مقالات پذیرفته شده در نهمین کنگره بین المللی زیست پزشکی
Recombinant Drugs and Their Global Market
Recombinant Drugs and Their Global Market
Haniyeh Zare,1,*Ali Moghadam,2
1. Department of Nanobiotechnology, Faculty of Advanced Technologies, Shiraz University, Shiraz, Iran 2. Research Institute of Biotechnology, College of Agriculture, Shiraz University, Shiraz, Iran
Introduction: Recombinant drugs, created through recombinant DNA technology, are revolutionizing medicine by enabling precise protein- and biologics-based therapies. Engineered proteins can target specific cells, reduce side effects, and improve efficacy [2,5]. Continuous manufacturing has lowered costs and increased production efficiency, supporting a global market exceeding USD 125 billion in 2020 [1,3]. The rise of microbial and alternative proteins also promotes sustainability and scalability [1]. mRNA and other novel therapies highlight the shift toward high-quality, clinically effective treatments [4].
Methods: Recombinant Antibodies: Recombinant antibodies (rAbs) are produced in vitro as precise alternatives to animal-derived antibodies, avoiding ethical concerns and improving reproducibility [7,8]. Technologies such as phage, yeast, and ribosome display enable selection from immune, naive, synthetic, or semi-synthetic libraries [7]. rAbs are widely used in research (ELISA, Western blot, flow cytometry), diagnostics, imaging, and targeted therapies for cancer and autoimmune diseases [7,8]. Their specificity and affinity can be enhanced through in vitro maturation and CDR modification. rAbs also integrate into antibody microarrays for large-scale proteome analysis and into biosensors for pathogen detection, including HIV [6,7,8]. Industrially, the global rAb market reached USD 12.4 billion in 2023 and is projected to exceed USD 23 billion by 2033, driven by increasing demand for personalized medicine, adoption of advanced selection methods, and the application of AI-assisted design [9,10]. Although regulatory approval processes and production costs remain significant barriers, rAbs have established themselves as essential tools for precision diagnostics and next-generation therapeutics [9,10].
Recombinant Hormones: Recombinant DNA enables production of pure protein hormones like GH, LH, and FSH in bacterial or mammalian cells, avoiding contamination risks [11,14]. Recombinant GH transformed treatment of GH deficiency, replacing scarce pituitary-derived hormone, with long-acting formulations improving adherence and clinical outcomes [15]. Recombinant LH, combined with FSH, improves ovarian stimulation in assisted reproduction [13]. Pediatric and adult endocrine therapies now rely on recombinant hormones for personalized treatments. Molecular studies reveal that genetic mutations in hormone genes or receptors cause many endocrine disorders, which can be effectively managed using recombinant hormone therapies [14]. Global rhGH market is projected to grow from USD 1.77–7.65 billion in 2024 to USD 18–24 billion by 2032–2034 [16].
Recombinant Vaccines: Recombinant vaccines offer high safety and targeted immune responses, produced in bacterial, yeast, insect, or mammalian cells [18]. Bacterial systems are fast and low-cost but limited in folding; yeast allows post-translational modifications; insect and mammalian cells produce complex proteins and virus-like particles [18]. Spike-based and RBD-based SARS-CoV-2 vaccines (e.g., NVX-CoV2373, ZF2001) show strong efficacy and neutralizing antibody responses [19]. Nanoparticle vaccines enhance immune durability, while plant-based systems offer scalable, cost-effective production [23]. Recombinant influenza HA vaccines provide improved efficacy, especially in adults over 50 [20,21]. The global recombinant vaccine market is projected to grow from USD 18.3 billion in 2025 to USD 30.6 billion by 2030 (CAGR 11.1%), with expansion linked to rising vaccine demand, technical improvements in production, and broader international research collaborations [24].
