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Traditional approaches to GMP facility design often tend to focus on the physical attributes or the process scales as a function of single-product throughput. This approach neglects the foundation of flexibility, especially in the process of balancing the quality of product and manufacturing costs. Hence, the design and implementation of flexible production processes is being established globally to meet the industry's emerging economic and production capacity requirements. The flexible biomanufacturing platform is characterized by operational and functional integration in the biomanufacturing process to adapt quickly to changing markets and production capacity demands for the improvement in quality, cost, complexity, and scale. Various flexible models have been proposed for biomanufacturing plants, which can be customized according to the program needs. Flexible biomanufacturing platform incorporates various tools in the process, such as manufacturing of multiple products with fast changeover, easy adoption of the manufacturing process, accommodation of both large and small volume production requirements, and easy conversion from clinical manufacturing to commercial production. Flexibility can be achieved in the equipment, process, or manufacturing facility. 

Globalization of the biopharmaceutical industry, patent expirations of blockbuster biopharmaceutical products, increasing pressure to reduce manufacturing costs, and shift in new product development toward more personalized products are expected to drive the flexible biomanufacturing platform market during the forecast period. However, regulatory requirements, selection of host manufacturers, high initial set-up cost, requirement of substantial pre-planning, concerns regarding product safety, efficacy, and quality, and capital investment and total product costs or profitability can hamper the growth of the flexible biomanufacturing platform market. 

The global flexible biomanufacturing platform market has been segmented based on technology and modality. In terms of technology, the market has been segmented into four types: single-use technology, modular environment, advanced process automation, and standardization. Single-use technology is the most preferred mode in flexible biomanufacturing process, accounting for the largest share of the flexible biomanufacturing platform market in terms of revenue in 2015. Dominance of the segment is attributed to its cost effectiveness, productivity, and efficiency. The technology reduces cross-contamination and allows multi-product bioprocessing of molecules. The single-use technology segment is projected to witness fastest growth as it lowers cost of equipment and saves labor time and cost. Modular environment is the second most popular segment of the flexible biomanufacturing platform market, wherein the controlled environmental modules (CEMs) handle and regulate each unit of operation. Based on modality, the flexible biomanufacturing platform market has been segmented into machine flexibility, material handling flexibility, and operational flexibility. Machine flexibility is the most commonly utilized technique and the segment captured the largest market share in 2015. Quick relocation of capacity, fast adaptability to capacity turnovers, and reduced time and labor costs are the major drivers of the machine flexibility segment. 

Geographically, the global flexible biomanufacturing platform market has been divided into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounted for the largest market share in terms of revenue in 2015. This is attributed to the rising number of complex molecules in the biologic pipeline, advancements in bioprocesses and capabilities, and rapid increase in product approvals in the pharmaceutical sector. Increasing demand for access to affordable biologic products in the developing economies such as Russia and Brazil, a desire for local production, and rising focus on personalized medicine for niche markets are the major factors anticipated to boost the flexible biomanufacturing platform market in North America and Europe in the next few years. 

Key players in the global flexible biomanufacturing platform market are GE Healthcare Life Sciences, Patheon, Inc., JHL Biotech, Xcellerex, Inc., McKinsey & Company, Nelson Biomedical, Setpoint Systems, Inc., R-Pharm, and Blue Ocean Biomanufacturing, among others. Management of disposable elements and increasing interaction with suppliers are the major strategies followed by key players to sustain in the flexible biomanufacturing platform market.

This study by TMR is all-encompassing framework of the dynamics of the market. It mainly comprises critical assessment of consumers' or customers' journeys, current and emerging avenues, and strategic framework to enable CXOs take effective decisions.

Our key underpinning is the 4-Quadrant Framework EIRS that offers detailed visualization of four elements:

  • Customer Experience Maps
  • Insights and Tools based on data-driven research
  • Actionable Results to meet all the business priorities
  • Strategic Frameworks to boost the growth journey

The study strives to evaluate the current and future growth prospects, untapped avenues, factors shaping their revenue potential, and demand and consumption patterns in the global market by breaking it into region-wise assessment.

The following regional segments are covered comprehensively:

  • North America
  • Asia Pacific
  • Europe
  • Latin America
  • The Middle East and Africa

The EIRS quadrant framework in the report sums up our wide spectrum of data-driven research and advisory for CXOs to help them make better decisions for their businesses and stay as leaders.

Below is a snapshot of these quadrants.

1. Customer Experience Map

The study offers an in-depth assessment of various customers’ journeys pertinent to the market and its segments. It offers various customer impressions about the products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.

2. Insights and Tools

The various insights in the study are based on elaborate cycles of primary and secondary research the analysts engage with during the course of research. The analysts and expert advisors at TMR adopt industry-wide, quantitative customer insights tools and market projection methodologies to arrive at results, which makes them reliable. The study not just offers estimations and projections, but also an uncluttered evaluation of these figures on the market dynamics. These insights merge data-driven research framework with qualitative consultations for business owners, CXOs, policy makers, and investors. The insights will also help their customers overcome their fears.

3. Actionable Results

The findings presented in this study by TMR are an indispensable guide for meeting all business priorities, including mission-critical ones. The results when implemented have shown tangible benefits to business stakeholders and industry entities to boost their performance. The results are tailored to fit the individual strategic framework. The study also illustrates some of the recent case studies on solving various problems by companies they faced in their consolidation journey.

4. Strategic Frameworks

The study equips businesses and anyone interested in the market to frame broad strategic frameworks. This has become more important than ever, given the current uncertainty due to COVID-19. The study deliberates on consultations to overcome various such past disruptions and foresees new ones to boost the preparedness. The frameworks help businesses plan their strategic alignments for recovery from such disruptive trends. Further, analysts at TMR helps you break down the complex scenario and bring resiliency in uncertain times.

The report sheds light on various aspects and answers pertinent questions on the market. Some of the important ones are:

1. What can be the best investment choices for venturing into new product and service lines?

2. What value propositions should businesses aim at while making new research and development funding?

3. Which regulations will be most helpful for stakeholders to boost their supply chain network?

4. Which regions might see the demand maturing in certain segments in near future?

5. What are the some of the best cost optimization strategies with vendors that some well-entrenched players have gained success with?

6. Which are the key perspectives that the C-suite are leveraging to move businesses to new growth trajectory?

7. Which government regulations might challenge the status of key regional markets?

8. How will the emerging political and economic scenario affect opportunities in key growth areas?

9. What are some of the value-grab opportunities in various segments?

10. What will be the barrier to entry for new players in the market?

Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.

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Flexible Biomanufacturing Platform Market