Continuous Manufacturing Market

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)

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Continuous Manufacturing Market Size

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.

Continuous Manufacturing Market, By Type of Drug Molecule, 2023-2035 (USD Million)

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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.

Market Share Insights

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:

Global Continuous Manufacturing Market: Report Attributes / Market Segmentations

Key Report Attribute Details

Historical Trend

2018-2021

Base Year

2022

Forecast Period

2023-2035

Market Size 2023

$2,080 Million

CAGR

6.4%

Type of Drug Molecule
  • Biologics
  • Small Molecules
Purpose of Manufacturing
  • In-House Manufacturing
  • Contract Manufacturing
Type of Product Manufactured
  • Active Pharmaceutical Ingredients
  • Finished Dosage Forms
Scale of Operation
  • Preclinical / Clinical
  • Commercial
Type of Continuous Biomanufacturing Process 
  • Upstream Bioprocessing
  • Downstream Bioprocessing
Company Size
  • Small
  • Mid-Sized
  • Large
  • Very Large
Key Geographical Regions
  • North America
  • Europe
  • Asia Pacific
Key Companies Profiled
  • Abbvie Contract Manufacturing
  • ACG Group
  • Boehringer Ingelheim
  • Corden Pharma
  • Glatt Group
  • Kaneka
  • Phlow
  • WuXi Biologics
(Full list of 100+ companies captured is available in the report)
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Excel Data Packs (Complimentary) 
  • Market Landscape Analysis for Small Molecule
  • Market Landscape Analysis for Biologics
  • Company Competitiveness Analysis for Small Molecule Manufacturers
  • Company Competitiveness Analysis for Biologic Manufacturers
  • Partnership and Collaboration Analysis
  • Expansions Analysis
  • Grant Analysis
  • Patent Analysis
  • Capacity Analysis for Small Molecule Manufacturers
  • Capacity Analysis for Biologic Manufacturers
  • Market Forecast and Opportunity Analysis

 

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.

Market Segmentation Overview

Market Share by Type of Drug Molecule

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.

Market Share by Purpose of Manufacturing

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.

Market Share by Type of Product Manufactured

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.

Market Share by Scale of Operation

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.

Market Share by Stage of Bioprocessing

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

Market Share by Company Size

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.

Market Share by Key Geographical Regions

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.

Key Market Insights

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.

Continuous Manufacturing versus Batch Processing

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.

Supply Chain Disruptions are Leading to the Growing Adoption of Continuous Manufacturing System

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.

Continuous Manufacturing Market List Continuous Manufacturing Market Landscape Continuous Manufacturing Market Competitiveness Analysis


Process Analytical Technology in Continuous Manufacturing

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.

Competitive Landscape of Small Molecule Continuous Manufacturing Companies

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.

Competitive Landscape of Biologic Continuous Manufacturing Companies

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.

Market Trend Analysis: Growing Interest in Continuous Manufacturing Market is Evident from the Rise in Partnership and Expansion Activity

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.

Continuous Manufacturing Market Trends: Increase in Patent Publications Reflect the Rising Interest of Companies in Continuous Manufacturing Process

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.

Continuous Manufacturing Market Size: Biologics Segment to Hold the Largest Market Share

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.

Regional Analysis: North America and Europe Emerged as the Hub of Continuous Manufacturing; Asia Pacific to be the Fastest Growing Market

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.

Continuous Manufacturing Market Small Molecules List Continuous Manufacturing Market Scale of Operation Continuous Manufacturing Market Stakeholders

Key Players in Continuous Manufacturing Market

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.

