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Continuous Manufacturing Small Molecule APIs Market Size is expected to have the highest CAGR from 2022 to 2033 | Emergen Research
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Key Drivers of Market Growth
Traditional batch manufacturing methods in the pharmaceutical industry often involve multiple steps, extended production times, and higher operational costs due to downtime and material waste. Continuous manufacturing offers a streamlined, end-to-end process that reduces production time, minimizes waste, and optimizes resource use.
Pharmaceutical companies are increasingly adopting continuous manufacturing to cut costs, improve operational flexibility, and respond quickly to market demand or supply chain challenges. Leading companies such as Pfizer, Eli Lilly, GSK, and Amgen have transitioned from batch to continuous manufacturing, improving efficiency and meeting regulatory requirements more effectively.
Additionally, the rising prevalence of chronic diseases is driving the demand for therapeutic drugs. For instance, the American Cancer Society reported approximately 1.9 million new cancer cases in the U.S. in 2022. To address this, pharmaceutical companies are developing innovative medications, such as Brenzawy (bexaglifozin), approved in January 2023 for treating Type 2 diabetes. These efforts are boosting the demand for small-molecule APIs and driving market growth.
Technological Innovations Supporting Growth
Advancements in manufacturing technology, including real-time data analytics, artificial intelligence (AI), and advanced process control, are transforming pharmaceutical production. These technologies enable companies to monitor and optimize manufacturing processes, improving efficiency and ensuring product quality.
A noteworthy development is the collaboration between Quartic.ai and Bright Path Laboratories in May 2020 to develop an AI-based platform for the continuous synthesis of APIs. This partnership highlights the integration of AI and continuous flow reactor technology, setting a benchmark for the future of pharmaceutical manufacturing.
Challenges Hindering Market Growth
Despite its advantages, continuous manufacturing faces challenges due to the high initial investment required. Transitioning from traditional batch processes involves substantial capital for specialized equipment, process control systems, and real-time monitoring technologies.
This cost barrier is particularly significant for small and medium-sized pharmaceutical companies, which may lack the financial resources to invest in such technologies. Overcoming this challenge requires a thorough cost-benefit analysis to highlight the long-term savings and efficiency gains offered by continuous manufacturing.
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Market Segmentation Highlights
The market is segmented into Generic APIs and Innovative APIs:
Generic APIs: This segment held the largest market share in 2023, driven by the growing demand for affordable medications, especially in emerging economies. Continuous manufacturing enhances cost efficiency and scalability, key factors for the competitive generic drug market.
Innovative APIs: This segment is growing rapidly due to the demand for novel drugs addressing unmet medical needs in areas like oncology and infectious diseases. Continuous manufacturing supports faster development and time-to-market for these groundbreaking therapies.
Continuous Manufacturing Small Molecule APIs Top Companies and Competitive Landscape
Continuous manufacturing of small molecule Active Pharmaceutical Ingredients is an industry that is becoming an efficient and innovative sector with increasing competitiveness.
Leader players in this industry are Abbvie Inc., Sterling Pharma Solutions, Evonik Industries AG, and Cambrex Corporation, while the new entrants include Amgen and Eli Lilly.
These companies increasingly apply continuous manufacturing processes to improve productivity, lower production costs, and deliver better-quality products. Such a move from batch-type manufacturing towards a continuous process has greater flexibility and scalability in addressing the growing demands of small molecule APIs in therapeutic areas.
As regulatory agencies, too, begin to be supportive of these new manufacturing technologies, the competitive dynamics should change and give a boost to further innovation and collaboration between the firms.
In October 2023, Sterling Pharma Solutions completed the acquisition of NewChem Technologies, a UK-based contract service provider focusing on organic chemistry.
NewChem serves clients in various areas, including pharmaceuticals, diagnostics, veterinary science, biotechnology, and chemistry. This acquisition enhances Sterling's service offerings and broadens its presence in these critical sectors.
Some of the key companies in the global Continuous Manufacturing Small Molecule APIs market include:
Pfizer Inc.
GSK plc. (GlaxoSmithKline)
Vertex Pharmaceuticals Incorporated
Janssen (a subsidiary of Johnson & Johnson)
Abbvie Inc.
Sterling Pharma Solutions
Evonik Industries AG
Cambrex Corporation
Patheon (part of Thermo Fisher Scientific)
Hovione
Lonza
Phlow
Asymchem
GEA Group AG
Thermo Fisher Scientific
Corning Incorporated
Coperion GmbH
Continuus Pharmaceuticals
Chemtrix
Vapourtec Ltd
Ehrfeld Mikrotechnik GmbH
NiTech Solutions Lt
Continuous Manufacturing Small Molecule APIs Latest Industry Updates
In June 2024, Vertex Pharmaceuticals presented data on TRIKAFTA, also known as KAFTRIO in the EU and UK, at the 47th ECFS Conference in Glasgow, which took place from June 5 to 8.
In November 2023, Vertex Pharmaceuticals stated that the EMA has approved a Type II variant application for KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in conjunction with ivacaftor.
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The main report offers detailed historical data and forecasts revenue growth at a global, regional, and country level, and provides analysis of the market trends in each of the segments from 2020 to 2033:
By Equipment Outlook (Revenue, USD Million; 2020-2033)
Reactors
Crystallizers
Filtration Systems
Mixers
Heat Exchangers
Others (Dryers, etc.)
By Unit Operation Outlook (Revenue, USD Million; 2020-2033)
Synthesis
Separation & Purification
Drying
By Type Outlook (Revenue, USD Million; 2020-2033)
Generic APIs
Innovative APIs
By End Use Outlook (Revenue, USD Million; 2020-2033)
CMOs/CDMOs
Pharmaceutical Companies
Academic & Research Institutes
By Regional Outlook (Revenue, USD Million; 2020-2033)
North America
United States
Canada
Mexico
Europe
Germany
France
United Kingdom
Italy
Spain
Benelux
Rest of Europe
Asia-Pacific
China
India
Japan
South Korea
Rest of Asia-Pacific
Latin America
Brazil
Rest of Latin America
Middle East and Africa
Saudi Arabia
UAE
South Africa
Turkey
Rest of MEA
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