Pharmaceutical Hot Melt Extrusion Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 37.12 Million |
| Market Size (2029) | USD 46.90 Million |
| CAGR (2024 - 2029) | 4.79 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Low |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Pharmaceutical Hot Melt Extrusion Market Analysis
The Pharmaceutical Hot Melt Extrusion Market size is estimated at USD 37.12 million in 2024, and is expected to reach USD 46.90 million by 2029, growing at a CAGR of 4.79% during the forecast period (2024-2029).
Factors such as the growing advantages associated with pharmaceutical hot melt extrusion, the increasing adoption in the pharmaceutical industry for drug manufacturing, and the rising pharmaceutical research and development expenditure are expected to boost the market’s growth significantly.
The advantages of the pharmaceutical hot melt extrusion process are expected to enhance market growth. For instance, according to a February 2024 article published in SpringerLink, hot-melt extrusion (HME) is a globally recognized and robust technology that enhances the bioavailability (BA) of poorly soluble active pharmaceutical ingredients (APIs) and offers an efficient continuous manufacturing process.
According to the same source, HME proved highly effective in improving the solubility and dissolution of poorly water-soluble drugs by creating amorphous solid dispersions. It acts as an essential tool for producing innovative pharmaceutical products. During the process, the API is mixed at a molecular level with thermoplastic binders and/or polymers while passing through high-temperature counter-rotating or corotating screw elements. This meticulous molecular mixing process transforms the API into an amorphous form, enhancing the dissolution rate. Thus, the high effectiveness of HME is expected to boost its adoption in the pharmaceutical industry.
Furthermore, according to an article published by Pharmaceutics in January 2024, many APIs display poor solubility, which causes challenges for their oral delivery, and an option to overcome this is by molecularly dispersing the API into a polymer matrix to create an amorphous solid dispersion (ASD). These dispersions have the potential to display increased solubility and dissolution rate due to the higher free energy of the amorphous state. HME is one method for producing ASDs, where the polymer and API are processed under elevated temperature and shear at typical residence times of 1–10 min, dependent on the extruder setup and material properties. HME offers a high-throughput manufacturing route without the need for organic solvents. Thus, the increasing usage of HME to improve the solubility of APIs is a major factor driving market growth, as it is increasing its adoption in the pharmaceutical industry.
Hence, the growing advantages associated with pharmaceutical HME and the increasing adoption in the pharmaceutical industry for drug manufacturing are some of the major factors driving the market growth. However, high initial investments and equipment costs are expected to restrain market growth.
Pharmaceutical Hot Melt Extrusion Market Trends
The Twin-Screw Extruders Segment is Expected to Witness Significant Growth Over the Forecast Period
Pharmaceutical twin-screw hot melt extruders are specialized machines used in the HME process to produce pharmaceutical formulations. These extruders contain two intermeshing screws that rotate and mix the drug with polymers and other excipients under high temperatures and pressure. The twin-screw design allows better mixing, enhanced material transport, and control over the extrusion process compared to single-screw extruders. The growing adoption in the pharmaceutical industry and the increasing pharmaceutical research and development expenses by pharmaceutical companies are the major factors promoting the segment's growth.
The growing advantages of twin-screw extruders in pharmaceutical HME are expected to enhance market growth significantly. For instance, according to an article published in SpringerLink in February 2024, twin-screw extruders (TSE) offer an extremely resourceful customizable mixer in HME that utilizes various combinations of conveying elements, kneading elements (configured both forward and reverse), and distributive mixing elements for continuous compounding and granulation. The source also stated that TSE is efficient for producing hot melt granulation of dosage forms like tablets, capsules, and granule-filled sachets and for crafting innovative formulations. These include dry powder inhalers, drying units for granules, nanoextrusion, 3D printing, complexation, and amorphous solid dispersions. Thus, the advantages of twin-screw extruders are expected to boost the segment’s growth.
