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Market positioning strategy

Understanding the value of Pharma R&D in the New Era

The biopharmaceutical industry is currently growing at a breakneck speed. Furthermore, promising innovations in the pharma market such as gene therapy and cellular therapy coupled with the rising market demand mean that there are no signs of slowing down in the sector over the next few  years. As a result, pharma R&D investments have doubled over the last decade. Apart from increasingly being an innovation-driven sector, the focus in the pharma industry is now shifting towards achieving ‘agility’ in product development in an effort to meet customer demands effectively and shorten the time-to-market. Moreover, as pharma R&D is highly capital-intensive, a strong foundation of technical capabilities is imperative for players in the sector.  Over the past decade, Pharma R&D horizons have expanded as a wider range of players are pursuing innovative therapies and solutions by leveraging a broader set of technologies. The exponential growth in the data in the pharma sector can be channeled into the R& D space. Experts at Infiniti Research believe that data can help pharma R&D with several benefits, some of which are mentioned below.

Big pharma has immense potential to make pharma R&D a strong contributor to value creation. Want more insights on this from our industry experts? Request a free proposal

Deeper patient understanding and better diagnosis

A rich pool of patient data is available in the pharmaceutical industry in the form of genomic, proteomic, microbiome, and biomarker data. But channeling and using this data pool for making the right diagnosis and enhancing better patient care is vital. Effective pharma R&D will allow pharmaceutical organizations to develop significantly stronger and evidence-driven hypothesis of data. This will eventually give room for a discussion on the value that particular medicine might deliver to patients and payers.

Structuring better therapies

Lead identification and optimization can now be effectively done using the data available through drug libraries, formulation, and clinical pharmacological data sets.  Several drug developments companies have begun attempts to automate their drug design via machine learning. A thorough pharmaceutical R&D is essential to understand the viability of such projects and assessing techniques of practical implementation.

Attain cost effectiveness and safety

Safety and cost effectiveness of drugs are critical issues facing most pharma companies at present. Pharma R&D takes a deep-dive approach to understand even the minor details of drug and therapy development, helping companies gain a clear understanding of the safety and cost-related roadblocks that they can expect. Effective pharma R&D also prescribe the best practices and strategies through which pharma companies can improve the cost effectiveness and reduce the risks involved in drug and clinical therapy development.  

Pharmaceutical companies desperately need to bolster R&D innovation and efficiency to attain long-term success. Get in touch with an expert from Infiniti Research to know more on we can assist your business in this.

regenerative medicines

Identifying Key Regenerative Medicine Manufacturing Challenges

Regenerative medicine is currently the hive of innovation in modern science with far-reaching benefits for big pharma, healthcare systems, and patient outcomes. We can expect a rapid pace of development in the US regenerative medicine market over the next decade. Some of the key factors fueling demand include the increasing investments in R&D activities and the rising incidence of chronic diseases in the country. Leading vendors have enhanced their R&D investments to develop innovative medical therapies, which is driving the overall growth of the market. Furthermore, M&A and strategic alliances among vendors will have a significant impact on the overall market growth and innovation. Nevertheless, the actual delivery of regenerative medicines has proven to be rather challenging with several roadblocks to commercially viable therapies that are capable of catering to unmet clinical needs. In this article, based on a series of discussions with industry analysts at Infiniti Research, we highlight some of the most relevant and pressing manufacturing challenges in regenerative medicine products.

Regenerative medicine

The promise of regenerative medicines requires an innovative look at the complete product lifecycle, including the development of an efficient distribution network. Planning to venture into this space? Request a free proposal for comprehensive insights about the market.

Regenerative medicine manufacturing challenges

Manufacturing expense

Cell therapy manufacturing processes are generally highly expensive. Scaling up from limited laboratory facilities to automated systems for bulk production will largely be based on cost, therefore impeccable financial and time planning become vital. As a first-generation technology, stakeholders we can expect greater stakeholder tolerance for higher pricing, but this will only be for a limited time period. 

Design quality

After collecting sufficient evidence of clinical effectiveness of regenerative medicines, bioreactor technologies are considered for the manufacture of regenerative medicine products. But even minor process changes at this stage will require new validation of the product performance. So, in the case of automation, robots manually reproduce the existing inefficient manual processes due to which the products are often based on obsolete technologies. As a result, the manufacture of regenerative medicines sometimes misses the opportunity to improve their quality by innovating process design.

