GVR Report cover Protein Engineering Market Report

Protein Engineering Market Analysis By Technology (Rational Protein Design, Directed Evolution, Hybrid Approach), By Protein Type (Insulin, Monoclonal Antibodies), By Product, By End-use, And Segment Forecasts, 2018 - 2025

  • Report ID: GVR-1-68038-456-7
  • Number of Pages: 100
  • Format: Electronic (PDF)
  • Historical Range: 2014 - 2016
  • Industry: Healthcare

Industry Insights

The global protein engineering market size was valued at 823.0 million in 2016 and is anticipated to grow at a CAGR of 15.9% throughout the forecast period. The market is predominantly driven by increasing preference for protein therapeutics over non-protein drugs. The high preference is presumed to be a consequence of positive clinical outcomes associated with these drugs.

Protein engineering is broadly used to circumvent weaknesses associated with drugs, and it possesses the potential to enhance affinity & efficacy of molecules for wide range applications, such as cardiac repair. This has led to unprecedented demand and, consequentially, a significant increase in the adoption of these tools for the development of advanced therapeutics, thereby resulting in rapid market progression. 

U.S. protein engineering market by technology, 2014 - 2025 (USD Million)

U.S. protein engineering market

For instance, advent of recombinant Monoclonal Antibodies (mAbs) is a result of extensive use of protein engineering tools. The humanization and chimerization of mAbs and additional approaches to improve them in vivo activity led to increase in the number of alternatives for the treatment of various cancers, transplant rejections, autoimmune diseases, and other conditions.

The engineered molecules exhibit enhanced efficacy, reduced immunogenicity, greater safety, and improved delivery. Humulin (human insulin), the first protein therapeutic developed through recombinant DNA technology, was approved by U.S.FDA in 1982. The ability to significantly modify the functioning of a particular drug molecule through protein engineering, such as modification of substrate-specificity of human butyrylcholinesterase, exemplifies the high potential of protein engineering on drug metabolism and medicine.

Rising urgency to curb high R&D costs in clinical trials is the high impact-rendering driver of the market. Elevated costs are consequences of a high failure rate in the preclinical development. The marketing and commercialization of new drug molecules is a complex process and demands a longer duration. Approximately 50% of the compounds fail in the early clinical trials, thus significantly contributing to the overall cost.

In addition, according to the Journal of Health Economics, the average expenditure during drug discovery and development process was found to be USD 800 million. Moreover, according to a survey by the Tufts Centre for the Study of Drug Development, one in 1,000 drug compounds reach later phases of clinical trials. The aforementioned factors exemplify the need for platforms such as protein engineering, which can help reduce research costs.

Incorporation of advanced software during preclinical development is believed to surpass a few stages of drug discovery and development of potential drug candidates later on. Furthermore, regulatory authorities are consistently striving to reduce the time and cost involved in the process of drug discovery. For instance, the U.S. FDA launched the Critical Path Initiative in an attempt to incorporate advanced technologies in the drug discovery processes.

Protein Engineering Market Trends

The increasing choice for protein therapeutics over non-protein drugs is projected to boost market growth. The high choice is expected to be a consequence of long-term clinical outcomes related to protein drugs. Protein engineering is being widely used to overcome the weaknesses typically connected with drugs that hold the potential to improve efficacy & affinity of molecules in inclusive applications range such as cardiac repair. This unprecedented demand has led to a significant increase in the adoption of protein engineering tools for the development of advanced protein therapeutics, thereby resulting in fast market development. 

Increasing urgency to limit high research and development costs in clinical trials is the major impact-rendering driver. High costs are the result of the high failure of drugs rate in preclinical development. The commercialization and marketing of novel drug molecules is a complex process and demands a longer duration. Approximately 50% of the compounds fail during the initial clinical trials, thus contributing to the overall cost.

In addition, as per the Journal of Health Economics, in 2019 the average spending during drug discovery and development procedures was found to be USD 83 billion. Moreover, as per the Tufts Centre for the Study of Drug Development, 1 in 1,000 drug compounds reach the later phases of clinical trials. The above-mentioned factors demonstrate the need for platforms such as protein engineering, which can help lessen research costs.

