Protein Therapeutics Market Size

Protein Therapeutics Market Size and Share:

The global Protein Therapeutics market size was valued at USD 367.0 Billion in 2024. Looking forward, IMARC Group estimates the market to reach USD 617.5 Billion by 2033, exhibiting a CAGR of 6% during 2025-2033.  North America currently dominates the market, holding a significant market share of over 45% in 2024. The increasing prevalence of chronic diseases such as cancer, diabetes, cardiovascular diseases (CVDs), and autoimmune disorders, rapid technological advancements in protein engineering, expanding biopharmaceutical industry, and the widespread product applications in diverse therapeutic areas are some factors propelling the market. In North America, the market is thriving due to the presence of advanced healthcare infrastructure, high disease prevalence, and ongoing investment in research and development (R&D).

The escalating prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is a key driver for the global protein therapeutics market. According to the World Health Organization (WHO), chronic diseases kill 41 million people each year. Out of this, cardiovascular diseases account for most deaths, or 17.9 million people annually, followed by cancers (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million including kidney disease deaths caused by diabetes). These conditions often require targeted and sophisticated treatment choices, which protein therapies are ideally suited to provide. To provide precision treatment with fewer off-target effects, monoclonal antibodies, a significant class of protein therapies, are made to target certain molecules implicated in disease processes.

Multiple factors contribute to the growth of the protein therapeutics market in the United States, including a high prevalence of chronic diseases, a strong research and development (R&D) infrastructure, and supportive healthcare regulations. The country has a high prevalence of ailments such as cancer, diabetes, and autoimmune diseases, which creates a considerable demand for sophisticated therapeutic options. As per industry reports, an estimated 129 million people have at least one major chronic disease in the country, while 42% have two or more, and 12% have at least five. Protein therapeutics, including monoclonal antibodies, insulin analogs, and enzyme replacements, are increasingly favored for their efficacy and targeted action. Additionally, the U.S. Food and Drug Administration (FDA) has streamlined regulatory pathways for biologics and biosimilars, encouraging market entry and competition, which enhances access and affordability.

Protein Therapeutics Market Trends:

Growing biopharmaceutical research and development investments

Biopharmaceutical companies and research institutions are increasingly focusing on the development of protein-based drugs due to their high specificity, efficacy, and targetability. The rise in R&D investments in the biopharmaceutical sector is fueling advancements in protein therapeutics. These investments support research activities related to protein engineering, drug discovery, and formulation optimization, leading to the development of novel and improved protein therapeutics. For instance, global biopharmaceutical companies invested a staggering $276 billion in research and development (R&D) activities in 2021. This investment spanned across 4,191 companies worldwide, underscoring the growing commitment to innovation in the sector. Furthermore, the substantial funds allocated to R&D enable researchers to explore new therapeutic targets, optimize protein structures for enhanced activity, and conduct extensive preclinical and clinical trials. These efforts contribute to the expansion of the market by introducing innovative treatments for various diseases. Moreover, the growing R&D investments facilitate the scaling-up of production processes for protein therapeutics, making them more accessible and cost-effective. This enables increased commercialization and market penetration of protein-based drugs.

Expansion of biosimilars

The expansion of the biosimilars market is significantly contributing to the market. Biosimilars are biologic drugs that are highly similar to approved reference protein therapeutics. As patents for several blockbuster biologics expire, the market for biosimilars is expanding rapidly. The availability of biosimilars provides cost-effective alternatives to expensive protein therapeutics, making them more accessible to patients and healthcare systems. This increased affordability enhances patient access to necessary treatments, driving market growth. Furthermore, the introduction of biosimilars fosters competition in the market. Competition leads to price reductions, encouraging market expansion and creating opportunities for biosimilar manufacturers and reference protein therapeutics companies to innovate and improve their products. For instance, in February 2022, Biocon Biologics Ltd., a subsidiary of Biocon Ltd., entered into a definitive agreement with Viatris Inc. to acquire Viatris’ biosimilars business. The deal was valued at US$ 3.3 Billion. Moreover, the regulatory frameworks and guidelines for biosimilars have become more established and streamlined, providing a clear pathway for their development and approval. This has instilled confidence in the healthcare community and resulted in increased biosimilar adoption. As the biosimilars market expands, it stimulates further research and development efforts in protein therapeutics. Manufacturers strive to develop more advanced and differentiated biosimilars, creating a positive outlook for the market.

