In comparison to batch production methods, continuous manufacturing is not only cost and time-efficient, but also enables reduction in energy and manpower requirement, footprint, process-related errors and product inconsistencies
Roots Analysis has announced the addition of “Continuous Manufacturing (Small Molecules and Biologics) Market (2nd Edition), 2022 - 2035” report to its list of offerings
The outbreak COVID-19 pandemic had disruptive impact on the overall pharmaceutical supply chain, due to the absence of workers at manufacturing sites and distribution networks’ restrictions. Continuous manufacturing offers a practicable solution as the continuous processes are automated on a larger scale, and the FDA and other regulatory bodies have demonstrated interest in the transition to modern manufacturing methods, including continuous manufacturing.
Key Market Insights
Over 70 companies claim to have expertise in continuous manufacturing of small molecule / biologic drugs
The continuous manufacturing market landscape is dominated by well-established players (founded before 1990), which represent nearly 60% of the total number of stakeholders. Amongst these, close to 50% players are headquartered in Europe, followed by those based in North America (33%).
Partnership activity in this field has increased at a CAGR of 37%, between 2013 and 2021
Research agreements and technology enhancement (~20%) emerged as the most common type of partnership model adopted by stakeholders engaged in this industry. 55% of the total deals were established post 2017, with the maximum activity being reported in 2018 (13).
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Over 60 expansion initiatives were undertaken in the period 2013-2021
Majority of the expansion projects (48%) were focused on establishment of a new facility / plant, followed by the initiatives taken for incorporating continuous manufacturing technology (30%) into the existing facilities of different companies. Additionally, close to 50% of the total number of expansions were undertaken in Europe.
Over 65% of the installed continuous manufacturing capacity belongs to large players
More than 95% of the annual continuous manufacturing capacity was dedicated to the production of small molecules. In addition, 60% of the overall capacity is installed in Europe, followed by North America (26%).
Around 120 grants were awarded to support ongoing R&D activities related to continuous manufacturing, between 2016 and 2021
Collectively, the capital amount awarded to support R&D in this field was estimated to be worth USD 58 million. It is worth noting that NIGMS emerged to be the most active organization which funded 30+ projects for a period of 1-10 years. A significant proportion of grants identified in the report were awarded to the Purdue University, followed by those awarded to Massachusetts Institute of Technology.
Several patents have been filed / granted related to continuous manufacturing
More than 95% of the patents were filed / granted; of these, more than 70% have been granted to non-academic players. Further, over 45% of the total number of patents were filed / granted in North America, followed by WIPO (~30%)
North America and Europe are anticipated to capture close to 80% share in the market, by 2035
Owing to increased investment and growing initiatives for adoption of continuous manufacturing in pharmaceutical domain in order to meet the future demand, the commercial market is likely to grow at a relatively faster pace at a CAGR of 17.73% in the long term. Further, among the continuous manufacturers, contract manufacturers are expected to dominate the market in 2035, capturing more than 75% of the market share.
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Key Questions Answered
· Who are the leading players providing in the continuous manufacturing services?
· In which regions are the majority of facilities related to continuous manufacturers located?
· What is the installed, global capacity for continuous manufacturing?
· Which partnership models are commonly adopted by stakeholders engaged in providing continuous manufacturing services?
· Who are the other key stakeholders (modular facility providers and technology / equipment developers) in this domain?
· Which factors are likely to influence the evolution of market?
· How has the patent landscape evolved over the last several years?
· Which research institutes have received majority of grants related to continuous manufacturing?
· Which organizations have taken significant in-house initiatives in the field of continuous manufacturing?
· How is the current and future market opportunity likely to be distributed across key market segments?
The financial opportunity within the continuous manufacturing market has been analysed across the following segments:
Purpose of Manufacturing
· In-House
· Contract service
Scale of Operation
· Commercial
· Preclinical / Clinical
Type of Continuous Manufacturing related Service
· API Manufacturing
· Final Dosage Form Manufacturing
Type of Drug Molecule
· Biologic
· Small Molecule
Key Geographical Regions
· North America
· Europe
· Asia Pacific
The research includes profiles of key players (listed below); each profile features a brief overview of the company, recent developments (including partnerships and collaborations) and an informed future outlook.
· AbbVie Contract Manufacturing
· ACG Group
· Ajinomoto Bio-Pharma Services
· Almac Group
· Aurobindo Pharma
· Boehringer Ingelheim
· Cambrex
· Colorcon
· Corden Pharma
· GEA Group
· Glatt Pharma
· Hovione
· Kaneka
· Lonza
· Patheon
· SK Pharmteco
· STA Pharmaceuticals
· WuXi AppTec
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