Global Recombinant DNA Technology Market - 2022-2029

Global Recombinant DNA Technology Market - 2022-2029

Market Overview

Recombinant DNA Technology Market was valued at USD 156.75 billion in 2021. It is forecasted to reach USD YY million by 2029, growing at a CAGR of 4.80% during the forecast period (2022-2029).

Recombinant DNA technology includes the insertion of the DNA into the genome with the gene of interest. It produces new genetic combinations by joining the DNA molecules from two different species and inserted into the host organism. The new genetic combination includes the genetic material from multiple sources not found in the genome. It results in the production of genetically modified organisms and products. Genetically modified organisms such as microorganisms, animals, and plants have shown enhanced product yield and increased adaptability for better survival.

Several companies are using recombinant DNA technology for producing insulin, Follistim, human growth hormones, monoclonal antibodies, human albumin, vaccines, gene therapy and other therapeutics. It is also used for producing genetically modified crops, cloned animals, biopesticides, biofuel, and other products.

Market Dynamics

Technology Advancement of Recombinant DNA Technology is Driving the Growth of the Market

The market is witnessing technological advancement for developing efficient diagnostic tools and therapeutics. The introduction of the Bac-to-Bac baculovirus expression systems provided an efficient method to produce recombinant baculovirus with desired genes in insect cells. Bac-to-Bac baculovirus expression systems have accelerated the cloning reaction compared to the restriction enzyme cloning which consumes a lot of time. CRISPR technology can alter DNA sequences and modify gene function. It is used in various applications such as correcting genetic defects, treating and preventing the spread of diseases and improving crops. There is increasing adoption of germline gene therapy to transfer the DNA into the cells that produce reproductive cells, eggs or sperm, in the body. This therapy is beneficial for correcting disease-causing gene variants that can be passed from generation to generation. Somatic gene therapy is used for transferring the DNA into the body tissues. It targets the body cells that are not passed from generation to generation.

Increasing Funding & Investment for Development of Recombinant Products is Expected to Fuel the Market Growth over the Forecast Period

Several organizations, associations, and institutes are raising the funding & investment for developing recombinant products. For instance, in March 2020, the Coalition for Epidemic Preparedness Innovations (CEPI), had invested USD 4.4 million in collaboration agreements with Novavax, Inc. and The University of Oxford to rapidly develop recombinant vaccine products against COVID-19. Under the terms of the agreement, CEPI would provide initial funding to Novavax to enable preparations for phase I trials. The University of Oxford would support the manufacture of vaccine materials required for preclinical and phase I testing. In July 2020, the United States Departments of Health and Human Services (HHS) and Defense (DoD) awarded the funding of USD 2.1 billion to Sanofi and GlaxoSmithKline for the development and manufacturing of the recombinant protein-based COVID-19 vaccine. Health and Human Services (HHS) and Defense (DoD) would provide the funding for Operation Warp Speed.

Ethical Issues Regarding the Use of Recombinant Products is Hampering the Market Growth

There are several ethical issues are associated with the use of recombinant products. There are several concerns including whether the recombinant products are biologically equivalent to the natural product, and recombinant proteins can result in immunogenic reactions that could limit their use. The use of the recombinant product is tampering with the genome. Differences in immunological sensitivities in animal and human systems have demonstrated disastrous effects. TeGenero trial conducted for testing an antibody TGN1412 among the patients with rheumatoid arthritis and B-cell chronic lymphocyte leukaemia has shown the harmful effects. Germ-cell gene therapy would ultimately diminish the human gene pool by removing genes considered to be bad. Only rich people would be benefited due to the high cost of gene therapy. The widespread use of gene therapy can make society to least accept the people who are different. There are also ethical concerns regarding gene therapy for enhancing basic human traits such as height, intelligence, or athletic ability.

