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Biopharmaceutical Excipients Market Size, Trends and Growth Outlook By Product {Solubilizers & Surfactants/Emulsifiers (Triglycerides, Esters), Polyols (Mannitol, Sorbitol), Carbohydrates (Sucrose, Dextrose, Starch), Specialty Excipients}, Formulation (Oral, Topical, Injectables) and Region (North America, Europe, Asia-Pacific, Rest of the World)‚ÄĒForecast to 2032


ID: MRFR/HC/9128-HCR | 120 Pages | Author: Kinjoll Dey| May 2024

Biopharmaceutical Excipients Market Overview:


The Biopharmaceutical Excipients market is anticipated to reach USD 2.4 Billion by 2032 at a CAGR 5.6% during the forecast period 2023-2032.


A biopharmaceutical excipient is an inert drug delivery substance methodologically prepared with the medically active ingredient that further processes the drug delivery in the recipient's system. Excipients are stable and reproducible, pharmacologically inert, and cost-effective. They are composed of corn, wheat, sugar, minerals, and othersuch substances. Biopharmaceutical excipients are available in different types of formulations such as capsules, topical creams, tablets, gels, injectables, and transdermal patches. In addition, these types of excipients provide accurate dosing of potent ingredients, offer mechanical strength to the ingredients, increase the surface area for the active ingredient, protect the medication from the environmental reaction, and mask the texture, smell, and taste of the drug.


Biopharmaceutical excipients are experiencing high demand due to increasing production of drugs during the pandemic outbreak, supporting government policies, and introduction of partial subsidy schemes minimizing production costs. The outbreak of the coronavirus across the globe created huge demands for specialized medicines that further drive excipient sales. The market players offer specific excipients for biopharmaceuticals that are composed of sucrose, sodium chloride, magnesium chloride hexahydrate, and disodium edetate dehydrate. Moreover, the increasing number of patients getting diagnosed with chronic disease is creating possibilities for the biopharmaceutical excipients manufacturers. The market growth is driven by the above-mentioned factors and is expected to accelerate during the forecast period.


COVID-19 Analysis


COVID-19 has impacted various industry verticals across the globe. The pandemic spread led to the closure of manufacturing units, transportation of raw materials, and distribution channels throughout the globe. During the initial days of lockdown, the production of drugs and health-related products ceased to avoid the spread of disease. The government authorities mandate the guidelines to restrict the ongoing R&D activities and biopharmaceutical manufacturing. However, the demand for generic and specialty medicines rose due to the increasing number of corona cases and existing patients diagnosed with chronic diseases. The pharmaceutical production was carried out with special guidelines, and the research laboratories were functional with a limited workforce.


The increasing number of COVID cases impulsed government authorities to manufacture drugs in a large volume to treat the affected patients. However, the manufacturing units were working with a low workforce as the employees and daily wagers traveled back to their hometown, limiting the production capacity of the organizations. The government authorities promised to provide meals, insurance and, higher wages for immediate deployment of the workforce in pharmaceutical manufacturing units. This created an opportunity for the biopharmaceutical excipient manufacturers and augmented the product sales during the pandemic outbreak.


Market Dynamics


Drivers


Increasing demand for sucrose-based excipients for medicine formulation



  • Sucrose is made up of glucose and fructose extracted from sugar cane and sugarbeets. It has a non-reducing crystalline disaccharide property that stabilizes the protein, lipids, and carbohydrates throughout the formulation stage of therapeutics. Hence it is highly acclaimed in the biopharmaceutical industry. In addition, sucrose-based excipients are used in the biopharmaceutical industry for preserving stem cells, stabilizing antibody-drug conjugate, monoclonal antibody, peptide, and vaccine. The non-toxic property of the sugar and high availability are driving the demand for sucrose-based excipients. Biopharmaceutical manufacturers use sucrose in the form of chewable tablets, lozenges, and tablets for medicine formulation.

  • Companies such as DFE Pharma (Germany) offer BioHale Sucrose, low endotoxin sucrose that is used in formulating medicines. High demand for sucrose-based excipients is observed in the recent timelines owing to its distinctive physical and chemical properties, specifically in aqueous solutions. Additionally, sugar is highly recommended in stabilizing protein medicines as it forms a glassy sugar coating around the protein that hinders its molecular mobility. Sucrose-based excipients are used in various dosage forms, such as parenteral or oral solid.


