Continuous Manufacturing Market

Market Size

The continuous manufacturing market valued at USD 2,599 million in 2025, is project to reach USD 2,847 million in 2026 and USD 4,193 million by 2035, representing a CAGR of 4.4% during the forecast period 2026 to 2035.

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Market Report: Key Takeaways

• In terms of type of drug molecules, the small molecules segment secures >65% of the overall revenue share of the global market.
• Bioprocessing has two stages, such as upstream bioprocessing and downstream bioprocessing. Of which, upstream bioprocessing holds the majority of the share (~95%) in 2026.
• In terms of dosage form, finished dosage forms hold the largest share (~65%) in 2026, followed by active pharmaceutical ingredients within the continuous manufacturing market by type of product manufactured.
• In terms of the scale of operation, the commercial scale of operation for biologics and small molecules captures the majority of the market share. Notably, the market for preclinical / clinical scale segment will grow at a relatively faster CAGR
• In terms of purpose of manufacturing, the market is segmented into in-house manufacturing, contract manufacturing and both. It is worth highlighting that currently, contract manufacturing segment is dominating (>70%) the market for biologics and small molecules.
• Notably, the global market analysis on company size is segmented into small, mid-sized and large. Presently, large companies segment holds the majority of the market share (~70%).
• In terms of geographical analysis, Europe is likely to hold majority of the market share in both biologics as well as small molecules.

Market Overview

Conventional pharmaceutical manufacturers use batch processing, following a series of sequential steps to produce drugs. However, this approach is associated with various challenges, including prolonged production timelines, inefficiencies in resource utilization, higher costs, and supply chain complexities. Thus, industry and non-industry players are increasingly investing in research and development activities for modernizing pharmaceutical manufacturing from batch to continuous.

Continuous manufacturing has emerged as a highly preferred approach for large-scale production of biologics and small molecules. Continuous manufacturing produces the desired product in an uninterrupted process by continuously introducing raw materials and reagents throughout a single production run. This continuous process minimizes downtime and maximizes equipment utilization, leading to higher efficiency and productivity, reduced unit costs (around 40-50%), and expediated drug commercialization.

Further, the adoption of continuous manufacturing offers several advantages, such as increased productivity and operational efficiency, and consistent product quality. Industry players are further optimizing these processes by integrating automation and real-time monitoring, which reduce human error and process variability. In addition to this, advancements in manufacturing technologies including continuous manufacturing and AI in drug manufacturing have been supported by regulatory bodies such as the FDA and EMAby issuing guidelines that expedite regulatory approvals for drugs produced using this method.

Recent Developments

• In June 2025, Recipharm Advanced Bio announced progress in its Recimagine CPS continuous xRNA manufacturing platform, which uses AI, advanced PAT, and digital process development to cut RNA drug production timelines by up to 67%. The modular platform integrates plasmid DNA and lipid nanoparticle production, enabling cost and time efficient RNA drug manufacturing from preclinical to commercial scale.
• In March 2025, STEER World entered into a collaboration with Gericke, to integrate STEER World’s patented Integraal™ continuous granulation technology with Gericke’s expertise in system integration, transforming the manufacturing of oral solid dosage.
• In January 2025, ReciBioPharm received a three-year grant from the Bill & Melinda Gates Foundation for supporting global deployment of xRNA Continuous Manufacturing technologies, with specific emphasis on enhancing access to RNA therapeutics in low- and middle-income countries.

Continuous Manufacturing Market Trends

• Partnerships and Collaborations: Continuous manufacturing service providers have forged several partnerships with other stakeholders to enhance their service portfolios. Amongst the publicly revealed partnerships and collaborations in the continuous manufacturing domain, around 55% were inked in the past three years.
• Rising Patent Publishing Activity: About 700 patents related to small molecules and biologics continuous manufacturing have been registered since 2020. It is worth noting that these patents focus on advancement in perfusion technology, automatic or computerized tools, and integrated systems designed for introduction, extraction or recirculation of materials.

Industry Experts on Continuous Manufacturing Market

The market report includes elaborate transcripts of interviews conducted with the following stakeholders:

• Founder and Chief Executive Officer, Small Organization, US
• Co-Founder and Chief Business Officer, Mid-sized Organization, US
• Chief Executive Officer, Large Organization, India
• Vice President Process Chemistry and Technology, Very Large Organization, US
• General Site Manager, Small Organization, US
• Technical Project Manager, Continuous Manufacturing and Crystallization, Very Large Organization, UK

Continuous manufacturing domain will mark a turning point in 2025. Russell Miller, (Vice-President of Global Sales and Marketing, Enzene), states, “Continuous manufacturing is on the forefront of a change in biologics manufacturing as we move forward. It has the opportunity to solve different problem statements that clients may have, whether it's product quality or cost of goods or productivity”.