The rising number of government initiatives aimed to work in the direction to enhance protein engineering capabilities which is anticipated to present the market with high growth potential opportunities. This has resulted in a significant increase in number of research activities & programmes, fund allotments and growing R&D investment. For instance, in December 2021, Nabla Bio announced the closing of  USD 11M Seed financing round led by Zetta Venture Partners and Khosla Ventures. This funding will be used to fast-track the advancement of an AI-first protein design platform, facilitating quick end-to-end engineering of next-generation antibody drugs. Moreover, in Jan 2022 Generate Biomedicines and Amgen announced a research collaboration contract to discover and produce protein therapeutics for 5 clinical targets. Moreover, growing prevalence of chronic and lifestyle diseases such as diabetes, cardiovascular diseases and others further enhance the protein engineering demand. According to the International Diabetes Federation, 2020, over 700 million adults globally will have diabetes by 2045.  China has the maximum number of diabetes accounts globally, with 116 million people having diabetes

High cost associated with the protein engineering is expected to restrain market growth over the forecast period. The majority of the protein engineering is of fair cost, but the cost of technology and other procedural costs pertaining to protein engineering process are high which suppresses the entry of new players in low and middle-income countries. Moreover, high amount of R&D investment involved in the development of new technology of these systems acts as a key factor contributing towards their high costs.

Limited availability of skilled professionals is the critical growth-restraining factor of the protein engineering market. The lack of skilled professionals can be attributed to the smaller number of training programs and modules pertaining to protein engineering, under implementation of the aforementioned training modules and high training costs involved.

Technology Insights

Rational design dominated the technology segment with a share of over 39.0% in 2016. The dominant share can be attributed to the extensive usage of this technology in antibody and enzyme engineering. The unprecedented expansion in commercial applications and enzyme engineering resulted in enhanced and modified enzymes possessing desired catalytic properties.

Site-directed mutagenesis is one of the frequently used rational design methods that aids in obtaining greater insights on enzyme binding and catalytic mechanisms, which thereby broadens the scope of functional prediction of new genome sequences. The consistent use of rational design has been exemplified in the development of a faster superoxide dismutase, one of the fastest known enzymes in nature.

In addition, it is anticipated that rational design can further be implemented as a consequence of the development of modeling tools and a rapidly growing number of 3Dstructures in databases. Protein remodeling is one of the major applications of rational design, serving as a major contributing factor to the dominant share of rational design.

Hybrid approach is presumed to attain the fastest CAGR of over 16.0% during the forecast period. Hybrid approaches that use a combination of directed evolution and rational design are increasingly used in various applications, such as for enhancement of redox proteins and enzymes. These enzymes hold high importance in the development of nanodevices for biosensing and other major nanotechnology applications, thus engendering future growth prospects.

Product Insights

Instrument accounted for the largest share in the product segment in 2016. The largest share captured by this segment is believed to be a consequence of high preference for automated technology by the researchers in order to facilitate a faster molecule development process. For instance, instrumentation of real-time PCR in quantitation of nucleic acids is highly preferred in academic research, as it facilitates a greater understanding of the chemical structure of mutated nucleic acids

Extensive usage of new technologies and process advancements in proteomic research are high-impact rendering drivers of the market. These technologies include mass spectrometry, gel electrophoresis, and computational prediction programs. These facilitate efficient identification, characterization of proteomes, and determination of function, which are critical aspects of protein engineering, thereby encouraging high adoption of instruments. These factors cumulatively are believed to be responsible for the substantial share in the product segment.

Software & services are expected to witness lucrative CAGR as a consequence of increasing usage in a wide array of applications that suit the interests and needs of researchers. In addition, majority of processes are dependent on software, which is the key factor presumed to be responsible for the high growth potential attained by the segment. The anticipated fast growth is also believed to be a result of complex, multilayered drug development system in which, these services may prove imperative.

The market players are involved in the development of an array of services that simplify the overall process. The services provided by these key players result in reduction of the overall expenditure and, thus, promote the use of these technologies by researchers and scientists.

Protein Type Insights

mAbs accounted for a dominant share of the protein type segment in 2016 and are anticipated to grow at a lucrative rate during the forecast period. Growing R&D expenditure in the development of therapeutically advanced mAbs is presumed to be one of the significant factors responsible for increased adoption of these tools.

High demand for personalized medicine is also considered as a high-impact rendering driver for the growth attained by this segment over the years. Moreover, protein engineering provides various benefits, such as fewer adverse effects and higher homogeneity & specificity of mAbs, which thereby drive the preference by researchers in the modeling of mAbs to yield therapeutically superior versions.

In addition, government initiatives to enable cost-effective production of mAbs are predicted to impel the usage over the coming years. For instance, the National Institute of Standards and Technology in the U.S. has issued biomanufacturing initiative and stringent regulatory guidelines to ensure the effective and safe manufacturing of low-cost, high-quality drugs globally.

The incorporation of technologically advanced genetic platforms that include protein engineering and next-generation sequencing is anticipated to increase the growth potential. In addition, the cost-effective nature of the aforementioned technologies is presumed to support research studies to develop new generation of mAbs, which is anticipated to present a billion-dollar opportunity to major pharmaceutical companies in the future.

