DUBLIN, June 26, 2023 /PRNewswire/ -- The "Biosimilars and Follow-On Biologics Market Report 2023" report has been added to ResearchAndMarkets.com's offering.
Regulatory Hurdles Slowing Down Access to Biosimilars
Even in mature areas where regulations for standard generics have been in place for some time, there are still certain challenges, particularly with regard to sophisticated generics. Product categories like respiratory and some long-acting injectables, for instance, still require a large amount of evidence production, which drives up costs and restricts the availability of generics in these markets. This is frequently accompanied by intellectual property (IP) disputes and legal actions, wherein originators are granted prolonged protection periods beyond the initial time intended for the submitted innovation, delaying Generics access.
In a similar vein, clinical trial expenses continue to be exorbitant despite the fact that the regulatory pathways for biosimilars have been well delineated. Even if it is predicted that improvements in regulatory science and characterisation abilities would lessen the necessity for such restrictions, this places researchers and producers at a high degree of risk.
Some emerging nations are still having trouble establishing the proper regulatory environment to facilitate quicker product development. While these variables have an impact on the development of generics and biosimilars, they have a stronger influence when players attempt to build a more inventive pipeline. It will be important to further simplify regulatory requirements to speed up market access while ensuring adequate quality and efficacy.
Emerging Economies Continue to Pose Challenges for Building Presence for Generics and Biosimilars Companies
While emerging nations provide a substantial development potential and an essential playing field for greater access to medicines, they also present major structural and competitive market challenges for generics and biosimilars enterprises. While fierce local competition makes it challenging for players to establish a presence in these markets, additional factors like unstable economic conditions, price controls, the push for local manufacturing in some markets, and shifting regulatory requirements across geographies are all affecting players' ability to successfully focus on these markets. It may also be less enticing for international firms to join in and assist the development of these markets due to currency repercussions in certain of the countries. Past partnerships and acquisitions have had varying degrees of success, which has limited overall growth performance for players in these fields.
In these conditions, local players who are familiar with the dynamics of their own marketplaces may have an even greater potential to grow developing economies. International players will need to concentrate on careful selection of target nations (e.g., markets with legislative requirements that are comparable to other markets, such as the US and EU) and implement a tailored portfolio approach to avoid costly expansion initiatives with little immediate return.
Key Questions Answered in the Report:
- How is the biosimilars and follow-on biologics market evolving?
- What is driving and restraining the biosimilars and follow-on biologics market?
- How will each biosimilars and follow-on biologics submarket segment grow over the forecast period and how much revenue will these submarkets account for in 2033?
- How will the market shares for each biosimilars and follow-on biologics submarket develop from 2023 to 2033?
- What will be the main driver for the overall market from 2023 to 2033?
- Will leading biosimilars and follow-on biologics markets broadly follow the macroeconomic dynamics, or will individual national markets outperform others?
- How will the market shares of the national markets change by 2033 and which geographical region will lead the market in 2033?
- Who are the leading players and what are their prospects over the forecast period?
- What are the biosimilars and follow-on biologics projects for these leading companies?
- How will the industry evolve during the period between 2023 and 2033? What are the implications of biosimilars and follow-on biologics projects taking place now and over the next 10 years?
- Is there a greater need for product commercialisation to further scale the biosimilars and follow-on biologics market?
- Where is the biosimilars and follow-on biologics market heading and how can you ensure you are at the forefront of the market?
- What are the best investment options for new product and service lines?
- What are the key prospects for moving companies into a new growth path and C-suite?
Forecasts to 2033 and other analyses reveal commercial prospects
- In addition to revenue forecasting to 2033, the new study provides you with recent results, growth rates, and market shares.
- You will find original analyses, with business outlooks and developments.
- Discover qualitative analyses (including market dynamics, drivers, opportunities, and restraints), Porter's Five Forces Analysis, PEST Analysis and recent developments.
The report also includes profiles and for some of the leading companies in the market, with a focus on this segment of these companies' operations.
