Eurobiosimilars Market Analysis and Reports | Spain Conference Series
Market Analysis - Eurobiosimilars 2024
Biosimilars: Global Markets
As per market researchers the global "Biosimilars Market by Product (Recombinant Non-Glycosylated Proteins (Insulin, rHGH, Interferon), Glycosylated (mAb, EPO), Peptides (Glucagon, Calcitonin)), Manufacturing Type (In-house, Contract), Disease (Oncology, Autoimmune) - Global Forecast to 2023", The biosimilars market is expected to reach USD 23.63 Billion by 2023 from USD 5.95 Billion in 2018, at a CAGR of 31.7%. Granulocyte colony-stimulating factors (G-CSFs) reached $379.3 million in 2013. This segment is expected to increase from $453.6 million in 2014 to $1.1 billion by 2019, a CAGR of 20.2% from 2014 to 2019.
Source: BCC Research
Importance & Scope:
The European-based pharmaceutical industry makes a major contribution to the Europe, not just in financial terms but also in terms of high-trait employment. Globally Pharma Market ranges from $870-$900 billion and in Europe $260-$280 billion.
A global biosimilars strategy:
Developed markets: Developed markets, with the exception of the United States, represent the greatest biosimilars presence today. Most biosimilars manufacturers have been and remain focused on the developed markets – whether it is for their historic and current opportunities (EU) or for their future market potential (United States, Japan). Dedicated regulatory pathways set the foundation for stringent, abbreviated approval processes which, in turn, have fed investor enthusiasm. Biosimilars adoption in developed markets has been primarily payer-driven, especially in European markets, given payers’ urgent, unmet need to contain public health care expenditures. Further market uptake has been slowed by prescribers’ skepticism and low patient awareness. Still, developed markets continue to have the highest number of biosimilars molecules in development – estimated at 29 in Europe, 19 in the United States and seven in Japan.
Emerging markets: In today’s emerging markets, biosimilars are still nascent, with little to no presence. However, in contrasting emerging markets with developed markets, the limited patient access to affordable biologics and the openness of physicians to low-cost therapies may offer potentially significant opportunities. Today, emerging markets represent a snippet of total world biologic sales in value, less than seven to eight percent (versus 48.6 percent in the United States).ix Treatment rates for flagship biologics are still low compared to developed markets, despite existing demand. For example, the treatment rate of MabThera® in Brazil is three times lower than in the UK and six times lower than in the US.x Additionally, a recent Kantor Health Survey found that 20 percent of emerging market autoimmune patients use a biologic, with the distribution of biologics varying from 29 percent in China to 12 percent in Russia and a mere 6 percent in Brazil.xi This may indicate the presence of large pockets of non-consumption, especially within the growing middle class.
Biosimilars Market Projected To Reach $41.7 Billion By 2024
Biosimilars Market, by Product (Revenue, USD Million, 2017 - 2024)
- Recombinant Non-Glycosylated Proteins
- Insulin
- Human Growth Hormones
- Granulocyte Colony-stimulating Factor (G-CSF)
- Interferons
- Recombinant Glycosylated Proteins
- Erythropoietin
- Monoclonal Antibodies
- Follitropin
Biosimilars Market, by Application (Revenue, USD Million, 2017 - 2024)
- Oncology
- Blood Disorders
- Growth Hormone Deficiency
- Chronic and Autoimmune Disorders
- Others
Biosimilars Market, by Region (Revenue, USD Million, 2017 - 2024)
- North America
- U.S.
- Canada
- Europe
- UK
- Germany
- China
- India
- Brazil
- Russia
- Asia Pacific
- Rest of the World
Analysis of selected countries:
United States
- FDA approval of the first biosimilar in March 2015 with Sandoz’s Zarxio (filgrastim)
- About 19 pipeline biosimilar molecules in development
- Represents about 50% of the global biologics market value and generates about 50% of the sales value growth
- Pending legislative decisions on data exclusivity period, naming conventions and interchangeability likely to have important implications.
