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US Protein Therapeutics Market

ID: MRFR/LS/18156-HCR
100 Pages
Garvit Vyas
October 2025

US Protein Therapeutics Market Research Report By Type (Monoclonal Antibodies, Insulin, Fusion Protein, Erythropoietin, Interferon), By Application (Cancer, Metabolic Disorders, Immunologic Disorders, Hematological Disorders) and By End User (Hospitals and Clinics, Specialty Centers) - Forecast to 2035

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US Protein Therapeutics Market Infographic
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US Protein Therapeutics Market Summary

As per MRFR analysis, the US protein therapeutics market size was estimated at 46.74 USD Billion in 2024. The US protein therapeutics market is projected to grow from 50.18 USD Billion in 2025 to 102.08 USD Billion by 2035, exhibiting a compound annual growth rate (CAGR) of 7.36% during the forecast period 2025 - 2035.

Key Market Trends & Highlights

The US protein therapeutics market is experiencing robust growth driven by innovation and increasing demand.

  • The rise of biosimilars is reshaping the competitive landscape of the protein therapeutics market.
  • There is a notable focus on rare diseases, which is driving research and development efforts in this sector.
  • Personalized medicine integration is becoming increasingly prevalent, enhancing treatment efficacy for patients.
  • Key market drivers include the increasing demand for biologics and technological advancements in drug development.

Market Size & Forecast

2024 Market Size 46.74 (USD Billion)
2035 Market Size 102.08 (USD Billion)

Major Players

Amgen (US), Genentech (US), AbbVie (US), Roche (CH), Bristol-Myers Squibb (US), Eli Lilly (US), Sanofi (FR), Merck & Co. (US), Novo Nordisk (DK)

US Protein Therapeutics Market Trends

the protein therapeutics market is experiencing notable growth, driven by advancements in biotechnology and an increasing demand for targeted therapies. The rise in chronic diseases and genetic disorders has led to a greater focus on developing innovative protein-based treatments. Regulatory agencies are also playing a crucial role in facilitating the approval process for new therapeutics, which may further enhance market dynamics. Additionally, the integration of personalized medicine into treatment protocols appears to be reshaping the landscape, as therapies are tailored to individual patient profiles, potentially improving outcomes. Moreover, the protein therapeutics market is witnessing a surge in investment from both public and private sectors. This influx of funding is likely to accelerate research and development efforts, leading to the introduction of novel therapies. Collaborations between academic institutions and pharmaceutical companies are becoming increasingly common, fostering innovation and expediting the transition from laboratory to clinical application. As the market evolves, it seems poised to address unmet medical needs, offering hope for patients with previously untreatable conditions.

Rise of Biosimilars

The emergence of biosimilars is transforming the protein therapeutics market. These products, which are similar to already approved biologics, offer cost-effective alternatives that may enhance patient access to essential therapies. As patents for original biologics expire, the introduction of biosimilars is expected to increase competition, potentially driving down prices and expanding treatment options.

Focus on Rare Diseases

There is a growing emphasis on developing therapies for rare diseases within the protein therapeutics market. This trend is fueled by advancements in genetic research and a better understanding of the underlying mechanisms of these conditions. As a result, pharmaceutical companies are increasingly investing in orphan drug development, which may lead to innovative treatments for previously neglected patient populations.

Personalized Medicine Integration

The integration of personalized medicine into the protein therapeutics market is gaining traction. By utilizing genetic and molecular profiling, therapies can be tailored to individual patient needs, enhancing efficacy and minimizing adverse effects. This approach not only improves treatment outcomes but also aligns with the broader trend towards precision healthcare.

US Protein Therapeutics Market Drivers

Increasing Demand for Biologics

The protein therapeutics market is experiencing a notable surge in demand for biologics, which are derived from living organisms. This trend is largely driven by the growing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders. According to recent estimates, the biologics segment is projected to account for over 40% of the total pharmaceutical market in the US by 2026. This increasing demand for biologics is compelling pharmaceutical companies to invest heavily in research and development, thereby propelling the growth of the protein therapeutics market. Furthermore, advancements in biotechnology are enabling the development of more effective and targeted therapies, which are likely to enhance patient outcomes and drive market expansion.

Rising Investment in Biotechnology

Investment in biotechnology is a critical driver of the protein therapeutics market. Venture capital funding for biotech firms has seen a substantial increase, with investments reaching approximately $20 billion in 2025 alone. This influx of capital is enabling companies to advance their research and development efforts, particularly in the field of protein therapeutics. Additionally, partnerships between biotech firms and larger pharmaceutical companies are becoming more common, facilitating the sharing of resources and expertise. This collaborative approach is likely to accelerate the development of innovative therapies, thereby enhancing the overall growth trajectory of the protein therapeutics market. As the biotechnology sector continues to thrive, it is expected to have a lasting impact on the protein therapeutics landscape.

Growing Awareness of Personalized Medicine

The increasing awareness of personalized medicine is significantly influencing the protein therapeutics market. Patients and healthcare providers are becoming more informed about the benefits of tailored therapies that cater to individual genetic profiles. This shift towards personalized treatment approaches is driving demand for protein therapeutics that can be customized to meet specific patient needs. As a result, pharmaceutical companies are focusing on developing targeted therapies that leverage genetic and molecular insights. The market for personalized medicine is projected to grow at a CAGR of over 10% through 2027, indicating a strong trend towards individualized treatment options. This growing emphasis on personalized medicine is likely to reshape the protein therapeutics market, fostering innovation and enhancing patient outcomes.

Technological Advancements in Drug Development

Technological innovations are playing a pivotal role in shaping the protein therapeutics market. The advent of advanced techniques such as CRISPR gene editing, monoclonal antibody technology, and high-throughput screening is revolutionizing the way new therapeutics are developed. These technologies not only expedite the drug discovery process but also improve the precision and efficacy of protein therapeutics. As a result, the market is witnessing a shift towards more sophisticated and targeted treatment options. The integration of artificial intelligence and machine learning in drug development is also expected to enhance the efficiency of clinical trials, potentially reducing the time to market for new therapies. This technological evolution is likely to attract significant investments, further stimulating growth in the protein therapeutics market.

Regulatory Support and Streamlined Approval Processes

The protein therapeutics market is benefiting from increased regulatory support and streamlined approval processes. Regulatory agencies, such as the FDA, are implementing initiatives aimed at expediting the review and approval of biologics and biosimilars. For instance, the FDA's 21st Century Cures Act has introduced measures to facilitate faster access to innovative therapies. This supportive regulatory environment is encouraging pharmaceutical companies to invest in the development of new protein therapeutics. Moreover, the establishment of clear guidelines for biosimilars is likely to enhance market competition, ultimately benefiting patients through increased access to affordable treatment options. As a result, the protein therapeutics market is expected to experience robust growth in the coming years.

Market Segment Insights

By Type: Monoclonal Antibodies (Largest) vs. Recombinant Proteins (Fastest-Growing)

The US protein therapeutics market is predominantly driven by Monoclonal Antibodies, which hold the largest market share among the segment values. This category has benefited from advancements in biotechnology and a growing demand for targeted therapies, giving it a significant edge in the market landscape. In contrast, Recombinant Proteins, although not leading, are rapidly gaining traction due to their increasing application in therapies and the growing pipeline of product approvals. Growth trends indicate that Monoclonal Antibodies will continue to be a cornerstone of the US protein therapeutics market, fueled by an expanding patient base and continuous innovation in drug development. Meanwhile, the rapid growth of Recombinant Proteins is driven by their versatility in treating various conditions and the increasing focus on personalized medicine, positioning them as a key area of interest for investors and developers alike.

Monoclonal Antibodies (Dominant) vs. Recombinant Proteins (Emerging)

Monoclonal Antibodies represent a dominant force in the US protein therapeutics market, characterized by their specificity and effectiveness in targeting disease pathways. They are extensively used in oncology, autoimmune diseases, and infectious diseases, showcasing their therapeutic versatility and high clinical efficacy. On the other hand, Recombinant Proteins are emerging as a vital component due to their application in a wide array of conditions, including hormonal imbalances and certain genetic disorders. The advancements in recombinant DNA technology allow for the production of more effective and safer therapeutic proteins, providing opportunities for growth in this segment.

