A buffer solution is comprised of a weak conjugate acid-base pair, for example, a weak acid and its conjugate base, or a weak base and its conjugate acid. Small quantities of other acids or bases are neutralized when added to the solution, and as a result, the solution resists changes in pH. Solutions with stable pH are required for the processing of protein-based biologic APIs because of their sensitivity to changes in pH. The stable pH range and capacity (the amount of acid/base that can be added without a change in pH) of a buffer are determined by the conjugate acid-base pair.
Most purification steps for downstream processing of biologics require buffers to equilibrate, condition, wash, elute, or concentrate the product. They are used in product isolation and purification steps to facilitate protein capture and polishing and also in the filtration process for the removal of viruses or depyrogenation. Aqueous solutions are also required for cleaning and disinfecting downstream processing equipment, such as chromatography matrices and membrane filtration systems. The main equipment involved in downstream processing with buffers includes mixers for buffer preparation, as well as equipment for purification, including packed-bed chromatography systems, fluidized beds, ultrafiltration and diafiltration membranes, microfiltration membranes, depth filtration cartridges, and virus-removal systems.
The global market for Bio Pharma Buffer
is expected to reach about 1110 Million USD by 2025 from 683 Million USD in 2018, registering a Compounded Annual Growth Rate (CAGR) of 7.22% during the analysis period, 2019-2025.
The key players are Avantor, Alfa Aesar (Thermo Fisher), Merck, Lonza, Bio-Rad, BD, GE, Healthcare, Promega Corporation, Hamilton Company, XZL BIO-TECHNOLOGY, SRL and so on. According to the revenue of these companies, we can know that the Bio Pharma Buffer industry is relative concentrated. Because the top 6 companies have more than 70% market share in 2017.
By product, the Bio Pharma Buffer market is segmented into Phosphate-Buffered Saline (PBS), Acetates, Tris and Others. Among them, the Tris buffers are the most popular product in global Bio Pharma Buffer market, which have the revenue market share of about 29% generally.
By end user, the Bio Pharma Buffer market is segmented into Research Institution, Pharmaceutical Industry and Other applications. Bio Pharma Buffer can be used in ELISA, blotting and other binding assays.
Significant and lasting barriers make entry into this market difficult. These barriers include, but are not limited to: (i) product development costs; (ii) capital requirements; (iii) intellectual property rights; (iv) regulatory requirement; and (v) Transitions’ unfair methods of competition.
Despite the presence of competition problems, due to the global recovery trend is clear, investors are still optimistic about this area, the future will still have more new investment enter the field. Even so, the market is intensely competitive .The study group recommends the new entrants just having money but without technical advantage and upstream and downstream support do not to enter into this field.