COVID-19 Impact Analysis

The global recombinant DNA technology market has witnessed drastic growth due to the COVID-19 pandemic as several biopharmaceutical companies are focusing on developing the vaccine by using recombinant DNA technology for the prevention of COVID-19. There is increasing research and development activities for developing the recombinant vaccine for COVID-19 with the rising number of people being affected by the COVID-19 infection. The pipeline comprised of several viral vectors, nucleic acid-based vaccines and antigen-presenting cells being developed for COVID-19. Viral vector vaccines are comprised of the recombinant virus that is attenuated to reduce its pathogenicity, and genes encoded with viral antigens are cloned using recombinant DNA techniques. Protein-based vaccines comprised of the protein purified from the virus or virus-infected cells, recombinant protein or virus-like particles

Several organizations, associations, institutes, and companies are entering into the collaboration for the development of a recombinant vaccine for COVID-19 infection. For instance, in April 2020, Sanofi had entered into the collaboration with GlaxoSmithKline plc to develop an adjuvanted vaccine for COVID-19. Under the terms of the agreement, Sanofi would contribute its S-protein COVID-19 antigen based on recombinant DNA technology. GlaxoSmithKline plc would contribute its proven pandemic adjuvant technology. This may be useful to produce more vaccine doses with the reduced amount of vaccine protein required per dose and thus protect more people.

Epidemiology

Chronic diseases are the leading cause of mortality and morbidity worldwide. According to the Centers for Disease Control and Prevention (CDC), around, 6 out of 10 adults are suffering from chronic diseases. Approximately, 4 out of 10 people develop two or more chronic diseases. Heart disease, cancer, chronic lung disease, stroke, Alzheimer's disease, diabetes, and chronic kidney disease are the most common chronic diseases. Tobacco consumption, poor nutrition, lack of physical activity, excessive alcohol use, and other disorders increase the risk of developing chronic diseases. According to the American Diabetes Association, approximately 34.2 million are suffering from diabetes in the United States. Out of these people, around 1.6 million are affected by type 1 diabetes.

Market Segment Analysis

The medical segment is expected to hold the largest share in the Recombinant DNA Technology market

By Product Type, the medical segment is anticipated to hold the largest share in the recombinant DNA technology treatment market owing to the higher adoption of recombinant DNA technology for producing pharmaceutical products. Recombinant DNA technology produces novel pharmaceutical products, safer or more effective versions of conventionally produced pharmaceuticals, and substances identical to conventionally made pharmaceuticals. The medical segment is classified as the therapeutic agent, human protein, and vaccine. Recombinant DNA technology is used to produce human proteins that can be used as diagnostic tools and therapeutics to treat various genetically linked diseases. Various recombinant proteins such as recombinant hormones, interferons, interleukins, growth factors, tumour necrosis factors, blood clotting factors, thrombolytic drugs, and enzymes are useful for the treatment of the diseases such as diabetes, dwarfism, myocardial infarction, congestive heart failure, cerebral apoplexy, multiple sclerosis, neutropenia, thrombocytopenia, anaemia, hepatitis, rheumatoid arthritis, asthma, Crohn’s disease, and others. Vaccines produced by using recombinant DNA technology are based on the expression of biological constructs encoding proteins from specific viral pathogens. These vaccines are made of protein or glycoprotein subunits synthesized in the laboratory.

Expression System Segment is Anticipated to Grow at the Fastest Growth Rate over the Forecast Period

By component, the market is segmented into an expression system and cloning vector. Expression systems are essential for expressing the proteins within the chosen host cell. There is increasing development of efficient protein expression systems at a large scale across the globe. The market is dominated by the availability of several expression systems such as bacteria expression system, yeast expression system, baculovirus expression system and mammalian expression system. The choice of the expression systems depends on various factors such as target protein property, intended application, protein yield and cost. The yeast expression system is the new exogenous protein expression system that contains the characteristics of both prokaryotic and eukaryotic expression systems. There is high usage of the yeast expression system in genetic engineering. The recombinant proteins expressed in the mammalian cell expression system includes the use of plasmid transfection and viral vector infection. There is increasing research for evaluating the potential of plants as the expression system for the production of genetically modified products.