The personalization and unique requirements of regenerative medicines require manufacturers to provide increased focus on precision and accuracy of processes. Get in touch with an expert from Infiniti research to identify gaps in your existing processes and bridge them with viable business strategies.

Biomaterials challenges

Challenges relating to biomaterials is mostly concerned with their selection than the manufacturing. The trends in material selection will eventually have a major impact on the manufacturing process. As traditional synthetic biodegradable polymers and a few bioactive ceramics that have been manufactured through conventional routes are no longer considered ideal, attention is now being turned toward biomaterials that have more relevant biological properties. But since they have critical nanostructural features, and may involve self-assembly and environmental responsiveness, they may not be compatible with normal top-down manufacturing and therefore could require changes in the production process.

Supply chain challenges

The clinical supply chains required to deliver regenerative medicines therapies are arguably the most complex the industry has seen so far, even more so than for biologic medicine. At present, while billions of dollars are being spent on regenerative medicine research and clinical studies, resources are yet to be allocated to the management and delivery of innovative medical therapies at scale. Furthermore, progress by the pharma industry in coming into compliance with the FDA’s regulations for regenerative medicines has been slow. This makes the process of bringing regenerative medicines at scale to the market even more challenging.  

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Realizing the Potential of Biopharmaceutical Cold Chain Packaging

For biopharmaceutical manufacturers, the market trends are favorable. Rising demand for targeted therapies and the globalization of specialty pharmaceutical commercialization are creating a host of growth opportunities for manufacturers. As a result, there is an unprecedented rise in the quantities of commercial and clinical drugs that are being shipped to patients across the globe. However, this also means that the stakes and costs for high-value cold chain products in global clinical trials have undergone a dramatic increase, due which the industry now operates in an environment where there is increased focus to minimize the loss on products or samples. This necessitates global manufacturers in the biopharmaceutical sector to keep abreast of the advances in biopharmaceutical cold chain packaging technology and processes that maintain the quality standards and ensure the safety of cold chain products. In this article, pharma industry experts lay down some macro-trends and key takeaways in biopharmaceutical cold chain packaging that manufacturers must consider as they work to identify innovations and drive new growth globally.

Meeting unique temperature needs

The rising hype around targeted therapies, biologics, and personalized medicines demand better temperature control measures in the biopharmaceutical supply chain. The wider range of new temperature requirements for these products requires manufacturers to focus on more than just cold shipping, it requires new biopharmaceutical cold chain packaging solutions. It becomes highly challenging to maintain product temperatures in a laboratory or storage setting. The difficulty increases exponentially in case the products must travel at a consistent temperature across thousands of miles over several days or weeks altogether. In such cases, product integrity can only be ensured through the right biopharma cold chain packaging solutions. Fortunately for biopharmaceutical manufacturers, there has been a significant expansion in the packaging and monitoring technologies for the biopharma cold chain.  Semi-active packaging, including expanded polystyrene (EPS) and expanded polyurethane (EPU) systems, remain as one of the most common and economical biopharmaceutical cold chain packaging choices for local or short-distance transportation. But this type of packaging solutions are unable to regulate their own internal temperatures and require a change in packaging configuration seasonally even if the route doesn’t change. Passive cold chain packaging solutions, on the other hand, are more focused on offering longer temperature control durations with lighter materials. These solutions are proven to maintain temperature control even through longer distances. GPS technologies and tracking can be used to monitor and gain a real-time view of shipment status throughout the products’ journey.

Although technology can benefit to a certain extent, it is vital for manufacturers to partner with organizations that can help find the solutions to align with their product-specific needs. Request a free proposal to know how Infiniti’s solutions have helped clients with similar requirements.

Expanding global clinical trials


The number of registered clinical trials across the globe has cross 1 million. The need for efficient global clinical trials are increasing with the rising regulatory mandate for tests to be conducted within the country where the manufacturers seek launch and market new drugs and targeted therapies. With the expansion of the global clinical trials market, there are significant hurdles that manufacturers must overcome in order to ensure that products arrive at the right place, at the right temperature, and within the expected time frame. Navigating geo-political roadblocks to ensure higher performance of the clinical and commercial supply chain is crucial for both manufacturers and cold chain packaging partners. To avoid any hindrances to clinical trials of drug shipments in emerging countries for time and temperature-sensitive medications, manufacturers should consider working with specialty logistics experts in these countries.