Rising aging population

The rising aging population is positively influencing the market. As the global population ages, there is a higher prevalence of age-related diseases and conditions such as Alzheimer's disease, Parkinson's disease, macular degeneration, and osteoporosis. Approximately 33% of adults worldwide experience multiple chronic conditions. Protein therapeutics are being developed and utilized to address these specific health challenges the aging population faces. Furthermore, protein therapeutics offer targeted treatment options for age-related diseases, providing improved efficacy and reduced side effects as compared to traditional therapies. They can target specific molecular pathways and address the underlying mechanisms of these diseases, thereby improving patient outcomes and quality of life. Moreover, the increasing product demand among the aging population is driving market growth. Pharmaceutical companies and research institutions are investing in the development of novel protein therapeutics to meet the specific needs of this demographic. Additionally, the growing aging population creates a larger market for protein therapeutics, prompting manufacturers to expand their product portfolios and increase production. This, in turn, leads to a wider availability of protein therapeutics and further drives market growth.

Protein Therapeutics Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global protein therapeutics market, along with forecasts at the global, regional, and country levels from 2025-2033. The market has been categorized based on product, therapy area, function, and region.

Analysis by Product:

• Monoclonal Antibodies (mAbs)
• Human Insulin
• Erythropoietin
• Clotting Factors
• Fusion Protein
• Others
   

Monoclonal Antibodies (mAbs) products stand as the largest product in 2024, holding over 49% of the market. Monoclonal antibodies (mAbs) are extensively used to treat cancer, autoimmune disorders, and inflammatory diseases. The increasing prevalence of these conditions, coupled with advancements in antibody engineering and production technologies, drives the demand for mAbs and contributes to the market growth. 

On the other hand, human insulin is a vital protein therapeutic for managing diabetes. With the rising incidence of diabetes worldwide, the demand for insulin and insulin analogs is increasing, leading to market growth in this segment. Moreover, erythropoietin (EPO) is another important therapeutic protein stimulating red blood cell production. It is used to treat anemia, particularly in patients with chronic kidney disease and cancer undergoing chemotherapy. The expanding patient pool requiring EPO therapy is driving the growth of this segment. 

Besides this, the clotting factors are proteins essential for blood clotting. They are used to manage bleeding disorders such as hemophilia. The growing awareness, diagnosis, and treatment of hemophilia fuel the demand for clotting factors and contribute to the market. In addition, fusion proteins, which combine two or more functional protein domains, have gained significant attention in the development of innovative therapeutics. They offer unique treatment approaches for various diseases, including cancer and autoimmune disorders, thus driving the market in this segment.

Analysis by Therapy Area:

• Metabolic Disorders
• Immunological Disorders
• Hematological Disorders
• Cancer
• Hormonal Disorders
• Genetic Disorders
• Others
   

Metabolic disorders lead the market, holding the largest market share. Metabolic disorders encompass conditions such as diabetes, obesity, and hypercholesterolemia. Protein therapeutics, such as insulin for diabetes management, are crucial in treating and controlling these disorders. The rising prevalence of metabolic disorders, coupled with the increasing demand for targeted and effective treatments, is driving the growth of the market in this segment. 

On the contrary, immunological disorders, including autoimmune diseases and inflammatory conditions, represent another significant therapy area for protein therapeutics. Monoclonal antibodies and other protein-based drugs modulate the immune system and target specific disease pathways. The growing incidence of immunological disorders and the expanding range of approved protein therapeutics for these conditions are driving the market. 

