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According to the latest market research report on the Recombinant Protein Market, published by IndustryARC, 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.
The Recombinant Protein Market research report is segmented By Product Type: Hormone, Enzymes, Antibodies, Others; By Application: Therapeutics, Biotechnology, Research; By Geography: North America, Latin America, Europe, APAC, Middle East & Africa which provides a comprehensive analysis of the global market & industry forecast (2024 - 2030).
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Asia Pacific Anticipated to Show the Fastest Growth in the Market:
The Asia Pacific region shows the fastest growth rate in the Recombinant Protein Market share with a CAGR of 9.81% during the forecast period (2024-2030). Asia-Pacific 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.
Recombinant Protein Market 2024-2030: Scope of the Report
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Recombinant Protein Market Report – Key Takeaways:
- Antibody’s are Leading the Market
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.
- Research Applications Dominate The Market Share
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.
- Rising Demand For Biologics Drives The Market
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.
- Stringent Regulations And Ethical Concerns Are A Major Challenge To The Market
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.
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Key Opportunity Analysis:
- Remarkable Rise In The Field Of Customized Medicine
Therapies in customized medicine are intended to target specific biological processes or proteins that are malfunctioning in a patient. Recombinant proteins enable the development of highly specific biopharmaceuticals, such as monoclonal antibodies, which can interact with these targets more accurately, lowering adverse effects and increasing effectiveness. Personalized medicines accounted for 39% of new pharmaceuticals authorized by the FDA in 2020, more than one-third of all new drug approvals. As more illnesses and ailments are recognized at the molecular level, the number of clinical uses for recombinant proteins grows larger. Companies that invest in recombinant technologies, biomanufacturing, and precision diagnostics are well-positioned to profit from this trend.
Furthermore, there is a growing number of companies and digital health technologies that personalize and improve patient care. International partnerships facilitate the global expansion of precision medicine, allowing companies to reach new markets and patient populations. For instance, in March 2024, Bayer and Thermo Fisher Scientific collaborated to increase patient access to precision cancer medicines. In March 2024, AstraZeneca entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The expansion of precision medicine into emerging markets presents opportunities for recombinant protein companies to offer their expertise and services in new regions.
Significant promise for recombinant proteins also exists in the domains of tissue engineering and regenerative medicine. The use of these recombinant proteins provides critical tools and approaches for tissue engineering and regenerative medicine, boosting tissue repair and regeneration while enhancing disease therapy and patient recovery. As technology advances and study deepens, additional discoveries and developments in this sector are predicted to emerge from recombinant proteins.
- Enhanced Protein Design Using Advanced Technologies:
With the increased availability of protein therapies for treating cancer and other disorders, construct design has become a more important talent in drug development. The recombinant protein market is experiencing a transformation as advanced technologies such as machine learning (ML), artificial intelligence (AI), and predictive tools like AlphaFold2 are being integrated into protein engineering. These developments are significantly simplifying the creation of recombinant proteins and opening new avenues for novel protein designs, de novo protein development, and the engineering of functional proteins.
Protein engineers are using fast emerging machine learning technologies, massive amounts of data, and AlphaFold's structure-predicting firepower to explore increasingly advanced de novo protein designs. For example, in January 2023, Profluent emerged from stealth mode with $9 million in early investment to assist the company's efforts to use ML to build new functional proteins. In January 2022, Generate Biomedicines inked a $50 million drug development agreement with Amgen, which may yield the business more than $1.9 billion in total, while a few months later, Arzeda raised $33 million in series B investment to support its ongoing protein design activities. Other firms are also entering the fray, including computational company Cradle, which emerged from stealth in November with a $5.5 million initial investment, and Monod Bio, which raised $25 million in preliminary funding in August.
Therefore, the expanding use of AI and machine learning to engineer novel proteins and predict protein functions offers significant opportunities to accelerate research, reduce costs, and improve the design and production of novel proteins.
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The Report also Covers the Following Areas:
- Recombinant Protein Market Size and Forecast
- Recombinant Protein Market Trends
- Recombinant Protein Market Analysis by Type
Recombinant Protein Market 2023-2030: Key Highlights
- CAGR of the market during the forecast period 2024-2030
- Value Chain analysis of key stakeholders
- Detailed analysis of market drivers and opportunities during the forecast period
- Recombinant Protein Market size estimation and forecast
- Analysis and predictions on end users’ behavior and upcoming trends
- Competitive landscape and Vendor market analysis including offerings, developments, and financials
- Comprehensive analysis of challenges and constraints in the Recombinant Protein Market
Covid and Ukrainian Crisis Impact:
- The COVID-19 pandemic has caused significant disruptions to global supply chains, impacting not just the transportation of completed items but also the cost and accessibility of raw materials. Both the COVID-19 pandemic and geopolitical crises can disrupt global supply chains. Manufacturing facilities may face challenges in sourcing raw materials, production delays, and transportation issues, affecting the supply of Recombinant Protein. One of the most notable impacts was the rapid development and deployment of recombinant-based COVID-19 vaccines, such as those produced by Moderna (mRNA vaccines) and AstraZeneca (viral vector vaccines). These vaccines were developed at unprecedented speeds, showcasing the power of recombinant DNA technology in addressing urgent public health crises.
- Price increases were caused by conflicts between Russia and Ukraine. Numerous businesses have temporarily closed their units in Ukraine and ceased operations in Russia. Additionally, because businesses are reluctant to engage in an area that is experiencing political and economic uncertainty, the Ukrainian crisis has also resulted in a decline in market investments. This can have an effect on the market's dynamics of supply and demand.
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List of Top Companies in the Recombinant Protein Market:
The Global Recombinant Protein Market is consolidated as the majority share is held by the leading Recombinant Protein manufacturers. The key companies profiled are listed below:
- 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.
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