Growing demand for lipid excipient for the production of COVID vaccines



  • In 2020, a large amount of the population was severely affected form the coronavirus that led to the high investment in R&D activities for the innovation of new vaccines, the establishment of new regulatory guidelines, and the development of new manufacturing capabilities. Biopharmaceutical manufacturers increased their research in the development of lipid nanoparticles for RNA vaccines. Companies such as Pfizer/BioNTech and Moderna developed large and fragile mRNA strands that use lipid-based excipients to stabilize the vaccine for COVID-19. They announced to manufacture 2 billion doses of vaccine and will be supported by the lipid excipients for its formulation. According to Pfizer/BioNTech, 2 metric tons of lipid excipients will be required for the formulation of 2 billion vaccines. Furthermore, the excipient manufacturers are expanding their manufacturing capabilities to fulfill the market demand. Such factors are augmenting the biopharmaceutical excipient market and are estimated to accelerate in the accessed time period.


Rising demand for stable and economical excipient for generic medicines


Market Restraints


Concerns pertaining to the adverse effects of biopharmaceutical excipients



  • The consumption of biopharmaceutical excipients may affect individuals differently. Dose per individual varies and may be toxic and hypersensitive after high consumption of the excipients-based biopharmaceuticals. High doses of medicines adversely affect infants and neonates. Moreover, incompatibilities between excipients and drugs can increase the rate of chemical degradation, forming more complex molecules making them toxic or allergic for administration. Furthermore, few individuals are allergic to the coloring agents, lactose, and other components used in the manufacturing of excipients. For instance, some people are allergic to tartrazine,which is a type of artificial coloring agent commonly used as a food dye. These common types of adverse effects and allergies might hamper the biopharmaceutical excipients market.


Technology Analysis


Nanotechnology is significantly being used in the development of advanced excipients. The use of nanotechnology will alter the size of the excipients from capsules and tablets to solidified micelles. The emergence of such technology aims to improve the drug delivery of medicines. Additionally, nanotech can be used to improve the hindered release of formulations. According to a study in the Journal of Pharmaceutical Sciences, the porous magnesium carbonate excipient can control the release of active pharmaceutical ingredients. Moreover, the introduction of 3D printing aims at augmenting the production of new generation excipient. It is used for the fabrication of the immediate release pharmaceutical tablets. The emergence of such technologies is propelling the biopharmaceutical excipients market.


Segment Overview


By Product



  • Solubilizers & Surfactants/Emulsifiers:Solubilizers are the substances that solubilize water-insoluble drugs, complexion, microemulsions, liposomes, emulsions, and micelles. Solubilizers are administered either orally or injected through veins and muscular or other passages. Solubilizers/emulsifiers are further categorized into triglycerides, esters, and others.

  • Polyols:This type of product is obtained through a biotechnological process with a highly effective and extremely reactive property. It has a limited quantity of reducing sugars hence is less reactive to amino groups and reducing sugars. Polyols are categorized into mannitol, sorbitol, and others.

  • Carbohydrates:It is an excipient made from carbohydrates such as sugar, starch, and fiber. These types of excipients are used as a sweetening agent, tablet and capsule diluent, tonicity agent, and vehicle for lyophilized preparation. Carbohydrate excipients are categorized into sucrose, dextrose, starch, and others.

  • Specialty Excipients:This type of excipient acts as binders, fillers, lubricants, and disintegrants.


By Formulation



  • Oral: It is a type of formulation that is administered orally and is engrossed through the intestine, stomach, or gastrointestinal tract. The oral formulations are taken in the form of tablets and capsules.

  • Topical:This type of formulation is produced using a base used for a particular site of the body or any kind of skin disorder. The product is designed to moisturize and amplify the diffusion of active ingredients.

  • Injectables:It is a kind of formulation that is stored in liquid and lyophilized forms. These types of formulations are administered through an intramuscular, intravenous, subcutaneous, and intra-articular stream.


Regional Analysis


North America


Increasing demand for medicines across the region is driving the North America biopharmaceutical excipients market


North America held the largest share of the global biopharmaceutical excipient market in 2020 due to the increasing manufacturing of generic and specialty drugs, growing investments in R&D activities, and the establishment of technically advanced research centers. The prominent players are involved in the diversification of their distribution channel and expansion of their manufacturing facilities across the region, engaging in mergers and acquisitions, and introduction of new product variants for business growth.


Asia Pacific


Supportive government policiesarepropelling the Asia-Pacific biopharmaceutical excipient market


The Asia-Pacific biopharmaceutical excipients market is projected to be the fastest-growing regional market due to the up-gradation of pharmaceutical manufacturing units, an increasing number of biopharmaceutical investors, supportive government policies for the production of medicines, and deployment of nanotech labs for innovation of advanced excipients. Moreover, other factors supporting the biopharmaceutical excipient market include substantial investments by industry players and the innovation of machines to produce a high volume of excipients in a limited time. Such factors are expected to propel the market growth during the forecast period.