Manufacturers around the globe are investing into biopharmaceutical cold chain packaging for effective solutions as the demand for personalized, high-value drugs with more active pharmaceutical ingredients shorter shelf-lives, and strict temperature requirements increases. Get in touch with an expert from Infiniti Research to know how we can help cold chain logistics providers identify market innovations and key challenges in different markets in order to cater to these demands.

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Opportunities and Challenges in the Global Biopharmaceutical Market

Biopharmaceuticals is currently at the core of the pharmaceutical sector. The opportunities in the global biopharmaceutical market are big and growing too rapidly. In fact, biopharmaceuticals generate global revenues over $150 billion, making up about 20 per cent of the total pharma market. It’s by far the fastest-growing part of the industry. Biopharma’s current annual growth rate is double that of conventional pharma, and the growth is expected to continue at that rate for the foreseeable future. However, the global pharmaceutical market is not entirely free of challenges and flaws. As biopharma companies move from the scientific frontier to the business mainstream, the companies in the global biopharmaceutical market will increasingly be forced to confront the same challenges of maintaining competitiveness by ensuring affordability, quality, and delivery performance.

Only through deep operational excellence can biopharma companies fulfill its potential to transform the health expectations of millions of people across the globe and successfully navigate both the promising and challenging elements of the sector. Request a free proposal to know how we help our clients in the biopharma sector achieve this.

Opportunities in the biopharmaceutical industry

Biopharmaceutical products are known for their efficacy and safety. Furthermore, the ability of these products to address and cure previously untreatable conditions allows companies in the global pharmaceutical market to command high prices for new and innovative drugs. Despite the high prices, the strong demand for biopharma products are driving sales and profitability in this market. According to our pharma industry analysis, investments made in the global biopharmaceutical market has yielded better returns than the pharma industry average, prompting clinical trials to become unprecedently high. The success of the clinical pipeline will lead to a higher number of new molecule launches, rising from a handful a few years. Moreover, robust, low-cost genetic profiling will improve treatment outcomes and serve to accelerate and enhance the outcomes of clinical trials, helping to reduce the cost of drug development.

Challenges in the global biopharmaceutical market

Managing demand for improved access

The downward cost pressure is expected to intensify with healthcare systems increasingly attempting to balance the rising demand with the reducing budgets. Consequently, payers may also find it challenging to justify the annual treatment costs demanded for some biopharmaceutical products. Furthermore, governments in emerging markets understand the critical role that biopharma will play in boosting healthcare outcomes, and they are demanding alternative ways to fulfill the rising demand for these products.

Many of the next major opportunities for biotech will require companies to develop new and different technologies and operating models. Get in touch with our experts to know how we can help you stay updated with latest innovations and strategies for success in the global biopharmaceutical market.

Quality compliance and regulatory scrutiny

Companies in the global biopharmaceutical market are struggling to keep up with the rising demands of regulators, primarily the US Food and Drug Administration. In the last five years, the industry has been subject to an unprecedented number of warning letters, and scrutiny is unlikely to decrease. Furthermore, the rising relevance of global markets (beyond the United States, European Union, and Japan) is increasing the complexity of multiple quality standards and regulatory regimes. Compliance, robustness of processes, and efficiency are keys to success for companies in the global biopharmaceutical markets.

Complexity in supply chain operations

The complexity of supply chain operations of companies in the global biopharmaceutical market are bound to increase with the rise of new processes and technologies. Moreover, the current production programs are already stretching the industry as even several top biopharmaceutical companies are failing to deliver to the market.

Know more about how Infiniti can help overcome key challenges faced by companies in the global biopharmaceutical market.

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Top Trends Shaping the Asian Biopharma Industry

Some of the earlier events in Asia, such as China’s market access blockade, Japan’s spending controls, and deceleration in Southeast Asia and India have contributed towards a flat enthusiasm for the biopharmaceutical sector in Asia. However, certain recent trends have reignited the interest in biopharma in this region, with key implications for pharma executives.