Leading companies:
- 3SBio
- AMEGA Biotech
- Amgen
- Apotex
- BIOCAD
- Biocon Limited
- Biogen, Inc.
- Celltrion Healthcare
- Coherus BioSciences
- Dr. Reddy's Laboratories
- Eli Lilly and Company
- Gedeon Richter PLC
- Intas Pharmaceutical
- Mabxience
- Viatris Inc. (Mylan NV)
- Novartis
- Pfizer
- Samsung Bioepis
- Stada Arzneimittel
- Teva Pharmaceutical
Key Topics Covered:
1 Report Overview
2 Executive Summary
3 Market Overview
3.1 Key Findings
3.2 Market Dynamics
3.2.1 Market Driving Factors
3.2.1.1 Incentivizing Providers to Adopt Biosimilars
3.2.1.2 Developed Regions Driving the Worldwide Biosimilars and Follow-on Biologics Market Growth
3.2.1.3 Biologics Patent Expiry Set to Open Fresh Revenue Pockets for Biosimilars Companies Over the Next Decade
3.2.1.4 Pricing Advantage of Biosimilars Comparison to Biologics Anticipated to Fuel Market Growth
3.2.2 Market Restraining Factors
3.2.2.1 High Cost Involvement, Uncertainty and Complexities in Manufacturing
3.2.2.2 Resistance from Biologics Manufacturers to Restrain Market Growth
3.2.2.3 Reluctance of Healthcare Providers to Switch to Biosimilars
3.2.3 Market Opportunities
3.2.3.1 Companies Can Use Information of Original Innovator thus Shorten Development & Approval Processes
3.2.3.2 Diversity in Approach Among the Authorities
3.3 Trends
3.3.1 Regulatory Hurdles Slowing Down Access to Biosimilars
3.3.2 Vulnerability of Global Pharmaceutical Manufacturing Amid COVID-19
3.3.3 Emerging Economies Continues to Pose Challenges for Building Presence for Generics and Biosimilars Companies
3.3.4 Digital Transformations as a Key Enabler to Strengthen Research in Biosimilars Industry
3.4 COVID-19 Impact Analysis
3.5 Porter's Five Forces Analysis
3.6 PEST Analysis
4 Biosimilars and Follow-on Biologics Market Analysis by Type of Manufacturing
4.1 Key Findings
4.2 Type of Manufacturing Segment: Market Attractiveness Index
4.3 Biosimilars and Follow-on Biologics Market Size Estimation and Forecast by Type of Manufacturing
4.4 In-House
4.5 CMOs
5 Biosimilars and Follow-on Biologics Market Analysis by Type
5.1 Key Findings
5.2 Biosimilars and Follow-on Biologics Market Size Estimation and Forecast by Type
5.3 Monoclonal Antibodies
5.4 Fusion Proteins
5.5 Insulin
5.6 Erythropoietin
5.7 Granulocyte-Colony Stimulating Factor
5.8 Interferon
5.9 Growth Hormones
5.10 Fertility Hormones
6 Biosimilars and Follow-on Biologics Market Analysis by Application
6.1 Key Findings
6.2 Application Segment: Market Attractiveness Index
6.3 Biosimilars and Follow-on Biologics Market Size Estimation and Forecast by Application
6.4 Blood Disorders
6.5 Oncology Diseases
6.6 Chronic & Autoimmune Diseases
6.7 Growth Hormone Deficiencies
7 Biosimilars and Follow-on Biologics Market Analysis by Technology
7.1 Key Findings
7.2 Technology Segment: Market Attractiveness Index
7.3 Biosimilars and Follow-on Biologics Market Size Estimation and Forecast by Technology
7.4 rDNA Technology
7.5 mAbs Technology
7.6 Bioassay Technology
8 Biosimilars and Follow-on Biologics Market Analysis by Region
For more information about this report visit https://www.researchandmarkets.com/r/3rrwal
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