The Biosimilar Drugs Market: 2016 – 2030 – Opportunities, Challenges, Strategies & Forecasts
Release Date: September 2016
Number of Pages: 304
Number of Tables and Figures: 48
Synopsis: Since their commercial inception in the 1980s, biologic drugs have grown into a $200 Billion market, driven by their effectiveness in key therapeutic areas such as oncology, diabetes and rheumatoid arthritis.
Unlike traditional small molecule drugs, biologic drugs are much harder to replicate and have allowed originators to maintain market dominance even after their patents have begun to expire. However, generic drug manufacturers are keen to invest in the area, eyeing long term revenue opportunities.
Many generic manufacturers are aggressively investing to establish the authenticity of their biosimilar products that aim to mimic biologic drugs at a lower price. Non-approved biosimilars already enjoy widespread proliferation in emerging markets, due to limited clinical requirements and the lack of stringent IP regulation.
Having established regulatory pathways for approving biosimilar drugs, developing markets such as the European Union are also beginning to benefit from a robust biosimilar market. Largely driven by regulatory efforts to reduce healthcare costs, SNS Research estimates that approved biosimilars will account for nearly $22 Billion in revenue by the end of 2020.
The “Biosimilar Drugs Market: 2016 – 2030 – Opportunities, Challenges, Strategies & Forecasts” report presents an in-depth assessment of the biosimilar drugs ecosystem including technology, economics, key trends, market drivers, challenges, investment potential, regulatory landscape, leading therapies, opportunities, future roadmap, value chain, ecosystem player profiles and strategies. The report also presents market size forecasts for biosimilar drugs from 2016 through to 2030. The forecasts are segmented for over 8 drug classes, 2 approval categories, 5 regions and 25 leading countries.
The report comes with an associated Excel datasheet suite covering quantitative data from all numeric forecasts presented in the report.
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Pricing: The report is available for the following price:
Single User License: USD 2,500
Company Wide License (Single Site): USD 3,500
Company Wide License (Global Site): USD 6,500
The report has the following key findings:
- Driven by the cost saving potential of biosimilar drugs, a number of countries have established regulatory pathways for their approval. We estimate that approved biosimilar drugs will account for nearly $22 Billion in revenue by the end of 2020.
- In terms to drug class categorization, we expect monoclonal antibodies to dominate the biosimilar drugs market by the end of 2020, with an estimated market share of over 35%.
- SNS Research estimates that biosimilars will cut global healthcare spending by over $100 Billion by the end of 2020, as several innovator biologic drugs come off patent.
- In a bid to control costs and expand their global reach, most biosimilar drug manufacturers are complementing their existing manufacturing and R&D locations with sites in low cost countries such as India, China, Brazil and Russia. These countries have been used as successful launch-pads for several prominent biosimilar drugs.
- High profile incidents, such as Intas’ recall of its biosimilar drug Razumab (Ranibizumab) following reports of adverse eye reactions, highlight the need for stringent regulatory standards to establish the safety and efficacy of biosimilars.
The report covers the following topics:
- Biosimilar drugs ecosystem
- Market drivers and barriers
- Technology, economics and key trends
- Approved and non-approved biosimilars
- Analysis of key drug classes and leading biosimilar drugs
- Regulatory landscape of biosimilar drugs throughout the globe
- Industry roadmap and value chain
- Profiles and strategies of over 190 leading ecosystem players, including biosimilar and innovator biologic drug manufacturers
- Strategic recommendations for ecosystem players
- Market analysis and forecasts from 2016 till 2030
Market forecasts are provided for each of the following submarkets and their subcategories:
- Approval Category Classification
- Approved Biosimilars
- Non-approved Biosimilars
- Drug Class
- mAbs (Monoclonal Antibodies)
- FC-Fusion Proteins
- EPO (Erythropoietin)
- G-SCF (Granulocyte-colony Stimulating Factor)
- HGH (Human Growth Hormone)
- Gonadotropins (Glycoprotein Hormones)
- Regional Markets
- Asia Pacific
- Middle East & Africa
- North America
- Latin & Central America
- Country Markets
- Saudi Arabia
- South Africa
- South Korea
Key Questions Answered:
The report provides answers to the following key questions:
- How big is the biosimilar drugs opportunity?
- What trends, challenges and barriers are influencing its growth?
- How is the ecosystem evolving by segment and region?
- What will the market size be in 2020 and at what rate will it grow?
- Which countries and submarkets will see the highest percentage of growth?
- How big is the market for biosimilar monoclonal antibodies?
- How does regulation impact the adoption of biosimilar drugs?
- How cheap are biosimilar drugs in comparison to their reference products?
- What is the cost saving potential of biosimilar drugs?
- Who are the key market players and what are their strategies?
- How will patent expirations of biologic drugs impact the market?
