Recombinant Proteins Market

Market Overview

The global recombinant proteins market size was valued at USD 1.25 billion in 2022. It is estimated to reach USD 3.27 billion by 2031, growing at a CAGR of 11.3% during the forecast period (2023–2031). A surge in chronic disease and chronic disease-related mortalities worldwide boosts the global market. The key players in the market are also taking several strategic initiatives to survive in the highly competitive market, thereby augmenting the market growth. Moreover, the increasing focus on research and development in recombinant proteins is resulting in a significant rise in the introduction of new products and advancements, which is expected to create opportunities for the global recombinant proteins market.

Recombinant proteins are those that are produced via the application of recombinant DNA technology. By combining genetic material from various sources, typically two distinct organisms, this technology entails the manipulation of DNA molecules. The insertion of a target gene or genes into the DNA of a host organism, such as yeast or bacteria, for manufacturing desired protein is made possible by recombinant DNA technology. There are numerous significant applications for recombinant proteins in biotechnology, medicine, and research.

Therapeutic proteins, including growth hormones and insulin, are manufactured using them to treat various diseases. The biopharmaceutical business, diagnostic test development, and vaccine production benefit greatly from their use in scientific study into the structure and function of proteins. Recombinant DNA technology has significantly transformed the protein synthesis process by enabling the synthesis of large amounts of rare or difficult-to-obtain specific proteins.

Market Dynamics

Global Market Drivers

Increasing Incidence of Chronic Diseases

The surge in chronic illnesses worldwide is boosting the global recombinant protein market. Recombinant proteins are currently used to treat several chronic illnesses, including cancer, cardiovascular, endocrine, and viral diseases. According to the September 2023 WHO update chronic disease accounts for 74% of deaths worldwide, equivalent to 41 million people annually.

Annually, 17.9 million people die from cardiovascular diseases, the leading cause of mortality from chronic diseases. Cancers are responsible for 9.3 million deaths, followed by chronic respiratory diseases with 4.1 million. Diabetes, which includes kidney disease-related fatalities, contributes to 2.0 million deaths. These four disease categories comprise more than 80% of all premature chronic disease-related fatalities. These factors foster the market expansion during the forecast period.

Strategic Acquisitions and Collaborations

The key participants in the global recombinant proteins market are involved in various strategic initiatives, helping them enhance their market share. For instance, in January 2022, Thermo Fisher Scientific Inc., the global leader in serving science, and PeproTech, Inc., a leading developer and manufacturer of recombinant proteins, jointly declared today that the acquisition, valued at approximately USD 1.85 billion in cash, was finalized by Thermo Fisher on December 30, 2021.

In addition, in April 2020, to increase the volume of SARS-CoV-2 (COVID-19) reagents produced, OXGENE™ and The Native Antigen Company formed a partnership to combine OXGENE's antigen development expertise with its proprietary Adenoviral Protein Machine Technology. Scaling up their antigen manufacturing capabilities, OXGENE and The Native Antigen Company will work together to offer high-purity, recombinant proteins to develop diagnostics and vaccinations. Such initiatives contribute to market growth.

Global Market Restraints

Lack of Trained Professionals

The field of recombinant proteins is very complex and requires a lot of expertise to get the desired results. Processes involving recombinant proteins necessitate proper interpretation of results, and researchers must also be able to analyze experimental results and test them with the experiment's hypothesis.

The recombinant protein serves specific purposes such as making a vaccine, utilizing gene therapy, drug delivery, antibody modifications, and enzyme modification. These tasks require modifying DNA and amino acid sequences to do the desired function, which is very complex. Hence, there is a significant need for highly qualified professionals and researchers in this field. However, the lack of such expertise hinders the market's growth.

Global Market Opportunities

Rising Product Launches and Innovation

The growing research and development in recombinant proteins is leading to surging product launches and innovations. For instance, in February 2023, a 'Recombinant Protein Toolbox' comprising six specialized proteins was developed by a research team from the Indian Institute of Technology Guwahati (IIT-G). This toolbox enables the conversion of healthy skin cells or any somatic cell from an adult human body into cardiomyocytes, which are heart cells. The heart cells generated through the utilization of this toolbox possess the capacity to regenerate impaired cardiac tissues and perform the identical function as the original heart cells.

In addition, in June 2022, AMSBIO introduced its StemFit Purotein® line of recombinant proteins designed for use in cell therapy that are characterized by their high activity and purity. Recombinant proteins from the StemFit Purotein® line are essential for differentiating ES and iPS cells into various cell types, including those of the liver, pancreas, kidney, heart, blood, and immune system. One advantageous feature of StemFit Purotein® products is that they are delivered in a frozen liquid state that is immediately usable, eliminating the need for a lengthy reconstitution process. Such product innovations are expected to create global recombinant protein market opportunities.

Regional Analysis

Based on region, the global recombinant proteins market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global recombinant proteins market shareholder and is expected to expand substantially during the forecast period. The North American region is anticipated to hold a significant share of the market during the forecast period because of the presence of a large pharmaceutical market, huge investment in the drug development and discovery initiative by a few of the largest pharmaceutical companies located in the region, high prevalence of chronic illnesses, and the presence of a solid healthcare infrastructure in the region. For instance, in collaboration with the Institute of Molecular Medicine (IMM), California, the Gates Biomanufacturing Facility (GBF) achieved successful completion of the complete cycle manufacturing process for the recombinant Bulk Drug Substance (BDS) of the anti-Tau vaccine, AV-1980R. IMM has designated GBF as its sole cGMP-grade BDS manufacturing partner to facilitate the clinical supply of AV-1980R and other recombinant protein vaccines. The financial support for this study was obtained from the National Institute on Aging (NIA) of the United States.

