PEGylation, a technique to get around some of the drawbacks of some biopharmaceuticals, is the term used to describe the alteration of biological molecules by covalent conjugation with polyethylene glycol (PEG), a non-toxic, non-immunogenic polymer. PEGylation improves the pharmacokinetic behavior of the medicine by altering the biological molecule's physical and chemical characteristics, such as its conformation, electrostatic binding, and hydrophobicity. PEGylation generally reduces immunogenicity while increasing medication solubility. PEGylation also prolongs the period that conjugates remain in the bloodstream, improves drug stability, and decreases proteolysis and renal excretion, all of which allow for less frequent dosing.
Global PEGylated proteins market is estimated to be valued at US$ 14,424.3 million in 2022 and is expected to exhibit a CAGR of 4.7% during the forecast period (2022-2030).
Figure 1. Global PEGylated Proteins Market Share (%), by Type, 2022
Global PEGylated Proteins Market- Drivers
Increasing product launch and approvals by regulatory authorities to key players in market are expected to drive market growth over the forecast period. For instance, in November 2021, PharmaEssentia Corporation, a global biopharmaceutical innovator based in Taiwan, announced that the U.S. Food and Drug Administration (FDA) had approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of adults with polycythemia vera (PV). BESREMi is an innovative monopegylated, long-acting interferon, which exhibits its cellular effects in polycythemia vera in the bone marrow.
High prevalence of chronic diseases such as cancer, autoimmune disease, hepatitis, and others is expected to drive market growth over the forecast period. For instance, according to the data published in WCRF International, a not-for-profit association related to cancer prevention research on diet, weight, and physical activity, 18,094,716 million cases of cancer were diagnosed in 2020 globally.
|Base Year:||2021||Market Size in 2022:||US$ 14,424.3 Mn|
|Historical Data for:||2017 to 2020||Forecast Period:||2022 to 2030|
|Forecast Period 2022 to 2030 CAGR:||4.7%||2030 Value Projection:||US$ 20,813.0 Mn|
Biogen Inc, Pfizer Inc, UCB S.A., Leadiant Biosciences, Inc., Amgen Inc., Thermo Fisher Scientific Inc., Horizon Therapeutics Plc., Novo Nordisk A/S, F. Hoffmann-La Roche AG, Bayer AG, BioMarin, RedHill Biopharma Ltd.
|Restraints & Challenges:||
Figure 2. Global PEGylated Proteins Market Share (%), by Region, 2022
Global PEGylated Proteins Market– Impact of Coronavirus (COVID-19) Pandemic
Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization had declared it a public health emergency on January 30, 2020.
COVID-19 has affected the economy in three main ways: by directly affecting production and demand of drugs and vaccines, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, UAE, Egypt, and others, faced problems with regard to the transportation of drugs and vaccines from one place to another. The coronavirus or COVID-19 outbreak started from Wuhan, China in 2019 and has spread across all the continents of the world, affecting various industries globally. Economy in countries all over the world such as India, Italy, Bangladesh, Sri Lanka, the U.S., Morocco, and others has been disrupted due to lockdowns implemented by governments to combat spread of coronavirus since 2020.
The impact of COVID-19 on the PEGylated proteins market is expected to be minimal. Proteins/peptides, antibodies, and vesicles are biochemically modified using polyethylene glycol (PEG) to give them several desirable properties that are thought to be useful for cell genetic modification or therapy. PEGylated proteins have been found to be effective for treating SARS-CoV-2 in patients with COVID-19. For instance, according to data published in June 2021, titled ‘PEGylated nanoparticle albumin-bound steroidal ginsenoside derivatives ameliorate SARS-CoV-2-mediated hyper-inflammatory responses’ on Elsevier B.V., stated that in SARS-CoV-2 ICU patients, PEGylated Nanoparticle Albumin-Bound (PNAB) -steroidal Ginsenoside can successfully reduce plasma levels of histone H4 and NETosis-Related Factors and reduce SREBP2-mediated systemic inflammation. PNAB-steroidal ginsenoside drugs may be helpful in treating coagulation and cytokine storm symptoms that are common in severe SARS-CoV-2 patients. On June 22, 2020, Massachusetts General Hospital, in collaboration with Eiger BioPharmaceuticals, which is a commercial-stage biopharmaceutical company initiated the Phase II, a Randomized Controlled Trial to evaluate the safety and efficacy of Pegylated Interferon Lambda vs. Placebo in Subjects Infected with COVID-19.
Global PEGylated Proteins Market: Key Developments
In September 2020, Humanigen, Inc., a clinical-stage biopharmaceutical company, and Lonza, a multinational manufacturing company for the pharmaceutical, biotechnology and nutrition sectors, announced a strategic collaboration to expand the manufacturing capacity for lenzilumab, a GM-CSF neutralising monoclonal antibody, currently in Phase 3 clinical trials for COVID-19.
In February 2021, Biogen, a multinational biotechnology company, announced that the U.S. Food and Drug Administration (FDA) had approved a new intramuscular (IM) injection route of administration for PLEGRIDY (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis (MS).
Global PEGylated Proteins Market: Restraint
The major factors that hinder growth of the global PEGylated proteins market include drawbacks associated with PEGylated therapeutic proteins and high costs associated with drug development. For instance, polyethylene glycol (PEG) itself shows potential risks such as immunogenicity of PEG and PEG-containing vacuoles in cells observed with PEGylated biologicals.
Global PEGylated Proteins Market- Key Players
Major players operating in the global PEGylated proteins market include Biogen Inc, Pfizer Inc, UCB S.A., Leadiant Biosciences, Inc., Amgen Inc., Thermo Fisher Scientific Inc., Horizon Therapeutics Plc., Novo Nordisk A/S, F. Hoffmann-La Roche AG, Bayer AG, BioMarin, RedHill Biopharma Ltd.
PEGylation is a process of addition of active polyethylene glycol (PEG) to different forms of therapeutic proteins for chemical modification. These chemically modified therapeutic proteins are called PEGylated protein therapeutics. PEGylated protein therapeutics are used in multiple conditions, such as cancer, hemophilia, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, and others. PEGylation is the term used to describe the covalent modification of biological molecules with the non-toxic, non-immunogenic polymer polyethylene glycol (PEG) in order to reduce the drawbacks of some biopharmaceuticals.
Due to its claimed "silent" qualities and biocompatibility, polyethylene glycol (PEG) is frequently used in medication delivery and nanotechnology. It is commonly accepted that PEGylation enables biomaterials and particle delivery methods to sidestep the immune system and extend circulation lifetimes. Nevertheless, PEGylation of proteins is a complicated procedure that can be completed using a variety of methods, depending on the type of the protein and the intended application. Inert PEG strings are covalently or non-covalently complexed with proteins of interest. Another crucial step is the purification of the PEGylated protein, which is mostly accomplished through chromatography and electrostatic interactions or molecular sizes.
Increasing adoption of inorganic strategies by key players in market such as product launch is expected to drive market growth over the forecast period. For instance, in February 2020, the Novo Nordisk launched ESPEROCT in the U.S. for the treatment of people with hemophilia A. It is a recombinant extended half-life factor VIII replacement therapy used to prevent or reduce the number of bleeding episodes, to treat and control bleeding, and to manage bleeding during surgery in people with hemophilia A. ESPEROCT is antihemophilic factor (recombinant), glycopegylated-exei.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.