Global Difficult to Express Proteins Market - 2021-2028
発行: DataM Intelligence
ページ情報: 英文 180 Pages
Difficult-to-express proteins are the proteins whose synthesis is difficult in conventional in vivo protein production platforms. Moreover, it is often challenging to express these proteins in heterologous expression systems due to their inherent properties, tendency to aggregate and form inclusion bodies, intrinsic nature and difficultly for the foreign host to fold a protein correctly. The special type of proteins such as membrane proteins, antibody types, proteases, kinases, and others are the difficult-to-express proteins.
The Global Difficult to Express Protein Market is valued USD XX billion in 2020 and is estimated to reach USD XX billion by 2028, at a CAGR of XX%.
The market growth is driven by the rising manufacturing of recombinant proteins for producing complex therapeutics. There is an increase in the research and development activities for the development of difficult-to-express proteins therapeutics due to their properties such as solubility, immunogenicity, and bioactivity when expressed in mammalian cells.
The market is witnessing the development of novel cell-free protein synthesis platforms based on the industrial working horse CHO cells that overcome the issues. For instance, In March 2019, Catalent had launched its next-generation cell line development technology i.e., GPEx Boost to enhance the GPEx expression platform through multiple improvements, including utilization of glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line. The combination of both technology and platform enhancements would result in the cell's improved ability to produce high titers and increase specific protein productivities of interest.
In March 2019, ExcepGed launched Y Combinator with technology that uses an engineered human cell line to produce full-length human proteins for drug discovery. This platform would be used to rapidly express proteins in mammalian cells with the potential to successfully express these larger proteins.
There is an increase in the development of several techniques such as different expression systems, promoters, cultivation media and condition, chaperone coexpression, solubilization ta, gs, others for producing and purifying difficult-to-express proteins. However, the high cost of systems and difficulty in analysing target is expected to hinder the market growth.
The pandemic has had a positive impact on the healthcare industry, including Difficult to Express Protein market. With Several vaccine development and drug discovery campaigns underway the protease segment is has seen a massive development. The SARS-CoV-2 main protease is considered a promising drug target, as it is dissimilar to human proteases. The ability to express and purify the proteins in large quantities is critical for basic research and for development of pharmaceutical agents. Covid-19 is expected to positively impact the SUMO fusion synthesis segment. SUMO fusion synthesis had been used in the expression and purification of SARS-CoV. fusion of SUMO to the N-termini of SARS-CoV proteins dramatically enhances expression in Escherichia coli cells.
The difficult-to-express proteins market is segmented based on protein as proteases, kinases, membrane proteins, and others. Membrane proteins segment account for the significant market share due to the increase in usage of membrane proteins for incorporation into, or binding to, membranes. Transport proteins are essential for the movement of molecules and ions across the membrane. Peripheral membrane proteins act by binding to integral membrane proteins through compatible binding sites. Integral membrane proteins are incorporated into the hydrophobic portion of the lipid bilayer.
Protease segment is expected to have positive market growth due to rising usage of proteases for brewing, tenderization of meat, milk coagulation, digestion, viral and cancer treatment.
Further, the market is also classified based on application into technology as cell-free protein synthesis, prokaryotic expression systems, sumo fusion system, gene fusion systems, and others. Cell-free protein synthesis accounts for the significant market share owing to its advantages in synthesizing difficult-to-express proteins because of its properties such as reaction environment openness and no cell viability constraints. It maximizes active protein production by optimizing the reaction environment with selective positive effectors and eliminating negative effectors.
Prokaryotic expression systems segment accounts for the significant market as it provides a cost-effective, tuneable, and easy to operate a source of recombinant proteins. Companies are introducing new approaches for the production of complex eukaryotic proteins in a prokaryotic expression.
By region, the difficult-to-express proteins market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East and Africa. Among all of the regions, the North America region dominated the difficult-to-express proteins market due to increasing research and development activities for the development of different technologies for the synthesis of difficult-to-express proteins. Several companies are entering into the collaborations with the other companies, organizations, and institutes for developing the products related to difficult-to-express proteins. It is further expected that the North America region would maintain its dominant position over the forecasted period.
Europe is expected to have a significant market share owing to the increasing investment from the government and non-government organizations. The growing prevalence of chronic disease shall stimulate market growth. Chronic diseases are the leading cause of mortality and morbidity in European Countries. The burden of developing chronic diseases such as cardiovascular disease, diabetes, asthma, chronic obstructive pulmonary disease (COPD), HIV/AIDS, mental disorder, and others increases aging populations. According to Eurostat, age-group of aged 65 and more accounts for one-fifth, i.e., 19 % of the European population.
Asia Pacific region is expected to have positive market growth due to increasing the number of several pharmaceutical and biotechnology companies developing therapeutics and technologies related to difficult-to-express proteins. There is an increase in the adoption of novel technologies for the synthesis of difficult-to-express proteins. The rising awareness regarding the novel technologies shall stimulate market growth over the forecasted period.
The difficult-to-express proteins market is highly competitive with the product diversification, revenue generation, and opportunities. Several local and international players are present in the market. R&D Systems, Bio-Rad Laboratories, Enzo Life Sciences, Sino Biological, Thermo Fisher Scientific, StressMarq Biosciences, and Lucigen are the leading market players with significant market share.
Companies are focusing on new product launches, technological advancement, product diversification, market expansion, and market penetration strategies for strengthening their position in the market. They are conducting research and development activities for developing difficult-to-express proteins with innovation and diversification. For instance, In May 2019, Catalent had launched its new OneBio Suite for the integrated development, manufacturing, and clinical supply of biologics. One Bio would help in addressing the challenges facing biologic development companies that are looking to accelerate programs to clinic or market, or that require greater simplicity in the development process, including fewer internal resource needs and a reduced risk of rework.
The companies are entering into the collaborations, mergers, licensing agreements, strategic partnerships and acquisitions to increase the demand for difficult-to-express proteins and their expansion across the globe. For instance, in April 2019, Calixar had entered into the exclusive licensing deal with Regeneron. Calyx had provided Regeneron exclusive rights to its technology and expertise. Calixar's technology platform would allow the company to isolate the full length and pure to highly pure membrane proteins while keeping their structure and function intact. The types of membrane proteins include GPCRs, ion channels, transporters, receptors, and viral proteins.
Lonza America had acquired exclusive rights to Transposagen's proprietary gene integration technology for the production of therapeutic proteins. Transposagen's gene integration technology would enable the efficient production of high-titer cell lines that provides the rapid and economical production of complex biological molecules. In September 2017, Airway Therapeutics entered into an exclusive licensing agreement with Glycotope GmbH [Glycotope]. Under the terms of this agreement, Airway had received the worldwide commercial rights to use Glycotope's proprietary cell line technology, GlycoExpress [GEX], to produce AT-100 (rhSP-D). The GlycoExpress would accelerate the development and large-scale manufacturing of a wide range of biologics, including antibodies and difficult-to-express proteins.
Companies are also raising the funding and investment for increasing their market presence across the globe. For instance, in March 2019, Algenex had raised the funding of Euros 4 million for the production of the recombinant biologics. The company would use the scale-up its proprietary CrisBio baculovirus-expression platform ahead of an anticipated submission to the European Medicines Agency (EMA) of a CrisBio-based minor species vaccine. It would further the commercial rollout of its TopBac system, a plug and play patented technology that increases existing baculovirus systems' productivities.
Bio-Rad Laboratories, Inc. is an American developer and manufacturer of specialized technological products for the life science research and clinical diagnostics markets established in 1952. Bio-Rad has a worldwide presence with more than 8000 employees and direct channels in 35 different countries outside U.S.