The global biopharmaceutical excipients market was valued at USD 2.13 billion in 2022. It is estimated to reach USD 3.75 million by 2031, growing at a CAGR of 7.76% during the forecast period (2023–2031).
Traditionally, biopharmaceutical excipients used in the pharmaceutical industry are inert components crucial to guarantee a drug's high quality, safety, and efficacy. These are substances other than the active drug included during manufacturing or in the finished pharmaceutical dosage form. Despite being regarded as therapeutically inert, they are essential to transport the active drug to a location in the body where the drug is intended to show its action.
A wide range of biopharma excipients is often added to formulations and dosage forms to stabilize proteins and optimize other desirable properties. Aside from considerations of the excipients' safety, toxicity, and immunogenicity, the choice of excipients in pharma is needed to be guided by the knowledge of degradation pathways of active pharmaceutical ingredients and mechanisms by which different excipients ameliorate those instabilities.
The need for diverse biological treatments is rising as the burden of cancer increases. Biopharma companies, both big and small, are still looking for the molecular causes of cancer and making drugs to stop cancer cells from growing. Thus, the biopharma industry is leading in shaping many aspects of the oncology marketplace. In addition, developed and emerging countries face a high burden of infectious diseases. Especially in low- and middle-income nations, contagious diseases, including HIV/AIDS, TB, malaria, and many others, cause a high mortality rate.
Infectious diseases are prevalent in developing territories due to the lack of awareness of personal hygiene, low healthcare expenditures, and lack of efficient physician services. The rising incidence of infectious diseases across emerging nations facilitates excellent opportunities for biopharmaceuticals. Drugs have a crucial role in the management of various conditions. Excipients used in manufacturing these biopharma drugs are crucial, and their demand is increasing due to the need for these drugs.
The biologics industry is increasing, and 40% of estimated biopharmaceuticals are investing in biologics development. The fastest-growing category of therapeutic items is biological products, particularly in the US. Furthermore, there is a growing need for head-to-head studies that compare the safety and effectiveness of different biologics treatment plans. Thus, the development and introduction of new biological drug substances are rising. For instance, the US Food and Drug Administration has approved more than 475 new prescription medications since 2000, including NMEs and new biologic license applications (FDA). These have contributed to new treatment options, resulting in improved length and quality of life, thereby driving market growth.
One of the main concerns of regulators is the quality and safety of pharmaceutical medicinal goods. By passing stricter restrictions in recent years, regulatory organizations have tightened their stance on preventing the adulteration of pharmaceuticals in excipients and APIs. However, the current regulatory landscape needs an independent excipient approval pathway, which can limit the entry of newer excipients into the market and new drug products. In addition, excipient manufacturers and product developers are hesitant to invest substantial resources and time in developing a new excipient, as it is uncertain that the product will be accepted in the regulatory review, hampering the market growth.
Novel excipients are a vital part of making sure that new, better, and safe drugs for the biopharmaceutical market are made. Most approved products only contain conventional, well-studied compendial excipients; hence, using novel excipients is unavoidable for formulating some advanced products. In addition, more companies prefer to bring sophisticated and innovative formulations that involve novel excipients. The FDA has defined a novel excipient as one that has not been used in an FDA-approved drug product. Thus, it does not have an established use in food.
Additionally, in order to modernize drug formulation and biopharmaceutical development processes, the FDA launches a testing program to check the safety and suitability of novel inactive ingredients in new drugs and biologics applications. The aim is to encourage sponsors of clinical trials to formulate innovative therapies with those new excipients that the FDA finds acceptable for use under this program. An independent approval program will encourage biopharmaceutical companies to evaluate novel excipients and give excipient suppliers a path to market, which does not involve waiting for 15–20 years. This is expected to create tremendous opportunities for market growth over the forecast period.
The global biopharmaceutical excipients market is segmented by excipient, biologics, scale of operation, and end-user.
By excipient, the global biopharmaceutical excipients market is divided into bulking agents, solubilizers and surfactants, buffering and tonicity agents, and others.
