Forecast Period
|
2024-2028
|
Market Size (2022)
|
USD 419.07 Million
|
CAGR (2023-2028)
|
6.08%
|
Fastest Growing Segment
|
Pharmaceutical and Biotechnology Companies
|
Largest Market
|
North America
|
Market Overview
Global Peptide Synthesis Market has valued at USD 419.07
Million in 2022 and is anticipated to project robust growth in the forecast
period with a CAGR of 6.08% through 2028. Peptides are synthesized through the
coupling of the carboxyl group of one amino acid with the amino group of
another amino acid molecule. To avoid unintended reactions, protective measures
are commonly employed. Chemical peptide synthesis typically initiates from the
carboxyl end of the peptide, progressing towards the amino terminus, which is
contrary to the direction of protein biosynthesis. Peptides serve as highly
effective and selective signaling molecules, binding to specific cell surface
receptors such as ion channels or G protein-coupled receptors (GPCRs),
triggering intracellular reactions. Their outstanding pharmacological profile
and intrinsic characteristics make peptides an ideal starting point for the
development of new therapies. Notably, peptides demonstrate exceptional safety,
tolerability, and efficacy in humans due to their specificity. When compared to
protein-based biopharmaceuticals, peptide therapeutics exhibit lower processing
complexity, resulting in production costs more akin to small molecules.
Key Market Drivers
Increasing Use in Pharmaceutical Industry
Peptides are highly potent and targeted
pharmacological ingredients, exhibiting a diverse range of biological actions.
Their broad chemical space, remarkable biological activity, and specificity,
coupled with their relative simplicity of synthesis, ready availability, and
low toxicity, position peptides as promising candidates for active medicinal
components. Peptides can be designed to specifically target certain receptors,
enzymes, or proteins in the body, allowing for highly targeted and precise
therapeutic interventions. This targeted approach reduces the risk of off-target
effects and enhances therapeutic efficacy. Peptides have a wide range of
therapeutic applications. They can be used to treat various medical conditions,
including cancer, metabolic disorders, cardiovascular diseases, autoimmune
disorders, and infectious diseases.
Peptides contribute significantly to the
therapeutic landscape, particularly in the fields of oncology, diabetes, and
obesity, generating billions of dollars in revenue. Moreover, the demand for
peptides is steadily increasing for the treatment of renal failure, rare
disorders, as well as cardiovascular and neurological conditions. Currently,
there are over 100 peptide-based medications available, and with nearly 700
peptide medicines and therapeutic peptides in preclinical development, this number
is projected to grow substantially.
Application of Peptides in Diabetes
The significant market growth can be attributed to
the notable increase in the adoption of peptides in the consumer healthcare
industries. Peptides have a diverse range of applications in treating various
lifestyle disorders, including cancers, diabetes, and obesity. The rising
prevalence of these metabolic and lifestyle disorders has opened up
opportunities for the utilization of peptide therapeutics in oncology and
metabolic disorders. For example, as per the 2021 statistics published by the
International Diabetes Federation, there were 537 million adults (20-79 years)
living with diabetes worldwide, which accounted for 1 in 10 individuals
affected by diabetes. Additionally, the same source reported that 541 million
adults had Impaired Glucose Tolerance (IGT), placing them at a high risk of
developing type 2 diabetes. Several peptide therapies, such as Glucagon-like
peptide-1amide, are known to stimulate insulin secretion postprandially and are
widely used in pancreatic therapy. Consequently, the demand for peptide drugs
is expected to rise in tandem with the increasing number of diabetic patients,
thereby driving the market throughout the forecast.
Focus on New Peptide-Based Treatments
The growing interest in peptides as potential
therapeutics and their diverse applications in various fields, such as
pharmaceuticals, biotechnology, and diagnostics, has led to increased research
activities. Researchers are exploring new peptide-based treatments and
developing peptide drugs for a wide range of medical conditions, driving the
demand for peptide synthesis. The successful development and approval of new
peptide-based drugs have generated enthusiasm in the pharmaceutical industry.
As more peptide-based therapies gain regulatory approval, the market for
peptide synthesis equipment and services expands to meet the demand for these
innovative drugs.
