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.