Biosimilars approved in the US
In the US, a legal framework for approving biosimilars was established in 2009, via the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
The BPCI Act is part of the healthcare reform legislation, which was signed into law on 23 March 2010 by President Barack Obama. The BPCI Act establishes an abbreviated approval pathway for biological products that are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ with, a US Food and Drug Administration (FDA)-licensed biological product.
FDA is still in the process of developing guidelines regarding these types of products and has issued several guidance documents on the subject.
Zarxio (filgrastim-sndz) was the first product approved in the US as a biosimilar in 2015. To date, FDA has approved four biosimilars within the product classes of anti-tumour necrosis factor-alpha (TNF-α) and granulocyte colony-stimulating factor, and a follow-on biological in the product class of insulin for use in the US.
FDA approved Biosimilars and follow-on Biologicals
|
Product name |
Active substance |
Therapeutic area |
Authorization date |
Manufacturer/ Company name |
|
Amjevita (adalimumab-atto) |
adalimumab |
Ankylosing spondylitis |
23 Sep 2016 |
Amgen |
|
Basaglar# |
insulin glargine |
Diabetes |
16 Dec 2015 |
Eli Lilly/Boehringer Ingelheim |
|
Epoetin Hospira |
epoetin alfa |
Anaemia (chronic kidney disease, Zidovudine, chemotherapy) |
Recommended for approval by FDA’s Oncologic Drugs Advisory Committee (ODAC) on 25 May 2017 |
Pfizer (Hospira) |
|
Erelzi (etanercept-szzs) |
etanercept |
Axial spondyloarthritis |
30 Aug 2016 |
Sandoz |
|
Inflectra |
infliximab |
Ankylosing spondylitis |
5 Apr 2016 |
Pfizer (Hospira) |
|
Renflexis (infliximab-abda) |
infliximab |
Ankylosing spondylitis |
21 Apr 2017 |
Samsung Bioepis |
|
Zarxio |
filgrastim |
Autologous peripheral blood progenitor cell collection and therapy |
6 Mar 2015 |
Sandoz |
|
*Data collected on 30 September 2016, updated 26 June 2017 Source: US FDA |
||||
EU5
- Most mature biosimilar market representing 80% of global biosimilar spending
- Performance to date viewed as “disappointing” by select manufacturers
- Nineteen biosimilar products authorized in four molecule classes: human growth hormone, erythropoietin, G-CSF and tumour necrosis factor (TNF)-inhibitor
- About 29 pipeline biosimilars molecules in development.
- World-class dedicated pathway leaving questions of substitutability at the pharmacy level to member states
- Payer-driven uptake
- Challenged by continued pressure from strict regulatory decisions, lingering fear from prescribers around biosimilars’ “similarity”, safety and efficacy, debates on automatic substitution and INN prescription.
Biosimilars approved in Europe
In the European Union (EU), a legal framework for approving biosimilars was established in 2003. This framework means that biosimilars can only be approved centrally via the European Medicines Agency (EMA) and not nationally.
EMA first developed guidelines for the approval of biosimilars via an abbreviated registration process during 2005 to 2006, and since then EMA has developed many general and specific guidelines for biosimilars .
Omnitrope (somatropin) was the first product approved in the EU as a biosimilar in 2006. To date, EMA has approved 38 biosimilars within the product classes of human growth hormone, granulocyte colony-stimulating factor, erythropoesis stimulating agent, insulin, follicle-stimulating hormone (FSH), parathyroid hormone and tumour necrosis factor (TNF)-inhibitor, for use in the EU. Three biosimilar approvals have been withdrawn; two for filgrastim biosimilars: Filgrastim ratiopharm in April 2011 and Biograstim in December 2016, and one for a somatropin biosimilar (Valtropin) in May 2012. This leaves a total of 35 biosimilars approved for use in Europe.
