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A biosimilar medicine possesses the similar pharmacokinetic and mode of action as an original biological medicine that has already been approved for therapeutic use. Biosimilars are made from a living organism such as bacteria and yeast or can also be derived from small molecules like human insulin, erythropoietin and monoclonal antibodies via recombinant DNA and gene expression technologies. Biosimilars are developed only when original biological medicines are commercially expired and therefore are known as follow on biologics or subsequent entry biologics. These molecules are used to treat same diseases as original molecules intended to. Like biosimilars, biosuperiors are also developed against already approved biological medicines but they possess attributes that are superior to the original molecules and not only replication. Biosuperiors are developed by utilizing revolutionary technologies including protein engineering, effector function enhancement, half-life extension through Fc engineering, bispecific molecules, antibody-drug conjugate technology and affinity maturation which enable biosuperiors with improved attributes over their innovator molecules.
Developing a new biological medicine can incur cost up to USD 1.2 billion that is also associated with a high risk of research and development failure. However, the overall cost and research and development risk with biosimilars and biosuperiors are less than the original biologics. By some estimates, from development to approval, a biosimilar may incur cost up to USD 75 million to USD 250 million. On account of a requisite of lower investment many pharmaceutical and biopharmaceutical companies are striving to enter into biosimilars and biosuperiors market. One such example is Medlmmune, a business unit of AstraZeneca plc that has increased its investment in research and development programs related with biosuperiors with an intention to maintain a clinical pipeline portfolio with minimal risk. They consider biosimilars and biosuperiors, new drug categories with immense opportunities and expect to get higher return on little investment. This indicates a favorable condition for biosimilars and biosuperiors therapeutic antibodies market to grow. Advances in technology such as polyclonal mixtures, Fc engineering and antibody-drug conjugate also drive the market growth by escalating research and development activities. 
The low price for biosimilars which usually costs in a range of 65%-75% of its original biological medicines is one of the key factors driving the demand for biosimilars worldwide. Biosimilars being cost effective alternative to innovator products also attract government and many payers, indicates a positive growth of the molecule.
Patent expiry of many blockbuster biologics in coming years is expected to intensify the competition among biosimilar and biosuperiors manufacturers. It is estimated that by 2020, many biologics with sales worth of USD 81 billion are expected to lose their exclusivity. These biologics include Avastin (bevacizumab), Herceptin (trastuzumab), Synagis (palivizumab), Enbrel (etanercept), Humira (adalimimab), Remicade (infliximab) and Rituxan (rituximab). These patent expiries of major biologics are expected to offer potential opportunities in North America as well as Europe. In Asia-Pacific region, low cost of biosimilars and biosuperiors will play a key role in driving the market growth as reimbursement scenario in the region is very poor and patients have to pay for the drugs from their own pocket only. A large pool of patient with various chronic diseases including lung cancer and prostate cancer will further drive the market growth in Asia-Pacific region.
AstraZeneca plc, Eli Lilly and Company, Bristol-Myers Squibb, GlaxoSmithKline, Amgen, Inc., Novo Nordisk, Abbott Laboratories, Sanofi and Novartis AG are some major companies operating in the market for biosimilars and biosuperiors therapeutics antibodies.

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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Biosimilars Biosuperiors Therapeutics Antibodies Market

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