Therapeutic Antibodies

Therapeutic Antibodies product developments and trends

The Therapeutic Antibodies market has been witnessing an increasing demand over the years. The major factors that are boosting the growth of the market are increasing prevalence of autoimmune diseases, personalized medicine, and the growing popularity of monoclonal antibodies.

Monoclonal antibodies

Monoclonal therapeutic antibodies are an emerging class of therapeutics that has the potential to transform the treatment of many diseases. They have the ability to target specific antigens in tumor cells, which leads to inhibition of tumor growth and destruction of the diseased tissue. Since the US FDA approved therapeutic mAbs in 1986, the class of drugs has become a leading force in the world of biopharmaceuticals.

The therapeutic monoclonal antibody market is expected to reach $150 billion by the end of 2019. Antibodies are large molecules that form four peptide chains. They are bound together by interchain disulfide bonds. Amino acid composition, stability, and other intrinsic and external factors can affect their aggregation and pharmaceutical properties.

Recent advances in antibody research have led to the development of many new antibody formats and strategies. These include bispecific mAbs, immunomodulators, and CAR-T cells. New technological advancements are also being made to enhance ADCC.

Therapeutic antibodies have shown remarkable efficacy in the treatment of a number of cancers and chronic inflammatory diseases. As such, this class of drugs has a large potential for further development. Currently, 79 therapeutic mAbs have been approved by the US Food and Drug Administration.

The rapid growth of this class of medicines has been attributed to their effectiveness and high specificity. This allows them to be used for a wide variety of applications, and their use as a therapeutic tool has grown considerably. A major benefit of these molecules is their low adverse effects. In addition to their use as a therapeutic tool, the unique sequences of antibodies also make it possible to engineer them to be tailored for a broad range of uses.

Antibody engineering has progressed over the last three decades. Specifically, technologies such as the hybridoma technique, phage display, and strategic mutation technologies have greatly enhanced basic research and enabled the successful translation of mAbs into clinical trials. Increasingly, scientists have also focused on the use of transgenic animals, which provides a greater number of options for the development of mAb drugs.

The global therapeutic monoclonal antibody market is expected by 2025 to be worth around US$300 billion. As the market continues to grow, it is expected that the number of therapeutic mAbs in clinical use will increase significantly.

Personalized medicine

The therapeutic antibodies market has grown rapidly in the last few years. With the advent of a highly personalized medicine paradigm and precision medicine, the role of antibody-based therapies in addressing a number of medical conditions is becoming increasingly prominent.

Therapeutic antibodies are now used to treat a range of human diseases, including cancer and autoimmune disorders. The growth of this market is expected to continue, with the global therapeutic monoclonal antibody (MAb) drug market expected to reach US$115.2 billion in 2018.

Antibodies are an important component of the immune system, which helps neutralize and kill infected cells. In addition, they play a critical role in growth factor-induced signaling. Because of their high affinity, mAbs are widely used in the treatment of oncology, infectious, and autoimmune diseases.

The development of therapeutic antibodies has significantly improved in the past few decades, thanks to the invention of advanced antibody engineering techniques. These technologies include phage display, CAR-T cell technology, and bispecific mAbs. Using these methods, antibodies can be engineered to meet the needs of multiple medical conditions.

Phage display is a well-established in vitro screening methodology that allows the selection of affinity variants with a broad range of affinity. This process is facilitated by the fusion of the phage coat protein with library proteins. It incorporates diverse exogenous genes, allowing for the identification of specific phage binders.

While phage display has several advantages, it has a limited lifespan. As such, academic institutions are encouraged to develop phage-based antibodies in the future.

Over the last two decades, major technological advances have made antibody drug discovery faster and more effective. The emergence of fully human antibodies has further opened up opportunities for mAb therapies. By the end of 2018, eight of the top ten bestselling drugs on the market were biologics.

A key attribute of therapeutic antibodies is their high affinity, which is necessary for their ability to neutralize infected cells and to bind to their target. Additionally, antibody drugs are typically low in immunogenicity, meaning that they can be safely administered to patients.

As the need for more effective therapeutic agents grows, researchers are developing a new class of therapeutic biologics. These products are designed for specific populations, and do not require large-scale manufacturing operations. They offer the potential for a higher degree of clinical precision, with fewer side effects.

Growing prevalence of autoimmune disorders

Autoimmune disorders are diseases caused by a malfunctioning of the immune system. These disorders affect various organs. They can also cause weight loss, fatigue and dizziness. Many of these diseases can be controlled with organic medications. The causes of these diseases are still unknown. However, scientists believe that they are caused by environmental factors or hereditary factors.

Inflammation is a classic sign of autoimmune disorders. The immune system attacks healthy cells by mistake. Some of the common autoimmune diseases include: Type 1 Diabetes, Multiple Sclerosis, Psoriasis and Rheumatoid Arthritis.

Due to the increasing prevalence of autoimmune diseases, research and development in the field is on the rise. Government initiatives are also encouraging the emergence of new products. This is paving the way for profitable opportunities in the market.

Increased awareness of patients regarding autoimmune diseases is also expected to propel growth in the autoimmune disease diagnostics market. Growing healthcare expenditure is also expected to spur growth of the global market.