End-use Insights 

Pharmaceutical & biotechnology companies held a dominant share in the end-use segment in 2016. The substantial share can be attributed to the increasing adoption of in silico models to develop new protein-based drugs in the following applications: cancer, diabetes, and central nervous system diseases.

These companies are consistently striving to sustain the market by developing drug variants of a patent expiring drugs by incorporating the computer modeling approach. The increasing inclination of public & private healthcare organizations toward promoting advanced engineering to yield better patient outcomes serves as one of the key factors responsible for the substantial share of the segment.

Global protein engineering market share by end-use, 2016 (%)

Global protein engineering market

Furthermore, supportive organizations allot funds to major pharmaceutical and biotechnology companies to develop new- and advanced generation therapeutics, thereby leading to greater adoption of engineering tools by these companies. The aforementioned factors are anticipated to be responsible for the dominant share registered by the segment.

Contract research organizations are expected to grow at a lucrative rate throughout the forecast period. This highest growth can be attributed to the growing inclination of companies to reduce overall expenditure along with utilization of benefits involved. It primarily includes cost advantages, increased efficiency of services, enhanced productivity, and higher focus on the core areas of development-all of which are critical to a company’s growth.

Regional Insights

In 2021, North America captured a dominant share of the market. Constant collaborations stimulated by major market players for growing their research and development skills are presumed to be accountable for the larger share captured by this region. Moreover, the established pharmaceutical companies in this region are broadly involved in the commercialization of innovative engineering tools and the advancement of their usage in the research area.

Strategic activities by major players in the U.S. is the major factor propelling the market growth in the region. For instance, in February 2022, Tierra Biosciences launched the Tierra Protein Platform, an industry-first eCommerce portal that allows customers to get the custom proteins validated, synthesized, and shipped to them. This platform provides a more convenient and faster solution than conventional methods for sourcing thousands of proteins for R&D.

The high prevalence of various chronic diseases, such as cancer and cardiovascular conditions, in India propels the market growth. In addition, an upsurge in the research and development will offer lucrative opportunities during the study period. For instance, in June 2021, Indian Institute of Science Education and Research, Bhopal researchers invented the latest technology that can provide active molecules to certain sections of proteins.

Competitive Insights 

The market is marked by the extensive implementation of sustainability strategies by the key players such as Agilent Technologies, Thermo Fisher Scientific, Waters Corporation, which accounts for their dominant market share. These players are highly focused on strategies such as mergers & acquisitions, new product development initiatives, and geographical expansion.

For instance, in March 2017, Agilent Technologies launched a research-grade triple quadrupole LC/MS system. This product was launched for expanding research capabilities to provide greater accuracy and sensitivity in various applications, such as environmental, clinical research, peptide quantitation, and forensic toxicology.

Similarly, in March 2017, the company expanded its biopharma product portfolio with an advanced mass spectrometry system. The expansion of this product portfolio was carried out to achieve the optimization of biopharma research.

Report Scope

Report Attribute

Details

Base year for estimation

2016

Actual estimates/Historical data

2014 - 2016

Forecast period

2017 - 2025

Market representation                                    

Revenue in USD Million and CAGR from 2017 to 2025

Regional scope

North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Country scope

U.S., Canada, UK, Germany, Japan, China, Brazil, Mexico, South Africa

Report coverage        

Revenue forecast, company share, competitive landscape, growth factors and trends

15% free customization scope (equivalent to 5 analyst working days)

If you need specific market information, which is not currently within the scope of the report, we will provide it to you as a part of customization


Segments Covered in the report

This report forecasts revenue growth at global, regional & country levels and provides an analysis of the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global protein engineering market on the basis of technology, product, protein type, end use, and region: 

  • Technology Outlook (Revenue, USD Million, 2014 - 2025)

    • Rational Protein Design

    • Directed Evolution

    • Hybrid Approach

  • Product Outlook (Revenue, USD Million, 2014 - 2025)

    • Instruments

    • Reagents

    • Software & Services

  • Protein Type Outlook (Revenue, USD Million, 2014 - 2025)

    • Insulin

    • Monoclonal Antibodies

    • Vaccines

    • Growth Factors

    • Colony Stimulating Factors

    • Coagulation Factors

    • Interferon

    • Others

  • End-use Outlook (Revenue, USD Million, 2014 - 2025)

    • Academic Research Institutes

    • CROs

    • Pharma & Biotech Companies

  • Regional Outlook (Revenue, USD Million, 2014 - 2025)

    • North America

      • The U.S.

      • Canada

    • Europe

      • The U.K.

      • Germany

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Mexico

      • Brazil

    • Middle East & Africa

      • South Africa

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