Biopharmaceutical Excipient Manufacturing Market– Forecast (2023-2035)”
Biopharmaceutical Excipient Overview
The Biopharmaceutical Excipient Manufacturing Market size is
forecast to reach USD 5,888.0 Million by 2035, after growing at a CAGR of 4.9% during
2023-2035. The major driving forces of this market are increasing incidences of
chronic diseases owing to sedentary lifestyles; substantial investments by
pharmaceutical companies in the development of medicines; and the
implementation of new techniques such as nanotechnology. For instance, according to the World Health Organization, by around
2050, chronic diseases such as cardiovascular diseases, cancer, diabetes, and
respiratory illnesses will account for 86% of the 90 million deaths each year:
a staggering 90% increase in absolute numbers, since 2019. However, the major
challenges currently faced by the biopharmaceutical industry are the side
effects of drugs; and developing environmental-friendly manufacturing
processes.
Report Coverage
The report “Biopharmaceutical Excipient Manufacturing Market–
Forecast (2023-2035)”, by IndustryARC, covers an in-depth analysis of the
following segments of the Biopharmaceutical Excipient Manufacturing market.
Distribution by Type of Excipient
based on Chemical Composition: Carbohydrates, Polyols, Polymers,
Proteins / amino acids, Salts, Lipids, Others,
Distribution
by Type of Excipient based on Function: Surfactants,
Stabilizers, Tonicity modifiers, Bulking agents, Buffering agents, Solubility
enhancers, Drug delivery system, Chelators, Antimicrobials, Antioxidants, and Others;
Distribution
by Type of Excipient based on Chemical Structure:
Organic, Inorganic;
Distribution
by Scale of Operation: Preclinical, Clinical, Commercial;
Distribution
by Type of Biologic: Vaccines, Proteins / peptides, Cell
therapies, Antibodies, Blood products;
Distribution
by Company Size: Small, Mid-sized, Large, Very Large;
By Geography:
North America, Europe, Asia-Pacific, Latin America, MENA, Rest of the
World.
Key Takeaways
·
Europe is the world's largest
market for biopharmaceutical excipients, with a leading market share of 33% in
2022. The European biopharmaceutical Excipients market is projected to grow
with a CAGR of 4.1% from 2023 to 2035 with a market size of $1.03 billion in
2022 and $1.76 billion in 2035 owing to significant industrial growth in the
region.
·
Pharmaceutical companies are
slightly optimistic about economic conditions in North America and the
Asia-Pacific due to positive momentum in the US, firm domestic demand, and
strong government expenditure in India. Asia-Pacific is projected to grow with the
fastest CAGR of 6.4% with a market size of $0.75 billion in 2022 and $1.71
billion in 2035.
·
Based on functions, Antimicrobials
held
the major market share of 24% in 2022. Excipients play a critical role in
biologics development by enhancing the solubility and bioavailability,
controlling the pH and tonicity of the APIs. Additionally, biopharmaceutical
excipients act as bulking agents, antioxidants, or preservatives.
Distribution by Type of
Excipient based on Chemical Composition - Segment Analysis
Proteins/Amino
Acids dominated the Biopharmaceutical Excipient Manufacturing Market in 2022. This
is due to rising consumer spending capacity and greater individual awareness of
preventative care and healthy lifestyles. They are used in health supplements
to relieve muscle soreness and fatigue, as well as to minimize the risk of
cardiovascular disease. Because of the popularity of veganism and
vegetarianism, there is a growing demand for plant-based protein sources.
Because plant-based proteins usually lack one or more key amino acids, amino
acid supplements are used to ensure that people on plant-based diets get enough
nutrients. They are also found in nutritional supplements, which are growing
more popular as individuals strive to improve their health and well-being. Amino
acid supplements are marketed for their possible benefits in terms of muscle
building, athletic performance, and overall health.
Distribution by Type of
Excipient based on Function - Segment Analysis
Antimicrobials dominated
the Biopharmaceutical Excipient Manufacturing Market in 2022. The
antimicrobials industry is expected to increase quickly in recent years. The
shift in growth trajectory is mostly due to firms resuming production after the
COVID-19 epidemic, when demand increased considerably. With the exponential
spread of coronavirus, the global antimicrobials market is predicted to grow
significantly. Furthermore, the growing frequency of numerous bacterial
infections would need the introduction of antimicrobials into the market.
Antimicrobials are one of the most powerful types of chemotherapy and have been
used to protect humans from infectious diseases. Antimicrobial agents destroy
or delay microorganisms. Microorganisms include bacteria, viruses, protozoans,
and fungi such as mold and mildew.
