Recombinant Protein Market - Industry Analysis, Market Size, Share, Trends, Application Analysis, Growth And Forecast 2024 - 2030

Recombinant Protein Market Overview

The Recombinant Protein market size is forecast to reach USD 4,654.07 million by 2030, after growing at a CAGR of 8.81% during the forecast period 2024-2030. The recombinant protein market encompasses the production and commercialization of proteins that are genetically engineered using recombinant DNA technology. This process involves inserting the gene responsible for a specific protein into host cells, such as bacteria, yeast, or mammalian cells, enabling these organisms to produce the desired protein in large quantities. Recombinant proteins have a wide range of applications, including therapeutics, diagnostics, research, and industrial processes. 

Report Coverage

The report “Recombinant Protein Market– Forecast (2024-2030)”, by IndustryARC, covers an in-depth analysis of the following segments of Recombinant Protein.

By  Product Type: Hormone, Enzymes, Antibodies, Others

By Application: Therapeutics, Biotechnology, Research

By Geography:  North America, Latin America, Europe, APAC, Middle East & Africa

Key Takeaways

• Startups are playing a pivotal role in advancing recombinant protein production through novel, cost-effective methods. On July 8, 2024, Chilean startup ByBug raised a $1.4 million seed round to develop a platform that produces recombinant proteins from genetically engineered black soldier flies, a process that is cheaper and more scalable compared to traditional precision fermentation using engineered microbes. Backed by prominent investors like Südlich Capital and Arpegio VC, this funding will support ByBug’s R&D expansion and help prepare for commercial operations in Tulsa, Oklahoma. Such innovative approaches are pushing the boundaries of recombinant protein production, reducing costs, and expanding the potential applications of these proteins across industries, thereby driving further growth in the market.
• On May 7, 2024, HTL Biotechnology has acquired the aesthetics and biomedical divisions of U.S.-based Modern Meadow, enhancing its role as a leader in pharmaceutical-grade biopolymers. Modern Meadow's cutting-edge recombinant protein technology, which includes human recombinant collagen type III (rhCOL3), is part of this transaction. The integration of expert teams from leading scientific research centers enables HTL Biotechnology to innovate in recombinant human collagen for cosmetic and medical applications, capitalizing on the growing demand for plant-based and ethical products. 
• Asia-Pacific (APAC) with 30% of the market, reflecting the region’s growing prominence in biotechnology and pharmaceutical manufacturing. The increasing healthcare expenditure in countries like China, India, and Korea has contributed to the rapid expansion of recombinant protein production in APAC. The Korean Ministry of Food and Drug Safety (KMFDS) received a biologics license application from SK Bioscience and GSK on April 29, 2022, for SKYCovione™, a recombinant protein-based COVID-19 vaccine candidate. This submission followed positive results from Phase III clinical trials and included GSK's pandemic adjuvant to enhance the vaccine’s efficacy. This development acts as a significant driver for the recombinant protein market in the Asia-Pacific (APAC) region.

By Product Type - Segment Analysis

The antibody segment's dominance in the recombinant protein market, accounting for 45% of market revenue in 2023, is largely driven by the increasing prevalence of chronic diseases like diabetes. The International Diabetes Federation (IDF) estimates that 1 in 10 persons worldwide, or more than 537 million people aged 20 to 79, had diabetes in 2021. This alarming rise in diabetes cases directly correlates with the growing demand for antibodies, which are essential in developing therapeutic proteins and diagnostic tools for managing diabetes and related health complications. As this population is projected to reach 643 million by 2030 and 783 million by 2045, the need for innovative antibody-based treatments is expected to continue growing.

Additionally, more than 75% of adults with diabetes reside in low- and middle-income countries, amplifying the need for cost-effective and accessible antibody-based therapies. With diabetes responsible for 6.7 million deaths in 2021, or 1 death every 5 seconds, the urgency for advanced antibody therapies to improve disease detection, treatment, and management is critical. This global health crisis is driving biotechnology companies to focus heavily on recombinant antibodies, further expanding the market as healthcare systems worldwide seek solutions to address the growing challenge of diabetes.

By Application- Segment Analysis

50% of the global recombinant protein market's revenue in 2023 came from research applications, which led the market. This significant share reflects the growing importance of recombinant proteins in advancing scientific discovery, particularly in fields such as drug development, molecular biology, and genetic engineering. With increasing investments in R&D from both academic institutions and biotech companies, the demand for recombinant proteins as essential research tools has surged, driving growth in this segment

Research applications in the recombinant protein market are being driven by significant funding and innovative approaches that aim to accelerate the development and production of these proteins. For instance, Northwestern University received a $50,000 grant from the National Science Foundation on June 1, 2023, to support research focused on speeding up recombinant protein screening. This funding highlights the growing recognition of the importance of improving screening processes to enhance the efficiency of recombinant protein development. Accelerated screening technologies are crucial for advancing drug discovery, biotechnology, and therapeutic innovations, further fueling research investment in this area. 

By Geography - Segment Analysis

In 2023, the global recombinant protein market is geographically dominated by North America, accounting for 40% of total market revenue. This significant share can be attributed to the region’s advanced biotechnology infrastructure, high investment in research and development, and a strong presence of key pharmaceutical and biopharmaceutical companies. The United States, in particular, plays a leading role in the development and production of recombinant proteins, driven by increasing demand for biologics and personalized medicine.

