Cell-Free Protein Expression Market Size, Share & Trends Analysis Report By Product (Accessories and Consumables, Lysate Systems), By Applications (Enzyme Engineering, High Throughput Production, Protein Labeling, Protein-Protein Interaction, Other Applications) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2022-2030

Market Overview

The global cell-free protein expression market size was valued at USD 265.32 million in 2023. It is expected to reach USD 541.97 million in 2032, growing at a CAGR of 8.26% over the forecast period (2024-32). The growing demand for biopharmaceuticals, including monoclonal antibodies, vaccines, and therapeutic proteins, drives the need for efficient protein expression systems. Cell-free protein expression offers a rapid and scalable method for producing these proteins.

 For molecular biologists in both primary and applied sciences, cell-free protein expression is crucial. Cell-free protein expression is gaining popularity among scientists working on high-throughput functional proteomics and genomics due to its many benefits over protein expression in living cells. Cell-free protein expression is necessary to create protein arrays like the nucleic acid programmable protein array (NAPPA) and use display technologies to engineer enzymes. A DNA template for the target protein, which can either be a plasmid or a product of the polymerase chain reaction, is needed for cell-free protein expression, as well as a solution containing all the elements required for transcription and translation, including translation factors, transcription factors, enzymes, and others.

Market Dynamics

Global Cell-Free Protein Expression Market Drivers

Rising Cases of Cancer and Infectious Diseases

Proteomics can identify breast cancer subtypes and specific protein and proteoform expression, which can assess cancer therapies at the cellular and tissular levels. In clinical trials, it can identify therapeutic target proteins. Proteomic analysis is a leading technique with growing importance in clinical applications, according to the 2021 study "Proteomic analysis of HIV and periodontitis." These tools allow rapid protein profiling of biological samples and the identification of disease-specific biomarkers. Proteomics for infectious disease therapy is expected to boost the cell-free protein expression market during the forecast period. The high prevalence of infectious and cancerous diseases increases the need for innovative and potent treatment approaches, driving the growth of the cell-free protein expression market.

Structural Modification and Shorter-Expression Time

The cell-free protein synthesis (CFPS) platform can be used to directly manipulate the environment of protein production because it is an open system. Higher protein titers can be produced using CFPS because all the system's energy is directed toward producing the desired protein, according to a research article published in Methods and Protocols in 2019. Additionally, customers can use batch, continuous flow, or continuous exchange reactions to reach the necessary protein titer, thanks to the flexibility of CFPS reactions. These benefits make CFPS the best choice for applications like creating large proteins, difficult-to-synthesize proteins, proteins encoded by genes with a high GC content, membrane proteins, and virus-like particles. Considering the numerous technical and workflow benefits the technique provides, cell-free protein expression methodologies are thus becoming more and more popular, which is fueling market expansion.

Global Cell-Free Protein Expression Market Restraints

High Cost of Protein Expression Systems

According to the July 2021 article "Cell-free gene expression," many laboratories are preparing custom cell-free expression (CFE) reagents, which are frequently expensive and time-consuming. The outcomes might not favor cell-free expression reliability and performance. This suggests that it might be less cost-effective, impeding market expansion. Alternative techniques, including the use of nucleoside monophosphates rather than nucleoside triphosphates, alternative energy regeneration systems rather than phosphorylated substrates, avoiding the use of exogenous tRNAs and cyclic AMPs, lowering the concentration of amino acids and nucleotides, as well as new high-cell-density cultivation techniques, and improvement in the quality of cell lines through genetic engineering, could aid in the production. As a result, market growth is anticipated to be constrained by the high cost of protein expression systems, the high cost of reagents, and the limitations of CFPE in small-scale capacity.