In addition, cancer remains one of the primary drivers of the market. Protein-based therapies, including monoclonal antibodies, antibody-drug conjugates, and immune checkpoint inhibitors, have revolutionized cancer treatment. The increasing incidence of cancer globally, coupled with the development of targeted therapies and immunotherapies, is propelling the growth of the market in oncology.

Analysis by Function:

• Enzymatic and Regulatory Activity
• Special Targeting Activity
• Vaccines
• Protein Diagnostics
   

Protein therapeutics with enzymatic and regulatory activity are vital in modulating biological processes and metabolic pathways. These proteins act as enzymes, receptors, or signaling molecules, offering therapeutic benefits in various diseases. The development of novel protein therapeutics with specific enzymatic or regulatory functions drives market growth in this segment. 

Special targeting activity refers to protein therapeutics targeting certain cells, tissues, or molecular targets. Monoclonal antibodies and antibody-drug conjugates are examples of protein therapeutics with special targeting activity. They can precisely recognize and bind to specific molecules or cells, providing highly targeted therapies. The increasing demand for targeted treatments in conditions such as cancer and autoimmune diseases fuels the growth of protein therapeutics in this segment. 

Vaccines are another significant segment in the market. Protein-based vaccines utilize specific proteins or peptides to stimulate an immune response and confer immunity against infectious diseases. The global focus on vaccination programs, the emergence of new infectious diseases, and the need for improved vaccine technologies drive market growth in this segment. 

Protein diagnostics involves using proteins or protein-based assays for diagnostic purposes. These diagnostics can detect specific proteins or biomarkers associated with diseases, aiding in early detection, disease monitoring, and personalized treatment. The growing demand for accurate and reliable diagnostic tools fuels the growth of protein diagnostics and contributes to the overall market. 

Regional Analysis:

• North America
  • United States
  • Canada
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa
   

In 2024, North America accounted for the largest market share of over 45%. The region benefits from advanced healthcare infrastructure, a strong presence of biopharmaceutical companies, and robust research and development activities. The presence of key players and extensive investments in protein therapeutics research contribute to market growth in North America. Additionally, the high prevalence of chronic diseases, a large aging population, and favorable reimbursement policies further drive the market in the region.

On the other hand, Asia Pacific is emerging as a rapidly growing market. The region has a large population base, increasing healthcare expenditure, and a rising prevalence of chronic diseases. Countries such as China, Japan, and India are witnessing substantial growth in the biopharmaceutical industry and investing in research and development. Moreover, the increasing awareness of personalized medicine and growing demand for cost-effective treatment options are driving the adoption of protein therapeutics in Asia Pacific.

Key Regional Takeaways:

North America Protein Therapeutics Market Analysis

The protein therapeutics market in North America is witnessing robust growth due to a combination of advanced healthcare infrastructure, high disease prevalence, and significant investment in research and development (R&D). The region has one of the highest incidences of chronic diseases, including cancer, diabetes, and autoimmune disorders, which necessitate innovative and effective treatment options. With a well-established biotechnology sector, North America is a global leader in developing and commercializing protein-based therapeutics, including monoclonal antibodies and fusion proteins. Favorable regulatory frameworks, such as expedited drug approvals by the U.S. FDA, further accelerate the market growth. Additionally, the region benefits from a strong focus on personalized medicine, where protein therapeutics play a critical role in offering targeted therapies with improved patient outcomes.

United States Protein Therapeutics Market Analysis

The United States accounts for 75% share of the market in North America. The high prevalence of chronic diseases, such as diabetes, autoimmune disorders, and cancer, is driving the market for protein therapies in the country. With more than 37 million Americans living with diabetes as of 2023, there is a high need for insulin and other protein-based treatments. The need for cutting-edge biologics to treat age-related disorders is further fueled by the aging population, which is predicted to reach more than 78 million by 2040. The development of next-generation protein therapies, such as fusion proteins and antibody-drug conjugates, is being streamlined by technological developments like recombinant DNA technology and the manufacture of monoclonal antibodies.

