Recombinant Proteins Manufacturing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service Type (Pre-clinical & Clinical Services, Commercial Production Services), By Host Cell (Mammalian Cells, Bacterial Cells, Insect Cells, Yeast & Fungi, Others), By End-user (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes), By Region and C

Published Date: November - 2024 | Publisher: MIR | No of Pages: 320 | Industry: Healthcare | Format: Report available in PDF / Excel Format

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Recombinant Proteins Manufacturing Services Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service Type (Pre-clinical & Clinical Services, Commercial Production Services), By Host Cell (Mammalian Cells, Bacterial Cells, Insect Cells, Yeast & Fungi, Others), By End-user (Pharmaceutical & Biotechnology Companies, Academic & Research Institutes), By Region and C

Forecast Period2025-2029
Market Size (2023)USD 3.06 Billion
CAGR (2024-2029)7.21%
Fastest Growing SegmentPre-clinical & Clinical Services
Largest MarketNorth America
Market Size (2029)USD 4.60 Billion

MIR Consumer Healthcare
Market Overview

Global Recombinant Proteins Manufacturing Services Market was valued at USD 3.06 Billion in 2023 and is anticipated to project steady growth in the forecast period with a CAGR of 7.21% through 2029. Global Recombinant Proteins Manufacturing Services play a pivotal role in the biotechnology and pharmaceutical industries, providing essential support for the production of biopharmaceuticals and therapeutic proteins. These services encompass a wide range of processes, from gene cloning and expression to purification and characterization, all tailored to meet the specific needs of clients involved in drug development, research, and diagnostics. In recent years, the demand for recombinant proteins has surged, driven by the growing prevalence of complex diseases, the rise of precision medicine, and the development of targeted therapies.

Recombinant proteins are critical in biomedicine, as they serve as essential tools for studying cellular processes, drug development, and disease treatment. Global recombinant protein manufacturing services bring together cutting-edge technologies and expertise to meet this demand efficiently. They typically offer comprehensive solutions, including plasmid DNA construction, cell line development, fermentation,

The global recombinant proteins manufacturing services industry has witnessed significant advancements in recent years, including the implementation of high-throughput technologies, improved expression systems, and enhanced downstream processing techniques. This has led to increased production efficiency and cost-effectiveness. Biopharmaceutical companies and research institutions rely on these services to obtain high-quality, well-characterized proteins for a diverse range of applications, including preclinical and clinical trials, diagnostic assays, and protein-based therapies.

Also, the COVID-19 pandemic has underscored the importance of recombinant proteins in vaccine development and therapeutic antibody production. Rapid and scalable manufacturing services have played a crucial role in addressing global health challenges.

Key Market Drivers

Biopharmaceutical Industry Expansion

The remarkable expansion of the biopharmaceutical industry is a major driving force behind the escalating demand for Global Recombinant Proteins Manufacturing Services. This industry's rapid growth is fueled by several factors, including the increasing prevalence of complex diseases, a shift towards personalized medicine, and the development of innovative targeted therapies. As biopharmaceutical companies endeavor to meet the healthcare needs of a global population, they heavily rely on recombinant proteins in their research, drug development, and therapeutic production processes.

The biopharmaceutical sector's expansion is most evident in the development and production of biologics, such as monoclonal antibodies, therapeutic proteins, and vaccines. These biologics have emerged as essential tools for treating a wide range of conditions, from cancer to autoimmune disorders. In addition, they have revolutionized the treatment of previously incurable diseases by offering more effective and targeted therapies.

As the biopharmaceutical industry continues to grow and evolve, the demand for recombinant proteins is only expected to increase. This expansion is not limited to well-established markets but extends to emerging economies where healthcare infrastructure is rapidly advancing. This global reach ensures that recombinant proteins manufacturing services are poised for sustained growth, with providers constantly enhancing their capabilities and capacities to meet the evolving needs of the biopharmaceutical sector.

Personalized Medicine and Targeted Therapies

The rise of personalized medicine and the increasing emphasis on targeted therapies have become instrumental in driving the demand for Global Recombinant Proteins Manufacturing Services. Personalized medicine represents a paradigm shift in healthcare, focusing on tailoring medical treatments to an individual's genetic, molecular, and clinical characteristics. This approach relies heavily on the use of recombinant proteins to create highly specific and effective therapeutic solutions.

The genetic diversity observed in various diseases, such as cancer, necessitates the development of therapies that are uniquely suited to the patient's genetic makeup. Recombinant proteins, being adaptable and customizable, offer an ideal platform for this level of personalization. They can be engineered to interact with specific cellular receptors or molecules, thereby enabling treatments that align precisely with a patient's genetic and molecular profile.

Rising Prevalence of Chronic Diseases

The rising prevalence of chronic diseases worldwide is a significant catalyst behind the increasing demand for Global Recombinant Proteins Manufacturing Services. Chronic diseases, such as cancer, diabetes, cardiovascular disorders, and autoimmune conditions, have reached epidemic proportions, posing a formidable challenge to global healthcare systems. Recombinant proteins play a pivotal role in addressing these health crises by serving as essential components in the development of novel treatments and diagnostic tools.

In the field of cancer, recombinant proteins are essential in the production of monoclonal antibodies and proteins that can specifically target cancer cells or associated biomarkers, thereby enabling more effective and less toxic treatments. Similarly, in diabetes, recombinant proteins are used to develop insulin analogs and other therapeutic agents designed to regulate blood glucose levels, offering improved management and quality of life for patients.


MIR Segment1

Key Market Challenges

Cost-Intensive Production

Cost-intensive production stands as a significant challenge hindering the growth and accessibility of Global Recombinant Proteins Manufacturing Services. Recombinant proteins, engineered to mimic naturally occurring proteins, play a pivotal role in biopharmaceuticals, diagnostics, and research. However, the process of producing these proteins can be both complex and costly, impacting the ability of smaller biotech companies and academic institutions to engage in vital research and therapeutic development.

Moreover, protein expression and purification require a skilled workforce with expertise in bioprocessing, quality control, and GMP compliance. These personnel, while essential for ensuring the production of high-quality recombinant proteins, represent another significant portion of the overall cost.

Regulatory Hurdles

Regulatory hurdles represent a formidable challenge in the global landscape of Recombinant Proteins Manufacturing Services. The biopharmaceutical industry, in which these services play a pivotal role, is subject to stringent oversight by regulatory agencies worldwide, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Ensuring compliance with these complex and ever-evolving regulations is vital for product safety and efficacy, but it can be an intricate and costly process.

One of the primary regulatory challenges is the need for manufacturers to meet the demanding Good Manufacturing Practices (GMP) standards. These standards set forth a rigorous framework for quality control, documentation, and process validation to ensure the safety, efficacy, and consistency of biopharmaceutical products. Adhering to GMP guidelines requires substantial investment in facilities, equipment, personnel training, and quality assurance processes, all of which add to the overall cost of recombinant protein manufacturing.

Key Market Trends


MIR Regional

Growing Demand for Biologics

The growing demand for biologics in the global healthcare landscape is a prominent driving force behind the remarkable expansion of Global Recombinant Proteins Manufacturing Services. Biologics, which encompass a wide range of complex therapeutic molecules, including monoclonal antibodies, therapeutic proteins, and vaccines, have become pivotal in the treatment of various diseases, including cancer, autoimmune disorders, and infectious diseases. This escalating demand for biologics has, in turn, heightened the need for recombinant proteins manufacturing services, which play an indispensable role in the production and development of these biopharmaceuticals.

To produce biologics, especially monoclonal antibodies and therapeutic proteins, the biopharmaceutical industry relies on recombinant proteins manufacturing services. These services provide the expertise, infrastructure, and specialized techniques necessary for the production of recombinant proteins, which are the foundation of many biologics. Recombinant proteins serve as essential building blocks for creating therapeutic molecules that can target specific disease-related proteins, pathways, or cells, leading to more effective treatments.

Advancements in Gene and Cell Therapies

Advancements in gene and cell therapies are propelling the demand for Global Recombinant Proteins Manufacturing Services to new heights. Gene and cell therapies represent a groundbreaking frontier in modern medicine, offering innovative treatment options for a range of genetic and acquired diseases, including inherited genetic disorders and cancer. These therapies, which involve the precise modification or replacement of genes or the use of engineered cells, heavily rely on recombinant proteins at various stages of development and production.

In gene therapy, recombinant proteins come into play as essential tools for the modification and delivery of therapeutic genes. They are used to create viral vectors or non-viral delivery systems that carry the therapeutic genetic material into target cells. These vectors are often custom designed to ensure precise and safe gene delivery, which is paramount for the success of gene therapy. Recombinant proteins manufacturing services are indispensable for producing these custom vectors, ensuring that they meet the highest quality and safety standards.

Cell therapies, particularly CAR-T cell therapies used to treat cancer, also benefit from recombinant proteins manufacturing services. Recombinant proteins are used to engineer and expand the patient's immune cells to recognize and destroy cancer cells selectively. The production of these genetically modified cells often requires intricate protein-based systems to drive cell proliferation and activation, thus making recombinant proteins a vital component in cell therapy development.

Segmental Insights

Service Type Insights

Based on Service Type, Commercial Production Services have emerged as the dominating segment in the Global Recombinant Proteins Manufacturing Services Market in 2023

Host Cell Insights

Based on Host Cell, Mammalian Cells have emerged as the dominating segment in the

Regional Insights

Based on Region, North America have emerged as the dominating region in the

Recent Developments

  • In January 2023, Agilent Technologies Inc. announced a partnership with Quest Diagnostics, the world’s leading provider of diagnostic information services. This collaboration aims to facilitate access to the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test for healthcare providers and patients across the United States. The agreement between Quest and Agilent will pave the way for widespread adoption of ctDx FIRST, a single-site premarket approved (ssPMA) test conducted at the Resolution Bioscience CLIA laboratory in Kirkland, Washington. ctDx FIRST stands as the inaugural liquid biopsy test approved by the U.S. Food and Drug Administration (FDA) as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients eligible for treatment with KRAZATI. KRAZATI (adagrasib) secured accelerated approval as a targeted therapy option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, and who have undergone at least one prior systemic therapy.

Key Market Players

  • Lonza Group Ltd. 
  • BoehringerIngelheim International GmbH
  • FUJIFILMDiosynth Biotechnologies USA, Inc. 
  • MerckKGaA
  • BrukerCorporation
  • SinoBiological, Inc.
  • GenScript Biotech Corporation
  • KanekaCorporation 
  • PolyplusTransfection S.A. 
  • BosterBiological Technology Co., Ltd.

 By Service Type

By Host Cell

By End-user

By Region

  • Pre-clinical & Clinical Services
  • Commercial Production Services
  • Mammalian Cells
  • Bacterial Cells
  • Insect Cells
  • Yeast & Fungi
  • Others
  • Pharmaceutical & Biotechnology Companies
  • Academic & Research Institutes
  • North America
  • Europe
  • Asia Pacific
  • South America
  • Middle East & Africa

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