The global Continuous Manufacturing market size is expected to be worth around US$ 2.5 billion by 2030, according to a new report by Vision Research Reports.
The global Continuous Manufacturing market size was valued at US$ 919.10 million in 2020 and is anticipated to grow at a CAGR of 13.85% during forecast period 2021 to 2030.
Although batch manufacturing is the dominant mode of product development within the pharma and biopharma industry, the companies have begun shifting their focus toward continuous manufacturing (CM). The key drivers for the transition from batch to continuous manufacturing include drug shortage, more stringent requirements for consistent quality, the need for reduced processing costs, and the demand for higher and improved productivity.
Regulatory authorities are increasingly supportive of this therapeutic development model. They are encouraging the adoption of CM through releasing drafts and guidelines. Moreover, the presence of communities and organizations that are devoted to the commercialization of this market within the pharma and biopharma sector is driving the revenue. CCP Summit 2020 is one of such summits that is engaged in exploring scientific and technological advancements to address the technology challenges and accelerate upfront investment in the market.
Small molecules dominated the market with a revenue share of 75.7% in 2020 with the increasing shift in focus from batch processing to continuous manufacturing for drug development. This transition is majorly due to its several commercial advantages such as reduced equipment size, cost-effectiveness, less time consumption, and rapid final product launch.
Some companies such as Eli Lilly, GlaxoSmithKline, AstraZeneca, Merck, Bayer, and Novartis have already implemented the process in their production units. This indicates the increasing interest of major pharma players in this drug development mode for both brands and generics. Furthermore, this technology has garnered much attention in the production of small-molecule active pharmaceutical ingredients.
The large molecule/biopharmaceutical production is witnessing a similar transition. Technological advancements in single-use technologies and fully integrated control systems and optimization in upstream and downstream processing are anticipated to positively impact the growth of the biopharmaceutical continuous manufacturing segment.
Finished-product manufacturing captured the largest share of 53.9% in 2020 owing to the high penetration of drug developers adopting this technique for the production of drugs. With the emergence of new products and services by different companies, the use of continuous manufacturing processes for drug products is anticipated to increase in the coming years, thus contributing to overall segment growth.
Continuous manufacturing of active pharmaceutical ingredients (API) is an emerging trend within the pharmaceutical industry owing to the fact that it is cost-effective and less time-consuming. A substantial number of companies around the world use this technique for API production. Pfizer is one of such companies, which is implementing a hybrid approach for continuous API manufacturing.
Solid formulations dominated the market in 2020 with a revenue share of 63.3%. As of November 2018, five solid dosage drugs have received FDA approvals, which are manufactured by continuous manufacturing. This has resulted in the dominance of this segment. Furthermore, companies such as Merck, GEA group, and Pfizer are innovating new products, such as the Portable Continuous Miniature and Modular (PCMM) system by Pfizer, which is anticipated to increase the use of this manufacturing process for solid dosage manufacturing.
With the increasing use of continuous manufacturing processes in solid dosage formations, the manufacturers and companies offering products in this segment are being receptive toward the development of these manufacturing processes for liquid dosage formulations. Liquid dosage forms have several advantages such as easy handling, faster absorption than solids, and more flexibility. Such advantages can lead to the increased need for the manufacturing of liquid dosage forms.
The contract manufacturers dominated the market with a revenue share of 66.1% in 2020 with the increasing availability of this technology in the market. CMOs are continuously investing in the expansion of their production facility to advance the segment growth. For instance, in June 2019, FUJIFILM Corporation announced a funding of USD 10 million investment to establish a full scale, fully integrated contract manufacturing facility in Billingham, U.K. for non-GMP manufacturing of biopharmaceuticals.
In addition, the number of Contract Manufacturing Organizations (CMOs) embracing CM technology as a flexible manufacturing alternative continues to increase. In recent times, several new therapies are gaining fast track or Breakthrough Drug status. This shortens the clinical development path to regulatory approval. This has posed a challenge to the CMOs to significantly speed up the development processes, thereby creating avenues for this market.
The clinical segment held the largest share of 46.5% in 2020. Continuous Manufacturing (CM) technology has higher penetration in clinical production. The companies using small-scale CM systems have reported potential API savings of more than 60.0% and a significant reduction in time-to-market for the final product, thereby driving revenue flow in the clinical scale segment.
One of the key reasons for low penetration in the commercial manufacturing space is the presence of well-established batch process-based workflow and facilities. However, the drug developers are seeking flexibility in the production process, which is anticipated to accelerate the adoption of CM systems for commercial scale. The companies are collaborating to advance the commercial-scale manufacturing processes, including blending, wet or dry granulation, fluid bed drying, and tableting and coating operations.
Integrated systems provide complete end-to-end solutions for different bioprocesses. These systems are centrally automated processes that operate as a single operating unit. The benefits of integrated systems include reduced overall cost, simplified process, low risk of an operating error, better quality outcomes, and compliance with CGMP. Such advantages are anticipated to be the contributing factors for the increased use of integrated systems in continuous bioprocessing.
North America accounted for the largest revenue share of 33.8% in 2020. The increasing number of end-users that have adopted CM technology or who are planning to implement it in their facility in the North American countries have contributed to the largest share of the regional market. Furthermore, the regulatory bodies are playing a vital role in driving revenue growth in this region.
The U.S. FDA and U.S. Pharmacopoeia are developing guidelines for continuous manufacturing in the pharmaceutical industry. For instance, in February 2019, the FDA launched draft guidance for industry, “Quality Considerations for Continuous Manufacturing”, which is expected to increase the number of companies embracing this technology.
Thermo Fisher Scientific, Inc.
Sartorius Stedim Biotech
GEA Group Aktiengesellschaft
Electrolab Biotech Ltd.
Scott Equipment Company
Boehringer Ingelheim International GmbH
Therapeutics Type Outlook
Finished Product Manufacturing
Liquid & Semi-solid Formulation
Other Semi-continuous Systems
Middle East & Africa
The Continuous Manufacturing market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.
The report provides size (in terms of volume and value) of Continuous Manufacturing market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.
This report focuses on the global Continuous Manufacturing market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Continuous Manufacturing market development in United States, Europe and China.
It is pertinent to consider that in a volatile global economy, we haven’t just conducted Continuous Manufacturing market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.
In terms of production side, this report researches the Continuous Manufacturing capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.
In terms of consumption side, this report focuses on the consumption of Continuous Manufacturing by regions (countries) and application.
Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Continuous Manufacturing market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.
With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Continuous Manufacturing market companies.
Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Continuous Manufacturing market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.
The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.
Overall, this is an in-depth research report specifically for the Continuous Manufacturing industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.
The Continuous Manufacturing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Continuous Manufacturing market.
Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Continuous Manufacturing market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.
Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Continuous Manufacturing market. These factors have benefited the growth of the global market for Continuous Manufacturing. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.
New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Continuous Manufacturing. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).
In this study, the years considered to estimate the market size of Continuous Manufacturing are as follows:
Reasons to Purchase this Report:
- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.
This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.
Market Size Estimation
Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).
The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.
Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.
All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.
Market Breakdown and Data Triangulation
After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.
Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.
The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.
The study objectives of this report are: