Protein Therapeutics Market Set to Surpass US$ 549.4 Bn by 2031, Driven by Advances in Biologics and Precision Medicine - TMR Analysis

Global Protein Therapeutics Market Size Outlook 2031

The global protein therapeutics market was valued at US$ 318.4 billion in 2022. The market is projected to grow steadily at a CAGR of 6.3% from 2023 to 2031, reaching over US$ 549.4 billion by 2031. This strong upward trajectory is attributed to rising demand for biologics, expansion of treatment options for chronic diseases, advancements in protein engineering technologies, and the rapid emergence of targeted and personalized therapies.

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Market Overview

Protein therapeutics-comprising monoclonal antibodies, enzymes, hormones, coagulation factors, interferons, and therapeutic peptides-have become central to modern healthcare. They offer high specificity, reduced toxicity, and better clinical efficacy compared to conventional small-molecule drugs. Their use spans multiple areas, including oncology, autoimmune diseases, metabolic disorders, hematology, infectious diseases, and rare genetic conditions.

The market is being shaped by:
• The increasing prevalence of cancer, diabetes, immune disorders, and cardiovascular diseases
• Technological advances in recombinant DNA technology, antibody engineering, and biologics manufacturing
• Rising focus on personalized medicine and precision therapies
• Growing acceptance and approval of biosimilars, expanding patient access
The protein therapeutics industry is transitioning toward next-generation biologics, including antibody-drug conjugates, bispecific antibodies, CAR-T support biologics, engineered protein scaffolds, and long-acting proteins.

Key Market Growth Drivers

1. Rising Prevalence of Chronic and Lifestyle Diseases
Cancer, autoimmune disorders, and diabetes are increasing globally, driving the need for effective biologic therapies. Protein drugs remain first-line treatments for many of these conditions.

2. Advances in Biopharmaceutical R&D
Breakthroughs in protein engineering, glycoengineering, and mRNA expression systems are enabling the development of more targeted and potent therapeutics.

3. Expansion of Biosimilars
Patent expiries of blockbuster biologics like Humira and Herceptin have accelerated the entry of biosimilars, broadening market outreach and reducing treatment costs.

4. Growing Demand for Targeted and Personalized Medicine
Precision-based therapies such as monoclonal antibodies and engineered peptides are increasingly preferred due to fewer side effects and superior efficacy.

5. Increase in Biologics Manufacturing Capacity
Pharmaceutical companies and CDMOs are heavily investing in scaling up biologics production using novel systems such as continuous bioprocessing and single-use bioreactors.

Analysis of Key Players in the Protein Therapeutics Market

The global protein therapeutics market is highly fragmented, characterized by the presence of numerous established biotechnology and pharmaceutical companies. Market participants are increasingly prioritizing R&D investments, strategic collaborations, and product innovation to strengthen their competitive positioning and expand their therapeutic pipelines.

Prominent companies operating in the protein therapeutics market include
• Thermo Fisher Scientific, Inc.
• Genzyme Corporation (Sanofi)
• AbbVie, Inc.
• Sanofi
• Leadiant Biosciences
• Takeda Pharmaceutical Company Limited
• Amicus Therapeutics
• Bayer AG
• Bristol-Myers Squibb
• Daiichi Sankyo Company
• Abbott
• Sanofi.
These players maintain diverse product portfolios spanning enzyme replacement therapies, monoclonal antibodies, recombinant proteins, and other advanced biologics targeting oncology, rare diseases, metabolic disorders, and immunological conditions.

Key players have been evaluated in the protein therapeutics market report based on parameters such as company overview, product/application portfolio, business segments, strategic initiatives, financial highlights, and recent developments.

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Key Developments in the Global Protein Therapeutics Industry

• January 2022 - Thermo Fisher Scientific, Inc.
Thermo Fisher completed the acquisition of PeproTech for US$ 1.85 billion in cash. PeproTech, a leading provider of recombinant proteins-including cytokines and growth factors-supports cell and gene therapy development as well as broader cell culture applications. The acquisition enhances Thermo Fisher's ability to deliver integrated, end-to-end solutions to life sciences and biopharma customers, strengthening its position in the fast-growing recombinant protein segment.