By Application: Oncology (Largest) vs. Autoimmune Diseases (Fastest-Growing)

In the US protein therapeutics market, the application segment is largely dominated by oncology, which captures a significant market share due to increasing incidences of cancer and advancements in treatment options. Autoimmune diseases, while holding a smaller share, are rapidly gaining traction as more targeted therapies are developed, making it a critical area for investment. Growth trends indicate that the oncology segment continues to benefit from robust research & development efforts, with increasing FDA approvals for new therapies. In contrast, the autoimmune diseases sector is witnessing an accelerated growth trajectory due to rising awareness and diagnosis of these conditions. This has been fueled by innovations in biologics and personalized medicine, enhancing treatment efficacy and patient compliance.

Oncology (Dominant) vs. Autoimmune Diseases (Emerging)

Oncology is positioned as the dominant application in the US protein therapeutics market, characterized by a well-established presence of biologics and monoclonal antibodies targeting various cancer types. This segment benefits from continuous research and substantial funding, driving innovations in treatment modalities. Conversely, autoimmune diseases represent an emerging segment that is rapidly evolving, fueled by a growing number of therapeutic options. This area includes treatments aimed at conditions such as rheumatoid arthritis and multiple sclerosis. The increasing prevalence of autoimmune disorders and advancements in biologic therapies are pivotal in shaping this segment, attracting significant interest from both healthcare providers and pharmaceutical companies.

By End Use: Hospital (Largest) vs. Research Laboratories (Fastest-Growing)

In the segment of the US protein therapeutics market, hospitals hold the largest share, driven by their extensive need for various therapeutic proteins to treat a wide range of medical conditions. Research laboratories, while smaller in market share, are rapidly gaining ground owing to increasing investment in research and development of new therapeutics. The growth trends indicate that hospitals will continue to dominate due to the rising prevalence of chronic diseases and the expanding need for advanced therapeutic options. Conversely, research laboratories are emerging as a vital segment, fueled by innovations in biotechnology and a surge in collaborations between academic institutions and pharmaceutical companies, which accelerates the development of novel protein therapeutics.

Hospital (Dominant) vs. Research Laboratories (Emerging)

The hospital segment in the US protein therapeutics market remains dominant due to its critical role in patient care and the increasing demand for effective treatments. Hospitals are equipped with advanced infrastructure and resources that facilitate the use of protein therapeutics in diverse therapeutic areas, including oncology and immunotherapy. On the other hand, research laboratories are viewed as an emerging segment, leveraging cutting-edge technology and methodologies to innovate and facilitate the discovery of new therapeutic proteins. These laboratories play a pivotal role in clinical trials and drug development, driving trends that support the expansion of protein therapeutics, making them essential for future healthcare advancements.

By Mode of Administration: Intravenous (Largest) vs. Subcutaneous (Fastest-Growing)

The market share distribution among the different modes of administration in the US protein therapeutics market indicates that intravenous administration holds the largest share, predominantly due to its widespread application in hospital settings for immediate therapeutic effects. Subcutaneous administration, while currently smaller in comparison, is rapidly gaining traction, particularly in the chronic disease management and patient home care segments. Intramuscular administration remains a traditional choice, catering to specific therapeutic needs but doesn’t show the same growth momentum as subcutaneous alternatives. Growth trends for the modes of administration in the US protein therapeutics market are influenced by increasing patient preferences for less invasive options, particularly subcutaneous routes, which offer ease of use and improved patient compliance. The shift toward decentralized healthcare and home-based therapies further drives the adoption of subcutaneous administration. Conversely, intravenous remains essential for urgent care and complex protein therapeutics that require rapid absorption, maintaining its significant market position.

