Oral Macromolecular Formulation Market

Oral Macromolecule Formulation Market Outlook (2023-2033)

The global revenue from the oral macromolecule formulation market stands at US$ 17.2 Mn in 2022, with the global market expected to grow at a CAGR of 5.0% to reach a valuation of approximately US$ 29.5 Mn by the end of 2033.

As assessed by Persistence Market Research, diabetes indication is set to hold a market share of around 45.7% in 2023. Overall, oral macromolecule formulation market sales account for approximately 1.6% revenue share in the global oral proteins & peptides market, which was valued at around US$ 1.1 Bn in 2022.

Sales Analysis of Market from 2016 to 2022 Vs Market Outlook for 2023 to 2033

The global market recorded a historic CAGR of 4.2% in the last 6 years from 2016 to 2022.

Oral delivery has been acknowledged as the most desirable route among them all, primarily because it provides the potential for solid formulations with long shelf lives, continuous distribution, and enhanced immune response.

The countless substantial risks associated with injections, including unsafe needle use, needle-associated anxiety and pain, the requirement of trained healthcare personnel, improper needle disposal, injuries to the bones and nerves, muscle atrophy, and needle stick injuries, can be resolved by oral macromolecule formulation.

The CDC estimates that there are 385,000 sharp injuries among health care workers (HCWs) each year in the US. Blood-borne infections can spread disease as a result of sharp injuries. Because of the pain and discomfort associated with injections, paediatric patients have a significant demand for oral formulations.

The most popular method of medicine administration is oral. Because of its advantages including non-invasiveness, patient compliance, and ease of medication delivery, it has become the most preferred approach.

For elderly persons and physically fragile individuals, self-administration of medications is especially crucial. For taking the necessary medications, using the oral mode of administration eliminates the need for help or a caretaker.

Oral macromolecular formulations are in considerable demand due to their low cost, especially in low-income regions.

Specialists in the research and contract manufacture of oral macromolecule formulations are dedicated to providing patients with novel and practical single-unit dosage forms that simplify their daily lives.

With the prevalence of diabetes increasing globally, there is a growing market for oral macromolecular formulations because diabetic patients occasionally require insulin (peptide hormone) therapy if previous therapies have failed to keep blood glucose levels within the acceptable range.

The intravenous administration of insulin is uncomfortable and challenging. As a result, the oral formulation of biomolecules like insulin will have significant adoption potential in the future among patients.

The global market is thus likely to show high growth over the coming years at a CAGR of 5.0% and reach a global market size of US$ 29.5 Mn by 2033.

How Can the Global Market Grow?

“Introduction of Novel Drug Delivery Systems”

Pharma manufacturers are concentrating on several methods for enhancing biologic oral administration to prevent enzymatic and acidic breakdown.

There are many ways to safeguard biologics, including administering them through enteric-coated systems.

Protease inhibitors can be used in conjunction with protein and peptide medications to shield bio therapeutics from the intestinal environment's photolytic enzymes.

Some biologics, especially peptides, can also have their chemical structures altered in order to increase their stability in GI fluids.

Some biologics may be suitable for oral delivery because of their superior intrinsic physicochemical stability against enzymatic breakdown in the gastrointestinal tract.

Nanotechnology-based drug delivery systems offer the potential to circumvent the drawbacks of the oral mode of administration, among other strategies. There are numerous medical fields where novel drug delivery methods are available.

To increase the solubility profile, dissolution, and subsequently the bioavailability of hydrophobic antihypertensive drugs, a variety of nano-carriers are available for oral drug administration. These include solid lipid nanoparticles, micelles, nanoemulsions, polymeric nanoparticles, dendrimers, liposomes carbon nanotubes, and others.

As a result, nanotechnology provides formulation experts with chances to expand their research and development in order to address the problems that occur with oral macromolecular formulations.

These factors are likely to propel the overall market for oral macromolecule formulation, over the forecast period.

Can the Market Growth Be Affected in Any Way?

“Drawbacks and Poor Absorption of Available Drug Formulations”

The absorption of oral macromolecule formulations is constrained by a number of physiological obstacles.

Due to their large molecular weight and low stability in the gastrointestinal (GI) tract, the majority of macromolecules are poorly absorbed when taken orally. Therefore, increasing the clinical usage of therapeutic macromolecules will greatly benefit from improvements in oral macromolecular drug delivery.

This is primarily due to the challenge of passing through the gut epithelium.

Furthermore, the majority of macromolecules consumed orally are vulnerable to rapid degradation by digestive enzymes. Digestive enzymes can break down most macromolecular drugs. Protein/polypeptide drugs are rendered inactive by peptidases found in intestine and pancreatic secretions, which cleave amide bonds. Gastric pH inactivates (degrades) several drugs, which decreases their absorption.

Orally administered drugs are subjected to an unfavourable environment where changes in the pharmacological absorption process take place. The stomach and small intestine contain a variety of digestive enzymes that can break down drugs, notably those that are peptide and protein-based.

Key market players face a significant challenge in overcoming this drawback. The market is thus set to be restrained by the above-mentioned factors.

Country-wise Insights

Why is the U.S. Market Booming?

