Bispecific Antibody Therapeutics Contract Manufacturing Market Size, Share & Trends Analysis Report By Indication (Cancer, CNS Conditions), By Route of Administration, By End-use, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global bispecific antibody therapeutics contract manufacturing market size was estimated at USD 5.29 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 36.4% from 2023 to 2030. Increasing research and development activities pertaining to the discovery of novel therapeutics is one of the major factors supporting the growth of the market for bispecific antibody (bsAB) therapeutics contract manufacturing during the analysis period. The market has been booming for the past few years, and exponential growth is anticipated to be witnessed during the analysis timeframe. This is primarily due to the robust pipeline of bispecific antibodies expected to be launched during the forecast period.

Furthermore, the growing pipeline of anti-cancer therapeutics is another significant factor supporting the lucrative growth of the market. For instance, the U.S. FDA stated that as of 2022, more than 85% of bispecific antibodies in clinical trials are cancer therapeutics. Hence, the aforementioned factors are supporting the growth of the market. The Covid-19 pandemic has led to rapid demand for wide-ranging therapeutics and new antibodies that potently neutralize variants by targeting multiple sites of the protein. These virus-neutralizing antibodies play an important role in defense against SARS-CoV-2. The antibodies are specifically investigated as a therapeutic option for individuals with mild or severe infections.

For instance, in November 2021, Sanyou Biopharmaceuticals (Shanghai) Co., Ltd. and Shanghai ZJ Bio-Tech Co., Ltd. developed SYZJ001, a bispecific antibody drug against COVID-19. SYZJ001 is an innovative drug developed in China against COVID-19, which is also the leading bispecific antibody drug worldwide. In addition, post-pandemic, there was a growing demand for bispecific antibody therapeutics owing to great therapeutic potential in cancer and other diseases. Furthermore, numerous bispecific antibodies have entered early phase clinical development. Thus, this factor is expected to have a positive impact on market growth in the coming years. In addition, a growing pipeline of bispecific antibody therapeutics is expected to increase the opportunity for market growth.

According to BioPharm International, bispecific antibody therapeutics ideally have broad clinical applications in tumor immunotherapy, neurological disorders, targeted drug delivery, or infective diseases. In addition, a total of 273 bispecific molecules have entered the clinic since 2001. This bispecific antibody is creating emerging demand for the development pipeline in the next five to ten years. Likewise, growing interest in bispecific antibody research and increasing funding in immunotherapy, new clinical trials, and approval drives the market growth. For instance, the REGN5459, which is a bispecific antibody has gained a 90.5% response rate in patients with refractory or relapsed multiple myeloma, according to the results of a phase I/II clinical trial.

Furthermore, human trials for the bispecific antibody results were presented at the 2023 American Association for Cancer Research Annual Meeting. The REGN5459 new findings have led to U.S. FDA approval for the first bispecific antibody targeting BCMA & CD3 for patients with persistent multiple myeloma. Furthermore, according to Sino Biological as of 2022, the EMA and/or FDA has approved six bispecific antibodies (bsABs) for cancer immunotherapy including the first approved bsAB, Catumaxomab. Catumaxomab was withdrawn in 2017 from the European Union market and three bsABs were approved in 2022 for marketing. In addition, by the 2023-year end, marketing application submission of five bsABs in late-stage clinical studies may take place. Likewise, 600+bsABs are presently under investigation.

Indication Insights

In 2022, the cancer segment gained a major market share of 55.7%. Cancer is the leading cause of death worldwide. In addition, for cancer, various effective strategies are widely studied wherein bsABs are rapidly growing and expanding in the area of cancer immunotherapy. These bsABs have attracted strong interest attributing to strong clinical efficacy in cancer patients, catalyzing efforts to translate the bsAB into effective therapies. For instance, in June 2022, the European Commission granted Roche company’s CD20xCD3 T-cell binding bispecific antibody Lunsumio (mosunetuzumab) a conditional marketing authorization. It will be used for the treatment of patients with follicular lymphoma, relapsed or refractory, who had received prior two systemic therapies.

