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The global continuous manufacturing market size is estimated to be worth USD 2,080 million in 2023 and anticipated to grow at a CAGR of 6.4% during the forecast period.
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Continuous manufacturing involves the production of pharmaceutical drug substance / drug products in a single run, while operating 24×7. In this process, the drug is developed from its base ingredients / raw materials and processed to the final product in one facility, without any hold time. For decades, pharmaceutical companies have been using batch processing method for drug manufacturing, wherein a specific quantity of a drug is produced through multiple sequential steps. However, batch processing / batch manufacturing of a drug substance or drug products can be slow and inefficient. As a result, drug developers have begun to adopt continuous manufacturing systems to streamline drug production process. Continuous manufacturing process has several advantages over traditional batch processing, which include reduction in facility footprint (by 70%), operational and running costs (by 40-50%) and easy scale up of continuous manufacturing process. Moreover, Food Drug Administration (FDA) is encouraging the adoption of 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. With the increasing adoption of continuous manufacturing process by drug manufacturers, the continuous manufacturing market for biologics and small molecule is likely to witness substantial market growth during the forecast period.
The market research report presents an in-depth analysis of the various companies that are engaged in the global market of continuous manufacturing, across different segments, as defined in the table below:
|Key Report Attribute
|Market Size 2023
|Type of Drug Molecule
|Purpose of Manufacturing
|Type of Product Manufactured
|Scale of Operation
|Type of Continuous Biomanufacturing Process
|Key Geographical Regions
|Key Companies Profiled
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One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential of the continuous manufacturing market, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period 2023-2035. The market report also features the likely distribution of the current and forecasted opportunity within the continuous manufacturing market across various segments, such as type of drug molecule (biologics and small molecules), purpose of manufacturing (in-house manufacturing and contract manufacturing), type of product manufactured (active pharmaceutical ingredient and finished dosage form), scale of operation (preclinical / clinical and commercial), stage of continuous bioprocessing (upstream bioprocessing and downstream bioprocessing), company size (small, mid-sized, large and very large) and key geographical regions (North America, Europe and Asia Pacific). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
Based on the type of drug molecule, the global continuous manufacturing market is categorized into small molecules and biologics. The small molecules segment occupies the highest share in 2023. However, biologics continuous manufacturing market segment is expected to witness substantial growth in the coming years.
Based on the purpose of manufacturing, the global continuous manufacturing market is categorized into contract manufacturing, in-house manufacturing and both contract and in-house manufacturing. The biologics contract manufacturing segment occupies the highest share in 2023 in the overall biologics continuous manufacturing market and this trend is expected to remain same during the forecast period. This can be primarily attributed to the rise in demand for biologics (including vaccines) post COVID-19 pandemic and lack of manufacturing capacity with drug developers.
Further, presently, the small molecules in-house manufacturing segment occupies the highest share in the overall small molecules continuous manufacturing market. This can be attributed to the fact that majority of the approved small molecule drugs (manufactured using continuous manufacturing technique) are being produced by drug developers in-house.
Based on the type of product manufactured, the global continuous manufacturing market is segmented into active pharmaceutical ingredients and finished dosage forms. With the anticipated approval of continuously manufactured biologics in the coming years, biologic finished dosage forms are likely to grow at a higher CAGR as compared to active pharmaceutical ingredients.
Further, currently, small molecule finished dosage forms segment occupies the largest market share in the overall small molecule continuous manufacturing market.
Based on the scale of operation, the global continuous manufacturing market is segmented into preclinical / clinical and commercial scale of operation. Presently, the market is dominated by revenues generated from commercial scale continuous manufacturing of biologics and small molecules, followed by preclinical / clinical scales of operations. This can be attributed to the fact that at present, several approved small molecules are currently produced via continuous manufacturing technique. Further, in the coming years, more small molecule drugs and biologics manufactured utilizing continuous manufacturing technology are expected to be approved.
