Protein Therapeutics Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028

Protein Therapeutics Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028

Global Protein Therapeutics Market has valued at USD 271.26 billion in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 6.80% through 2028. Protein therapeutics refers to a class of medical treatments that utilize proteins or peptides as therapeutic agents to diagnose, prevent, or treat diseases. These therapeutic proteins can be naturally occurring proteins, genetically engineered proteins, or synthetic peptides. Protein therapeutics have become a fundamental part of modern medicine, offering targeted and highly specific approaches to managing various medical conditions. Protein therapeutics can be produced through various methods, including recombinant DNA technology, cell culture, and bioprocessing. These methods ensure the production of pure and consistent protein products. One of the key advantages of protein therapeutics is their high specificity. They can be designed to target specific molecules or receptors, minimizing off-target effects, and reducing side effects compared to traditional small-molecule drugs. Continued technological innovations in protein production and purification processes were reducing manufacturing costs and improving the quality and safety of protein therapeutics.

Continuous innovations in protein engineering, including antibody-drug conjugates, bispecific antibodies, and fusion proteins, were expanding the therapeutic capabilities of protein-based drugs. Immunotherapies, such as immune checkpoint inhibitors and CAR-T cell therapies, were gaining traction in the treatment of cancer and autoimmune diseases, propelling market growth. The aging global population was leading to an increased prevalence of age-related diseases, creating a larger patient pool for protein therapeutics. The growth of biosimilars, which are similar but not identical versions of biologics, was enhancing competition and providing cost-effective treatment options for patients. Advances in genomics and biomarker discovery were promoting personalized medicine approaches, leading to the development of protein therapeutics tailored to individual patient profiles. Developing countries were experiencing increased healthcare expenditure, better access to healthcare, and a growing demand for advanced therapies, driving market expansion in these regions.

Key Market Drivers

Advancements in Protein Engineering

Directed evolution is a powerful technique that mimics the process of natural selection to improve the properties of proteins. It involves generating a library of protein variants, selecting those with desired traits, and then iteratively refining them through multiple rounds of mutation and selection. Directed evolution has been used to enhance enzyme activity, stability, and specificity for industrial and therapeutic applications. Computational methods, such as molecular modeling and structural analysis, enable scientists to predict how changes in a protein's amino acid sequence will impact its structure and function. Rational protein design allows for the custom engineering of proteins with specific properties, including enhanced binding affinity or altered catalytic activity. Antibody engineering techniques have led to the development of highly specialized monoclonal antibodies for targeted therapies. This includes the creation of bispecific antibodies that can simultaneously bind two different targets, as well as antibody-drug conjugates (ADCs) that deliver cytotoxic drugs to cancer cells. Fusion proteins are created by combining two or more protein domains or sequences to create multifunctional molecules. These fusion proteins can have enhanced stability, solubility, and therapeutic properties. For example, some fusion proteins combine the Fc region of an antibody with another protein to extend its half-life in the body.

Synthetic biology techniques enable the creation of entirely synthetic proteins and protein assemblies with designed functions. This field has applications in creating new biocatalysts, biosensors, and drug delivery systems. Protein-Drug Conjugates (PDCs) are designed to deliver cytotoxic drugs directly to target cells by attaching them to specific proteins or antibodies. This approach minimizes damage to healthy tissues and improves the therapeutic index of cancer treatments. Protein engineering plays a crucial role in the design and development of vaccines. Scientists can engineer viral proteins or antigenic regions to elicit a more potent and specific immune response while reducing potential side effects. Technologies like CRISPR-Cas9 have been adapted for protein engineering, allowing for precise modifications of genes encoding proteins. This enables the creation of designer proteins with desired properties. Phage display is a technique used to discover and engineer new proteins with specific binding properties. It involves displaying a library of protein variants on the surface of bacteriophages (viruses that infect bacteria) and selecting those that bind to a target of interest. Advancements in understanding protein folding kinetics and thermodynamics have improved our ability to design proteins with stable and predictable structures, which is essential for their function. This factor will help in the development of the Global Protein Therapeutics Market.