On the other hand, the autoinflammatory and autoimmune diseases segment is expected to witness a stable growth rate of 34.3% over the forecast period. Novel bsAB therapeutics are widely used owing to the potential of bsABs to significantly improve efficacy over treatment options. According to Global Autoimmune Institute, the current data estimates that autoimmune diseases affect at least 14 million people in the U.S. In addition, there are 80 to 100 known autoimmune-related conditions. Furthermore, approximately 80% of those diagnosed women have autoinflammatory and autoimmune diseases.

Route of Administration Insights

In 2022, the intravenous segment accounted for the largest share of 45.0% of the global market revenue. These therapeutics through IV support the immune system to attack and kill cancer cells more effectively. In addition, antibody drugs offer a promising treatment breakthrough for patients with certain types of cancer. Furthermore, according to the American Society of Hematology (ASH), bsAB therapy had a success rate for 73% of patients. The Phase I clinical trial had 232 patients enrolled at several cancer centers globally between January 2018 and November 2021.

The doses of the therapy were given to patients either intravenously or injected under their skin. The subcutaneous segment is anticipated to grow at the fastest CAGR of 36.8% during the forecast period. A significant response rate was observed in subcutaneously bsABs among patients with relapsed or refractory multiple myeloma. The rising adoption of the subcutaneous route of administration is likely to boost market growth over the estimated period. Therefore, these factors are favoring the growth of the segment.

End-use Insight

In terms of end-uses, the biopharmaceutical companies segment dominated the market with the largest revenue share of over 46.6% in 2022. Biopharmaceutical companies strive to increase the production of bsABs owing to the ongoing need for new and improved drugs. In addition, increasing clinical trials drive market growth. Furthermore, biopharmaceutical companies have emerging and potentially highly profitable areas of next-generation antibody products.

For instance, in March 2023, InvoX Pharma Limited announced that F-star, a subsidiary of invoX company announced the agreement with Takeda company for an immuno-oncology bsAB. On the other hand, pharmaceutical companies are expected to hold the second position in the global bsAB therapeutics contract manufacturing market. There is growing interest in investigating and investing in this immunotherapy. In addition, more than 85% of bsABs are in clinical trials for cancer therapeutics.

Regional Insight

North America dominated the market with the largest revenue share of 69.7% in 2022. Growth in the region can be attributed to the presence of a well-established market, the growing burden of cancer, and infectious diseases, leading to the emerging requirement for the market. The growing research activities, rising number of clinical trials, and investment drive regional growth. The U.S. is the largest market for bsAB therapeutics contract manufacturing due to rising clinical trial, research, and development activities.

Moreover, investments by companies are anticipated to increase the demand for the market in the region. Asia Pacific is likely to witness the fastest CAGR of 36.6% during the forecast period. Growth in the region is due to several factors, including the burden of cancer and the requirement for new drugs across countries, such as Japan and China. In addition, increased market demand and a rising number of partnerships and collaborations among companies are some of the factors expected to propel growth during the forecast period.

Key Companies & Market Share Insights

The major players in the global market are focused on the adoption of in-organic strategic initiatives, such as mergers, partnerships, and acquisitions. For instance, in June 2022, the European Commission granted Roche company’s CD20xCD3 T-cell binding bsAB Lunsumio (mosunetuzumab) a conditional marketing authorization. It will be used for the treatment of follicular lymphoma, relapsed or refractory, in patients who have received prior two systemic therapies. Some prominent players in the global bispecific antibody therapeutics contract manufacturing market are:

• Lonza

• Roche's

• Creative Biolabs

• AbbVie

• Amgen

• Janssen

• Johnson & Johnson

• IQVIA

• WuXi Biologics

• Sino Biological Inc.

Bispecific Antibody Therapeutics Contract Manufacturing Market Report Scope

Global Bispecific Antibody Therapeutics Contract Manufacturing Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the bispecific antibody therapeutics contract manufacturing market report based on indication, route of administration, end-use, and region:

• Indication Outlook (Revenue, USD Million, 2018 - 2030)

  • Cancer

  • Infectious Diseases

  • Autoinflammatory and Autoimmune Diseases

  • CNS Conditions

  • Others

• Route of Administration Outlook (Revenue, USD Million, 2018 - 2030)

  • Intravenous

  • Subcutaneous

  • Others

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Pharmaceutical Companies

  • Biopharmaceutical Companies

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • Rest of Europe

  • Asia Pacific

    • Japan

    • China

  • Rest of Asia Pacific

    • Rest of the World