According to an article published by Pharmaceutics in February 2023, HME using twin screw extruders has various advantages, such as there being no organic solvents in the processing, the small footprint of the equipment, the ease of increasing the batch size of pharmaceutical products, and consequent scalability from pilot to industrial setting. Thus, the increasing adoption of twin-screw extruders in the pharmaceutical industry is expected to enhance the segment’s growth. Furthermore, the rising research and development funding for major chronic diseases such as cancer is also likely to promote the usage of twin-screw hot melt extruders in pharmaceutical manufacturing. As the research and development for cancer drugs increases, the usage of advanced technologies such as twin screw extruders is also expected to grow as it offers several advantages over other types of pharmaceutical manufacturing, hence boosting segment growth.
Thus, factors such as the increasing usage of twin-screw hot melt extruders in pharmaceutical manufacturing, the growing advantages, and the rising research and development funding for major chronic diseases such as cancer are expected to boost the segment's growth.
North America is Expected to Hold a Significant Share of the Market
North America is expected to hold a significant market share due to the rapid growth of the healthcare sector. Factors such as increasing pharmaceutical spending and the growing usage of HME in the pharmaceutical industry are expected to enhance the market’s growth in the region significantly.
The growing pharmaceutical spending in the region is a significant factor driving the market’s growth as it is expected to boost the usage of advanced technologies such as HME for the rising demand for pharmaceuticals. For instance, according to an article published in the American Journal of Health-System Pharmacy in April 2024, it was estimated that the overall pharmaceutical expenditures in the United States grew by 13.6% in 2023, compared to 2022, amounting to a total of USD 722.5 billion. Thus, rising pharmaceutical spending is expected to boost the demand for pharmaceutical HME equipment during manufacturing.
The rising usage of pharmaceutical products manufactured using the HME process is also expected to enhance the market’s growth in the region. For instance, Venclexta is a drug offered by AbbVie Inc., which is manufactured using the HME process. As per the 2023 Annual Report published by AbbVie Inc. in February 2024, the sales revenue of Venclexta increased to USD 2.28 billion in FY 2023 from USD 2 billion in FY 2022. Hence, the rising revenue of such drugs produced via the HME process indicates the high demand, which is expected to increase the usage of HME for drug manufacturing procedures.
The advantages associated with pharmaceutical HME are expected to boost the market’s growth in the region significantly. For instance, according to the data updated by Thermo Fisher Scientific Inc., a US company, stated that HME formulations are ideal for pharmaceutical products, as the HME process is a solvent- and dust-free continuous process with remarkably few processing steps. With high reproducibility in a small laboratory footprint, HME has several advantages over products manufactured using spray-dried dispersion formulations. Thus, the significant benefits offered by the HME process are expected to increase its adoption in the region, boosting market growth.
Hence, factors such as rising pharmaceutical spending and the growing advantages associated with pharmaceutical HME are expected to boost market growth in the region.
Pharmaceutical Hot Melt Extrusion Market Industry Overview
The pharmaceutical hot melt extrusion market is moderately consolidated due to the presence of a limited number of companies that manufacture and distribute pharmaceutical hot melt extruders. The competitive landscape includes an analysis of several international and local companies that hold market shares and are well known, including Thermo Fisher Scientific Inc., Coperion GmbH, Leistritz Extrusionstechnik GmbH, Umang Pharmatech Pvt. Ltd, and Jiangsu Xinda Tech Limited.
Pharmaceutical Hot Melt Extrusion Market Leaders
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Thermo Fisher Scientific Inc.
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Coperion GmbH
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Leistritz Extrusionstechnik GmbH
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UMANG PHARMATECH PVT. LTD.
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Jiangsu Xinda Tech Limited
*Disclaimer: Major Players sorted in no particular order
Pharmaceutical Hot Melt Extrusion Market News
- October 2023: Aragen, a provider of contract research, development, and manufacturing services for the pharmaceutical, biotechnology, agrochemicals, and animal health industries, commissioned its new formulations manufacturing facility in Hyderabad, India. This state-of-the-art facility was set up with an investment of USD 3 million. The facility was strategically designed to accommodate the addition of hot melt extrusion capabilities by 2024.