Distribution by Type of
Excipient based on Chemical Structure – Segment Analysis
Organic dominated the Biopharmaceutical Excipient Manufacturing Market in
2022. Growing pharmaceutical drug demand is predicted to drive the organic
biopharmaceutical excipients market forward. Pharmaceutical drugs are chemical
substances or compounds that are used to prevent, diagnose, treat, or relieve
various diseases, medical conditions, or symptoms in humans. The increased need
for pharmaceutical medications has increased the demand for organic
pharmaceutical excipients, which provide acceptable and compatible constituents
for organic drug formulations and aid in the physiological absorption of the
drug. According to the European Federation of Pharmaceutical Industries and
Associations, a Europe-based pharmaceutical industry association, global
pharmaceuticals production increased by 4.6 percent in June 2022, from €286,697
million ($308,881 million) in 2020 to €300,000 ($323,214) in 2021.
Distribution by Scale of
Operation - Segment Analysis
Clinical dominated the Biopharmaceutical Excipient Manufacturing Market in
2022. The biopharmaceutical excipient market in clinical operation is driven by
the increasing demand for biopharmaceutical drugs, especially in the treatment
of chronic diseases such as cancer, diabetes, and autoimmune disorders.
Biopharmaceutical drugs have unique formulation requirements, and excipients
play a crucial role in meeting these requirements. The U.S. Food and Drug
Administration (FDA) approved BASF Solutions' Soluplus® branded excipient in
2022 as part of its initiative to assess the acceptance and security of
excipients for use in clinical trials without regard to a particular New Drug
Application. Excipients, or inactive substances, like the trademarked Soluplus®
excipient, are essential for facilitating the drug development process for
active pharmaceutical compounds that are poorly soluble. In addition, the
continuous advancements in biotechnology and drug delivery technologies have
led to the development of novel excipients that can enhance the drug's
bioavailability, stability, and therapeutic efficacy. This drives the demand
for innovative excipients in clinical operations.
Distribution by Type of
Biologic -
Segment Analysis
Vaccines dominated
the Biopharmaceutical Excipient Manufacturing Market in 2022. The
biopharmaceutical excipient market in vaccines is driven by the increasing
demand for vaccines for preventive healthcare and disease control. In the
creation of novel medications, biopharmaceuticals, and vaccinations to combat
the coronavirus and other illnesses, excipients are essential. According to
Excipient World, in 2020, a U.S.-based biotechnology firm has introduced
Remdesivir an antiviral drug which emphasizes the crucial excipient that
purified water had in the COVID-19 vaccine's development. With a population of
over 330 million, the United States alone requires the production of at least
660 million doses of the COVID-19 vaccine. Millions of gallons of pharmaceutical-grade
water are currently produced every day, most of which is used directly for
vaccine development and testing. The rise in the production of vaccines is
anticipated to drive the market growth.
Distribution by Company Size -
Segment Analysis
Large dominated
the Biopharmaceutical Excipient Manufacturing Market in 2022. When it comes to
large company size, several factors play a role in the biopharmaceutical
excipient market. Large pharmaceutical companies typically have a greater
demand for excipients due to their extensive drug portfolios and production
scale. Mid-sized companies in biopharmaceutical excipient manufacturers include
Kerry Group, Avantor, Lubrizol Corp, BASF, Roquette Freres, FMC Corp, Croda
International, Ashland Global Holdings, and ABITEC. These companies often
engage in extensive research and development activities, leading to the
formulation of various biopharmaceutical drugs that require different
excipients.
Geography - Segment Analysis
Europe Biopharmaceutical Excipient Manufacturing Market generated a
revenue of $1.03 Million in 2022 and is projected to reach a revenue of $1.76 Million
by 2035 growing at a CAGR of 4.1% during 2023-2035. By promoting the best use
of excipients in medications, the International Pharmaceutical Excipients
Council (IPEC) Europe produces standards to improve patient safety. Since 1992,
IPEC Europe has brought together manufacturers, distributors, and users of
pharmaceutical excipients. Because of rising healthcare costs and an aging
population, Europe's pharmaceutical industry is booming. This rise fuels the
demand for pharmaceutical excipients, which are used to create new medications
and improve current ones. Excipients in biopharmaceuticals play an important
role in increasing medication stability, solubility, and bioavailability. Drug
formulation processes and excipient functions are constantly improving, which
drives market expansion. In recent years, the
discovery of biological medications has resulted in significant changes in the
pharmaceutical industry environment. Large corporations have shifted their
focus away from small molecule medications and toward the discovery and
production of complex biological chemicals produced by a range of species.
