DUBLIN, August 8, 2022 /PRNewswire/ — The “Biopharmaceutical Excipients Market – Global Outlook and Forecast 2022-2027” report has been added to from ResearchAndMarkets.com offer.
The global biopharmaceutical excipients market is expected to grow at a CAGR of 7.56% during the period 2022-2027.
Constantly changing trends in the pharmaceutical sector, including the development of new drugs, continuous manufacturing and innovative pharmaceutical technologies, have contributed to an increase in demand for excipients with advanced functions. Between 40 and 70% of marketed drugs and up to 90% of all newly registered chemical entities 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 solve the problem.
High-concentration biological formulations represent a growing percentage of the drug development pipeline as drug manufacturers seek to deliver advanced therapies that the patient or caregiver can administer at home. These high concentrations include protein-protein interactions due to higher viscosities. Excipients can help minimize these interactions without negatively affecting protein stability and other aspects of biological formulations. This is driving a move towards carefully selected combinations of viscosity-reducing excipients.
Biologics – Pipeline and product approvals, a major driver of the biopharmaceutical excipients market
With an increasing number of infectious diseases and cancers, there is a high demand for various biological drugs. Innovative biopharmaceutical companies are constantly working with stakeholders in the R&D landscape to develop new methods of treating these diseases. To date, 258 vaccines are in preparation to treat and prevent serious infectious diseases. According to one study, trends in global vaccine R&D revealed that the proportion of new vaccine candidates entering all stages of clinical development has increased by 3 to 5 percentage points over the past two decades. Small and medium-sized companies accounted for almost 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 growing, with approximately 40% of biopharmaceuticals in the industry pipeline. Biologics are the fastest growing class of therapeutics, especially in the United States. Since 2000, more than 475 new prescription drugs (New Molecular Entities (NMEs) and New Biologics License Applications) have been approved for use by the United States Food and Drug Administration. . The increasing approvals of biopharmaceuticals will likely increase the need for new excipients used in their formulation and contribute to the growth of the market.
New excipients creating a major shift from traditional excipients
As drug substances become increasingly complex, formulation challenges will continue to grow. New excipients can have a significant impact on drug development and, by extension, the number and types of treatments available to patients. A new excipient differs from an excipient in that it has not been used before in an approved drug. In a critical step to modernize drug formulation and biopharmaceutical development, the FDA is launching a program to test the safety and suitability of new inactive ingredients for use in new drugs and biologics. The goal is to encourage clinical trial sponsors to formulate innovative therapies with these new excipients that the FDA deems acceptable for use in this program.
Growing trend towards outsourcing the manufacture of biopharmaceutical excipients
In today’s market, pharmaceutical companies cite improved quality and faster time-to-market as key reasons to outsource business functions to contract research organizations (CROs) and development organizations. and contract research (CDMO). Formulators are increasingly faced with the complexity of ingredients in their pharmaceutical products and the incorporation of multiple active elements, increasing regulations, changing social and consumer preferences, and the environmental implications that have impact on production and eventual decomposition. This has led to the outsourcing of ingredient manufacturing, which also includes excipients as an important component.
Challenges Hindering the Growth of Biopharmaceutical Excipients
The quality and safety of pharmaceutical products are the main concerns of regulators. In recent years, regulatory agencies have strengthened their position on the prevention of drug adulteration in active pharmaceutical ingredients (APIs) and excipients by adopting new regulations. However, the current regulatory landscape or the lack of an independent approval pathway for excipients may limit the entry of new excipients into the market and, subsequently, new drugs.
Main topics covered:
1 Research methodology
2 research objectives
3 Research process
4 Scope and coverage
5 Report assumptions and caveats
6 The market at a glance
7 Presentation
8 Market Opportunities and Trends
9 Market Growth Catalysts
10 Market Restrictions
11 Market Landscape
12 Vehicle
13 Organic products
14 Scale of Operation
15 End user
16 Geography
17 North America
18 Europe
19 Apac
20 Latin America
21 Middle East & Africa
22 Competitive Landscape
23 key company profiles
24 other important suppliers
25 Report Summary
26 Quantitative summary
27 Appendix
Companies cited
- Merck KGAA
- BASF SE
- Forward
- Evonik Industries
- Rocket Brothers
- Aceto
- Angus Chemicals
- Apothecon
- global ashland
- BioSpectra
- BOC Science
- CG Group
- Clariant
- Colorcon
- DFE-Pharma
- DOW
- Eastman Chemicals
- IMCD SA
- Innophos
- Invitria
- JRS Pharma
- Kirsch Pharma
- Meggle
- Novo Nordisk
- PFANSTIEHL
- Phamonix
- Shin-Etsu Chemical
- Sigachi Industries
- Chemical Spectrum
- Tereos
- Lubrizol
- Wacker Chemicals
For more information about this report visit https://www.researchandmarkets.com/r/3n9c2s
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SOURCE Research and Markets