Global Cell-Free Protein Expression Market Opportunities

Growing Use of Technology

The ability to study the cellular protein production machinery and externally power them necessitates exploring fresh ways by researchers to deliver better solutions with decreased time and expense. It also aids in producing proteins that could be harmful to cells or need specific conditions to fold correctly. The market for cell-free protein expression is currently relatively small due to its limited usage. However, it is expected to increase dramatically over the next few years as there is a likelihood that these technologies will be widely deployed. In reshaping the synthetic biology landscape by developing potent in vitro platforms, the future of cell-free protein expression systems appears to be very promising. The development of a cell-free protein expression system in recent years has made it possible to produce recombinant proteins, a significant advancement in biomedical technologies.

Regional Analysis

By Region, the global cell-free protein expression market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America.

North America Dominates the Global Market

North America is the most significant shareholder in the global cell-free protein expression market and is expected to grow at a CAGR of 6.68% during the forecast period. The pharmaceutical sector is one of the industries with the highest research expenditures in the US. The industry has a significant stake in using cutting-edge techniques to improve pipeline development and support advancements in patient care. Some of the world's largest academic and research institutions and biotechnology industries are in the United States. Since many mammalian proteins, including growth hormones, insulin, antibodies, and vaccines, are produced industrially, there may be an increase in demand for protein expression systems due to industries making more significant investments in the research and development of products.

Europe is expected to grow at a CAGR of 6.51%, generating USD 102.72 million during the forecast period. The largest concentration of biotechnology firms in Europe, a top-notch research infrastructure, and internationally renowned scientists have all contributed to Germany's successful establishment as a global center for medical biotechnology, which has led to an increase in the country's number of biotechnology labs and research facilities. German research institutions have long-standing partnerships with several pharmaceutical companies and are significant end-users of services for protein engineering. These institutions deal with toxic proteomics, protein/drug interactions, and the complete characterization of natural and recombinant proteins used in human therapy. For instance, around 628,519 new cancer cases were reported in Germany, based on estimates from Globocan 2020. The five most common cancers are breast, lung, prostate, colorectum, and bladder. As a result, the growing prevalence of these infectious and cancerous diseases has contributed to market expansion.

Asia-Pacific is anticipated to grow significantly over the forecast period. China has made a reputation for itself as the center of research and development over the last ten years. China is very active in the cell-free protein expression market because protein expression is a large field. The nation is working to find several top-tier research facilities in and around Shanghai and an excellent life science research infrastructure. Due to these extensive research efforts, China currently holds a sizable portion of the Asia-Pacific market under investigation. The high incidence of infectious and cancerous diseases drives up the need for innovative and efficient treatment methods, leading to increased use of protein expression products, which drives up the cell-free protein expression market's growth.

According to a study conducted in China and published in the journal Bioresources and Bioprocessing in July 2021 under the title "Development and comparison of cell-free protein synthesis systems derived from typical bacterial chassis," these systems have excellent controllability, tolerance, stability, and the capacity to produce proteins quickly. Cell-free protein synthesis (CFPS) systems have emerged as an excellent substitute for pathway prototyping, protein synthesis, and biosensing. Due to greater adoption, the numerous advantages of cell-free protein systems will propel the market's growth in China.

The Gulf Cooperation Council (GCC) region comprises Saudi Arabia, Kuwait, Bahrain, Qatar, the United Arab Emirates, and Oman. The Arabian nations are trying to improvise R&D. There is a rising need for cutting-edge research in Saudi Arabia's healthcare industry, which leads to increased proteomics and genomics research driving the cell-free protein expression market. With a robust healthcare infrastructure and the highest per capita drug spending in the Middle East and Africa, Saudi Arabia and the United Arab Emirates are two of the most developed markets in the region. As a result, there is a tremendous opportunity to expand numerous drug development-related research activities.

Brazil's market for cell-free protein expression is expected to expand over the forecast period due to several factors, including the rising incidence of cancer and infectious diseases, increased R&D activity, and numerous proteomics and protein expression labs. According to the November 2021 article "Personalized medicine in Brazil: a new paradigm, old problems," personalized or precision medicine is steadily gaining acceptance in the nation's public healthcare system. According to the article, numerous studies are being conducted nationwide at every stage of the innovation cycle, from initial research to wide-scale adoption. Therefore, the rising demand for personalized medicine will accelerate the development of proteomics and genomics, positively affecting market expansion. In addition, the Global Cancer Observatory forecasts that Brazil will experience 259,949 cancer deaths and an estimated 592,212 new cancer cases in 2020. Additionally, the same source projects that by 2040, there will be up to 995,000 new cancer cases. The market is expected to be driven by increased research and development in proteomics and drug discovery due to the high prevalence of cancer disorders.