Market Share Insights

Market Share by Type of Drug Molecule

• In the current year, small molecules segment dominates the market (>65%) as per continuous manufacturing market analysis. This is a result of simple production process of small molecules due to its chemical nature, in contrast to biologics, which require more complex extraction procedures from living cell.
• Vertex Pharmaceuticals’ Orkambi (fixed dose combination of lumacaftor/ivacaftor) was the first drug manufactured on a fully continuous line, to receive approval. The drug is available as a tablet form for treatment of cystic fibrosis. Other approved small molecules include Symdeko, Daurismo, Prezista, Verzenio and Trikafta.
• Biologics segment is likely to grow at a higher CAGR during the forecast period, driven by several advantages, such as high target specificity and fewer drug interactions which facilitate their application in treating various disorders, including cancer and rare disorders.
• There have been recent investments in facility expansion for continuous manufacturing of biosimilars. In September 2025, Indian CDMO Enzene announced opening of a new facility in New Jersey, US, which is set up with EnzeneX 2.0 platform, a fully connected continuous manufacturing (FCCM) technology.

Market Share by Stage of Bioprocessing

• According to our continuous manufacturing market report, upstream bioprocessing holds the major share (~95%) in 2026. This is because of the fact that upstream processing lays the foundation for downstream processing, which involves purification and formulation of the final product. Thus, efficiency and quality of the upstream processes significantly influence the yield and quality of the final product.
• In the long run, the downstream bioprocessing segment will show lucrative growth potential, growing at a relatively higher CAGR (18.9%) during the forecast period, due to the increasing productivity and consistency in the overall downstream process.

Market Share by Type of Product Manufactured

• Finished dosage forms hold the largest share (~65%) in the current year. This is a result of the increase in the approvals for the commercialization of finished doses to end-user.
• Active pharmaceutical ingredients segment shows remunerative growth potential, growing at a higher CAGR during the forecast period. This rapid growth is primarily due to the increasing flexibility in introducing quick changes to formulations and production parameters, which will play a crucial role in expediting production of small batches of custom APIs for personalized therapies or rare diseases.

Market Share by Purpose of Manufacturing

• Contract manufacturing segment dominates (>70%) the market for both biologics and small molecules in 2026. This is because of the increased competence of contract manufacturers in providing tailored solutions which allow parent companies to focus on their core competence rather than investing their resources in developing their own manufacturing facilities for production process.
• In-house manufacturing segment is likely to grow at a higher CAGR during the forecast period.

Market Share by Scale of Operation

• Commercial scale of operation for biologics and small molecules captures maximum continuous manufacturing market share (~90%) in 2026. This is a result of increased industrial adoption of perfusion based continuous bioprocessing technologies. These technologies are preferred option for manufacturing of biologic APIs that are unstable under production conditions.
• Continuous manufacturing for preclinical / clinical scale segment will grow at a relatively faster pace. Several factors, such as the growing pipeline of biopharmaceutical drugs, anticipated patent expiry of some of the blockbuster biologics, along with the rising demand of personalized medicines, strengthen the reliability of continuous manufacturing processes in both biologics and small molecule drug production.

Market Share by Company Size

• Large company segments hold majority continuous manufacturing market size (with 90% share) in the current year. This is a result of dedicated resources and capabilities with the large biologics / small molecule manufacturers which allow them rapid implementation of market trends in their manufacturing workflow as compared to mid-sized or small manufacturers.
• Mid-sized companies are making continuous investments to expand their capabilities and streamline continuous manufacturing operations. Detailed methodology across the global continuous manufacturing industry and revenue generated across various segments is available in the full report.

Market Share by Key Geographical Regions

• As per our continuous manufacturing market forecast, Europe is likely to capture majority share in both biologics (~40%) and small molecules (>50%) market segments. This is due to the efforts of researchers in R&D activities to expedite the implementation of continuous manufacturing technologies across their facilities.
• It is worth highlighting that the continuous manufacturing for small molecules will grow at a relatively faster pace in Asia-Pacific.

Market Key Insights

Competitive Landscape of Biologics 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 55% of these companies are large and very large firms, indicating the presence of well-established players in this market, which have a know-how of technological advancements related to the domain. None of the currently approved biologics is manufactured using a fully continuous process. However, an omalizumab biosimilar (AVT23) from Alvotech is the first monoclonal antibody to be manufactured using a fully continuous process. The biosimilar is manufactured using BiosanaPharma’s 3C Platform. Marketing authorization application (MAA) with EMA is planned before end of 2025.