Rising Aging Population

With aging comes a higher risk of developing age-related and chronic diseases such as cancer, diabetes, Alzheimer's disease, and cardiovascular disorders. Many of these conditions are treated with protein-based therapeutics, including monoclonal antibodies, cytokines, and growth factors. Older adults often have multiple chronic conditions that require ongoing treatment. Protein therapeutics can provide effective management and control of these conditions, improving the quality of life for aging individuals. The immune system tends to weaken with age, making older adults more susceptible to infections and less responsive to traditional vaccines. Protein-based vaccines and immunotherapies, such as monoclonal antibodies, can help bolster immunity and protect against diseases.

Cancer incidence increases with age, and many targeted therapies for cancer are based on monoclonal antibodies and other protein therapeutics. These therapies can provide better outcomes and reduced side effects compared to traditional treatments. Age-related macular degeneration (AMD) and diabetic retinopathy are more common in older adults. Protein therapeutics, like anti-VEGF antibodies, have become a standard of care for treating these eye conditions. As people age, the risk of osteoporosis and fractures increases. Protein therapeutics like parathyroid hormone analogs are used to improve bone density and reduce the risk of fractures in older adults. Age is a significant risk factor for neurodegenerative diseases like Alzheimer's and Parkinson's disease. Protein-based therapies are being developed to target the underlying mechanisms of these conditions. Some age-related health issues, such as hormonal imbalances, can be managed with protein-based hormone replacement therapies. Older adults may experience delayed wound healing and tissue repair. Growth factors and cytokines, which are protein-based therapeutics, can aid in these processes. Improved healthcare and medical advancements have led to longer life expectancy. As people live longer, they may require ongoing medical treatment and interventions that include protein-based therapies. This factor will pace up the demand of the Global Protein Therapeutics Market.

Growing Immunotherapy

Immunotherapy has revolutionized the treatment of cancer. Monoclonal antibodies, checkpoint inhibitors, and CAR-T cell therapies, which are all protein-based immunotherapies, have shown remarkable efficacy in certain cancer types. They work by enhancing the immune system's ability to identify and target cancer cells. The success of these therapies has significantly increased the demand for protein-based treatments in oncology. Immunotherapy is not limited to cancer treatment. It is also being explored for the treatment of autoimmune diseases, infectious diseases, and other conditions. As research expands into these areas, it creates opportunities for new protein therapeutics to be developed and commercialized. Many immunotherapies are tailored to individual patients based on their specific immune profiles and the characteristics of their diseases. This personalized approach to treatment is driving the development of customized protein therapeutics, which can be more effective and less toxic than one-size-fits-all treatments. Combinations of different immunotherapies or immunotherapy with other forms of treatment, such as chemotherapy or radiation therapy, are being explored to enhance treatment efficacy. These combinations often involve protein-based therapeutics, further increasing their demand.

The success of immunotherapies has led to the development of biosimilars, which are similar but not identical versions of originator biologics. Biosimilars offer more affordable options for patients and healthcare systems while driving competition in the market. The regulatory landscape for immunotherapies has evolved to accommodate their unique mechanisms and patient populations. Regulatory approvals have facilitated the market entry of protein-based immunotherapies. The continued growth of clinical trials in immunotherapy research has driven the demand for protein therapeutics. Pharmaceutical companies and research institutions are investing heavily in developing and testing new immunotherapies. Immunotherapies have been adopted globally, increasing their accessibility and market reach. Emerging markets are also starting to play a significant role in driving demand for protein therapeutics, including immunotherapies. The success of immunotherapies has encouraged pharmaceutical and biotechnology companies to invest in R&D for new protein therapeutics. This investment has resulted in a robust pipeline of immunotherapies in various stages of development. Patients with conditions like cancer are increasingly seeking immunotherapy as a treatment option due to its potential for durable responses and fewer side effects compared to traditional treatments. This factor will accelerate the demand of the Global Protein Therapeutics Market.

