A biosimilar is a variant of biopharmaceutical which is marketed following the expiry of the original patent.
A biosimilar is a variant of biopharmaceutical which is marketed following the expiry of the original patent.
HUMIRA's primary patent expired in the United States on December 31, 2016, but the drug remained protected by additional patents until 2023. The last of these patents related to formulations and methods of use expired in 2023, which allowed for the introduction of biosimilars. Consequently, the availability of biosimilar versions of HUMIRA began in the U.S. in 2023.
Recent advancements in cancer treatment, including immunotherapy and targeted therapies, have undoubtedly brought about significant improvements in patient outcomes. However, it is important to address the impact of these advancements on the overall cost of cancer care and the measures being taken to ensure accessibility and affordability for patients. The introduction of innovative treatments like immunotherapy and targeted therapies has contributed to rising costs in cancer care. These therapies often involve extensive research and development, specialized manufacturing processes, and personalized treatment approaches, which can increase the overall cost of treatment. Additionally, the use of combination therapies and the need for long-term treatment maintenance can further escalate expenses. To ensure accessibility and affordability, various steps are being taken by researchers, healthcare professionals, and policymakers: Health Insurance Coverage: Efforts are being made to include these advanced treatments in health insurance coverage. Negotiations between insurance providers and pharmaceutical companies aim to establish reasonable reimbursement rates, making these therapies more accessible to a broader population. Clinical Trials and Research: Participation in clinical trials allows patients to access innovative treatments at reduced or no cost. Research organizations and pharmaceutical companies often sponsor clinical trials to evaluate the efficacy and safety of new treatments, providing opportunities for patients to benefit from these advancements without bearing the full financial burden. Cost-effectiveness Analysis: Health economic evaluations and cost-effectiveness analyses are conducted to assess the value of these therapies. By considering the clinical benefits, quality of life improvements, and long-term cost implications, policymakers can make informed decisions regarding reimbursement and pricing strategies. Expanded Access Programs: Expanded access or compassionate use programs enable patients who do not meet the eligibility criteria for clinical trials to access promising therapies. These programs aim to provide early access to treatments before they receive regulatory approval, ensuring that patients have more options, particularly when standard treatments have been exhausted. Price Negotiations: Governments and healthcare systems negotiate with pharmaceutical companies to establish fair and affordable prices for these treatments. These negotiations seek to strike a balance between encouraging innovation and ensuring access to patients who could benefit from these therapies. Generic and Biosimilar Drugs: Over time, as patents expire and generic or biosimilar versions of these therapies become available, the cost of treatment can decrease, improving affordability for patients. Increased competition in the market can drive down prices and make these treatments more accessible. Patient Assistance Programs: Pharmaceutical companies often provide patient assistance programs, which offer financial support, copayment assistance, or access to medications at reduced costs for eligible patients who might otherwise face financial barriers to treatment. Efforts are ongoing to strike a balance between the need for innovation and ensuring affordable access to these advancements in cancer treatment. Collaboration among stakeholders, policy interventions, and continued research into cost-effective therapies are vital to addressing the financial challenges and ensuring that patients can benefit from these transformative treatments without undue financial burden.
Bharat Book Bureau Provides the Trending Market Research Report on “Formulation Development Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2018-2028 Segmented by Service, By Formulation, By Therapeutic Area, By Region and Competition”under Life Sciences Market Research Report Category. The report offers a collection of superior Market research, Market analysis, competitive intelligence and Market reports. Formulation Development Outsourcing Market is anticipated to witness impressive growth during the forecast period. This can be ascribed to the growing demand for new drugs, patent expirations, and a focus on developing poorly water-soluble compounds to improve bioavailability. Also, the growing demand for overcoming the risk associated with development and growing demand for generics and biosimilar drugs is expected to create lucrative growth during the forecast period. Similarly, pharmaceutical organizations are increasingly focusing on their R&D activities to stay competitive and flexible, which is a major factor fueling the growth of the market over the years. In June 2021, Taylor France published a paper regarding the use of 3D printing for the formulation and development of personalized medicines. In March 2022, the United States Agency for International Development (USAID) announced USD 150 million in funding for drug development. Such initiatives are likely to benefit the market's growth. Cost savings Cost savings are one of the key drivers of the growth of the Global Formulation Development Outsourcing Market. Pharmaceutical companies are under pressure to reduce costs and improve efficiency, and outsourcing formulation development can help them achieve these goals in several ways. First, outsourcing formulation development allows pharmaceutical companies to avoid the capital expenditures associated with building and maintaining facilities and equipment, as well as the ongoing costs of staffing and training employees. Instead, companies can leverage the expertise and infrastructure of CDMOs (Contract Development and Manufacturing Organizations) to develop their drug formulations. Second, outsourcing formulation development can help pharmaceutical companies to reduce their overall development costs. By