- September 2023: Scientists at the University of Mississippi developed a vaginal, 3D-printed film that can improve drug delivery options for cervical cancer patients. The researchers combined hot-melt extrusion and 3D printing to design patient-specific doses.
Pharmaceutical Hot Melt Extrusion Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Advantages Associated with Hot Melt Extrusion for Pharmaceutical Manufacturing
4.2.2 Increasing Adoption in Pharmaceutical Industry for Drug Manufacturing and Rising Pharmaceutical R&D Expenditure
4.3 Market Restraints
4.3.1 High Initital Investment and Equipment Costs
4.4 Porter's Five Force Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value- USD)
5.1 By Product Type
5.1.1 Twin-Screw Extruders
5.1.2 Single-Screw Extruders
5.1.3 Others
5.2 By End-User
5.2.1 Pharmaceutical Companies
5.2.2 Contract Manufacturing Organizations (CMO)
5.2.3 Academic and Research Institutes
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Rest of the World
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Thermo Fisher Scientific Inc.
6.1.2 Coperion GmbH
6.1.3 Leistritz Extrusionstechnik GmbH
6.1.4 Umang Pharmatech Pvt. Ltd
6.1.5 VJ Instruments
6.1.6 STEERLife India Pvt. Ltd
6.1.7 Jiangsu Xinda Tech Limited
6.1.8 Shanghai Chooshin Industrial Co. Ltd
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Pharmaceutical Hot Melt Extrusion Market Industry Segmentation
Pharmaceutical hot melt extrusion (HME) is a process used in the pharmaceutical industry to enhance the solubility, bioavailability, and controlled release of drugs. In this process, a drug and polymer (or other excipients) are melted together at high temperatures and forced through an extruder to form a solid, often in the form of pellets, tablets, or films.
The pharmaceutical hot melt extrusion market is segmented by product type, end user, and geography. By product type, the market is segmented into twin-screw extruders, single-screw extruders, and others. By end user, the market is segmented into pharmaceutical companies, contract manufacturing organizations (CMO), and academic and research institutes. By geography, the market is segmented into North America, Europe, Asia-Pacific, and Rest of the World. The report offers market sizes and forecasts in terms of value (USD) for the above segments.
| By Product Type | |
| Twin-Screw Extruders | |
| Single-Screw Extruders | |
| Others |
| By End-User | |
| Pharmaceutical Companies | |
| Contract Manufacturing Organizations (CMO) | |
| Academic and Research Institutes |
| Geography | ||||||||
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| Rest of the World |
Pharmaceutical Hot Melt Extrusion Market Research FAQs
How big is the Pharmaceutical Hot Melt Extrusion Market?
The Pharmaceutical Hot Melt Extrusion Market size is expected to reach USD 37.12 million in 2024 and grow at a CAGR of 4.79% to reach USD 46.90 million by 2029.
What is the current Pharmaceutical Hot Melt Extrusion Market size?
In 2024, the Pharmaceutical Hot Melt Extrusion Market size is expected to reach USD 37.12 million.
Who are the key players in Pharmaceutical Hot Melt Extrusion Market?
Thermo Fisher Scientific Inc., Coperion GmbH, Leistritz Extrusionstechnik GmbH, UMANG PHARMATECH PVT. LTD. and Jiangsu Xinda Tech Limited are the major companies operating in the Pharmaceutical Hot Melt Extrusion Market.
Which is the fastest growing region in Pharmaceutical Hot Melt Extrusion Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Pharmaceutical Hot Melt Extrusion Market?
In 2024, the North America accounts for the largest market share in Pharmaceutical Hot Melt Extrusion Market.
What years does this Pharmaceutical Hot Melt Extrusion Market cover, and what was the market size in 2023?
In 2023, the Pharmaceutical Hot Melt Extrusion Market size was estimated at USD 35.34 million. The report covers the Pharmaceutical Hot Melt Extrusion Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Pharmaceutical Hot Melt Extrusion Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Pharmaceutical Hot Melt Extrusion Industry Report
Statistics for the 2024 Pharmaceutical Hot Melt Extrusion market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Pharmaceutical Hot Melt Extrusion analysis includes a market forecast outlook for 2024 to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
