Rest of the World) and Leading Developers: 2023-2035 The microbiome manufacturing market is expected to reach USD 27 billion by 2023 anticipated to grow at a CAGR of 17% during the forecast period 2023-2035.

The human body hosts various communities of microbes, encompassing both beneficial and harmful species, collectively known as microbiota. Similarly, the ecosystem of commensal, symbiotic, and pathogenic microorganisms within a host system is termed the microbiome. The role of microbiota in disease development and pathogenesis has led to growing interest in microbiome-based therapeutics within the medical science community. Over the past two decades, significant advancements have been made in microbiome therapy research and its therapeutic applications. Live biotherapeutic products (LBPs), a category of microbiome therapy, utilize live microorganisms, such as bacteria, viruses, or fungi, to prevent or treat various diseases. LBPs are specifically designed for therapeutic purposes and are regulated as medicinal products or biologics in many countries. These therapeutic modalities consist of well-characterized specific strains of microorganisms extensively researched for their intended medical applications, followed by rigorous testing and clinical trials to demonstrate safety and efficacy in treating or preventing specific medical conditions. Furthermore, the microbiome-based therapeutic approach holds potential in profiling the patient's microbiome composition using gene sequencing, leading to the development of tailored treatment options.

It is noteworthy that in November 2022, the US Food and Drug Administration (FDA) approved the first microbiome-based therapy, RBX2660 (developed by Rebiotix), for the treatment of recurrent Clostridium difficile infection. With several promising microbiome-based live biotherapeutic products advancing through clinical pipelines, this emerging therapeutic segment is expected to become one of the fastest-growing global markets within the pharmaceutical industry in the coming years. Despite numerous developments in microbiome-based therapies and decades of experience in growing bacteria to produce biologics, the biotech industry still lacks sufficient infrastructure for microbiome manufacturing, including live biotherapeutic products manufacturing. Large-scale manufacturing of live bacterial therapies faces various challenges. Some key concerns for contemporary innovators include prolonged development timelines, stringent temperature control requirements, complex engineering of diverse aerobic/anaerobic strains (depending on the type of microbe), and inconsistencies related to the quality attributes of the final product. Consequently, outsourcing microbiome therapeutics manufacturing to Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs) has emerged as a lucrative option for developers of human microbiome therapies to address existing manufacturing issues. These CMOs and CDMOs, part of the broader biologics contract manufacturing market, are increasingly focusing on enhancing their offerings by incorporating novel technologies to streamline microbiome manufacturing processes, increase production efficiency, and improve quality. This trend is expected to further drive growth in both the microbiome and microbiome manufacturing markets.Report Coverage

The report comprehensively examines the microbiome manufacturing market based on type of product manufactured, type of formulation, type of primary packaging used, scale of operation, company size, key geographical regions and leading developers.

It thoroughly analyzes market influences such as drivers, restraints, opportunities, and challenges, while evaluating competitive landscapes for top players. Forecasts are provided for segment revenues across major regions.

The report provides a comprehensive overview of the human microbiota and microbiome concept, covering various microbiome therapeutics. It discusses the functions of the microbiota, highlighting insights from the Human Microbiome Project (HMP). Additionally, it outlines the manufacturing process of microbiome therapeutics, including challenges and the growing trend of outsourcing. It also lists crucial factors for innovator companies to consider when selecting a Contract Manufacturing Organization (CMO) partner.

A detailed analysis of the current landscape of microbiome manufacturing services for developing microbiome therapeutics is presented, considering parameters such as establishment year, company size, headquarters, scale of operation, type of product manufactured, primary packaging, type of microbe, services offered, number of manufacturing facilities, and microbial species used. The report also includes information on in-house manufacturers of live biotherapeutic products and microbiomes.

An in-depth overview of strategically positioned microbiome manufacturing facilities in major geographical regions (North America, Europe, and Asia-Pacific) is provided, highlighting pivotal manufacturing centers for microbiome products.

The competitiveness of microbiome manufacturing service providers is evaluated, considering factors such as establishment year, scale of operation, product type, formulation, primary packaging, number of facilities, and services offered.

Detailed profiles of companies offering contract manufacturing services for live biotherapeutic products at clinical and commercial scales are presented, focusing on company overviews, service portfolios, microbiome manufacturing facilities, recent advancements, and future prospects.

An evaluation of microbiome-centric initiatives by major pharmaceutical corporations is conducted, including partnerships, financial commitments, pipeline development, therapeutic focus areas, and portfolio breadth. A spider web analysis is used to compare these companies' activities across various parameters.

A comprehensive examination of completed, ongoing, and anticipated clinical trials involving diverse microbiome therapeutics is provided, considering parameters such as trial registration date, status, phase, patient demographics, sponsoring entity, industry participants, study methodology, therapeutic focus, and geographical regions.

The total manufacturing capacity for microbiome-based therapies is estimated based on data disclosed by industry participants, emphasizing capacity allocation across different company scales and major geographic regions.

Estimation of the annual clinical and commercial demand for microbiome therapeutics involves analyzing the target patient population participating in ongoing and planned clinical trials sponsored by both industry and non-industry entities, considering factors such as disease prevalence, trial enrollment, and market trends.

A qualitative assessment outlines key considerations for microbiome therapeutics developers when determining whether to internally manufacture their products or outsource to a Contract Manufacturing Organization (CMO).

A case study examines the current market environment of contract research organizations specializing in microbiome studies and providers of dietary supplements, detailing their founding year, organizational size, and headquarters location.

Key Market Companies

Biose

BJP Laboratories

Capsugel

Chr. Hansen

Inpac Probiotics

NIZO

WACKER

Winclove