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31-Oct-2023

Future Trends and Partnerships in the Buffer Manufacturing Market

Summary

Buffer solutions play an important role in most biopharmaceutical processes, such as purification, isolation, filtration, protein capturing, chromatographic filtration, crystallization steps, and reactions. Being a vital formulation of drug development, buffers are also used to control pH and maintain the stability of drugs in their final form. Buffer manufacturing requires space, higher titers, resources, and a lean operation system, which adds to the cost of drug development. Conventional buffer manufacturing is tedious and consumes time. To overcome the challenges, pharmaceutical industries are either looking for advanced tech-driven buffer manufacturing or outsourcing buffers from third-party vendors.
  • Author Company: Roots Analysis
  • Author Name: Pemba Lahmo
Editor: Pemba Lahmo Last Updated: 01-Nov-2023

Recently, the trend of outsourcing buffer manufacturing system has been adopted by pharmaceutical companies as it reduces the cost of buffer formulation, eliminates space and temperature maintenance requirements, and, most importantly, cuts down the time needed to produce buffers. Additionally, there is a requirement for a novel buffer manufacturing system with automation to streamline buffer formulation. Driven by the challenges above and the growth trend of outsourcing, it is anticipated that the buffer preparation market will witness steady growth at a CAGR of 5.9% in the coming future, according to Roots Analysis.

 

Buffer Manufacturing Market: Current Landscape

At present, the buffer manufacturing market is leaning towards outsourcing and the wide-scale adoption of novel systems that reduce the risk of errors as they are integrated with exclusive features, including pressure sensors, pH sensors, temperature sensors, and filters. It is worth noting that with advancements in technology, an automated single-use inline dilution system has been launched that offers controlled dilution of concentrated buffer solutions and optimizes the delivery for downstream processing. Technological advancements such as automation and high throughput screenings are driving the growth of the buffer manufacturing industry.

 

Top Buffer Manufacturing Market Players

With the increasing demand for buffer formulation, several companies have taken the initiative of outsourcing buffer manufacturing from specialized partners. An expert leverages technologies such as automated buffer preparation systems and automated buffer management processes to provide the best solutions that meet current requirements. Some of the top buffer manufacturing market players who are actively engaged in the outsourcing include:

  • Asahi Kasei
  • Avantor
  • Canvax
  • Cytiva
  • Lonza
  • Merck
  • Pall Corporation
  • Thermo Fisher Scientific
  • Uniogen

 

To meet the demand, buffer manufacturing companies are emerging with partnerships and collaboration trends to upscale the production of buffers.

 

Recent Partnerships in the Buffer Manufacturing Market

In order to enhance productivity, many buffer manufacturing market players have undergone partnerships and collaborations. The majority of the deals and trends are emphasized on strategic alliance and distribution agreements. Some of the top partnerships in the buffer manufacturing market include:

  • In August 2023, GeminiBio signed an agreement with Asahi Kasei Bioprocess America in order to enhance biomanufacturing processes by utilizing MOTIV, the latter's inline buffer management system.
  • In April 2023, Canvax announced its market portfolio expansion by adding a whole new category that emphasizes liquids solutions and custom-made buffers under GMP-grade and commercial scale.
  • In June 2021, Avantor announced the acquisition of Ritter GmbH, the leading manufacturer of bioprocessing systems and equipment, to expand its capabilities of manufacturing biopharmaceuticals, including buffers.

 

Future Trends That Are Driving Buffer Manufacturing Market

Buffer manufacturing is labor-intensive and requires a significant floor space and advanced operational units. At the same time, buffer storage can be challenging as it requires controlled temperature and large floor space. To overcome the challenges, many buffer manufacturing market players, including Canva, Lonza, and Merck, are adapting the in-line conditioning system and buffer preparation systems that enable them to prepare buffers from raw materials. Furthermore, advances in technology in the future are driving the buffer manufacturing market.

  • Demand for pre-formulated Buffers

Pre-formulated buffers are rapidly gaining popularity in the biopharmaceutical industry as they are easy to use and convenient to handle. It reduces storage space problems and is cost-effective in comparison to manufacturing buffers in in-house production units. The key trend of adopting pre-formulated buffers is driving the future market as it reduces the load from the companies of development of buffers that consume time and space—allowing pharmaceuticals to focus on drug development.

  • Outsourcing of Buffers From Third Parties

Notably, the operational challenges have shifted pharmaceutical companies to outsource buffers from third parties. Outsourcing allows companies to focus on drug development and enable them to leverage automated buffer preparation system to overcome human error possibilities—thereby scaling the production of other therapeutic products. Outsourcing from high-tech-driven buffer manufacturing partners gives assurance of receiving GMP-grade buffers that meet quality standards of both upstream and downstream processes.

Furthermore, outsourcing also helps to save space and allows optimization of multiple buffer solutions at one time. There is no requirement for validation documents and quality tests, as outsourcing companies are liable to meet all quality standards. With significant advantages of outsourcing, more companies are focused on outsourcing buffer manufacturing in the future.

  • Adoption of Advanced Buffer Formulation Technologies

Today, buffer manufacturing market players, specifically those involved in outsourcing, are adapting advanced buffer formulation technologies such as in-line buffer conditioning, continuous buffer exchange, and concentrated buffer formulation technology to manufacture buffers from raw materials.

The integration of automated technologies with advanced sensors enables companies to produce large amounts of buffers within a short time. The trend of adaptation of advanced buffer formulation technologies has shown promising results in up-scaling drug manufacturing and eliminating the wastage of time companies do in manufacturing buffers.

  • Increasing Demand for Custom Buffer Solutions

The pharmaceutical industry is shifting to develop target-specific therapeutic drugs; the requirement for tailored buffer solutions has increased to meet particular manufacturing requirements. For instance, if a company is trying to purify protein, it is vital to keep it active and stable, most importantly when performing experiments such as surface Plasmon resonance, activity assays, structural studies using X-ray and cryo-EM, and ion exchange chromatography.

In such cases, companies need custom buffers that prevent protein aggregation and unfolding. Driven by this factor, the trend of custom buffer solutions has increased to meet particular experiment requirements, and in the future, it is expected that buffer manufacturing companies will produce custom buffer solutions.

 

Buffer Manufacturing Future Prediction

Overall, buffer manufacturing is a crucial process in the pharmaceutical industry and manufacturing of buffers is a labor-intensive and costly endeavor process. Additionally, it requires significant floor space for manufacturing and storage during large production. The trend of outsourcing has helped to mitigate the challenges of buffer manufacturing. The emerging trends followed by the adoption of technological advancements help to meet the high demand for buffers without creating pressure on drug development companies. In the future, buffer manufacturing will shift to adopt more innovative solutions and provide customized buffer solutions so companies can invest time in designing drugs.

 

About Roots Analysis

Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research / consulting services dedicated to serve our clients in the best possible way.