Further, about 75% of the continuous biologic manufacturers offer contract manufacturing services for continuous manufacturing of the abovementioned biologics. Additionally, majority of these firms are located in North America (~40%) followed by Europe.

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.

Interestingly, the majority (~70%) of the small molecule manufacturers are contract manufacturers, followed by the companies that operate both as in-house developers and contract manufacturers.

Market Size Analysis: What is the Opportunity for the Continuous Manufacturing Market?

The global continuous manufacturing market size is around $ 2,847 million in 2026 and is expected to grow at a CAGR of 4.4% during the forecast period. In terms of the type of drug molecule, the small molecules segment holds the largest share of the market, driven heavily by innovations in specialized small molecule API manufacturing techniques. It is worth highlighting that the Food Drug Administration has approved about six small molecule drug products manufactured via continuous manufacturing. 

Further, the market size for biologics continuous manufacturing is likely to grow at a relatively higher CAGR of 9.9% during the forecast period. In the short-term, the growth will primarily be driven by manufacturing biosimilars using continuous manufacturing processes. Big biosimilar companies such as Sandoz have also invested in continuous manufacturing technology.

What are the Key Drivers of Continuous Manufacturing Market?

The continuous manufacturing industry is experiencing steady growth, primarily driven by the rising prevalence of chronic diseases, which has significantly increased the demand for various biologics and small molecules. To meet this growing demand, pharmaceutical companies are adopting advanced manufacturing approaches including continuous manufacturing that offers enhanced drug production capacity and efficiency. Further, continuous manufacturers use AI-driven systems to optimize production, monitor product quality in real time, and predict equipment failures, improving consistency and reducing human error.

Market Segmentation Insights

Key Report Attributes	Details
Historical Trend	Since 2021
Forecast Period	Till 2035
Market Size in 2026	$ 2,847 Million
Market Size in 2035	$ 4,193 Million
CAGR (Till 2035)	4.4%
Type of Drug Molecule	Biologics Small Molecules
Stage of Bioprocessing	Upstream Bioprocessing Downstream Bioprocessing
Type of Product Manufactured	Active Pharmaceutical Ingredients Finished Dosage Forms
Scale of Operation	Preclinical / Clinical Commercial
Purpose of Manufacturing	In-House Manufacturing Contract Manufacturing Both
Company Size	Small Mid-sized Large
Key Geographical Regions	North America Europe Asia-Pacific
Market in North America	US Mexico Puerto Rico
Market in Europe	Belgium France Germany Ireland Italy Switzerland UK Rest of Europe
Market in Asia-Pacific	Australia China India Japan Singapore South Korea Taiwan
Excel Data Packs (Complimentary)	Market Landscape (Biologics) Market Landscape (Small Molecules) Company Competitiveness Analysis (Biologics) Company Competitiveness Analysis (Small Molecules) Partnerships and Collaborations Recent Expansions Grants Analysis Patent Analysis Capacity Analysis (Biologics) Capacity Analysis (Small Molecules) Market Forecast and Opportunity Analysis
Key Players	AbbVie Contract Manufacturing Abzena AGC Biologics Boehringer Ingelheim Corden Pharma Glatt Kaneka Phlow Wuxi Biologics
PowerPoint Presentation (Complimentary)	Available
Customization Scope	15% Free Customization

Frequently Asked Questions

Question 1: What is continuous manufacturing of drug products?

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

Question 2: How big is the continuous manufacturing market?

Answer: The global market size in 2026 is expected to be around $2,847 million.

Question 3: What is anticipated CAGR of market for continuous manufacturing?

Answer: The continuous manufacturing market growth is expected at a CAGR of 4.4% over the forecast period.

Question 4: What are the key growth drivers in the continuous manufacturing industry?

Answer: The global industry is primarily driven by several factors: improved quality and consistency of the final product, lower manufacturing costs, and enhanced process efficiency.

Question 5: What are the leading market segments in the continuous manufacturing domain?

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

Question 6: Which region has the highest continuous manufacturing market share?

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

Question 7: What is an example of continuous manufacturing?

Answer: Some examples of drugs being produced with continuous manufacturing includes Orkambi, Verzenio®, Symdeko® and Trikafta.

Question 8: Who are the leading companies offering continuous manufacturing of drug products?

Answer: AbbVie Contract Manufacturing, Abzena, AGC Biologics, Boehringer Ingelheim, Corden Pharma, Glatt, Kaneka, Phlow and Wuxi Biologics.