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. For a sample of the report or any further inquiries please contact info@snstelecom.com 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 Key Findings: 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. Topics Covered: 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 Forecast Segmentation: 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) Insulin Interferons HGH (Human Growth Hormone) Gonadotropins (Glycoprotein Hormones) Others Regional Markets Asia Pacific Europe Middle East & Africa North America Latin & Central America Country Markets Brazil Canada China Egypt France Germany Greece India Israel Italy Japan Mexico Netherlands Poland Portugal Russia Saudi Arabia South Africa South Korea Spain Switzerland Taiwan Turkey UK USA 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: 3SBio Abbott Laboratories AbbVie ABPI (Association of the British Pharmaceutical Industry) Accord Healthcare ACETO Corporation Acino Holding Actavis Actelion Adcock Ingram Aesica Pharmaceuticals AET (Alfred E Tiefenbacher) Group AET BioTech (AET BioTechnology) Agila Specialties Ajinomoto Group Akron Pharmaceuticals Alexion Pharmaceuticals Alfa Wasserman Allergan Almirall AMA (African Medicines Regulatory Agency) Amega Biotech Amgen Amneal Pharmaceuticals AMRI (Albany Molecular Research, Inc.) ANVISA (Brazilian Health Surveillance Agency) Apobiologix ApoPharma Apotex Arch Pharmalabs Aryogen ASKA Pharmaceutical Company Aspen Holdings Astellas Pharma AstraZeneca Aurobindo Pharma Auxilium Pharmaceuticals AXXO Baxalta Baxter International Bayer BD (Becton, Dickinson and Company) BD Bioscience Berlin Chemie Bharat Biotech Biocad Biocon Biodel Biogaran Biogen Biogen Laboratorios Bionovis Biopartners Holdings Biosidus Biotechpharma Bioton BioXpress Therapeutics BMS (Bristol-Myers Squibb) Boehringer Ingelheim Bolder BioTechnology Brazilian Ministry of Health Breckenridge Pharmaceutical Cassara Biotech CDSCO (Central Drug Standards and Control Organization, India) Cedarburg Pharmaceuticals Celgene Corporation Celltrion Healthcare CFDA (China Food and Drug Administration) Chemo Group Chiesi Farmaceutici Chong Kun Dang Pharmaceutical Corporation Chugai Pharmaceutical Company Cipla Cipla BioTec Claris Injectables Claris Lifesciences Claris Otsuka COFEPRIS (Federal Commission for the Protection against Sanitary Risks, Mexico) Coherus BioSciences Consort Medical Covidien CPGP (Shanghai CP Guojian Pharmaceutical Company) Creative Biomart Cypress Pharmaceutical Daiichi Sankyo Daiichi Sankyo Espha Department of Health, Mexico Dong-A Pharmaceutical Dong-A Socio-Holdings Company Dong-A ST Dr. Reddy's Laboratories Dusa Pharmaceuticals EDA (Egyptian Drug Authority) EGA (European Generic Medicines Association) Egis Pharmaceuticals Eisai Eli Lilly and Company Elmed Eisai Company EMA (European Medicines Agency) Emcure Pharmaceuticals Endo International Epirus Biopharmaceuticals Essetifin ESTEVE Farma ESTEVE Group Eurofarma Laboratorios Ferring Pharmaceuticals Flamel Technologies Formycon Fresenius Kabi Fuji Pharma Company Fujifilm Corporation Fujifilm Holdings Corporation Fujifilm Kyowa Kirin Biologics Fujifilm Pharma Gador Galderma Galenika Gedeon Richter Gene Techno Science Genepharm Genexine Gennova Biopharmaceuticals Genor Biopharma  GGL (Glenmark Generics Limited) Gilead Sciences Glenmark Pharmaceuticals Globalpharma Green Cross Corporation Grifols Gruenenthal Group GSK (GlaxoSmithKline) Guangdong BeiKang Pharmaceutical Company Hanmi