On January 10, 2024, Nucleus Biologics, known as The Cell Performance Company™ and a leading provider of customized cell culture media for the cell and gene therapy sector, entered into a manufacturing, distribution, and collaboration agreement with Core Biogenesis, an innovator specializing in recombinant human proteins produced in plants. With the goal of providing more affordable and well-defined reagents and media solutions, this collaboration names Nucleus Biologics as the GMP manufacturer for Core Biogenesis' recombinant proteins and gives them distribution rights for these goods within the cell and gene therapy industry. As demand for advanced therapies rises, partnerships like this contribute to the scalability and affordability of recombinant protein production, driving further market expansion.

Drivers – Recombinant Protein Market

• Rising Demand For Biologics: 

The rising demand for biologics is a powerful driver of the recombinant protein market. As biologics become more central to modern medicine, targeted treatments, and vaccine development, the need for recombinant proteins to produce these therapies is predicted to grow. For instance, in September 2024, Axio BioPharma, which specializes in research-grade manufacturing of monoclonal antibodies (mAbs), launched recombinant protein manufacturing services to meet the growing demands of the biopharmaceutical industry.

Because of their great selectivity and efficacy, biopharmaceutical proteins have become a particularly attractive class of medications. Monoclonal antibodies are among the many biologics that are recombinant protein treatments. Biologics, which are complex molecules derived from living organisms, rely heavily on recombinant proteins for their production. Besides, there are an increasing number of companies investing in research and development of biologics. For example, Eurofins CDMO Alphora, Inc. said in January 2024 that its pilot-scale biologics development facility was successfully completed. With an expansive area of 3,300 square feet, this facility is exclusively dedicated to developing and scaling mAbs and other therapeutic proteins derived from mammalian sources.

In the pharmaceutical sector, biologics are gaining popularity because of their superior effectiveness, high specificity, and fewer adverse effects as compared to conventional small-molecule medications. Because biologics provide focused therapeutic methods for the treatment of chronic illnesses including diabetes, autoimmune disorders, and cancer, this preference is clear. 
For example, as per the International Diabetes Federation, in 2021 around 537 million people lived with diabetes all over the world and the number of diabetic patients is expected to reach 643 million and 783 million by 2030 and 2045 respectively. Innovative biologic therapies are becoming more and more in demand as the prevalence of these chronic conditions continues to rise worldwide. This rise in demand is expected to drive the recombinant protein market in the CDMO industry.

• Advances In Protein Production And Biotechnology:

Recombinant protein production technique development has always adhered to traditional procedures set up decades ago. This procedure entails selecting relevant genetic components from current expression toolkits by trial and error, then adjusting process-related parameters one by one in shaking flasks, or laboratory-scale bioreactors. Nowadays, the combination of high-throughput protein detection technologies with culture platforms, including MTPs, micro bioreactors, and parallel fermentation systems, has improved the efficiency of the cultivation, screening, and optimization processes. For example, Escherichia coli has become the primary host for recombinant protein production due to its low fermentation needs, fast growth capabilities, and consistent high-level expression. 

Advancements in biotechnology have revolutionized the field of protein production, enabling scientists to create custom recombinant proteins with precision and efficiency. For example, the production of recombinant proteins has grown from the gramme to the kilogramme scale due to the progress of biotechnology. Similarly, a variety of protein drugs have been successfully marketed, including mAbs, recombinant vaccines, and hormones, demonstrating that recombinant proteins already play a significant role in the biopharmaceutical field. These therapeutic proteins have established a strong market presence and continue to contribute to the growing market demand for recombinant proteins in medicine.

Challenges – Recombinant Protein Market

• Stringent regulations and ethical concerns: 

Regulatory bodies such as the U.S. Food and Drug Administration, the European Medicines Agency, and others require extensive clinical testing and detailed data to ensure that recombinant proteins meet safety and efficacy standards before they can be approved for therapeutic use. Ensuring the safety and efficacy of recombinant proteins necessitates strong regulatory regimes that can differ dramatically across nations. For example, in the EU, where GMO rules are tougher, recombinant proteins created using GMOs may undergo greater regulatory scrutiny, making it more difficult to embrace innovative technology than in less stringent locations.

Recombinant protein regulations are rather extensive and differ based on the nation and the protein's intended usage. 
For instance, the FDA regulates recombinant proteins under various guidelines. For therapeutic recombinant DNA-derived products, the FDA requires detailed submissions covering chemistry, manufacturing, and controls (CMC) information. This includes descriptions of the drug substance, manufacturing methods, and contamination precautions. Animal medication products made from recombinant proteins also need to adhere to labelling regulations and current good manufacturing standards (cGMP). In India, the Recombinant DNA Advisory Committee (RDAC) is tasked with periodically reviewing national and international biotechnology breakthroughs and recommending appropriate safety standards for India in recombinant research, use, and applications.

Market Landscape

In 2023, the top ten players in the Recombinant Protein market share accounted for 80.68% of the share. Major players in the Recombinant Protein market Eli Lilly and Company, Thermo Fisher Scientific Inc., Novavax Inc., Pfizer Inc., Bio-Rad Laboratories Inc., Merck KGaA, Sino Biological, Inc., Novo Nordisk AS, STEMCELL Technologies Inc., Abcam plc.

Developments:

• On May 10, 2024, With its Matrix-MTM adjuvant, Novavax, Inc., and Sanofi have signed a co-exclusive licensing deal. Both Novavax and worldwide public health depend on this collaboration. 
• PeproTech, Inc., and Thermo Fisher Scientific Inc. one of the world leaders in supporting science, declared that Thermo Fisher had completed the acquisition of PeproTech on January 05, 2022.

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