Based on the stage of bioprocessing, the global biologics continuous manufacturing market is segmented into upstream bioprocessing and downstream bioprocessing. Currently, the biologics continuous manufacturing market is majorly driven by upstream bioprocessing. This can be attributed to the fact that no approved biologic is presently being manufactured utilizing end-to-end continuous technology. It is worth mentioning that the upstream continuous bioprocessing is comparatively more established, owing to the extensive usage of perfusion technologies by the biologic manufacturers from past two decades
Based on the company size, the global continuous manufacturing market is segmented into small, mid-sized, large and very large companies. Presently, the market is dominated by very large and large players. This can be attributed to the fact that large and very large players have well-established facilities, which have been / are being integrated with continuous bioprocessing capabilities to improve operational efficiencies and reduce the manufacturing cost of novel biologics.
This segment highlights the distribution of continuous manufacturing market across various geographies, such as North America, Europe and Asia-Pacific. According to our projections, the biologics continuous manufacturing market in Europe is likely to capture majority (39.6%) of the share, and this trend is unlikely to change in the future. It is worth highlighting that the market in Asia-Pacific is expected to grow at a relatively healthy CAGR (9.1%), during the period 2023-2035.
Similarly, the small molecules continuous manufacturing market in Europe is likely to capture majority (90.1%) of the share, and this trend is unlikely to change in the future.
The “Continuous Manufacturing Market (3rd Edition): Industry Trends and Global Forecasts, till 2035 - Distribution by Type of Drug Molecule (Biologic and Small Molecule), Purpose of Manufacturing (In-House Manufacturing and Contract Manufacturing), Type of Product Manufactured (Active Pharmaceutical Ingredients and Finished Dosage Forms), Scale of Operation (Preclinical / Clinical and Commercial), Stage of Bioprocessing (Upstream Bioprocessing and Downstream Bioprocessing), Company Size (Small, Mid-Sized, Large and Very Large), and Key Geographical Regions (North America, Europe and Asia Pacific)” market report features an extensive study of the current market landscape, market size, market forecast and future opportunities for the companies involved in the continuous manufacturing market. The market report highlights the efforts of several small molecule and biologic manufacturers engaged in this rapidly emerging segment of pharmaceutical industry. Key takeaways of the small molecule and biologics continuous manufacturing market report are briefly discussed below.
Traditional pharmaceutical batch processing involves series of steps for API manufacturing / drug product manufacturing. Additionally, during batch processing, each batch goes through a sequence of steps, and the entire batch must be completed before a subsequent batch can be processed. Conversely, continuous manufacturing is an uninterrupted production process where raw materials are continuously fed, and drug substance / drug product is continuously manufactured. Moreover, continuous manufacturing offers real-time quality control, increases efficiency due to uninterrupted production process, which further reduces downtime and manufacturing costs. The abovementioned advantages offered by continuous manufacturing technology over batch processing technology makes it a promising technique for manufacturing small molecule and biologics. Additionally, production of drugs through continuous manufacturing takes less time to get regulatory approval as compared to drugs manufactured using batch processing, resulting in an estimated cost saving benefit of around USD 171-USD 537 million to the pharmaceutical manufacturers.
COVID-19 pandemic severely impacted the supply chain of key pharmaceutical ingredients, emphasizing the need for manufacturing essential medicines domestically on time to ensure supply chain resilience. It is important to note that traditional batch processing relies on complex supply chain to manufacture raw materials for API manufacturing and drug product manufacturing. Conversely, continuous manufacturing can easily accommodate scale-up and post-approval changes in drug production which is advantageous in case of drug shortages. It is worth noting that the Biden administration has supported increased funding of pharmaceutical continuous manufacturing technologies to overcome challenges associated with pharmaceutical supply chain. Such developments will support the continuous manufacturing market growth.
According to the US Food and Drug Administration, process analytical technology (PAT) is a mechanism to design, analyze, and control manufacturing process of pharmaceuticals through the measurement of critical process parameters that affect critical quality attributes of a drug substance. With the rise in adoption of continuous manufacturing, the need for continuous, real-time assurance for drug substance / drug product quality has also risen. Process analytical technology enables real-time process control, making the continuous manufacturing process more robust, facilitating production of high quality pharmaceuticals.
