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Global Biopharmaceutical Excipients Market - Outlook and Forecast 2022-2027
The global biopharmaceutical excipients market had a value of $2.08 billion in 2021. It is projected to reach $3.2 billion by 2027, growing at a CAGR of 7.56% from 2022 to 2027. Excipients are essential components of biopharmaceutical drug products that serve various purposes such as acting as active ingredients, enhancing stability, emulsifying and suspending agents, binders, preservatives, antioxidants, and lubricants. They differ from prodrugs in manufacturing or are present in the finished dosage form of pharmaceutical products. Excipients have targeted roles, ranging from protecting the active pharmaceutical ingredient (API) to facilitating the manufacturing process, which drives the demand for excipients in developing effective formulations.
The pharmaceutical sector experiences constant trends, including new drug development, continuous manufacturing, and innovative drug technologies. These trends contribute to an increased demand for excipients with advanced functions. A significant percentage of marketed drugs (40-70%) and new chemical entities (NCEs) face the challenge of poor water solubility. This can negatively affect the bioavailability of the API and impact its therapeutic effect. To address this issue, the market for solubility-enhancing excipients and related technologies is expanding.
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USD 2.1 billion in 2020
Excipient, Biologics, Scale of Operation, End-User, and Geography
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High-concentration biologic formulations are becoming more prominent in the drug development pipeline as manufacturers aim to provide advanced therapeutics that patients can administer at home. These high concentrations often lead to protein-protein interactions due to increased viscosities. Excipients can help reduce these interactions without compromising protein stability and other aspects of biologic formulations. Consequently, there is a shift towards carefully selected combinations of viscosity-reducing excipients.
With the increasing prevalence of infectious diseases and cancer, the demand for biologic drugs is high. Innovative biopharmaceutical companies are collaborating with stakeholders across the R&D landscape to develop new ways to treat these diseases. Currently, there are 258 vaccines in the pipeline for treating and preventing severe infectious diseases. Over the past two decades, the proportion of new vaccine candidates entering all stages of clinical development has increased by 3-5 percentage points. Small and medium-sized companies lead in Phase I vaccine trials, while large companies dominate late-stage (Phase III) trials.
The biologics industry is growing rapidly, accounting for approximately 40% of biopharmaceuticals in the pipeline. Biological products are the fastest-growing class of therapeutic products, particularly in the U.S. Since 2000, more than 475 new prescription medicines, including new molecular entities (NMEs) and new biologics license applications, have been approved by the U.S. Food and Drug Administration. The increasing approval of biopharmaceuticals is expected to drive the demand for novel excipients used in their formulation and contribute to market growth.
As drug substances become more complex, there will be continued challenges in formulation. Novel excipients can significantly impact drug development and expand the range of treatments available to patients. The FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics. This program aims to encourage sponsors of clinical trials to formulate innovative therapies using new excipients approved by the FDA.
Pharmaceutical companies are increasingly outsourcing business functions to contract research organizations (CROs) and contract development and research organizations (CDMOs) in order to improve quality and speed up time to market. Formulators face challenges in dealing with complex ingredients, incorporating multiple active elements, complying with regulations, and adapting to changing social and consumer preferences. Outsourcing manufacturing, including the production of excipients, has become a significant component in addressing these challenges.
Regulatory agencies prioritize the quality and safety of pharmaceutical products. In recent years, these agencies have implemented new regulations to prevent adulteration of active pharmaceutical ingredients (API) and excipients. However, the current regulatory landscape or the lack of an independent excipient approval pathway can hinder the entry of new excipients into the market and limit the development of new drug products.
There are many challenges associated with excipient quality management, managing extended supply chains, and establishing certification schemes for producing and supplying excipients. Failing to address these challenges can lead to counterfeit or substandard excipients entering the supply chain. Additionally, formulating biological drug products using excipients poses challenges due to the complexity and fragility of the active compounds.
During the pandemic, companies rushed to develop new biopharmaceuticals, drug products, vaccines, and repurpose existing ones. Consequently, the importance of excipients in these products has increased significantly. Excipients played a vital role in the development of novel therapies and robust pharmaceutical products to combat COVID-19 and other diseases. The selection and use of appropriate excipients enabled the stabilization of biologics and vaccines during processing and storage.
The market is segmented based on various factors, including excipient, biologics, scale of operation, end-user, and geography.
Segmentation by Excipient
Solubilizers & Surfactants
Buffering & Tonicity Agents
Segmentation by Biologics
Segmentation by The Scale of Operation
Segmentation by End-User
Pharma & Biotech Companies
CMOs & CDMOs
Academic & Research Institutes
Segmentation by Geography
Middle East & Africa
The global market for biopharmaceutical excipients is divided into various segments, including bulking agents, solubilizers & surfactants, buffering & tonicity agents, and others. In 2021, bulking agents held the largest market share of 39% and are projected to exhibit the highest incremental growth throughout the forecast period.
