Biosimilars and Follow-on Biologics Market: Introduction
- Biosimilars are medicinal products that contain biological active substances that have been shown to be similar to existing approved biological drugs (so-called "reference medicinal products") in terms of quality, biological activity, safety, and efficacy. A comprehensive comparability exercise is used to demonstrate the resemblance to the reference medicinal products.
- Follow-on biologics are medications obtained primarily from biological sources such as bacteria and yeast. Small molecules, such as human insulin or erythropoietin, or complex compounds, such as monoclonal antibodies, can make up biosimilar pharmaceuticals. Given the loss of exclusivity for branded pharmaceuticals, biosimilars are gaining traction.
Key Drivers, Restrains, and Opportunities of Global Biosimilars and Follow-on Biologics Market
- Monoclonal antibodies (mAbs), insulin, erythropoietin (EPO), interferons, growth hormones, and fertility hormones are the key therapeutic areas with high revenue potential in the market. Recent changes in FDA’s approach to biosimilars have favored the expansion of the global biosimilars and follow-on biologics market.
- Increase in research on follow-on insulin has attracted sizable research investments by biopharmaceutical companies. However, commercialization of biosimilars into routine clinical practice is implausible. The pace of commercialization of biosimilars is reliant on better regulatory and pricing structures. Increase in incidence of diseases across the world and better access to health care for all drive demand for biosimilar drugs.
- Restrictions in developing and registering biosimilar pharmaceuticals and the complexity of manufacturing procedures restrain the global market. Drugs are difficult to verify and must adhere to stringent rules. Moreover, drugs differ from each other in terms of raw materials and manufacturing processes, which is likely to hamper the development of biosimilars in the near future.
- The COVID-19 pandemic has had a significant impact on the global economy at different levels, including the healthcare industry. The global market is likely to witness a steep decline in sales of biosimilars and follow-on biologics during the lockdown period due to the shutdown of manufacturing units, acute shortages in raw materials, and a lack of potential workforce. Production and supply chain activities have faced significant disruptions due to the pandemic. However, the market is expected to recover gradually, providing attractive sales opportunities in several regions in the near future.
Europe to Capture Major Share of Global Biosimilars and Follow-on Biologics Market
- Europe is anticipated to account for major share of the global biosimilars and follow-on biologics market during the forecast period. The region's dominance is attributed to the technologically advanced health care infrastructure, strong patient awareness, and regulatory harmonization in the region. Increase in investment in biosimilar drug development, availability of high quality research infrastructure, and drug companies' strategies to prevent new players from entering the market.
- The biosimilars and follow-on biologics market in Asia Pacific is likely to grow at a rapid pace during the forecast period owing to rise in prevalence of chronic diseases. This is attributed to the prevalence of chronic diseases and improving health infrastructure in this region. In developing countries, collaboration with domestic players is a major opportunity for biosimilars. Several companies, such as Amgen and Novartis, are collaborating with businesses in Asia in order to gain access to the biopharmaceutical market.
Key Players Operating in Global Biosimilars and Follow-on Biologics Market
The global biosimilars and follow-on biologics market is highly competitive and mature due to the participation and presence of large number of established as well as new players.
Major players operating in the global biosimilars and follow-on biologics market are:
- Novartis AG
- Pfizer, Inc.
- Amgen, Inc.
- Coherus Biosciences, Inc.
- Dr. Reddy’s Laboratories
- Biocon Limited
- Mylan NV (Viatris, Inc.)
- Roche Diagnostics
- Merck KGaA
- Samsung Bioepis Co., Ltd.
- Other Prominent Players
Global Biosimilars and Follow-on Biologics Market: Research Scope
Global Biosimilars and Follow-on Biologics Market, by Type
- Human Growth Hormone
- Monoclonal Antibodies
- Granulocyte-Colony Stimulating Factor
Global Biosimilars and Follow-on Biologics Market, by Application
- Blood Disorders
- Oncology Diseases
- Chronic & Autoimmune Diseases
- Growth Hormone Deficiencies
Global Biosimilars and Follow-on Biologics Market, by Region
- North America
- Rest of Europe
- Asia Pacific
- Australia & New Zealand
- Rest of Asia Pacific
- Latin America
- Rest of Latin America
- Middle East & Africa
- GCC Countries
- South Africa
- Rest of Middle East & Africa
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.
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.