Report Coverage

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:

  • A preface providing an introduction to the full report, Continuous Manufacturing Market, 2023-2035
  • An outline of the systematic research methodology adopted to conduct the study on continuous manufacturing market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of our findings.
  • An overview of economic factors that impact the overall continuous manufacturing market outlook, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
  • An executive summary of the key insights captured during our research, offering a high-level view of the current landscape of continuous manufacturing industry and its likely evolution in the short to mid and long term.
  • A general overview of historical evolution of continuous manufacturing, providing details on continuous manufacturing in pharmaceutical industry, regulatory landscape, early adopters of continuous manufacturing technology, anticipated shift from batch processing towards continuous manufacturing, comparison of batch processing with continuous manufacturing, key challenges and future perspectives associated with continuous manufacturing of small molecule products and biologic products.
  • A detailed assessment of the overall market landscape of the continuous biologic manufacturers, based on several relevant parameters, such as year of establishment, company size (in terms of employee count) and location of headquarters (North America, Europe and Asia Pacific). It also features a detailed analysis based on type of player (contract manufacturers, in-house drug developers and both), scale of operation (preclinical, clinical and commercial), type of biologic manufactured (antibodies, proteins / peptides, enzymes, vaccines, viral vectors and others), type of product manufactured (active pharmaceutical ingredients (API) and finished dosage forms (FDF)), location of continuous manufacturing facilities, type of continuous manufacturing facility (single-use, hybrid and multi-use), stage of bioprocessing (upstream bioprocessing, downstream bioprocessing and both), stage of upstream bioprocessing (N stage perfusion, N-1 stage perfusion and concentrated fed batch), stage of downstream bioprocessing (cell retention, centrifugation / separation, primary purification / capture, secondary purification / polishing, viral inactivation, viral clearance and continuous diafiltration / ultrafiltration), type of upstream manufacturing process (continuous and others), type of downstream manufacturing process (continuous, semi-continuous and others), type of overall manufacturing process (continuous and semi-continuous), quality certificates obtained (FDA, EMA, PMDA and others) and range of bioreactor capacity (10-100 Liters, >100-500 Liters, >500-1,500 Liters, >1,500-5,000 Liters and >5,000 Liters).
  • A detailed competitiveness analysis of the continuous biologic manufacturers based on company strength (in terms of number of years of experience of a company in this domain and company size) and product portfolio strength (in terms of scale of operation, number of biologics manufactured, type of product manufactured, type of upstream bioprocessing, type of downstream bioprocessing, type of overall manufacturing process and quality certificates obtained). 
  • A detailed assessment of the overall market landscape of the continuous small molecule manufacturers, based on several relevant parameters, such as year of establishment, company size (in terms of employee count) and location of headquarters (North America, Europe and Asia Pacific). It also features a detailed analysis on type of player (contract manufacturers, in-house drug developers and both), scale of operation (preclinical, clinical and commercial), type of dosage form (tablets / capsules, powders/ granules and liquids), type of product manufactured (active pharmaceutical ingredients (API), intermediates and finished dosage forms (FDF)), location of continuous manufacturing facilities, stage of continuous API manufacturing (chemical reaction, extraction, crystallization, distillation, filtration, purification and drying), stage of continuous FDF manufacturing (raw materials preparation, mixing and blending, granulation, drying, compression, coating, quality control and  packaging), type of API manufacturing process (continuous and semi-continuous), type of FDF manufacturing process (continuous and semi-continuous) and quality certificates obtained (FDA, EMA, PMDA, WHO, ANVISA and others).
  • A detailed competitiveness analysis of the continuous small molecule manufacturers based on company strength (in terms of number of years of experience of a company in this domain and company size) and product portfolio strength (in terms of scale of operation, number of biologics manufactured, type of API manufacturing process, type of FDF manufacturing process and quality certificates obtained). 
  • Elaborate profiles of prominent companies based in North America (shortlisted based on number of continuous manufacturing facilities) with expertise in continuous manufacturing of biologics and small molecule. Each profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and leadership team), details related to its financial performance (if available), continuous manufacturing service portfolio, dedicated continuous manufacturing facilities, recent developments and an informed future outlook. 
  • Elaborate profiles of prominent companies based in Europe (shortlisted based on number of continuous manufacturing facilities) with expertise in continuous manufacturing of biologics and small molecule. Each profile features a brief company overview (including information on year of establishment, number of employees, location of headquarters and leadership team), details related to its financial performance (if available), continuous manufacturing service portfolio, dedicated continuous manufacturing facilities, recent developments and an informed future outlook.
  • Elaborate profiles of prominent companies based in Asia Pacific (shortlisted based on number of continuous manufacturing facilities) with expertise in continuous manufacturing of biologics and small molecule. Each profile features a brief company overview (including information on year of establishment, number of employees, location of headquarters and leadership team), details related to its financial performance (if available), continuous manufacturing service portfolio, dedicated continuous manufacturing facilities, recent developments and an informed future outlook.