Mode of Administration: Intravenous (Dominant) vs. Subcutaneous (Emerging)

Intravenous administration is characterized by its ability to provide rapid drug delivery and is commonly used in acute care settings such as hospitals for conditions that require immediate medical intervention. This method allows for precise control over dosing and therapeutic response, making it indispensable for many medical professionals. On the other hand, subcutaneous administration is emerging as a popular alternative, especially for chronic conditions like diabetes and rheumatoid arthritis, where patient autonomy and ease of administration are crucial. This method of administration not only enhances patient convenience but also allows for self-administration, which is increasingly appealing in today's healthcare landscape.

Get more detailed insights about US Protein Therapeutics Market

Key Players and Competitive Insights

The protein therapeutics market is characterized by a dynamic competitive landscape, driven by innovation, strategic partnerships, and a focus on addressing unmet medical needs. Major players such as Amgen (US), Genentech (US), and AbbVie (US) are at the forefront, leveraging their extensive research capabilities and established market presence to enhance their product offerings. Amgen (US) emphasizes biopharmaceutical innovation, particularly in oncology and inflammatory diseases, while Genentech (US) focuses on personalized medicine and targeted therapies. AbbVie (US) is strategically positioned through its robust pipeline and recent acquisitions, which bolster its therapeutic portfolio, particularly in immunology and oncology. Collectively, these strategies contribute to a competitive environment that is increasingly focused on advanced therapeutic solutions and patient-centric approaches.

Key business tactics within the protein therapeutics market include localizing manufacturing and optimizing supply chains to enhance efficiency and responsiveness. The market structure appears moderately fragmented, with a mix of established players and emerging biotech firms. The collective influence of key players shapes market dynamics, as they engage in strategic collaborations and partnerships to expand their reach and capabilities. This collaborative approach not only enhances product development but also fosters innovation across the sector.

In October 2025, Amgen (US) announced a strategic partnership with a leading AI firm to enhance its drug discovery processes. This collaboration aims to integrate artificial intelligence into the research and development phases, potentially accelerating the identification of novel therapeutic candidates. The strategic importance of this move lies in Amgen's commitment to leveraging cutting-edge technology to maintain its competitive edge in a rapidly evolving market.

In September 2025, Genentech (US) launched a new biosimilar product aimed at increasing access to critical therapies for patients with chronic conditions. This initiative reflects Genentech's strategy to diversify its product portfolio while addressing cost concerns in the healthcare system. The introduction of biosimilars is likely to enhance competition and drive down prices, thereby benefiting patients and healthcare providers alike.

In August 2025, AbbVie (US) completed the acquisition of a biotech company specializing in gene therapy, significantly expanding its capabilities in the protein therapeutics space. This acquisition is strategically important as it positions AbbVie to tap into the growing gene therapy market, which is expected to witness substantial growth in the coming years. By integrating these advanced technologies, AbbVie aims to enhance its therapeutic offerings and solidify its market position.

As of November 2025, current competitive trends in the protein therapeutics market are increasingly defined by digitalization, sustainability, and the integration of AI technologies. Strategic alliances are shaping the landscape, enabling companies to pool resources and expertise to drive innovation. Looking ahead, competitive differentiation is likely to evolve from traditional price-based competition to a focus on innovation, technological advancements, and supply chain reliability. This shift underscores the importance of agility and responsiveness in meeting the evolving needs of patients and healthcare systems.

Key Companies in the US Protein Therapeutics Market market include

Industry Developments

The US Protein Therapeutics Market continues to experience significant developments, with companies like Genentech, Novartis, and Merck and Co. leading the charge in innovative therapeutics. In September 2023, Eli Lilly received FDA approval for its new diabetes drug, enhancing its offerings in the protein therapeutics sector. Recent growth in market valuations for companies such as Bristol Myers Squibb and Gilead Sciences reflects increased demand for biologic therapies, pushing market dynamics toward high-value solutions. In August 2023, Regeneron Pharmaceuticals announced its acquisition of Checkmate Pharmaceuticals, strengthening its oncology portfolio.

Pfizer and Amgen are investing heavily in Research and Development, focusing on novel protein-based therapies for chronic diseases.

