Global Bioprocess Validation Market - 2020-2027
|生物工藝驗證的全球市場：2020-2027 Global Bioprocess Validation Market - 2020-2027|
|出版日期: 按訂單生產||內容資訊: 英文||
Validation is a method of building documentary evidence demonstrating a process, activity or procedure, carried out in production or testing maintains the desired level of compliance at all stages. Validation is an act of documenting and demonstrating that any process, procedure, and activity will consistently drive to the required results. It includes the qualification of equipment and systems.
A bioprocess is a specific process that uses complete living cells or their components to obtain desired products. Transport of energy and mass is fundamental to many biological and environmental processes. Bioprocess applications are diverse, and the products can be found in pharmaceutical, chemical, and nutrition industries.
The market is driven by the stringent safety and quality regulations governing product certification and testing across the biopharmaceutical and pharmaceutical industries, high demand for the outsourcing of Bioprocess Validation Market services, and regulatory mandates in the healthcare industry to maintain compliance with good manufacturing practices. Additionally, increasing awareness about the advantages of biopharmaceutical drugs, and the growing number of CROs & CDMOs, the favorable government initiatives to promote the growth of the pharmaceutical and biotechnology industries in several countries such factors are propel the market growth during forecast period.
The production process within the pharmaceutical industry undergoes a series of recalls, reworks, and product failures. This factor necessitates the presence of a system for evaluating the viability of an experiment or product development channel. The global bioprocess validation market has expanded on account of advancements in the field of pharmaceutical manufacturing. Several success factors need to be considered before employing a particular route of administration within the healthcare and pharmaceutical sectors. Hence, the global bioprocess validation market is expected to grow into a lucrative industry in the years to follow.
The need to reduce production cost across pharmaceutical and food companies necessitates the use of bioprocess validation systems. Furthermore, the Food and Drug Administration (FDA) in the U.S. has also played a key role in ascribing values for bioprocess validation. The next decade is expected to witness increased spending on development of modules for analyzing production processes. This factor, coupled with the use of sophisticated facilities in the pharmaceutical industry, shall propel market demand. Feasibility of operations and processes is amongst the most daunting concerns in the pharmaceutical industry. This factor will drive the growth of market in the forecast period.
However, government regulation and the high price is expected to hamper the market during the forecast period.
The global bioprocess validation market is segmented based on test type by extractables/leachables testing services, microbiological testing services, integrity testing services, and physiochemical testing services, compatibility testing services, and others. The extractables/leachables testing services segment held the largest market share due to presence of regulatory mandates and guidelines regarding the testing of extractables and leachables; increasing outsourcing of testing services by biopharmaceutical manufacturers; the growing requirement for product safety, identity, purity, and quality; and the increasing risk of product adulteration.
The extractables/leachables testing services is extremely important across protection of patients and majorly for regulatory documentation for establishments such as FDA and EMA. Additionally, the pharmaceutical sector has undergone a robust development for its betterment, the extractables and leachables plays a crucial role in the patient's safety and drug product interaction.
Harmful contaminants or chemicals from packaging and especially primary packaging have often shown contamination of pharmaceutical products. This may lead to create threatening and challenge to the safety for several patients using these products regularly. In 2010, one of the company McNeil Consumer Healthcare, recall more than 500 lots of Tylenol, Benadryl, Motrin, and Zyrtec. In this case, the chemical is potential carcinogen reacted with the outer packaging into the drug containers. These factors have restrained the growth of the healthcare market, however, in order to avoid these kind of mishaps, the players are adopting extractables/leachables testing services, which is likely to drive segment growth.
The microbiological testing services is expected to have positive market growth in the forecast period. Microbiology testing services are a crucial requirement across many industries worldwide where products, processes and human health are at risk of being negatively affected by the presence and breeding of micro-organisms such as specific pathogens, bacteria, yeast and moulds.
Every day, products and materials come into contact with micro-organisms. Although many are harmless, many can cause significant contamination, damage and risk to human health. Some microbes can utilize your product as a food source, breaking the material down into nutrients and irreversibly changing the product whilst other microbes can spoil food, negatively affect production environments, products and infrastructure. They can cause severe illness or contaminate sterile environments. This factor will drive the growth of market in the forecast period.
Further, the market is also classified based on process as media containers and bags, freezing and thawing process bags, filter elements, and others. The freezing and thawing process bags segment is held the largest market share. The constant evolution and betterment of the cryopreservation technique over the years has laid the foundation for the formation of these freeze and thaw process bags. More and more biotechnological and pharmaceutical companies have adopted the approach of using these systems for the storage of their medicines and drugs and thus have helped in driving the growth of the segment.
There are several advantages of using these freeze and thaw process bags. These bags are easy to use, easily transportable, and have larger storage capacity. Moreover, with the technological advancement, the freezing time of these bags has been reduced drastically due to the heath exchange plans. Such an arrangement offers efficient and effective heat transfer as well as it helps in protecting the bags. One can also keep a close eye on the progress of the freezing process in these bags. Such advantages have made these systems quite popular among the end-users and thus, helped in driving the growth of the segment.
By region, the global bioprocess validation market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, North America dominated the global medical coding market and is expected to grow at the highest CAGR during the forecast period due to the concentration of a large number of key service providers of bioprocess validation in the region. In addition to that, strict regulations pertaining to the production of biopharmaceutical products are adding impetus to the demand for bioprocess validation systems in the region.
Also the presence of the pharmaceutical and biotechnology companies are driving the growth of the market in the region. These companies are responsible for creating a solid demand for proper protein drugs and sample storage systems. In addition to this, rapidly developing domestic infrastructure coupled with the growing need for more improved and enhanced medications, therapies, and therapeutics is thus driving the demand for the bioprocess validation. This factor will drive the growth of market in the region.
The Asia-Pacific region is expected to have third-largest share due to the higher growth rate is attributed to increasing capacities of numerous biopharmaceutical manufacturers and increased spending on research and development activities in life sciences.
The bioprocess validation market is highly competitive with the presence of several international and local markets. Product diversification, revenue generation, and opportunities intensify the market competition Cobetter Filtration Equipments Co., Ltd., SGS S.A., DOC S.r.l., Thermo Fisher Scientific, Toxikon Corporation, Sartorius Stedim Biotech, Eurofins Scientific, Pall Corporation, and MEISSNER FILTRATION PRODUCTS, INC. are the leading market players with significant market share. The major players are using product development, novel product launches, market expansion, and product diversification strategies for holding their position in the market.
The companies are entering into collaborations, mergers, strategic partnerships, and acquisitions to expand their presence and meet the rising demand for the bioprocess validation across the globe.
For instance, in August 2018, Merck KGaA launched the BioReliance Product Characterization Portfolio to enhance its service portfolio in the bioprocess validation market..