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February 2025
The global recombinant proteins market size was calculated at USD 3.36 billion in 2025 and is predicted to reach around USD 8.08 billion by 2034, expanding at a CAGR of 10.24% from 2025 to 2034. Growth in the market can be attributed to factors such as rising incidence of chronic diseases like cancer, diabetes, and autoimmune disorders, growing demand for biologics and biosimilars due to the expiration of patients, rising demand for customized medicine, and increasing government initiatives are anticipated to drive market growth.
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Recombinant DNA (rDNA) technology, which combines at least two DNA sequences that rarely occur together in nature, is used to create recombinant proteins. High protein yields, free of animal contaminants, and regulated batch-to-batch fluctuation are all possible with recombinant protein synthesis. The possible use of these rDNA libraries and the resulting proteins as replacement therapy, inhibitors of disease pathways, or other anti-disease medicines are then carefully examined.
Recombinant protein manufacturing is a well-established biotechnological method for producing certain proteins of interest on a large scale. The process of creating recombinant proteins starts at the genetic level when the target protein's coding sequence is isolated and cloned into an expression plasmid vector. The vector and the desired gene are then transferred to an appropriate host, which causes gene expression, transcription, and messenger RNA (mRNA) translation into proteins. Despite being generated from human DNA, the majority of therapeutic recombinant proteins are produced in microbes like bacteria, yeast, or animal cells in culture. In order to boost research productivity and expand their revenue-generating products, major companies in the recombinant proteins market are investing in their R&D programs.
AI is transforming the recombinant proteins market by accelerating protein design, engineering production, quality control, and improving efficiency across various stages. Through machine learning, AI is able to keep updated on vital bioreactor parameters and make real-time modifications to preserve ideal production conditions. It also quickly identifies and optimizes protein structures, reducing development time and cost. By examining patient data, it also makes it possible to create personalized medicines, which result in more specialized care. By identifying differences in protein structure and purity, AI also improves quality control. In general, AI is influencing the future of recombinant proteins by accelerating, improving the accuracy, and lowering the cost of biopharmaceutical development.
Increasing Incidence of Chronic Disorders
The necessity for targeted and efficient protein treatment approaches has ultimately increased due to the growing incidence of chronic illnesses. According to the American Cancer Society, the most prevalent malignancies are those of the skin, prostate, colorectal, lung, and breast. To counter this, a number of projects have been started to use recombinant DNA technologies to provide more effective immunotherapy. The goal of these recombinant products is to eradicate the tumor and strengthen the immune system's resistance to malignant cells. Immunostimulants, vaccines, antibodies, immunotoxins, and fusion proteins are the most significant recombinant products used in anticancer therapy.
High Cost Production
Using recombinant DNA technology to produce proteins in large quantities requires a significant investment of time, labor, and resources. Furthermore, the cost of recombinant proteins for medicinal applications might be in the billions of dollars per kilogram. The manufacturing of recombinant proteins is expensive due to these variables, which eventually raises the cost of therapeutic goods. This constrains their accessibility and restricts market expansion by making them costly for many patients, particularly in developing nations. Furthermore, the high cost of production puts pressure on biopharmaceutical businesses to grow their profits, which can raise medicine costs and ultimately lead to pressure from regulators and payers.
Rising demand for recombinant proteins for biotherapeutics
Biotherapeutic medications made from recombinant proteins have transformed the way that many illnesses, such as cancer, autoimmune conditions, and infectious diseases, are treated. Because biotherapeutics may target certain cells and tissues and are successful in treating a variety of ailments, their demand is growing. The economics and efficiency of the drug development process have been greatly enhanced by the use of recombinant proteins in biotherapeutics. As a result, the development of biotherapeutic medications has been a top focus for many pharmaceutical firms, which is expected to support the recombinant protein market's expansion throughout the course of the projected year.
On the basis of product, the cytokines & growth factors segment held the largest revenue share of the recombinant proteins market in 2024. It is widely used in a variety of domains, including immunology, neurology, COVID-19, HIV/AIDS, and cancer. The category is expanding as a result of the growing global acceptance of cytokines in cancer treatment and their recognition as biomarkers for disease detection. The rising prevalence and incidence of cancer, funding for cancer treatment research, and giving rise to new goals for chemotherapy are driving market expansion. The market is also increasing internationally due to the need for recombinant protein products in regenerative medicine and increased funding for research and development in the battle against cancer.