Drivers – Biopharmaceutical Excipient Manufacturing Market
· The growing emphasis of pharmaceutical companies on the generic
market
Key
market participants are concentrating on the development and commercialization
of innovative biopharmaceutical excipients. DFE Pharma, for example, released a
new excipient product line called 'BioHale' in April 2021 to address global supply
difficulties for biopharmaceutical businesses. Furthermore, as demand for
biopharmaceutical excipients grows, manufacturing facilities are expanding
geographically. For example, in May 2022, DFE Pharma launched a new facility in
India to provide pharmaceutical players with fast-track formulation services,
including excipients, to obtain the proper formulations.
·
Multifunctional excipients are becoming more popular
Industry acceptance of multi-functional biopharmaceutical excipients is
also driving market expansion. They are efficient and effective in improving
the biopharmaceutical manufacturing process. Better product quality, increased
production, and lower operational costs are all associated benefits. The
success of COVID-19 vaccines is mostly dependent on their effectiveness, which
has been improved by the use of efficient drug delivery systems; this provides
enormously lucrative potential for market entities. Multifunctional excipients
such as Ludiflash, F-MELT, and Avicel CE-15 have been created specifically for
ODT formulations. They are custom-made to provide binding during compression
(to produce a hard tablet at a low compression pressure) and quick disintegration
when exposed to a medium. They are handled in such a way that they disintegrate
with a creamier mouthfeel, boosting the formulation's overall palatability. In
some situations (such as Ludiflash, which contains around 90% mannitol), the
excipient itself gives a sweet taste to the product, reducing the need for
sweetener in the formulation.
Challenges – Biopharmaceutical Excipient Manufacturing Market
· Manufacturing complexity
Some biopharmaceutical excipients, such as
lipids, have sophisticated and capital-intensive manufacturing procedures. As a
result, demand for pharmaceutical excipients for biologics has increased
significantly. However, the accompanying manufacturing procedures for some
biopharmaceutical excipients, such as lipids, are highly sophisticated,
capital-intensive, and fraught with several problems. Excipient variability,
excipient concentrations, capital-intensive manufacturing procedures, multiple
difficulties, viscosity, analytical characterisation, and isotonic formulations
can all contribute to the complexity of biopharmaceutical excipient
manufacturing.
· Regulatory approval
Because innovative excipients do not have a separate approval process,
they can only be approved for a specific function in a medication dosage
formulation. Pharmaceutical excipient manufacturing standards face many challenges:
There is no special approval mechanism in place for novel excipients, Excipients
do not have regulatory status in the United States, Excipients used in
pharmaceutical preparations are not subject to any strict criteria.
Market Landscape
Technology launches,
acquisitions, and R&D activities are key strategies adopted by players in
the Biopharmaceutical Excipient Manufacturing market. In 2021, the Biopharmaceutical
Excipient Manufacturing Market share has been consolidated by the top ten players
accounting for 38.3% of the share. Major players in the Biopharmaceutical
Excipient Manufacturing Market are Dupont, Evonik, BASF, FMC Crop., Ashland.
Merck, Cargill, and others.
Developments:
Ø
On 2nd
June 2023, Evonik introduced cutting-edge peptides for biopharmaceutical
applications. Evonik cQrex® KC is a peptide that improves cell culture media
performance and is utilized in the production of biological medicines. The
biopharmaceutical industry's media formulators and cell culture process
developers may now optimize cystine supply and boost cell culture productivity
thanks to this novel peptide. The newest product in Evonik's arsenal of cQrex®
cell culture chemicals, cQrex® KC, is intended to boost productivity and
efficiency in cell culture procedures that generate viral vectors, cell
treatments, vaccines, and monoclonal antibodies.
Ø
On 1st
September 2022, the science and technology company Merck introduced Sodium
Chloride Granulated EMPROVE EXPERT Ph Eur, BP, ChP, JP, USP, a multi-compendial
excipient with broad applications in both pharma and biopharma. This expands
the company's granulated product line.
Ø
On April 21, 2021, DFE Pharma,
a German-based provider of biopharmaceutical excipient solutions, announced the
launch of BioHale, a new product line designed to help biopharmaceutical firms
with their global supply issues. The new line will supply manufacturers and
drug developers with high-quality excipient technology and services to promote
therapeutic formulation, as well as market purity and low endotoxin excipients
for use in the formulation.