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The global pharmaceutical continuous manufacturing market size is estimated to grow by USD 548.94 million at a CAGR of 12.74% between 2023 and 2028. The pharmaceutical industry, like many others, is increasingly focused on sustainability, recognizing its importance in reducing environmental impacts, conserving resources, and meeting corporate responsibility goals. Sustainability initiatives include minimizing waste, reducing energy consumption, and implementing environmentally friendly production methods. However, continuous manufacturing methods not only enhance efficiency and product quality but also significantly reduce the environmental impact of pharmaceutical production. As the industry continues to prioritize sustainability, the global market for continuous manufacturing is expected to grow substantially during the forecast period.
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The market share growth by the final drug product manufacturing segment will be significant during the forecast period. The final drug product manufacturing segment encompasses the last stages of drug production, where APIs and other components are formulated into finished dosage forms, such as tablets, capsules, or injectables, in a continuous manufacturing process. This offers notable advantages in terms of efficiency and speed. The ability to continuously process raw materials into final dosage forms reduces production timelines and increases productivity.
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The final drug product manufacturing segment was the largest and was valued at USD 222.19 million in 2018. The global prevalence of acute and chronic diseases, including cardiovascular, neurological, orthopedic, and respiratory diseases, is increasing significantly, which is driving the demand for drugs. For instance, chronic diseases such as cancer and cardiovascular diseases (CVDs), among others, are common among people in Europe. The incidences of chronic diseases such as cancer have increased in Europe. Similarly, CVDs are also prevalent among people of all ages in Europe. As a result of growing chronic conditions, the use of drugs has become more widespread as patients seek out effective and convenient treatment options for their chronic conditions. Thus, the growing chronic conditions worldwide will drive the demand for drugs and, in turn, will propel the growth of this segment during the forecast period.
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North America is estimated to contribute 35% to the growth of the global market during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the market during the forecast period. The North American market is a dynamic and rapidly evolving sector. This region, which includes the US, Canada, and Mexico, has been at the forefront of adopting innovative manufacturing processes in the pharmaceutical industry. North America is a hub for technological innovations. The pharmaceutical industry in this region has been quick to adopt such techniques, leveraging automation, real-time monitoring, and process control. Moreover, the FDA has been supportive of technology. The FDA has issued guidance documents and conducted workshops to help pharmaceutical companies adopt this technology and also promotes with data models among manufacturers, as it enhances process control, lowers variability, and boosts the consistency and quality of the final product.
For instance, in March 2023, the FDA released the final guidelines on the use of continuous manufacturing in drug production, as mandated by the International Council for Harmonization (ICH). According to the announcement, this publication represents the proactive measures of the FDA to facilitate the pharmaceutical industry's transition to these sophisticated processes. Such initiatives from regulatory bodies will positively impact the growth of the regional market during the forecast period.
The market is witnessing significant growth, driven by the pharmaceutical industry's need for essential medicines and drugs. This demand is exacerbated by health systems striving to meet the needs of patients amidst drug shortages, particularly in areas like sterile injectable and oncology/cancer treatments. Innovative solutions like semi-continuous systems and integrated continuous manufacturing are gaining traction, offering advantages such as reduced manual handling and enhanced production efficiency. These systems cater to various manufacturing processes, including tablet production, granulation, coating, and more. With untapped emerging markets and the rising demand for biologics, the market continues to expand, offering opportunities for growth and development. There are multiple factors influencing market growth. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges.
The evolving API manufacturing scenario in developing countries is notably driving market growth. India and China are rapidly evolving as viable sources for key intermediates and bulk process intermediate (BPI). In the late 1980s and early 1990s, the majority of Chinese companies manufactured large volumes of low-cost drugs, with many focusing on fermentation products and simple synthetic compounds. Considering the presence of developed infrastructure and growing economic development, India and China have started producing high-quality APIs and drug intermediates for regulated markets. Also, innovators have started focusing on these countries for outsourcing late-stage intermediates, and a few global manufacturers have formed joint ventures with local API manufacturers. Furthermore, it was observed that the innovators are increasingly partnering with local API manufacturers for high-quality bulk manufacturing activities, particularly with those in developing countries, owing to low development and production costs.
However, developing countries are increasingly becoming significant players in API production, seeking to meet the global demand for pharmaceuticals. It offers cost-effective, efficient, and sustainable solutions that align with the objectives of these countries. This trend is expected to foster the adoption of these practices worldwide, contributing to the expansion of the market during the forecast period.
