The Biosimilars and Follow-On Biologics Market Report 2023-2033: This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.
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.
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.
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 Continues 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.
What Questions Should You Ask before Buying a Market Research 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
- 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?
You need to discover how this will impact the biosimilars and follow-on biologics market today, and over the next 10 years:
- Our 337-page report provides 127 tables and 154 charts/graphs exclusively to you.
- The report highlights key lucrative areas in the industry so you can target them - NOW.
- It contains in-depth analysis of global, regional and national sales and growth.
- It highlights for you the key successful trends, changes and revenue projections made by your competitors.
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.
Segments Covered in the Report
Type of Manufacturing
- In-House
- CMOs
Type
- Monoclonal Antibodies
- Fusion Proteins
- Insulin
- Erythropoietin
- Granulocyte-Colony Stimulating Factor
- Interferon
- Growth Hormones
- Fertility Hormones
- Others
Application
- Blood Disorders
- Oncology Diseases
- Chronic & Autoimmune Diseases
- Growth Hormone Deficiencies
- Others
Technology
- RDNA Technology
- MAbs Technology
- Bioassay Technology
North America
- U.S.
- Canada
Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe
Asia Pacific
- Japan
- China
- India
- Rest of Asia Pacific
Latin America
- Brazil
- Mexico
- Rest of Latin America
MEA
- GCC
- South Africa
- Rest of MEA
Leading companies and the potential for market growth
- 3SBio, Inc.
- AMEGA Biotech
- Amgen Inc.
- Apotex, Inc.
- BIOCAD
- Biocon Limited
- Biogen, Inc.
- Celltrion Healthcare Co., Ltd.
- Coherus BioSciences
- Dr. Reddy’s Laboratories Ltd.
- Eli Lilly and Company
- Gedeon Richter PLC
- Intas Pharmaceutical Ltd.
- Mabxience SA
- Viatris Inc. (Mylan NV)
- Novartis AG
- Pfizer Inc.
- Samsung Bioepis Co. Ltd.
- Stada Arzneimittel AG
- Teva Pharmaceutical
How will the Biosimilars and Follow-on Biologics Market, 2023 to 2033 report help you?
In summary, this 330+ page report provides you with the following knowledge:- Revenue forecasts to 2033 for Biosimilars and Follow-on Biologics Market, 2023 to 2033 Market, with forecasts for Type of Manufacturing, Type, Application, Technology each forecast at a global and regional level - discover the industry’s prospects, finding the most lucrative places for investments and revenues.
- Revenue forecasts to 2033 for five regional and 18 key national markets - See forecasts for the Biosimilars and Follow-on Biologics Market, 2023 to 2033 market in North America, Europe, Asia-Pacific, Latin America, and MEA. Also forecasted is the market in the US, Canada, Mexico, Brazil, Germany, France, UK, Italy, China, India, Japan, and Australia among other prominent economies.
- Prospects for established firms and those seeking to enter the market - including company profiles for 20 of the major companies involved in the Biosimilars and Follow-on Biologics Market, 2023 to 2033.
Information found nowhere else
With this new report, you are less likely to fall behind in knowledge or miss out on opportunities. See how this work could benefit your research, analyses, and decisions. The study is for everybody needing commercial analyses for the Biosimilars and Follow-on Biologics Market, 2023 to 2033, market-leading companies. You will find data, trends and predictions.Table of Contents
1 Report Overview
3 Market Overview
4 Biosimilars and Follow-on Biologics Market Analysis by Type of Manufacturing
5 Biosimilars and Follow-on Biologics Market Analysis by Type
6 Biosimilars and Follow-on Biologics Market Analysis by Application
7 Biosimilars and Follow-on Biologics Market Analysis by Technology
8 Biosimilars and Follow-on Biologics Market Analysis by Region
9 North America Biosimilars and Follow-on Biologics Market Analysis
10 Europe Biosimilars and Follow-on Biologics Market Analysis
11 Asia Pacific Biosimilars and Follow-on Biologics Market Analysis
12 Latin America Biosimilars and Follow-on Biologics Market Analysis
13 MEA Biosimilars and Follow-on Biologics Market Analysis
14 Company Profiles
15 Conclusion and Recommendations
Companies Mentioned
- 3SBio, Inc.
- AMEGA Biotech
- Amgen Inc.
- Apotex, Inc.
- BIOCAD
- Biocon Limited
- Biogen, Inc.
- Celltrion Healthcare Co.,Ltd.
- Coherus BioSciences
- Dr. Reddy’s Laboratories Ltd.
- Eli Lilly and Company
- Gedeon Richter PLC
- Intas Pharmaceutical Ltd.
- Mabxience SA
- Novartis AG
- Pfizer Inc.
- Samsung Bioepis Co. Ltd.
- Stada Arzneimittel AG
- Teva Pharmaceutical
- Viatris Inc. (Mylan NV)
- Alteogen
- Amega Biotech
- Apotex
- Astellas Pharma
- BioXpress Therapeutics
- Boehringer Ingelheim
- Bristol-Myers Squibb
- CCM Duopharma
- Dong-A Pharmaceutical
- Dr. Reddy’s Laboratories
- Eisai
- Eli Lilly
- Emcure Pharmaceuticals
- Eurofarma
- FibroGen
- Fuji Pharma
- Gan & Lee
- Gennova
- Geropharm
- Gilead Sciences
- GlaxoSmithKline
- Intas Biopharmaceuticals
- JCR Pharmaceuticals
- Qilu Pharmaceutical
- Ranbaxy Laboratories
- Regeneron Pharmaceuticals
- Reliance Life Sciences (RLS)
- Virchow Biotech
- Wanbang Biopharmaceuticals
- Wockhardt
- Xiamen Amoytop Biotech
- Zenotech
- Argentine Ministry of Health
- Cardiovascular and Renal Drugs Advisory Committee
- Cardiovascular Drugs Advisory Committee
- Centers of Medicare and Medicaid Services (CMS)
- Central Drugs Standard Control Organisation
- Centre for Drug Evaluation (CDE)
- China Food and Drug Administration
- Comisión Federal para la Protección contra Riesgos Sanitarios
- Committee for Medicinal Products for Human Use
- European Generic Medicines Association (EGA)
- European Medicines Agency (EMA)
- Intellectual Property Appellate Board (IPAB)
- Korea Food and Drug Administration
- Mexican Supreme Court
- Ministry for Health Labour and Welfare (MHLW)
- National Health Service (NHS)
- National Institute for Health and Care Excellence (NICE)
- Norwegian Ministry of Health
- Pan American Health Organization
- Pharmaceuticals and Medical Devices Agency (PMDA)
- Russian Ministry of Health
- Scottish Medicines Consortium (SMC)
- Stanford University
- State Employees' Social Security and Social Services Institute (ISSSTE)
- The Brazilian Ministry of Health
- The Drug Regulatory Authority of Pakistan
- The Ministry of Food and Drug Safety (MFDS)
- The National Conference of State Legislatures (US)
- The United Laboratories (TUL)
- Therapeutic Goods Administration
- Toronto University
- UK Medicines and Healthcare Products Regulatory Agency (MHRA)
- University of California, San Francisco
- University of Tokyo
- US Center for Disease Prevention and Control (CDC)
- US Court of Appeals
- US Food and Drug Administration (FDA)
- US Patent and Trademark Office
- World Health Organization (WHO)