Global Fusion Protein Biosimilars Market: Market Outlook
Biologic drugs are commonly used to treat various diseases but their high cost has raised the emerging scope for biosimilars in the market. A fusion protein biosimilars has come forth as a new modality, as an alternate of biologic products. The fusion protein biosimilars combines the customized pharmacological properties of biological ligands, together with multiple functions of the fragmented crystallizable domain of immunoglobulins. The fusion protein biosimilars are used in several clinical studies based on applications like cancer, HIV-AIDS, chronic inflammatory diseases, and many other chronic diseases. Moreover, the first therapeutic Fc fusion protein was established for the AIDS treatment. Thus the wide applications of fusion protein biosimilars has increased the demand for fusion protein biosimilars in the global market. Currently, 11 fusion proteins have been approved by the Food and Drug Administration (FDA) and there are several new Fc fusion proteins being in the pre-clinical and clinical development stage. Thus, the rising prevalence of such chronic diseases expects to surge the demand for biosimilars in the market in the coming years.
What are the key trends impacting growth of the Fusion Protein Biosimilars Market?
Government initiatives to pioneer fusion protein biosimilars is another trending factor that expects to explore lucrative opportunities in the fusion protein biosimilars market in coming years. The U.S. Food and Drug Administration established an abbreviated licensure pathway Biologics Price Competition and Innovation Act (BPCIA) for biological products that are demonstrated to be biosimilar or interchangeable. This pathway intended to allow more options for chronic disease treatment that expects to increase access to lifesaving medications, and potentially lower health care costs through competition. Along which shift towards improvement of regulatory environment across the global markets are evolving rapidly, with widespread global industrial biologic development and manufacturing experience, go along with the rising standards of clinical care.
What are the key factors that expected to drive the Fusion Protein Biosimilars Market growth?
The wide applications of fusion protein biosimilar in various chronic diseases like cardiovascular disorder, cancer, HIV-AIDS, and chronic inflammatory disorders is the key factor that expects to drive the demand in the fusion protein biosimilars market during the forecast period. Approval of fusion protein biosimilar is expected to benefit manufacturers and explore lucrative opportunities for organizations specializing in generics and biosimilars to grow their businesses rapidly. For instance, in November 2019, Celgene received FDA approval for activin receptor-IgG1 Fc fusion protein, rDNA [luspatercept-aamt - Reblozyl] used to treat anemia in adults with beta thalassemia. Additionally, the launch of new fusion protein biosimilars in the market also benefits the patients by increasing treatment options and lowering the costs of complex, life-saving treatments. Thus, the surge in demand for cost-effective fusion protein biosimilars expects to explore lucrative opportunities for the manufacturers to invest more in the fusion protein biosimilars development which in turn drives the fusion protein biosimilars market growth. Favorable insurance by Medicare or Medicaid, the Centers for Medicare & Medicaid Services (CMS) or any other plan providers, along with FDA approval pathway for fusion protein biosimilar medications for cost reductions projects to high patient access which in turn surge the demand for the biosimilars that expects to fuel the fusion protein biosimilars market during the forecast period.
What are the restraining factors that expected to hamper the growth of the Fusion Protein Biosimilars Market?
As the fusion proteins are highly complex structure the analytical characterization of fusion protein is far more difficult than that of monoclonal antibodies that has surged the demand for conventional generic platform. Development of alternatives expects to impede the fusion protein biosimilars market during the forecast period. As biosimilars have to undergo extensive clinical trials, to compare them with the original biologic drug to ensure their similarity and interchangeable property that needs time to study. Thus, stringent regulatory approvals and time-consuming factor for clinical studies expects to hamper the fusion protein biosimilars market growth.
Key Segments of the Fusion Protein Biosimilars Market Covered in the Report
Based on the product, the fusion protein biosimilars market has been segmented as
- Cytokines Recombinant protein
- Immunoglobin (Ig) fusion protein
- Parathyroid Hormone (PTPH) fusion protein
Based on application, the fusion protein biosimilars market has been segmented as
- Respiratory disease
- Cardiovascular disorder
Based on end-users, the fusion protein biosimilars market has been segmented as
- Research institutes
Based on the region, the fusion protein biosimilars market has been segmented as
- North America
- Latin America
- South Asia
- East Asia
- Middle East & Africa
Why Cancer holds the highest share the fusion Protein Biosimilars Market?
Cancer expects to hold the higher share in the fusion protein biosimilars market owing to the rising cancer cases among the growing population in the world. Cancer is a growing global concern stated by the World Health Organization (WHO). Biosimilars are in high demand for cancer therapies. According to the Globocan 2020 data, in 2020, the incidence of new cancer cases was estimated to be around 19,292,789, with nearly about 9,958,133 deaths due to cancers.
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The prominent key players operating are
- Pfizer Inc.
- Eli Lilly and Company
- Sandoz International GmbH
- F. Hoffmann-La Roche Ltd.
- AbbVie Inc.
- Dr. Reddy’s Laboratories Ltd.
- Samsung Bioepis
- Teva Pharmaceutical Industries Ltd.
- Mylan N.V., Novartis AG
- Fresenius Kabi AG
- STADA Arzneimittel AG
- Celltrion Healthcare Co.Ltd.
- Thermo Fisher Scientific Inc.
- Daiichi Sankyo Co Ltd.
- Aurobindo Pharma
- Absolute Antibody
- Bioverativ Therapeutics Inc.