Increasing demand for continuous manufacturing in the biopharmaceutical industry is an emerging trend shaping the market growth. It is extending beyond traditional small-molecule pharmaceuticals to biologics and vaccines. The biopharmaceutical industry is embracing continuous biomanufacturing, which offers benefits in terms of process flexibility and scalability. This offers several advantages over traditional batch manufacturing, including improved efficiency, reduced costs, and enhanced product quality. This eliminates the batch-to-batch variability inherent in traditional methods, leading to a more streamlined and efficient production process. This provides real-time data and monitors the production process, allowing for immediate adjustments to ensure product quality and consistency. This continuous monitoring and control can help prevent variability and reduce the risk of product recalls, leading to a higher overall level of product quality and safety.
Further, the growing demand for innovative biopharma therapies, such as monoclonal antibodies and gene therapies, is driving the adoption of continuous manufacturing. These complex therapies require a high level of consistency and quality which makes it an ideal approach to ensure their production. Overall, the growing demand for these processes in the biopharmaceutical industry is expected to be a major driving force behind the growth of the market during the forecast period.
The high initial investment is a significant challenge hindering market growth. Transitioning from traditional batch manufacturing to continuous processes often requires substantial upfront investments in new equipment and technology. Companies may face financial constraints in making this transition. The product often demands specialized equipment and systems, which can be expensive to acquire and install. This includes continuous granulators, continuous mixers, and real-time monitoring and control systems. These capital-intensive investments can strain the budgets of pharmaceutical manufacturers, particularly smaller or emerging companies. Integrating technology into existing facilities may require facility upgrades, process modifications, and significant investments in infrastructure.
Moreover, the perceived risk of investing in a technology that may not yield immediate returns can be a barrier to entry. Companies may be uncertain about the return on investment (ROI) for continuous manufacturing. The lengthy payback period and uncertainty about the technology's long-term benefits can discourage investments. Thus, the high initial investment required can deter the growth of the market in focus during the forecast period by discouraging adoption, particularly among smaller pharmaceutical companies.
The market research report includes the adoption lifecycle of the market research and growth, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth and forecasting strategies.
Global Market Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:
Coperion GmbH - The company offers products such as pharma extruders, and process equipment.
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Million" for the period 2024 to 2028, as well as historical data from 2018 to 2022 for the following segments
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The market is experiencing significant growth, driven by advancements in technology and a focus on efficiency and quality within the pharmaceuticals industry. With initiatives like the Drug Shortage Task Force, there's a push towards integrating continuous systems for manufacturing molecules and biologics, ensuring a streamline drug production process from upstream bioprocessing to downstream bioprocessing. Continuous systems enable integrated process control and quality monitoring, reducing material waste and enhancing drug quality. This approach also facilitates staff training and optimizes the production of active pharmaceutical ingredients and finished products. From solid dosage to liquid dosage manufacturing, the emphasis is on streamlining drug production while ensuring the efficacy and safety of small molecule drugs and other pharmaceutical formulations. In addition, with an emphasis on efficiency and quality, the industry is adopting integrated continuous system for the production of active pharmaceutical ingredient and finished dosage forms.
Also, this approach encompasses solid dosage manufacturing and the utilization of pharmaceutical drug substances and base ingredients to ensure consistency and efficacy. Other semi-continuous system complement this framework, further optimizing drug production from Preclinical / clinical stages. By leveraging continuous manufacturing, pharmaceutical companies can effectively streamline processes, reducing time-to-market and enhancing product quality while maintaining the integrity of drug molecules and active pharmaceutical ingredients throughout the production cycle. Also, the adoption of innovative technologies such as semi-continuous systems and equipment like continuous coaters, continuous blenders, continuous dryers, and continuous compressors. These advancements enable seamless and efficient production processes, enhancing productivity and reducing manufacturing costs. Continuous manufacturing ensures consistent product quality and streamlines the drug development lifecycle.
Market Scope |
|
Report Coverage |
Details |
Page number |
171 |
Base year |
2023 |
Historic period |
2018-2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 12.74% |
Market Growth 2024-2028 |
USD 548.94 million |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
12.26 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 35% |
Key countries |
US, Germany, UK, China, and Japan |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
Chemtrix BV, Continuus Pharmaceuticals, Coperion GmbH, Corning Inc., Dr. Helmut Rothenberger Holding GmbH, Eli Lilly and Co., Freund Vector Corp., GE Healthcare Technologies Inc., GEA Group AG, Gebruder Lodige Maschinenbau GmbH, Gericke AG, Honeywell International Inc., Hosokawa Micron Corp., Hovione, KORSCH AG, L.B. Bohle Maschinen und Verfahren GmbH, LMT Group, Novartis AG, Pfizer Inc., Siemens AG, SK Inc., Syntegon Technology GmbH, and Thermo Fisher Scientific Inc. |
Market dynamics |
Parent market analysis, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, Market condition analysis for the market forecast period. |
Customization purview |
If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized. |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Application
7 Market Segmentation by Product
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Trends
11 Vendor Landscape
12 Vendor Analysis
13 Appendix
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