The peptide synthesis market has experienced
significant growth, attributed to increased research activities, novel product
approvals, and the rise in funding for research and development. Advanced
peptide synthesizers have played a crucial role in this growth. Notably, in
April 2021, ISSAR Pharma announced the licensing of their peptide-based New
Chemical Entities (NCEs), along with pre-investigational new drug (IND) filing
and a United States patent. These remarkable developments in peptide drugs are
anticipated to drive market demand.
Expanding Applications in Diagnostics and Imaging
Peptide-based biosensors are designed to detect
specific biomolecules or analytes in biological samples. These biosensors can
be used for early disease detection, monitoring treatment responses, and
measuring various biochemical parameters. Peptide sequences with high affinity
and selectivity for target molecules are incorporated into the biosensor to
ensure accurate and sensitive detection.
Peptides are used to develop imaging agents that
can bind to specific disease-related targets in the body. These imaging agents
are used in molecular imaging techniques such as positron emission tomography
(PET), single-photon emission computed tomography (SPECT), and magnetic
resonance imaging (MRI). Peptide-based imaging agents provide non-invasive and
targeted visualization of disease sites, aiding in diagnosis and treatment
planning. Peptides play a vital role in diagnostic applications, encompassing
the advancement of peptide-based biosensors, imaging agents, and biomarkers.
The increasing demand for non-invasive and targeted diagnostic tools, like
peptide-based imaging agents for molecular imaging and peptide-based biosensors
for disease detection, is propelling market growth.
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Key Market Challenges
Purification and Quality Control
During peptide synthesis, side reactions and
formation of by-products can occur, leading to impurities in the final product.
Ensuring high purity involves careful optimization of the synthesis conditions
to minimize the formation of impurities. Achieving high purity can be
resource-intensive, as it may require substantial amounts of reagents,
solvents, and specialized equipment. The cost of purification can add to the
overall production expenses. Moving from small-scale to large-scale peptide
synthesis can present challenges in maintaining consistent purity levels.
Factors such as reaction kinetics and mass transfer can differ at larger
scales, necessitating additional process optimization. Obtaining peptides of
high purity is crucial for their successful application in research and
therapeutics. Purification methods, such as high-performance liquid
chromatography (HPLC), can be time-consuming and require optimization for each
peptide sequence. Quality control measures are essential to ensure the
accuracy, consistency, and safety of synthesized peptides. Maintaining
high-quality standards and efficient purification processes can be a challenge
for the peptide synthesis market.
Regulatory Issues
Peptides are highly sought after for the treatment
of cardiovascular and neurological disorders, renal failure, and rare diseases.
Currently, there are over 100 FDA-approved peptide-based medications available
in the market. The number of peptide medicines in clinical trials or
preclinical research has surpassed 700, indicating a significant potential for
expansion. These peptide-based medications are classified as both
small-molecule and large-molecule biologics. However, their unique position
between small molecules and large proteins has posed regulatory challenges.
While most of these medications are chemically synthesized, their mechanisms of
action vary widely.
Developing a comprehensive set of regulatory rules
that adequately address the safety and quality requirements for such a diverse
range of molecular entities with distinct modes of action is a complex task.
The absence of established regulatory criteria for this class of medications
further complicates matters. Moreover, there exists a disagreement between the
Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
regarding the regulatory clearance of peptide-based medications. The FDA
classifies peptide medications as small-molecule pharmaceuticals under the
authority of the FDA's Center for Drug Evaluation and Research (CDER), whereas
the EMA favors a centralized approach over the mutual recognition procedure.
This lack of uniform regulatory guidelines has
hindered the acquisition of permits for therapeutic peptides, limiting their
application areas. Consequently, it serves as a significant barrier to the
growth of the global peptide synthesis industry.
Key Market Trends
Increasing Opportunity in Rare Diseases
Therapeutics
Peptides can be strategically designed to target
specific molecular pathways or genetic mutations associated with rare diseases.
This precision-oriented approach allows for more effective and tailored
therapeutic interventions. Peptides can be customized to address specific rare
mutations or genetic variants, enabling treatments to be tailored to individual
patients through personalized medicine approaches. Peptide-based therapies
often offer non-invasive delivery options, making them an appealing choice for
patients with rare diseases who may have limited tolerance for invasive
procedures. Regulatory agencies provide incentives and special designations for
drugs developed to treat rare diseases, creating opportunities for companies to
pursue research and development in this field.
