Global Biosimilars Market Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for Best-Selling Biologics
The Global Biosimilar market by product is projected to grow at a compound annual growth rate (CAGR) of 45.22%. The market is driven mainly by a constrained payer environment and patent expiration of several best-selling biologics. However, developmental cost and complexities, strategies from originators and interchangeability concerns pose a challenge to market growth.
A biosimilar is a biotherapeutic that is clinically highly similar to an approved original biologic (reference product) in terms of active ingredients and has no meaningful differences in efficacy and safety. Biosimilars are also known as follow-on biologics or subsequent entry biologics.
A total of 492 products are in development. The Preclinical stage contains the largest number of pipeline products: 232. The late-stage pipeline (Phase III and Pre-registration) account for 24% of the overall pipeline, with 120 products. The global biosimilar pipeline is dominated by companies from emerging markets.
The most active companies in the early-stage pipeline are from India and China. South Korean companies such as Celltrion and Samsung Bioepis and Indian companies such as Biocon and Dr. Reddy’s Laboratories have a strong late-stage pipeline. Pfizer and Amgen have a strong late-stage pipeline as well.
There exist enormous commercial opportunities for biosimilar manufacturers over the coming years, given the number of high-revenue-generating biologics that will go off patent in the next five years, and promising revenue forecasts for biosimilars in late-stage development.
There exist a diverse number of biosimilars in the pipeline for a wide range of therapy areas, with several of these in the later stages of development. Government support for biosimilars is increasing in key mature and emerging markets, given the cost-saving opportunities that these products represent for national healthcare budgets.
The latest report, ""Global Biosimilars Market Increasingly Lucrative Market Fueled by Constrained Payer Environment and Patent Expiries for Best-Selling Biologics"" provides an in-depth assessment of the current developments and trends in the global biosimilars market.
This report also assesses the state of the biosimilar R&D and commercial landscape through multilevel analytics that include data split by therapy area, stage of development, molecule, and company. Global revenue forecasts to 2024 for biosimilars with strong market potential, both in development and in the market, are provided.
The report also details out current biosimilar regulatory frameworks and guidelines implemented in the US, Europe, Japan, China, South Korea, India and Brazil, and recent developments in the landscape within these markets
- How does the global biosimilar pipeline look like in 2018?
- What is the distribution of pipeline biosimilars by stage of development?
- Which are the therapy areas set to benefit the most from biosimilar drugs in development?
- Which biosimilars are commonly targeted in the pipeline?
- How many companies are currently involved in biosimilar drug development? Which are the most active in the pipeline?
- What is the size of the global biosimilar market?
- How much revenue will promising biosimilar drugs in the market, and in development, record to 2024?
- What are the key factors driving growth in the global biosimilars market?
- What are the factors restraining the growth of global biosimilar market?
- How does legislation regarding biosimilar interchangeability differ among key geographical markets?
- How will legal or political changes in the landscape affect the biosimilar market?
- What are the key differences in biosimilar regulatory pathways between US, Europe, Japan, South Korea, China, Brazil, and India?
- What are the regulatory evidence requirements in each country?