The bulking agent segment is responsible for the largest market share and is anticipated to grow at a CAGR of 7.90% over the forecast period. Bulking agents help carry the drug by providing a matrix, typically in low quantities. These include sugars, polyols, amino acids, polymers, and proteins. Generally, lactose, sucrose, mannitol, trehalose, dextran, and glycine are commonly used as bulking agents in biopharmaceuticals. Aqueous solution-based biologics can pose stability issues because of the hydrolytic degradation of active molecules. Lyophilization is a technique that is used to stabilize pharmaceutical products by removing water from aqueous drug solutions. In addition, bulking agents are added to lyophilized products to prevent product blowouts, especially in low-concentration products. Amino acids, such as arginine, aspartic acid, lysine, glycine, histidine, proline, methionine, glutamic acid, and others, are used as bulking agents for various biopharmaceuticals.
Solubilizer agents, such as surfactants, are solubilizer excipients added to biopharmaceutical formulations to increase the solubility of poorly soluble drugs, thereby increasing the bioavailability of the corresponding API. Surfactants play various roles in modulating the bioavailability and solubility of APIs, surging the stability of active ingredients in dosage forms; maintaining pH and osmolality of liquid formulations; helping active ingredients to maintain preferred polymorphic forms; preventing aggregation or dissociation; acting as emulsifying agents and antioxidants, and managing immunogenic responses of active ingredients.
By biologics, the global biopharmaceutical excipients market is segmented into monoclonal antibodies, vaccines, and others.
The monoclonal antibodies segment owns the highest market share and is expected to grow at a CAGR of 9.44% over the forecast period. Six categories of excipients are used for monoclonal antibodies: buffers, salts, surfactants, polyol/ disaccharide/ polysaccharides, amino acids, and antioxidants. Six commonly used buffers keep pH between 4.7 and 7.4: acetate, citrate, histidine, succinate, phosphate, and hydroxymethyl aminomethane (Tris). Most formulations (80%) use one of three surfactants—polysorbate 80, polysorbate 20, and poloxamer 188. In addition, all freeze-dried (lyophilized) formulations use one or a mix of polyol/disaccharide/polysaccharide (such as mannitol, sorbitol, sucrose, trehalose, and dextran 40). Two amino acids (glycine and arginine) are used in about 20% of MAb formulations. Antioxidants include ascorbic acid, methionine, and ethylenediaminetetraacetic acid (EDTA), a chelating agent presumably intended to prevent heavy metal-induced oxidation.
Vaccines are inherently less stable than small molecules, and their formulation development is often challenging with stringent product development timelines. Their complex molecular structure, lack of well-defined stability-indicating assays, and a multitude of degradation mechanisms create significant hurdles for the formulation development of vaccines. Some excipients are added to a vaccine formulation for a specific purpose. Typical excipients include salts, weak acids and bases, sucrose, and crucial lipid excipients.
By the scale of operation, the global biopharmaceutical excipients market is segmented into commercial and research.
The commercial segment is the highest contributor to the market and is anticipated to grow at a CAGR of 7.96% over the forecast period. With growing infectious diseases and the onset of epidemics and pandemics, there is a massive demand for manufacturing a billion doses of biologics within months. The need for producing biologics in large quantities is rising as their use becomes more widespread. Biopharmaceutical manufacturing large-scale drug substances and products is a highly challenging task. With a high patient population in the commercial phase, the rapid development of large-scale production is a critical step that requires enormous volumes of ingredients.
Any biologic should go through preclinical testing before going on sale. Preclinical studies are essential for establishing a candidate's physical, chemical, and biological characteristics to detect possible risks and help in planning protocols for subsequent clinical studies in human subjects for the evaluation of the safety and efficacy of the candidate drug. Major biopharmaceutical drugs, such as vaccines, monoclonal antibodies, and cell and gene therapies, are increasingly demanding as researchers develop the latest treatments. Several vaccines are in the pipeline for wide-ranging infectious diseases, and the advent of COVID-19 has further drastically increased their demand. In the short span and urgency of vaccines, there has also been a tremendous demand for excipients.