Biologics encompass a range of products such as monoclonal antibodies, vaccines, recombinant proteins, cell and gene therapy, interferons, growth factors, and others. Monoclonal antibodies constituted the largest share of 45.04% in 2021 and are expected to demonstrate significant incremental growth in the forecast period. Monoclonal antibodies are produced by cloning a unique white blood cell, resulting in subsequent antibodies originating from a single parent cell. They typically exhibit monovalent affinity, binding to a specific epitope on an antigen, in contrast to polyclonal antibodies, which bind to multiple epitopes. Bispecific monoclonal antibodies can also be engineered to target two epitopes.
The formulation development of vaccines poses challenges due to their inherent instability compared to small molecules. Complex molecular structures, a lack of well-defined stability assays, and numerous degradation mechanisms create hurdles in the formulation development of vaccines.
The biopharmaceutical excipients market is further segmented into commercial and research applications. In 2021, the commercial sector accounted for the highest market share of 73.20% and is anticipated to experience the highest incremental and absolute growth of $862.44 million and 56.60%, respectively, during the forecast period.
The demand for manufacturing billions of doses of biologics within short periods has surged with the rise of infectious diseases, epidemics, and pandemics. The growing adoption of biologics necessitates increased production volumes, presenting significant challenges in large-scale biopharmaceutical manufacturing. To meet the needs of a large patient population in the commercial phase, the rapid development of large-scale production requires substantial quantities of ingredients.
The biopharmaceutical excipients market is segmented into pharma & biotech companies, contract manufacturing organizations (CMOs) & contract development and manufacturing organizations (CDMOs), and academic & research institutes. In 2021, pharma & biotech companies held the largest market share of 57.63% and were expected to experience significant incremental growth of $640.83 million during the forecast period.
North America dominated the global biopharmaceutical excipients market in 2021 with a share of 34.10%. However, the Asia-Pacific (APAC) region is projected to exhibit the fastest growth, with a CAGR of 9.01% during the forecast period. North America benefits from its well-established biopharmaceutical industry and the presence of leading manufacturing companies. The demand for biopharmaceutical excipients in this region has increased due to the rise in drug development, particularly in the vaccine market, driven by heightened awareness of vaccination and its benefits against infectious diseases.
Europe experiences a growing demand for biopharmaceutical excipients due to factors such as increasing populations, the emergence of infections, demand for vaccines, improved biopharma facilities, and the impact of COVID-19. However, in terms of growth rate, APAC stands out as the fastest-growing region for biopharmaceutical excipients. Countries like China and Japan play major roles in this region due to lower labor costs and increased outsourcing of inorganic and organic chemical manufacturing. Latin America, the Middle East, and Africa hold smaller shares in the global biopharmaceutical excipients market.
The global biopharmaceutical excipients market is characterized by fragmentation, with a diverse range of vendors contributing to its revenue. These vendors vary from emerging mid-sized companies to well-established players. The market leaders employ various strategies such as product launches and approvals, marketing and promotional activities, increased investment in research and development, and strengthening of their distribution networks to expand their market share and presence.
For example, in 2020, DFE Pharma introduced a new portfolio of biopharmaceutical excipients designed to stabilize biologics, capitalizing on the growing demand in the biologics sector. Additionally, MilliporeSigma partnered with ReForm Biologics to commercialize ReForm’s excipients used in biotherapeutic formulations.
Merck KGaA, DFE Pharma, Avantor, BASF SE, Evonik Industries AG, and Rouquette Freres are some of the established players that hold a significant share in the global biopharmaceutical excipients market. Other notable vendors making their mark in the market include Aceto, Ashland Global Holdings, Biohale, Biospectra, Clariant, Colorcon, Dow Chemical Industries, Fuji Chemical Industries, IMCD, Innophos, JRS Pharma, Kirsch Pharma, Novo Nordisk, Pfanstiehl, Pharmonix Biologicals, and Sigachi Industries.
Key companies profiled in this report include Merck KGAA, BASF SE, Avantor, Evonik Industries, Roquette Freres, Aceto, Angus Chemical, Apothecon, Ashland Global, BioSpectra, BOC Sciences, C.G. Group, Clariant, Colorcon, DFE Pharma, DOW, Eastman Chemical, IMCD N.V., Innophos, Invitria, JRS Pharma, Kirsch Pharma, Meggle, Novo Nordisk, PFANSTIEHL, Pharmonix, Shin-Etsu Chemical, Sigachi Industries, Spectrum Chemical, Tereos, The Lubrizol, Wacker Chemie.
Key Questions Answered
What is the size of the biopharmaceutical excipients market?
The biopharmaceutical excipients market had a value of $2.08 billion in 2021 and is projected to reach $3.2 billion by 2027.
What is the expected growth rate of the biopharmaceutical excipients market?
The global biopharmaceutical excipients market is anticipated to grow at a compound annual growth rate (CAGR) of 7.56%.
Who are the leading companies in the global biopharmaceutical industry?
Merck KGAA, BASF SE, Avantor, Evonik Industries, and Roquette Freres are the market leaders in the global biopharmaceutical industry.
What are the key trends fueling market growth?
The key trends driving market growth include the increasing prevalence of cancer and infectious diseases, a rising number of product approvals for biologics, and the growing need for outsourcing biopharmaceutical excipients.