Peptides offer promising solutions for the
treatment of rare genetic disorders and orphan diseases. The expansion of the
peptide synthesis market presents an opportunity to develop and manufacture
peptide-based therapeutics targeting these conditions. Companies can focus on
designing and synthesizing peptides that specifically address molecular targets
associated with rare diseases, thus catering to unmet medical needs.
Use of Peptides in the Development of Personalized
Medicine
The notion of individualized therapy aimed at
achieving the best response and maximizing safety margins to enhance patient
care has generated considerable interest in personalized treatment. Proteomic
analysis presents itself as an appealing and effective approach for deciphering
the molecular profiles of distinct tissues, whether healthy or diseased. The
emergence of personalized proteomics or proteomic profiling represents a
significant stride forward in understanding disease path mechanisms.
Within the framework of the EU-funded ElectroMed
project, researchers have proposed the development of a user-friendly platform
to facilitate electrochemically guided peptide synthesis. This innovative platform
will be based on a microfluidic multiplexing system, controlled by software,
thus promoting the broader application of proteomics in personalized medicine.
Additionally, label-free sensors utilizing
nanomaterials will be employed to detect and quantify ligand-receptor
complexes. This technological advancement will enable the automated injection
of various reagents required for ligand synthesis, thereby facilitating
personalized and controlled peptide synthesis in the context of personalized
treatment.
The growing investments in personalized medicine
can be largely attributed to the rising prevalence of diseases such as cancer
and cardiovascular disease (CVD), along with the increasing demand for
treatments with minimal adverse effects. Personalized medicine has the
potential to enhance healthcare quality while simultaneously reducing costs.
Consequently, players in the peptide synthesis market stand to benefit from
these advancements in the field of customized medicine.
Segmental Insights
Technology Insights
Liquid-Phase Peptide
Synthesis (LPPS) has dominated the global market throughout the forecast
period, while solid-phase peptide synthesis has shown the fastest growth. The
integration of automation and advancements in both liquid and solid-phase peptide
synthesis has significantly contributed to cost reduction in peptide synthesis.
Consequently, this is expected to drive the adoption of peptide synthesis
worldwide, resulting in increased global revenue during the forecast period.
Conventional studies suggest that solid-phase peptide synthesis is a suitable
approach for GMP manufacturing and API process development due to its
cost-effectiveness in synthesizing long peptide sequences (more than 10 amino
acids) with smaller volumes. However, it is important to note that purification
costs associated with solid-phase peptide synthesis can potentially increase
manufacturing costs at any scale of production. On the other hand, liquid-phase
peptide synthesis is commonly used for developing shorter peptide sequences and
large volumes. In some cases, hybrid approaches are employed for synthesizing
long sequences at large volumes.
End User Insights
The pharmaceutical and
biotechnology sector constituted a significant portion of the revenue share in
2022. In recent years, there has been a substantial surge in the development of
biologic drugs, biomolecules, and biopharmaceutical therapeutics. Consequently,
the biotech and pharmaceutical industries are increasingly focusing on peptides
and proteins as targets for drug discovery. Although proteins and peptides
share several characteristics with substantial therapeutic potential, they
possess fundamental distinctions. Companies are now providing tailored peptide
synthesis, protected amino acids, peptide libraries and reagents, Active
Pharmaceutical Ingredient (API) production, Good Manufacturing Practice (GMP)
manufacturing, as well as unnatural amino acids and derivatives. The
specialized requirements of peptides drive extensive research, particularly in
the realm of drug delivery systems. Numerous life sciences companies are
adopting innovative strategies for peptide-based drug development to formulate
stable, bioavailable, and manufacturing-friendly compositions. Notable
advancements in administration systems, such as nasal, parenteral,
controlled-release, transdermal, pulsatile, and oral delivery, are being made
to enhance the effectiveness of peptide administration. Peptides often exhibit
minimal toxicity, high specificity, and fewer toxicological challenges compared
to other small molecule drugs, thereby facilitating the development of
therapeutics that would otherwise be commercially challenging.
