Biopharmaceutical Excipients Market - Global Outlook and Forecast 2022-2027

The global biopharmaceutical excipients market is expected to grow at a CAGR of 7.56% during 2022-2027.

Excipients are fundamental components of any biopharmaceutical drug product, which act as active ingredients, stability enhancers, emulsifying and suspending agents, binders, preservatives, antioxidants, and lubricants. These differ from prodrugs in manufacturing or are present in a finished pharmaceutical product dosage form. Excipients have targeted roles, ranging from protecting the API to easing the manufacturing process, which, in turn, drives the need and stipulation of excipients for developing effective formulations.

The constant shift of trends in the pharma sector, including new drug development, continuous manufacturing, and innovative drug technologies, has donated to a surge in demand for excipients with advanced functions. Between 40-70% of marketed drugs and up to 90% of all new chemical entities (NCEs) registered to suffer from poor water solubility. This can have significant negative consequences on the bioavailability of the active pharmaceutical ingredient (API), potentially impacting the therapeutic effect. The market for solubility-enhancing excipients and related technologies is proliferating to tackle the problem.

High-concentration biologic formulations account for an increasing percentage of the drug development pipeline as drug manufacturers seek to offer advanced therapeutics that the patient or caregiver can administer in the home setting. These high concentrations include protein-protein interactions due to higher viscosities. Excipients can help minimize these interactions without negatively impacting protein stability and other aspects of biologic formulations. This is driving a shift towards carefully selected combinations of viscosity-reducing excipients.

Biologics- Pipeline and Product Approvals, a Major driver for Biopharmaceutical Excipients Market

With a growing number of infectious diseases and cancers, there is a high demand for various biologic drugs. Innovative biopharmaceutical companies are continuously operating with stakeholders across the R&D landscape for the expansion of newer ways to treat such diseases. To date, 258 vaccines are in the pipeline for treating and preventing severe infectious diseases. According to a study, trends in global vaccine R&D found that the proportion of new vaccine candidates entering all stages of clinical development increased by 3-5 percentage points over the past two decades. Small and medium-sized companies accounted for nearly twice as many new Phase I vaccine trials as large companies, but large companies dominated late-stage (Phase III) vaccine trials.

The biologics industry is increasing, with an estimated 40% of biopharmaceuticals in the industry pipeline. Biological products are the fastest-growing class of therapeutic products, especially in the U.S. Since 2000, more than 475 new prescription medicines (new molecular entities (NMEs) and new biologics license applications) have been approved for use by the U.S. Food and Drug Administration. The growing approvals of biopharmaceuticals will likely increase the need for novel excipients used in their formulation and contribute to market growth.

Novel Excipients Creating a Major Shift from Traditional Excipients

As drug substances become increasingly complex, formulation challenges will continue to grow. Novel excipients can significantly impact drug development and, by extension, the number and types of treatments available to patients. A novel excipient differs from an excipient in that it has not been previously used in an approved drug. In an essential step for modernizing drug formulation and biopharmaceutical development, FDA is launching a program to test the safety and suitability of novel inactive ingredients for use in new drugs and biologics. The aim is to encourage sponsors of clinical trials to formulate innovative therapies with those new excipients that FDA finds acceptable for use under this program.

Growing Trend Outsourcing the Manufacture of Biopharmaceutical Excipients

In today's market, pharmaceutical companies cite improved quality and faster time to market as the main reasons for outsourcing business functions to contract research organizations (CROs) and contract development and research organizations (CDMOs). Formulators are increasingly facing complexity with ingredients in their drug products and incorporating multiple active elements, increasing regulations, changing social and consumer preferences, and environmental implications impact production and eventual decomposition. This led to the outsourcing of ingredients manufacturing which also includes excipients as a significant component.

Challenges Restraining the Growth of Biopharmaceutical Excipients

The quality and safety of pharmaceutical products are the top concerns of regulators. In recent years, regulatory agencies have strengthened their position on preventing drug adulteration in active pharmaceutical ingredients (API) and excipients by enacting new regulations. However, the current regulatory landscape or lack of an independent excipient approval pathway can limit the entrance of new excipients into the market and, subsequently, new drug products.

Many challenges are associated with excipient quality management, managing extended supply chains, and developing certification schemes for producing and supplying excipients. Not satisfactorily meeting these challenges creates the potential for counterfeit or substandard excipients to enter the supply chain. Furthermore, several challenges also exist in formulating biological drug products using excipients due to the complexity and fragility of the active compounds.