Furthermore, Roche and AbbVie have been actively involved in expanding their therapeutic applications in autoimmune disorders and cancer treatment, contributing to the market's resilience. Over the past two years, the market has seen transformative shifts, including groundbreaking approvals and partnerships that improve patient outcomes. The pharmaceutical landscape remains competitive, with major players adapting to regulatory changes and emphasizing patient-centric initiatives, underscoring the vibrant growth trajectory that characterizes the US Protein Therapeutics Market.

Future Outlook

US Protein Therapeutics Market Future Outlook

The Protein Therapeutics Market is projected to grow at a 7.36% CAGR from 2024 to 2035, driven by advancements in biotechnology, increasing chronic disease prevalence, and personalized medicine.

New opportunities lie in:

  • Development of biosimilars to enhance market access and affordability.
  • Investment in AI-driven drug discovery platforms for faster therapeutic development.
  • Expansion of cold chain logistics to ensure product integrity during distribution.

By 2035, the protein therapeutics market is projected to achieve substantial growth and innovation.

Market Segmentation

US Protein Therapeutics Market Type Outlook

  • Monoclonal Antibodies
  • Recombinant Proteins
  • Hormones
  • Vaccines

US Protein Therapeutics Market End Use Outlook

  • Hospital
  • Research Laboratories
  • Pharmaceutical Companies

US Protein Therapeutics Market Application Outlook

  • Oncology
  • Autoimmune Diseases
  • Infectious Diseases
  • Metabolic Disorders

US Protein Therapeutics Market Mode of Administration Outlook

  • Intravenous
  • Subcutaneous
  • Intramuscular

Report Scope

MARKET SIZE 202446.74(USD Billion)
MARKET SIZE 202550.18(USD Billion)
MARKET SIZE 2035102.08(USD Billion)
COMPOUND ANNUAL GROWTH RATE (CAGR)7.36% (2024 - 2035)
REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
BASE YEAR2024
Market Forecast Period2025 - 2035
Historical Data2019 - 2024
Market Forecast UnitsUSD Billion
Key Companies ProfiledAmgen (US), Genentech (US), AbbVie (US), Roche (CH), Bristol-Myers Squibb (US), Eli Lilly (US), Sanofi (FR), Merck & Co. (US), Novo Nordisk (DK)
Segments CoveredType, Application, End Use, Mode of Administration
Key Market OpportunitiesAdvancements in biologics manufacturing enhance efficiency in the protein therapeutics market.
Key Market DynamicsRising demand for innovative protein therapeutics drives competitive dynamics and regulatory adaptations in the market.
Countries CoveredUS

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FAQs

What is the expected market size of the US Protein Therapeutics Market in 2024?

The US Protein Therapeutics Market is expected to be valued at approximately 52.97 USD Billion in 2024.

What is the projected market size of the US Protein Therapeutics Market by 2035?

By 2035, the US Protein Therapeutics Market is projected to reach around 110.59 USD Billion.

What is the expected CAGR for the US Protein Therapeutics Market from 2025 to 2035?

The expected CAGR for the US Protein Therapeutics Market from 2025 to 2035 is 6.921 percent.

Which segment of the US Protein Therapeutics Market has the largest market share in 2024?

In 2024, the segment of Monoclonal Antibodies holds the largest market share valued at 24.0 USD Billion.

What is the market value for Insulin in the US Protein Therapeutics Market in 2024?

The market value for Insulin in the US Protein Therapeutics Market is estimated to be 12.0 USD Billion in 2024.

Who are the key players in the US Protein Therapeutics Market?

Major players in the US Protein Therapeutics Market include companies such as Genentech, Novartis, and AstraZeneca.

What is the expected market size for Fusion Protein by 2035?

The market size for Fusion Protein is expected to grow to 15.0 USD Billion by 2035.

What are the growth drivers for the US Protein Therapeutics Market from 2025 to 2035?

Growth drivers for the US Protein Therapeutics Market include increasing prevalence of chronic diseases and advancements in biopharmaceuticals.

What challenges could the US Protein Therapeutics Market face in the coming years?

The US Protein Therapeutics Market may face challenges such as regulatory hurdles and high development costs.

What is the projected market value for Erythropoietin in 2024?

The projected market value for Erythropoietin in 2024 is estimated at 5.0 USD Billion.

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