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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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Pharma packaging industry

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.

Chinese biopharmaceuticals market industry

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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Anatomy of the Medical Imaging Market – Where’s it Heading?

At first, it may be difficult to comprehend on how devices can circumvent through all the tissues, muscles, nerves, and bones to get the picture that helps doctors diagnose different diseases. Accurate diagnosis is one of the most critical aspects of health care, and detailed medical imaging is required by healthcare professionals to pinpoint the medical problem. Without medical imaging, they can only bring down the possibility to a few given conditions by monitoring the symptoms. However, with medical imaging devices, the problems can be located easily with perfection. There have been numerous advancements in the medical imaging technology, with doctors being able to see things in more details without causing harm to the patients. As a result, more and more diagnostic imaging Request Free Proposalprocedures are being performed. So, what are the trends in the medical imaging market?

Hybrid imaging technology

Hybrid imaging is the most talked about advancement in imaging technology. The PET and CT scan technology in one machine has augmented the innovations in this field. The system has been so successful that major imaging system manufacturers no longer provide standalone PET systems. Hybrid PET/CT, PET/MRI, and SPECT/CT are amongst others that have received attention. Numerous hospitals are now replacing their standalone systems for hybrid systems. For instance, while evaluating the skeletal system, a SPECT/CT system offers accurate localization and improves the information provided by CT.

Trends in Medical Imaging MarketSafer imaging systems

The general public is usually worried about the level and dosage of radiation they receive from imaging systems. As a result, doctors and patients may be reluctant when it comes to performing necessary scans. However, there have been technological advancements in this field as systems with lowered doses of ionizing radiation reduce the harmful effects of radiation. Reducing the radiation dose in a medical imaging system also provides them with a competitive advantage over their competition. Additionally, shifting from analog to digital system offers medical professionals with more accurate and faster imaging capabilities.

Value-based payments method

It is possible that a majority of the imaging tests prescribed by the doctors are deemed unnecessary. Additionally, even after having such images, the diagnosis and treatment plans are not very effective. With the advent of value-based payments methods, the current landscape is set to change. Both manufacturers and healthcare professionals will look to increase the quality and efficiency of their imaging service to please patients and improve their health outcome.

Use of contrast agents

Contrast agents are used in diagnostic imaging to enhance the image visualization. It provides detailed information, which can assist medical professionals in accurate diagnosis. The rising number of chronic diseases all around the world will drive the use of contrast agents in medical imaging market. Governments all across the world are also increasingly granting approvals for the use of contrast agents.

Cryogen-free preclinical MRI scanners

Radiologists today have a wide range of imaging technologies to choose from. As a result, it is bringing a radical change to preclinical medical imaging. Amongst all medical imaging technologies, cryogen-free MRI is gaining popularity as it uses a dry magnet that does not require liquid helium. Consequently, it significantly reduces the size and weight of MRI scanners. Also, such scanners can incorporate multimodality imaging capability and provide improved image resolution. In the near future, it may allow MRI to be used in cardiac imaging and time-resolved contrast enhanced angiography.

For more information on the trends in the medical imaging market:

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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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