Asia is popular for its dynamic markets and its rapid growth. Although over the past year the enthusiasm in the region for biopharma has been flat, several recent biopharma trends have turned the tables. This has brought about several market changes that make it essential for companies to reassess their strategy and go-to-market model. In this blog, biopharmaceutical industry experts at Infiniti Research discuss some of the recent biopharmaceutical industry trends in Asia and share perspectives on their implications for executives in biopharmaceutical companies.

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Key biopharma trends in Asia

CDFA reforms in full stride in China

The recent China Food and Drug Administration (CFDA) reforms are more optimistic fundamentals that aim to support industry growth through innovation. Over the past few years, the CDFA has made significant strides in terms of addressing critical gaps in the system. Furthermore, there have been several reforms published on the drug-registration policy. These policies have been designed to improve the registration process and to encourage companies in the biopharmaceutical industry to bring innovation to China. This includes therapies for addressing severe and rare diseases and fast tracking approval for therapies. As a result of these new drug approvals, a record number of approvals and new product launches were seen over the last couple of years. The biopharma industry in China is accelerating against the backdrop of the new CDFA reform.

Price reforms in Japan

The Japanese ministry of health made a proposal in 2017 to overhaul the current drug pricing regulations. This reform will affect both the new drug pricing and in market pricing revisions across all drug categories including off-patent long-listed products, patented prescription drugs, and generics. This includes changes such as narrowing price maintenance premium (PMP) for patented products. The PMP will now be applicable only to selected drugs and full premium will be awarded only to a subset of companies. The scope of the premium will be limited to innovative drugs and the amount of premium will be matched to a company’s contribution to R&D.

Emerging fund pools in Southeast Asia and China

In China, there has been an upward trend in the expansion of reimbursement of innovative drugs. Furthermore, companies in the biopharma industry in China have also started to experiment with new models to improve patients’ access to medicines. China remains an important growth engine for companies. With these biopharma trends and changing outlook in China, the country remains a highly lucrative market and an important growth engine for companies in the biopharma industry.

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Digital and advanced analytics in healthcare

Although big data and other digital technologies have been constant buzzwords in the biopharma industry in Asia, now we are seeing their gradual uptake by several companies in the sector. Governments in Asian countries like China and Japan have introduced policies to promote the application of such advanced biopharma trends. Furthermore, even physicians and medical reps, especially in Japan, have already shifted away from pharmaceutical sales reps as their primary information source and use digital channel as their primary source. In China, for instance, studies show that doctors spend over two hours of their working day on an average online and have switched from computers to smartphones to support many of their professional activities. Consequently, digitalization is going to be one of the key biopharma trends that are going to revolutionize Asia.

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How to Rollout a Successful Biopharmaceutical Product Launch Plan

A product launch is no child’s play, a significant amount of planning and execution strategies are decided on before the actual product launch. A product’s performance during its launch often indicates how successful it will be during its life cycle. Take the example of the movie business; the opening weekend is the critical barometer to predict how popular the movie will turn out to be at the box office. That dynamic holds true in the biopharmaceutical industry as well. However, in the current market scenario, biopharmaceutical product launch is more challenging than ever before. Rising regulatory issues, growing stakeholder expectations, numerous market-access hurdles, and stiff competition are some of the critical hindrances coming in the way of biopharma companies. So how can players in the biopharmaceutical space overcome these hurdles and roll out a successful product launch plan?Request Free Proposal

Create a game plan

Managers need to think strategically if they aim at leading their team to victory in the case of a product launch. They must take into account market conditions, how much companies have spent to support a competing product, and the product’s positioning at a particular point in time. Considering only competitors’ past actions leaves managers unprepared to react to changes in rivals’ tactics. Instead, companies must plan for the “game” that lies ahead, predicting the successive moves that competitors might make in to tackle a new market entrant. War-gaming can prove to be a useful tool for identifying possible market disruptions, study the probability of various competitive actions, estimate their impact, and design an appropriate response.