- What are the future prospects of approved and non-approved biosimilar drugs?
- What strategies should biosimilar and innovator drug manufacturers adopt to remain competitive?
List of Companies Mentioned:
The following companies and organizations have been reviewed, discussed or mentioned in the report:
ABPI (Association of the British Pharmaceutical Industry)
AET (Alfred E Tiefenbacher) Group
AET BioTech (AET BioTechnology)
AMA (African Medicines Regulatory Agency)
AMRI (Albany Molecular Research, Inc.)
ANVISA (Brazilian Health Surveillance Agency)
ASKA Pharmaceutical Company
BD (Becton, Dickinson and Company)
BMS (Bristol-Myers Squibb)
Brazilian Ministry of Health
CDSCO (Central Drug Standards and Control Organization, India)
CFDA (China Food and Drug Administration)
Chong Kun Dang Pharmaceutical Corporation
Chugai Pharmaceutical Company
COFEPRIS (Federal Commission for the Protection against Sanitary Risks, Mexico)
CPGP (Shanghai CP Guojian Pharmaceutical Company)
Daiichi Sankyo Espha
Department of Health, Mexico
Dong-A Socio-Holdings Company
Dr. Reddy's Laboratories
EDA (Egyptian Drug Authority)
EGA (European Generic Medicines Association)
Eli Lilly and Company
Elmed Eisai Company
EMA (European Medicines Agency)
Fuji Pharma Company
Fujifilm Holdings Corporation
Fujifilm Kyowa Kirin Biologics
Gene Techno Science
GGL (Glenmark Generics Limited)
Green Cross Corporation
Guangdong BeiKang Pharmaceutical Company
Hanmi Pharmaceutical Company
Hanwha Chemical Company
HMP (Harvest Moon Pharmaceuticals)
Israeli MoH (Ministry of Health)
Johnson & Johnson
JT (Japan Tobacco)
Kaken Pharmaceutical Company
Kowa Health Care America
Kowa Pharmaceuticals America
Kowa Research Institute
Kremers Urban Pharmaceuticals
Kyowa Hakko Kirin
Kyowa Pharmaceutical Industry Company
Les Laboratoires Servier (Servier Group)
LG Life Sciences
MCC (Medicines Control Council, South Africa)
MEDICE Arzneimittel Pütter
Meiji Seika Pharma Company
Merck and Co.
MFDS (Ministry of Food and Drug Safety, South Korea)
MHLW (Ministry for Health Labor and Welfare, Japan)
Ministry of Health and Family Welfare, India
Ministry of Health, Labour and Welfare, Japan
Ministry of Science and Technology, India
Mitsubishi Chemical Holdings Corporation
Mitsubishi Tanabe Pharma
Mitsui & Company
MN (Mustafa Nevzat) Pharma
Mochida Pharmaceutical Company
Nichi-Iko Pharmaceutical Company
Nipro Pharma Corporation
NORCB (National Organization for Research & Control of Biologics, Egypt)
Ono Pharmaceutical Company
Osaka Synthetic Chemical Laboratories
Otsuka Holdings Company
Par Pharmaceutical Holdings
Pierre Fabre (Laboratoires Pierre Fabre)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
Qilu Pharmaceutical Company
RLS (Reliance Life Sciences)
Roche Holding (F. Hoffmann-La Roche)
Russian MoH (Ministry of Health)
Santen Pharmaceutical Company
Sanwa Kagaku Kenkyusho Company
Sartorius Stedim Biotech
Sawai Pharmaceutical Company
SEDICO (South Egypt Drug Industries Company)
SFDA (Saudi Food and Drug Authority)
Shanghai Celgen Biopharmaceutical Company
Shanghai Fosun Pharmaceutical Group
Shionogi & Company
SL Pharm (Beijing SL Pharmaceutical Company)
Somar (Grupo Farmaceutico Somar)
Sumitomo Dainippon Pharma Company
Sun Pharma (Sun Pharmaceutical Industries)
Supera Farma Laboratorios
Taisho Pharmaceutical Holdings
Takeda Pharmaceutical Company
Tanabe Seiyaku Hanbai Company
Taro Pharmaceutical Industries
Teva Pharmaceutical Industries
Teva-Kowa Pharma Company
The Medicines Company
Tonghua Dongbao Pharmaceutical Company
Towa Pharmaceutical Company
TPI (Therapeutic Proteins International)
U.S. CBER (Centre for Biologics Evaluation and Research)
U.S. CDER (Centre for Drug Evaluation and Research)
U.S. FDA (Food and Drug Administration)
United Therapeutics Corporation
Valeant Pharmaceuticals International
Ventana Medical Systems
Walvax Biotechnology Company
WHO (World Health Organization)
Yichang Chang Jiang Pharmaceutical Company