- and others are actively involved in the fusion protein biosimilars market.
What strategies are the Key Players adopting for Increasing their Market Share in the Fusion Protein Biosimilars Market?
Increasing competition among pharmaceutical and biotechnological companies to penetrate the fusion protein biosimilars market has led the manufacturers to actively invest in research areas. Manufacturers have increased focus on the development and launch of effective biosimilars that would meet the similarity in the composition, efficacy, and results that are similar to biological products. New product launches and collaborations help companies to gain maximum revenue share and expand regional presence and existing product portfolio.
For instance, In January 2020, Coherus BioSciences, Inc. entered into a licensing agreement with Innovent Biologics, (Suzhou) Co., Ltd., a leading Chinese biopharmaceutical company, in order to commercialize biosimilar candidate to Avastin (bevacizumab) in North American countries like U.S and Canada.
Additionally, in September 2018, SOTIO had acquired Cytune Pharma. This agreement was signed to allow the company the usage of Cytune’s SO-C101, a human fusion protein of IL-15 along with their clinical programs in lung, prostate, and ovarian cancer which is based on their autologous dendritic cell therapy platform DCVAC.
What are the Key Opportunities in Fusion Protein Biosimilars Market?
Biosimilars are expected to be a cost-effective alternative to high-priced branded biologics, resulting in a positive impact that can emerge opportunities for the stakeholders in the fusion protein biosimilars market. The regulatory approvals of an accelerated timeline for biosimilars signal a change in the industry and the potential for severe drops in profits for pharmaceutical companies. Increased research efforts and pipeline drugs expect to lay lucrative opportunities for the fusion protein biosimilars market growth in the coming years. For instance, approximately 37 therapeutic fusion products are in clinical development and thirteen products have been approved by the FDA and the EMA. They follow the commercial successes of mAbs with five blockbuster products (aflibercept, etanercept, dulaglutide, abatacept and efmoroctocog α.
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Why Europe has witnessed to be dominant Sales of Fusion Protein Biosimilars Market?
Europe expects to dominate the fusion protein biosimilars market due to the presence of a well-defined regulatory framework for biosimilars and the presence of giant pharmaceutical companies such as Novartis, Johnson & Johnson, Pfizer Inc., Merck & Co., Sanofi, AstraZeneca, GlaxoSmithKline and many others. Furthermore, favorable regulatory scenario, well-developed healthcare infrastructure and a growing number of product launches have fueled the European fusion protein biosimilars market growth. Several biosimilars are introduced in the European fusion protein biosimilars market owing to applicability in various indications and higher cost arbitrage. Along, the rising prevalence of chronic disease in the region has raised the demand for clinical studies which in turn has surge demand for biosimilars in the European fusion protein biosimilars market. For instance, as per Joint Research Centre (JRC) of the European Commission, the cancer burden was estimated to have risen to 2.7 million new cases (including all types of cancers, except non-melanoma skin cancer) while around 1.3 million deaths were found in 2020.
What is the Repercussion of the Covid-19 Pandemic on the Fusion Protein Biosimilars Market Growth?
The COVID-19 impact projected a significant impact on the fusion protein biosimilars market due to the lockdown and break on transportation across the world, shortage in supply chain and raw materials, has negatively impacted biosimilar production. During amid COVID-19 pandemic, have shifted their priorities towards COVID-19 medication and vaccine development, this shift has contributed a remarkable impact on the fusion protein biosimilars market. Most of the pipeline products are exhibiting a slow pace of research and development activities as most of the clinical trials has been focusing to combat the COVID-19 crisis and reduce the exposure of coronavirus infection worldwide. For instance, as per JCO Global Oncology 2020, in the COVID-19 pandemic, nearly about 88% of the cancer care centres faced difficult challenges. The challenges associated in delivering usual cancer attention and caution due to lack of personal protective equipment, strict precautionary measures, and staff shortage. Additionally, this impact was observed in low-income and middle income countries. Therefore, COVID-19 has projected a short term negative impact on cancer therapies, which indirectly is expected to project a short-term negative impact on the fusion protein biosimilars market.
The report covers exhaustive analysis on:
- Fusion protein biosimilars market Segments
- Fusion protein biosimilars market Dynamics
- Fusion protein biosimilars market Size
- Supply & Demand
- Current Trends/Issues/Challenges
- Competition & Companies involved
- Value Chain
Regional Analysis Includes
- North America (U.S., Canada)
- Latin America ( Brazil, Mexico, Argentina, Rest of LATAM)
- Europe (Germany, Italy, UK, Spain, France, Russia, BENELUX, Rest of Europe)
- East Asia (China, Japan, S. Korea,)
- South Asia (India, Indonesia, Malaysia, Thailand, Rest of South Asia)
- Oceania (Australia, New Zealand)
- The Middle East and Africa (GCC, Turkey, South Africa, Rest Of MEA)
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- Detailed overview of fusion protein biosimilars market
- Changing market dynamics in the industry
- In-depth fusion protein biosimilars market segmentation
- Historical, current and projected market size in terms of volume and value
- Recent industry trends and developments
- Competitive landscape
- Strategies of key players and products offered
- Potential and niche segments, geographical regions exhibiting promising growth
- A neutral perspective on market performance
- Must-have information for market players to sustain and enhance their market footprint.
NOTE - All statements of fact, opinion, or analysis expressed in reports are those of the respective analysts. They do not necessarily reflect formal positions or views of the company.
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