By end-user, the global biopharmaceutical excipients market is divided into pharma and biotech companies, CMOs and CDMOs, and academic and research institutes.
The pharma and biotech company segment is the highest contributor to the market and is estimated to grow at a CAGR of 7.59% over the forecast period. Pharmaceutical and biotech companies manufacture many biological drugs, such as vaccines, monoclonal antibodies, cell and gene therapies, growth factors, interferons, recombinant hormones, and others. These companies are experienced and produce quality drugs efficiently and cost-effectively. Therefore, large volumes of medicines are manufactured by these companies, and the consumption of excipients is high.
Academic and research institutes perform research and development of novel biopharmaceuticals, especially cell and gene therapies, which are in high demand. As a result, there is a minimal need for excipients for formulating the drug product. Gene therapy companies often rely on academic researchers to procure innovation. All the first approved CAR-T and in vivo gene therapy products were first tested on humans by educational institutions. Additionally, the industry collaborates with academic and research centers in various fields. Overall, the participation is sound and complements the NIH-sponsored research. For example, industrial partners are creating GMP-grade vectors for many clinical trials in academic and research centers.
By region, the global biopharmaceutical excipients market is divided into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant shareholder in the global biopharmaceutical excipients market and is anticipated to grow at a CAGR of 7.15% during the forecast period. The demand for biopharmaceutical excipients is increasing across the region with a rise in the prevalence of infectious diseases. This growing population base requires enormous volumes of drug development, increasing adoption of biologics, emerging novel and multifunctional excipients, rising awareness of vaccines in developing countries, and the vast presence of biopharmaceutical excipient manufacturers.
In addition, the demand for biopharmaceutical drugs, such as vaccines, monoclonal antibodies, biologics, and others, has been growing in the North American region due to the prevalence of infectious diseases. Infectious diseases such as tuberculosis, haemophilus influenzae type b, Hepatitis B, meningococcal meningitis, tetanus, diphtheria, measles, yellow fever, and whooping cough accounted for the most common infectious diseases in North America. Furthermore, the increased use of parenteral products and heavy investments in biologics development will likely increase the demand for excipients, such as polyols, proteins, amino acids, surfactants, buffering agents, and others.
Europe is estimated to grow at a CAGR of 7.49% over the forecast period. The increasing elderly population, the prevalence of bacterial and viral infections, increasing demand for biologics, the growing activity of multifunctional excipients, and expanding biopharma and biotech industry are significant factors contributing to the growth of biopharmaceutical excipients in Europe. There is a high expansion of biotech and pharma companies into Europe. It is likely to emerge as a leading biotech sector, after the US, due to its overall sizeable commercial potential, robust hotspots of research and industry expertise to support innovation, focus on advanced therapy medicinal products, and Europeans being more open to innovative drugs compared to the US patients. Over half of the emerging biotech expanding on their own launched an orphan drug into European markets. In addition, Europe is an important market for biotech companies launching new drugs, as it accounts for over 20% of the global pharma market.
Asia-Pacific is the fastest-growing region for biopharmaceutical excipients. Emerging countries, such as China, are significant players due to low labor costs and increased outsourcing of inorganic and organic chemical manufacturing. This is majorly due to the involvement of contract manufacturers in the development of vaccines, which are growing at a constant pace. Asia-Pacific is estimated to rise as the fastest-growing region for developing and manufacturing vaccines. China, Japan, South Korea, India, and Australia are major revenue contributors in this region.
Latin America and the Middle East and Africa accounted for small shares in the global biopharmaceutical excipients market. These regions are expected to witness slow growth in coming years in the emergence of biopharmaceutical companies, the rising demand for novel excipients, the growing demand for biological drugs, and others.
The key players in the global biopharmaceutical excipients market are
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