Biosimilar monoclonal antibodies can be defined as biological molecules derived from living cells or organisms. These are large complex molecules. Biosimilars are developed after the expiry of patent of approved recombinant drugs, and are also known as biologics. These biologics display a certain level of variability which can be attributed to the variations in the biological expression system of the recombinant and the manufacturing process. Biosimilars are regulated by the various governing bodies in different countries. In the U.S., the FDA regulates the release of these biosimilars, which are required to undergo pharmacovigilance regulations as its reference approved monoclonal antibody. In Europe, biosimilars are approved by the European Medicines Agency (EMEA). Manufacturers of biosimilars are required to submit risk management plan in addition to the marketing application.
Increase in patent expiries of blockbuster monoclonal antibodies has led to a rise in interest among pharmaceutical companies to develop biosimilars. This is projected to drive the market during the forecast period. Focus on research and development contributing to innovative product pipeline and expanding health care infrastructure fuel the growth of the biosimilar monoclonal antibodies market. Additionally, increasing demand for cost effective treatment among patients boosts the growth of the market. Furthermore, launch of biosimilars owing to the patent expiries of Johnson & Johnson’s Remicade, Roche’s Herceptin, and Abbott’s Humira is one of the major factors propelling the market. However, stringent regulations related to product approvals and cost structure associated with the manufacturing process are likely to hamper market growth during the forecast period. Furthermore, lack of clarity related to the regulations concerning the development of biosimilar monoclonal antibodies in various emerging markets is expected to act as a restraint of the market.
The global biosimilar monoclonal antibodies market can be segmented based on indication, molecule, distribution channel, and region. In terms of indication, the market can be categorized into autoimmune diseases, oncology, hematology, gastrointestinal diseases, and others. Based on molecule, the biosimilar monoclonal antibodies market can be classified into bevacizumab, trastuzumab, infliximab, rituximab, abciximab, and adalimumab. The rituximab and infliximab segments are anticipated to dominate the market during the forecast period. Oncology was the dominant segment in 2016 and the trend is anticipated to continue in the next few years. In terms of distribution channel, the market can be divided into hospital pharmacies, retail pharmacies, specialty pharmacies, and others. The retail pharmacies and others segments, which includes online pharmacies, are anticipated to record substantial growth during the forecast period.
Geographically, the global biosimilar monoclonal antibodies market can be segmented into five regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America accounted for the highest share of the global market in terms of revenue in 2016 and the trend is anticipated to continue during the forecast period. Strong growth in the region can be attributed to increase in product approvals, well-established health care infrastructure, and favorable reimbursement scenario. Europe is expected to be the second leading market for biosimilar monoclonal antibodies. However, the sluggish economy in the region is likely to negatively impact the growth of the market. The market in Asia Pacific is anticipated to record a significantly high CAGR owing to factors such as increasing patient population, growing government focus on enhancing health care facilities, and increase in product approvals in Japan.
Leading players operating in the global biosimilar monoclonal antibodies market are Biocon Limited, Allergan plc, Accord Healthcare Ltd., Boehringer Ingelheim GmbH, 3SBio, Inc., Novartis AG, Amgen, Inc., Alvartis Pharma, Pfizer, Inc., Celltrion, Alfred E. Tiefenbacher (GmbH & Co. KG), Hospira, and Dr. Reddy's Laboratories, among others.
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
- 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.
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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.