Reasons to buy
- Develop an overview of the current biosimilar landscape in key markets
- Learn how regulatory or legal changes will affect the market
- Identify market prospects
1 Executive Summary
2.1 Defining Biosimilars
2.2 Comparative Analysis: Biosimilars vs Generics
2.4 Why Biosimilars? SWOT Analysis
3 Key Drivers
3.1 Constrained Payer Environment
3.3 Patent expiration
4 Key Barriers
4.1 Development complexities and cost
4.2 Strategies from originators
4.3 Interchangeability and substitution concerns
5 Biosimilars In Mature Markets
5.1 Biosimilar Approval Pathways Across Key Mature Markets
5.2 Biosimilars in EU
5.2.1 Developments in the EU Biosimilar Landscape: Gainsharing
5.3 Biosimilars in the US
5.3.1 Developments in the US Biosimilar Landscape: Reimbursement
5.3.2 Developments in the US Biosimilar Landscape: Rebate
5.4 Biosimilars in Japan
6 Biosimilars In Emerging Market
6.1 Biosimilar Approval Pathways Across Key Emerging Markets
6.2 Biosimilars in South Korea
6.3 Biosimilars in China
6.3.1 Developments in the Chinese Biosimilar Landscape: Reforms
6.3.2 Developments in the Chinese Biosimilar Landscape: Investments
6.4 Biosimilars in Brazil
6.5 Biosimilars in India
6.6 Strategies for Biosimilars Manufacturers in Emerging Markets
7 Global Biosimilar Pipeline Analysis
7.1 Global Biosimilar Pipeline by Stage of Development
7.2 Global Biosimilar Pipeline by Therapy Area
7.3 Global Biosimilar Pipeline by Indication: Top 10 targeted indications
7.4 Global Biosimilar Pipeline by Molecule: Top 10 targeted biosimilars
7.5 Most Active Manufacturers in the Global Biosimilar Pipeline: Product Volume by Stage of Development
7.6 Most Active Manufacturers in the Global Biosimilar Pipeline: Product Volume by Molecule
7.7 Most Active Manufacturers in the Global Biosimilar Late Stage Pipeline
8 Global Biosimilar Market And Product Sales Forecast
8.1 Global Rituximab Biosimilar Market Forecast 2017 - 2024
8.2 Rituximab Biosimilar Market: ABP 798 Global Sales Forecast 2017 - 2024
8.3 Global Infliximab Biosimilar Market Forecast 2017 - 2024
8.4 Infliximab Biosimilar Market: Inflectra Global Sales Forecast 2017 - 2024
8.5 Global Trastuzumab Biosimilar Market Forecast 2017 - 2024
8.6 Trastuzumab Biosimilar Market: Kanjinti Global Sales Forecast 2017 - 2024
8.7 Global Bevacizumab Biosimilar Market Forecast 2017 - 2024
8.8 Bevacizumab Biosimilar Market: Mvasi Global Sales Forecast 2017 - 2024
8.9 Global Adalimumab Biosimilar Market Forecast 2017 - 2024
8.10 Adalimumab Biosimilar Market: Global Imraldi Sales Forecast 2017 - 2024
8.11 Insulin Glargine Biosimilar Market: Basaglar Global Sales Forecast 2017 - 2024
8.12 Etanercept Biosimilar Market: Benepali Global Sales Forecast 2017 - 2024
9 Strategic Alliances
9.1 Global Biosimilar Partnership Deals by Region and Value
9.2 Global Biosimilars Partnership Deals by Year
9.3 Global Biosimilar Licensing Deals by Region and Value
9.4 Global Biosimilar Licensing Deals by Year
9.5 Top 10 Targeted Biosimilars in Strategic Alliances
9.6 Most Active Companies in Strategic Alliances
10 Company Profile
10.4 Samsung Bioepis
10.7 Dr. Reddy's Laboratories
Positive developments in mature markets
In Europe, the uptake of biosimilars has been heterogeneous across countries due to existing differences in biosimilar policies. However, the biosimilars market is poised to witness strong growth, as the safety of biosimilars has been established and incentives are increasing. Recent incentives such as gain sharing has been a driver for improving biosimilar uptake across multiple European countries.
The US biosimilar market has been hindered by a lack of market access due to legal issues, contracting dynamics, regulatory uncertainties, and lack of prescriber awareness and incentives. However, the recent changes in reimbursement policies can improve biosimilar adoption. Rebate agreements between pharmaceutical companies and pharmacy benefit managers has been a key barrier for biosimilar uptake.
However, the Trump administration has proposed to remove rebates, which could induce market growth in US.
The Japanese biosimilar market growth has been sluggish. However, the market is set to grow, driven by the government’s agenda to cut healthcare expenditure. Foreign companies that collaborate with local companies will be best positioned to leverage this opportunity.