By product, the antibodies segment is estimated to grow significantly in the recombinant proteins market during the forecast period. Western blotting, immunohistochemistry, and ELISA are among the diagnostic procedures that heavily rely on recombinant antibodies. They are perfect for identifying disease-related antigens and biomarkers due to their excellent sensitivity and specificity. Their need for diagnostic applications has increased as a result, especially for conditions including autoimmune disorders, infections, and cancer.
The therapeutics segment dominated the recombinant protein recombinant proteins market in 2024. Protein-based treatments are expected to become more in demand as disorders, including cancer, immunological disorders, metabolic disorders, and genetic abnormalities, become more common. Furthermore, one of the world's top causes of death is cancer, and the World Health Organisation (WHO) projects a significant increase in cancer cases in the years to come. Consequently, it is anticipated that the therapeutics market will expand.
Based on the application, the drug discovery & development segment is estimated to grow significantly in the recombinant proteins market during the forecast period. Research and development efforts are growing, which is helping the market flourish. Important market participants' product releases are also anticipated to propel the category. Diseases including diabetes, cancer, infectious diseases, hemophilia, and anemia can all be effectively treated using protein therapies. Globally, there will be 643 million diabetics by 2030 and 783 million by 2045, according to the International Diabetes Federation. The need for the creation of efficient recombinant proteins is anticipated to increase in the upcoming years due to the significant rise in the number of people with diabetes.
Based on end-users, the pharma & biotechnology companies segment dominated the global recombinant proteins market in 2024. The trend towards biologics and biosimilars has led to bio-manufacturers investing millions of dollars in research and development to expand their product pipeline, develop new technologies, and improve bioprocessing instruments. Developments in recombinant protein products have also been aided by growing consumer demand, increased player rivalry, and a variety of end-user applications.
Over the course of the forecast period, the academic and research institutes segment is anticipated to develop at a significant rate in the recombinant proteins market. Additionally, the R&D sector saw a rise in investments in industry-academia engagement and collaborations.
The Centre for Therapeutic Innovation (CTI) at Pfizer serves as a forum for cooperation across healthcare organizations. CTI actively works with researchers and academic institutions to address the issues by using Pfizer's ideas. These kinds of partnerships support research into new drugs and possible treatments for patients, which ultimately drives market expansion.
Based on the host cell, the mammalian cell segment held the largest recombinant proteins market share in 2024. The need for mammalian protein expression is rising in conjunction with the growth of the proteomics and biologics sector. Protein expression systems are readily available and can be easily integrated into high throughput systems for efficient proteomics and biologics research. Furthermore, the growing incidence and prevalence of cancer, as well as increasing research and development (R&D) activities, have led to a greater focus on developing biopharmaceutical goods, which in turn is driving the market's rise.
The bacterial cell segment is anticipated to witness significant growth over the forecast period. In biotechnology and research, the use of bacterial cells as host cells has grown dramatically. Because of their easy handling, well-characterized genetics, and quick growth, bacterial cells, primarily Escherichia coli (E. coli), are desirable for protein expression. Over the course of the projection period, the expansion of bacterial cells is expected to be driven by the increasing demand for a variety of applications, including drug research and antibodies.
North America held the largest revenue share of the recombinant proteins market in 2024. The market for recombinant proteins in North America was dominated by the US. The market has expanded due to increased investment in research, the accessibility of healthcare facilities, and a number of important market participants due to the rising incidence of cancer in the area.
The American Cancer Society's 2024 report projects that 1.9 million new instances of cancer will be detected in the U.S. in 2024. Due to aging populations and population growth, this number is predicted to rise to 2.4 million by 2035. For such reasons, recombinant proteins have been shown to be effective in cancer conditions, the prevalence of chronic illnesses, and the presence of competitors, research funding, mergers, and acquisitions in the region is driving up demand for recombinant protein therapies.
Asia-Pacific is expected to grow at a significant CAGR during the forecast period. Increased public and private financing for recombinant protein research and development, supportive government policies and regulations, and the growing incidence of target illnesses in an aging population are all factors contributing to the region's market expansion. Proteomic and genomic research techniques have improved, which helps the region grow. Additionally, during the course of the forecast period, the growing healthcare infrastructure is anticipated to support the geographical expansion of the recombinant proteins market. Additionally, it is anticipated that government support for biotechnology R&D would propel regional market expansion.
In September 2024, Axio BioPharma, a respected producer and provider of quality recombinant proteins, announced that it is presently accepting recombinant protein manufacturing projects. The founder and CEO of Axio BioPharma, Justin Byers, claimed that the company's mission is to be the go-to partner for enterprises producing novel biologics. They are committed to accelerating the development of life-saving therapies through innovative manufacturing methods.
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February 2025
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