Key Market Challenges

Manufacturing Complexities

Proteins are inherently complex molecules with precise three-dimensional structures. The manufacturing process must ensure the correct folding, post-translational modifications (e.g., glycosylation), and assembly of proteins to maintain their therapeutic efficacy. Protein therapeutics are often produced using genetically engineered cell lines, such as Chinese hamster ovary (CHO) cells or human cell lines. Developing stable and high-yielding cell lines is a time-consuming and intricate process. Upstream processing involves cell culture, where cells are grown in bioreactors and fed with nutrients to produce therapeutic protein. Maintaining optimal conditions for cell growth and protein expression is challenging and requires precise control of variables such as temperature, pH, and nutrient supply. Downstream processing involves the purification and isolation of the therapeutic protein from the cell culture. This step includes multiple chromatography and filtration steps to remove impurities, ensuring the final product's purity and safety. Stringent quality control measures are essential to verify the identity, purity, and potency of protein therapeutics. Analytical techniques must be highly sensitive and specific to detect and quantify impurities or variants. Transitioning from small-scale laboratory production to large-scale manufacturing presents technical challenges. Maintaining product consistency and quality on larger scales is critical. Protein therapeutics are subject to rigorous regulatory scrutiny. Manufacturers must adhere to good manufacturing practices (GMP) and meet stringent regulatory requirements, which can vary by region and country.

Product Pricing and Access

Developing protein-based therapeutics is a costly and resource-intensive process. This includes research and development, preclinical and clinical trials, regulatory compliance, and manufacturing scale-up. These expenses are often factored into the pricing of the final products. The production of protein therapeutics involves complex bioprocessing techniques, stringent quality control, and the use of specialized facilities. All these factors contribute to high manufacturing costs, which can impact product pricing. Regulatory agencies like the FDA and EMA have strict quality and safety standards for biologics and protein therapeutics. Complying with these regulations necessitates extensive testing and documentation, which adds to development costs. Companies invest heavily in research and development, and they often rely on patent protections to recoup their investments. This can lead to monopolies and high prices for branded protein therapeutics. Many protein therapeutics have limited competition, especially for rare diseases or conditions with a small patient population. This lack of competition can result in higher prices. While biosimilars offer the potential for cost savings, the development and regulatory approval of biosimilars can be time-consuming and expensive. Consequently, biosimilars may not always lead to substantial price reductions. Variations in healthcare reimbursement policies among countries and regions can impact patients' ability to access expensive protein therapeutics. In some cases, insurance coverage may be limited, requiring patients to bear a significant financial burden.

Key Market Trends

Biologics Dominance

Biologics, which include protein-based therapeutics such as monoclonal antibodies, enzymes, and vaccines, have gained prominence in the pharmaceutical industry. These biologics are derived from living organisms or cells, in contrast to small-molecule drugs that are chemically synthesized. Biologics are known for their high specificity and efficacy. They can be designed to target precise molecules or pathways involved in diseases, resulting in reduced off-target effects and enhanced therapeutic outcomes. The development and approval of monoclonal antibodies and other biologics for cancer immunotherapy have been a major driver of this trend. Immune checkpoint inhibitors, CAR-T cell therapies, and targeted therapies have revolutionized cancer treatment. Biologics have also played a critical role in the treatment of autoimmune diseases such as rheumatoid arthritis, multiple sclerosis, and psoriasis. Monoclonal antibodies that modulate immune responses have been instrumental in managing these conditions. Biologics are used in the development of vaccines and antiviral therapies. The COVID-19 pandemic has highlighted the importance of biology in responding to global health crises. Biologics offer opportunities for personalized medicine approaches. They can be customized to match the genetic or disease profiles of individual patients, potentially improving treatment outcomes. The emergence of biosimilars, which are similar but not identical versions of originator biologics, has increased competition and provided more affordable options for patients. Biosimilars are helping to expand access to biologic treatments.

