A protein is made from a fusion gene, which is created by joining parts of two different genes. These genes may occur naturally in the body by the transfer of DNA between chromosomes. Fusion genes and proteins can also be prepared in the laboratory by combining genes or parts of genes from the same or different organisms. Fusion Protein aids in purification of the cloned genes, as reporters of expression level, and as histochemical tags to enable visualization of the location of proteins in a cell, tissue, or organism. Certain fusion proteins combine whole peptides and therefore contain all functional domains of original proteins. While, some other fusion proteins, particularly those that occur naturally, combine only portions of coding sequences and therefore do not maintain the original functions of the parental genes. The naturally occurring fusion proteins are generally found in the cancer cells, where they may function as oncoproteins.
The design and structure of fusion proteins are capable of creating novel epitopes, and hence the immunogenicity potential needs to be assessed to avoid any undesired strong hypersensitivity or an immune response. Biotechnology could be used to engineer molecules that incorporate genes for two proteins. The resultant fusion protein can offer a combination of attributes that augment its ability to treat disease. For instance, several fusion proteins have been created by combining the domain of a cell surface receptor with the tail portion of an antibody. Etanercept is a type of fusion protein produced by recombinant DNA. It fuses the tumor necrosis factor receptor to the constant end of the IgG1 antibody.
The rising use of genetically engineered fusion proteins in the treatment of cancer worldwide is likely to upsurge the market growth in the near future.
The regulatory reforms of particular countries that restrict the sale or clinical trials of fusion in that region could be the restraining factors in the fusion protein market. Also, upcoming alternatives for fusion proteins could hamper the protein fusion market.
The protein fusion market is bifurcated on the following bases:
• Ophthalmic clinics
• Microarray technologies
• Bio-therapeutic Drugs
• Flow Cytometry
• Binding assays
• In vitro
• In vivo
In the above mentioned applications, the FC or fragment crystallizable based fusion protein behaves like a supporting module where proteins can be attached while retaining the native biological activity. The Fc domain can also improve the in vitro, in vivo and solubility and stability of some binding partners.
Geographically, the global protein fusion market is divided into North America, Europe, Asia Pacific, and Latin America, Middle East and Africa. North America is attributed to have the significant share in the market with countries like U.S and Canada, owing to presence of well-equipped advanced devices and global market leaders such as Astellas Pharma, Amgen Inc., Regeneron, and others. Europe market is expected to share the same potential with the countries like Germany, France, U.K, Spain, Italy, and others.
An upsurge in the healthcare expenditure in several countries across Asia Pacific such as India, Japan, China, Russia, Australia, Pakistan, and others is attributed to boost the global fusion protein market. LAMEA market is also attributed to grow in the upcoming years with the presence of countries such as Brazil, Argentina, Turkey, South Africa, Saudi Arabia, and others.
The global key manufacturers of global fusion protein market are:
• Astellas Pharma (U.S)
• Amgen Inc. (U.S)
• Regeneron (U.S)
• Ligand Pharmaceuticals (U.S)
• Bristol-Myers Squibb (U.S)
• Viventia (U.S)
• Sanofi Genzyme (U.S)
• Celgene Biotechnology Company (U.S)
In the previous year 2017, Celgene, acquired Delinia (a biotechnology company, developing novel therapeutics for autoimmune diseases). DEL106 is a novel IL-2 mutein Fc fusion protein designed to preferentially upregulate regulatory T cells or Tregs, immune cells that are critical to maintaining natural self-tolerance and immune system homeostasis. Increasing Tregs as a means of restoring immune system balance can benefit patients with a variety of autoimmune diseases such as systemic rheumatoid arthritis and lupus erythematosus.