biopharmaceutical cold chain packaging Archives - Business Intelligence

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biosimilars market

Themes Shaping the Global Biosimilars Market and What Players Can Do to Stand Out

The global biosimilars market is set for continued growth owing to patent expirations of some of the best-known biologics in the coming years. Despite many practical biosimilars challenges in Europe and the US, both these regions will continue to mature and offer growth opportunities to players in the sector. However, the downward price pressure in the biosimilars market indicates intense competition among key players in the sector. In this scenario, a key differentiator for biosimilars companies will be the ability to design and implement new development and commercial models. By doing so, players can offset the impact of declining prices and rising competition. Our biosimilars market forecast estimates that sales in the sector will surpass $ 10 billion in size by 2022. In this article, healthcare industry experts at Infiniti Research identify some top-of-mind themes that are set to shape the biosimilars market in the years to come and also evaluates what players can do to stand out in the dynamic market.

Although the biosimilars industry has developed rapidly and regulation has advanced significantly over the years with approval processes now in place in many countries, there may be several opportunities to further streamline the regulatory process and accelerate path to market. RFP to know how we can help you effectively identify and capitalize on them before they turn into lost opportunities.

Market development in the US and Europe

Due to the increasing acceptance of biosimilars as an equal to patented drugs in terms of safety, efficacy, immunogenicity, the sales in the biosimilars market in Europe is growing at an unprecedented rate. However, the progress in the biosimilars market across the European region remains uneven. The demand for retail products and self-injectable biologics have weaker demand. This indicates reflects to lower levels of awareness in these segments when compared to hospital-administered products. In contrast, the biosimilars market growth in the US remains fairly flat. In the US, only three biosimilars are currently actively marketed while others remain tied up in patent disputes or are awaiting patent expiry. Furthermore, several regulatory efforts in progress in the US add to the challenges of players in the US biosimilars market.

Price management to create value

Pricing is a vital factor that plays a crucial role in the success of a biosimilar product. Price optimization helps manufacturers create greater leverage in its commercial budget. This can, in turn, be used to enhance competitive positioning, improve business growth and even create product differentiation in the biosimilars market. As in the generics and MedTech sectors, a sound price-to-volume model is vital in the biosimilars market to make the right tradeoffs across accounts. A strong model can better support contract management based on a real-time understanding of the biosimilars market. Moreover, it can also enable quick decisions and help manufacturers calibrate risk/reward ratios.

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Agile go-to-market strategies

Given the intense market competition, biosimilar companies are gradually evolving into highly technical and specialized organizations. As the current generation of biosimilars is complex in comparison to the earlier generations, it is essential to ensure that they are tested and launched in a much more restricted analytical and clinical environment. Additionally, biosimilars companies must also have the ability to take bold decisions on where to invest and identify ways to set up a commercial footprint. It is also important for companies in the sector to demonstrate the ability to rapidly trade-off resources based on dynamic market conditions.

Want to identify unmet needs and investment opportunities in the biosimilars market? Learn how our solutions can help you.

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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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