  • A detailed analysis of the partnerships inked between various continuous manufacturing companies, since 2018, including acquisitions, manufacturing agreements, technology development agreements, facility development / establishment agreements, technology utilization agreements, process development agreements, technology licensing agreements, research and development agreements, joint ventures, mergers and commercialization agreements.
  • A detailed analysis of the recent expansions undertaken by various companies engaged in continuous manufacturing of biologics and small molecule, based on several relevant parameters, such as year of expansion, type of expansion, company size, location of headquarters, scale of operation, type of drug molecule, type of product, location of expanded facility and amount invested in expansions. Further, the chapter highlights the most active players (in terms of number of recent expansions) and geographical distribution of the expansion activity.
  • A detailed review of close to 70 academic grants focused on continuous manufacturing of small molecule and biologics, based on several relevant parameters, such as year of grant award, amount awarded, funding institutes, support period, type of grant application, purpose of grant award, activity code, study section involved, popular NIH departments, prominent program officers, popular recipient organizations and regional distribution of the overall activity.
  • An in-depth analysis of various patents that have been filed / granted related to continuous manufacturing, since 2018, taking into consideration parameters, such as patent publication year, geographical region, CPC symbols, leading players (in terms of number of patents filled / granted) and type of organization. In addition, the chapter includes a detailed patent benchmarking and an insightful valuation analysis, highlighting the leading patents (in terms of number of citations).
  • A detailed overview of various technology gaps related to continuous downstream bioprocessing that are currently preventing its implementation, including gaps related to bioburden control, continuous multi-column chromatography, continuous viral inactivation process, continuous viral filtration process, continuous ultrafiltration / diafiltration, continuous buffer supply considerations and continuous monitoring of downstream process.
  • An overview of various initiatives undertaken by the leading pharmaceutical companies (in terms of revenues), covering both partnered as well as in-house projects.
  • A case study of the companies offering technologies / equipment that can potentially be used in continuous manufacturing of biologics, providing information on the geographical location of potential stakeholders and the type of technology / equipment provided.
  • A case study on the roadmap for the adoption of continuous manufacturing processes, discussing different strategies that can be followed by the company in order to adopt this technology or transition from batch manufacturing to continuous manufacturing.
  • An overview of the companies offering modular facilities / modular cleanrooms, highlighting applications of modular facilities in the pharmaceutical industry and their advantages over conventional pharmaceutical facilities. Additionally, it includes a detailed analysis of companies providing modular facilities based on several relevant parameters, such as type of industry served, geographical coverage and type of modular construction. Furthermore, it provides an overview of modular cleanrooms and lists the companies engaged in offering such cleanrooms with detailed analysis based on, year of establishment, location of headquarters and type of modular cleanroom offered.
  • A detailed analysis on the global installed continuous upstream bioprocessing capacity based on the information available in the public domain and insights generated via detailed secondary research. The analysis takes into consideration the installed perfusion capacity of various small, mid-sized, large, and very large companies engaged in this industry. The analysis highlights the distribution of the overall capacity across various scales of operation (preclinical, clinical, and commercial), type of player (in-house drug developers, contract manufacturers and both) and key geographical regions (North America, Europe and Asia Pacific)
  • A detailed analysis on the global installed continuous small molecule API manufacturing capacity based on the information available in the public domain and insights generated via detailed secondary research. The analysis takes into consideration the installed continuous API manufacturing capacity of various small, mid-sized, large, and very large companies engaged in this industry. The analysis highlights the distribution of the overall capacity across various scales of operation (preclinical, clinical, and commercial), type of player (in-house drug developers, contract manufacturers and both) and key geographical regions (North America, Europe and Asia Pacific)
  • A detailed market forecast analysis in order to estimate the existing market size and future opportunity for continuous manufacturing over the next 12 years. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market size during the forecast period 2023-2035. 
  • Detailed projections of the current and future opportunity within the continuous manufacturing market across different types of drug molecules, such as biologics and small molecules.
  • Detailed projections of the current and future opportunity within the continuous manufacturing market across different purposes of manufacturing, such as in-house manufacturing and contract manufacturing.
  • Detailed projections of the current and future opportunity within the continuous manufacturing market across different types of product manufactured, such as active pharmaceutical ingredients and finished dosage forms.
  • Detailed projections of the current and future opportunity within the continuous manufacturing market across different scales of operation, such as preclinical / clinical and commercial.
  • Detailed projections of the current and future opportunity within the continuous manufacturing market across different stages of continuous bioprocessing, such as upstream bioprocessing and downstream bioprocessing.
  • Detailed projections of the current and future opportunity within the continuous manufacturing market based on company size (small, mid-sized, large and very large).
  • Detailed projections of the current and future opportunity within the continuous manufacturing market across various geographies, such as North America, Europe, Asia-Pacific.
Continuous Manufacturing Market Emerging Players Continuous Manufacturing Market Partnerships and Collaborations Continuous Manufacturing Market Recent Expansions