Pharmaceutical Company Hanwha Chemical Company Health Canada HEC Pharm HELM AG Helvetic BioPharma Henlius Biopharmaceuticals Hetero Hikma Pharmaceuticals Hi-Tech Pharmacal HMP (Harvest Moon Pharmaceuticals) Hospira iBio ILKO ILKOGEN Impax Laboratories Impax Pharmaceuticals Intas Pharmaceuticals Ipsen Israeli MoH (Ministry of Health) ISU ABXIS Janssen Pharmaceutica Jazz Pharmaceuticals Johnson & Johnson JT (Japan Tobacco) Kaken Pharmaceutical Company Kaneka Corporation Kowa Company Kowa Health Care America Kowa Pharmaceuticals America Kowa Research Institute Kremers Urban Pharmaceuticals Krka Kyowa Hakko Kirin Kyowa Pharmaceutical Industry Company Laboratorios Beta Laboratorios Roemmers Landsteiner Scientific Lannett Company Leo Pharma Les Laboratoires Servier (Servier Group) LG Life Sciences Lil Therapeutics Lundbeck Lupin mAbxience Mallinckrodt Maruho Company Matrix Laboratories MCC (Medicines Control Council, South Africa) Meda MEDICE Arzneimittel Pütter Medley Farma Meiji Holdings Meiji Seika Pharma Company Menarini Group Merck and Co. Merck KGaA Merck Serono Merz Pharma 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 Mitsui Group MN (Mustafa Nevzat) Pharma Mochida Pharmaceutical Company Momenta Pharmaceuticals Mylan Natco Pharma Nichi-Iko Pharmaceutical Company Nippon Kayaku Nippon Shinyaku Nipro Pharma Corporation Nobel Ilac NORCB (National Organization for Research & Control of Biologics, Egypt) Novartis Novo Nordisk Oncobiologics Ono Pharmaceutical Company OPKP Health Orion Orygen Biotecnologia Osaka Synthetic Chemical Laboratories Otsuka Holdings Company Paladin Labs Par Pharmaceutical Holdings Pensa Dose Pensa Pharm Perrigo Company Pfenex Pfizer Pharma Dynamics Pharmacyclics Pharmstandard Pierre Fabre (Laboratoires Pierre Fabre) Piramal Enterprises Piramal Group PlantForm Corporation Pliva PMDA (Pharmaceuticals and Medical Devices Agency, Japan) Prasco Laboratories PregLem Probiomed Protalix Biotherapeutics Purdue Pharma Qilu Pharmaceutical Company Ranbaxy Laboratories Recordati Regeneron Pharmaceuticals RLS (Reliance Life Sciences) Roche Holding (F. Hoffmann-La Roche) Russian MoH (Ministry of Health) Samsung Bioepis Samsung BioLogics Samsung Group Sandoz International Sanofi Santen Pharmaceutical Company Sanwa Kagaku Kenkyusho Company Sartorius Stedim Biotech Sawai Pharmaceutical Company SEDICO (South Egypt Drug Industries Company) Seikagaku Corporation Sequent Scientific SFDA (Saudi Food and Drug Authority) Shanghai Celgen Biopharmaceutical Company Shanghai Fosun Pharmaceutical Group Shionogi & Company Shire SL Pharm (Beijing SL Pharmaceutical Company) Somar (Grupo Farmaceutico Somar) STADA Arzneimittel Stelis Biopharma Strativa Pharmaceuticals Strides Arcolab Sumitomo Dainippon Pharma Company Sun Pharma (Sun Pharmaceutical Industries) Supera Farma Laboratorios Suzuken Company Taisho Pharmaceutical Holdings Takeda Pharmaceutical Company Tanabe Seiyaku Hanbai Company Taro Pharmaceutical Industries Teijin Teijin Pharma Teva Pharmaceutical Industries Teva-Kowa Pharma Company The Medicines Company Tonghua Dongbao Pharmaceutical Company Torrent Group Torrent Pharmaceuticals 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) UCB United Therapeutics Corporation USV Valeant Pharmaceuticals International Varifarma Ventana Medical Systems Vertex Pharmaceuticals Walvax Biotechnology Company Warner-Chilcott West-Ward Pharmaceuticals WHO (World Health Organization) Wockhardt Xbrane Biopharma Yichang Chang Jiang Pharmaceutical Company Zentiva Zydus Cadila