• April 2022 - AbbVie & Plexium Collaboration
AbbVie entered into a strategic partnership with Plexium to develop and commercialize targeted protein degradation (TPD) therapeutics focused on neurological disorders. The collaboration integrates AbbVie's extensive neuroscience expertise with Plexium's proprietary TPD platform to unlock previously undruggable targets. The agreement includes preclinical research activities, with AbbVie having the option to advance selected programs into later stages of development. This collaboration reinforces Plexium's leadership in TPD and expands AbbVie's capabilities in next-generation neurological therapies.

Market Challenges & Opportunities

Challenges
1. High Production Costs
Biologics manufacturing requires specialized facilities, strict regulatory compliance, and high operational costs.
2. Stringent Regulatory Pathways
Protein therapeutics must undergo extensive clinical testing, prolonging approval timelines.
3. Cold Chain & Storage Complexities
Temperature-sensitive biologics require sophisticated storage and logistics systems.
4. Competition From Small-Molecule Targeted Therapies
In certain categories, small molecules and oral targeted drugs are gaining traction.

Opportunities
1. Growing Biosimilars Market
As more protein drugs lose patent protection, opportunities emerge for affordable biosimilars.
2. Rise of Personalized and Precision Medicine
Demand for tailored biologic therapies, especially in cancer and immunotherapy, is increasing.
3. Advances in Protein Engineering
Novel platforms like CRISPR-based protein design and AI-assisted antibody discovery offer new avenues for innovation.
4. Emergence of mRNA & Synthetic Biology
These technologies enable cost-effective development of complex proteins and rapid production cycles.
5. Strong Demand in Emerging Markets
Rising healthcare spending in Asia-Pacific, Africa, and Latin America is accelerating biologics uptake.

Investment Landscape and ROI Outlook

The protein therapeutics market remains one of the highest-value segments of the biopharmaceutical industry.

Investment Strengths
• High clinical success rates compared to small molecules
• Strong pricing power and premium reimbursement
• Expanding disease applications and patient population
• Growing pipeline of innovative biologics

ROI Outlook
With a CAGR of 6.3% through 2031, the market offers strong and stable returns, especially for companies investing in:
• Monoclonal antibody pipelines
• Biosimilars manufacturing
• Advanced biologics production technologies
• Precision immunotherapies
Biotech startups with breakthrough protein platforms continue to attract substantial venture capital.

Market Segmentations

By Product Type
• Monoclonal Antibodies
• Insulin
• Fusion Proteins
• Interferons
• Enzymes
• Coagulation Factors
• Peptide Hormones
• Therapeutic Peptides
• Vaccines
• Others

By Application
• Oncology
• Diabetes & Metabolic Disorders
• Autoimmune Diseases
• Hematological Disorders
• Infectious Diseases
• Genetic Disorders
• Cardiovascular Diseases
• Endocrine Disorders

By End User
• Hospitals
• Clinics
• Specialty Centers
• Research Institutes
• Homecare Settings

By Region
• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa

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Why Buy This Report?

✔ Covers in-depth 2031 forecasts with market values and growth trends
✔ Detailed competitive analysis of all major biopharmaceutical players
✔ Includes insights on emerging protein platforms and biosimilars
✔ Helps investors identify high-growth opportunities
✔ Ideal for pharma companies, biotech startups, consultants, and R&D teams
✔ Provides strategic guidance for market entry and expansion

FAQs

1. What is the projected size of the protein therapeutics market by 2031?
The market is expected to exceed US$ 549.4 billion by 2031.

2. What is driving market growth?
Rising chronic diseases, biologics innovation, biosimilar expansion, and growing R&D investments.

3. Which product segment dominates the market?
Monoclonal antibodies currently hold the largest share.

4. Which region leads the global market?
North America, supported by advanced biotech infrastructure and high biologics adoption.

5. What role do biosimilars play in market expansion?
Biosimilars are increasing accessibility, reducing costs, and creating new market opportunities globally.

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