Regional Insights
North America, specifically the Peptide Synthesis
Market, dominated the market in 2022. North America has demonstrated the
highest contribution to the global market, primarily due to the strong presence
of major market players. This is further supported by increased awareness of
available peptide synthesis technologies and a growing emphasis on
commercial-scale production of peptide drugs.
On the other hand, the Asia Pacific region is
projected to witness the fastest growth during the forecast period. This can be
attributed to the rising investments by market players in the region,
increasing awareness of novel peptide treatments, higher healthcare spending by
governments and patients, collaborations between multinational companies and
local players for distribution, and the escalating incidence of chronic
diseases in low- and middle-income countries.
Recent Developments
- In May 2023,
PolyPeptide, a global Contract Development and Manufacturing Organization
(CDMO) specializing in peptide- and oligonucleotide-based Active
Pharmaceutical Ingredients (APIs), and Numaferm, a biotech company based
in Germany with expertise in process development and production of
peptides and proteins, have entered into a Preferred Partner Collaboration
Agreement for peptide development and production. This collaboration
leverages PolyPeptide's cGMP manufacturing capabilities, regulatory
knowledge, and market access, along with Numaferm's biochemical production
platform and expertise in sustainable peptide manufacturing.
- In June 2023, IRBM, an
innovative contract research organization, announced the signing of a new
agreement with Merck & Co. Inc., Rahway NJ USA, known as MSD outside
the USA and Canada, to further their collaboration in the field of peptide
therapeutics.
- In June 2022, Evonik
introduced a novel peptide aimed at enhancing the productivity of
cell-culture-based biopharmaceuticals. cQrex AC represents a chemically
defined and highly soluble source of L-cystine, facilitating an adequate
supply of this pivotal amino acid to cells.
- In May 2022, the
United States Food and Drug Administration granted approval for Mounjaro
(tirzepatide) injection to enhance blood sugar control in adults with type
2 diabetes, as an adjunct to diet and exercise. Mounjaro belongs to a
class of medications known as dual glucose-dependent insulinotropic
polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists.
Key Market Players
·
PolyPeptide Group
·
Merck KGaA
·
Thermo Fisher Scientific
·
Enamine Ltd.
·
Alfa Chemistry
·
CEM Corporation
·
GenScript
·
AAPPTec
·
Bachem Holding
·
AnaSpec, Inc.
By Product
|
By Technology
|
By Application
|
By End User
|
By Region
|
• Equipment
• Reagents and Consumables
• Others
|
• Solid-Phase Peptide Synthesis (SPPS)
• Solution-Phase Synthesis (SPS)
• Liquid-Phase Peptide Synthesis (LPPS)
|
•
Therapeutics
•
Diagnosis
•
Research
|
•
Pharmaceutical and Biotechnology Companies
•
Contract Manufacturing Organization (CMO)
•
Academic and Research Institutes
|
•
North America
•
Europe
•
Asia Pacific
•
South America
•
Middle East & Africa
|
Report Scope:
In this report, the Global Peptide Synthesis Market
has been segmented into the following categories, in addition to the industry
trends which have also been detailed below:
- Peptide Synthesis Market, By Product:
o Equipment
o Reagents and Consumables
o Others
- Peptide Synthesis Market, By Technology:
o Solid-Phase Peptide Synthesis (SPPS)
o Solution-Phase Synthesis (SPS)
o Liquid-Phase Peptide Synthesis (LPPS)
- Peptide Synthesis Market, By Application:
o Therapeutics
o Diagnosis
o Research
- Peptide Synthesis Market, By End User:
o Pharmaceutical and
Biotechnology Companies
o Contract Manufacturing
Organization (CMO)
o Academic and Research
Institutes
- Peptide Synthesis Market, By
Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ France
§ United Kingdom
§ Italy
§ Germany
§ Spain
o Asia-Pacific
§ China
§ India
§ Japan
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
§ Kuwait
§ Turkey
§ Egypt
Competitive Landscape
Company Profiles: Detailed analysis of the major companies
present in the Global Peptide Synthesis Market.
Available Customizations:
Global Peptide Synthesis market report with
the given market data, Tech Sci Research offers customizations according to a
company's specific needs. The following customization options are available for
the report:
Company Information
- Detailed analysis and
profiling of additional market players (up to five).
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