Recombinant Enzymes: Agalsidase alfa, a recombinant enzyme for Fabry disease, significantly improves cardiac and renal outcomes, particularly when therapy begins early, while neurological benefits are limited due to poor blood–brain barrier penetration and potential anti-drug antibodies (ADAs) [25]. In late-onset Pompe disease, ERT with alglucosidase alfa, avalglucosidase alfa, or cipaglucosidase alfa/miglustat improves walking distance and pulmonary function, though long-term progression continues, and ADAs remain a challenge [26]. Recombinant anti-inflammatory enzymes, such as engineered catalase, superoxide dismutase, and TEV protease, target oxidative stress and inflammatory pathways with enhanced specificity and safety [27]. Despite challenges like short half-life, immunogenicity, and production costs, strategies including pegylation, glycoengineering, and nanoparticle encapsulation have expanded clinical potential. The recombinant enzyme market is projected to grow from USD 431.9 million in 2024 to USD 788.6 million by 2030 [28].
Recombinant Interferons: Interferons (IFNs) regulate antiviral immunity, bacterial and fungal defense, autoimmune diseases, and cancer. Type I (IFN-α/β), II (IFN-γ), and III (IFN-λ) differ in receptor specificity and tissue effects [30]. Recombinant IFNs treat hepatitis, multiple sclerosis, immune disorders, and certain cancers, acting through JAK-STAT signaling and induction of interferon-stimulated genes (ISGs). Limitations include flu-like symptoms, hematologic effects, and frequent injections, addressed by PEGylation and engineered variants. The global recombinant interferon market is projected to grow from USD 2.5 billion in 2024 to over USD 4 billion by 2033 [30].
Fusion Proteins and Bispecific Antibodies: Fusion proteins, including bispecific antibodies (bsAbs), combine multiple functional domains for multifunctional therapeutics, such as linking T cells to tumors or blocking dual signaling pathways [31]. Fc-based and fragment-based bsAbs differ in half-life, tissue penetration, and engineering strategies (knob-into-hole, DuoBody, CrossMab). BsAbs like Blinatumomab (CD3×CD19) and Amivantamab (EGFR×cMET) demonstrate clinical efficacy in oncology, though CRS, immunogenicity, and on-target off-tumor toxicity require careful management. Advances in Fc engineering, half-life extension, and tumor microenvironment-activated prodrugs improve safety and efficacy. The global fusion protein market is projected to grow from USD 32.83 billion in 2025 to USD 54.4 billion by 2030 [32].
Results: This review shows that recombinant therapeutics—including antibodies, hormones, vaccines, enzymes, interferons, and fusion proteins—have achieved notable progress in providing targeted treatment options for both acute and chronic diseases. Clinical studies consistently demonstrate their therapeutic effectiveness, while market analyses highlight rapid global expansion. For example, the recombinant protein therapeutics market was valued at approximately USD 56.99 billion in 2024 and is projected to nearly double, reaching about USD 108.38 billion by 2033. Likewise, the research and diagnostics segment is expected to grow from USD 3.01 billion in 2024 to USD 5.58 billion by 2030. The recombinant enzyme sector is also expanding, forecasted to rise from USD 431.9 million in 2024 to roughly USD 788.6 million by 2030. In addition, the contract development and manufacturing organization (CDMO) market was valued at USD 20.89 billion in 2023 and is anticipated to grow at an annual rate of nearly 14% through 2030. Overall, these findings highlight not only the clinical potential of recombinant drugs but also their substantial role in reshaping healthcare strategies and the pharmaceutical industry.
Conclusion: Recombinant therapeutics, including enzymes, antibodies, vaccines, cytokines, and fusion proteins, provide targeted treatments, improve patient outcomes, and support personalized medicine. Although high production costs, complex purification, stability issues, and regulatory hurdles remain significant obstacles, the market continues to expand. With ongoing innovation in molecular design, manufacturing, and regulatory processes, recombinant drugs are expected to play a decisive role in future disease management and generate both measurable economic and clinical impact [33–36].