biopharmaceutical industry Archives - Business Intelligence

Tag: biopharmaceutical industry

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.

Want more insights into our solutions portfolio?

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.

Market Forecasting Solutions + Surgical Equipment Market

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.

Fortune 500

Pharmaceutical manufacturing

Winning in Emerging Markets: What Big Pharma Companies Must Do

Emerging markets are highly promising and offer a plethora of opportunities for pharmaceutical companies. As a result, there is an unprecedented increase in the number of companies in the life sciences industry that are turning to emerging markets such as Brazil, India, and China to set up their businesses. Pharma industry experts at Infiniti Research believe that big pharma companies that are innovative and advanced in terms of manufacturing, logistics and distribution, and understanding customer needs are more likely to gain an edge over the others in these coveted markets. Despite several efforts, some big pharma companies often fail to gain a major foothold in these regions. This issue occurs due to several reasons. Sometimes, new entrants in the big pharma market discover that operating and selling in emerging markets can be challenging due to market access requirements including manufacturing, logistics, and supply chain can be complex. Furthermore, unfavorable regulatory environment, dynamic pricing and reimbursement practices, and talent management challenges also pose major challenges for big pharma companies in emerging markets.

In this article, Pharma industry experts at Infiniti Research share some of the key strategies that big pharma companies can use to succeed in new and emerging markets.

Growth strategies for big pharma companies are increasingly dependent on expansion into emerging markets. Request a free proposal to know how we can help support your market expansion plan into emerging markets.

How big pharma can compete effectively in emerging markets

Big pharma companiesOne of the primary steps in establishing and executing a growth strategy for big pharma companies involve identifying commonalities across markets. These commonalities must support cost-effective approaches while taking into account the unique regulatory constraints and consumer attributes of different regions. Here are three key approaches for big pharma companies to capitalize on attractive opportunities in emerging markets.

Group customers into clusters

Customer submarkets in emerging countries can be identified within a national or regional market by analyzing and grouping consumers who have common health needs. Creating customer clusters in emerging markets will help big pharma companies to identify various customer challenges in the market and create tailored solutions to cater to the needs of these groups.

Identify cross-border commonalities

Constricting emerging market entry to national boundaries is a common mistake that big pharma companies make. An approach that is too focused on national or regional boundaries could mean that customer similarities across markets are not being sufficiently leveraged to create solutions that can move across borders. Identifying cross-border insights can enable big pharma companies to serve groups or clusters of customers more effectively and efficiently.

Timely and cost-effective execution

Given the fact that most life sciences companies operate in functional silos, executing solutions across markets in a timely and cost-effective manner could prove challenging. Therefore, big pharma companies must focus on creating a single, coherent strategy rather than trying to coordinate separate strategies. Two capabilities that are especially critical when planning the rapid execution of an emerging-market strategy include developing the ability to understand and to get close to the customer and improving the risk management capabilities.

Learn more about Infiniti’s solutions for big pharma companies

Pharmaceutical manufacturing

IoT in Pharmaceutical Manufacturing: How it will Make a Difference

Internet of things (IoT) has the power to revolutionize pharmaceutical manufacturing in everything ranging from drug discovery to remote patient access and monitoring. Top pharma companies around the globe are increasingly adopting IoT technologies in their manufacturing plants in an effort to achieve optimization and improve process efficiency. Earlier, different data formats for different processes in a pharmaceutical manufacturing plant made data access and interpretation a significant challenge for effective communication. IoT technologies enable standardization within a pharmaceutical manufacturing plant by effectively connecting network, equipment, and systems across the plant. Furthermore, Pharma companies can also use IoT technologies to gain access to real-time data and visibility of operations through the entire manufacturing process. Here’s a detailed look on how IoT will transform pharmaceutical manufacturing.

Despite technological advancements, the pressing matter pharma companies have to address is how to achieve more control over their operations within and outside the facilities to remain competitive, optimize time-to-market, avoid shipment delays, and reduce the waste. Request a free proposal to know we can help overcome this dilemma.

IoT in Pharmaceutical Manufacturing

Pharmaceutical manufacturingIndustrial mechanics and maintenance

Although the use of industrial monitoring devices are already widespread in the pharmaceutical industry, real-time status information is yet to be widely available. Using pharma IoT monitoring sensors companies can instantaneously feed all relevant facility data into a single dashboard, alerting a supervisor in case of any abnormal conditions or urgent maintenance requirements. IoT in pharmaceutical manufacturing will also enable handling critical conditions remotely.

Managing pharma supply chain

Once the drugs leave the manufacturing plant, they travel through different modes of transport and may be subject to varying temperatures and weather conditions. Although in most cases care is undertaken to maintain the packages within the prescribed temperatures, chances of variations during transit cannot be completely ruled out. IoT can be helpful in such situations to provide real-time data to manufacturers every step of the way with improved supply chain visibility. The temperature changes or any damage to the products will be immediately notified to the manufacturers and determine whether the drugs are fit to sell or not.

In the pharmaceutical industry, mistakes have serious consequences, so progress will always be slow and cautious. Get in touch with our experts to learn how our solutions can help companies in the pharmaceutical industry.

Controlling drug manufacturing environment

In pharmaceutical manufacturing, sub-optimal environmental conditions can often prove to be fatal. However, this obstacle can be easily handled with the help of IoT. Pharma IoT establishes transparency in drug production and storage environment by allowing multiple sensors to monitor environmental indicators such as temperature, humidity, radiation, and light in real-time.

Learn more about Infiniti’s solutions for the pharma industry

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.

Would you like to learn more about our solutions for the healthcare industry? Request a free brochure for insights into our services portfolio and learn how we help global clients overcome their business challenges!

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.

Stay current on the latest market updates and leverage advanced solutions to achieve your business goals. Request a free proposal for more insights on how our solutions can help your business.

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.

Learn more about Infiniti’s solutions for business.

Close
Infiti Logo

Hello there!

Contact us to know more about our cost-effective custom market research offerings to support efficient market penetration, new product launch, and devise strategies to monitor and outperform your competitors.

Cookie Policy

The Site uses cookies to record users' preferences in relation to the functionality of accessibility. Please refer to the help guide of your browser for further information on cookies, including how to disable them. Review our Privacy & Cookie Notice