Competitive Landscape


Colorcon (US) is one of the leading players in the biopharmaceutical excipients market, offering products such as starch 1500, startab, starcap, and ambaerlite, and duolite ion exchange resin. These excipients can stabilize moisture-sensitive drugs, offer low dose content uniformity, and are compliant with regulatory standards. In addition, products such as startab are compressible starch excipients that provide excellent flow and compressibility. The product is manufactured at GMP facilities and is compliant with government guidelines. Moreover, satrcap a maize starch excipient, offers high flow and low adhesion functionality. Starcap provides lasting stability to reactive drugs. Furthermore, the company introduced ion-exchange resin-based excipients that are applied for taste masking, solubility enhancing, drug stabilizing, and abuse deterrence.


Industry players are coming up with various commercial strategies to augment their market footprint. The organizations are capitalizing on innovations and product launches to expand their product portfolio, further driving the biopharmaceutical excipients market. In addition, the market players are offering contractual agreements, approvals from government authorities, collaborations, funding, product promotions, and partnering with other players to expand their global footprint.


List of Key Companies Covered in this Report:



  • Merck KGaA (Germany)

  • Colorcon (BPSI Holdings Inc)(.S)

  • BASF SE(Germany)

  • Associated British Foods plc (UK)

  • Signet Excipients Pvt. Ltd (IMCD) (Netherlands)

  • Sigachi Industries Limited (India)

  • Spectrum Chemical Manufacturing Corp. (US)

  • Roquette Fr√®res (France)

  • Clariant (Switzerland)

  • DFE Pharma (Germany)

  • Rettenmaier & S√∂hneGmbh + Co Kg (Germany)

  • Evonik Industries AG (Germany)


Recent Developments

  • In May 2019,Colorcon, Inc. (US) launched a starch-based tableting excipient for direct compression. The product is developed using particle engineering and is approved by regulatory authorities across the globe.

  • In March 2020, Signet Chemical Corporation Pvt. Ltd(India) changed its name to Signet Excipients Pvt. Ltd.Furthermore, in November 2020, the company was acquired by IMCD N.V.(Netherlands),a leading global distributor of specialty chemicals and ingredients.

  • In September 2020,Sigachi Industries (India), a cellulose-based excipient manufacturer, filed an IPO worth USD 600 million.

  • In March 2020, Roquette (France) launched an online technical platform,"Innovation Hub,"for researchers and developersto formulate ideas and information exchange.

  • In April 2021,DFE Pharma (Germany) launched an excipient solution for biopharma,BioHale Sucrose,that offers exceptional purity stabilization for biologics.


Report Overview


The study covers the existing short-term and long-term market effect, as well as helping decision-makers to draught short-term and long-term plans for businesses by region. The report covers major regions in North America, Europe, Asia-Pacific, and the Rest of the World. The report analyzes market drivers, restraints, opportunities, challenges, Porter's Five Forces, Value Chain, and impact of COVID on the market.


Scope of the Report & Segmentation


By Product



  • Solubilizers & Surfactants/Emulsifiers

    • Triglycerides

    • Esters

    • Others



  • Polyols

    • Mannitol

    • Sorbitol

    • Others



  • Carbohydrates

    • Sucrose

    • Dextrose

    • Starch

    • Others



  • Specialty Excipients


By Formulation



  • Oral

  • Topical

  • Injectables

Report Attribute/Metric Details
  Market Size  USD 2.4 Billion
  CAGR 5.6%
  Base Year   2020
  Forecast Period   2023-2032
  Historical Data   2018-2019
  Forecast Units   Value (USD Million)
  Report Coverage   Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
  Segments Covered   Treatment Procedure, Cellulite Type and End Use
  Geographies Covered   North America, Europe, Asia-Pacific, and Rest of the World (RoW)
  Key Vendors   Merck KGaA (Germany), Colorcon (BPSI Holdings Inc.) (U.S.), BASF SE(Germany), Associated British Foods plc (UK), Signet Excipients Pvt. Ltd (IMCD) (Netherlands), Sigachi Industries Limited (Hyderabad), Spectrum Chemical Manufacturing Corp. (U.S.), Roquette Frères (Roquette Frères) Clariant (Switzerland), DFE Pharma (Germany) J. Rettenmaier&SöhneGmbh + Co Kg (Germany) Evonik Industries AG (Germany)
  Key Market Opportunities   The emrgence of 3D pinters for customized drug manufacturing
  Key Market Drivers   Increasing demand of sucrose based excipients for medicine formulation
 

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