Innovation has been aided by regulatory support, such as the FDA's accelerated approval processes for innovative biologics. Biopharmaceutical firms are making significant investments in research and development; in 2023, the United States will still be the world's largest market, generating about 60% of biopharmaceutical innovation. Furthermore, the manufacture of protein therapies is now more scalable due to the availability of a strong infrastructure for manufacturing and clinical trials. The industry is anticipated to be further supported by the rise of customized medicine and the launch of biosimilars, which provide affordable substitutes for pricy biologics without sacrificing efficacy or safety.

Europe Protein Therapeutics Market Analysis

Growing chronic illness rates and a strong focus on healthcare innovation in the region are driving the market for protein therapies in Europe. The European Medicines Agency (EMA) recommended 77 medicines for marketing authorization in 2023, demonstrating the region's dedication to cutting-edge protein-based therapies. Since cancer accounts for 2.7 million new cases in Europe each year, there is a great need for targeted therapy using protein medicines like interferons and monoclonal antibodies. European governments and health institutions are making significant investments in biotechnology and personalized medicine, with programs such as Horizon Europe offering major financing for research and development. The market is led by nations with strong healthcare systems and high patient awareness, such as Germany, France, and the UK. Furthermore, the EU's cost-cutting measures are encouraging the growing acceptance of biosimilars, which is increasing market penetration by making protein-based medications more accessible.

Asia Pacific Protein Therapeutics Market Analysis

The market for protein therapies in Asia-Pacific is expanding quickly as a result of rising healthcare costs, an increase in the number of chronic illnesses, and the use of cutting-edge medical technology. Insulin and other protein-based therapies are essential in tackling this expanding healthcare issue in China and India, which have the highest diabetes populations in the world. Leaders in biopharmaceutical innovation, South Korea and Japan have made large expenditures in the development of biosimilars and monoclonal antibodies.

Demand is being increased by the burgeoning middle class and rising knowledge of sophisticated biologics in emerging economies. To lessen reliance on imports, the governments in the area are encouraging domestic manufacturing and research and development. China's "Healthy China 2030" policy, for instance, promotes the creation of innovative biopharmaceuticals, such as protein therapies. Furthermore, collaborations between regional and international pharmaceutical firms are augmenting the introduction of reasonably priced protein therapies throughout Asia-Pacific.

Latin America Protein Therapeutics Market Analysis

The rising incidence of chronic illnesses and the development of better healthcare facilities are driving the market for protein therapies in Latin America. To improve patient outcomes, nations with high incidences of diabetes and cancer, such as Brazil and Mexico, are implementing cutting-edge biologics. Government healthcare initiatives and increased investments in biopharmaceutical R&D are boosting the manufacturing and marketing of protein therapies. Additionally, the emergence of biosimilars, which provide affordable substitutes, is opening up more therapy possibilities in the area.

Middle East and Africa Protein Therapeutics Market Analysis

The rising prevalence of chronic illnesses and a growing emphasis on expanding access to healthcare are driving the market for protein therapies. In line with their goal of modernizing healthcare systems, nations in the Middle East like as Saudi Arabia and the United Arab Emirates are making significant investments in biopharmaceuticals. Access to protein therapies, especially for conditions like diabetes and cancer, is being improved in Africa thanks to international partnerships and funding programs run by agencies like the WHO. Furthermore, local production facilities and awareness campaigns are progressively extending the reach of these cutting-edge remedies throughout the region.