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 majority (~75%) of the small molecule manufacturers are focused on API manufacturing followed by the companies focused on FDF manufacturing. Further, more than 50% of the continuous small molecule manufacturers are based in Europe, followed by North America and Asia Pacific.
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 market. Further, close to 75% of the continuous biologic manufacturers offer contract manufacturing services for continuous manufacturing of the above mentioned biologics. Majority of these 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.
Several stakeholders have been forging alliances with other industry / non-industry players in continuous manufacturing market for manufacturing small molecule and biologics. It is worth highlighting that, since 2018, close to 40 strategic partnerships have been inked in the industry. Given the various advantages of continuous manufacturing process, the stakeholders are also acquiring other companies specializing in various aspects of continuous manufacturing in order to expand their existing capabilities and build a comprehensive product / service portfolio. In January 2023, Cambrex acquired Snapdragon Chemistry gaining access to the company’s continuous manufacturing technologies and know how.
Owing to the increasing adoption of continuous manufacturing system, several players in continuous manufacturing market have made significant investments in order to expand their existing facilities or establish new production plants. It is worth highlighting that over 40% of these expansions have been inked since 2021. Majority of the expansions reported in this market were focused on the expansion of existing capacity. Notably, most of the deals were focused on small molecule continuous manufacturing (~60%) followed by continuous manufacturing of biologics. Some examples of firms involved in expansion initiatives for small molecule drugs include (in alphabetical order) Ajinomoto OmniChem, Axplora, CONTINUUS Pharmaceuticals, Hovione and Kaneka. It is interesting to note that close to 50% of the expansions were primarily carried out by players based in Europe, followed by players based in North America. As such, the continuous manufacturing companies in other regions are also expected to continue to carry out capacity expansions, driving the market growth for continuous manufacturing market.
Close to 700 patents related to continuous manufacturing of small molecule and biologics have been filed, since 2020, highlighting the substantial efforts made by industry stakeholders and researchers in continuous manufacturing market. Around 40% of these patents were filed / granted in North America, followed by patents filed / granted under the jurisdiction of Asia Pacific and World Intellectual Property Organization (WIPO). In addition, the maximum number of patents focused on continuous manufacturing were filed by Genzyme, Boehringer Ingelheim, Amgen, EMD Millipore and Repligen.
The global market for continuous manufacturing (including small molecule and biologics market) is estimated to be worth USD 2,080 million in 2023. With further increase in the adoption of continuous manufacturing, the market growth is expected to be increased at a CAGR of ~6.4% over the forecast period. It is worth highlighting that, in terms of type of drug molecule, small molecule is expected to capture the majority market share of the continuous manufacturing market during the forecast period. This can be attributed to the fact that six small molecule drugs products manufactured via continuous manufacturing are currently approved by the US Food Drug Administration. As such, the development in the pharmaceutical continuous manufacturing market (small molecules) will drive the technological evolution, which will support the growth of the biologics continuous manufacturing over the long-term.
Presently, North America and Europe capture more than 60% of the overall continuous manufacturing biologics market size, and more than 90% of the overall continuous manufacturing small molecule market size. In recent years, adoption of continuous manufacturing in North America has witnessed a tremendous increase owing to the regulatory support and early approval for continuous manufacturing applications by the Food Drug Administration. It is worth highlighting that, in the coming years, owing to the anticipated increase in the establishment of continuous manufacturing facilities in Asia Pacific, this region is likely to grow at a higher CAGR as compared to other regions.
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 and Wuxi Biologics. This market report includes an easily searchable excel database of all the companies who have adopted continuous manufacturing either for biologics or small molecules.
The continuous manufacturing market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market research report includes:
Several recent developments have taken place in the field of continuous manufacturing. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall trends that have been outlined in our continuous manufacturing market analysis.
Author(s): Pemba Lahmo, Divya Nagla