Furthermore, the soaring frequency of chronic diseases in the region is expected to boost the market studied. For instance, in April 2021, the Canadian Cancer Society data stated that cancer is Canada's leading cause of mortality, accounting for roughly one-third of all deaths. This is poised to increase the testing demand, increasing the region's recombinant protein growth.

Europe has the world's best and most established healthcare systems. This well-established healthcare system is also fueling the growth of the recombinant proteins market in the region. The key players in the region are taking initiatives to introduce novel recombinant proteins. For instance, in July 2023, Paras Biopharma (Biologics CDMO) Finland, a prominent biopharmaceutical technology development company in the Nordic region, utilized its fully-equipped biologics production facility in Finland to optimize recombinant protein expression in Microbial Systems. The organization is ecstatic to announce its progress in scale-up studies toward commercial-scale production of recombinant proteins that are entirely folded and biologically active at concentrations of 12g or more/L in fermentation broth. This innovative Biomultifold system will be operational and accessible for forthcoming research projects, streamlining operations and reducing expenses. Thus, such launches are expected to boost market expansion.

The Asia-Pacific market is anticipated to grow during the forecast period because of rising research and development expenditures. According to the Statistics Bureau of Japan 2021, Japan's total R&D spending in fiscal year (FY) 2020 was 19.24 trillion yen, and research and development spending as a percentage of GDP was 3.59 %, up 0.08 %age point from the previous fiscal year. The increasing R&D expenditure, especially in healthcare, is expected to boost the market growth.

In addition, the surging incidences of chronic illnesses, along with the surging geriatric population in the region, are further expediting the market development. For instance, as per an article published in NLM, reportedly, around 21% of the geriatric population in India suffers from at least one chronic illness. Chronic disease affects 16% of the elderly residing in rural areas and 29% of the elderly residing in urban areas. Diabetes and hypertension comprise approximately 68% of all chronic diseases. These factors are estimated to boost the regional market expansion.

Segmental Analysis

The global recombinant proteins market is segmented by product, application, and end-user.

Based on product, the global recombinant proteins market is divided into growth factors and chemokines, immune response proteins, structural proteins, membrane proteins, kinase proteins, regulatory proteins, recombinant metabolic enzymes, adhesion molecules and receptors, and other recombinant proteins. 

The growth factors and chemokines segment is the largest revenue contributor and is expected to expand substantially over the forecast period. Growth factors and chemokines are essential signaling molecules that significantly influence many physiological processes, most notably immune responses, cell migration, differentiation, and growth. They belong to the category of cytokines, which are diminutive proteins utilized for intercellular communication. In addition, peptides or proteins known as growth factors promote the proliferation and development of particular cells. They perform critical functions in tissue development, regeneration, and maintenance.

Chemokines, which function as chemotactic signals to direct the migration of immune cells to particular sites within the body in response to an infection or inflammation, constitute a subgroup of cytokines. An understanding of the functions and regulation of these substances is crucial in the development of treatments and therapies for a comprehensive range of medical conditions, such as cancer, tissue regeneration, and inflammatory diseases.

Based on application, the global recombinant proteins market is bifurcated into drug discovery and development, research, therapeutics, and other applications. 

The therapeutics segment dominates the global market and is expected to expand substantially over the forecast period. Protein therapeutics, or biopharmaceuticals or biologic drugs, are pharmaceutical substances composed of proteins or peptides. Recombinant proteins are used to develop several types of protein therapeutics, biologics, vaccines, cell and gene therapies, and others. A diverse array of diseases and medical conditions, including autoimmune disorders, cancer, and infectious diseases, are treated by the development of these medications. The surging incidence of this disease is expected to boost the segment growth. For instance, according to GLOBOCAN 2020, there were 19,292,789 newly diagnosed cancer cases and 9,958,133 cancer-related deaths worldwide in 2020.

Based on end-user, the global recombinant proteins market is divided into drug discovery and development, therapeutics, research, and others. 

The pharmaceuticals and biotechnology companies segment is the most significant contributor to the market. Pharmaceutical and biotechnology companies are entities whose principal activities encompass the investigation, advancement, production, and promotion of goods relevant to life sciences and healthcare. Despite their close relationship and frequent overlap, there are several notable distinctions between these two categories of businesses. In addition, pharmaceutical and biotechnology companies each contribute significantly to the advancement of medical science and the enhancement of healthcare. They frequently partner with government agencies, academic institutions, and research organizations to develop and introduce novel treatments and therapies to the market. These businesses may consist of specialized organizations or lesser multinational corporations.

Recent Developments

• July 2023- Dyadic International, Inc. issued the following update concerning its Phase 1 Clinical Trial for the recombinant protein receptor binding domain (RBD) booster vaccine candidate DYAI-100 COVID-19. The Data Safety Monitoring Board (DSMB) ascertained the absence of significant vaccine-related safety concerns through an interim analysis of the Day 29 data for both the low and high-dose groups.

• May 2023- The National Medical Products Administration of China granted "Drug Clinical Trial Approval" to recombinant bivalent COVID-19 protein vaccine (Sf9 cells) and recombinant trivalent COVID-19 trimeric protein vaccine (Sf9 cells), both of which were developed by WestVac Biopharma/West China Medical Center, Sichuan University in response to the latest circulating XBB variants.