With 10 years now added to its repertoire, European Biosimilars Congress is really turning into a staple meeting where Biosimilars partners accumulate to address the present and future condition of Biosimilars in the Europe.
The addition of two dedicated streams at the European Biosimilars Congress meeting proved to be highly successful, providing valuable insights from two distinct groups. One group excelled in the scientific and technical aspects, offering in-depth knowledge and expertise in research and manufacturing. The other group excelled in the business and strategic aspects, providing valuable insights into market trends, commercialization strategies, and regulatory considerations. This dual-stream approach allowed participants to gain a comprehensive understanding of both the scientific and commercial aspects of the biosimilars industry. The positive response and knowledge exchange from these two specialized streams contributed to the overall success of the European Biosimilars Congress meeting.
The 2024 establishment of this meeting will enable us to keep on diving further into both the investigation of Biosimilars improvement – and the business requirements for organizations that keep on seeking FDA endorsement.
The Organizing Committee is delighted to invite you to attend the Euro Biosimilars one of its remarkable Pharmaceutical conferences, to be held during April 04-05, 2024 at Madrid, Spain. European Biosimilars Congress is a global annual event. This European Biosimilars Congress 2024 will bring together scientists, researchers, business development managers, CEOs, directors, IP Attorneys, Regulatory Officials and CROs from around the world. Many biologics products are making their entry in the pharma market and experiencing a notable rise in their usage over the conventional medications.
At Euro Bisimilars 2024 meet your target audiences from around the world focused on learning about biologics and Biosimilars. This conference would be your single best opportunity to reach the largest assemblage of participants from the biologics and Biosimilars community.
2022 Highlights:
- 300+ Participation (70 Industry: 30 Academia)
- 10+ Keynote Speakers
- 50+ Plenary Speakers
- 20+ Exhibitors
- 14 Innovative Educational Sessions
- 5+ Workshops
- B2B Meetings
Euro Biosimilars 2024 has everything you need:
Open panel discussions: Providing an open forum with experts from academia and business to discuss on current challenges in Biosimilars & Biologics, where all attendees can interact with the panel followed by a Q&A session.
Speaker and poster presentations: Providing a platform to all academicians and industry professionals to share their research thoughts and findings through a speech or a poster presentation.
Editorial board meeting: Discussing on growth and development of open access Bioanalysis and Biomedicine International Journals and recruiting board members and reviewers who can support the journal.
Round table meetings: Providing a platform where industry professionals meet academic experts.
The Euro Biosimilars 2024 conference will host a diverse range of exhibitors, with over 50+ organizations and international pavilions participating. The exhibition will feature a wide array of industry stakeholders, including equipment manufacturers, suppliers, systems providers, finance and investment firms, R&D companies, project developers, trade associations, and government agencies. This diverse representation underscores the significance and breadth of the biosimilars sector. Attendees can expect to engage with leading companies and institutions from various sectors, fostering collaborations, knowledge exchange, and advancements in the field of biosimilars.
In addition to the products and services you will have access to valuable content, including Keynote Presentations, Product Demonstrations and Educational Sessions from today’s industry leaders.
The Euro Biosimilars 2024 has everything you need, all under one roof, saving you both time and money. It is the event you cannot afford to miss!
Target Audience:
- Directors, CEO’s of Organizations
- Business Development Managers
- Chief Scientific Officers
- R&D Researchers from Biosimilar and Bioslogics Industries
- Professors, Associate Professors, Assistant Professors
- PhD Scholars
- Patent Attorneys
- Intellectual Property Attorneys
- Investment Analysts
- Association, Association presidents and professionals
- Noble laureates in Health Care and Medicine
- Bio instruments Professionals
- Bio-informatics Professionals
- Software development companies
- Research Institutes and members
- Supply Chain companies
- Manufacturing Companies
- CRO and DATA management Companies
- Training Institutes
- Business Entrepreneurs