Segmental Insights

Protein Function Insights

In 2022, the Global Protein Therapeutics Market largest share was held by Vaccines segment and is predicted to continue expanding over the coming years. Protein therapeutics generally involve the use of proteins, such as monoclonal antibodies or recombinant proteins, for therapeutic purposes. Many vaccines are made using proteins as antigens. These antigens can be proteins or protein subunits derived from the target pathogen. For example, some COVID-19 vaccines use the spike protein of the SARS-CoV-2 virus as the antigen to trigger an immune response. When a vaccine is administered, the immune system recognizes the foreign antigen as a potential threat and mounts an immune response. This involves the production of antibodies and the activation of immune cells, such as T cells, that can recognize and destroy the pathogen. Vaccines have had a profound impact on global public health by preventing countless cases of infectious diseases, reducing mortality rates, and even leading to the eradication of some diseases (e.g., smallpox). They are essential tools in combating epidemics and pandemics.

Product Type Insights

In 2022, the Global Protein Therapeutics Market largest share was held by Monoclonal Antibodies segment in the forecast period and is predicted to continue expanding over the coming years. Monoclonal antibodies have demonstrated remarkable therapeutic efficacy in treating a wide range of diseases, including cancer, autoimmune disorders, and infectious diseases. They target specific antigens with high precision, reducing the risk of off-target effects. Monoclonal antibodies are versatile and can be designed to target various disease-related proteins and receptors. This versatility has led to their use in a broad spectrum of medical conditions. Monoclonal antibodies have a longer track record of successful development and clinical use compared to other types of protein therapeutics. This history of success has built confidence in their therapeutic potential. Immunotherapy, which includes the use of monoclonal antibodies, has gained prominence in cancer treatment. Drugs like checkpoint inhibitors (e.g., PD-1 and CTLA-4 inhibitors) and CAR-T cell therapies, which incorporate mAbs, have revolutionized cancer care. The biosimilars market for monoclonal antibodies has been growing rapidly. As patents for some originator mAbs expire, biosimilar versions offer more affordable treatment options, increasing accessibility for patients.

Regional Insights

The North America region dominates the Global Protein Therapeutics Market in 2022. North America, particularly the United States and Canada, has a highly developed healthcare infrastructure. This includes world-renowned research institutions, academic medical centers, and a robust pharmaceutical industry that fosters innovation and the development of protein therapeutics. North America has a robust R&D ecosystem that includes government agencies, private research organizations, and biotechnology companies. Funding from both public and private sources supports cutting-edge research in biotechnology and protein therapeutics. Many of the world's largest pharmaceutical and biotechnology companies are headquartered in North America. These companies have the resources and expertise to invest in protein therapeutics research, development, and commercialization. North America attracts a significant number of clinical trials for protein therapeutics. Regulatory agencies like the U.S. Food and Drug Administration (FDA) provide a clear regulatory pathway for drug approvals, making it an attractive region for conducting clinical research.

Key Market Players

Amgen Inc.

Eli Lilly and Company.

F. Hoffmann-La Roche Ltd.

Johnson & Johnson Services, Inc

Merck KGaA

Pfizer Inc

AstraZeneca Plc.

Teva Pharmaceutical Industries Ltd

Bristol-Myers Squibb Company

AbbVie Inc.

Report Scope:

In this report, the Global Protein Therapeutics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Protein Therapeutics Market, By Protein Function:
• Enzymatic & Regulatory
• Protein Diagnostics
• Vaccines
• Protein Therapeutics Market, By Product Type:
• Blood Clotting Factor
• Erythropoietin
• Follicle Stimulating Hormone
• G-CSF
• Insulin
• Interferons
• Monoclonal Antibodies
• Global Protein Therapeutics Market, By region:
• North America
• United States
• Canada
• Mexico
• Asia-Pacific
• China
• India
• South Korea
• Australia
• Japan
• Europe
• Germany
• France
• United Kingdom
• Spain
• Italy
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Protein Therapeutics Market.

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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