It is worth highlighting that, Food Drug Administration (FDA) is also encouraging the adoption of a continuous manufacturing system by publishing guidance documents focused on quality considerations of continuous manufacturing process and documents related to continuous manufacturing of drug substance and drug product.

Key Report Takeaways

Around 60 players are currently engaged in continuous and semi-continuous manufacturing of biologics, worldwide; majority of these players are contract manufacturers

Presently, majority of the continuous manufacturing players are based in the US; the current market landscape of continuous biologic manufacturers features both new entrants and established players

With the rise in demand for biologics, service providers and drug developers are upgrading their technical expertise to efficiently manufacture high quality products using continuous manufacturing

Currently, close to 50 small molecule manufacturers claim to have expertise in continuous manufacturing; most of these players are large or very large firms

Most of the continuous small molecule manufacturers provide contract manufacturing services at all three scales of operation; over 40% of these manufacturers offer continuous upstream processing services

Stakeholders are actively upgrading their existing capabilities and adding new competencies in order to enhance their respective portfolios and build a competitive edge in this field

The growing interest in this domain is evident from the rise in partnership activity; in fact, the maximum number of collaborations related to continuous manufacturing were inked in 2023

Industry players are putting extensive efforts to expand their existing capacities and capabilities for both clinical and commercial scale continuous manufacturing of biologics and small molecules

Since 2020, close to 700 patents have been filed / granted by various stakeholders in order to protect the intellectual property generated within this domain; close to 30% of patents were published in 2022

Grants worth over USD 45 million, disbursed across 65+ instances, have been awarded for research related to continuous manufacturing; more than 30% of these grants extend a support period of up to five years

The continuous biologics manufacturing market is likely to grow at a CAGR of 8.8%, till 2035; presently, majority of the market share is occupied by upstream bioprocessing followed by downstream bioprocessing

The continuous small molecules manufacturing market is anticipated to grow at a CAGR of 3.4%, till 2035; North America is expected to capture the majority share (over 50%) of the market by 2035

Competitive Landscape of Continuous Manufacturing Market

Presently, close to 60 manufacturers have adopted end to end continuous manufacturing and semi-continuous manufacturing process for various types of biologics, including antibodies, enzymes, proteins / peptides, vaccines and viral vectors. It is interesting to note that close to 50% of these companies are large and very large firms, indicating the presence of well-established players in this continuous manufacturing market.

Further, close to 75% of the continuous biologic manufacturers offer contract manufacturing services for continuous manufacturing of the above-mentioned biologics. The small molecule continuous manufacturing companies landscape features close to 50 manufacturers having expertise in end-to-end continuous manufacturing or semi continuous manufacturing of drug products.

The market landscape is well-fragmented, featuring the presence of small, mid-sized, large, and very large companies, which claim to have the required expertise in continuous small molecule API manufacturing and Finished Dosage Form (FDF) manufacturing. It is interesting to highlight that the majority (~75%) of the small molecule manufacturers are focused on API manufacturing followed by the companies focused on FDF manufacturing.

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Regional Outlook

Majority of the continuous biologic manufacturers are headquartered in North America (~40%) followed by Europe and Asia Pacific. Additionally, it is important to highlight that, presently, biologics segment captures the majority share of the continuous manufacturing market. Further, more than 50% of the continuous small molecule manufacturers are based in Europe, followed by North America and Asia Pacific.

Market Key Players

Examples of key companies engaged in continuous manufacturing market (which have also been profiled in this market report; the complete list of companies is available in the full report) include:

Abbvie Contract Manufacturing

ACG Group

Boehringer Ingelheim

Corden Pharma

Glatt Group

Kaneka

Phlow

WuXi Biologics

It is interesting to note that in May 2023, Sandoz (unit of Novartis) entered into an agreement with Just-Evotec Biologics to develop and manufacture multiple biosimilar candidates utilizing Just-Evotecs proprietary drug substance development platform and continuous manufacturing technology.

Continuous Manufacturing Market Segments

Based on research, Roots Analysis has segmented the market into Type Drug Molecule, Purpose of Manufacturing, Type of Product Manufactured, Scale of Operation, Stage of Bioprocessing, Company Size and Geography.

by Type of Drug Molecule

Biologics

Small Molecules

by Purpose of Manufacturing

Contract Manufacturing

In-House Manufacturing

by Type of Product Manufactured

Active Pharmaceutical Ingredients

Finished Dosage Forms

by Scale of Operation

Preclinical / Clinical

Commercial

by Stage of Bioprocessing

Upstream Bioprocessing

Downstream Bioprocessing

by Company Size

Small

Mid-Sized

Large

Very Large

by Key Geographical Regions

North America

Europe

Asia-Pacific

About Roots Analysis

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