Segmental Analysis

The global cell-free protein expression market is segmented by product and application.

Based on The Product, the global market is bifurcated into accessories and consumables and lysate systems.

The lysate systems segment is the highest contributor to the market and is expected to grow at a CAGR of 6.46% during the forecast period. The most popular commercially available lysate system is E. coli lysates. Since E. coli lysates lack endogenous genetic information, they have the advantages of having a very high protein yield and being tolerable to most additives. The codons used in E. coli-based systems differ, with some being eukaryotic-specific. Additionally, no post-translational modifications are possible, restricting the system's application in synthesizing human therapeutics. In order to solve these issues, significant progress has been made. One method is the "PURE system," mainly free of pointless E. coli cellular components. Compared to a conventional lysate-based system, the PURE system allows for in vitro studies in a much cleaner environment and performs better in applications like incorporating synthetic amino acids and ribosome display.

Cell-free protein expression uses vectors, amino acids, accessory proteins, salts, nucleotides, and energy mix. Cell-free protein synthesis allows protein expression, metabolic engineering, and drug development. In vivo, a cell-free system has an open system, does not rely on living cells, and can direct all its energy toward protein production. DNA vector and immune system developments influence the development of protein-based treatments. Virus-mediated gene delivery offers an easy-to-use, adaptable, and repeatable system for in vitro transfection studies. Plasmid DNA vaccines provide a quick, easy, and comprehensive immune response while overcoming the therapy's efficacy and safety. In addition, these novel plasmid DNA vaccines may help prevent cancer and infectious diseases.

Based on The Application, the global market is bifurcated into enzyme engineering, high throughput production, protein labeling, and protein-protein interaction.

The protein-protein interaction segment owns the highest market share and is expected to grow at a CAGR of 6.62% during the forecast period. Since novel biologic drugs acting as binding inhibitors have the potential to alter the therapeutic landscape completely, protein-protein interactions are highly desirable targets in the drug discovery and development process. Despite the growing accessibility of genomic data, protein-protein interactions remain challenging to study. The enormous complexity of the interaction networks present in cells poses one of the main difficulties in developing inhibitors of protein-protein binding. It is possible to plex interactions more effectively by using CFPS techniques. CFPS systems can also significantly speed up laboratory research. As was already mentioned, the lack of a cell wall makes it simple to bring substrates, including those that are challenging to use in live cells, into contact with enzyme libraries to screen for novel reactions. The market segment of protein-protein interactions is thus anticipated to be driven by rising biotherapeutics R&D and expanding CFPS applications in academia and life sciences research.

For most applications, including protein-protein interaction studies and protein-nucleic acid interactions, labeling and detecting proteins expressed using cell-free systems are required. Stable-isotope-labeled proteins for NMR structure assignment or X-ray crystallography using CFPS are also crucial in structural biology projects. Promega's FluoroTect Detection and Transcend Detection Systems, created for non-radioactive protein labeling in cell-free protein synthesis, are some labeling products presently on the market. These labeling solutions work by adding marked lysine residues to the polypeptide chain. Thus, CFPS-based protein labeling techniques are anticipated to grow steadily over the forecast period due to expanding applications and advantages over traditional labeling techniques.

Recent Developments

• March 2024 - A $11.4 million Series A round led by Material Impact was concluded by Tierra Biosciences, a California-based firm creating AI-guided cell-free technology to facilitate high-throughput bespoke protein synthesis. Prosus Ventures, In-Q-Tel (IQT), Hillspire, Freeflow Ventures, Creative Ventures, and Social Capital were among the new and returning investors who contributed to the round, which brings the company's total funding to over $7 million in grants and $6 million in seed capital.