Recombination DNA technology allows one to accurately alter genes by creating a new gene from two or more different species and introducing it in a host. Such technology has been the key factor of successful gene therapy. Besides, it enabled enormous progress in generating recombinant drugs, therapeutic agents, and vaccines, which in turn made it possible to eliminate the use of human donors, considerably raising healthcare and people’s general quality of life.
Key Growth Drivers and Opportunities
Advancements in Genetic Engineering: One of the main reasons for the market expansion of genetic engineering is the supporting technological advancements that enable the manufacture of the new drugs, vaccines, and gene therapies to be more exact, efficient, and cost less. These kinds of progresses have given to the genetic modification a vast application not only in the medical field but also in the agricultural and industrial sectors, which are the major consumers of the recombinant DNA technology.
Challenges
The market for recombinant DNA technology has certain limitations that include the high cost of research and development, issues of ethics and regulations, difficulties in gene manipulation due to technical nature, worries about biosafety, and the possibility of misuse, all of which can hinder a broader usage of the technology.
Innovation and Expansion
FDA-Grade CRISPR/Cas9 Nuclease Is Now Available for Off-the-Shelf Purchase from Biomay
In May 2025, Leading recombinant protein maker Biomay stated that their CRISPR/Cas9 nuclease is now commercially available, adding a substantial component to its line of off-the-shelf products for genome-editing applications.
Customers that buy Cas9 from Biomay will profit from the company’s unmatched performance history and knowledge as a market-registered GMP manufacturer of the nuclease. Recombinant Cas9, the key ingredient of CASGEVY, the first CRISPR genome editing product available on the market, is manufactured by Biomay, an FDA-approved company.
Polyplus Obtains GMP Certification for the Production of Recombinant DNA and Proteins
In March 2024, A good manufacturing practice (GMP) certification for the synthesis of recombinant proteins has been granted to Xpress Biologics, a Polyplus firm that is owned by Sartorius.
Additionally, the facility in Belgium has renewed its GMP accreditation for DNA production in January 2023. Under certification numbers BE/GMP/2023/093 and MIA 2100 IMP, the new GMP certification for protein manufacturing includes the manufacture of recombinant proteins, including antibody fragments, employing microbial expression systems such as E. coli and P. pastoris. In order to improve capacity, a GMP production line is planned for the Belgium facility, and an additional GMP clean room has been installed for the creation of GMP cell banks.
Inventive Sparks, Expanding Markets
F. Hoffmann-La Roche Ltd., Cibus, Ltd., New England Biolabs, Inc., Trofacgen, Inc., GenScript, Corporation, GlaxoSmithKline plc., Novo Nordisk A/S, Monsanto Company, Eli Lily and Company, Horizon Discovery Group PLC, Amgen Inc., and Novartis AG are the major companies that operate the recombinant DNA technology market.
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