Recent Developments in Continuous Manufacturing Market

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.

  • In May 2023, Sandoz (unit of Novartis) entered into an agreement with Just-Evotec Biologics to develop and manufacture multiple biosimilar candidates utilizing Just-Evotec’s proprietary drug substance development platform and continuous manufacturing technology.
  • In April 2023, Arranta Bio (a Recipharm firm) signed an agreement with MIT to develop a continuous manufacturing technology for mRNA therapeutics.
  • In April 2023, Exothera inked a deal with Quantoom Biosciences to gain access to Nfinity, a continuous manufacturing technology / platform for RNA synthesis.
  • In March 2023, Curia collaborated with Corning to expand and accelerate continuous-flow development and manufacturing programs for the chemical and biopharmaceutical industries globally. The collaboration marks the first global installation of Corning’s G1 production system to support higher-quality API manufacturing using flow-chemistry technology.

Author(s): Pemba Lahmo, Divya Nagla

Frequently Asked Questions

Question 1: What is continuous manufacturing?

Answer: Continuous manufacturing is defined as an uninterrupted production process where raw materials are continuously fed, and final products are continuously formed.

Question 2: What is an example of continuous manufacturing?

Answer: Continuous manufacturing is a flow production method that manufactures, produces, or processes materials without interruption.

Question 3: What is continuous manufacturing of drug products?

Answer: A method for manufacturing pharmaceutical products end-to-end, on a single, uninterrupted production line.

Question 4: What is the continuous manufacturing process FDA?

Answer: An advanced manufacturing technology that sends materials produced during each process step directly and continuously to the next step for further processing, whereby input materials are continuously fed into production and transformed, and processed output materials are continuously removed.

Question 5: Why is continuous manufacturing important?

Answer: Continuous manufacturing offers several advantages over conventional batch processing including reduction in facility footprint, reduction in operational and running costs, better quality of final product and easy scale up of the manufacturing process.

Question 6: How big is the continuous manufacturing market?

Answer: The global continuous manufacturing market size is expected to be worth around $2,080 million in 2023.

Question 7: What is the CAGR of continuous manufacturing market?

Answer: The continuous manufacturing industry is expected to grow at a CAGR of 6.4% over the forecast period.

Question 8: What are the key growth drivers in the continuous manufacturing industry?

Answer: Shortage in medicines due to disruptions in supply chain, better quality of final product, reduction in manufacturing costs and increased process efficiency.

Question 9: What are the leading market segments in the continuous manufacturing market?

Answer: Currently, in terms of type of molecule, small molecule segment captures the largest continuous manufacturing market share.

Question 10: Which region has the highest market share in the continuous manufacturing market?

Answer: Presently, North America and Europe capture more than 60% of the overall continuous biologics manufacturing market, and more than 90% of the overall continuous small molecule manufacturing market.

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