Dublin, Aug. 09, 2022 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Excipients Market - Global Outlook and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering.
The global biopharmaceutical excipients market is expected to grow at a CAGR of 7.56% during 2022-2027.
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 of 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.
Key Topics Covered:
1 Research Methodology
2 Research Objectives
3 Research Process
4 Scope & Coverage
5 Report Assumptions & Caveats
6 Market at a Glance
8 Market Opportunities & Trends
9 Market Growth Enablers
10 Market Restraints
11 Market Landscape
14 Scale of Operation
17 North America
20 Latin America
21 Middle East & Africa
22 Competitive Landscape
23 Key Company Profiles
24 Other Prominent Vendors
25 Report Summary
26 Quantitative Summary
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