working with CDMOs that specialize in formulation development, companies can benefit from economies of scale, as well as the expertise of specialized professionals. This can result in reduced development costs and faster time-to-market. Third, outsourcing formulation development allows pharmaceutical companies to allocate their resources more effectively. By focusing on their core competencies, such as drug discovery, marketing, and sales, companies can free up resources to invest in other areas of their business. This can help companies to improve their competitive position and increase their profitability. Focus on core competencies. Core competencies are another key factor influencing the growth of the Global Formulation Development Outsourcing Market. Pharmaceutical companies are increasingly recognizing the importance of focusing on their core competencies to remain competitive and innovative. Outsourcing formulation development can help companies achieve this goal in several ways. First, outsourcing formulation development allows pharmaceutical companies to focus on their core competencies, such as drug discovery, marketing, and sales. By working with CDMOs (Contract Development and Manufacturing Organizations) that specialize in formulation development, companies can free up resources to invest in areas where they have a competitive advantage. This can help them to develop new drugs more quickly and efficiently and to bring them to market faster. Second, outsourcing formulation development allows pharmaceutical companies to access specialized expertise and facilities that they may not have in-house. Many CDMOs specialize in specific areas of formulation development, such as biologics, sterile products, or controlled substances. About Bharat Book Bureau: Bharat Book is Your One-Stop-Shop with an exhaustive coverage of 4,00,000 reports and insights that includes latest Market Study, Market Trends & Analysis, Forecasts Customized Intelligence, Newsletters and Online Databases. Overall a comprehensive coverage of major industries with a further segmentation of 100+ subsectors. Contact us at: Bharat Book Bureau Tel: +91 22 27810772 / 27810773
Bharat Book Bureau Provides the Trending Market Research Report on “Biosimilars Market by Drug Class, Indication, Region – Global Forecast to 2028”under Consumer Goods Market Research Report Category. The report offers a collection of superior Market research, Market analysis, competitive intelligence and Market reports. The global Biosimilars Market size is projected to reach USD 66.9 billion by 2028 from USD 29.4 billion in 2023, at a CAGR of 17.8% during the forecast period. Factors such as regulatory approvals, favorable reimbursement policies, rising demand for cost effective biosimilars is driving the market growth. “The monoclonal antibodies product segment accounted for the highest growth rate in the biosimilars market, by drug class, during the forecast period” In 2022, the monoclonal antibodies product segment accounted for the largest share of the biosimilars market, mainly due to the low prices of biosimilar monoclonal antibodies compared to the reference drugs and increased adoption of labs in the the treatment of cancer, autoimmune disorders, and osteoporosis. The growth of the fastest-growing segment was attributed to the rising incidence of cancer and chronic diseases globally. Increased approval for interchangeability insulin is likely to have positive impact on market. “Oncology segment accounted for the largest share of the indication segment in 2022.” Based on the indication, the biosimilars market is segmented into oncology, inflammatory and autoimmune diseases, chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, and other indications. Rising demand for cancer drugs, growth hormones across various regions is propelling the growth of the market. “Asia Pacific region is likely to grow at a faster pace.” The biosimilars market is segmented into Europe, Asia Pacific, North America, latin America and Middle East and Africa. The APAC market is expected to be the fastest-growing regional segment during the forecast period due to the presence of numerous emerging players, less-stringent government regulations, and increasing cooperation among leading and regional players for development, manufacturing and commercialization of biosimilars. The primary interviews conducted for this report can be categorized as follows: •By Respondent: Supply Side- 70%, and Demand Side - 30% •By Designation (Supply Side): Managers - 45%, CXOs & Directors - 30%, Executives- 25% •By Region: North America -40%, Europe -25%, Asia-Pacific -20%, Latin America -10%, and Middle East and Africa -5% Lists of Companies Profiled in the Report: §Novartis AG (Switzerland) §Pfizer Inc. (US) §Dr. Reddy’s Laboratories Ltd. (India) §F. Hoffmann-La Roche Ltd (Switzerland) §Eli Lilly & Company (US) §Amgen Inc. (US) §Teva Pharmaceutical Industries Ltd. (Israel) §Samsung Biologics (South Korea) §Fresenius SE & Co. KGaA (Germany) §Boehringer Ingelheim International GmbH. (Germany) §STADA Arzneimittel AG (Germany) §Coherus BioSciences (US) §FUJIFILM Kyova Kirin Biologics Co., Ltd. (Japan) §USV Limited (India), §Amneal Pharmaceuticals LLC. (US) §Celltrion Healthcare (South Korea) §Biocon (India) §Intas Pharmaceuticals Ltd. (India) §Reliance Life Sciences (India) §AMEGA Biotech (Argentina) §Apotex, Inc. (Canada) §BIOCAD (Russia) §mAbxience (Spain) §Probiomed (Mexico) §Kashiv BioSciences, LLC (US), §Formycon AG (Germany) §Polpharma Biologics Group (Poland) §Amphastar Pharmaceuticals, Inc. (US) §Alvotech (Iceland) §UCB SA, (Belgium) Research Coverage: This report provides a detailed picture of the biosimilars market. It aims at estimating the size and future growth potential of the market across different segments, such as drug class, indication and region. The report also includes an in-depth competitive analysis of the key market players, along with their company profiles, recent developments, and key market strategies. About Bharat Book Bureau: Bharat Book is Your One-Stop-Shop with an exhaustive coverage of 4,00,000 reports and insights that includes latest Market Study, Market Trends & Analysis, Forecasts Customized Intelligence, Newsletters and Online Databases. Overall a comprehensive coverage of major industries with a further segmentation of 100+ subsectors. Contact us at: Bharat Book Bureau Tel: +91 22 27810772 / 27810773 \