Cross-functional market access team

Traditionally, winning in the marketplace has been achieved by having sales representatives continually communicating information about a product’s efficacy and safety directly to physicians. Today, biopharmaceutical companies need to effectively make the case for their product to a host of payers and health technology assessment (HTA) agencies, which are now operating in most markets. Though many companies have a market access team, it rarely includes individuals from different verticals across the organization. To have a constructive conversation with payers, companies must create a cross-functional market-access team comprised of individuals from various departments such as R&D, sales and marketing, and medical affairs. This team can get in touch with payers and HTA agencies and then keep them updated on the decisions made throughout the R&D process. The team should especially communicate the type of patient populations that are being targeted and the expected benefits. This will give payers and HTA agencies the opportunity to provide guidance on the kind of efficacy and safety data they would be looking for.

Innovative pricing

Price increases have been a significant driver of growth for pharmaceutical companies, accounting for 65% of the industry’s growth worldwide. Although the biopharmaceutical industry has relied heavily on price increases, it is not leveraging pricing as a tool for gaining competitive advantage. Biopharmaceutical companies should study innovative pricing strategies during product development and make pricing a core pillar of the product’s profile. Innovative pricing is often critical to gaining market access and receiving reimbursement.

Build stakeholder relationships

The ideal biopharmaceutical selling model focuses on a single channel: the physician. But this approach is no longer relevant in a world where myriad stakeholders exert significant influence over prescribing decisions. A consistent challenge is getting a comprehensive view of which stakeholders matter the most, who is connected to whom, and who influences the stakeholder network. Social-network analysis helps biopharma companies to identify which institutions or individuals – key opinion leaders, payers, HTA agencies, guideline committees, or physician and patient groups are the most influential across stakeholder groups.


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Market Intelligence Engagement: How Infiniti Helped a Prominent Biopharmaceutical Company Enhance their Operational Efficiency by 20%

Today, the biopharmaceutical space is investing highly in clinical development to effectively prevent and treat the growing number of life-threatening diseases. With health being top priority, prominent biopharma players are revisiting their strategies and technologies to enhance their operational efficiency. The growing concern to reduce the cost of drug development is compelling organizations to ensure affordability, quality, and performance in the products offered. Moreover, the growth of the biopharmaceutical space is largely determined by the innovations in terms of immunotherapies, antibody drug conjugates, and cell therapies. As the biopharma companies are moving to the business mainstream, several factors may influence the growth of the industry. These include:

  • Maintaining competitiveness: Today, the healthcare systems are trying to cope up with the rising demand for reliable healthcare services among the end-users. With the shift toward more biopharmaceutical products, prominent players are facing pressures to reinvent their production capabilities to meet customer expectations. Moreover, the government policies are encouraging more players to enter the market in a bid to offer safe medications to people.
  • Complexity in the supply chain operations: The relentless growth in technology increases the complexity of the biopharma operations as current production programs are failing to bridge the demand-supply concern. So, to meet the growing healthcare demands, organizations should adopt lean practices to reduce operating costs across manufacturing and quality divisions.

To address these challenges and understand the current market requirements, organizations are leveraging a market intelligence solution. A market intelligence solution helps businesses gain timely and relevant information about the company’s market to ensure accurate and confident business decision. Moreover, businesses can ascertain the demand for products and services and understand the competitive effectiveness of the products in the market.IR_Brochure

The Business Challenge

  • The client:  Leading biopharmaceutical player

The client, a prominent biopharmaceutical company, wanted to outline the demand for products and the market likeliness to respond to a new entrant. Through an effective market intelligence engagement, the client wanted to segment the market based on the competitor information, product information, and customer information and devise marketing campaigns to meet the business requirements. The primary concern of the client was to minimize the risk of the investment decisions being wrong. Moreover, the client in the biopharmaceutical companies space also wanted to stay ahead of the competition and obtain an advantage over other competitors.

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Our Approach

To tailor the products and marketing efforts around the customer needs, the market intelligence experts at Infiniti carried out extensive research methodology. The research methodology covered interviews and discussions with prominent stakeholders in the biopharmaceutical companies space. Moreover, with the help of reliable sources such as trade shows, company presentations, and industry forums, the experts also gained better clarity into the market requirements in the biopharmaceutical companies space.

The Solution Benefit and the Business Impact

The market intelligence solution offered by Infiniti helped the client in the biopharmaceutical companies space streamline their marketing resources based on the customer requirements. The client was able to identify and address the potential bottlenecks in terms of the compliance requirements and supply chain disruptions and was able to enter potential markets in an agile and seamless manner. Moreover, the solution also sought ways to invest in the market that promises better results.

