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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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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.

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Market Segmentation Aids a Company Specializing in Industrial Biotechnology to Develop Better Marketing Campaigns for the Target Segments

Industrial biotechnology is one of the most promising fields for resource conservation, pollution prevention, and cost reduction. It is every so often referred to as the “third wave in the healthcare industry.” Rising demand for new technologies such as recombinant technology, DNA sequencing, fermentation, tissue engineering is expected to drive the popularity of industrial biotechnology among various industries, including the pharmaceutical industry.  

Our recent analysis shows that the companies specializing in industrial biotechnology for the pharmaceutical industry are facing challenges such as:

  • The Current Investment Environment: Given the weakened economy, investors are wary of investing in industrial biotechnology companies given the absolute amount of money they need to start-up and come on line. However, getting to scale, involves more time and money than in other industries such as information technology. Also unique to industrial biotechnology investment is the need for companies to take feedstock requirements into account in their investment plans.
  • Cost Containment and Cost Cutting: Trends in this area indicate industrial biotechnology companies are increasing their outsourcing in the regions that improve productivity and reduce costs. Moreover, company budget increases are not being directed toward rebuilding an in-house staff that had been reduced or eliminated in recent years.

Many such factors are compelling companies to leverage the use of market segmentation solutions. Market segmentation solutions help companies in the pharmaceutical industry to segment their marketing efforts based on demographic data and improve their performance. These solutions help companies in the pharmaceutical industry to create robust marketing campaigns to improve customer loyalty which, in turn, increases the lifetime value of the customers.IR_RFP Furthermore, market segmentation solutions help firms specializing in industrial biotechnology to gain insights into the latest pharmaceutical industry trends.

The Business Challenge

  • The Client: Industrial biotechnology company

The client, a leading industrial biotechnology company, wanted to improve their business strategy to enter new market segments and achieve better bottom-line results. The client also wanted to re-strategize their branding strategy without comprising on their offerings. The company wanted to gain an understanding of their current market position and profile different consumer groups.

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The Journey

Infiniti’s market segmentation experts followed a blended approach, comprising interviews and discussions with leading stakeholders in the industrial biotechnology market to help the client identify the key market segments and allocate their marketing budget effectively. The experts further compiled information from a wide array of secondary sources such as paid industry databases, company presentations, and industry forums to help the client identify lucrative opportunities in the pharmaceutical industry.

The Solution and the Business Impact

With the help of Infiniti’s market segmentation solution, the industrial biotechnology company was able to segment the market in terms of demography and geography and accordingly allocate resources to increase their performance. Additionally, the client was able to gain an understanding of the product portfolios and subsequently develop a focused marketing strategy to maximize their potential in the pharmaceutical industry.

The Future

In contrast with some mainstream pharmaceutical industry segments, industrial biotechnology today is trending toward increased growth and profitability. Trends affecting the industrial biotechnology industry include increased state, regional and local initiatives aimed at developing and maintaining a skilled workforce and increasing company budgets and having an expanded presence of biotechnology-centered incubators and economic development centers. This will increase the number of industrial biotechnology companies and products present in the market in coming years.

A must-read case study for pharmaceutical industry strategy specialists and decision makers looking to develop a better understanding of the applications of industrial biotechnology.


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