Competitive Landscape:

Top companies are investing heavily in scientific research to identify new therapeutic targets and develop protein-based drugs with enhanced efficacy and safety profiles. They leverage their protein engineering, molecular biology, and biotechnology expertise to design and optimize therapeutic proteins. Furthermore, these companies establish strategic collaborations with academic institutions, research organizations, and other pharmaceutical companies to access new technologies, expand their pipelines, and accelerate development. Collaborations enable the exchange of knowledge, resources, and expertise, fostering innovation and driving the market. Moreover, successful commercialization strategies play a vital role in driving market growth. These companies employ robust marketing and sales efforts to promote and distribute their products to healthcare providers and patients worldwide. They conduct extensive clinical trials, generate compelling clinical data, and obtain regulatory approvals to ensure market access. Additionally, the top companies continuously invest in manufacturing capabilities and quality control systems to meet the growing demand and ensure a consistent supply of their products. This commitment to manufacturing excellence helps them meet the needs of patients, healthcare providers, and payers, further driving the market growth.

The report provides a comprehensive analysis of the competitive landscape in the global protein therapeutics market with detailed profiles of all major companies, including:

• Amgen Inc.
• Abbott Laboratories
• Abbvie Inc.
• Baxter International Inc.
• Biogen Inc.
• Csl Behring L.L.C. (CSL Limited)
• Eli Lilly and Company
• F. Hoffmann-La Roche AG (Roche Holding AG)
• Johnson & Johnson
• Merck & Co. Inc.
• Novo Nordisk A/S (Novo Holdings A/S)
• Pfizer Inc.

Latest News and Developments:

• February 2024: BioNTech SE and Autolus Therapeutics plc entered into a strategic collaboration to advance their autologous CAR-T cell therapy programs toward commercialization, subject to regulatory approvals. The partnership includes a license and option agreement, as well as a securities purchase agreement. This collaboration aims to leverage both companies' expertise in next-generation immunotherapies for cancer and other serious diseases, with the goal of progressing their respective CAR-T programs.
• February 2024: Lumosa Therapeutics, based in Taiwan, initiated two Phase II clinical trials to investigate LT3001, a treatment candidate for acute ischemic stroke (AIS). The trials, named Lumosa 203 (NCT05198323) and Bright (NCT05403866), are randomized, placebo-controlled, and double-blinded. The Lumosa 203 study will evaluate the efficacy of LT3001 versus a placebo in AIS patients undergoing endovascular thrombectomy (EVT), with standard-of-care therapies provided when appropriate.
• January 2024: Ractigen Therapeutics entered into a collaboration with University Medical Center Utrecht to develop saRNA-based therapies for neurodevelopmental disorders. The partnership was expected to leverage Ractigen’s saRNA platform and oligonucleotide delivery systems alongside Professor Bobby Koeleman’s research team, renowned for their work on childhood epilepsies. The collaboration aims to translate promising preclinical findings into effective treatments by identifying novel gene targets for therapeutic development. 
• January 2021: Abbott Laboratories received FDA clearance for their Tendyne Transcatheter Mitral Valve Replacement (TMVR) system, a minimally invasive therapy for patients with severe mitral regurgitation. It enhances patients' function and quality of life by providing a less invasive mitral valve replacement option for select individuals with symptomatic, severe MR (≥ grade 3), as an alternative to traditional mitral valve surgery.
• May 2020: AbbVie Inc., acquired Allergan, a pharmaceutical company known for its portfolio of therapeutic products, including Botox. This acquisition was finalized after receiving approval from the necessary government authorities and the Irish High Court, as required by the transaction agreement.

Protein Therapeutics Market Report Scope:

Key Benefits for Stakeholders:

• IMARC’s report offers a comprehensive quantitative analysis of various market segments, historical and current market trends, market forecasts, and dynamics of the protein therapeutics market from 2019-2033.
• The research study provides the latest information on the market drivers, challenges, and opportunities in the global protein therapeutics market.
• The study maps the leading, as well as the fastest-growing, regional markets. It further enables stakeholders to identify the key country-level markets within each region.
• Porter's five forces analysis assists stakeholders in assessing the impact of new entrants, competitive rivalry, supplier power, buyer power, and the threat of substitution. It helps stakeholders to analyze the level of competition within the protein therapeutics industry and its attractiveness.
• Competitive landscape allows stakeholders to understand their competitive environment and provides an insight into the current positions of key players in the market.