The Future

As the new classes of molecules evolve, biopharmaceutical companies will leverage the use of innovations to improve manufacturing, supply, and quality-assurance approaches. Moreover, biopharmaceutical companies will also rely on technologies such as hybrid systems to suit specific product and market conditions.


A must-read case study for strategy specialists and decision makers looking to develop an understanding of the biopharmaceutical companies space.

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Pharmaceutical Industry

Pharmaceutical Industry Challenges – Roadblocks to the Industry’s Growth Prospects

The growth of the pharmaceutical industry has slowed down over the last few years. Experts suggest that the market has reached its saturation level. However, due to recent advances in technological innovation, the market is anticipated to witness further growth. Innovations such as wearable devices, real-world evidence, telemedicine, nanotechnology, and precision medicine are expected to change the landscape of the pharmaceutical industry. Despite such innovations, the pharma industry has started facing some tough tests recently.

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Pharmaceutical Industry Challenges

Pharmaceutical Industry Growth Slowdown

Numerous market research reports have highlighted the fact that the pharmaceutical industry will experience a slowdown in the next few years since the major markets are nearing their saturation point. Historically, the pharma industry has experienced a sporadic increase in growth rates with the introduction of generic medicines for diseases like hepatitis and cancer. Therefore, it can be estimated that the growth prospects of the pharmaceutical industry are currently dependent on the invention of effective medications.

Biosimilar Showdown

Biosimilar drugs are capable of increasing the efficacy of medicines and patient safety at an economical cost. However, big players in the pharmaceutical industry are opposed to biosimilars as it’s hurting their innovative capacities. In the US, the FDA has approved 41 new medicines, the most in 18 years, with more drugs in the pipeline. The recent Sandoz vs. Agmen case has also brought into limelight the fact that the cheaper version of complex and pricier drugs, called biosimilars, get to patients faster.

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Contact USShift to Value-based Payments

As a whole, the healthcare industry is moving towards value-based payments from volume-based or fee-for-service based payments. This system rewards the increment in quality and value of healthcare services. Companies in the pharmaceutical industry are also looking to implement value based purchasing but will face challenges in estimating an appropriate time-frame for manufacturers to demonstrate drug efficacy. Therefore, it will be difficult for new drugs to compete in the value-based payment system.

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Single-Use Technology – Taking Biopharmaceuticals to a Whole New Level

Largely used in the biopharma industry, the single use technology (SUT) has emerged as one of the foolproof methods to bring down contamination and improve the overall quality of the pharma products. Industry majors like GEHealthcare, ThermoFisher, and VWR, have already made major investments in this technology. Cleaning validation is critical in the biopharma industry, and this is what single use technology offers – right from biosynthesis to the formulation process, this technology reduces the risk of cross-contamination, is eliminating the need for cleaning validation altogether.

How single use technology will help the biopharma companies?

Regarded as one of the most important trends in the biopharma space, Single Use Technology helps in:

1.     Bringing down negative impact on the environment

When compared to the carbon footprint created by wastewater, energy, and chemicals, the plastics used in the SUT process are relatively safer. In spite of being incinerated, the carbon footprint contributed by this technology is negligible.

2.     High productivity and low cost

Being used just for a one time, the need to clean and reuse the utilities have come down. This not only saves time, but also reduces the cost of the entire operation. Also, the amount of energy consumed is brought down. When it comes to productivity, Single Use Technology helps in increasing it, as the time spent by the labor on changing the disposable systems, and sanitizing the traditional stainless steel system.

3.     Efficient manufacturing and sustainable process

Sustainability is a major goal which many biopharma companies are working to attain. And this is exactly what is attained through the single use technology process. Also, by making significant reductions in labor, not only does single use technology speed up the manufacturing process, but it also makes product changeovers easier to achieve. Not to forget, adherence to high quality and safety makes it easier for biopharma companies to manufacture products which meet the requirement of the regulatory agencies.

It is due to these advantages that industry experts regard the single use technology as a major game changer in the biopharma industry. With growth of the global market for biopharmaceuticals, the demand for SUT is also on a rise – which is good news for both the producers as well as consumers of the biopharma products.

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