Impact of COVID-19 on Biopharmaceutical Excipients

During the pandemic, companies rushed to develop new biopharmaceuticals, drug products, vaccines, and re-purpose older drug products. Due to this, the importance of the critical function excipients in these products has risen. Excipients played a vital role in the progression of new biopharmaceuticals, pharmaceuticals, and vaccines to fight COVID-19 and other diseases. Therefore, various excipients are required to stabilize biologics and vaccines during processing and storage. Selection and use of the appropriate excipients enabled the development of novel therapies and robust pharmaceutical products.

By Excipient

The global biopharmaceutical excipients market is segmented by bulking agents, solubilizers & surfactants, buffering & tonicity agents, and others. In 2021, bulking agents accounted for the highest share of 39% and were expected to have the most significant incremental growth during the forecast period.

By Biologics

Biologics included monoclonal antibodies, vaccines, recombinant proteins, cell and gene therapy, interferons, growth factors, and others. In 2021, monoclonal antibodies accounted for the highest share of 45.04% and were expected to have the most significant incremental growth during the forecast period. A monoclonal antibody (mAb or moAb) is an antibody made by cloning a unique white blood cell. All subsequent antibodies derived this way trace back to an individual parent cell. Monoclonal antibodies can have monovalent affinity, binding only to the same epitope (the part of an antigen recognized by the antibody). In contrast, polyclonal antibodies bind to multiple epitopes and are usually made by several different antibody-secreting plasma cell lineages. Bispecific monoclonal antibodies can also be engineered by increasing the therapeutic targets of one monoclonal antibody to two epitopes.

Vaccines are inherently less stable than small molecules, and 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.

By Scale of Operation

The global biopharmaceutical excipients market is segmented by commercial and research. In 2021, retail accounted for the highest share of 73.20% and was expected to grow with the highest incremental and absolute growth of $862.44 million and 56.60%, respectively, during 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. With a greater uptake of biologics, the need for manufacturing high quantities of these drugs is increasing. 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.

By End-user

The global biopharmaceutical excipients market is segmented by pharma & biotech companies, CMOs & CDMOs, and academic & research institutes. In 2021, pharma & biotech companies accounted for the highest share of 57.63% and were expected to have the most significant incremental growth of $640.83 million during 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. With a greater uptake of biologics, the need for manufacturing high quantities of these drugs is increasing. 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.

By Geography

In 2021, North America dominated the global biopharmaceutical excipients market with 34.10%. However, APAC is likely the fastest-growing region in the worldwide biopharmaceutical excipients market, with the highest CAGR of 9.01% during the forecast period. The North American biopharmaceuticals market is well established, with prominent biopharmaceutical manufacturing companies based in the region. The rise in drug development has significantly increased the demand for biopharmaceutical excipients in this region. The US is the major revenue contributor in North America mainly due to an increase in the vaccine market, reflecting the growth in awareness of vaccinations and their benefits against infectious diseases.

Increasing populations, the emergence of infections, demand for vaccines, improved biopharma facilities, and the advent of COVID-19 are significant factors boosting the demand for biopharmaceutical excipients in Europe. However, APAC is the fastest-growing region for biopharmaceutical excipients. Emerging countries such as China and Japan are the major players due to low labor costs and increased outsourcing of inorganic and organic chemicals manufacturing. Latin America, the Middle East, & Africa accounted for minor shares in the global biopharmaceutical excipients market.

COMPETITIVE LANDSCAPE

The global biopharmaceutical excipients market is fragmented, with vendors ranging from emerging mid-sized to established players contributing to its revenue. Most of the leading players focus on implementing various strategies such as product launches and approvals, marketing, and promotional activities, increased R&D investments, and strengthening their distribution networks to enhance their share and presence in the market. For instance, in 2020, DFE Pharma launched a new portfolio of biopharmaceutical excipients for stabilizing biologics to capitalize on increasing growth in the biologics sector. In the same year, MilliporeSigma agreed with ReForm Biologics to commercialize ReForm's excipients used in biotherapeutic formulations.

Established players that accounted for a significant share in the global biopharmaceutical excipients market include Merck KGaA, DFE Pharma, Avantor, BASF SE, Evonik Industries AG, and Rouquette Freres. Other prominent vendors that are emerging in the global biopharmaceutical excipients market are 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, Sigachi Industries.

Vendors

• Merck KGAA
• BASF SE
• Avantor
• Evonik Industries
• Roquette Freres

Other Prominent Vendors

• 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

1. HOW BIG IS THE BIOPHARMACEUTICAL EXCIPIENTS MARKET?
2. WHAT IS THE BIOPHARMACEUTICAL EXCIPIENTS MARKET GROWTH?
3. WHO ARE THE MARKET LEADERS IN THE GLOBAL BIOPHARMACEUTICAL INDUSTRY?
4. WHAT ARE THE TOP TRENDS DRIVING THE MARKET GROWTH?