Geographical Analysis

North America region holds the largest market share global Recombinant DNA Technology market

North America region is dominating the global recombinant DNA technology market accounted for the largest market share in 2019 due to higher adoption of the recombinant DNA technology in medicines, agriculture, industries, and research. There is increasing recombinant DNA technology for the prevention, treatment, and management of diseases with the increasing prevalence of chronic diseases. The United States accounts for the highest market share due to the presence of a large number of biopharmaceutical manufacturing companies. There is rising usage of advanced recombinant DNA technologies for developing veterinary products, genetically modified crops, and biopesticides. Researchers are also using recombinant DNA technology to alter the biomass for improving its use for biofuel production.

There is increasing research and development activities for biopharmaceuticals. Several companies are entering into collaboration with institutes, organizations, and associations for developing biopharmaceuticals. For instance, in February 2020, Sanofi had entered into collaboration with the Biomedical Advanced Research and Development Authority (BARDA), a component of the United States Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response for the development of the recombinant vaccine for novel coronavirus. Under the terms of the agreement, Sanofi would use its egg-free, recombinant DNA platform to produce a vaccine for novel coronavirus. BARDA would provide the expertise and reallocated funds to support the vaccine’s development. In December 2019, Sanofi had entered into the collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to establish the state-of-the-art facilities in the United States for the production of an adjuvanted recombinant vaccine for the influenza pandemic.

Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period

Asia-Pacific region is the fastest-growing region in the global recombinant DNA technology market as there is an increase in market players developing recombinant DNA technology products. Several companies are shifting their manufacturing base to the Asia-Pacific region due to the availability of skilled and cheap labourers. There is rising demand for recombinant and genetically modified products for human health, food and agriculture.

Companies are focusing on improving the recombinant DNA technology for the production of genetically modified crops to increase crop yields, reduce costs for food or drug production, reduce the need for use of pesticides, enhance the nutrient composition and food quality, resistance to pests and disease. There is growing penetration of recombinant DNA technology for providing selective improvements in pharmaceutics, gene therapy, vaccine design and bioremediation. Several organizations, associations, and institutes are raising the funding & investment for the use of recombinant DNA technology for healthcare, food and agriculture.

Competitive Landscape:

The recombinant DNA technology market studied is a fragmented market with a large number of market players. F. Hoffmann-La Roche Ltd, Biogen, Amgen Inc, Novartis AG, Eli Lilly and Company, Pfizer Inc., Novo Nordisk A/S, Sanofi, Merck KGaA, GlaxoSmithKline plc., and Thermo Fisher Scientific, Inc are the market players with the significant market share. The major players are adopting several growth strategies such as product launches, product approvals, mergers, licensing, acquisitions, and collaborations, contributing to the growth of the recombinant DNA technology market globally. For instance,

Mergers & Collaborations:

On 21st May 2021, Biogen announced it collaborated with Ginkgo Bioworks on a license agreement to develop a Novel Gene Therapy Manufacturing platform.

On 2nd January 2020, Amgen announced it has a strategic collaboration with BeiGene to expand its oncology presence in China.

Product Launch & Approvals:

On 3rd August 2021, Amegan Inc announced that it will build its Biologics Manufacturing Facility with 550 million USD in Holly Springs.

On 1st April 2019, GenScript launched a Single-stranded DNA Service for CRISPR-based Gene Editing. The new service offers researchers access to high-quality, pure ssDNA for CRISPR-based gene insertion, ultimately helping to accelerate the development of gene therapy, cell therapy, and transgenic animal models for cancer research and treatment.

Acquisition:

In October 2020, Proteintech acquired ChromoTek, a manufacturer of Camelid, single-domain antibodies i.e., nanobodies. ChromoTek is the market leader in nanobodies high-performance recombinant reagents for breakthrough research discoveries.

Partnership:

In August 2020, Novavax, Inc had entered into a partnership with Takeda Pharmaceutical Company Limited for the development, manufacturing and commercialization of NVX‑CoV2373 for COVID‑19 in Japan. NVX‑CoV2373 is a stable, prefusion protein developed using the Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M adjuvant.