Several market players are investing in research and development programs. These companies are implementing mergers and acquisitions and are developing innovative products. Moreover, technological advancements in the medical field are providing lucrative opportunities for the autoimmune disease diagnostics market.

Asia Pacific is expected to lead the autoimmune disease diagnosis market in the coming years. Various government initiatives to strengthen the healthcare infrastructure in the region will boost the market. Moreover, the growing number of geriatric patients is also contributing to the market’s growth.

Europe registered the largest share in the autoimmune disease diagnosis market in 2014. It is also attributed to the increase in the awareness of autoimmune diseases among the patients. With the rising number of patients, there is an increasing demand for faster diagnostics.

In addition, the global autoimmune disease diagnosis market is propelled by the growing incidence of various autoimmune diseases and improved laboratory techniques. Furthermore, partnerships between physicians and clinical laboratories are also expected to provide substantial support to the market.

Key players operating in the autoimmune disease diagnosis market are Quest Diagnostics Incorporated, Bio-Rad Laboratories, Inc., Siemens Healthcare Private Limited, Exagen Inc. and Progentec Diagnostics, Inc.

Major fuelling factors for market growth

The global therapeutic monoclonal antibody (mAb) market was estimated to reach US$115.2 billion in 2018. This market is expected to witness significant growth at a CAGR of 13.2% during the forecast period.

The market is segmented by application, source, and geography. The application segment comprises autoimmune diseases, cancers, and other applications. By geography, the markets are divided into North America, Europe, Asia Pacific, and Latin America.

In the recent past, the therapeutic antibodies market has witnessed rapid growth. It has seen an increase in research funding, product approvals, and accelerated development of biotherapeutics. However, there are high risks associated with the development of monoclonal antibodies. Therefore, the market is likely to experience high challenges in the future. Nevertheless, the growing demand for biosimilars and improved health reimbursement policies will positively influence the market over the forecast period.

The global autoimmune diseases market is expected to grow due to the rising incidences of rheumatoid arthritis, inflammatory bowel disease, and other autoimmune disorders. The growing prevalence of chronic diseases is also expected to have an impact on the market. Moreover, the increased geriatric population and increased government expenditure on the treatment of chronic diseases are also expected to contribute towards the market.

Therapeutic antibodies are also anticipated to gain prominence in the future due to a rise in unmet needs in various countries. Antibody therapy is increasingly being used to treat a number of autoimmune conditions.

The humanized monoclonal antibody segment is poised to experience a significant surge in the future. Several companies have started humanizing the mAbs to improve the clinical efficacy and patient tolerance. Additionally, increased research funding and increasing number of therapies are expected to boost the market over the forecast period.

Chimeric mAbs also experienced a substantial growth in the past. Currently, chimeric mAbs are approved by regulatory authorities for various applications. Some of the chimeric mAbs that are currently in clinical use include: Obinutuzumab, nivolumab, durvalumab, and programmed death-ligand 1 (PD-1). These mAbs are highly effective in treating a wide range of autoimmune conditions.

Furthermore, the therapeutic monoclonal antibody therapy market has been fueled by the growing interest of pharmaceutical manufacturers in this lucrative market. Several major players in the industry are focusing on the research and development of monoclonal antibodies in order to expand their presence in the market.

Therapeutic antibodies are a big business. The FDA has approved more than 30 antibodies for marketing. This includes several blockbuster biopharmaceuticals. PatentPC assists clients in this industry to manage intellectual property issues and ensures they are able to navigate development hurdles while achieving ambitious financial goals.

Immunotherapy is one of the most promising ways to cure a variety of diseases, from autoimmune disorders to cancer. The IP landscape for therapeutic antibodies is highly competitive and complex. PatentPC’ legal team has the technical knowledge and legal expertise to protect patents, launch new products, and litigate disputes in any location.

These strategic issues are worth considering:

Freedom to Operate

Patents do not give the patent holder an affirmative right to use the patented technology. A patent only gives the right to prohibit others from using the technology. There is a possibility that companies could unwittingly violate a third-party patent by making, using, or selling patented technology. As innovators attempt to commercialize their proprietary antibody technologies, there have been a lot of third-party patents.

Management of Product Life Cycle

The breakthrough technologies that were developed more than a decade ago are responsible for many of the recent therapeutic antibodies. These technologies are no longer considered revolutionary, but they become more widespread and more accepted by the industry. This has made it more difficult to argue for the patentability of these products. This can be addressed by companies adopting a well-planned filing plan that seeks out to time the filing of new patent applications in a way that minimizes the threat posed to their prior patents while maximizing patent terms for potentially disruptive products. Innovators can still obtain patents for new inventions that are related to a valuable antibody product if they have a well-planned patent lifecycle management strategy.

Congress and courts are constantly changing the legal environment in which antibody patents can be obtained and enforced. Recent decisions of the U.S. Supreme Court could affect the patentability of recombinant antibody patents, as well as patent holders’ rights to license their technology or prohibit others from using it. PatentPC has skilled lawyers with industry experience and technical knowledge to assist innovators in therapeutic antibody industries.