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

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:


Abbott Laboratories


ABPI (Association of the British Pharmaceutical Industry)

Accord Healthcare

ACETO Corporation

Acino Holding



Adcock Ingram

Aesica Pharmaceuticals

AET (Alfred E Tiefenbacher) Group

AET BioTech (AET BioTechnology)

Agila Specialties

Ajinomoto Group

Akron Pharmaceuticals

Alexion Pharmaceuticals

Alfa Wasserman



AMA (African Medicines Regulatory Agency)

Amega Biotech


Amneal Pharmaceuticals

AMRI (Albany Molecular Research, Inc.)

ANVISA (Brazilian Health Surveillance Agency)




Arch Pharmalabs


ASKA Pharmaceutical Company

Aspen Holdings

Astellas Pharma


Aurobindo Pharma

Auxilium Pharmaceuticals



Baxter International


BD (Becton, Dickinson and Company)

BD Bioscience

Berlin Chemie

Bharat Biotech






Biogen Laboratorios


Biopartners Holdings




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 BioTec

Claris Injectables

Claris Lifesciences

Claris Otsuka

COFEPRIS (Federal Commission for the Protection against Sanitary Risks, Mexico)

Coherus BioSciences

Consort Medical


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


Eli Lilly and Company

Elmed Eisai Company

EMA (European Medicines Agency)

Emcure Pharmaceuticals

Endo International

Epirus Biopharmaceuticals




Eurofarma Laboratorios

Ferring Pharmaceuticals

Flamel Technologies


Fresenius Kabi

Fuji Pharma Company

Fujifilm Corporation

Fujifilm Holdings Corporation

Fujifilm Kyowa Kirin Biologics

Fujifilm Pharma




Gedeon Richter

Gene Techno Science



Gennova Biopharmaceuticals

Genor Biopharma

GGL (Glenmark Generics Limited)

Gilead Sciences

Glenmark Pharmaceuticals


Green Cross Corporation


Gruenenthal Group

GSK (GlaxoSmithKline)

Guangdong BeiKang Pharmaceutical Company

Hanmi Pharmaceutical Company

Hanwha Chemical Company

Health Canada

HEC Pharm


Helvetic BioPharma

Henlius Biopharmaceuticals


Hikma Pharmaceuticals

Hi-Tech Pharmacal

HMP (Harvest Moon Pharmaceuticals)





Impax Laboratories

Impax Pharmaceuticals

Intas Pharmaceuticals


Israeli MoH (Ministry of Health)


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


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





Maruho Company

Matrix Laboratories

MCC (Medicines Control Council, South Africa)


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


Natco Pharma

Nichi-Iko Pharmaceutical Company

Nippon Kayaku

Nippon Shinyaku

Nipro Pharma Corporation

Nobel Ilac

NORCB (National Organization for Research & Control of Biologics, Egypt)


Novo Nordisk


Ono Pharmaceutical Company

OPKP Health


Orygen Biotecnologia

Osaka Synthetic Chemical Laboratories

Otsuka Holdings Company

Paladin Labs

Par Pharmaceutical Holdings

Pensa Dose

Pensa Pharm

Perrigo Company



Pharma Dynamics



Pierre Fabre (Laboratoires Pierre Fabre)

Piramal Enterprises

Piramal Group

PlantForm Corporation


PMDA (Pharmaceuticals and Medical Devices Agency, Japan)

Prasco Laboratories



Protalix Biotherapeutics

Purdue Pharma

Qilu Pharmaceutical Company

Ranbaxy Laboratories


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


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


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 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)


United Therapeutics Corporation


Valeant Pharmaceuticals International


Ventana Medical Systems

Vertex Pharmaceuticals

Walvax Biotechnology Company


West-Ward Pharmaceuticals

WHO (World Health Organization)


Xbrane Biopharma

Yichang Chang Jiang Pharmaceutical Company


Zydus Cadila