“Rising Geriatric Population and Growing Patent Approvals”

The U.S. is set to account for around 49.6% share in the global market in 2023.

In 2050, one in six persons on the earth will be beyond the age of 65, according to the World Population Prospects: the 2019 revision. By 2050, one in four persons in North America may be 65 or older. During the projection period, the market's growth is anticipated to be driven by an increasing geriatric population. Additionally, the market is anticipated to be driven by technological advancements, an increase in patent approvals, and regional research on the application of nanotechnology for drug delivery.

These factors are set to propel the growth of the macromolecule formulation market within the U.S.

Will Germany Be a Lucrative Market for Oral Macromolecule Formulation?

“Rising R&D for Novel Drug Delivery Systems”

Germany is set to hold around 9.9% share of the global market in 2023.

In January 2021, in collaboration with Janssen Research & Development LLC, the German independent research institute BioMed X announced a new study that aims to identify novel transport mechanisms in the human intestinal tract that may be used for oral delivery of various therapeutic modalities.

With the growing advancements in R&D activities for novel drug delivery systems, the growth of the market is set to advance within Germany over the forecast period.

How is China Emerging as a Prominent Country in the Oral Macromolecule Formulation Market?

“Growing National Funding and Increasing Research Activities”

China is set to hold a market share of about 1.5% of the global market in 2023.

As the market for protein and peptide pharmaceuticals has boomed in recent years due to their increased effectiveness and biocompatibility, the National Natural Science Foundation of China has financed various studies on novel oral delivery of protein and peptide drugs.

As the burden of diabetes and several inflammatory disorders is on the rise, several funding and collaboration activities to support the research and development of novel biologics have supported the growth of the market within China.

Moreover, with growing outsourced production capabilities for biopharmaceuticals within the country, the market is expected to gain traction in terms of revenue share, over the forecast period.

Category-wise Insights

Which Indication is Largely in Focus within the Global Market?

“Effective Management of Conventional Therapies for Diabetes by Oral Macromolecule Formulations”

The diabetes segment is set to hold around 45.7% share of the total market in 2023.

Conventional drug delivery methods are always subject to some limitations, including inefficient or incorrect dosages that have no therapeutic impact, drug metabolism that results in lowered potency or altered effects, and a lack of target specific sensitivity. The subject of nano delivery systems is a growing area of research. The FDA has approved a number of nanotherapeutics in the last 20 years for the treatment of diabetes.

Anti-diabetic phytocompounds can be protected from enzymatic and/or chemical degradation in the gastrointestinal tract (GIT) by oral nano delivery systems, but they can also offer other advantages, such as avoiding first-pass metabolism, improving pharmacokinetic and pharmacodynamic profile, quick onset of action, targeted therapy, prolonged release of drugs, reduced dosages and frequency of administration, along with fewer side effects.

Which End User Offers the Market a Profitable Outlook?

“Rising Research and Advancements in Novel Targeted Therapeutics”

Biopharmaceutical companies are set to hold a larger share of about 84.7% in 2023 globally.

There is an increasing trend of biopharmaceutical research on the safe and effective delivery of oral medications. Biopharmaceutical companies are increasingly enhancing their production capabilities to enhance the development of safe and stable oral formulations for drug delivery. Moreover, with the rising concerns regarding the limitations of injectable drugs for targeted delivery, such as the occurrence of sharp injuries, and proliferation of infections, the growth of the biopharmaceutical companies segment is propelled by the rising research and production of novel protein and peptide biomolecules which present greater patient compliance, higher bioavailability, and lower limitation to drug absorption.

These factors will thus propel the biopharmaceutical companies to pose a larger share within the global market, as end users, for the development and production of oral macromolecule formulations.

Competition Landscape

Strategic alliances are formed between top pharmaceutical companies and the providers of oral macromolecule formulation. The expansion of the global market is anticipated to be fuelled by the rising demand for pharmaceutical outsourcing.

Despite the fact that the market is not particularly consolidated, a few players are still concentrating on expanding into developing regions and are engaging in marketing events, partnerships, collaborations, and alliances in order to further increase their market presence.

The top techniques used by major firms to increase their presence in various regions include facility expansions.

Some key instances of development include:

• Catalent Inc. announced in September 2021 that it has agreed into a commercial supply deal with Phathom Pharmaceuticals, which commercialises breakthrough therapies for gastrointestinal diseases, for its lead drug, vonoprazan, a revolutionary, orally active-potassium competitive acid blocker (P-CAB).
• In a phase 2b research involving patients with type 2 diabetes in the early stages, Diabetology Ltd. reported in June 2021 that their oral insulin, (CapsulinTM), had successfully completed 25,000 dosing episodes.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies in the oral macromolecule formulation market, which are available in the full report.

Oral Macromolecule Formulation Market Report Scope

Key Segments Covered in Oral Macromolecule Formulation Industry Research

Indication:

• Inflammatory Bowel Disorder
  • Crohn’s Disease
  • Ulcerative Colitis
• Diabetes
• Others

End User:

• Biopharmaceutical Companies
• Academic and Research Institutes

Region:

• North America
• Latin America
• Europe
• South Asia
• East Asia
• Oceania
• Middle East & Africa

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