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  • The growing use of biologics, drugs with newer mechanisms of action, and combination therapies are trending in the global rheumatoid arthritis (RA) market. BCC Research reveals in its new report that the biosimilars market should grow at a torrential five-year (2015-2020) compound annual growth rate (CAGR) of 71%. 

    Rheumatoid arthritis is a chronic inflammatory disease characterized by progressive joint damage, disability and systemic complications. The goal of treatment in RA is to achieve clinical remission. When remission, defined as the absence of signs and symptoms of inflammation, is unattainable, the target of treatment is to lower disease activity, particularly in patients with established RA. This report provides perspective on drugs and therapies used in the management of RA. 

    The global market for therapies for RA is expected to grow from USD 19.9 billion in 2015 to nearly USD 21.3 billion by 2020, reflecting a five-year CAGR of 1.3%.As a therapeutic class, anti-interleukin biologics should grow from nearly USD 1.2 billion in 2015 to USD 1.5 billion in 2020 on a five-year CAGR of 4.4%. Biosimilars as a therapeutic class should reach nearly USD 5.4 billion in 2020 on a five-year CAGR of 71.0%, up from an anticipated USD 368 million in 2015. 

    The market for RA treatments in the seven major markets (U.S., France, Italy, Germany, Spain, U.K., and Japan) is expected to reach USD 16.3 billion and USD 17.2 billion in 2015 and 2020, respectively, reflecting a five-year CAGR of approximately 1%. The genericization and introduction of biosimilars for major products such as etanercept, infliximab and rituximab will impact market growth. 


    The market in the rest of the world (RoW), including India and China, should total USD 3.6 billion and USD 4.1 billion in 2015 and 2020, respectively, growing at a five-year CAGR of about 2.5%. The introduction of cheaper biosimilars and Janus kinase inhibitors (JAKs) will drive market growth. 

    The biosimilars market will witness incredible growth both in the RoW and globally. Their robust adoption is expected in the seven major markets, where healthcare providers are pushing for more affordable options to the high cost of biologics therapy, particularly for chronic immunological diseases. 


    "Worldwide, the value of the biosimilars market will grow from about USD 174 million in 2014 to almost USD 5.4 billion in 2020 due to the introduction of biosimilars," says BCC Research analyst Geeta Ogra Bedi. "Presently, a growing number of biosimilars are in the late stage of clinical development. Although biosimilars don't promise the kind of cost savings generated by their small-molecule counterparts, they still possess the ability to yield significant cost savings."

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  • All animals begin life as a single cell from which arise the many different cell types, such as heart, lung, blood, etc., that are specific to that type of animal. However, once the process of cell differentiation has led to many different tissues, each organism has a new, opposite imperative – keeping new cells in each type of tissue the same as their brethren. Cancers arise in a tissue when a cell becomes different from its neighbors and thus represent a failure to maintain this critical uniformity. 

  • An episode of major depression can be crippling, impairing the ability to sleep, work, or eat. In severe cases, the mood disorder can lead to suicide. But the drugs available to treat depression, which can affect one in six Americans in their lifetime, can take weeks or even months to start working. 

  • In what is being called the first-ever test of open-source drug-discovery, researchers from around the world have successfully identified compounds to pursue in treating and preventing parasite-borne illnesses such as malaria as well as cancer. 

  • People living with HIV who naturally produce broadly neutralizing antibodies (bNAbs) that may help suppress the virus have different immunological profiles than people who do not, researchers report. While bNAbs cannot completely clear HIV infections in people who have already acquired the virus, many scientists believe a successful preventive HIV vaccine must induce bNAbs. The new findings indicate that bNAb production may be associated with specific variations in individual immune functions that may be triggered by unchecked HIV infection. Defining how to safely replicate these attributes in HIV-uninfected vaccine recipients may lead to better designed experimental vaccines to protect against HIV. The study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. 

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  • Shire plc  announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for SHP626 (volixibat) for an investigational treatment of adults who have nonalcoholic steatohepatitis (NASH) with liver fibrosis. Shire is developing SHP626 as a once daily, orally-administered inhibitor of the apical sodium dependent bile acid transporter (ASBT), a protein which is primarily responsible for recycling bile acids from the intestine to the liver. NASH is a serious, chronic liver disease for which there are currently no approved drugs. 

  • Pfizer Inc. announced top-line results from Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) Sustain, the third phase 3 study of Xeljanz (tofacitinib citrate) being investigated in patients with moderately to severely active ulcerative colitis (UC). OCTAVE Sustain is a 52 week study that evaluated oral tofacitinib 5 mg and 10 mg twice daily (BID) as a maintenance treatment in adult patients with moderately to severely active UC who previously completed and achieved clinical response in either the OCTAVE Induction 1 or OCTAVE Induction 2 studies. 

  • Caladrius Biosciences, Inc., a cell therapy company combining an industry-leading development and manufacturing services provider, PCT, with a select therapeutic development pipeline, announces that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of type 1 diabetes mellitus (TID), making it the first known therapeutic candidate for treatment of T1D to receive the designation. 

  • ADMA Biologics, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for RI-002, an Intravenous Immune Globulin (IVIG), for the treatment of patients with Primary Humoral Immunodeficiency Disease (PIDD). 

  • 1 August 2016
    Novotech looking for Senior/ Clinical Data Manager

    Headquartered in Australia and focused exclusively on the Asia Pacific, Novotech is internationally recognized as a leading regional CRO. With the increasing pace of globalisation in drug development, Novotech’s expertise in the vibrant and fast growing Asian region has been instrumental in the success of hundreds of phase I-IV clinical trials from Australia to India.
    Our highly experienced 140 strong staff based in 8 countries and 15 locations across the region provide access to patients from a population base of over 1.5 billion people. This breadth of reach, supported by the most sophisticated market data commercially available, enables us to conduct extremely thorough feasibility assessments for almost any study.

    Post: Senior/Clinical Data Manager

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