The Contract Manufacturing Services Market for Stem Cells is Expected to be Worth Over USD 2.5 Billion by 2030, Claims Roots Analysis

Driven by a robust and growing pipeline of stem cell therapies, the demand for development and manufacturing services for such advanced product candidates is anticipated to increase beyond the capabilities of innovator companies alone

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Roots Analysis

Aug 29, 2019, 11:15 ET

LONDON, Aug. 29, 2019 /PRNewswire/ -- Roots Analysis has announced the addition of the "Stem Cell Contract Manufacturing Market, 2019-2030" report to its list of offerings.

Owing to a highly regulated production environment and the need for state-of-the-art technologies and equipment, it is difficult for innovators to establish in-house expertise for the large-scale manufacturing of stem cell therapies. As a result, stem cell therapy developers are increasingly relying on contract manufacturing organizations (CMOs) for their product development and manufacturing needs.

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Key Market Insights

Over 80 CMOs presently claim to provide manufacturing services for stem cells therapies

The market landscape is fragmented, featuring a mix of companies of all sizes; however, small and mid-sized companies represent 70% of the overall number of industry stakeholders. It is worth highlighting that over 50% of the CMOs claim to be capable of accommodating both clinical and commercial scales of operation.

100+ strategic alliances have been inked since 2015

In fact, nearly 60% of the abovementioned deals were established post 2016. Majority of these agreements were observed to be focused on the manufacturing of various types of stem cells. It is worth highlighting that the maximum number of partnerships related to stem cell therapies were reported in 2018.

More than 80,000+ patients were reported to have been enrolled in stem cell therapy related trials, since 2010

As a result, the manufacturing demand for such therapies can be anticipated to grow significantly over the next decade. The report features detailed projections of the future clinical and commercial demand for stem cell manufacturing, based on parameters, such as target patient population, dosing frequency, dose strength, source of stem cells, type of stem cells and key geographies.

Currently, there are more than 100 facilities dedicated to stem cell manufacturing

The maximum share of the installed capacity belongs to large (more than 1,000 employees) and very large (more than 5,000 employees) companies. The report provides a detailed capacity analysis, taking into consideration the reported manufacturing capacities of industry stakeholders, and offering estimates on the distribution of the global contract manufacturing capacity for stem cell therapies, by company size, scale of operation and geography.

By 2030, North America and Europe are anticipated to capture over 70% of the market share

Overall, the market is anticipated to witness an annualized growth rate of more than 20% over the next decade. In the long-term, the opportunity is expected to be well distributed across key stakeholder companies, which offer services for a diverse range of allogenic and autologous stem cell therapies.

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Key Questions Answered

Who are the leading CMOs with expertise in stem cell production?
What is the annual clinical and commercial demand for stem cell therapies?
What is the current installed manufacturing capacity for stem cell therapies?
What are the key challenges faced by stem cell manufacturers?
What kind of partnership models (manufacturing agreements, licensing, process development, product development & commercialization, acquisitions, and others) are commonly adopted by stakeholders in this industry?
Which type of stem cells are anticipated to be responsible for generating the maximum revenues in this domain?
What fraction of stem cell manufacturing operations are presently outsourced to CMOs?
How is the current and future market opportunity likely to be distributed across key market segments?

The USD 2.5 billion (by 2030) financial opportunity within the stem cells contract manufacturing market has been analyzed across the following segments:

Scale of Operation

Preclinical
Clinical
Commercial

Size of Contract Manufacturer

Small-sized
Mid-sized
Large / Very Large

Source of Stem Cells

Autologous
Allogenic

Type of Stem Cells

Adult
Embryonic
Induced Pluripotent

Key geographical regions

North America (US)
Europe (UK, France, Germany, Italy and Spain)
Asia (Japan)
Rest of the World

The report features inputs from eminent industry stakeholders, according to whom the contract manufacturing opportunity related to stem cell therapies can be expected to witness substantial growth due to the rising demand for regenerative medicine across a number of therapeutic areas. The report includes detailed transcripts of discussions held with the following experts:

Brian Dattilo (Manager of Business Development, Waisman Biomanufacturing)
David Mckenna (Professor and American Red Cross Chair in Transfusion Medicine, University of Minnesota)
Fiona Bellot (Business Development Manager, Roslin Cell Therapies)
Gilles Devillers (General Manager, Bio Elpida)
Mathilde Girard (Department Leader, Cell Therapy Innovation and Development, YposKesi)

The research covers detailed profiles of key players (illustrative list provided below) from across key global markets (North America, Europe and Asia-Pacific); each profile provides an overview of the company, information on its service portfolio, manufacturing facilities, financial performance (if available), details on recent developments, as well as an informed future outlook.